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.
News Provided by GlobeNewswire via QuoteMedia
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.
News Provided by GlobeNewswire via QuoteMedia
Cardiex: Biomarker Technologies, Digital Solutions to Address the World’s Largest Health Disorders
Cardiex Limited (ASX:CDX) leverages its proprietary SphygmoCor® technology to develop and market vascular biomarker technologies and digital solutions focused on the world’s largest health disorders. SphygmoCor®, the company's groundbreaking technology, has set the benchmark for noninvasive measurement of central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
The unique physiologic insights from the company’s devices provide clinically relevant information that helps guide treatment decisions and offer profound benefits for all members of the healthcare community:
For Healthcare Providers: Enable physicians to make more informed treatment decisions based on clinically relevant vascular health data.
For Patients: Give patients the tools to make better decisions about their own health.
For Pharmaceutical Companies: Generate reliable, real-world, clinically relevant data to accelerate drug development and commercialization.
Cardiex’s goal is to establish a holistic ecosystem that promotes cardiovascular well-being and empowers users to proactively manage their health as an integral part of individuals' health routines, contributing to a paradigm shift in preventive cardiovascular care.
The company’s first-mover advantage and exclusive technology FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics grant it a distinctive market position. CDX recently secured AU$14 million in funding, which is enough to steer the company towards profitability.
Company Highlights
- Cardiex Limited is an ASX-listed medical technology company that develops and markets vascular biomarker technologies and digital solutions for the world’s largest health disorders.
- The company’s offerings encompass FDA-cleared medical and home health devices alongside digital solutions tailored for managing health and wellness, delivering unique physiologic insights that inform clinical treatment decisions.
- The company’s groundbreaking technology – named SphygmoCor® – set the benchmark for measuring central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
- These biomarkers, extensively researched and detailed in numerous peer-reviewed journals, assess cardiovascular risk and guide disease management by predicting organ damage (such as the heart, brain, and kidneys) and outcomes (including heart failure, ischemic heart disease, and stroke), significantly influencing disease prognosis and clinical treatment.
- CDX received five FDA clearances from 2002 to 2023, the most recent for the CONNEQT Pulse, a world-first connected vascular biometric monitor. The CONNEQT Pulse targets new and significant healthcare channels and transitions the company towards a recurring revenue model based on monthly subscription fees.
- CDX's technology is uniquely FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics – thereby granting it a distinctive competitive market position. With a significant funding round recently secured, CDX is poised for profitability ahead.
This Cardiex profile is part of a paid investor education campaign.*
Click here to connect with Cardiex Limited (ASX:CDX) to receive an Investor Presentation
Medtronic: Americans Favor Quality Over Quantity in Pursuit of Longevity
According to a new survey from Medtronic and Morning Consult, nearly two-thirds of U.S. adults say they'd opt for a shorter, healthier life than a longer one with health issues
Americans overwhelmingly say that when they think about longevity, it's more than just living longer - it's about living their healthiest, best lives. While most want to live to 90-well past the average U.S. life expectancy of 77.5 years-nearly two-thirds (66%) would choose a shorter, healthier life over a longer one with health issues. These findings, from a survey conducted by global healthcare technology leader Medtronic with Morning Consult, highlight a gap between U.S. adults' desire to live healthier years and the opportunity for more people to improve their quality of life through healthcare technology
With almost limitless health-related information at our fingertips and new healthcare innovations emerging daily, the American dream of extending both our lifespan and quality of life seems possible. However, only 39% of U.S. adults say they are taking preventative health measures such as screenings and regular medical check-ups, and less than a third (29%) are discussing longevity with their doctor. Only about half are focused on eating healthy (53%) and exercising (51%), despite diet and physical inactivity being leading contributors to chronic disease. And while 80% of Americans believe healthcare technology can help them live longer and healthier, only 18% are taking advantage of it.
