ALR Technologies Inc. ("ALRT") (OTCQB: ALRT), the diabetes management company, is pleased to announce an update with respect to its migration to Singapore. Further to its Form 8-K filed May 20, 2022, and press release issued May 20, 2022, the Registration Statement on Form F-4 filed by its affiliate, ALR Technologies SG Ltd. ("ALRT Singapore"), has been declared effective by the Securities and Exchange Commission (the "SEC"). ALRT anticipates mailing the corresponding prospectus and information statement to its stockholders on or around October 4, 2022. ALRT expects to consummate the previously announced reincorporation merger in which ALRT will become a wholly owned subsidiary of ALRT Singapore as soon as practicable following the required 20-day waiting period subsequent to mailing of the prospectus and information statement, subject to the satisfaction of customary closing conditions, including certain regulatory approvals from FINRA, the OTC Markets Group, ACRA (Singapore), and the Secretaries of State of Nevada and Delaware.
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ALR Technologies Announces Reincorporation Merger
ALR Technologies Inc. ("ALRT USA") (OTCQB: ALRT), the diabetes management company, today announces that further to its release on June 1, 2021, ALRT USA has entered into an Agreement and Plan of Merger and Reorganization (the "Reincorporation Merger Agreement") with ALR Technologies SG Pte. Ltd., a Singapore company limited by shares ("ALRT Singapore"), and its wholly-owned subsidiary, ALRT Delaware, Inc., a Delaware corporation ("ALRT Delaware"), relating to a proposed merger transaction (the "Reincorporation Merger") for the purpose of changing the jurisdiction of incorporation of ALRT USA from Nevada to Singapore.
The Reincorporation Merger will consist of a one-for-one share exchange, where at closing of the transaction, ALRT Delaware will merge with and into ALRT USA, and ALRT USA will be the surviving entity and a wholly-owned subsidiary of ALRT Singapore. ALR Delaware will then cease to exist. At closing, the stockholders of ALRT USA will exchange their shares of common stock, and any options or warrants to purchase shares of common stock which they might hold, on a one-for-one basis, for ordinary shares ("ALRT Singapore Ordinary Shares") and options or warrants to subscribe for ALRT Singapore Ordinary Shares, as applicable. The shareholders of ALRT USA prior to the transaction will have the same number of shares and same proportionate ownership of ALRT Singapore as held in ALRT USA. The parties to the Reincorporation Merger expect that the ALRT Singapore Ordinary Shares will trade on the OTCQB subsequent to the close of the transaction.
The Reincorporation Merger Agreement has been approved by the board of directors of ALRT USA. The transaction has also been approved by the majority shareholders of ALRT USA, subject to dissemination to all shareholders of the Company, and a 20-day waiting period after dissemination, of an Information Statement explaining in detail the terms of the transaction to all shareholders of ALRT USA (the "Information Statement"). The Information Statement will also include a prospectus relating to the ALRT Singapore Ordinary Shares to be received by shareholders of ALRT USA (the "Prospectus"). The proposed forms of the Information Statement and Prospectus are included in a registration statement on Form F-4 to be filed by ALRT Singapore with the US Securities and Exchange Commission (the "SEC"), and completion of the transaction is subject to the effectiveness of the registration statement, and other customary closing conditions. To effect the Reincorporation Merger, the following related events have been approved by the Board of Directors and majority shareholders of ALRT USA:
- Solely for the purpose of facilitating the merger, and to meet requirements of Singapore Law, ALRT USA has transferred its ownership of its existing subsidiary, ALRT Singapore, to an entity controlled by Sidney Chan.
- ALRT Singapore has incorporated ALRT Delaware as a new subsidiary, also for the express purpose of facilitating the Reincorporation Merger.
- ALRT USA, ALRT Singapore, and ALRT Delaware have entered into the Reincorporation Merger Agreement.
"The Reincorporation Merger Agreement is necessary to complete our corporate migration to Singapore," said Sidney Chan, Chairman and CEO of ALR Technologies. "Singapore has established itself as a business epicenter and redomiciling ALRT to Singapore will better position the Company to achieve a stronger global presence. Over the last 7 years, the Company has increased its presence in Singapore and Southeast Asia in response to their publicized commitments to battle the plague of diabetes. We are working with Diabetes Singapore and Singapore General Hospital with respect to human health initiatives. Furthermore, better access to businesses and skilled personnel in Singapore and neighboring countries are key drivers for the migration, and we believe we will be better positioned to receive government support as a Singapore domiciled enterprise."
To effect the Reincorporation Merger Agreement and to close the transaction, the parties to the transaction will require clearance from the SEC, regulatory approvals from FINRA, the OTC Markets Group, ACRA (Singapore), Secretary of State of Nevada, and Secretary of State of Delaware. Upon effectiveness of the registration statement from the SEC, ALRT USA intends to disseminate the final form of Information Statement and Prospectus to all of its shareholders, and to close the Reincorporation Merger after completing the required 20 day waiting period after dissemination.
As previously announced, ALRT USA and ALRT Singapore continue to evaluate listing possibilities on additional or alternative share trading exchanges, including the NYSE American Exchange, and intends to apply for listing when and if qualified.
About ALR Technologies Inc.
ALRT USA is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division of ALRT USA has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
On June 1, 2021, ALRT USA announced its intention to migrate to Singapore. More information about the company can be found at www.alrt.com. Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com.
Contact
Ken Robulak (US)
Phone: +1 (727) 736-3838
Anthony Ngai (Singapore)
Phone: +65 3129 2924
Email: ir@alrt.com
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the annual report on Form 10-K and other filings of ALRT USA with the SEC. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The forward-looking statements included in this news release are made as of the date hereof. ALRT USA disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
ALR Technologies Announces Update to Singapore Migration Merger and GluCurve Pet CGM Commercialization
ALRT further announces the proposed distribution agreement between ALRT Singapore and a leading animal health company for the commercialization of the GluCurve Pet CGM previously anticipated in September is now expected to be completed in the fourth quarter of 2022.
"We have a very strong relationship with both our hardware manufacturer and the leading animal health company we're working with on a distribution agreement for the GluCurve. After much discussion and consideration, we have decided to push back the commercialization date to later in Q4," explained Joe Stern, Head of Animal Health at ALRT and ALR Singapore. "The GluCurve production line is up and running, but our manufacturer has experienced delays before final testing can occur and our completed distribution agreement can be signed. During this time, we will continue to work closely with our planned partner on marketing content, strategy, and execution of the launch."
Mr. Stern concludes, "We believe this extra time will contribute to a stronger and more successful launch in the coming months. We have universally received fantastic feedback on both the product and its need in the marketplace, and we look forward to providing more updates in the near future."
About the GluCurve Pet CGM
The GluCurve Pet CGM is a Continuous Glucose Monitoring System for diabetic cats and dogs, consisting of an Applicator, Sensor, Transmitter, GluCurve App, and Veterinary Web Portal.
The Sensor is located inside the Applicator and once applied to a pet, the Sensor Electrode chemically reacts with glucose in the hypodermic interstitial fluid to generate an electrical signal. The electrical signal is analyzed to generates blood glucose values, which are sent to the GluCurve App where it is displayed for the pet owner and uploaded to the Veterinary Web Portal.
The GluCurve Pet CGM measures glucose levels every 3 minutes for a total of 480 readings each day, for up to 14 days. The monitor is equipped with built in memory that can store all 14 days of data to prevent the loss of readings when the pet owner is away from their pet. In addition, insulin injections and feeding times can be input into the GluCurve App which uploads the data to the Veterinary Web Portal. Inside the Veterinary Web Portal, glucose readings are organized into time saving graphs and tables with additional features such as glucose curve comparisons and overlays, insulin dose calculators, best practice guidelines, and more.
About ALR Technologies Inc.
ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes.
In addition, the animal health division of ALRT has developed the GluCurve Pet CGM, a solution to assist veterinarians better determine the efficacy of insulin treatments and to help to identify the appropriate dose and frequency of administration for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
More information about ALRT can be found at www.alrt.com .
About ALR Technologies SG Ltd.
ALRT Singapore is an affiliate of ALRT and is seeking to commercialize the GluCurve Pet CGM. More Information regarding ALRT Singapore can be found at https://sg.alrt.com .
Cautionary Statement Regarding Forward-Looking Statements
Regarding ALRT Singapore
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the Registration Statement on Form F-4 filed by ALRT Singapore with the SEC on September 15, 2022, other risks and uncertainties listed from time to time in documents filed with the SEC, and the following factors: ALRT Singapore's operation as a development-stage company with limited operating history and a history of operating losses; the need for substantial additional funding to continue the development of ALRT Singapore's product candidates before it can expect to become profitable from sales of its products and the possibility that it may be unable to raise additional capital when needed; the outcome of ALRT Singapore's review of strategic options and of any action that it may pursue as a result of such review; the chance that ALRT Singapore may become exposed to costly and damaging liability claims resulting from the testing of its product candidates in the clinic or in the commercial stage; the chance that ALRT Singapore's clinical trials may not be completed on schedule, or at all, as a result of factors such as delayed enrollment or the identification of adverse effects; uncertainty surrounding whether any of ALRT Singapore's product candidates will receive the regulatory approval necessary for commercialization; if ALRT Singapore's product candidates obtain regulatory approval, its product candidates being subject to expensive, ongoing obligations and continued regulatory overview; enacted and future legislation may increase the difficulty and cost for ALRT Singapore to obtain marketing approval and commercialization; dependence on governmental authorities and health insurers establishing adequate reimbursement levels and pricing policies; ALRT Singapore's products may not gain market acceptance, in which case ALRT Singapore may not be able to generate product revenues; ALRT Singapore's reliance on its current strategic relationships and the potential success or failure of strategic relationships, joint ventures or mergers and acquisitions transactions; ALRT Singapore's reliance on third parties to conduct its non-clinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; ALRT Singapore's ability to obtain, maintain and protect its intellectual property rights and operate its business without infringing or otherwise violating the intellectual property rights of others; ALRT Singapore's ability to comply with the requirements under applicable loan facilities, including repayment of amounts currently outstanding and overdue, and amounts outstanding when due; ALRT Singapore's ability to qualify for quotation and remain on the OTCQB as a trading market for its common stock; the chance that certain intangible assets related to ALRT Singapore's product candidates will be impaired; the occurrence of any event, change or other circumstances that could give rise to the right of ALRT Singapore or ALRT to terminate the merger agreement; the outcome of any legal proceedings that may be instituted against ALRT Singapore or ALRT; the failure to satisfy any of the remaining conditions to the closing of or otherwise consummate the reincorporation merger on a timely basis or at all; the possibility that the anticipated benefits of the reincorporation merger are not realized when expected or at all, including as a result of the impact of, or problems arising as a result of the strength of the economy and competitive factors in the areas where ALRT Singapore and ALRT do business; the possibility that the reincorporation merger may be more expensive to complete than anticipated, including as a result of unexpected factors or events; diversion of management's attention from ongoing business operations and opportunities; potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the reincorporation merger. ALRT Singapore can give no assurance that any goal or plan or expectation set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements. The forward-looking statements are made as of the date of this communication, and ALRT Singapore does not intend, and assumes no obligation, to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events or circumstances, except as required by applicable law.
