HeartSciences Inc

HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis

Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems

HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”) powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Device designation for its Aortic Stenosis (“AS”) ECG algorithm.

Aortic Stenosis is one of the most serious and common heart valve diseases, often progressing silently and leading to severe, life-threatening outcomes if left undetected. Early symptoms are frequently vague or absent, resulting in delayed diagnosis and treatment. If unrecognized, AS can cause irreversible myocardial damage and significant deterioration in cardiac function.

The algorithm would offer a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. Once cleared by the FDA, the algorithm will be accessible through HeartSciences' MyoVista Insights™ cloud-based platform which would directly integrate with hospital electronic health record (“EHR") systems, requiring no additional hardware or testing. This technology provides several key clinical advantages:

  • Detection in asymptomatic or under-evaluated patients who may not yet show signs of AS.
  • Real-time or retrospective analysis using existing ECG data already captured during routine care.
  • Expanded access to early diagnosis, especially in underserved areas lacking specialized cardiac imaging or providers.

The algorithm was developed using advanced convolutional neural network (CNN) deep learning techniques and trained on more than 120,000 ECG records. In performance evaluations, it demonstrated the ability to detect aortic stenosis up to 24 months prior to confirmatory echocardiography, with diagnostic accuracy (AUROC) increasing as the disease progressed.

This breakthrough gives clinicians the ability to identify aortic valve disease earlier in its course, allowing for timely interventions and improved patient outcomes. The AI-ECG algorithm was developed at the Icahn School of Medicine at Mount Sinai by Dr. Akhil Vaid.

"Receiving FDA Breakthrough Device Designation marks another significant milestone for HeartSciences," said Andrew Simpson, CEO of HeartSciences. "By combining the widespread accessibility of ECGs with the power of deep learning, our aortic stenosis algorithm has the potential to transform how this serious and often silent disease is detected—leading to earlier referrals, better treatment pathways, and ultimately, improved lives."

About HeartSciences

HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve ECG’s clinical utility. Millions of ECGs are performed every week and the Company's objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and intends to provide these AI-ECG algorithms on a device agnostic cloud-based solution as well as a low-cost ECG hardware platform. Working with clinical experts, HeartSciences ensures that all solutions are designed to work within existing clinical care pathways, making it easier for clinicians to use AI-ECG technology to improve their patient's care and lead to better outcomes. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test.

For more information, please visit: https://www.heartsciences.com. X: @HeartSciences

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 29, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2024, filed with the SEC on September 12, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2024, filed with the SEC on December 16, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2025, filed with the SEC on March 13, 2024 and in HeartSciences' other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Investor Relations:

Integrous Communications
Mark Komonoski
Partner
Phone: 877-255-8483
Email: mkomonoski@integcom.us

Media Contact:

HeartSciences
Gene Gephart
Phone: +1-682-244-2578 Ext. 2024
Email: info@heartsciences.com

Source

The Conversation (0)
AbbVie Invites People Living with Migraine to Enter the Second Annual AbbVie Migraine Career Catalyst Award Contest to Support Their Professional Goals

AbbVie Invites People Living with Migraine to Enter the Second Annual AbbVie Migraine Career Catalyst Award Contest to Support Their Professional Goals

  • The AbbVie Migraine Career Catalyst Award™ contest is now open for entries, offering financial support to help winners pursue career and professional development goals.
  • As the only company with three approved products designed to meet patient needs across the spectrum of migraine, AbbVie is   committed to supporting the migraine community beyond treatment.
  • Migraine affects productivity and career growth—up to 90% of people with migraine report it interferes with their ability to function at work, highlighting the need for meaningful support beyond treatment.

- AbbVie (NYSE: ABBV) today announced the second annual AbbVie Migraine Career Catalyst Award ™ contest is now accepting entries. AbbVie is proud to continue this nationwide initiative supporting people living with migraine by awarding 20 entrants with $2,500 each that they may use to pursue their personal, professional, and educational goals.

"Migraine can be an invisible barrier to success in the workplace where the condition is often misunderstood or stigmatized," said Carl Cincinnato , executive director, Migraine at Work, a nonprofit initiative under the World Health Education Foundation dedicated to improving workplace environments for individuals living with migraine. "Initiatives like the AbbVie Migraine Career Catalyst Award™ contest not only provide financial support but also serve as a powerful form of advocacy for people living with migraine."

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
AbbVie to Present at the Goldman Sachs 46th Annual Global Healthcare Conference

AbbVie to Present at the Goldman Sachs 46th Annual Global Healthcare Conference

AbbVie (NYSE: ABBV) will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on Tuesday, June 10, 2025 . Management will participate in a fireside chat at 10:20 a.m. Central time .

A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the session will be available later that day.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
AbbVie Partners with Chicago Cubs on "Striking Out Cancer"

AbbVie Partners with Chicago Cubs on "Striking Out Cancer"

Chicago -based institutions aim to create greater awareness for cancer advocacy and to support non-profit cancer organizations

AbbVie (NYSE: ABBV) announced a multi-year partnership with the Chicago Cubs to support people living with cancer through a campaign called "Striking Out Cancer" which starts today when the Chicago Cubs play the Cincinnati Reds. As part of the first year of the partnership, AbbVie will make a $233 donation for every strikeout by a Chicago Cubs pitcher at home during the 2025 regular season. The donation amount is in honor of the approximately 233 Americans diagnosed with cancer every hour, according to the American Cancer Society. 1

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting ( May 30 - June 3, 2025 ). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
AbbVie and U of T Mississauga's SpinUp Announce Neuropeutics Inc as First AbbVie Biotech Innovators Award Recipient

