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 Completion of Pivotal Non-Inferiority Study on the GluCurve Pet CGM
ALR Technologies Inc. ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, today announced successful results from the conclusion of the non-inferiority study conducted on the GluCurve Pet CGM which was previously announced on February 10, 2022 and February 28, 2022. GluCurve is the first of its kind Continuous Glucose Monitor (CGM) specifically for diabetic cats and dogs.
Notable findings from the study:
- Utilizing a chemistry analyzer as the baseline, the GluCurve Pet CGM was more accurate than the leading Blood Glucose Meter (BGM) for animals 47.8% of the time.
- 100% of the GluCurve Pet CGM readings paired to the chemistry analyzer reference values were within ±20%, compared to 86.9% from the animal BGM
- The GluCurve Pet CGM's average deviation from the baseline was 9.7% compared to 8.2% from the animal BGM.
- No clinically significant differences were found when comparing the GluCurve Pet CGM to the chemistry analyzer or leading animal BGM.
- GluCurve displayed otherwise unavailable data on insulin injection times, eating habits, activity, and stress seen through changes in glucose on a day-to-day basis.
Dr. Imperato, lead veterinarian in the study commented, "The GluCurve Pet CGM plugs a long-standing gap in managing veterinary diabetic patients; not only will veterinarians finally receive effortlessly accurate data, the patients will live longer too."
"The non-inferiority study further demonstrates the significant need for GluCurve in veterinary medicine. The in-home data collected is invaluable to veterinarians and by analyzing and organizing it into effective patient management it greatly reduces the effort and time needed by clinicians to treat diabetic pets," said Sidney Chan, Chairman and CEO of ALR Technologies. "Now that we have the successful results of the non-inferiority study, a MOU for manufacturing with a definitive agreement in the works, and conducted preliminary discussions with the leading animal health pharmaceutical companies, we are well positioned to start realizing the full potentials of ALRT. We will now focus our attention on completing a partnership agreement in the near future to commercially launch GluCurve Pet CGM in a meaningful way in Q3 2022."
About ALR Technologies
ALR Technologies is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes: an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices; a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and will expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals. Thus, delivering the same optimization of diabetic drug therapies to pets as to humans.
On June 1, 2021, ALR Technologies Inc. announced its intention to migrate to Singapore. More information about ALR Technologies Inc. can be found at www.alrt.com. Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Ken Robulak (US)
Phone: +1 (727) 736-3838
Anthony Ngai (Singapore)
Phone: +65 3129 2924
Email: ir@alrt.com
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events or the negative of these terms are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Specifically, that the Company will enter into partnership to launch GluCurve Pet CGM, that GluCurve Pet CGM will launch in Q3 2022 or thereafter. The forward-looking statements included in this news release are made as of the date hereof. ALR Technologies disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
News Provided by GlobeNewswire via QuoteMedia
Top 5 Small-cap Medical Device Stocks (Updated January 2025)
The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device technology. In 2024 alone,30 new devices were approved by the US Food and Drug Administration (FDA).
Wearable medical devices and the use of artificial intelligence in medical technology are two key trends in this sector. Moving forward, BCC Research projects that the global medical device industry will increase from US$810.4 billion in 2024 to US$1.3 trillion by 2029, expanding at a CAGR of 9.8 percent.
Investors who want exposure to this wave of growth may want to consider NASDAQ small-cap medical device stocks. Below, the Investing News Network has compiled a list of the top NASDAQ medical device companies based on yearly gains.
All data was compiled on January 14, 2025, using TradingView’s stock screener, and the medical device makers listed below had market caps between US$50 million and US$500 million at that time.
1. Delcath Systems (NASDAQ:DCTH)
Year-over-year gain: 202.86 percent
Market cap: US$405.43 million
Share price: US$12.69
Delcath Systems is a pharmaceutical and medical device company focused on “interventional oncology,” specifically in the treatment of primary and metastatic liver cancers. Delcath's commercial product portfolio is focused on combining its Hepactic Delivery System (HDS) with the chemotherapeutic drug melphalan for "high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects."
