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Faraday Pharmaceuticals to Host KOL Webinar on the Unmet Need in the Prevention of Ischemia-Reperfusion Injury in Acute STEMI

SEATTLE, July 16, 2024 (GLOBE NEWSWIRE) — Faraday Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage following acute ST-elevation myocardial infarction (STEMI) through the reduction of reperfusion injury during percutaneous coronary intervention (PCI), today announced it will host a virtual KOL webinar on Tuesday, July 30, 2024, at 11:00 AM ET. To register for the webinar, click here. The webinar will feature Dr. Cheerag Shirodaria (Oxford University Hospitals), Dr. Marc Bonaca (University of Colorado Anschutz), and Dr. Antonio Gutierrez (Duke University Hospital and Durham VA Medical Center), who will discuss the unmet need and current treatment landscape in preventing ischemia-reperfusion injury and highlight the effects of STEMI on heart failure and other patient outcomes. The webinar will also review data from the development of FDY-5301, an investigational product being evaluated by Faraday in minimizing cardiac damage following acute STEMI. The company’s pivotal Phase 3 Iocyte AMI-3 trial of FDY-5301 in anterior STEMI patients undergoing primary percutaneous intervention is now fully enrolled with topline data anticipated in 2H 2025. A live question and answer session will follow the formal presentations. About Cheerag Shirodaria, BSc, MBBS, MD, FRCP, MBA Dr. Cheerag Shirodaria is Chief Development Officer at Caristo Diagnostics and a Cardiologist at Oxford University Hospitals in the UK. He is an interventional cardiologist who is also an expert in cardiac imaging, particularly cardiac MRI (CMR) and coronary CT angiography (CCTA), having completed his doctoral thesis in Oxford on novel vascular imaging techniques using CMR. He was heavily involved in the design and execution of the phase 2 STEMI trial involving FDY-5301 and is a member of the Executive Steering Committee of the IOCYTE-AMI trial. As co-founder and former CEO of Caristo, he has developed and commercialized novel imaging AI imaging tools to predict future cardiometabolic risk. Dr Shirodaria obtained his medical degree from St Bartholomew’s Hospital Medical College, his medical doctorate from the University of Oxford and his MBA from London Business School. About Marc Bonaca, MD, MPH Dr. Marc Bonaca is a cardiologist and vascular medicine specialist serving as executive director of CPC and Director of Vascular Research & Professor of Medicine at the University of Colorado Anschutz. Dr. Bonaca earned his medical degree from the University of Connecticut and his MPH at Harvard. He completed his medical residency, cardiology fellowship, and vascular medicine fellowship at Brigham and Women’s Hospital and a dedicated research fellowship at the TIMI Study Group. He became faculty at BWH and Harvard Medical School and an investigator at TIMI. He directed pharmacovigilance at TIMI and was an investigator on several large outcomes trials including TRA2P-TIMI 50, PEGASUS-TIMI 54, DECLARE-TIMI 58, and REAL TIMI 63B. In 2018, he joined the faculty at the University of Colorado as Professor of Medicine and the William R. Hiatt Endowed Chair in Cardiovascular Research. He is the Executive Director of CPC, an affiliated non-profit Academic Research Organization. At CPC, he has led several clinical trials with CPC as the lead ARO, including VOYAGER PAD, PREVENT HD, and ASPEN, and is leading several ongoing trials, including BRIGHT and EVOLVE MI, a 4000-patient pragmatic multinational acute coronary syndrome trial. Dr. Bonaca’s research focus is on ischemic risk with atherosclerotic vascular disease, risk prediction, and risk modification using pharmacologic and biologic therapies. He has extensive experience designing and conducting large, multicenter randomized clinical trials, and analyzing registries and real-world datasets. His areas of