"Health conditions can impact anyone at any age, so it's critical that we expand treatment options while also continuing to focus on prevention, so people can prioritize what's most important to them," said Dr. Laura Mauri, chief scientific, medical and regulatory officer at Medtronic. "The role of technology in helping people live longer and better lives is accelerating. It's enabling more personalized treatments, quicker recoveries and earlier diagnosis. What's more, every day researchers are discovering new technologies that continue to improve longevity and quality of life."
Perhaps the greatest power of technology is the range of options - and hope - it can give people regardless of their current health status. Already, healthcare technology is helping catch cancer before it progresses, treat pain with less oral medication and reduce the burden from chronic diseases.
"In my 19 years as a diabetic, I feel more supported by my diabetes technology than I ever have before," said Cameron Moore, who uses a Medtronic insulin pump with meal detection technology. "It means I worry less about complications so I can focus on the here and now of life with my family and enjoy each day to the fullest."
There are steps people can take today to take charge of their health and live their best life. Follow the acronym T.E.C.H.:
- Talk to your doctor - Thanks to technologies like AI, there are new screening options that help detect and treat diseases earlier, including several common cancers and avoiding stroke. Ask your doctor what's available and how it might benefit you.
- Explore treatment options - No one wants to be defined by their disease or ailment. Technology is helping reduce the burden of living with chronic conditions, like diabetes, high blood pressure, heart disease and neurologic disease and tech can also be an alternative to opioids for chronic pain.
- Check your assumptions - Some people delay getting treatment due to worry about a long hospitalization or recovery time. Non-invasive or minimally invasive surgery procedures are resulting in fewer complications, shorter hospital stays and faster return to normal activities.
- Honor your needs - Ensure your doctor knows what's important to you - attending a special event, continuing an activity you enjoy, or simplifying your care. This will help them develop a treatment plan with you that prioritizes your quality of life.
For more information on how Medtronic is advancing healthcare through technology and helping people live longer and healthier, visit Medtronic.com.
About the Consumer Perceptions of Longevity Survey
The survey was conducted by decision intelligence company Morning Consult among a nationally representative sample of 2,200 adults in the U.S. from February 15-20, 2024, with an unweighted margin of error of +/- 2 percentage points.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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.
Contacts:
Erika Winkels
Public Relations
+1-763-526-8472
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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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Cardiex Limited
Overview
Cardiex Limited (ASX:CDX) is an ASX-listed medical technology company leveraging its proprietary SphygmoCor® technology to develop and market vascular biomarker technologies and digital solutions focused on the world’s largest health disorders. The company’s groundbreaking technology – SphygmoCor® – set the benchmark for noninvasive measurement of central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
While measuring arterial health parameters had always been considered clinically beneficial, it was not considered for routine out-patient clinical use as it previously required an invasive catheterization procedure with a pressure sensor inserted into the aorta. Founded on 40 years of hemodynamics studies and backed by 20+ years of research, Cardiex’s SphygmoCor technology employs non-invasive techniques to assess "central aortic waveforms," offering valuable insights into various clinically significant arterial health parameters including arterial stiffness, central blood pressure (the pressure at the heart), pulse pressure, and crucial indicators of vascular health for major organs such as the heart, brain and kidneys.
Assessing central blood pressure directly at the heart is deemed superior to conventional blood pressure measurements taken at the arm, primarily owing to the heart's proximity to vital organs. Cardiex’s FDA-cleared devices replace traditional blood pressure technology for first-line screening and monitoring of arterial health status. The unique physiologic insights from the company’s devices provide clinically relevant information that helps guide treatment decisions and offer profound benefits for all members of the healthcare community:
For Healthcare Providers: Enable physicians to make more informed treatment decisions based on clinically relevant vascular health data.
For Patients: Give patients the tools to make better decisions about their own health.
For Pharmaceutical Companies: Generate reliable, real-world, clinically relevant data to accelerate drug development and commercialization.