The HDS is approved in the US and Europe under different commercial names and categories. In the US, it is marketed in combination with melphalan as the FDA-approved Hepzato Kit, which is considered a combination drug and device product. In Europe, the HDS is marketed as device-only under the name Chemostat Hepatic Delivery System for Melphalan and is regulated as a Class III medical device.
Delcath Systems’ share price got its first big boost in the second quarter of 2024, rising nearly 45 percent from US$5.56 on May 5 to US$8.04 on May 21, 2024, a period that included the publication of encouraging results from its FOCUS Study in metastatic uveal melanoma patients treated with the Hepzato Kit and its first quarter financials highlighting total revenues of US$3.1 million, up more than 416 percent over the same quarter in the previous year.
A series of positive study results released in late August sent shares in Delcath rising another 37 percent. This included an independent study conducted by the University Hospital of Leipzig, Germany, which shows the efficacy and safety of repeated chemosaturation treatments using Delcath’s Chemostat system for the treatment of patients with primary or secondary liver tumors.
On December 2, Delcath announced that it received FDA clearance for its investigational new Drug application for a Phase 2 clinical trial evaluating Hepzato in combination with standard of care for liver-dominant metastatic colorectal cancer. The clearance gives Delcath the authorization to initiate patient enrollment, which the company expects to begin in the second half of 2025. The news sent Delcath’s stock up to US$12.64 per share.
Shares in Delcath reached their highest yearly peak of US$12.79 on January 13, 2025, after the company shared outstanding preliminary fourth quarter and full-year total revenues of about US$15.1 million and US$37.2 million, respectively.
2. Sensus Healthcare (NASDAQ:SRTS)
Year-over-year gain: 147.76 percent
Market cap: US$108.01 million
Share price: US$6.59
Sensus Healthcare is a medical device company that delivers and develops non-invasive treatments for skin cancer and keloids. The company has developed a patient-centric treatment platform based on its superficial radiotherapy (SRT and IG-SRT) technology.
In early May 2024, Sensus Healthcare posted product sales milestones and robust first quarter financials that gave its share price a nearly 70 percent boost to US$6.42 on May 16. The company announced the sale of the first SRT-100 Vision (IG-SRT) system in Asia, followed by the commercial sale of the SRT-100 to a veterinary specialist in Israel, its first for veterinary use outside the United States. Lastly, Sensus reported Q1 2024 revenues of US$10.7 million, up from US$3.4 million in the prior-year quarter.
Sensus' share price received its next big bump up in November after the company reported its Q3 financials, including revenues of US$8.8 million compared to US$3.9 million in the prior-year quarter. On November 20, the company’s stock reached its highest point of the past year at US$8.94 per share.
3. Pro-Dex (NASDAQ:PDEX)
Year-over-year gain: 118.55 percent
Market cap: US$146.02 million
Share price: US$44.80
Pro-Dex develops and manufactures battery-powered and electrical surgical instruments used in the orthopedic, spine, maxocranial facial and dental markets. Some of its customers include Smith & Nephew, the Lawrence Livermore National Laboratory, Medtronic (NYSE:MDT) and Arthrex.
Shares of Pro-Dex traded relatively sideways for much of the past year, with its biggest gains coming in the last four months. After the company announced its fiscal 2024 fourth quarter and full-year financial results in early September, its stock climbed nearly 42 percent to US$31.34 by October 1. Net sales for its Q4 ended June 30 increased by 41 percent year-over-year to US$15 million, while net sales for the fiscal year grew by 17 percent to US$53.8 million over the prior year.
Pro-Dex saw its stock price rally yet again in November, surging nearly 60 percent to US$49.55 per share on November 12. This latest upward momentum followed the company’s October 31 release of its fiscal 2025 first quarter financials. Net sales for the quarter ended September 30, 2024, increased 25 percent from the same quarter in the previous year to US$14.9 million.
4. AngioDynamics (NASDAQ:ANGO)
Year-over-year gain: 92.18 percent
Market cap: US$477.29 million
Share price: US$11.80
AngioDynamics is a global medical technology company that design, manufacturers and sells high-quality, minimally invasive medical devices. Its focus is on vascular access, surgery, peripheral vascular disease and oncology.
In mid-July, shares of AngioDynamics jumped 25 percent to US$7.51 following the release of its fiscal 2024 fourth quarter and full-year financials.