interest include PAD, PVD, and diabetes, with a focus on the breadth of risk including ischemic limb outcomes, microvascular complications, and major adverse cardiovascular events. He is also investigating the cardiac, vascular, and thrombotic complications associated with novel oncologic therapies. At CPC, he has focused on building a robust faculty and operational group dedicated to high quality, efficient trials leveraging health networks, informatics, and decentralized design. About J. Antonio T. Gutierrez, MD Dr. Antonio Gutierrez’s clinical interests include diagnostic and interventional coronary angiography, peripheral angiography and percutaneous intervention, and vascular medicine. His research interests are focused on peripheral artery disease. He has been involved in multiple clinical trials involving patients with atherosclerotic disease and has published several peer-reviewed articles and reviews. Dr. Gutierrez received his Bachelor of Arts from the College of the Holy Cross in 2000, Doctorate of Medicine from Case Western Reserve University School of Medicine in 2007, and Masters of Health Science in Clinical Research from Duke University School of Medicine in 2012. He completed his residency in Internal Medicine at Duke University Medical Center in 2010 and was appointed Chief Medical Resident of the Durham VA Medical Center in 2011. Dr. Gutierrez completed his General Cardiology and Vascular Medicine Fellowships at Brigham and Women’s Hospital and a Clinical Research Fellowship at the TIMI Study Group. Most recently Dr. Gutierrez matriculated his Interventional Cardiology Fellowship at Duke University Medical Center. Dr. Gutierrez is currently an Assistant Professor of Medicine at Duke University Hospital and Staff Physician at the Durham VA Medical Center. About STEMI Acute STEMI is a leading cause of cardiovascular death and remains a primary cause of the development of heart failure. Standard treatment of a STEMI involves PCI, during which a catheter is inserted into the artery to remove the blockage and restore blood flow. Following a STEMI, one of the critical factors influencing patient outcomes is reperfusion injury, which occurs when the oxygen-rich blood supply returns to the ischemic heart muscle. About FDY-5301 FDY-5301 is an elemental reducing agent containing sodium iodide for which Faraday has obtained method of use patent protection in major markets worldwide. Faraday has selected FDY-5301 for investigation in the belief that its properties are well-suited to mitigate ischemia-reperfusion injury (IRI). In preclinical IRI models, FDY-5301 reduced tissue damage, infarct size, and inflammation. FDY-5301 functions as a catalytic neutralizer of hydrogen peroxide, a prominent reactive oxygen species implicated in the IRI cascade leading to cardiomyocyte death, and also acts as an immunomodulating agent. A Phase 2 clinical trial of FDY-5301 in STEMI patients demonstrated that it was well-tolerated and provided encouraging signals of potential efficacy in minimizing cardiac damage. Results from that trial — known as Iocyte AMI — were reported in the January 15, 2022, issue of the International Journal of Cardiology. About Faraday Pharmaceuticals, Inc. Faraday Pharmaceuticals® is a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage in acute STEMI. The company was founded by Dr. Mark Roth of the Fred Hutch Cancer Center and is backed by an investor group led by ARCH Venture Partners and Polaris Partners. The company’s lead program, FDY-5301, is in a pivotal Phase 3 trial and is designed to reduce IRI in acute STEMI, a leading cause of death and a primary cause of the development of heart failure. The company is headquartered in Seattle. For more information, visit www.faradaypharma.com or follow the company on LinkedIn. Contact:Brian BlackmanChief Financial Officerbblackman@faradaypharma.com Contact:PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com