AbbVie and U of T Mississauga's SpinUp Announce Neuropeutics Inc as First AbbVie Biotech Innovators Award Recipient

  • Following a national competition, AbbVie and SpinUp – the University of Toronto's lab-based, life sciences accelerator – announce Neuropeutics Inc as recipient of first AbbVie Biotech Innovators Award
  • Neuropeutics Inc receives a year of laboratory space and equipment at no cost, as well as access to support and mentorship

AbbVie (NYSE: ABBV) in partnership with the University of Toronto's SpinUp, are pleased to announce Neuropeutics Inc as the recipient of the AbbVie Biotech Innovators Award, a national prize to help foster innovation and support growth in Canada's life sciences sector. Following a competitive selection process, the award, funded by AbbVie, has been granted to Neuropeutics Inc for developing small molecules preventing and reversing protein aggregation as therapeutics for neurodegenerative diseases.

AbbVie Biotech Innovators Award. (CNW Group/AbbVie Canada)

"We are delighted to have this opportunity to collaborate with a global biopharmaceutical company such as AbbVie, and the University of Toronto's SpinUp, to advance Neuropeutics' therapeutic research and development across multiple neurodegenerative diseases. At Neuropeutics, we are committed to developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. This award allows us to pursue that mission with greater momentum," said Dr. Marc Shenouda , CEO & Co-Founder of Neuropeutics Inc.

Neuropeutics Inc's scientific entrepreneurial spirit directly aligns with the mandate of the AbbVie Biotech Innovators Award to foster research, innovation and growth within Canada's life sciences sector. A hallmark of neurodegenerative diseases is protein aggregation. One such protein is TDP-43, a normally nuclear DNA/RNA binding protein, which in disease conditions becomes mislocalized and forms cytoplasmic aggregates causing neuronal toxicity. Neuropeutics Inc has developed a novel strategy to address diseases such as: Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Alzheimer's disease, Huntington's disease and Parkinson's disease.

"It was impressive and motivating to see the variety of entries and the calibre of early-stage biotech companies who applied for the Award. We thank all who participated in this life science competition," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "After a rigorous evaluation process, it is with great pleasure that we are announcing that Neuropeutics has been named the recipient of the AbbVie Biotech Innovators Award for its pioneering work in neurodegenerative diseases. We look forward to supporting the journey of Neuropeutics, in collaboration with SpinUp, to accelerate their efforts to deliver life-changing innovation to patients."

"Congratulations to Neuropeutics on being the first AbbVie Biotech Innovators Award recipient, and welcome to SpinUp – the University of Toronto's wet lab incubator," said France Gagnon , Vice-Principal, Research and Innovation at the University of Toronto Mississauga. "This is the place where the potential of Neuropeutics' work in neurodegenerative diseases can be realized and the impact on life sciences can be game changing. We are pleased to collaborate with AbbVie, a global leader in the biopharmaceutical industry, to offer this unique opportunity to this competitively chosen startup."

The AbbVie Biotech Innovators Award was launched in 2024 in collaboration with SpinUp, a purpose-built laboratory for chemistry and biological work or wet lab incubator at the University of Toronto . The Award is to support early-stage Canadian biotechnology startup companies with the potential to generate transformational therapies in areas that align with AbbVie's therapeutic areas of focus: immunology, oncology, neuroscience, and eye care. Neuropeutics Inc will receive a year of laboratory space at no cost, in addition to access to SpinUp's core equipment, services, entrepreneurship programming, and research talent community at the University of Toronto . Neuropeutics Inc will also benefit from mentorship by AbbVie's scientific and business executives.

For more information on the AbbVie Biotech Innovators Award, please visit: https://spinup.utm.utoronto.ca/biotech-innovators-award/ .

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Instagram or find us on LinkedIn .

About SpinUp
SpinUp is the first wet lab startup incubator at the University of Toronto , Canada's leading centre for learning and discovery and one of the world's top-two universities for health science productivity . SpinUp is purpose built to drive life science innovation. It offers early-stage start-ups access to outstanding and highly subsidized wet lab space, equipment, entrepreneurship programming and expertise at a brand new, state-of-the-art research facility at U of T's Mississauga campus. Visit our website at spinup.utm.utoronto.ca and connect with us on Instagram and LinkedIn .

SpinUp is proudly part of U of T Entrepreneurship , a network of 12 accelerators across three campuses. Over the past 10 years, this network has supported more than 1,200 capital-backed companies, which have created 17,000 jobs and raised $12 billion in external investment. U of T now launches more research-based start-ups than any university in North America outside of MIT . The AbbVie Biotech Innovators Award is part of U of T Mississauga's Blue Ticket program at SpinUp, which provides a one-year SpinUp membership.

About Neuropeutics Inc  
Neuropeutics is a for-profit Canadian pharmaceutical company developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. To learn more, please visit us at www.neuropeutics.ca , contact us at info@neuropeutics.ca , and connect with us on LinkedIn .

Neuropeutics Inc CSO & co-founder Dr. Janice Robertson (left) and Dr. Marc Shenouda, CEO & Co-Founder. (CNW Group/AbbVie Canada)

SOURCE AbbVie Canada

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2025/22/c0315.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Adicet Bio to Participate in a Fireside Chat at the 2025 Jefferies Global Healthcare Conference

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference being held from June 3-5, 2025 in New York.

Details of the event are as follows:
Date: Wednesday, June 4, 2025
Time: 4:20 p.m. ET

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×