“Within our Mechanical Thrombectomy segment, we achieved key milestones by receiving both FDA 510(k) clearance and CE Marking for AlphaVac in the treatment of pulmonary embolism,” Jim Clemmer, President and CEO of AngioDynamics, stated. “These indications open up multiple large, fast-growing markets, and helped to drive a more than 68% sequential increase in AlphaVac revenue during the fourth quarter.”
AngioDynamics received FDA 510(k) clearance for its NanoKnife System for prostate tissue ablation on December 9, sparking a 31 percent rally that brought the share price to US$9.33 on December 16.
Shares in AngioDynamics hit their highest yearly peak of US$12.94 on January 8 following the release of the company’s fiscal 2025 second quarter financials. Net sales for the quarter came in at US$73 million, up 9.2 percent compared to the prior-year quarter.
5. KORU Medical Systems (NASDAQ:KRMD)
Year-over-year gain: 85.84 percent
Market cap: US$186.56 million
Share price: US$4.07
KORU Medical Systems develops and manufactures medical devices and supplies in the United States and internationally, with a focus in mechanical infusion products. Its Freedom Syringe Infusion System first received FDA clearance in 1994. Based on this system, its primary products include the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets.
Shares in KORU Medical made their biggest price gains in the last few months of 2024, rising more than 67 percent from the end of October to a yearly peak of US$4.40 per share on December 12.
On October 31, KORU Medical released positive data that it had presented days prior at the Partnership Opportunities in Drug Delivery Conference in Boston, Massachusetts. The data demonstrates nursing preference for use of the KORU FreedomEdge Infusion System over manual syringe administration for subcutaneous oncology infusion.
In mid-November, the company shared its third quarter 2024 financial results, which included net revenues of US$8.2 million, up 17 percent over the prior year period.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
Medtronic announces CMS national coverage analysis for Symplicity Spyral Renal Denervation System
- National coverage analysis is the first-of-its kind for a minimally invasive, interventional treatment for high blood pressure
- Milestone is supported by large public health need and robust, long-term data from the SPYRAL-HTN global clinical program
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic's request to support Medicare beneficiary access to the Symplicity™ Spyral renal denervation (RDN) system, used in the Symplicity blood pressure procedure.
"Hypertension is a global health epidemic that impacts a wide variety of patients," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral. We appreciate CMS' efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy."
CMS' action follows Medtronic's work with the agency to pilot the framework for the Transitional Coverage for Emerging Technologies (TCET) pathway to establish coverage for the Symplicity Spyral renal denervation system, a U.S. FDA-approved breakthrough device. As referenced in the CMS tracking sheet, the expected completion date for the national coverage analysis is October 11, 2025 . Until a national coverage determination is put into effect, Symplicity blood pressure procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients.
About the Symplicity Spyral renal denervation procedure
The Symplicity Spyral RDN system, approved by the U.S. Food and Drug Administration (FDA) in November 2023 , is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. Symplicity Spyral is the only commercially available RDN device with the breadth of durable, consistent, long-term data and single catheter design. The SPYRAL-HTN clinical program has demonstrated 18 mmHg office blood pressure reductions out to three years in a real-world setting, 1 has the longest and largest real-world registry 2 and the largest dataset showing long-term reductions without the need for additional medication. 2-3
The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN in over 4,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk. The Symplicity blood pressure procedure has demonstrated sustained and durable drops in blood pressure out to three years in randomized control and real-world registry trials. 5-8 The Symplicity RDN system is approved for commercial use in over 75 countries around the world.
About Hypertension
Hypertension, or high blood pressure, impacts more than1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death. 4 Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly 80% of adults with hypertension do not have it under control 1 and half of hypertension patients become non-adherent to medication within one year. 4-5
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow 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.
1 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomized, sham-controlled trial. The Lancet. 2022; 399:1401-1410.
2 Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug ;80(8):1759-177.
3 Kandzari DE et al. Long-term Safety and Efficacy of Radiofrequency Renal Denervation in the Presence of Antihypertensive Drugs: 24-Month Results from the SPYRAL HTN–ON MED Randomized Trial. TCT 2024
4 WHO. Hypertension fact sheet. September 13, 2019 . Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension . Accessed February 15, 2022 .