SCCT 2024: HeartFlow to Present New Data on Coronary Artery Disease Management with Coronary Computed Tomography Angiography

MOUNTAIN VIEW, Calif., July 16, 2024 (GLOBE NEWSWIRE) — HeartFlow, a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced it will be presenting new findings on the use of coronary computed tomography angiography (coronary CTA) in coronary artery disease (CAD) management and insights on CTA reimbursement at the upcoming 19th Annual Scientific Meeting of SCCT. The annual meeting will take place on July 18-21, 2024 in Washington, D.C. Subset data from the PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) Trial will also be presented. The PRECISE clinical trial data, originally presented in late 2022, confirmed CTA + FFRCT increases diagnostic accuracy, reduces unnecessary testing and offers higher confidence in identifying patients needing treatment versus traditional testing (stress nuclear, stress echo, and invasive coronary angiography). The new subset data analyzes the association between body mass index, testing performance and clinical outcomes in patients with stable chest pain. New insights from the ADVANCE Registry, including analysis on the relationship between risk factors and quantified atherosclerotic burden and differences in plaque quantification in a Japanese patient population will be shared. Along with the significant work HeartFlow has undertaken to develop age and sex specific nomograms, these data will be a pivotal step to better stratify patients and impact treatment decisions going forward. “The critical role of CTA in the diagnosis and management of coronary artery disease continues to drive every decision we make, ensuring the right patients are getting the right care at the right time,” said Campbell Rogers, Chief Medical Officer of HeartFlow. “This year, we are excited to share the latest insights on the importance of quantifying coronary artery plaque, as well as changes in the reimbursement landscape. We are pleased to continue providing robust clinical evidence as to how our products can help health care providers manage their patient’s heart health.” Details of the presentations are as follows: Session: Poster Session 8 – CT in Non-Acute Chest PainTitle: “Association Between Body Mass Index, Testing Performance And Clinical Outcomes In Patients With Stable Chest Pain: Insights From The PRECISE Trial”Date: Friday, July 19, 2024Time: 9:30 – 10:15 AM EDTLocation: Exhibit Hall Session: Poster Session 16 – Plaque ImagingTitle: The Relationship Of Risk Factors And Quantified Atherosclerotic Burden On Coronary Computed Tomographic Angiography – Lessons From The ADVANCE RegistryDate: Saturday, July 20 Time: 9:30 – 10:35 AM EDTLocation: Exhibit Hall Session: Poster Session 16 – Plaque ImagingTitle: Quantitative Differences Between Japanese And Non-Japanese Patients’ Coronary Computed Tomographic Angiography Derived Plaque – Insights From The ADVANCE RegistryDate: Saturday, July 20 Time: 9:30 – 10:35 AM EDTLocation: Exhibit Hall Session: Business Aspects of Cardiac CT – Part TwoTitle: “How clinicians can work with administrators to maximize cardiac CT reimbursement” Presenter: Cara SantilloDate: Thursday, July 18, 2024Time: 4:05 PM – 4:20 PM EDT Location: Liberty N-P Heartflow invites attendees to two sponsored events, including “Women in CT Happy Hour,” which will take place on July 18 from 6:00 PM – 7:00 PM EDT in the 2nd Floor Lobby, and “The Power of HeartFlow AI in the Management of CAD from Diagnosis to Treatment” symposium, which will take place on July 19 from 11:55 AM – 12:45 PM EDT in the Capitol/Congress Room. About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media ContactLinly KuSr. Digital Marketing Managermedia@heartflow.com Investor ContactNick Laudico VP of Business Development and Investor Relationsnlaudico@heartflow.com

TeleSpecialists Revolutionizes Stroke Care with Launch of Innovative EMS Integration Service

EMS Integration to enhance door-to-needle times and elevate patient outcomes
FORT MYERS, Fla., July 16, 2024 /PRNewswire/ — TeleSpecialists, LLC, the nation’s largest inpatient provider of TeleStroke and TeleNeurology services, launches its EMS Integration service as an enhancement to its current neurology services. This new service will allow TeleSpecialists’ board-certified neurologists to expedite stroke treatment and improve patient outcomes.
TeleSpecialists introduces the EMS Integration service for EMS and local hospitals, to enhance patient care in telestroke and teleneurology. This program enables physicians to interact with EMS teams, and hospitals simultaneously during patient transport. Early teleneurology involvement reduces door-to-needle times by connecting a neurologist on-screen during transit to conduct essential tests. With improved efficiency and collaboration, patients can receive a CT scan immediately upon arrival at the hospital. 
“At TeleSpecialists, we are dedicated to pioneering innovations that enhance patient care. Our EMS Integration service represents a major advancement in our ability to improve patient outcomes, particularly in stroke care,” said Nima Mowzoon, MD, MBA, CEO of TeleSpecialists. “By enabling real-time neurology consultations en route to the hospital, we can significantly expedite treatment times and save more lives. This initiative is a testament to our commitment to leveraging technology to deliver the highest quality care to our communities.”
The introduction of the EMS Integration program emphasizes the organization’s commitment to clinical collaboration and continuous improvement in stroke care. This program aims to establish seamless communication between EMS providers and TeleSpecialists to provide timely and effective care for stroke patients in diverse settings. By integrating EMS into its TeleNeurology processes, the company seeks to optimize the delivery of critical interventions and resources, ultimately improving patient outcomes.
The launch of the EMS Integration program at Oak Hill and Bayonet Point Hospital in Hernando County marks a significant milestone in expanding and enhancing TeleSpecialists’ services. With over 10 years of experience and over one million patients seen, this initiative underscores the company’s commitment to delivering improved outcomes to these communities.
About TeleSpecialists, LLCAs the leader in TeleStroke and TeleNeurology and a reliable provider of exceptional TelePsychiatry services in the US, we lead the industry with unmatched quality, scale, and expertise. We seamlessly integrate cutting-edge technology with compassionate care, always striving to preserve and enhance lives through our commitment to excellence.
SOURCE TeleSpecialists