Regarding ALRT
With respect to ALRT, stockholders are cautioned that any forward-looking statements that relate to time periods before the closing of the reincorporation merger, as identified through the use of words or phrases as noted above, including statements regarding the expected timing of the closing of the reincorporation merger, are subject to risks, assumptions and uncertainties that are difficult to predict. Although ALRT believes that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements. Such factors include, without limitation, the "Risk Factors" referenced in ALRT's definitive information statement related to the reincorporation merger and filed with the SEC on September 29, 2022, and its other SEC filings, including its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and the following factors: the occurrence of any event, change or other circumstances that could give rise to the right of ALRT Singapore or ALRT to terminate the merger agreement; the outcome of any legal proceedings that may be instituted against ALRT Singapore or ALRT; and the failure to satisfy any of the remaining conditions to the closing of the reincorporation merger on a timely basis or at all. The forward-looking statements are made as of the date of this communication, and ALRT does not intend, and assumes no obligation, to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events or circumstances, except as required by applicable law.
Important Additional Information
This news release is being made in respect of the pending reincorporation merger involving ALRT and ALRT Singapore. As described above, in connection with the pending reincorporation merger ALRT Singapore filed with the SEC a Registration Statement on Form F-4, which has been declared effective by the SEC (the "Registration Statement"), which included a preliminary information statement of ALRT and a prospectus of ALRT Singapore (the "Information Statement/Prospectus"). It is anticipated that the definitive Information Statement/Prospectus will be mailed or otherwise delivered to the stockholders of ALRT on or about October 4, 2022. Stockholders are urged to read the Registration Statement and Information Statement/Prospectus and any other relevant documents filed with the SEC, as well as any amendments or supplements to those documents, because they will contain important information.
This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
Stockholders are able to obtain a free copy of the Registration Statement and Information Statement/Prospectus, as well as other filings containing information about ALRT and ALRT Singapore, without charge, at the SEC's website (https://www.sec.gov). Copies of the Registration Statement and Information Statement/Prospectus and the filings with the SEC incorporated by reference therein can also be obtained, without charge, by directing a request to ALR Technologies Inc., 7400 Beaufont Springs Drive, Suite 300, Richmond, Virginia 23225, Attention: Corporate Secretary.
Contact Information
ALR Technologies Inc.
Investor Contact
Email Investor Relations: ir@alrt.com
Email Animal Health Inquiries: animalhealth@alrt.com
Phone US: +1 804 554 3500
Phone Singapore: +65 3129 2924
ALR Technologies SG Ltd.
Investor Contact
Email Investor Relations: ir@alrt.com
Email Animal Health Inquiries: animalhealth@alrt.com
Phone US: +1 804 554 3500
Phone Singapore: +65 3129 2924
News Provided by GlobeNewswire via QuoteMedia
ALR Technologies Announces Update on the GluCurve Pet CGM Distribution and Commercialization
ALR Technologies SG Pte. Ltd ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, announces a distribution agreement with a global leader in animal health is now anticipated to be complete in September. The delay from the previous target of late August is not expected to affect commencement of commercialization. Furthermore, the Company has placed its first Purchase Order ("PO") for the GluCurve Pet CGM hardware with delivery scheduled for October.
"Finalizing a distribution partnership is taking longer than initially projected, but we believe we'll have it completed soon. Consequently, we have placed our first PO to ensure we begin selling in October," commented Joe Stern, Head of Animal Health at ALRT. "We are very happy with how things are progressing, we are in the process of securing booths at the Consumer Electronics Show which is the most influential tech event in the world, and the Veterinary Meeting & Expo (VMX) which is the largest veterinary conference in the world. We have also been identifying KOLs to work with on publications, case studies, testimonials, etc. to lay the foundation for our marketing plan. We want to thank our shareholders for their patience, and we look forward to sharing more details in the near future."
About the GluCurve Pet CGM
The GluCurve Pet CGM is a Continuous Glucose Monitoring Systems for diabetic cats and dogs, consisting of an Applicator, Sensor, Transmitter, GluCurve App, and Veterinary Web Portal.
The Sensor is located inside the Applicator and once applied to a pet, the Sensor Electrode chemically reacts with glucose in the hypodermic interstitial fluid to generate an electrical signal. The electrical signal is analyzed to generates blood glucose values, which are sent to the GluCurve App where it is displayed for the pet owner and uploaded to the Veterinary Web Portal.
The GluCurve Pet CGM measures glucose levels every 3 minutes for a total of 480 readings each day, for up to 14 days. The monitor is equipped with built in memory that can store all 14 days of data to prevent the loss of readings when the pet owner is away from their pet. In addition, insulin injections and feeding times can be inputted into the GluCurve App which uploads the data to the Veterinary Web Portal. Inside the Veterinary Web portal, glucose readings are organized into time saving graphs and tables with additional features such as glucose curve comparisons and overlays, insulin dose calculators, best practice guidelines, and more.
ALR Technologies SG Pte. Ltd.
ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTCQB under the symbol "ALRT". On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company's jurisdiction of incorporation from Nevada to Singapore (the "Redomicile Merger Agreement"). The Redomicile Merger Agreement is subject to the required approval of the Company's stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed early in the fourth quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.
More information about the ALR Technologies Inc. can be found at www.alrt.com . Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Email Investor Relations: ir@alrt.com
Email Animal Health Inquiries: animalhealth@alrt.com
Phone (US): +1 804 554 3500
Phone (Singapore): +65 3129 2924
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the annual report on Form 10-K and other filings of ALRT with the SEC. Forward-looking statements include, but are not limited to, representations to the effect that the Company will finalize the distribution agreement, if finalized that the delay will not impact the commercialization schedule, the Company will have supply of the CGM hardware from its supplier and the Redomicile Merger will close early in the fourth quarter of 2022.There can be no assurance that such statements included within this news release will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The forward-looking statements included in this news release are made as of the date hereof. ALRT disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
News Provided by GlobeNewswire via QuoteMedia
ALR Technologies Announces First Shipment of GluCurve Pet CGMs Expected in October and Update on the Manufacturing Agreement
ALR Technologies SG Pte. Ltd ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, announces the Company has received manufacturing approval from Infinovo Medical Co., Ltd. ("Infinovo") to place the first purchase order ("PO") for the GluCurve Pet CGM with an expected delivery date of October 2022. Furthermore, the manufacturing and supply agreement with Infinovo was subject to certain closing conditions, including entering into a binding sales and distribution agreement for the GluCurve Pet CGM by July 31, 2022. Both parties agreed to let that agreement terminate and are now working on completing a new agreement under the same terms, extending the closing condition for ALRT to enter into a binding sales and distribution agreement for GluCurve to August 31, 2022.
"We have agreed in principle on the key terms for a global sales and distribution agreement with a leading animal health company," commented Joe Stern, Head of Animal Health at ALRT. "The last step in their due diligence process is to evaluate the GluCurve Pet CGM internally by using it on their own sample of customers and their respective pets. This step is taking longer than we initially projected due to scheduling delays. After discussing the delays with Infinovo we agreed it would be in both parties' best interest to complete a new contract extending the date of the closing condition for a sales and distribution agreement date to August 31, 2022. Based on our non-inferiority study results earlier this year, we do not expect this delay to alter our commercialization schedule and will provide further updates on timing and details of the initial launch upon the execution of the global sales and distribution agreement."
The GluCurve Pet CGM is the first and only continuous glucose monitoring system for diabetic cats and dogs. Veterinarians can quickly apply the monitor onto pets before sending them home where glucose levels are remotely recorded every 3 minutes and securely uploaded to the ALRT cloud. In the cloud, the data is analyzed and organized into time saving graphs and tables that are displayed in the veterinarian's patient management portal along with additional features such as glucose curve comparisons and overlays, insulin dose calculators, best practice guidelines, and more. The pet owner will also have access to live time glucose readings and graphs through the GluCurve app for iOS and Android.
ALRT is pleased to announce an updated investors presentation has been uploaded to the investor relations section of their website and can be viewed at https://www.alrt.com/investors .
ALR Technologies SG Pte. Ltd.
ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTC:QB under the symbol "ALRT". On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company's jurisdiction of incorporation from Nevada to Singapore (the "Redomicile Merger Agreement"). The Redomicile Merger Agreement is subject to the required approval of the Company's stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed during the third quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.
More information about ALR Technologies Inc. can be found at www.alrt.com . Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Email Investor Relations: ir@alrt.com
Email Animal Health Inquiries: animalhealth@alrt.com
Phone (US): +1 804 554 3500
Phone (Singapore): +65 3129 2924
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the annual report on Form 10-K and other filings of ALRT with the SEC. There can be no assurance that such statements included within this news release will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Specifically, there is no assurance the Company will enter into a new manufacturing agreement with Infinovo, enter into a global sales and distribution agreement with a leading animal health company, or that such sales and distribution agreement will be executed in time to meet the closing conditions for the Manufacturing and Supply Agreement with Infinovo The forward-looking statements included in this news release are made as of the date hereof. ALRT disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
News Provided by GlobeNewswire via QuoteMedia
ALR Technologies Completes Definitive Manufacturing Agreement with Infinovo Medical for the GluCurve Pet CGM Hardware
ALR Technologies SG Pte. Ltd ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, announces the completion of a definitive manufacturing agreement with Infinovo Medical Co. Ltd ("Infinovo") to manufacture and supply the Continuous Glucose Monitor ("CGM") hardware that will be utilized as part of the ALRT GluCurve Pet CGM (the "Manufacturing Agreement"). The Manufacturing Agreement gives ALRT the exclusive global rights to distribute the Infinovo CGM hardware for the animal health market, providing long-term production and supply. Subject to the satisfaction of all closing conditions it is expected that initial deliveries of product by Infinovo will be made during Q4 of 2022
"Executing the Manufacturing Agreement with Infinovo marks another major milestone in our path to commercialization and profitability," comments Sidney Chan, Chairman and CEO of ALRT. "Our next targeted milestone is securing distribution for the ALRT GluCurve Pet CGM. We have been working with many of the largest global distributors and pharmaceutical companies in animal health, evaluating different distribution opportunities ranging from joint venture partnerships to sales and distribution agreements. We believe we have narrowed in on the right company and right deal structure to best bring value to our shareholders and to those who care for diabetic pets. We hope to announce the details of this pivotal next step in the near future."
The Manufacturing Agreement is subject to certain closing conditions including the completion of a distribution agreement with a third party by July 31, 2022.
About Infinovo Medical Co. Ltd
Founded in 2016, Infinovo is an innovative medical technology company, focusing on developing an accurate and affordable CGM for patients which will be available for both Type 1 and Type 2 Diabetics. https://www.infinovo.com/
ALR Technologies SG Pte. Ltd.
ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTC:QB under the symbol "ALRT". On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company's jurisdiction of incorporation from Nevada to Singapore (the "Redomicile Merger Agreement"). The Redomicile Merger Agreement is subject to the required approval of the Company's stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed during the third quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.
More information about the ALR Technologies Inc. can be found at www.alrt.com. Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Ken Robulak (US)
Phone: +1 (727) 736-3838
Anthony Ngai (Singapore)
Phone: +65 3129 2924
Email: ir@alrt.com
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the annual report on Form 10-K and other filings of ALRT with the SEC. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements include representations to the effect that the Company will receive initial deliveries of product from Infinovo in Q4 2022 and that the Redomicile Merger will close in Q3 2022. The forward-looking statements included in this news release are made as of the date hereof. ALRT disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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ALR Technologies Announces Completion of Pivotal Non-Inferiority Study on the GluCurve Pet CGM
ALR Technologies Inc. ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, today announced successful results from the conclusion of the non-inferiority study conducted on the GluCurve Pet CGM which was previously announced on February 10, 2022 and February 28, 2022. GluCurve is the first of its kind Continuous Glucose Monitor (CGM) specifically for diabetic cats and dogs.
