Author: Ken Dropiewski

Positron Corporation Enters Agreement to Acquire FDA 510(k) for NeuSight PET-CT

Niagara Falls, NY, June 12, 2024 (GLOBE NEWSWIRE) — Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical support services, is pleased to announce it has entered an agreement to acquire the FDA 510(k) for the NeuSight PET-CT from its cooperative partner Neusoft Medical Systems’ subsidiary, Shenyang Intelligent Neuclear Medical Technology Co.   A 510(k) is a premarket submission made to the FDA (U.S. Food and Drug Administration) to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Positron’s ownership of the existing 510(k) and FDA clearance will enable the marketing and sale of the NeuSight PET-CT 64 slice imaging system. This 510(k) also will facilitate future FDA clearances, including for the Company’s Affinity PET-CT 4D 64 slice system. This agreement allows Positron to immediately market and sell the NeuSight PET-CT, with plans to introduce Positron’s Affinity PET-CT 4D pending acceptance of an amended 510(k) submission.   Adel Abdullah, President of Positron stated, “Gaining the 510(k) is a significant milestone in Positron’s mission to offer outstanding PET-CT technology and solutions to healthcare practices and hospitals serving both the cardiac and oncology segments of molecular imaging. Our PET imaging product line will now feature PET-CT which will expand access for physicians and practitioners seeking to utilize the full capabilities of the PET modality in nuclear cardiology and oncology.  PET-CT imaging remains at the forefront of oncology studies and has become vital to the future of nuclear cardiology. With the addition of PET-CT, Positron has a range of core products that blend cutting edge technology with strong economics, appealing to most nuclear imaging specialist and practices.” Mr. Abdullah further added, “We appreciate the full support of Neusoft Medical Systems whose unwavering support and expertise in imaging technologies and extensive R&D continues to enhance our current and future capabilities. I am confident in Positron’s important role in advancing the PET modality and our commitment to delivering the best value in the industry.” About Positron Corporation Positron Corporation is a medical technology company that co-develops, manufactures, and sells  state-of-the-art PET and PET-CT imaging systems and clinical services to nuclear medicine healthcare providers throughout North America. Positron specializes in the field of cardiac Positron Emission Tomography (PET) imaging, the gold standard in cardiac diagnostics. Positron’s innovative PET/PET-CT technologies, clinical services and practice solutions enables healthcare providers to accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine. Positron’s Attrius® PET and NeuSight PET-CT imaging systems and distinct market position are substantial advantages unique to Positron that will facilitate the adoption of cardiac PET and the growth of the nuclear imaging market. Positron will soon offer a state-of-the-art PET-CT 4D molecular imaging device in the Affinity PET-CT 4D 64-Slice. Positron’s PET-CT(s) will enable nuclear cardiologists to utilize the full capabilities of molecular imaging and nuclear medicine. Positron’s PET-CT systems will also enable the Company to fully service and meet the demands of the vast oncology imaging segment of nuclear medicine.  Positron is committed to expanding the cardiac and oncology PET modality by delivering the best technology and value to imaging specialists and will continue to advance its technology through its co-developer, supplier, and R&D venture with Shenyang Intelligent Neuclear Technology Co. a subsidiary of Neusoft Medical Systems.    About Neusoft Medical Systems Co., Ltd. Neusoft Medical Systems is a leading global clinical diagnosis and treatment solution provider, headquartered in China. Neusoft Medical Systems is constantly innovating its portfolio of medical imaging diagnosis and clinical solutions in CT, MRI, DSA, XR, PET/CT, RT, US and IVD. Neusoft Medical Systems also is developing MDaaS (Medical Devices & Data as a Service), a strategic product line built using the Internet, big data, artificial intelligence, combined with other technologies improving medical institutions’ ability to diagnose and treat patients, achieving operational excellence. Innovation is always the driving force of Neusoft Medical Systems. Neusoft Medical Systems is collaborating with global scientists and medical institutions dedicated to advancing the technology of medical imaging solutions. Together with 45,000 installations in more than 110 countries, Neusoft Medical Systems provides advanced, high-quality medical imaging solutions to patients around the world. Neusoft Medical Systems is dedicated to being an excellent value innovator of global healthcare services. Through innovation and excellent operations, Neusoft Medical Systems is advancing healthcare products across a wide range of medical solutions and services to enhance global healthcare for all. Forward-Looking Statements  This press release contains statements which may constitute “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Positron Corporation, and members of its management as well as the assumptions on which such statements are based. Words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and similar expressions are forward-looking statements and involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results even if new information becomes available in the future. FOR FURTHER INFORMATION, please visit the company’s website at www.positron.com, or contact: investor@positron.com

Philips launches Duo Venous Stent System for treatment of symptomatic venous outflow obstruction

