SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF) has commenced enrollment in the United States.
Coronary/Structural Heart
Edwards Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix
July 24, 2024 04:15 PM Eastern Daylight Time IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology, […]
Prevencio Granted U.S. Patent for Highly Accurate, Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease
July 24, 2024 09:07 AM Eastern Daylight Time KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., a leader in AI-powered blood tests for cardiovascular diagnostics, announces that the United States Patent and Trademark Office has issued a patent for its highly accurate blood test, HART CADhs, which assesses a patient’s risk of obstructive coronary artery […]
Magenta Medical Closes $105M Financing Led by Novo Holdings
Other new investors include Viking Global Investors and RA Capital Management Funding will support Magenta’s clinical programs in support of FDA approval for Elevate, the world’s smallest heart pump KADIMA, Israel, July 23, 2024 /PRNewswire/ — Magenta Medical, developer of Elevate™, the world’s smallest heart pump, has closed a $105M financing round led by global healthcare […]
Elucid Commences International PRE-VUE CCT Registry Study
Multi-center, Retrospective Trial to Assess Prognostic Accuracy of Elucid’s Plaque and Plaque-based FFRCT Software in Patients with Clinically Indicated CCTA July 18, 2024 07:05 AM Eastern Daylight Time WASHINGTON & BOSTON–(BUSINESS WIRE)–SCCT2024 – Elucid, a pioneering AI medical technology company providing physicians with imaging analysis software based on ground truth histology to support […]
HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease
Technology offers benefits of HeartFlow Plaque Analysis with the new addition of 3D interactive capabilities, integrated with lesion specific FFRCT values
HFSA Announces Selection of New Officers and Board of Director Members
WASHINGTON, July 18, 2024 /PRNewswire/ — The Heart Failure Society of America (HFSA) recently announced the selection of new officers and board members for the society with terms starting at the conclusion of the HFSA Annual Scientific Meeting 2024 (ASM), which will take place September…
Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal
— Portuguese Ministry of Health approves VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular (CV) events in patients with established cardiovascular disease (CVD)1 — — Approval marks eighth national reimbursement of VAZKEPA® in Europe —
BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application
SUNNYVALE, Calif., July 17, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announces that the Unites States Patent Office has granted Patent No: 12,036,371 titled “Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter,” with a patent term that will expire in 2035. The present invention relates to medical methods for transseptal access to the heart using steerable introducers based on the Company’s Morph DNA technology. This additional patent protection for BioCardia’s current and future products in this important existing market enhances shareholder value. Procedures that leverage transseptal delivery include atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and percutaneous left ventricular assist device placement, among others. Worldwide revenue from the transseptal access systems market was $941.3 million in 2022, with the global market estimated to expand at a Compound Annual Growth Rate of 7.3%, reaching $2.1 billion by the end of 2033(1). Morph DNA designs enable the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements appear as a double helix like that in a strand of DNA. This design is intended to enable smooth navigation and prevent “whip,” when the build-up of mechanical forces in the device causes a catheter to suddenly jump from one orientation to another. “All of the biotherapeutic interventions we support for treatment of heart failure, refractory angina, and acute myocardial infarction going forward are expected to utilize this same introducer technology platform,” said Peter Altman, PhD, BioCardia’s President and Chief Executive Officer. “This is an elegant solution to a long-standing technical issue. The solution enhances the level of physician control in our procedures, and BioCardia is working to provide or partner this solution for the roughly five hundred thousand transseptal procedures performed in the United States each year, and for other vascular access markets that can benefit from the advantages our patented solution provides.” About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph vascular navigation product platforms. For more information visit: www.BioCardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the advantages of the Morph DNA design, and the potential transseptal access delivery vascular market for the Morph DNA steerable introducer product Family. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. (1) Persistence Market Research (2022). “Transseptal Access Systems Market Outlook (2023-2033).” New York, NY. Persistence Market Research Pvt. Ltd.
WELL Health Launches its AI-POWERED Co-pilot for Cardiologists powered by HEALWELL AI to Help Improve Detection of Cardiovascular Disease
WELL has launched its new AI-powered physician co-pilot to assist cardiologists in better identifying patients at high risk of cardiovascular disease (“CVD”). WELL is exclusively partnering with HEALWELL AI, a leader in AI enabled disease diagnosis, as an extension of the WELL AI Decision Support (“WAIDS”) product offering.