Notable findings from the study:
- Utilizing a chemistry analyzer as the baseline, the GluCurve Pet CGM was more accurate than the leading Blood Glucose Meter (BGM) for animals 47.8% of the time.
- 100% of the GluCurve Pet CGM readings paired to the chemistry analyzer reference values were within ±20%, compared to 86.9% from the animal BGM
- The GluCurve Pet CGM's average deviation from the baseline was 9.7% compared to 8.2% from the animal BGM.
- No clinically significant differences were found when comparing the GluCurve Pet CGM to the chemistry analyzer or leading animal BGM.
- GluCurve displayed otherwise unavailable data on insulin injection times, eating habits, activity, and stress seen through changes in glucose on a day-to-day basis.
Dr. Imperato, lead veterinarian in the study commented, "The GluCurve Pet CGM plugs a long-standing gap in managing veterinary diabetic patients; not only will veterinarians finally receive effortlessly accurate data, the patients will live longer too."
"The non-inferiority study further demonstrates the significant need for GluCurve in veterinary medicine. The in-home data collected is invaluable to veterinarians and by analyzing and organizing it into effective patient management it greatly reduces the effort and time needed by clinicians to treat diabetic pets," said Sidney Chan, Chairman and CEO of ALR Technologies. "Now that we have the successful results of the non-inferiority study, a MOU for manufacturing with a definitive agreement in the works, and conducted preliminary discussions with the leading animal health pharmaceutical companies, we are well positioned to start realizing the full potentials of ALRT. We will now focus our attention on completing a partnership agreement in the near future to commercially launch GluCurve Pet CGM in a meaningful way in Q3 2022."
About ALR Technologies
ALR Technologies is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes: an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices; a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and will expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals. Thus, delivering the same optimization of diabetic drug therapies to pets as to humans.
On June 1, 2021, ALR Technologies Inc. announced its intention to migrate to Singapore. More information about ALR Technologies Inc. can be found at www.alrt.com. Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Ken Robulak (US)
Phone: +1 (727) 736-3838
Anthony Ngai (Singapore)
Phone: +65 3129 2924
Email: ir@alrt.com
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events or the negative of these terms are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Specifically, that the Company will enter into partnership to launch GluCurve Pet CGM, that GluCurve Pet CGM will launch in Q3 2022 or thereafter. The forward-looking statements included in this news release are made as of the date hereof. ALR Technologies disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
News Provided by GlobeNewswire via QuoteMedia
Zero Candida Announces Full Transaction and Being Trading November 25th on the TSX Venture Exchange (Canada)
Zero Candida (the "Company" or "ZCT"), (TSXV: ZCT) an Israeli FemTech medical device start-up, is pleased to announce full Transaction and Being Trading on November 25th on the TSX Venture Exchange (Canada) symbol : ZCT.
Zero-Candida technology (ZCT) is FemTech developing an AI smart tampon-like device based on therapeutic light source with a selected wave-length and intensity that can treat the Candida fungus successfully of 99.999% an POC overnight. Vulvo-Vaginal Candidiasis ("VVC") affects about 75% of women globally, ZCT device is a Game changer that has the potential to change the treatment of women and the FemTech industry in the world. The first of its kind of technology using a controlled "Blue Light," destroys the vagina fungus at record speed and without side effects. The treatment is Safety & carried out by a tampon-like medical device which, according to medical experts, provides an optimal solution for removing the fungus altogether and preventing the recurrence of the disease.
Zero Candida is working on creating a technology to enable the hybrid medicine services to be provided by gynecologists to populations that until now received no treatment at all, including, among others, in the developing countries. The ZCT device is Collect and transmits treatment data to the attending physician in real time, for assessment, treatment personalization and monitoring. Seamless data transfer through Wi-fi chip and VoIP, allows for the convenience of remote care and treatment consulting. Another significant advantage of the Zero Candida device is treatment without side effects, supporting growing demand from women to improve their health without the use of chemicals.
Eli Ben Haroosh, Founder & CEO: "Today, is a great day for the FemTech industry and women's treatments around the world, our new technology will be a game changer in the field of women's health. The company is advancing in its research with the hope of involving hospitals and academic institutions around the world. Our company's vision is to complete a pre-clinical study by 6/2025 and submit it to the FDA."
The company continues to develop a final prototype for human use and will complete it by Q1 2025. "Zero Candida has a potential to become a technological leader and use its ground-breaking technology to expand boundaries of non-chemical candida treatment," added Ben Haroosh.
Summary of Transaction
Pursuant to the business combination agreement (the "Agreement") between a Canadian reporting issuer (the "Reporting Issuer") and the Company, the transaction is expected to be contemplated by a three-cornered amalgamation, where the Reporting Issuer's wholly owned Israeli subsidiary incorporated solely for the purpose of the transaction, is expected to amalgamate with ZC. Each holder (each a " ZC Shareholder") of ZC Share, other than a ZC Shareholder who exercised Dissent Rights (as defined in the Israeli Companies Law) is expected to receive 8.6277 eight and six thousand two hundred seventy seven ten-thousandths) shares in the capital of the Reporting Issuer (each a "Resulting Issuer Share") in exchange for each ZC Share held by such ZC Shareholder, resulting in the Company issuing up to an aggregate of 12,223,232 Resulting Issuer's Shares (which will represent approximately 85.94% of the issued and outstanding Resulting Issuer Shares, without taking into consideration any ZC share purchase warrants to be exercised immediately prior to completion of the Transaction, stock options or a concurrent financing). Additionally, the holders of stock options of ZC will be entitled to receive Resulting Issuer Shares, instead of ZC Shares, on the exercise of their options.
About Zero Candida:
ZC is a private FemTech technology company incorporated under the corporate laws of the State of Israel. ZC is developing an AI smart tampon-like device based on AI on a therapeutic light source with a selected wave-length and intensity that can treat the Candida fungus successfully of 99.999% an POC. Vulvo-Vaginal Candidiasis ("VVC") affects about 75% of women globally, each year 138 million women are affected world-wide and 492 million over their lifetime. Recurrent VVC (4 or more episodes per year) is increasingly documented to become drug resistant to existing treatments and constitutes up to 10% of the cases of VVC. Existing treatments are unable to overcome the high rate of recurrence, since the root cause of the condition is poorly understood and addressed.
ZC has signed pre-clinical agreements with hospitals in Israel and Europe and the company has successfully completed a safety trial for the use of a pre-clinical device in large animals (sheep) ZC continues the development of the final product for human use in preparation for a clinical trial that will take place in June 2025.
Zero Candida's device will bring the field of gynecology into the 21st century with hybrid medicine and technology-based diagnostics. At the same time as developing the treatment procedure, Zero Candida is working on creating a technology to enable the hybrid medicine services to be provided by gynecologists to populations that until now received no treatment at all, including, among others, in the developing countries.
Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward-Looking Statements
This news release includes certain statements and information that constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, are forward-looking statements. The Company provides no assurance that forward-looking statements and information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements or information. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company does not undertake to update any forward-looking statements, other than as required by law. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by Zero Candida. Readers are cautioned not to place undue reliance on forward-looking statements.
Logo - https://mma.prnewswire.com/media/2420533/4723164/ZERO_CANDIDA_Logo.jpg
Contact:
Eli Ben Haroosh, CEO & Founder
E: info@zero-candida.com
Website: www.Zero-Candida.com
Facebook: @Zero-candida
Healing People and Planet: 3 Things You Need to Know About This Shared Innovation Challenge
By Ken Washington, Chief Technology and Innovation Officer, and Raman Venkatesh, Chief Sustainability Officer, Medtronic
When you think about healthcare technology, you may imagine the pacemaker assisting your dad's ailing heart, the sutures your child received after a bike accident, or the pulse oximeter placed on your finger during your annual physical exam. You probably don't think about the energy or resources required to manufacture those products, nor the resulting emissions and waste.
Most discussions about healthcare are, understandably and rightfully, centered on its ability to restore health and save lives; rarely do we talk about its environmental impact. Yet, the healthcare sector is responsible for approximately 4.6% of global greenhouse gas emissions-the equivalent of 514 coal-fired power plants annually, with medical devices and technology among the drivers. And in the U.S., healthcare is the second largest contributor to landfill waste.
It's time to get real about the reality that human health is linked to the health of the planet. We can't be committed to one without also being committed to the other.
The same force that revolutionizes patient care holds the key to creating a more sustainable industry: innovation. Both of us have seen how approaching innovation, with a deliberate focus on sustainability, is better for people, the planet, and profits. Consider the automotive industry where many innovations have made electric vehicles more enjoyable to own and drive, while also providing a cleaner transportation solution. And healthcare, where virtual visits that arose as a necessity during the pandemic, are showing a positive impact on the environment, while also making care more convenient and accessible.
So, how else can health tech make health better for you and the planet? Here are three not-so-simple ways:
Recognize good things take time
We know developing new healthcare technology requires patience and a substantial initial investment before we see long-term success. We need to apply this same mindset to sustainable technology.
Some companies stick with existing solutions because new sustainable technologies are expensive or aren't ready for wide-scale adoption. That's why pilot projects are crucial stepping stones to broader implementation by giving sustainable technology the time it needs to mature and prove its effectiveness. Successful pilot projects often inspire a scalable roadmap for long-term cost efficiency.
At the same time, we need to balance short-term financial pressures with long-term environmental goals. That means adopting a future-oriented view, recognizing today's technology will only get better and become more accessible and affordable over time.
For example, innovations in solar panels over the past decade have made them significantly more cost-effective as a sustainable energy source. This has allowed Medtronic to install 22 solar arrays across 16 locations, generating more than 35 MWs of power-enough to power more than 22,000 homes. And we recently signed a virtual power purchase agreement which adds renewable energy at a scale equivalent to nearly all our U.S. energy needs.
Companies that make these strategic investments today, with the same patience and investment they apply to product development, are setting themselves up for greater growth and profits down the line.
Reimagine products and packaging
Sustainable product and packaging design are some of our industry's most complex challenges due to strict regulatory requirements that restrict circular design solutions.
Companies can begin reducing resource use and waste with takeback programs, recycling product components and transitioning to digital instructions for use. But the goal isn't just to reduce waste-it's to create products that maintain the highest standards of patient care while contributing to a circular economy.
To do that, we need to design products and packaging with their end-of-life journey in mind, whether that's reprocessing, recycling, or biodegradation. It's important to remember there are many ways to reach sustainability goals and although reprocessing is becoming more common practice, sometimes single use devices can be the right option, especially if reprocessing increases risk to patient safety.
It is the conscious actions at the beginning that count a lot-for example, designing for sustainability before the first prototype is even developed. Industry leaders are dedicating R&D teams to spot opportunities for circular solutions within products' lifecycles, like the Sustainability Development Center at Medtronic. (Learn more in our latest Impact Report.)
Recruit partners
No one can solve our industry's environmental challenges alone. It requires collaboration across the healthcare ecosystem.
This starts with our supply chains, given that Scope 3 emissions typically account for over 90% of a healthcare technology company's carbon footprint, including at Medtronic. Engaging suppliers, logistic partners, employees and customers will not only help address emissions, but it will also build resilience against future risks that threaten supply chain stability.
We also need to think beyond our own value chain and look to others in the industry, academia, civil society, and government to develop breakthrough solutions and new enabling policies and incentive frameworks. For example, the Dutch government's ESCH-R: Creating Circular Hospitals Together program is helping address critical circularity gaps in healthcare with sponsorship from industry partners (including Medtronic). Collaborative approaches like this are key to building the infrastructure, developing the technologies, and creating the standards needed for a collective impact.