5 Bhatt, D. et al, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. The Lancet. September 18, 2022. DOI: https://doi.org/10.1016/S0140-6736 (22)01787-1.
6 Mahfoud, F. et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. August 2023; DOI: 10.1161/HYPERTENSIONAHA.123.21283.
7 Mahfoud, F. et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. April 2022. https://doi.org/10.1016/S0140-6736(22)00455-X(opens new window)
8 Mahfoud, F. et al. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. Journal of the American College of Cardiology. November 2022. https://doi.org/10.1016/j.jacc.2022.08.802
Contacts: | |
Krystin Hayward Leong | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-508-261-6512 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system-302349766.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
Medtronic announces CMS national coverage analysis for Symplicity Spyral Renal Denervation System
- National coverage analysis is the first-of-its kind for a minimally invasive, interventional treatment for high blood pressure
- Milestone is supported by large public health need and robust, long-term data from the SPYRAL-HTN global clinical program
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic's request to support Medicare beneficiary access to the Symplicity™ Spyral renal denervation (RDN) system, used in the Symplicity blood pressure procedure.
"Hypertension is a global health epidemic that impacts a wide variety of patients," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral. We appreciate CMS' efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy."
CMS' action follows Medtronic's work with the agency to pilot the framework for the Transitional Coverage for Emerging Technologies (TCET) pathway to establish coverage for the Symplicity Spyral renal denervation system, a U.S. FDA-approved breakthrough device. As referenced in the CMS tracking sheet, the expected completion date for the national coverage analysis is October 11, 2025 . Until a national coverage determination is put into effect, Symplicity blood pressure procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients.
About the Symplicity Spyral renal denervation procedure
The Symplicity Spyral RDN system, approved by the U.S. Food and Drug Administration (FDA) in November 2023 , is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. Symplicity Spyral is the only commercially available RDN device with the breadth of durable, consistent, long-term data and single catheter design. The SPYRAL-HTN clinical program has demonstrated 18 mmHg office blood pressure reductions out to three years in a real-world setting, 1 has the longest and largest real-world registry 2 and the largest dataset showing long-term reductions without the need for additional medication. 2-3
The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN in over 4,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk. The Symplicity blood pressure procedure has demonstrated sustained and durable drops in blood pressure out to three years in randomized control and real-world registry trials. 5-8 The Symplicity RDN system is approved for commercial use in over 75 countries around the world.
About Hypertension
Hypertension, or high blood pressure, impacts more than1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death. 4 Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly 80% of adults with hypertension do not have it under control 1 and half of hypertension patients become non-adherent to medication within one year. 4-5
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow 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.
1 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomized, sham-controlled trial. The Lancet. 2022; 399:1401-1410.
2 Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug ;80(8):1759-177.
3 Kandzari DE et al. Long-term Safety and Efficacy of Radiofrequency Renal Denervation in the Presence of Antihypertensive Drugs: 24-Month Results from the SPYRAL HTN–ON MED Randomized Trial. TCT 2024
4 WHO. Hypertension fact sheet. September 13, 2019 . Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension . Accessed February 15, 2022 .
5 Bhatt, D. et al, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. The Lancet. September 18, 2022. DOI: https://doi.org/10.1016/S0140-6736 (22)01787-1.
6 Mahfoud, F. et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. August 2023; DOI: 10.1161/HYPERTENSIONAHA.123.21283.
7 Mahfoud, F. et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. April 2022. https://doi.org/10.1016/S0140-6736(22)00455-X(opens new window)
8 Mahfoud, F. et al. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. Journal of the American College of Cardiology. November 2022. https://doi.org/10.1016/j.jacc.2022.08.802
Contacts: | |
Krystin Hayward Leong | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-508-261-6512 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system-302349766.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
Medtronic achieves CE Mark approval for BrainSense Adaptive deep brain stimulation and Electrode Identifier, a groundbreaking advance in personalized, sensing-enabled care for people with Parkinson's through innovative brain-computer interface technology
European approval introduces the world's only closed-loop DBS system with real-time, self-adjusting brain stimulation for people with Parkinson's disease
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, announced today CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR). In addition, the first programming was completed today, performed by Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. This landmark approval and first-in- Europe patient programming demonstrate significant advancements in personalized DBS therapy for people with Parkinson's in Europe including the UK.