For more than two decades, the company’s SphygmoCor technology has set the benchmark for vascular biomarker assessments, adopted by premier hospitals and pharmaceutical giants worldwide. SphygmoCor is the chosen technology for measuring central blood pressure in all of the "top 20 hospitals" in the US and has played a crucial role in the clinical trials of leading firms including Bayer, AstraZeneca, Roche, Novartis and GlaxoSmithKline.
Between 2002 and 2023, CDX received five FDA clearances, the latest for the CONNEQT Pulse, a first-of-its-kind connected vascular biometrics monitor.
Cardiex devices have previously been sold and used exclusively in clinical settings – principally by specialist clinicians, for research, and by pharmaceutical companies for drug assessment. The introduction of CONNEQT Pulse represents a significant shift for Cardiex, allowing the company to enter the connected care market and transition from niche segments to the mass healthcare market. Priced comparably to a home health monitor, the CONNEQT Pulse is positioned for widespread adoption and can be deployed at scale in general healthcare practices, homes, or any location where patients are present.
The CONNEQT Pulse will also bolster Cardiex's portfolio in clinical trial solutions with the introduction of a decentralized clinical trial (DCT) platform. The Cardiex DCT platform empowers clinical trial managers to remotely monitor thousands of patients in their homes, enabling pharmaceutical companies to more effectively evaluate potential vascular outcomes across various trial phases. This leads to increased efficiency and cost-effectiveness in trial outcomes.
Furthermore, in response to the growing demand for proactive health monitoring, Cardiex will be launching an innovative wrist-worn device that leverages the SphygmoCor technology to deliver a medical grade wearable with capabilities far beyond conventional health trackers. The CONNEQT Band will be a wearable “cuffless” device designed to monitor vascular health in patients as well as to provide general health insights to consumers.
Cardiex’s goal is to establish a holistic ecosystem that promotes cardiovascular well-being and empowers users to proactively manage their health as an integral part of individuals' health routines, contributing to a paradigm shift in preventive cardiovascular care.
The company’s first-mover advantage and exclusive technology FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics grant it a distinctive market position. CDX recently secured AU$14 million in funding, which is enough to steer the company towards profitability.
With the entry into the connected care home market with the CONNEQT Pulse, CDX is transitioning towards a recurring revenue model based on monthly subscription fees. This should excite investors, given that the recurring revenue model will receive a higher multiple by the market, thereby boosting the company's valuation.
Company Highlights
- Cardiex Limited is an ASX-listed medical technology company that develops and markets vascular biomarker technologies and digital solutions for the world’s largest health disorders.
- The company’s offerings encompass FDA-cleared medical and home health devices alongside digital solutions tailored for managing health and wellness, delivering unique physiologic insights that inform clinical treatment decisions.
- The company’s groundbreaking technology – named SphygmoCor® – set the benchmark for measuring central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
- These biomarkers, extensively researched and detailed in numerous peer-reviewed journals, assess cardiovascular risk and guide disease management by predicting organ damage (such as the heart, brain, and kidneys) and outcomes (including heart failure, ischemic heart disease, and stroke), significantly influencing disease prognosis and clinical treatment.
- CDX received five FDA clearances from 2002 to 2023, the most recent for the CONNEQT Pulse, a world-first connected vascular biometric monitor. The CONNEQT Pulse targets new and significant healthcare channels and transitions the company towards a recurring revenue model based on monthly subscription fees.
- CDX's technology is uniquely FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics – thereby granting it a distinctive competitive market position. With a significant funding round recently secured, CDX is poised for profitability ahead.
Products and Brands
The company’s solution is organised under two brands: ATCOR and CONNEQT.
ATCOR
ATCOR offers solutions for hospitals, research and pharma, and specialist clinician markets. ATCOR's solutions have been utilized in 46 pharmaceutical clinical trials thus far, across more than 1,700 study sites worldwide, and have been highlighted in over 2,400 peer-reviewed studies showcased in top-tier medical journals. It offers two devices – the company’s flagship device, the SphygmoCor XCEL, and the SunTech Oscar 2 with “SphygmoCor Inside”.