Vectorious Medical Technologies Announces First U.S. Patient Implanted with the V-LAP Left Atrial Pressure Sensor

TEL AVIV, Israel, July 16, 2024 /PRNewswire/ — A patient in Cincinnati has become the first in the United States to receive an innovative system that enables remote monitoring of his heart and congestion status, as well as self-adjustment of diuretics.

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First U.S. Patient Implanted with the V-LAP Left Atrial Pressure Sensor by Vectorious Medical Technologies: A New Treatment Paradigm for Heart Failure Patients

Vectorious Medical Technologies Ltd. developed a miniature pressure sensor that is implanted within the heart via standard minimally invasive transvenous catheterization. The sensor measures Left Atrial Pressure (LAP), the earliest and most accurate indicator of fluid overload and congestion status. The system supports a scalable, physician-directed patient self-management approach, allowing heart failure (HF) patients to take an active role in managing their disease. By using the V-LAP system, patients can better understand their disease and adjust diuretics, daily activities, and fluid volume accordingly.

The first V-LAP implantation in the United States was performed by Sitaramesh Emani, MD, Director of Heart Failure Clinical Trials at The Christ Hospital in Cincinnati, Ohio. To date, 56 V-LAP implantations have been performed, resulting in more than 40,000 days of LAP monitoring. This study, together with the ongoing clinical program in Europe and Israel, will further inform an upcoming U.S. pivotal trial.  
“The successful first U.S. V-LAP implantation represents a pivotal moment in heart failure management. By integrating real-time left atrial pressure monitoring into patient care, we are on the cusp of a transformative shift towards more proactive, personalized treatment strategies. This innovative approach aims to improve patient outcomes through a reduction in hospitalizations and enhancement of overall quality of life for heart failure patients, but will do so by empowering patients to actively manage their own care. The data collected from the VECTOR-HF IIb trial will be instrumental in moving our field forward”. Said Dr. Sitaramesh Emani.Initial studies of the V-LAP system, which were recently published in the European Journal of Heart Failure, have shown promising results. During 85% of the overall follow-up duration (26.98 patient-years, 9,593 LAP monitoring days), patient self-management alone, with no physician intervention, was sufficient to keep HF patients without congestion and within safe LAP ranges. This resulted in a significant decrease in the rate of HF-related hospitalizations and a notable improvement in quality of life, based on the 6-minute walk distance and the Kansas City Cardiomyopathy Questionnaire.Eyal Orion, MD, co-founder and CEO of Vectorious, said, “We look forward to expanding our clinical activities in the U.S. and work closely with physicians, nurses, FDA, and our partners towards a pivotal trial. Recent data published in JAMA Cardiology suggests recent plateaus or reversals after long-standing declines in cardiovascular mortality, particularly for HF related mortality in the U.S. between 1999 and 2021. I strongly believe that the technology and Treatment paradigm we develop have the potential to reverse this concerning trend, and our team is fully committed to this mission.”About Vectorious Medical Technologies Ltd.Vectorious is a Tel Aviv-based, privately held company, founded in 2011. The company’s V-LAP System enables heart failure patients to better control their disease by remotely monitoring the heart’s Left Atrial Pressure (LAP) and detecting fluid accumulation in the earliest stages of the disease, prior to physiological symptoms. A patient app further empowers the patient to self-titrate medication in real-time based on data extracted from the heart. For more information, please visit the company website.Contact:Lili Arbely-ElbazVectorious Medical Technologies.+972-(0)525909192[email protected]Photo – https://mma.prnewswire.com/media/2462304/V_LAP_Sensor.jpgSOURCE Vectorious Medical Technologies Ltd.