For 30 years, people with Parkinson's disease have benefitted from deep brain stimulation (DBS), a technology that transmits electric signals to the brain to disrupt certain unwanted movement. With BrainSense™ aDBS, people with Parkinson's disease can now benefit from real-time, adaptive therapy that dynamically adjusts stimulation based on each person's unique brain activity, both in clinical settings and daily life 1 . BrainSense™ Electrode Identifier can improve DBS programming by ensuring optimal initial contact selection in less time 2 .
Caregivers and healthcare providers alike intimately understand how disruptive Parkinson's can be on one's daily life. Affecting over 1.2 million patients in Europe alone and more than 10 million people worldwide, Parkinson's is known to impact an individual's mobility, speech, focus, sleep, independence, and overall ability to participate fully in work, family, and social life. From sipping a cup of coffee to holding hands with a loved one, the disease can be debilitating and demoralizing, stripping away what many of us take for granted. For spouses and caregivers, this can be immensely demanding and distressing 3,4 .
"BrainSense™ technology † is at the center of personalizing DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform," said Paolo Di Vincenzo , president of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customize care for people with Parkinson's, and we're just getting started. The mission is to impact and improve many more lives with Medtronic DBS therapy."
The Medtronic Percept™ DBS system with BrainSense™ technology is designed to record and analyze brain signals, enabling therapies tailored to each patient's unique neurological patterns 1 . Medtronic has been at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy with the specific purpose of making advances in prevention, detection, diagnosis, rehabilitation, and restoration for patients with complex neurological conditions. As the world leader in DBS therapy, the Medtronic Percept™ neurostimulators with BrainSense™ technology serves as a benchmark for DBS sensing innovation.
"Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson's," said Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. "By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation that can be adapted to an individual's unique needs."
Medtronic is the originator of continuous deep brain stimulation (cDBS), which has been available for decades as a proven therapy for managing certain Parkinson's disease symptoms. BrainSense™ Adaptive DBS (aDBS) takes treatment to the next level, dynamically calibrating stimulation based upon a patient's own brain signals 1 .
"Medtronic remains the first and only company in the world to offer a complete sensing-enabled DBS system, and now we have enhanced this innovation to allow patients with Parkinson's to spend less time thinking about their disease," said Amaza Reitmeier , vice president and general manager, Neuromodulation marketing and strategy at Medtronic. "Patients and clinicians have been eagerly awaiting these BrainSense™ technology enhancements, which represent another transformative step forward in our ability to personalize therapy for people living with Parkinson's."
The Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial further highlights the potential of aDBS in clinical practice. Conducted as a global, multi-center, prospective, single-blind randomized crossover study (between two modes of aDBS), the trial evaluates the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to cDBS for eligible Parkinson's patients receiving DBS therapy. Developed in collaboration with more than a dozen world-renowned neurologists and neurosurgeons from leading academic institutions across the globe, this study represents the largest and longest assessment of aDBS conducted in both clinical and home settings 1 . The study methodology and sensing data from the Medtronic study were published in npj Parkinson's Disease , a journal within the prestigious Nature Portfolio.
"The CE Mark approval of BrainSense TM Adaptive DBS is a critical advancement in how we treat Parkinson's disease," said Alan Whone , PhD, professor of movement disorders neurology, University of Bristol and North Bristol NHS Trust. "Its potential to address certain challenging motor symptoms and improve day-to-day disease management offers new hope for patients and their families, broadening the transformative impact of deep brain stimulation."
BrainSense™ Electrode Identifier (EI) elevates precision and efficiency to unprecedented levels by providing a detailed view of each Parkinson's patient's unique brain signals and guiding clinicians to the exact location of the strongest signal in a fraction of the time needed for standard monopolar reviews 2 . This exclusive technology pinpoints the optimal contact location by leveraging local field potentials (LFP) and alpha-beta activity to guide optimized and effective programming compared to the standard of care, the monopolar review 2 .