The transformation to sustainable healthcare won't happen overnight, but momentum is building, and it will grow because it is good for business and good for the planet. Together, we can create a healthcare technology industry that heals not only people but also the planet we all share.
After all, the healthiest future is one where innovation and sustainability are inseparable.
View additional multimedia and more ESG storytelling from Medtronic on 3blmedia.com.
Contact Info:
Spokesperson: Medtronic
Website: https://www.3blmedia.com/profiles/medtronic
Email: info@3blmedia.com
SOURCE: Medtronic
View the original press release on accesswire.com
News Provided by ACCESSWIRE via QuoteMedia
Healing People and Planet: New Impact Report Outlines How Medtronic Is Shaping the Future of Health
Medtronic
Medtronic releases 2024 Impact Report highlighting success in healthcare equity with new data from the Healthy Neighbor program, in addition to community engagement and environmental sustainability progress
November 20, 2024 /3BL/ - Medtronic plc, a global leader in healthcare technology, has today released its fiscal year 2024 (FY24) Impact Report. The report highlights the company's continued commitment to advancing health equity, increasing representation and inclusion, and reducing its environmental footprint. One of the highlights in this year's report is the early success of the Healthy Neighbor program, a transformative initiative addressing health inequities in chronic disease care.
Established in collaboration with Virtua Health, a 15,000-person academic health system, Healthy Neighbor extends access to integrated clinical and social care for hypertension and diabetes management within Camden, New Jersey. Launched in 2023, Healthy Neighbor trained a team of dedicated community health workers and a registered nurse to provide tailored support, combining SPICE, the Medtronic LABS open-source digital health platform, with social resource navigation.
Early results1 show that 71% of enrolled patients with high blood pressure and 63% of patients with previously uncontrolled diabetes achieved meaningful progress in blood pressure and blood glucose control.
"We are incredibly proud of the Healthy Neighbor program," said Geoff Martha, Medtronic chairman and CEO. "Our partnership with Virtua Health underscores our belief that to drive true impact, healthcare must be accessible, localized, and powered by technology and partnerships. We aim to develop a replicable model for community-based care that can improve outcomes for millions across the world."
The Medtronic 2024 Impact Report reveals broader commitments to patients, people, and planet. Key FY24 accomplishments include:
Patients - Putting patients first:
Medtronic places patient centricity at the forefront of its Mission through clinical research and targeted programs. In FY24, the company:
Shared data from the 87% women-enrolled global SMART Trial, led by Dr. Roxana Mehran and Dr. Howard Herrmann. Women are commonly under-represented in clinical trials. This trial addresses gender disparities in heart disease detection and treatment, setting a new standard for inclusive healthcare research.
Achieved a 33% reduction in product complaint rate for key product families. Complaint rates are an important indicator of patient experience and product quality. The company exceeded its 10% reduction target in aggregate product complaints by FY25 for key product families.
Invested $2.7 billion in research and development directed toward pioneering medical innovations for millions globally.
Supported over 550,000 healthcare professionals with over $121 million invested in medical education, participation in Medtronic Academy, in-person events at training centers, and Medtronic Mobile Labs.
Improved healthcare access for more than 78 million patients through increased access initiatives, putting the company on track to reach its target of 79 million patients annually by FY25.
Flowed 20.7% of revenue from products and therapies released in the prior 36 months (vitality index), exceeding its goal of 20% by FY25.
People - Striving for zero barriers:
Medtronic strives for zero barriers to health, opportunity, and well-being for its employees and the communities it serves. In FY24, the company:
Visited Alabama A&M University, a historically Black college, with the Medtronic Mobile Lab, offering students hands-on experience with cutting-edge technology and supporting diversity in science and engineering.
Reached 51% womenin Medtronic's global workforce, and 41% U.S. employees from diverse backgrounds. The company is on track to achieve 45% women in manager-and-above roles globally (currently at 44%) and 30% representation of ethnically diverse groups in manager-and-above roles in the U.S. (currently at 28%) by FY26.
Drove positive health outcomes for populations outside of the reach of its product portfolio by impacting 166,400 lives through Medtronic LABS.
Planet - Reducing impact for a healthier planet:
Medtronic is committed to reducing its environmental impact through science-based targets, focusing on emissions reduction and sustainable practices. In FY24, the company:
Secured energy expected to meet 50% of its electricity needs across its five Irish sites, reinforcing Medtronic's commitment to a healthier planet through a recent Power Purchase Agreement.2
Achieved a 52% reduction in emissionsintensity compared to FY20, surpassing its FY25 target of a 50% reduction in greenhouse gas (GHG) emissions intensity.
Met 42% of operational energy needswith renewables and are on track to achieve its target of sourcing 50% of energy from renewable and alternative sources by FY25.
Reduced operational waste by 19% and water use intensity by 28% since FY20. The company is also 90% of the way to achieving its goal to reduce packaging waste by 25% for four targeted, high-volume product families compared to FY21.
The Medtronic 2024 Impact Report reflects the company's key environmental, social, and governance (ESG) topics in alignment with leading reporting frameworks and standards, including the Global Sustainability Standards Board's (GSSB) Global Reporting Initiative (GRI); the International Sustainability Standards Board's (ISSB) Sustainability Accounting Standards Board (SASB) Standards; the Financial Stability Board's (FSB) Task Force on Climate-related Financial Disclosures (TCFD); and the World Economic Forum's (WEF) Stakeholder Capitalism Metrics.
View the full report here.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts:
Erika Winkels
Public Relations
+1-763-526-8478
Ryan Weispfenning
Investor Relations
+1-763-505-4626
Editor notes
1. Outcomes are within a cohort of patients enrolled in Healthy Neighbor between August 1, 2023, and August 26, 2024, who had both a baseline and follow-up reading. A significant improvement in blood pressure is defined as achieving blood pressure control (
2. FY45 Decarbonization Roadmap: Recognizing the risks that climate change poses to human health and long-term global financial stability, Medtronic has set an ambition to achieve net-zero emissions across Scope 1, 2, and 3 by FY45. To achieve our ambition, we will pursue setting targets through the Science-Based Targets initiative (SBTi), a multiyear process which provides companies with a clearly defined path to reduce GHG emissions in line with the Paris Agreement. Signed by 191 countries, plus the European Union, the Paris Agreement aspires to limit global warming to 1.5 degrees Celsius compared to pre-industrial levels.
2024 Impact Report Cover Page
View additional multimedia and more ESG storytelling from Medtronic on 3blmedia.com.
Contact Info:
Spokesperson: Medtronic
Website: https://www.3blmedia.com/profiles/medtronic
Email: info@3blmedia.com
SOURCE: Medtronic
View the original press release on accesswire.com
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Artificial Intelligence Reshaping Healthcare Industry with Unimaginable Potential
FN Media Group News Commentary - The Healthcare Artificial Intelligence (AI) market exhibits a high degree of innovation, characterized by ongoing advancements in technology. Rapid developments in ML, deep learning, NLP, and computer vision are driving the evolution of AI-powered healthcare solutions. One primary factor driving market growth is the increasing demand in the healthcare sector for enhanced efficiency, accuracy, and better patient outcomes. According to a March 2024 Microsoft-IDC study, 79% of healthcare organizations are presently utilizing AI technology. In addition, the return on investment (ROI) is realized within 14 months, generating USD 3.20 for every USD 1 invested in artificial intelligence (AI). AI technologies hold transformative potential in various areas including medical imaging analysis, predictive analytics, personalized treatment planning, and drug discovery, potentially transforming conventional healthcare practices. A report from Grand View Research said the global AI in healthcare market size, which was estimated at USD 19.27 billion in 2023, is expected to grow at a CAGR of 38.5% from 2024 to 2030. The report said: "Mergers & acquisitions (M&As) play a significant role in shaping the healthcare AI market landscape. Companies [that] engage in M&A activities to expand their AI software and services increase their market reach or acquire specialized technology and expertise. End-users are becoming increasingly aware of the potential benefits of AI in improving patient care, operational efficiency, and healthcare outcomes. Education initiatives and industry events helped raise awareness about the capabilities and applications of AI in healthcare." A.I. companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Teladoc Health, Inc. (NYSE: TDOC), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Clover Health Investments, Corp. (NASDAQ: CLOV).
Grand View Research continued: "The software solution component segment is anticipated to grow at the fastest CAGR of 38.7% over the forecast period. The segment growth is attributed to the rapidly growing adoption of AI-based software solutions among healthcare providers, payers, and patients… The services component segment is anticipated to witness significant growth from 2024 to 2030. The growth of this segment can be attributable to the rising penetration of AI-based technologies in several healthcare applications, such as clinical trials , virtual assistants, robot-assisted surgeries, dosage error reduction, and fraud detection. The healthcare providers (hospitals, outpatient facilities, and others) segment is expected to grow significantly over the forecast period. AI-powered medical imaging analysis tools aid healthcare providers in interpreting medical images like X-rays, MRIs, and CT scans. These tools improve diagnostic accuracy, shorten interpretation time, and facilitate early disease detection, resulting in prompt interventions and enhanced patient care. In addition, hospitals are leveraging AI-driven predictive analytics to anticipate patient admission rates, pinpoint at-risk populations, and allocate resources effectively. These factors are driving the segment growth."
Avant Technologies, Inc. (OTCQB: AVAI) Â and Ainnova Advancing Proprietary Retinal Camera to Market with Vision AI Software - Avant Technologies, Inc. ("Avant" or the "Company"), and its partner Ainnova Tech, Inc. (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced the companies will advance Ainnova's proprietary low-cost retinal camera, which will be used for fundus photography, and seamlessly packaged together with Ainnova's Vision AI software platform for commercialization. By combining the two technologies, Ainnova's versatile camera will provide precise retinal scans to its AI software leading to even more accurate data.
Vision AI is a powerful cutting-edge, AI-driven platform that can quickly and accurately detect the early markers of a host of diseases by applying AI models to examine imaging data from the eye to expedite earlier detection and allow patients to better manage their disease. The diseases that Vision AI can detect include diabetic retinopathy and other retinopathies, such as glaucoma, macular edema, age-related macular degeneration and other anomalies, as well as other diseases that do not require retinal images, and instead use other datapoints that Ainnova will integrate into the software like the detection of kidney disease, liver fat, cardiovascular risk, and pre-diabetes.
Currently, Ainnova's Vision AI software works well with any fundus camera on the market; however, Ainnova and Avant are aiming for exclusivity by developing a lower-cost, easier-to-use camera that captures retinal images automatically and then uploads those images to the Vision AI software platform, which then produces a "risk report" in mere seconds. Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova, will develop the retinal cameras as part of the joint venture and licensing deal to facilitate the development of Ainnova's technology portfolio. AAC owns the licensing rights to develop, maintain, and market Ainnova's technology portfolio in both North America (United States and Canada) and throughout Europe.
Vinicio Vargas, Chief Executive Officer of Ainnova and member of AAC's Board of Directors, said, "The cost of a fundus camera has always been a barrier to entry into ... this market, so our low-cost camera should allow us to not only enter the market but to capture a large share of the market. To that end, I will be meeting with a leading U.S. provider of digital healthcare solutions to discuss a potential distribution agreement, investment, and regulatory support."
AAC will market the two technologies as a Software as a Service (SaaS) + retinal camera package with the hope of making retinal scans a part of routine healthcare. The business model is a pay-per-use platform, per patient, monthly, aimed at primary care clinics, insurance companies, opticians, pharmacies, occupational health companies that provide the service to employees of many companies, and pharmaceutical companies that sell the treatments or therapies.