Circle Cardiovascular Imaging Announces Leadership Transition

CALGARY, AB, July 16, 2024 /PRNewswire/ — Circle Cardiovascular Imaging (“Circle” or the “Company”), the global leader in AI-driven cardiovascular imaging solutions, today announced that Erkan Akyuz has been appointed Chief Executive Officer, effective August 5, 2024. He will succeed Circle co-founder and CEO Greg Ogrodnick, who is stepping down after successfully leading the Company for more than 16 years.
Akyuz brings extensive leadership experience in healthcare and imaging technology, having served as President and CEO at major healthcare and medical systems companies including Rhapsody, Change Healthcare and Toshiba Medical Systems, where, under his leadership, the companies experienced improved profitability, customer retention and growth. Recognized for his ability to transform business models, Akyuz combines his technological background with his strategic prowess to drive operational excellence.
“I have long admired Circle and its role at the forefront of the medical imaging industry, offering best-in-class AI-powered solutions to hospitals, physicians and patients on a global scale,” said Erkan Akyuz. “I am thrilled to be joining this impressive team and look forward to leading Circle as we continue to advance our mission of improving patient outcomes worldwide.”
Akyuz is joining Circle, the leading provider of AI-based cardiac imaging and reporting solutions, during a period of accelerated growth and product innovation. Since Thoma Bravo’s investment in Circle in April 2022, the Company has expanded its global footprint from approximately 50 countries to over 90 countries and has continued to innovate on its cutting-edge AI-driven solutions. Earlier this year, Circle launched its next generation platform, cvi42 6.1, which is centered around growing with the medical field with a focus on accessibility, interoperability and efficiency.
“On behalf of the Thoma Bravo team, I want to thank Greg for his unwavering leadership and commitment to innovation that led Circle to become the category leader that it is today,” said Carl Press, a Partner at Thoma Bravo. “Under Greg’s stewardship, Circle transformed from a university-led research project into a market leading diagnostic platform that has benefitted tens of thousands of cardiology patients globally. We are humbled by the impact that he has made in the world of medical imaging and are truly grateful for our partnership with him. At the same time, we are thrilled to welcome Erkan to Circle and look forward to working closely together as we build on a strong foundation and continue to drive product innovation and growth globally.”
“It has been a privilege to lead the dedicated and passionate team at Circle, and I am proud of what we have achieved together,” said Greg Ogrodnick. “I’m confident that Erkan is the right person to lead Circle in the next phase of its journey, and I look forward to watching the Company’s continued success.”
About Circle Cardiovascular Imaging Inc.     
Circle Cardiovascular Imaging (Circle) is a Canadian-based company that was founded in 2007, established with the aim of developing innovative software solutions to enhance cardiovascular imaging analysis and improve patient care. Circle’s imaging platform provides best-in-class cardiovascular image reading and reporting for cardiac MR, cardiac CT, cardiac interventional planning, and electrophysiology.
At the heart of everything we do is our unrelenting drive to continually offer better solutions for healthcare providers that improve healthcare outcomes. This fuels our creativity, informs our decisions and is the reason we are passionate about our work. Our roots are medical and digital, our passion is contagious, and our people are amongst the best.    
Annually, millions of cardiac exams – in over 1700 hospitals and in more than 90 countries – are estimated to be interpreted using cvi42. For additional information, please visit www.circlecvi.com or contact: [email protected]
SOURCE Circle Cardiovascular Imaging Inc.

