ALR Technologies Announces First Shipment of GluCurve Pet CGMs Expected in October and Update on the Manufacturing Agreement

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.


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ALR Technologies Announces Update to Singapore Migration Merger and GluCurve Pet CGM Commercialization

ALR Technologies Announces Update to Singapore Migration Merger and GluCurve Pet CGM Commercialization

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 Update on the GluCurve Pet CGM Distribution and Commercialization

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."

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ALR Technologies Completes Definitive Manufacturing Agreement with Infinovo Medical for the GluCurve Pet CGM Hardware

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

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ALR Technologies

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.

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ALR Technologies Announces Completion of Pivotal Non-Inferiority Study on the GluCurve Pet CGM

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:

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMedâ„¢ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuardâ„¢ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

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Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

  • FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
  • HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
  • Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
  • Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.

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Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

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New Simplera Sync sensor for the MiniMed 780G System now FDA approved

New Simplera Sync sensor for the MiniMed 780G System now FDA approved

Latest approval expands Medtronic CGM portfolio in the U.S.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Syncâ„¢ sensor for use with the MiniMedâ„¢ 780G system. With this approval, the MiniMedâ„¢ 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detectionâ„¢ technology with both the Guardianâ„¢ 4 sensor and Simplera Syncâ„¢ sensor.

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Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

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Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

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The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk

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