Vinicio Vargas added, "Our vision is that the retina will be a new standard in primary care, as basic as taking a patient's blood pressure, and together with other datapoints, such as demographic data or laboratory results, to generate a complete report of preventive medicine." CONTINUED… Read this and more news for Avant Technologies at: https://www.financialnewsmedia.com/news-avai/
In other Artificial Intelligence industry developments and happenings in the market recently include:
Teladoc Health, Inc. (NYSE: TDOC), the global leader in whole-person virtual care, this year released new data today from two studies, presented at the American Diabetes Association's 84th Scientific Sessions, that illustrate the company's unmatched predictive modeling capabilities to help members with type 2 diabetes control their blood sugar through participation in Teladoc Health's diabetes management program.
The new data shows a 3X increase in engagement leading to an additional 0.4 reduction in A1c (8.2 to 7.8) for members targeted with personalized health nudges (notifications that are sent to mobile or cellular connected devices) after being identified as at-risk for uncontrolled diabetes through artificial intelligence (AI). Additionally, diabetes members who received personalized next-best actions, powered by predictive modeling, in their weekly email were 50% more likely to engage with a health coach.
Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, recently announced the collaboration with Flatiron Health, a leading healthtech company dedicated to expanding the possibilities of point of care solutions in oncology, to integrate its comprehensive genomic testing directly into Flatiron's cloud-based Electronic Medical Record (EMR) platform, OncoEMR ® through the Molecular Profiling Integration (MPI). This integration will provide oncologists with seamless access to Tempus' suite of testing options, enhancing their ability to deliver personalized cancer care.
Flatiron's MPI—a two-way integration between laboratories and OncoEMR—will allow the 4,200 providers at more than 800 community-based cancer care locations across the U.S. in Flatiron's network to order and receive results from Tempus directly in the OncoEMR workflow. The integration will enable electronic ordering, order tracking, and the receipt of Tempus test results directly within the OncoEMR platform, significantly reducing administrative burden and improving the experience for care providers.
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, announced recently at the North American Spine Society (NASS) 39th Annual Meeting in Chicago the commercial launch of several software, hardware, and imaging innovations. These enhancements are designed to advance AiBLEâ„¢, the Medtronic smart ecosystem of innovative navigation, robotics, data and AI imaging software, and implants that enable more predictable outcomes in spine and cranial procedures. In line with its commitment to increasing the quality of care for patients with spinal conditions, Medtronic also announced a partnership with Siemens Healthineers to explore opportunities to further expand access to advanced pre- and post-operative imaging technologies for spine care.
New advancements in the AiBLEâ„¢ ecosystem build upon the company's commitment to procedural innovation and execution, and include the following: O-armâ„¢ 4.3 software, which introduces advanced navigation volumes, dose reduction, and enhanced image confirmation. With this release, Medtronic now offers the industry's longest 3D scan length for cone-beam CT images, which allows surgeons to capture additional spine levels in one scan and streamline their workflow. O-armâ„¢ is the first and only intraoperative imager that uses AI, with 70% less radiation dose compared to the standard protocol, while maintaining image quality. Medtronic Implant Resolution (MIR) further enhances decision-making by reducing metal artifacts around select screws, enabling confident final screw placement.
Clover Health Investments, Corp. (NASDAQ: CLOV ) A.I. News - Counterpart Health, Inc. ("Counterpart"), a leading AI-powered physician enablement platform, recently announced a multi-year agreement with The Iowa Clinic, P.C., one of the most highly regarded multispecialty healthcare groups in the United States. This deal positions The Iowa Clinic as one of Counterpart's anchor customers in the Midwest, as Counterpart drives a broader strategic expansion across the country. Counterpart is a subsidiary of Clover Health Investments, Corp. ("Clover Health").
Founded in 1994, The Iowa Clinic is a benchmark for excellence in American healthcare, recognized as one of America's Top 100 Healthcare Providers by Becker's Hospital Review and a recipient of multiple Press Ganey Guardian of Excellence Awards for patient satisfaction. As the largest physician-owned multispecialty group in its community, with over 250 providers across more than 40 specialties, The Iowa Clinic is celebrated for its pioneering physician-governed, patient-centered model. It also has been recognized for its leadership in patient safety by the Leapfrog Group and quality care by the NCQA. The clinic is a frequent collaborator in national research and an early adopter of advanced diagnostic technologies, with its physicians regularly featured in Castle Connolly's list of America's Top Doctors. Renowned for its clinical expertise and commitment to innovation, The Iowa Clinic consistently delivers world-class, patient-centered care.
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Medtronic receives FDA clearance for new InPen app, paving the way for its Smart MDI system launch with Simplera CGM
New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM). The company's Smart MDI system combines its InPen™ smart insulin pen with its newest Simplera™ CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.
With this clearance, the system will be the first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals on multiple daily injection (MDI) therapy.
For people with diabetes who need daily insulin injections, bolusing before a meal is essential as it helps regulate glucose levels and prevent blood sugar spikes after eating. Minimizing the frequency of these glucose highs reduces the risk of both short- and long-term complications and supports better overall health. However, it's estimated that individuals living with diabetes regularly miss 1 out of 3 doses. The Missed Dose alert function helps to minimize the frequency of these glucose highs. 1 The Medtronic Smart MDI system reduces the guesswork out of diabetes management, helping to address a significant unmet need for MDI users who struggle with juggling numerous decisions related to insulin dosing on a daily basis.
"I'm thrilled about the launch of the Medtronic Smart MDI system with the InPen™ app and Simplera™ CGM. This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management," said Diana Isaacs , PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP. "By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia." 2,3
Medtronic will initiate a limited market release beginning with existing standalone CGM and InPenâ„¢ customers followed by a broad commercial launch.
1. MacLeod, J, Heungyong Im, G, Smith, M, Vigersky, RA. Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen. Diabetes Technology & Therapeutics. 2024. 26:1, 33-39. |
2. Vigersky et al., Impact Of InPen Smart Insulin Pen Use on Real-World Glycemic and Insulin Dosing Outcomes in Individuals with Poorly Controlled Diabetes. Presented at: American Diabetes Association; 81st Scientific Sessions; 2021 Jun 25-29. |
3. Chien A, Thanasekaran S, Gaetano A, Im G, Wherry K, MacLeod J, Vigersky RA. Potential cost savings in the United States from a reduction in sensor-detected severe hypoglycemia among users of the InPen smart insulin pen system. J Manag Care Spec Pharm. 2023 Mar;29(3):285-292. |
About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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SOURCE Medtronic plc
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Medtronic reports second quarter fiscal 2025 financial results
Delivering on commitments, executing ahead of expectations, and raising guidance
Innovation driving sustained growth across many franchises:Â TAVR, PFA, Leadless Pacemakers, Diabetes, Spine, and Neuromodulation
-Â Medtronic plc (NYSE: MDT) today announced financial results for its second quarter (Q2) of fiscal year 2025 (FY25), which ended October 25, 2024 .
Key Highlights
- Revenue of $8.4 billion increased 5.3% as reported and 5.0% organic
- GAAP diluted earnings per share (EPS) of $0.99 ; non-GAAP diluted EPS of $1.26
- Company raises FY25 organic revenue growth and EPS guidance
Financial Results
Medtronic reported Q2 worldwide revenue of $8.403 billion , an increase of 5.3% as reported and 5.0% on an organic basis. Organic revenue growth comparison excludes:
- Other revenue of $37 million in the current year and $61 million in the prior year; and
- Foreign currency translation benefit of $45 million on the remaining segments.
As reported, Q2 GAAP net income and diluted earnings per share (EPS) were $1.270 billion and $0.99 , respectively, representing increases of 40% and 46%, respectively. As detailed in the financial schedules included at the end of this release, Q2 non-GAAP net income and non-GAAP diluted EPS were $1.620 billion and $1.26 , respectively, representing a decrease of 3% and an increase of 1%, respectively. Included in Q2 non-GAAP diluted EPS was a -9 cent impact from foreign currency translation. Non-GAAP adjusted diluted EPS grew 8% on a constant currency basis.
"Our momentum is building as we keep executing on our commitments, delivering yet another consecutive quarter of strong results that came in ahead of expectations," said Geoff Martha , Medtronic chairman and chief executive officer. "Innovation matters, and innovation is really driving our growth today. As we look ahead, we're confident that this diversified growth will keep going, especially given the strength of our pipeline in high-impact markets that will allow us to benefit even more patients around the world."
Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Revenue of $3.102 billion increased 6.1% as reported and 5.6% organic, with a high-single digit increase in SHA and mid-single digit increases in CRHF and CPV, all on an organic basis.
- CRHF results included mid-single digit growth in Cardiac Rhythm Management, driven by high-single digit growth in Defibrillation Solutions and Cardiac Pacing Therapies, including high-teens growth in Micraâ„¢ transcatheter pacing systems; Cardiac Ablation Solutions had flat results as strong growth of the PulseSelectâ„¢ pulsed field ablation (PFA) system offset declines in cryoablation
- SHA results driven by high-single digit growth in Structural Heart, on the U.S. launch of the Evolutâ„¢ FX+ TAVR system, and low-double digit growth in Cardiac Surgery
- CPV delivered mid-single digit growth in both Coronary, with strength in guide catheters and balloons, and Peripheral Vascular Health
- Ramping commercial availability of the Afferaâ„¢ Mapping and Ablation System and Sphere-9â„¢ catheter following late October U.S. Food and Drug Administration (FDA) approval
- Received CE Mark for Evolutâ„¢ FX+ TAVR system in late October; started commercial launch across Europe this month
- Launched Avalus Ultraâ„¢ surgical valve in Western Europe and VitalFlowâ„¢ Extracorporeal Membrane Oxygenation (ECMO) system in the U.S.
- In September, Symplicityâ„¢ blood pressure procedure named to FORTUNE 2024 'Change the World' list
- Earlier this month, granted transitional pass-through (TPT) payment under the U.S. Medicare Hospital Outpatient Prospective Payment System beginning January 1, 2025 , for Symplicity Spyralâ„¢ renal denervation (RDN) catheter, used in the Symplicityâ„¢ blood pressure procedure
Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Revenue of $2.451 billion increased 7.1% as reported and 6.7% organic, with a low-double digits increase in Neuromodulation and mid-single digit increases in both CST and Specialty Therapies, all on an organic basis.
- CST above market performance driven by continued adoption of the AiBLEâ„¢ ecosystem of spine implants and enabling technology, with mid-single digit growth in Core Spine and high-single digit growth in Biologics and Neurosurgery
- Specialty Therapies results driven by mid-single digit growth in both Neurovascular, with continued strength in hemorrhagic stroke products, and Pelvic Health, on continued adoption of the InterStim Xâ„¢ system; ENT grew low-single digits on strength in capital placements
- Neuromodulation drove above market performance, with high-teens growth in Brain Modulation on the continued launch of the Perceptâ„¢ RC deep brain stimulator (DBS) with BrainSenseâ„¢ technology; Pain Therapies grew low-double digits, including low-double digit growth in U.S. Pain Stim on the continued launch of the Inceptivâ„¢ spinal cord stimulator
- Medtronic pioneering ADAPT-PD clinical trial methods and preliminary data studying adaptive deep brain stimulation (aDBS) published in September in npj Parkinson's Disease , part of the prestigious Nature Portfolio of journals
- In September, expanded AiBLEâ„¢ spine surgery ecosystem with new technologies and announced partnership with Siemens Healthineers to co-market and integrate the Siemens Healthineers Multitom Raxâ„¢ imaging system
Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. Revenue of $2.128 billion increased 1.2% as reported and increased 0.7% organic, with low-single digit organic increase in ACM and flat organic result in SE. SE year-over-year results were affected by a difficult comparison from prior year supply recovery in Surgical and increased high-single digits sequentially.