Humacyte Board of Directors Strengthened with Addition of John P. Bamforth and Keith Anthony Jones

DURHAM, N.C., July 16, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, announced the addition of pharmaceutical industry veteran Dr. John P. Bamforth and distinguished health system and academic physician Dr. Keith Anthony (Tony) Jones to the Company’s Board of Directors. “We are delighted to welcome two distinguished commercialization and health system leaders to the Humacyte Board as we prepare for our planned commercial launch of the Acellular Tissue Engineered Vessel (ATEV™) in the vascular trauma indication,” said Dr. Laura Niklason, Founder, President, and Chief Executive Officer of Humacyte. “John is widely recognized for his leadership at Lilly and brings deep commercialization and brand-development expertise that will be critical to us as we continue our planned transition to commercial operations. Tony has extensive medical expertise and administrative experience from his leadership roles at University of Alabama-Birmingham Health System, which will be a valuable perspective as we prepare to introduce the ATEV into major health systems. We look forward to their contributions as we work toward our anticipated U.S. market launch.” John P. Bamforth, PhD has served as Executive Director of Eshelman Innovation, a translational innovation institute at the University of North Carolina–Chapel Hill, since 2019. Prior to joining Eshelman Innovation, Dr. Bamforth spent 30 years at Eli Lilly and Company (“Lilly”) until his retirement in 2018, in an array of roles primarily focused on brand development and commercialization. In 2012, he was appointed Chief Marketing Officer for Lilly’s multi-billion-dollar U.S. business and in 2016 he became Chief Marketing Officer for Lilly’s global business. In 2017, Dr. Bamforth co-founded the Ciara Arts and Sciences Foundation dedicated to enabling disadvantaged youth to attend college. Dr. Bamforth holds a BPharm from the University of Bath and a Ph.D. and D.Sc. (Hon.) from Aston University in England. Keith Anthony Jones, M.D., has served as the Chief Physician Executive of the University of Alabama at Birmingham (“UAB”) Health System since 2017. Dr. Jones has served as the Maurice S. Albin Professor of Anesthesiology and Perioperative Medicine at the University of Alabama Heersink School of Medicine (“UABHSOM”) since 2019. Since 2017, Dr. Jones has also served as Senior Associate Dean for Clinical Affairs of UABHSOM. Since 2017, Dr. Jones has served as President of the University of Alabama Health Services Foundation, which is the Faculty Practice Plan for UABHSOM and employs approximately 1,400 academic physicians. From 2006 to 2017, Dr. Jones served as Chair of the Department of Anesthesiology and Perioperative Medicine for UABHSOM and Chief of Anesthesiology Services for UAB Hospital. He is a member of the American Society of Anesthesiologists, where he has served on and led numerous committees. Dr. Jones holds a B.S. in Microbiology from the University of Alabama and an M.D. from the UABHSOM, and completed his anesthesiology residency and postdoctoral fellowship at the Mayo Graduate School of Medicine. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. As announced previously, based on guidance from the FDA, the proper or generic (non-brand) name “Acellular Tissue Engineered Vessel” (ATEV) replaces the term “Human Acellular Vessel” (HAV) previously used for the engineered vessel product candidate. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application is currently under review by the FDA and was granted Priority Review with a PDUFA date of August 10, 2024 for use of the ATEV in the vascular trauma indication. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s RMAT designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for peripheral artery disease also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the expected PDUFA date for our ATEV in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of the BVP relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Cytokinetics Announces Seven Upcoming Presentations at the European Society of Cardiology Congress 2024