SphygmoCor XCEL: The SphygmoCor XCEL measures central and brachial blood pressures, providing insights into cardiovascular function. Additionally, it assesses numerous other clinically relevant vascular biomarkers, offering a comprehensive understanding of arterial stiffness and health. These advanced physiological measurements enable early detection of potential cardiovascular issues, guiding targeted interventions for maintaining or improving overall cardiovascular health.
SunTech Oscar 2 with “SphygmoCor Inside”: Jointly developed and marketed by SunTech Medical and Cardiex, the Oscar 2™ ABPM with “SphygmoCor Inside” produces a suite of unique vascular health features and health insights captured by the SphygmoCor technology over a continuous period. It provides valuable diagnostic information that traditional ambulatory blood pressure monitors are incapable of measuring.
CONNEQT
CONNEQT is focused on devices and solutions for home health, remote patient monitoring, and decentralized clinical trials. Cardiex offers two devices under the CONNEQT brand – the recently FDA-cleared CONNEQT Pulse and the upcoming CONNEQT Band wearable. The company estimates CONNEQT’s total addressable market opportunity to be nearly $283 billion across three markets – remote patient monitoring ($175 billion), health wearables ($104 billion), and decentralized clinical trials ($14 billion).
CONNEQT Pulse: The CONNEQT Pulse provides measurements of both central and brachial blood pressures, alongside vascular biomarkers reflecting arterial stiffness and overall vascular health—metrics once exclusively only available to specialist clinics, research, and pharmaceutical companies. As a Bluetooth-enabled device, it empowers patients and health enthusiasts to track their arterial health from home, employing the same advanced tools used by top cardiologists in research centers and clinics.
Physicians can prescribe the CONNEQT Pulse to patients requiring heart health monitoring. Patient data seamlessly integrates with the CONNEQT Patient Management Portal (CPMP), a HIPAA-compliant cloud-based tool that enables healthcare providers to remotely track patients' arterial health by way of a tablet. Furthermore, consumers and patients can access comprehensive arterial health insights, coaching, lifestyle programs, and additional health resources via the CONNEQT app.
CONNEQT Band: CONNEQT Band is a world's-first dual sensor arterial health wearable device featuring an innovative design with dual (wrist-and finger-based) photoplethysmography (PPG) optical sensors. The wrist-based sensor continuously captures physiological data such as heart rate, respiration, stress, activity, sleep, and pulse oximetry, while our patented on-demand finger-based side sensor uniquely derives clinically meaningful vascular biomarkers representing arterial stiffness and cardiovascular health.
By combining data from both sensors, the CONNEQT Band offers users a comprehensive view of their overall cardiovascular health which has never been available outside of a physician’s office. The CONNEQT Band is also supported by the CONNEQT app, available for both iOS and Android devices, which serves as a hub where users can easily access detailed reports, track their progress over time, explore content, and receive personalized health insights and recommendations.
The CONNEQT Band is currently in the process of FDA submission preparation. This innovative device is poised to extend the company's portfolio in connected health technology, offering users a new, user-friendly tool for monitoring their health metrics. With its cutting-edge features, the CONNEQT Band is expected to make a significant impact in the way individuals manage their wellness, bridging the gap between advanced health monitoring and everyday convenience.
A significant global market opportunity in wearable health devices is driven by nearly 1.3 billion hypertensive and other vascular disease patients. Some of the other wearable device firms have attracted significant funding at high valuations in recent times. For instance, Oura Health, a Finnish company that makes smart rings for tracking sleep and physical activity, was valued at $2.55 billion in April 2022.