- SE results included flat results in both Advanced Surgical Technologies, with strength in Advanced Energy, driven by continued adoption of the LigaSureâ„¢ Maryland XP vessel sealer, offsetting declines in Advanced Stapling; General Surgical Technologies grew low-single digits, with strength in Hernia and Wound Management products
- ACM performance included high-single digit growth in Nellcorâ„¢ Blood Oxygen Management products
Diabetes
Revenue of $686 million increased 12.4% as reported and 11.0% organic.
- U.S. revenue grew high-single digits on the continued adoption of the MiniMedâ„¢ 780G automated insulin delivery (AID) system
- International revenue grew low-double digits on increasing CGM attachment rates and the continued roll-out of Simplera Syncâ„¢ sensor
- In September, meta-analysis of 28 randomized control trials published in Diabetes/Metabolism Research and Reviews concluded MiniMedâ„¢ 780G achieved highest time-in-range among seven commercial AID systems
Guidance
The company today raised its FY25 revenue growth and EPS guidance.
The company raised its FY25 organic revenue growth guidance to 4.75% to 5% versus the prior range of 4.5% to 5%. The organic revenue growth guidance excludes the impact of foreign currency and revenue reported as Other. Including Other revenue and the impact of foreign currency exchange, if recent foreign currency exchange rates hold, FY25 revenue growth on an adjusted basis would be in the range of 3.4% to 3.9%.
The company raised its FY25 diluted non-GAAP EPS guidance to the new range of $5.44 to $5.50 versus the prior $5.42 to $5.50 . This includes an estimated -5% impact from foreign currency exchange based on recent rates, unchanged from the prior guidance. The company's guidance represents FY25 diluted non-GAAP EPS growth in the range of 4.6% to 5.8%.
"We're restoring our earnings power through our focus on underlying margin improvement, delivering another quarter of high-single digit constant currency adjusted EPS growth," said Gary Corona , Medtronic interim chief financial officer. "And now, as the impact from foreign currency abates, we expect to report high-single digit adjusted EPS growth in the back half of our fiscal year, in line with our long-term commitment to deliver durable, mid-single digit organic revenue growth with EPS leverage."
FY24 Impact Report
Today, Medtronic released its FY24 Impact Report demonstrating the company's sustainability progress. Medtronic also launched a new Impact webpage and FY24 Highlights Report featuring notable key performance indicators and stories, as well as an online Data Hub that shows the company's commitment to transparent disclosure and reporting:
- Achieved 2025 goal to reduce greenhouse gas intensity by 50% a year early, with a 52% reduction in FY24
- Exceeded goal to reduce aggregate product complaint rate by 10% for identified product families, with a 33% reduction in FY24
- More than 78 million patients served through expanded access strategies
- $2.7B spent in R&D investments to drive innovation
Video Webcast Information
Medtronic will host a video webcast today, November 19 , at 8:00 a.m. EST ( 7:00 a.m. CST ) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com , and this earnings release will be archived at news.medtronic.com . Within 24 hours of the webcast, a replay of the webcast and transcript of the company's prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com .
Medtronic plans to report its FY25 third and fourth quarter results on Tuesday, February 18, 2025 , and Wednesday, May 21, 2025 , respectively. Confirmation and additional details will be provided closer to the specific event.
Financial Schedules and Earnings Presentation
The second quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com . To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here . To view the first quarter earnings presentation, click here .
MEDTRONIC PLC WORLD WIDE REVENUE (1) (Unaudited) | ||||||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||||||
(in millions) | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||||||||||
Cardiovascular | $Â Â Â Â 3,102 | $Â Â Â Â 2,923 | 6.1Â % | $Â Â Â Â Â Â Â Â Â 16 | $Â Â Â Â 3,086 | $Â Â Â Â 2,923 | 5.6Â % | $Â Â Â Â 6,108 | $Â Â Â Â 5,773 | 5.8Â % | $Â Â Â Â Â Â Â (23) | $Â Â Â Â 6,132 | $Â Â Â Â 5,773 | 6.2Â % | ||||||||||||||
Cardiac Rhythm & Heart Failure | 1,578 | 1,492 | 5.8 | 11 | 1,567 | 1,492 | 5.0 | 3,114 | 2,938 | 6.0 | (8) | 3,122 | 2,938 | 6.2 | ||||||||||||||
Structural Heart & Aortic | 881 | 819 | 7.6 | 4 | 877 | 819 | 7.1 | 1,736 | 1,633 | 6.3 | (8) | 1,744 | 1,633 | 6.8 | ||||||||||||||
Coronary & Peripheral Vascular | 643 | 613 | 4.9 | 1 | 642 | 613 | 4.8 | 1,259 | 1,202 | 4.7 | (7) | 1,266 | 1,202 | 5.3 | ||||||||||||||
Neuroscience | 2,451 | 2,288 | 7.1 | 10 | 2,441 | 2,288 | 6.7 | 4,768 | 4,506 | 5.8 | (8) | 4,776 | 4,506 | 6.0 | ||||||||||||||
Cranial & Spinal Technologies | 1,234 | 1,157 | 6.7 | 3 | 1,231 | 1,157 | 6.4 | 2,382 | 2,260 | 5.4 | (6) | 2,387 | 2,260 | 5.6 | ||||||||||||||
Specialty Therapies | 737 | 705 | 4.6 | 5 | 732 | 705 | 3.9 | 1,450 | 1,400 | 3.5 | (2) | 1,452 | 1,400 | 3.7 | ||||||||||||||
Neuromodulation | 480 | 426 | 12.6 | 2 | 478 | 426 | 12.1 | 937 | 846 | 10.8 | (1) | 938 | 846 | 10.9 | ||||||||||||||
Medical Surgical | 2,128 | 2,103 | 1.2 | 10 | 2,117 | 2,103 | 0.7 | 4,123 | 4,107 | 0.4 | (18) | 4,142 | 4,107 | 0.8 | ||||||||||||||
Surgical & Endoscopy | 1,649 | 1,641 | 0.5 | 9 | 1,641 | 1,641 | — | 3,193 | 3,187 | 0.2 | (13) | 3,207 | 3,187 | 0.6 | ||||||||||||||
Acute Care & Monitoring | 478 | 462 | 3.6 | 1 | 477 | 462 | 3.3 | 930 | 921 | 1.0 | (5) | 935 | 921 | 1.6 | ||||||||||||||
Diabetes | 686 | 610 | 12.4 | 9 | 678 | 610 | 11.0 | 1,333 | 1,189 | 12.1 | 5 | 1,329 | 1,189 | 11.8 | ||||||||||||||
Total Reportable Segments | 8,366 | 7,923 | 5.6 | 45 | 8,322 | 7,923 | 5.0 | 16,333 | 15,575 | 4.9 | (46) | 16,379 | 15,575 | 5.2 | ||||||||||||||
Other (2) | 37 | 61 | (38.9) | — | — | — | — | (15) | 111 | (113.5) | (2) | — | — | — | ||||||||||||||
TOTAL | $Â Â Â Â 8,403 | $Â Â Â Â 7,984 | 5.3Â % | $Â Â Â Â Â Â Â Â Â 45 | $Â Â Â Â 8,322 | $Â Â Â Â 7,923 | 5.0Â % | $Â Â Â 16,318 | $Â Â Â 15,686 | 4.0Â % | $Â Â Â Â Â Â Â (48) | $Â Â Â 16,379 | $Â Â Â 15,575 | 5.2Â % |
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(2) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the three months ended July 26, 2024, impacting year-to-date figures, $90 million of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | The three months ended October 25, 2024 includes $82 million of revenue adjustments related to $37 million of inorganic revenue for the transition activity noted in (2) and $45 million of favorable currency impact on the remaining segments. The three months ended October 27, 2023 excludes $61 million of inorganic revenue related to the transition activity noted in (2). |
(5) | The six months ended October 25, 2024 excludes $61 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $75 million of inorganic revenue related to the transition activity noted in (2), and $46 million of unfavorable currency impact on the remaining segments. The six months ended October 27, 2023 excludes $111 million of inorganic revenue related to the transition activity noted in (2). |
MEDTRONIC PLC U.S. (1)(2) REVENUE (Unaudited) | ||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||
(in millions) | FY25 | FY24 | Growth | Adjusted | Adjusted | Growth | FY25 | FY24 | Growth | Adjusted | Adjusted | Growth | ||||||||||||
Cardiovascular | $Â Â Â Â 1,434 | $Â Â Â Â 1,427 | 0.5Â % | $Â Â Â Â 1,434 | $Â Â Â Â 1,427 | 0.5Â % | $Â Â Â Â 2,836 | $Â Â Â Â 2,776 | 2.2Â % | $Â Â Â Â 2,836 | $Â Â Â Â 2,776 | 2.2Â % | ||||||||||||
Cardiac Rhythm & Heart Failure | 768 | 782 | (1.8) | 768 | 782 | (1.8) | 1,534 | 1,502 | 2.1 | 1,534 | 1,502 | 2.1 | ||||||||||||
Structural Heart & Aortic | 388 | 367 | 5.7 | 388 | 367 | 5.7 | 757 | 724 | 4.5 | 757 | 724 | 4.5 | ||||||||||||
Coronary & Peripheral Vascular | 278 | 278 | 0.1 | 278 | 278 | 0.1 | 546 | 550 | (0.8) | 546 | 550 | (0.8) | ||||||||||||
Neuroscience | 1,677 | 1,560 | 7.5 | 1,677 | 1,560 | 7.5 | 3,242 | 3,057 | 6.0 | 3,242 | 3,057 | 6.0 | ||||||||||||
Cranial & Spinal Technologies | 926 | 863 | 7.2 | 926 | 863 | 7.2 | 1,781 | 1,685 | 5.7 | 1,781 | 1,685 | 5.7 | ||||||||||||
Specialty Therapies | 418 | 403 | 3.6 | 418 | 403 | 3.6 | 816 | 795 | 2.6 | 816 | 795 | 2.6 | ||||||||||||
Neuromodulation | 333 | 293 | 13.7 | 333 | 293 | 13.7 | 645 | 577 | 11.8 | 645 | 577 | 11.8 | ||||||||||||
Medical Surgical | 944 | 948 | (0.4) | 944 | 948 | (0.4) | 1,825 | 1,815 | 0.5 | 1,825 | 1,815 | 0.5 | ||||||||||||
Surgical & Endoscopy | 675 | 688 | (1.9) | 675 | 688 | (1.9) | 1,304 | 1,308 | (0.2) | 1,304 | 1,308 | (0.2) | ||||||||||||
Acute Care & Monitoring | 269 | 260 | 3.6 | 269 | 260 | 3.6 | 521 | 508 | 2.6 | 521 | 508 | 2.6 | ||||||||||||
Diabetes | 232 | 217 | 6.9 | 232 | 217 | 6.9 | 447 | 405 | 10.4 | 447 | 405 | 10.4 | ||||||||||||
Total Reportable Segments | 4,286 | 4,151 | 3.3 | 4,286 | 4,151 | 3.3 | 8,350 | 8,054 | 3.7 | 8,350 | 8,054 | 3.7 | ||||||||||||
Other (3) | 18 | 23 | (22.2) | — | — | — | 37 | 45 | (19.0) | — | — | — | ||||||||||||
TOTAL | $Â Â Â Â 4,304 | $Â Â Â Â 4,175 | 3.1Â % | $Â Â Â Â 4,286 | $Â Â Â Â 4,151 | 3.3Â % | $Â Â Â Â 8,387 | $Â Â Â Â 8,099 | 3.6Â % | $Â Â Â Â 8,350 | $Â Â Â Â 8,054 | 3.7Â % |
(1) | U.S. includes the United States and U.S. territories. |
(2) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(3) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested. |
MEDTRONIC PLC INTERNATIONAL REVENUE (1) (Unaudited) | ||||||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||||||
(in millions) | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||||||||||
Cardiovascular | $Â Â Â Â 1,668 | $Â Â Â Â 1,496 | 11.5Â % | $Â Â Â Â Â Â Â Â 16 | $Â Â Â Â 1,652 | $Â Â Â Â 1,496 | 10.4Â % | $Â Â Â Â 3,272 | $Â Â Â Â 2,996 | 9.2Â % | $Â Â Â Â Â Â Â (23) | $Â Â Â Â 3,295 | $Â Â Â Â 2,996 | 10.0Â % | ||||||||||||||