Late Breaking Clinical Trial Presentations to Feature Additional Results from SEQUOIA-HCM Related to Patient-Reported Health Status, Cardiac Structure and Function and Biomarkers Analyses of Safety and Outcomes from FOREST-HCM Related to Withdrawal of Standard of Care Medications to be Presented SOUTH SAN FRANCISCO, Calif., July 16, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced seven upcoming presentations, including four Late Breaking Clinical Trial presentations related to aficamten, at the European Society of Cardiology Congress 2024, taking place in London, UK from August 30, 2024 – September 2, 2024. Late Breaking Clinical Trials Title: Effect of Aficamten on Patient-Reported Health Status in Obstructive Hypertrophic Cardiomyopathy: Results from SEQUOIA-HCMPresenter: John A. Spertus, M.D., M.P.H., Professor, Daniel J. Lauer Missouri Endowed Chair in Metabolic and Vascular Disease Research, Clinical Director, University of Missouri Kansas City Healthcare Institute for Innovations in Quality and Saint Luke’s Mid America Heart InstituteDate: September 1, 2024Topic: European Society of Cardiology Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic StenosisSession Type: Late-Breaking ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:15 AM BSTLocation: Bishkek Title: Impact of Aficamten on Echocardiographic Cardiac Structure and Function in Adults with Symptomatic Obstructive Hypertrophic CardiomyopathyPresenter: Sheila Hegde, M.D., M.P.H., Cardiovascular Medicine Specialist, Division of Cardiovascular Medicine, Brigham and Women’s HospitalDate: September 1, 2024Topic: European Society of Cardiology Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic StenosisSession Type: Late-Breaking ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:26 AM BSTLocation: Bishkek Title: Effect of Aficamten on Structure and Function in Patients with Obstructive Hypertrophic Cardiomyopathy: The SEQUOIA-HCM CMR SubstudyPresenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science UniversityDate: September 1, 2024Topic: European Society of Cardiology Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic StenosisSession Type: Late-Breaking ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:37 AM BSTLocation: Bishkek Title: Safety and Outcomes of Standard of Care Medications Withdrawal in Patients with Obstructive Hypertrophic Cardiomyopathy Treated with Aficamten in FOREST-HCM TrialPresenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science UniversityDate: September 1, 2024Topic: European Society of Cardiology Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic StenosisSession Type: Late-Breaking ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:48 AM BSTLocation: Bishkek Oral Presentations Title: Clinical Application of Biomarkers in Obstructive Hypertrophic Cardiomyopathy: Insights from SEQUOIA-HCMPresenter: Caroline Coats, M.D., Ph.D., Lead Clinician, West of Scotland Inherited Cardiac Conditions Service, Honorary Senior Lecturer, School of Cardiovascular and Metabolic Health, University of GlasgowDate: September 1, 2024Topic: Hypertrophic Cardiomyopathy Session Title: Novel Therapies for Hypertrophic Cardiomyopathy: Recent Developments and Future ProspectsSession Type: Advances in ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:51 AM BSTLocation: Dublin Title: Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy: An Integrated Safety AnalysisPresenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science UniversityDate: September 1, 2024Topic: Hypertrophic Cardiomyopathy Session Title: Novel Therapies for Hypertrophic Cardiomyopathy: Recent Developments and Future ProspectsSession Type: Advances in ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 9:09 AM BSTLocation: Dublin Moderated ePoster Title: Menopausal Status and Clinical Outcomes in Women with Heart Failure with Reduced Ejection Fraction: the GALACTIC-HF TrialPresenter: Maria A. Pabon, M.D., Instructor of Medicine, Brigham and Women’s Hospital, Harvard Medical School; Associate Director, Cardiac Imaging Core LabDate: September 2, 2024Topic: Cardiovascular Disease in Women Session Title: Cardiovascular Disease in WomenSession Type: Moderated ePostersSession Time: 9:00-9:50 AM BSTLocation: Station 6 About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to any of our other clinical trials, statements relating to the potential benefits of omecamtiv mecarbil, aficamten, or any of our other drug candidates. Cytokinetics’ research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics’ other drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

CVRx to Report Second Quarter 2024 Financial and Operating Results and Host Conference Call on July 29th, 2024

MINNEAPOLIS, July 15, 2024 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim™, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, today announced that it plans to release second quarter 2024 financial and operating results after market close on Monday, July 29th, 2024. The Company will host a conference call to review its results at 4:30pm Eastern Time the same day. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on the developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner or Mike VallieICR Westwicke443-213-0501ir@cvrx.com Media Contact:Laura O’NeillFinn Partners212-867-1762laura.oneill@finnpartners.com