"BrainSense™ Electrode Identifier allows clinicians to now conduct an accurate and precise initial programming, offering a level of personalization unmatched in the field," said Domenico De Paolis , vice president of Neuromodulation International at Medtronic. "Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection. CE Mark approval is just the first step in our effort to bring this new technology to customers around the world."
Since 1987, Medtronic has served more than 185,000 people with movement disorders and other indications in more than 70 countries with its life-changing DBS therapy 5 .
BrainSense™ aDBS and BrainSense™ Electrode identifier will be available in Europe in early 2025. Patients considering DBS therapy should discuss treatment options with their provider. Medtronic has filed for U.S. FDA approval of aDBS; it is not yet approved for sale or distribution in the United States .
To learn more about Medtronic DBS with BrainSense™ technology, visit our website .
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow 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.
† The sensing feature of the Percept™ PC and Percept™ RC system is intended for use in patients receiving DBS where chronically recorded bioelectric data may provide useful, objective information regarding patient clinical status.
References
- Thompson, J., Radcliffe , E., Ojemann, S.,et al. Monopolar sensing improves the efficiency of DBS programming in Parkinson's disease [abstract]. Mov Disord . 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/monopolar-sensing-improves-the-efficiency-of-dbs-programming-in-parkinsons-disease/ . Accessed 11/15/2024
- Stanslaski S, Summers RLS, Tonder L, et al. Sensing data and methodology from the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) clinical trial. NPJ Parkinsons Dis. 2024;10(1):174.
- OECD/European Commission (2024), Health at a Glance: Europe 2024: State of Health in the EU Cycle , OECD Publishing, Paris, https://doi.org/10.1787/b3704e14-en .
- Parkinson's Foundation. (2025). Statistics: Get informed about Parkinson's disease with these key numbers. Retrieved from https://www.parkinson.org
- Medtronic data on file.
Contacts: | |
Naomi Rodiles | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-612-427-5521 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-achieves-ce-mark-approval-for-brainsense-adaptive-deep-brain-stimulation-and-electrode-identifier-a-groundbreaking-advance-in-personalized-sensing-enabled-care-for-people-with-parkinsons-through-innovative-brain-comp-302348702.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
Medtronic achieves CE Mark approval for BrainSense Adaptive deep brain stimulation and Electrode Identifier, a groundbreaking advance in personalized, sensing-enabled care for people with Parkinson's through innovative brain-computer interface technology
European approval introduces the world's only closed-loop DBS system with real-time, self-adjusting brain stimulation for people with Parkinson's disease
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, announced today CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR). In addition, the first programming was completed today, performed by Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. This landmark approval and first-in- Europe patient programming demonstrate significant advancements in personalized DBS therapy for people with Parkinson's in Europe including the UK.
For 30 years, people with Parkinson's disease have benefitted from deep brain stimulation (DBS), a technology that transmits electric signals to the brain to disrupt certain unwanted movement. With BrainSense™ aDBS, people with Parkinson's disease can now benefit from real-time, adaptive therapy that dynamically adjusts stimulation based on each person's unique brain activity, both in clinical settings and daily life 1 . BrainSense™ Electrode Identifier can improve DBS programming by ensuring optimal initial contact selection in less time 2 .
Caregivers and healthcare providers alike intimately understand how disruptive Parkinson's can be on one's daily life. Affecting over 1.2 million patients in Europe alone and more than 10 million people worldwide, Parkinson's is known to impact an individual's mobility, speech, focus, sleep, independence, and overall ability to participate fully in work, family, and social life. From sipping a cup of coffee to holding hands with a loved one, the disease can be debilitating and demoralizing, stripping away what many of us take for granted. For spouses and caregivers, this can be immensely demanding and distressing 3,4 .
"BrainSense™ technology † is at the center of personalizing DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform," said Paolo Di Vincenzo , president of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customize care for people with Parkinson's, and we're just getting started. The mission is to impact and improve many more lives with Medtronic DBS therapy."