Cardiac Rhythm & Heart Failure | 811 | 710 | 14.2 | 11 | 799 | 710 | 12.6 | 1,580 | 1,436 | 10.0 | (8) | 1,588 | 1,436 | 10.6 | ||||||||||||||
Structural Heart & Aortic | 492 | 451 | 9.1 | 4 | 488 | 451 | 8.3 | 980 | 909 | 7.8 | (8) | 988 | 909 | 8.7 | ||||||||||||||
Coronary & Peripheral Vascular | 365 | 335 | 8.9 | 1 | 364 | 335 | 8.7 | 713 | 652 | 9.3 | (7) | 720 | 652 | 10.4 | ||||||||||||||
Neuroscience | 774 | 728 | 6.3 | 10 | 764 | 728 | 5.0 | 1,526 | 1,449 | 5.3 | (8) | 1,535 | 1,449 | 5.9 | ||||||||||||||
Cranial & Spinal Technologies | 308 | 293 | 5.0 | 3 | 305 | 293 | 3.9 | 600 | 576 | 4.2 | (6) | 606 | 576 | 5.2 | ||||||||||||||
Specialty Therapies | 319 | 302 | 5.8 | 5 | 315 | 302 | 4.3 | 634 | 605 | 4.8 | (2) | 636 | 605 | 5.1 | ||||||||||||||
Neuromodulation | 146 | 133 | 10.4 | 2 | 144 | 133 | 8.8 | 292 | 269 | 8.8 | (1) | 293 | 269 | 9.1 | ||||||||||||||
Medical Surgical | 1,183 | 1,155 | 2.5 | 10 | 1,173 | 1,155 | 1.6 | 2,298 | 2,292 | 0.3 | (18) | 2,317 | 2,292 | 1.1 | ||||||||||||||
Surgical & Endoscopy | 974 | 953 | 2.3 | 9 | 966 | 953 | 1.4 | 1,889 | 1,879 | 0.5 | (13) | 1,902 | 1,879 | 1.2 | ||||||||||||||
Acute Care & Monitoring | 209 | 202 | 3.5 | 1 | 208 | 202 | 2.8 | 409 | 413 | (0.9) | (5) | 414 | 413 | 0.4 | ||||||||||||||
Diabetes | 455 | 394 | 15.5 | 9 | 446 | 394 | 13.2 | 886 | 784 | 13.1 | 5 | 882 | 784 | 12.5 | ||||||||||||||
Total Reportable Segments | 4,080 | 3,772 | 8.2 | 45 | 4,035 | 3,772 | 7.0 | 7,983 | 7,521 | 6.1 | (46) | 8,028 | 7,521 | 6.7 | ||||||||||||||
Other (2) | 19 | 37 | (49.4) | — | — | — | — | (51) | 66 | (178.3) | (2) | — | — | — | ||||||||||||||
TOTAL | $Â Â Â Â 4,099 | $Â Â Â Â 3,809 | 7.6Â % | $Â Â Â Â Â Â Â Â 45 | $Â Â Â Â 4,035 | $Â Â Â Â 3,772 | 7.0Â % | $Â Â Â Â 7,931 | $Â Â Â Â 7,587 | 4.5Â % | $Â Â Â Â Â Â Â (48) | $Â Â Â Â 8,028 | $Â Â Â Â 7,521 | 6.7Â % |
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(2) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the three months ended July 26, 2024, impacting year-to-date figures, $90 million of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | The three months ended October 25, 2024 includes $64 million of revenue adjustments related to $19 million of inorganic revenue for the transition activity noted in (2), and $45 million of favorable currency impact on the remaining segments. The three months ended October 27, 2023 excludes $37 million of inorganic revenue related to the transition activity noted in (2). |
(5) | The six months ended October 25, 2024 excludes $97 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $38 million of inorganic revenue related to the transition activity noted in (2), and $46 million of unfavorable currency impact on the remaining segments. The six months ended October 27, 2023 excludes $66 million of inorganic revenue related to the transition activity noted in (2). |
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited) | |||||||
Three months ended | Six months ended | ||||||
(in millions, except per share data) | October 25, 2024 | October 27, 2023 | October 25, 2024 | October 27, 2023 | |||
Net sales | $Â Â Â Â Â Â Â Â Â Â Â 8,403 | $Â Â Â Â Â Â Â Â Â Â Â 7,984 | $Â Â Â Â Â Â Â Â Â 16,318 | $Â Â Â Â Â Â Â Â Â 15,686 | |||
Costs and expenses: | |||||||
Cost of products sold, excluding amortization of intangible assets | 2,946 | 2,761 | 5,707 | 5,390 | |||
Research and development expense | 697 | 698 | 1,373 | 1,365 | |||
Selling, general, and administrative expense | 2,757 | 2,686 | 5,412 | 5,299 | |||
Amortization of intangible assets | 413 | 425 | 827 | 855 | |||
Restructuring charges, net | 30 | 40 | 77 | 94 | |||
Certain litigation charges, net | — | 65 | 81 | 105 | |||
Other operating income, net | (34) | (31) | (33) | (30) | |||
Operating profit | 1,595 | 1,340 | 2,873 | 2,608 | |||
Other non-operating income, net | (173) | (154) | (330) | (230) | |||
Interest expense, net | 209 | 180 | 376 | 329 | |||
Income before income taxes | 1,559 | 1,313 | 2,827 | 2,510 | |||
Income tax provision | 281 | 402 | 500 | 802 | |||
Net income | 1,278 | 911 | 2,327 | 1,708 | |||
Net income attributable to noncontrolling interests | (9) | (2) | (15) | (8) | |||
Net income attributable to Medtronic | $Â Â Â Â Â Â Â Â Â Â Â 1,270 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 909 | $Â Â Â Â Â Â Â Â Â Â Â 2,312 | $Â Â Â Â Â Â Â Â Â Â Â 1,700 | |||
Basic earnings per share | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 0.99 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 0.68 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1.79 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1.28 | |||
Diluted earnings per share | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 0.99 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 0.68 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1.79 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1.28 | |||
Basic weighted average shares outstanding | 1,282.4 | 1,330.2 | 1,288.6 | 1,330.3 | |||
Diluted weighted average shares outstanding | 1,286.9 | 1,331.9 | 1,292.5 | 1,332.8 |
The data in the schedule above has been intentionally rounded to the nearest million. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||||
Three months ended October 25, 2024 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $Â 8,403 | $Â Â 2,946 | 64.9Â % | $Â Â Â Â 1,595 | 19.0Â % | $Â Â Â 1,559 | $Â Â Â Â Â Â 1,270 | $Â Â Â Â 0.99 | 18.0Â % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 413 | 4.9 | 413 | 338 | 0.26 | 18.2 | ||||||||
Restructuring and associated costs (2) | — | (11) | 0.1 | 46 | 0.5 | 46 | 37 | 0.03 | 19.6 | ||||||||
Acquisition and divestiture-related items (3) | — | (5) | 0.1 | (25) | (0.3) | (25) | (30) | (0.02) | (20.0) | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | (10) | (21) | (0.02) | (100.0) | ||||||||
Medical device regulations (5) | — | (9) | 0.1 | 12 | 0.1 | 12 | 10 | 0.01 | 16.7 | ||||||||
Certain tax adjustments, net | — | — | — | — | — | — | 16 | 0.01 | — | ||||||||
Non-GAAP | $Â 8,403 | $Â Â 2,921 | 65.2Â % | $Â Â Â Â 2,041 | 24.3Â % | $Â Â Â 1,995 | $Â Â Â Â Â Â 1,620 | $Â Â Â Â 1.26 | 18.3Â % | ||||||||
Currency impact | (45) | (103) | 1.1 | 145 | 1.9 | 0.09 | |||||||||||
Currency Adjusted | $Â 8,358 | $Â Â 2,818 | 66.3Â % | $Â Â Â Â 2,186 | 26.2Â % | $Â Â Â Â 1.35 | |||||||||||
Three months ended October 27, 2023 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $Â 7,984 | $Â Â 2,761 | 65.4Â % | $Â Â Â Â 1,340 | 16.8Â % | $Â Â Â 1,313 | $Â Â Â Â Â Â Â Â Â 909 | $Â Â Â Â 0.68 | 30.6Â % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 425 | 5.3 | 425 | 360 | 0.27 | 15.3 | ||||||||
Restructuring and associated costs (2) | — | (15) | 0.2 | 91 | 1.1 | 91 | 76 | 0.06 | 17.6 | ||||||||
Acquisition and divestiture-related items (3) | — | (6) | 0.1 | 58 | 0.7 | 58 | 51 | 0.04 | 12.1 | ||||||||
Certain litigation charges, net | — | — | — | 65 | 0.8 | 65 | 50 | 0.04 | 23.1 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | 25 | 21 | 0.02 | 20.0 | ||||||||
Medical device regulations (5) | — | (21) | 0.3 | 30 | 0.4 | 30 | 24 | 0.02 | 20.0 | ||||||||
Certain tax adjustments, net (6) | — | — | — | — | — | — | 176 | 0.13 | — | ||||||||
Non-GAAP | $Â 7,984 | $Â Â 2,720 | 65.9Â % | $Â Â Â Â 2,009 | 25.2Â % | $Â Â Â 2,008 | $Â Â Â Â Â Â 1,667 | $Â Â Â Â 1.25 | 16.9Â % |
See description of non-GAAP financial measures contained in the press release dated November 19, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum. |
(2) | Associated costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business-related charges. The three months ended October 25, 2024, also include gains related to certain business or asset sales. |
(4) | We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations. |
(5) | The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period. |
(6) | The charge primarily relates to the establishment of a valuation allowance against certain net operating losses. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||||
Six months ended October 25, 2024 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $ 16,318 | $Â Â 5,707 | 65.0Â % | $Â Â Â Â 2,873 | 17.6Â % | $Â Â Â 2,827 | $Â Â Â Â Â Â Â Â 2,312 | $Â Â Â Â 1.79 | 17.7Â % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 827 | 4.9 | 827 | 678 | 0.52 | 18.0 | ||||||||
Restructuring and associated costs (2) | — | (20) | 0.1 | 108 | 0.6 | 108 | 87 | 0.07 | 19.4 | ||||||||
Acquisition and divestiture-related items (3) | — | (16) | 0.1 | (13) | (0.1) | (13) | (19) | (0.01) | (46.2) | ||||||||
Certain litigation charges, net | — | — | — | 81 | 0.5 | 81 | 68 | 0.05 | 16.0 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | (27) | (38) | (0.03) | (37.0) | ||||||||
Medical device regulations (5) | — | (20) | 0.1 | 27 | 0.2 | 27 | 22 | 0.02 | 18.5 | ||||||||
Other (6) | 90 | — | 0.4 | 90 | 0.5 | 90 | 70 | 0.05 | 22.2 | ||||||||
Certain tax adjustments, net | — | — | — | — | — | — | 33 | 0.03 | — | ||||||||
Non-GAAP | $ 16,408 | $Â Â 5,651 | 65.6Â % | $Â Â Â Â 3,993 | 24.3Â % | $Â Â Â 3,921 | $Â Â Â Â Â Â Â Â 3,213 | $Â Â Â Â 2.49 | 17.7Â % | ||||||||
Currency impact | 46 | (134) | 0.9 | 246 | 1.5 | 0.16 | |||||||||||
Currency Adjusted | $ 16,454 | $Â Â 5,517 | 66.5Â % | $Â Â Â Â 4,239 | 25.8Â % | $Â Â Â Â 2.65 | |||||||||||
Six months ended October 27, 2023 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $ 15,686 | $Â Â 5,390 | 65.6Â % | $Â Â Â Â 2,608 | 16.6Â % | $Â Â Â 2,510 | $Â Â Â Â Â Â Â Â 1,700 | $Â Â Â Â 1.28 | 32.0Â % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 855 | 5.5 | 855 | 724 | 0.54 | 15.2 | ||||||||
Restructuring and associated costs (2) | — | (30) | 0.2 | 182 | 1.2 | 182 | 152 | 0.11 | 16.5 | ||||||||
Acquisition and divestiture-related items (3) | — | (12) | 0.1 | 107 | 0.7 | 107 | 97 | 0.07 | 9.3 | ||||||||
Certain litigation charges, net | — | — | — | 105 | 0.7 | 105 | 81 | 0.06 | 22.9 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | 89 | 85 | 0.06 | 5.6 | ||||||||
Medical device regulations (5) | — | (42) | 0.3 | 62 | 0.4 | 62 | 49 | 0.04 | 21.0 | ||||||||