Sheba Startup Innovalve Bio Medical Ltd Acquired by Edwards Lifesciences Corporation

RAMAT GAN, Israel – July 15, 2024 – ARC Innovation at Sheba Medical Center, Israel’s largest medical center announced today another successful startup exit from within its innovation ecosystem with the acquisition of Innovalve Bio Medical Ltd by Edwards Lifesciences Corporation (NYSE: EW), a global leader in patient-focused medical innovations […]

Life Seal Vascular Inc. Awarded Prestigious NSF SBIR Grant to Advance Innovative Endovascular Aortic Aneurysm Sac Management Technology

More than $274,000 in NSF funding to develop breakthrough aneurysm sac management technologyCOSTA MESA, Calif., July 15, 2024 /PRNewswire/ — Life Seal Vascular Inc. (www.lifesealvascular.com), a pioneering company dedicated to revolutionizing endovascular treatment, is thrilled to announce that it has been awarded the highly competitive National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant. This funding will accelerate the development of Life Seal Vascular’s cutting-edge technology to improve patient outcomes and advance the field of endovascular aortic repair (EVAR).

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Life Seal Concept

“We are honored to receive this prestigious SBIR grant from the NSF. This funding is a testament to the innovative potential of our technology and our commitment to advancing EVAR care,” said Bob Mitchell, Executive Chairman of the Board at Life Seal Vascular Inc. “With this support, we are well-positioned to advance the development of our breakthrough aneurysm sealing solutions and make a significant impact on the lives of EVAR patients worldwide.”

The NSF SBIR grant will enable Life Seal Vascular to further develop its proprietary aneurysmal sac sealing technology. Designed as an adjunctive therapy to native endografts, Life Seal Vascular’s groundbreaking approach seals the entire aneurysmal sac potentially eliminating endoleaks, reducing reintervention rates and improving clinical outcomes for EVAR patients.
Dr. Michel Reijnen, a renowned vascular surgeon, commented on the significance of Life Seal Vascular’s technology, stating, “The advancements being made by Life Seal Vascular are truly remarkable. Their innovative solutions have the potential to revolutionize EVAR, offering patients safer and more effective treatment options. I am excited to see the positive impact this technology will have on the field and on patient care.”The NSF SBIR program is a highly competitive initiative that supports scientific excellence and technological innovation through the investment of federal research funds. Life Seal Vascular’s selection for this grant underscores the company’s dedication to advancing medical technology and its potential to deliver transformative healthcare solutions.This grant is supported by the U.S. National Science Foundation under award number 2407378.About Life Seal Vascular, Inc.Life Seal Vascular Inc. specializes in innovative sealing technologies for endovascular repair of aortic aneurysms. Their proprietary solutions has the potential to eliminate endoleaks, the main cause of reinterventions in Endovascular Aneurysm Repair (EVAR). By completely sealing the aneurysm, Life Seal Vascular’s devices ensure predictable deployment and do not interfere with imaging, thereby enhancing the effectiveness and safety of endovascular repair procedures.For more information about Life Seal Vascular Inc. and its groundbreaking technology, please visit [www.lifesealvascular.com](http://www.lifesealvascular.com).About U.S. National Science Foundation Small Business ProgramAmerica’s Seed Fund powered by the U.S. National Science Foundation Small Business programs focuses on transforming scientific and engineering discoveries into products and services with commercial and societal impact. The deep technologies that are funded show promise, but their success hasn’t yet been validated. And, each year, the NSF awards $200+ million in research and development (R&D) funding to about 400 startups across the United States. America’s Seed Fund is a program within the National Science Foundation and housed within the Directorate for Technology, Innovation and Partnerships.Media Contact:Bob MitchellExecutive Chairman of the BoardLife Seal Vascular Inc.Hannah Friend602-618-3377[email protected]SOURCE Life Seal Vascular, Inc.