Board of Directors & Management
Craig Cooper – Chief Executive Officer and Executive Director
Craig Cooper has established numerous prosperous health, digital media, technology and wellness ventures. Notably, he co-founded Boost Mobile, a prominent telecommunications company recognized as one of the leading mobile phone businesses in the USA. He is acknowledged as a distinguished authority and influential figure on a global scale in mobile and wireless technology, as well as businesses related to digital health and medical technology. His venture capital endeavors have secured over AU$3 billion, financing some of the most impactful global digital media technology companies. Cooper is also a principal of C2 Ventures, Cardiex’s largest shareholder.
Niall Cairns – Executive Chairman
Niall Cairns boasts a successful 25-year record of investing in both private and public companies. He has played a pivotal role in advancing the global expansion of more than 50 enterprises spanning various sectors, including digital media, agtech, medtech, consumer internet, and SaaS-based businesses. Cairns is also a principal of C2 Ventures, Cardiex’s largest shareholder.
King Nelson – Non-executive Director
King Nelson brings over 30 years of extensive experience in medical devices. He was previously the president and CEO at Uptake Medical Corporation, concentrating on treatments for emphysema and lung cancer. Before Uptake, he served as president and CEO of Kerberos Proximal Solutions, a company later acquired by FoxHollow Technologies. He was also president and CEO of VenPro, a heart valve business acquired by Medtronic. King also accumulated 19 years of experience with Baxter International and American Hospital Supply Corporation, progressing through various roles with increasing responsibilities. These roles included serving as division president for Dade Diagnostics, Bentley Labs, and Baxter’s Perfusion Services. Nelson is currently the CEO at Q’Apel Medical, a medical device company specializing in neurovascular disease.
Charlie Taylor – Non-executive Director
Charlie Taylor has over three decades of international advisory experience and recently concluded his tenure as senior partner at McKinsey, where he oversaw the health and public sector practice. Taylor has counseled numerous private and public sector healthcare organizations in Australia and globally, covering areas such as strategy, digitalization, operational enhancements, growth transformations, international expansion, supply chain management, mergers and acquisitions, and board governance. He is a non-executive director of Healius, a leading Australian health diagnostics company, and a part-time senior board advisor at McKinsey for the health and public sector practice.
Sanjeev Bhavnani, M.D. – Chief Clinical Officer
Dr. Sanjeev Bhavnani has served as a senior medical officer at the Digital Health Center of Excellence within the FDA's Center for Devices and Radiological Health (CDRH), overseeing clinical and scientific initiatives concerning digital health and medical devices incorporating artificial intelligence.
Bhavnani is also currently a senior cardiologist and principal investigator of digital health and machine learning at Scripps Clinic in San Diego, California, where he leads programs to develop and validate new technologies and to evaluate the safety and effectiveness of DHTs, nanosensors, cloud-based analytical platforms, handheld imaging technologies, AI/ML algorithms and software as a medical device. For over a decade, Bhavnani was the principal investigator of 90 clinical trials and patient care programs. These programs have enrolled over 30,000 patients in the US and in resource-limited areas. His team developed the SMART-FHIR integration interface for DHT data into EMRs for remote patient monitoring, remote therapeutic monitoring, and chronic care management, creating a real-world data platform to monitor the healthcare quality of DHT and ML devices in traditional and new consumer models of care delivery.
Catherine Liao – Chief Strategy Officer
Catherine Liao has served as our chief strategy officer since September 2022. Previously, Liao served as chief executive officer of Blumio, a pioneering medical device startup, from February 2016 to September 2022, where she led efforts in raising capital, formed a leadership and advisory board rich in knowledge spanning healthcare innovations, enterprise technology, and sensor technology. Her notable achievements include leading the commercialization of a groundbreaking medical radar sensor development platform, which garnered significant industry attention and was eventually acquired by Cardiex. Liao holds an MBA from Imperial College London and a Master of Science in Health Economics from the London School of Economics. These credentials underscore her deep and comprehensive insight into the intricacies of both the business world and the healthcare sector, demonstrating a balanced expertise critical for navigating and innovating within today’s complex healthcare economies.