The Medtronic Percept™ DBS system with BrainSense™ technology is designed to record and analyze brain signals, enabling therapies tailored to each patient's unique neurological patterns 1 . Medtronic has been at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy with the specific purpose of making advances in prevention, detection, diagnosis, rehabilitation, and restoration for patients with complex neurological conditions. As the world leader in DBS therapy, the Medtronic Percept™ neurostimulators with BrainSense™ technology serves as a benchmark for DBS sensing innovation.
"Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson's," said Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. "By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation that can be adapted to an individual's unique needs."
Medtronic is the originator of continuous deep brain stimulation (cDBS), which has been available for decades as a proven therapy for managing certain Parkinson's disease symptoms. BrainSense™ Adaptive DBS (aDBS) takes treatment to the next level, dynamically calibrating stimulation based upon a patient's own brain signals 1 .
"Medtronic remains the first and only company in the world to offer a complete sensing-enabled DBS system, and now we have enhanced this innovation to allow patients with Parkinson's to spend less time thinking about their disease," said Amaza Reitmeier , vice president and general manager, Neuromodulation marketing and strategy at Medtronic. "Patients and clinicians have been eagerly awaiting these BrainSense™ technology enhancements, which represent another transformative step forward in our ability to personalize therapy for people living with Parkinson's."
The Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial further highlights the potential of aDBS in clinical practice. Conducted as a global, multi-center, prospective, single-blind randomized crossover study (between two modes of aDBS), the trial evaluates the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to cDBS for eligible Parkinson's patients receiving DBS therapy. Developed in collaboration with more than a dozen world-renowned neurologists and neurosurgeons from leading academic institutions across the globe, this study represents the largest and longest assessment of aDBS conducted in both clinical and home settings 1 . The study methodology and sensing data from the Medtronic study were published in npj Parkinson's Disease , a journal within the prestigious Nature Portfolio.
"The CE Mark approval of BrainSense TM Adaptive DBS is a critical advancement in how we treat Parkinson's disease," said Alan Whone , PhD, professor of movement disorders neurology, University of Bristol and North Bristol NHS Trust. "Its potential to address certain challenging motor symptoms and improve day-to-day disease management offers new hope for patients and their families, broadening the transformative impact of deep brain stimulation."
BrainSense™ Electrode Identifier (EI) elevates precision and efficiency to unprecedented levels by providing a detailed view of each Parkinson's patient's unique brain signals and guiding clinicians to the exact location of the strongest signal in a fraction of the time needed for standard monopolar reviews 2 . This exclusive technology pinpoints the optimal contact location by leveraging local field potentials (LFP) and alpha-beta activity to guide optimized and effective programming compared to the standard of care, the monopolar review 2 .
"BrainSense™ Electrode Identifier allows clinicians to now conduct an accurate and precise initial programming, offering a level of personalization unmatched in the field," said Domenico De Paolis , vice president of Neuromodulation International at Medtronic. "Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection. CE Mark approval is just the first step in our effort to bring this new technology to customers around the world."
Since 1987, Medtronic has served more than 185,000 people with movement disorders and other indications in more than 70 countries with its life-changing DBS therapy 5 .
BrainSense™ aDBS and BrainSense™ Electrode identifier will be available in Europe in early 2025. Patients considering DBS therapy should discuss treatment options with their provider. Medtronic has filed for U.S. FDA approval of aDBS; it is not yet approved for sale or distribution in the United States .
To learn more about Medtronic DBS with BrainSense™ technology, visit our website .
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow 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.
† The sensing feature of the Percept™ PC and Percept™ RC system is intended for use in patients receiving DBS where chronically recorded bioelectric data may provide useful, objective information regarding patient clinical status.
References
- Thompson, J., Radcliffe , E., Ojemann, S.,et al. Monopolar sensing improves the efficiency of DBS programming in Parkinson's disease [abstract]. Mov Disord . 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/monopolar-sensing-improves-the-efficiency-of-dbs-programming-in-parkinsons-disease/ . Accessed 11/15/2024
- Stanslaski S, Summers RLS, Tonder L, et al. Sensing data and methodology from the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) clinical trial. NPJ Parkinsons Dis. 2024;10(1):174.
- OECD/European Commission (2024), Health at a Glance: Europe 2024: State of Health in the EU Cycle , OECD Publishing, Paris, https://doi.org/10.1787/b3704e14-en .