The co-pilot will be deployed into WELL Diagnostic Centres, Canada’s largest cardiology and medical diagnostic group, providing support and assisting cardiologists in over 40 locations across Ontario.
CVD stands as the leading cause of death globally, accounting for approximately 32% of deaths worldwide in 2019(1), underscoring the critical need for early detection. HEALWELL also expects to leverage this technology to help accelerate life sciences research and development opportunities related to CVD and drive new business opportunities for its newly acquired Clinical Research Organization (“CRO”), BioPharma Services Inc.
VANCOUVER, BC and TORONTO, July 17, 2024 /PRNewswire/ – WELL Health Technologies Corp. (TSX: WELL) (OTCQX: WHTCF) (“WELL” or the “Company”) a digital health company focused on tech-enabling healthcare providers, and its investee company, HEALWELL AI Inc. (TSX: AIDX) (OTCQX: HWAIF) (“HEALWELL”), a healthcare technology company focused on AI and data science for preventative care, are jointly pleased to announce the launch of WELL’s AI-powered co-pilot for cardiologists exclusively powered by HEALWELL AI, aimed at identifying patients at high risk of cardiovascular disease (“CVD”). This significant expansion of WELL’s AI capabilities builds on the success of its second-generation AI-powered physician co-pilot, WELL AI Decision Support (“WAIDS”), developed exclusively in partnership with HEALWELL. This enhancement adds to its existing rare and chronic disease detection abilities and is an extension to the WAIDS offering.
The co-pilot for cardiologists will be deployed in WELL Diagnostics Centres, Canada’s largest cardiology and medical diagnostic group with over 40 locations in Ontario. It will be available to cardiologists within the WELL Diagnostic Centres ecosystem, providing invaluable support in the early detection and management of cardiovascular disease.
Dina Sergi, CEO of WELL Diagnostic Centres, highlighted the tool’s impact, “The integration of HEALWELL’s AI-powered co-pilot for cardiologists into our WELL Diagnostic Centres represents a game-changing advancement. By offering precise risk stratification and actionable insights, this tool enhances their ability to proactively manage cardiovascular health and improve patient care.”
Dr. Alexander Dobranowski, CEO of HEALWELL, commented, “The launch of our AI-powered co-pilot for specialists marks a significant milestone in our mission to enhance healthcare through advanced technology. By expanding our AI capabilities to include cardiovascular disease detection, we are equipping cardiologists with enhanced tools and decision support necessary to identify at-risk patients earlier, ultimately improving patient outcomes and reducing healthcare costs. The integration of this tool into WELL’s Diagnostic Centres is particularly important, as it provides us access to Canada’s largest cardiology group. This vast dataset not only assists hundreds of cardiologists within the WELL Diagnostic Centres ecosystem but also allows us to continuously refine and enhance the co-pilot.”
Dr. Paul Kannampuzha, Chief Cardiology Officer of WELL Diagnostic Centres commented. “As a cardiologist, I am encouraged by how AI can help provide improved disease detection and decision support for cardiologists across the country. I believe this technology will help drive improved preventative care and ensure patients don’t fall through the cracks.”
Cardiovascular disease (CVD) is a group of disorders affecting the heart and blood vessels and is the leading cause of death globally, responsible for approximately 32% of deaths worldwide in 2019(1). In Canada, recent estimates suggest that CVD costs about $22 billion per year and is considered the second leading contributor to healthcare costs(2). Identifying patients with worsening cardiovascular conditions earlier is crucial, as cardiovascular disease is the third leading cause of death in Canada.
The global market for pharmaceutical drugs supporting cardiovascular disease was valued at approximately USD 144.1 billion in 2023. It is projected to grow at a compound annual growth rate (CAGR) of approximately 4% over the next decade, reaching an estimated USD 207.8 billion by 2033 (Precedence Research)(3). HEALWELL expects to leverage this technology to help accelerate life sciences research and development opportunities related to CVD and drive new business opportunities for its newly acquired Clinical Research Organization (CRO), BioPharma Services Inc.