Certain tax adjustments, net (7) | — | — | — | — | — | — | 375 | 0.28 | — | ||||||||
Non-GAAP | $ 15,686 | $Â Â 5,306 | 66.2Â % | $Â Â Â Â 3,919 | 25.0Â % | $Â Â Â 3,910 | $Â Â Â Â Â Â Â Â 3,262 | $Â Â Â Â 2.45 | 16.4Â % |
See description of non-GAAP financial measures contained in the press release dated November 19, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum. |
(2) | Associated costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business-related charges. The six months ended October 25, 2024, also include gains related to certain business or asset sales. |
(4) | We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations. |
(5) | The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period. |
(6) | Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(7) | The charge relates to an income tax reserve adjustment associated with the June 2023, Israeli Central-Lod District Court decision, the establishment of a valuation allowance against certain net operating losses and amortization of previously established deferred tax assets from intercompany intellectual property transactions. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||
Three months ended October 25, 2024 | |||||||||||||||
(in millions) | Net | SG&A | SG&A | R&D | R&D | Other | Other | Other Non- | |||||||
GAAP | $Â Â Â Â Â 8,403 | $Â Â Â Â 2,757 | 32.8Â % | $Â Â Â Â Â Â 697 | 8.3Â % | $Â Â Â Â Â Â Â Â (34) | (0.4)Â % | $Â Â Â Â Â Â Â Â Â (173) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Restructuring and associated costs (2) | — | (6) | (0.1) | — | — | — | — | — | |||||||
Acquisition and divestiture-related items (3) | — | (19) | (0.2) | — | — | 50 | 0.6 | — | |||||||
Medical device regulations (4) | — | — | — | (4) | — | — | — | — | |||||||
(Gain)/loss on minority investments (5) | — | — | — | — | — | — | — | 10 | |||||||
Non-GAAP | $Â Â Â Â Â 8,403 | $Â Â Â Â 2,732 | 32.5Â % | $Â Â Â Â Â Â 693 | 8.2Â % | $Â Â Â Â Â Â Â Â Â Â 16 | 0.2Â % | $Â Â Â Â Â Â Â Â Â (163) | |||||||
Six months ended October 25, 2024 | |||||||||||||||
(in millions) | Net | SG&A | SG&A | R&D | R&D | Other | Other | Other Non- | |||||||
GAAP | $Â Â Â 16,318 | $Â Â Â Â 5,412 | 33.2Â % | $Â Â Â 1,373 | 8.4Â % | $Â Â Â Â Â Â Â Â (33) | (0.2)Â % | $Â Â Â Â Â Â Â Â Â (330) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Restructuring and associated costs (2) | — | (11) | (0.1) | — | — | — | — | — | |||||||
Acquisition and divestiture-related items (3) | — | (27) | (0.3) | — | — | 55 | 0.3 | — | |||||||
Medical device regulations (4) | — | — | — | (7) | (0.1) | — | — | — | |||||||
Other (6) | 90 | — | — | — | — | — | — | — | |||||||
(Gain)/loss on minority investments (5) | — | — | — | — | — | — | — | 27 | |||||||
Non-GAAP | $Â Â Â 16,408 | $Â Â Â Â 5,374 | 32.8Â % | $Â Â Â 1,366 | 8.3Â % | $Â Â Â Â Â Â Â Â Â Â 23 | 0.1Â % | $Â Â Â Â Â Â Â Â Â (303) |
See description of non-GAAP financial measures contained in the press release dated November 19, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
(2) | Associated costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, exit of business-related charges, and gains related to certain business or asset sales. |
(4) | The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period. |
(5) | We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations. |
(6) | Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||
Six months ended | |||
(in millions) | October 25, 2024 | October 27, 2023 | |
Net cash provided by operating activities | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,944 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,536 | |
Additions to property, plant, and equipment | (924) | (815) | |
Free Cash Flow (2) | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,020 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 721 |
See description of non-GAAP financial measures contained in the press release dated November 19, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
(2) | Free cash flow represents operating cash flows less property, plant, and equipment additions. |
MEDTRONIC PLC CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||
(in millions) | October 25, 2024 | April 26, 2024 | ||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,394 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,284 | ||
Investments | 6,595 | 6,721 | ||
Accounts receivable, less allowances and credit losses of $195 and $173, respectively | 6,260 | 6,128 | ||
Inventories | 5,479 | 5,217 | ||
Other current assets | 2,710 | 2,584 | ||
Total current assets | 22,438 | 21,935 | ||
Property, plant, and equipment, net | 6,438 | 6,131 | ||
Goodwill | 41,161 | 40,986 | ||
Other intangible assets, net | 12,423 | 13,225 | ||
Tax assets | 3,572 | 3,657 | ||
Other assets | 4,009 | 4,047 | ||
Total assets | $Â Â Â Â Â Â Â Â Â Â Â Â 90,042 | $Â Â Â Â Â Â Â Â Â Â Â Â 89,981 | ||
LIABILITIES AND EQUITY | ||||
Current liabilities: | ||||
Current debt obligations | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 3,719 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,092 | ||
Accounts payable | 2,376 | 2,410 | ||
Accrued compensation | 1,893 | 2,375 | ||
Accrued income taxes | 947 | 1,330 | ||
Other accrued expenses | 3,260 | 3,582 | ||
Total current liabilities | 12,195 | 10,789 | ||
Long-term debt | 24,607 | 23,932 | ||
Accrued compensation and retirement benefits | 1,084 | 1,101 | ||
Accrued income taxes | 1,432 | 1,859 | ||
Deferred tax liabilities | 473 | 515 | ||
Other liabilities | 1,534 | 1,365 | ||
Total liabilities | 41,326 | 39,561 | ||
Commitments and contingencies | ||||
Shareholders' equity: | ||||
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,282,553,150 and | — | — | ||
Additional paid-in capital | 20,824 | 23,129 | ||
Retained earnings | 30,919 | 30,403 | ||
Accumulated other comprehensive loss | (3,250) | (3,318) | ||
Total shareholders' equity | 48,494 | 50,214 | ||
Noncontrolling interests | 222 | 206 | ||
Total equity | 48,716 | 50,420 | ||
Total liabilities and equity | $Â Â Â Â Â Â Â Â Â Â Â Â 90,042 | $Â Â Â Â Â Â Â Â Â Â Â Â 89,981 |
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) | |||
Six months ended | |||
(in millions) | October 25, 2024 | October 27, 2023 | |
Operating Activities: | |||
Net income | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 2,327 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,708 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 1,337 | 1,344 | |
Provision for credit losses | 45 | 37 | |
Deferred income taxes | 57 | (36) | |
Stock-based compensation | 242 | 219 | |
Other, net | (98) | 182 | |
Change in operating assets and liabilities, net of acquisitions and divestitures: | |||
Accounts receivable, net | (181) | (117) | |
Inventories | (278) | (616) | |
Accounts payable and accrued liabilities | (707) | (699) | |
Other operating assets and liabilities | (800) | (486) | |
Net cash provided by operating activities | 1,944 | 1,536 | |
Investing Activities: | |||
Acquisitions, net of cash acquired | — | (22) | |
Additions to property, plant, and equipment | (924) | (815) | |
Purchases of investments | (4,019) | (3,403) | |
Sales and maturities of investments | 4,338 | 3,336 | |
Other investing activities, net | 1 | (59) | |
Net cash used in investing activities | (604) | (963) | |
Financing Activities: | |||
Change in current debt obligations, net | (67) | 1,321 | |
Issuance of long-term debt | 3,209 | — | |
Dividends to shareholders | (1,795) | (1,836) | |
Issuance of ordinary shares | 232 | 149 | |
Repurchase of ordinary shares | (2,780) | (378) | |
Other financing activities, net | (64) | 153 | |
Net cash used in financing activities | (1,265) | (591) | |
Effect of exchange rate changes on cash and cash equivalents | 35 | (214) | |
Net change in cash and cash equivalents | 110 | (232) | |
Cash and cash equivalents at beginning of period | 1,284 | 1,543 | |
Cash and cash equivalents at end of period | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,394 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,311 | |
Supplemental Cash Flow Information | |||
Cash paid for: | |||
Income taxes | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,335 | $Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1,110 | |
Interest | 513 | 476 |
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow on LinkedIn .
FORWARD LOOKING STATEMENTS
 This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company's periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. In some cases, you can identify these statements by forward-looking words or expressions, such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "looking ahead," "may," "plan," "possible," "potential," "project," "should," "going to," "will," and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release, including to reflect future events or circumstances.
NON-GAAP FINANCIAL MEASURES
 This press release contains financial measures, including adjusted net income, adjusted diluted EPS, and organic revenue, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. References to quarterly or annual figures increasing, decreasing or remaining flat are in comparison to fiscal year 2024, and references to sequential changes are in comparison to the prior fiscal quarter.
Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company's underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management's review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company's consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.
Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking organic revenue growth guidance excludes the impact of foreign currency fluctuations, as well as significant acquisitions or divestitures. Forward-looking diluted non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.
Multitom Raxâ„¢ is a trademark of Siemens Healthcare GmbH.
Contacts: | |
Erika Winkels | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-763-526-8478 | +1-763-505-4626 |
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SOURCE Medtronic plc
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