- Parkinson's Foundation. (2025). Statistics: Get informed about Parkinson's disease with these key numbers. Retrieved from https://www.parkinson.org
- Medtronic data on file.
Contacts: | |
Naomi Rodiles | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-612-427-5521 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-achieves-ce-mark-approval-for-brainsense-adaptive-deep-brain-stimulation-and-electrode-identifier-a-groundbreaking-advance-in-personalized-sensing-enabled-care-for-people-with-parkinsons-through-innovative-brain-comp-302348702.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
Thermo Fisher Scientific's Olink Platform Selected for World's Largest Human Proteome Study
UK Biobank Pharma Proteomics Project aims to create a comprehensive map of disease-associated protein levels in the human body to advance biomarker discovery
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced the UK Biobank Pharma Proteomics Project (UKB-PPP) has selected its Olink ® Explore Platform to support the world's largest human proteomics study of its kind. UKB-PPP aims to analyze more than 5,400 proteins from 600,000 samples to fuel the discovery of new protein biomarkers that can be used to predict, diagnose and treat diseases.
"Studies on the human proteome are having a profound impact on our customers' fundamental understanding of disease and the advancement of life sciences research," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher. "The unprecedented scale of this project, with support from our next-generation proteomics solution, underscores the potential to deepen their knowledge and develop new applications to improve human health."
Advancement of the Olink Explore Platform, which is designed to enable deep analysis of the thousands of proteins in the human body, provides researchers with the ability to study the role they play in many types of diseases. Published studies in this emerging field, known as population proteomics, have demonstrated the potential protein signatures have to help advance the future of precision medicine.
"Proteomics provides an incredibly detailed snapshot of health. This new frontier of science can unveil how genetics and external factors – like diet, exercise and climate – interact, and will help to pinpoint the key causes of diseases and identify drug targets," said Professor Naomi Allen, chief scientist of UK Biobank. "It has already led to important scientific discoveries, such as identifying proteins that can help to diagnose disease – including multiple sclerosis - and helping to identify those at higher risk of developing dementia and cancer many years before clinical diagnosis. Over 19,000 researchers around the world are using UK Biobank data; adding proteomic data to everything else we hold will enable scientists to make rapid discoveries to help diagnose and treat life-altering diseases."
UKB-PPP is a collaboration between UK Biobank and 14 leading biopharmaceutical companies, with the goal to make available important information on the human proteome to UK Biobank-approved researchers across the world. In turn, the data can be used to validate and identify new drug targets, advance diagnostics, and help accelerate targeted drug discovery to support the development of more effective and safer medications.
"UKB-PPP brings together scientists from the world's leading pharmaceutical companies with the most advanced research technologies," said Chris Whelan, Ph.D., chair and principal investigator of UKB-PPP. "Success for projects of this size depends on having partners with the ability to scale reliably and effectively. We are excited to once again have Thermo Fisher's Olink platform as the supporting proteomics technology to drive this study."
UKB-PPP builds on the findings released in 2023 from the pilot project, which also leveraged the Olink Explore platform to analyze more than 54,000 samples from UK Biobank . The research was first published in Nature in October 2023 and has already been cited more than 400 times, laying the foundation for scientists to better understand how and why diseases develop and to advance targeted treatments. One study, published in Nature Communications , leveraged data from the pilot study to identify protein risk factors for certain cancers up to seven years in advance of diagnosis.
UKB-PPP is scheduled to begin in Q1 2025, with plans to make the proteomic data available to UK Biobank-approved researchers in staggered releases starting in 2026, followed by the full dataset in 2027. UKB-PPP will initially analyze more than 5,400 proteins from 300,000 samples and seek supplemental funding to analyze an additional 300,000 samples, bringing the total for the project to 600,000 samples.
Acquired by Thermo Fisher in July 2024, the Olink proteomics platform is a next generation proteomics solution that empowers researchers to measure more than 5,400 proteins with high specificity, speed, and the flexibility to study complex biological processes.
To learn more about the Olink Platform, please visit www.thermofisher.com/olink
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20250109316914/en/
Media Contact Information:
Sandy Pound
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com
Website: www.thermofisher.com
Investor Contact Information:
Rafael Tejada
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com
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