Footnotes:
https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-%28cvds%29
https://link.springer.com/article/10.1007/s41669-021-00257-8
https://www.precedenceresearch.com/cardiovascular-drugs-market
About WELL Health Technologies Corp.
WELL’s mission is to tech-enable healthcare providers. We do this by developing the best technologies, services, and support available, which ensures healthcare providers are empowered to positively impact patient outcomes. WELL’s comprehensive healthcare and digital platform includes extensive front and back-office management software applications that help physicians run and secure their practices. WELL’s solutions enable more than 34,000 healthcare providers between the US and Canada and power the largest owned and operated healthcare ecosystem in Canada with more than 175 clinics supporting primary care, specialized care, and diagnostic services. In the United States WELL’s solutions are focused on specialized markets such as the gastrointestinal market, women’s health, primary care, and mental health. WELL is publicly traded on the Toronto Stock Exchange under the symbol “WELL” and on the OTC Exchange under the symbol “WHTCF”. To learn more about WELL, please visit: www.well.company.
About HEALWELL AI
HEALWELL is a healthcare technology company focused on AI and data science for preventative care. Its mission is to improve healthcare and save lives through early identification and detection of disease. Using its own proprietary AI technology and competencies which includes data science, electronic health records and clinical research offerings, the Company is developing and commercializing advanced clinical decision support systems that can help healthcare providers detect rare and chronic diseases, improve efficiency of their practice and ultimately help improve patient health outcomes. HEALWELL is publicly traded on the Toronto Stock Exchange under the symbol “AIDX” and on the OTC Exchange under the symbol “HWAIF”. To learn more about HEALWELL, please visit https://healwell.ai/.
Forward-Looking Statements
Certain statements in this press release, constitute “forward-looking information” and “forward looking statements” (collectively, “forward looking statements”) within the meaning of applicable Canadian securities laws and are based on assumptions, expectations, estimates and projections as of the date of this press release. Forward-looking statements in this press release include statements with respect to, among other things, the deployment of WAIDS at WELL Health Diagnostic Centres, the use of the WAIDS to improve patient care, and the use of AI technology by HEALWELL to drive research and development opportunities related to CVD. Forward-looking statements are often, but not always, identified by words or phrases such as “opportunity”, “potential”, “improve”, “expect”, “intend”, “create” or variations of such words and phrases or statements that certain future conditions, actions, events or results “will”, “may”, “could”, “would”, “should”, “might” or “can” be taken, occur or be achieved, or the negative of any of these terms . Forward-looking statements are necessarily based upon management’s perceptions of historical trends, current conditions and expected future developments, as well as a number of specific factors and assumptions that, while considered reasonable by HEALWELL as of the date of such statements, are outside of HEALWELL’s control and are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in the forward-looking statements ultimately being entirely or partially incorrect or untrue. Forward looking statements contained in this press release are based on various assumptions, including, but not limited to: the ability of HEALWELL to utilize AI technologies to detect CVD indicators; the ability to collaborate with the pharmaceutical industry for research and development opportunities, HEALWELL’s continued compliance with third party intellectual property rights; HEALWELL’s continued compliance with privacy laws; and that the risk factors noted below, collectively, do not have a material impact on HEALWELL’s business, operations, revenues and/or results. By their nature, forward-looking statements are subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections, or conclusions will not prove to be accurate, that assumptions may not be correct, and that objectives, strategic goals and priorities will not be achieved.
Known and unknown risk factors, many of which are beyond the control of HEALWELL, could cause the actual results of HEALWELL to differ materially from the results, performance, achievements, or developments expressed or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed under the section entitled “Risk Factors” in HEALWELL’s most recent annual information form dated April 1, 2024, which is available under HEALWELL’s SEDAR+ profile at www.sedarplus.com. The risk factors are not intended to represent a complete list of the factors that could affect HEALWELL and the reader is cautioned to consider these and other factors, uncertainties and potential events carefully and not to put undue reliance on forward-looking statements. There can be no assurance that forward looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. HEALWELL disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. All of the forward-looking statements contained in this press release are qualified by these cautionary statements.
SOURCE WELL Health Technologies Corp.