Mark Gorelick, Ph.D. – Chief Product Officer
Dr. Mark Gorelick has served as Cardiex’s chief product officer since December 2020, bringing a wealth of experience from various leadership roles in the health and wellness technology sector. With an impressive tenure beginning in 2007, he has been at the helm as managing director of XPhys Technologies, a company at the forefront of developing innovative fitness, health, and wellness products. His strategic vision was further demonstrated through his role as vice-president of Digital Health, from 2018 to 2019, at Performance Lab Technologies, acclaimed for its software development prowess in the health sector. Further cementing his reputation in health technology, Gorelick served as the chief science officer at PAI Health (originally Mio Global) from 2015 to 2018, where he was instrumental in advancing health technology software solutions. Holding a BSc and MSc in kinesiology from Dalhousie University and a Ph.D. in biomedical science from University of Wollongong, Gorelick’s educational background underscores his deep-rooted understanding and innovative approach to biomedical science and kinesiology, reinforcing his invaluable contribution to our company and the broader health technology landscape.
This profile was written in collaboration with Couloir Capital.
Americans favor quality over quantity in pursuit of longevity
According to a new survey from Medtronic and Morning Consult, nearly two-thirds of U.S. adults say they'd opt for a shorter, healthier life than a longer one with health issues
Americans overwhelmingly say that when they think about longevity, it's more than just living longer—it's about living their healthiest, best lives. While most want to live to 90—well past the average U.S. life expectancy of 77.5 years—nearly two-thirds (66%) would choose a shorter, healthier life over a longer one with health issues. These findings, from a survey conducted by global healthcare technology leader Medtronic with Morning Consult, highlight a gap between U.S. adults' desire to live healthier years and the opportunity for more people to improve their quality of life through healthcare technology.
With almost limitless health-related information at our fingertips and new healthcare innovations emerging daily, the American dream of extending both our lifespan and quality of life seems possible. However, only 39% of U.S. adults say they are taking preventative health measures such as screenings and regular medical check-ups, and less than a third (29%) are discussing longevity with their doctor. Only about half are focused on eating healthy (53%) and exercising (51%), despite diet and physical inactivity being leading contributors to chronic disease. And while 80% of Americans believe healthcare technology can help them live longer and healthier, only 18% are taking advantage of it.
"Health conditions can impact anyone at any age, so it's critical that we expand treatment options while also continuing to focus on prevention, so people can prioritize what's most important to them," said Dr. Laura Mauri , chief scientific, medical and regulatory officer at Medtronic. "The role of technology in helping people live longer and better lives is accelerating. It's enabling more personalized treatments, quicker recoveries and earlier diagnosis. What's more, every day researchers are discovering new technologies that continue to improve longevity and quality of life."
Perhaps the greatest power of technology is the range of options—and hope—it can give people regardless of their current health status. Already, healthcare technology is helping catch cancer before it progresses, treat pain with less oral medication and reduce the burden from chronic diseases.
"In my 19 years as a diabetic, I feel more supported by my diabetes technology than I ever have before," said Cameron Moore , who uses a Medtronic insulin pump with meal detection technology. "It means I worry less about complications so I can focus on the here and now of life with my family and enjoy each day to the fullest."
There are steps people can take today to take charge of their health and live their best life. Follow the acronym T.E.C.H.:
- T alk to your doctor – Thanks to technologies like AI, there are new screening options that help detect and treat diseases earlier, including several common cancers and avoiding stroke. Ask your doctor what's available and how it might benefit you.
- E xplore treatment options – No one wants to be defined by their disease or ailment. Technology is helping reduce the burden of living with chronic conditions, like diabetes, high blood pressure, heart disease and neurologic disease and tech can also be an alternative to opioids for chronic pain.
- C heck your assumptions – Some people delay getting treatment due to worry about a long hospitalization or recovery time. Non-invasive or minimally invasive surgery procedures are resulting in fewer complications, shorter hospital stays and faster return to normal activities.
- H onor your needs – Ensure your doctor knows what's important to you— attending a special event, continuing an activity you enjoy, or simplifying your care. This will help them develop a treatment plan with you that prioritizes your quality of life.
For more information on how Medtronic is advancing healthcare through technology and helping people live longer and healthier, visit Medtronic.com.
About the Consumer Perceptions of Longevity Survey
The survey was conducted by decision intelligence company Morning Consult among a nationally representative sample of 2,200 adults in the U.S. from February 15-20, 2024 , with an unweighted margin of error of +/- 2 percentage points.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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.
Contacts: | ||
Erika Winkels | Ryan Weispfenning | |
Public Relations | Investor Relations | |
+1-763-526-8472 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/americans-favor-quality-over-quantity-in-pursuit-of-longevity-302118841.html
SOURCE Medtronic plc
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/17/c6028.html
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Bausch Health to Announce First-Quarter 2024 Results on May 2
Bausch Health Companies Inc. (NYSE:NHC)(TSX:BHC) will release first-quarter 2024 financial results on Thursday, May 2, 2024. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call
Conference Call Details
Date: | Thursday, May 2, 2024 |
Time: | 8:00 a.m. U.S. EDT |
Webcast: |
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive a PIN, which will be sent an hour before the conference call.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
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Investor Contact: | Media Contact: | |
Garen Sarafian | Kevin Wiggins | |
ir@bauschhealth.com | corporate.communications@bauschhealth.com | |
(877) 281-6642 (toll-free) | (908) 541-3785 |
SOURCE: Bausch Health Companies Inc.
View the original press release on accesswire.com
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Court of Appeals for the Federal Circuit Issues Ruling in Norwich Case that Prevents FDA Approval of Norwich's Abbreviated New Drug Application Until 2029
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that the U.S. Court of Appeals for the Federal Circuit in the matter of Salix Pharmaceuticals, LTD. et al v. Norwich Pharmaceuticals, Inc., affirmed the May 17, 2023 decision of the U.S. District Court for the District of Delaware that had denied Norwich Pharmaceuticals, Inc.'s motion for modification of the court's final order preventing the U.S. Food and Drug Administration (FDA) from approving its abbreviated new drug application (ANDA) for XIFAXAN (rifaximin) 550 mg before Oct. 2, 2029. The Court of Appeals also affirmed the August 10, 2022 decision of the District Court that invalidated certain U.S. Patents protecting the composition and use of XIFAXAN® for treating IBS-D. As a result of the Federal Circuit's decision, Norwich's abbreviated new drug application for XIFAXAN (rifaximin) 550 mg remains barred from approval by the U.S. Food and Drug Administration until Oct. 2, 2029
"We are pleased that the Federal Circuit maintained the judgment preventing the approval of Norwich's abbreviated new drug application for XIFAXAN (rifaximin) 550 mg by the U.S. Food and Drug Administration until October 2029," said Thomas J. Appio, Chief Executive Officer. "While we are disappointed that the Federal Circuit affirmed the invalidity of certain XIFAXAN IBS-D patents and disagree with this aspect of the Court's decision, we will continue to vigorously defend our intellectual property. We remain committed to advocating for the safety of patients who have benefited from continued access to XIFAXAN, and we look forward to continuing to serve those patients."
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company's appeal with respect to, and actions to vigorously defend, its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
Investor Contact: | Media Contact: | |
Garen Sarafian | Kevin Wiggins | |
ir@bauschhealth.com | corporate.communications@bauschhealth.com | |
(877) 281-6642 (toll free) | (848) 541-3785 |
SOURCE: Bausch Health Companies Inc.
View the original press release on accesswire.com
News Provided by ACCESSWIRE via QuoteMedia
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