June 12, 2024                                                                                                                                                                Sanger Heart & Vascular Institute, Atrium Health, treated the first patient with the new implantable medical device following FDA premarket approval Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the first implant of the Duo Venous Stent System, an implantable medical device indicated to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI), following premarket approval (PMA) from the U.S. Food and Drug Association (FDA). On June 11, Dr Erin Murphy – vascular surgeon and director of the Venous and Lymphatic Program at the renowned Sanger Heart & Vascular Institute, Atrium Health, in Charlotte, N.C., and an investigator in the VIVID study, which contributed to the device’s FDA approval – successfully used the Duo Venous Stent System for the first time outside of a clinical trial. Impacting 25 million people globally [1], deep venous disease results from venous thromboembolism, a condition that occurs when a blood clot forms in the vein [2]. It is the third most common cardiovascular disease [2]. Deep venous anatomy and obstructions can present a multitude of complexities and mechanical challenges. Engineered for the unique demands of venous anatomy and obstructions, the Duo Venous Stent System is comprised of two stents – Duo Hybrid and Duo Extend – of various sizes. Duo Hybrid has a distinct integrated design that combines multiple zones of differing mechanical properties into a single stent [3]. For long lesions, Duo Extend smoothly overlaps with the Duo Hybrid to extend therapy. These two stents are designed to work together and minimize the risk of stent fracture and corrosion, while providing an option to stent within caudal veins with smaller diameters [3]. “Duo is the first stent that offers a differential design for the challenges of venous anatomy – a focal area that withstands the forces of compression as well as the flexibility to accommodate curvature of the vessel,” said Dr Kush Desai, a highly regarded Interventional radiologist and associate professor of Radiology, Surgery and Medicine at Northwestern University in Chicago, as well as a leading enroller and investigator for the VIVID study. “Consequently, Philips is well positioned to support CVI treatment by offering a robust portfolio of medical technology that includes both intravascular ultrasound and a differentiated venous stenting system.” VIVID studyThe VIVID study is a global, prospective, multi-center, single-arm, non-blinded clinical trial conducted in the U.S. and Poland, evaluating the safety and efficacy of the Philips Duo Venous Stent System in the treatment of nonmalignant iliofemoral occlusive disease. It enrolled 162 subjects at 30 centers with three patient populations – non-thrombotic iliac vein lesion (NIVL), post-thrombotic syndrome (PTS) and acute deep vein thrombosis (aDVT). The VIVID study is now in 36-month follow-up and upon FDA PMA approval transitioned from an investigational device exemption (IDE) study to a post-approval study (PAS): NCT04580160. The VIVID study met all of its primary safety and efficacy performance goals. The 12-month effectiveness endpoint for primary patency reached 90.2%, which exceeded the performance target goal of 77.3%. The 12-month primary safety endpoint of 98.7% also exceeded the corresponding performance goal of 89%. In addition, quality of life and venous functional assessments that were performed in the VIVID study – including Clinical-Etiology-Anatomy-Pathophysiology (CEAP), Venous Clinical Severity Score (VCSS), Villalta, EQ-5D-3L and VEINES scores – showed sustained improvements compared to baseline at 12 months. “The VIVID study’s 12-month results demonstrate the safety and efficacy of the Duo Venous Stent System in the treatment of chronic venous insufficiency, a vascular condition affecting millions of people worldwide,” said principal investigator Dr Mahmood Razavi, M.D., an interventional radiologist with St. Joseph Vascular in Orange County, Calif. “Duo represents a meaningful addition to the tools that clinicians can use to treat CVI patients,” Dr Razavi added, “especially when used in conjunction with intravascular ultrasound, or IVUS. Ultimately, the new device promises to enable excellent clinical outcomes and drive significant quality of life improvements.”  The VIVID study was the first clinical trial to mandate IVUS use to aid in lesion assessment and stent sizing prior to device implantation. According to prior published research, IVUS supports accurate diagnosis of venous disease and has been shown to change 57% of treatment plans compared to venography alone [4]. Led by Philips, intravascular imaging is used in more than 70% of venous stent procedures [5]. “The launch of the Duo Venous Stent System represents another step forward in achieving our aspiration to innovate interventional procedures with advanced medical technology,” said Heather Hudnut Page, Vice President and Business Leader of Peripheral Vascular at Philips. “In this context, we look forward to bringing the combined offering of intravascular ultrasound and Duo to the interdisciplinary teams – from vascular surgeons to interventional radiologists and interventional cardiologists – who share our overarching goal of enhancing patient care.” [1] Market Model Sources- DVD: 1 US Physician Quant Survey- Leveraged for NIVL prevalence assumption as ~25% of Symptomatic DVD 2 Thrombosis: a major contributor to the global disease burden. J Thromb Haemost 2014; 12: 1580–90. – Leveraged for DVT incidence in some countries (ex. EU5) 3 DRG VTE Epidemiology Reports- Leveraged for DVT incidence in some countries 4 Inari Medical presentation and Khan, SR, Arch Intern Med 2004- Leveraged for assumption of PTS.[2] Scheres LJJ, Lijfering WM, Cannegieter SC. Current and future burden of venous thrombosis: Not simply predictable. Res Pract Thromb Haemost. 2018 Apr 17;2(2):199-208. doi: 10.1002/rth2.12101. PMID: 30046722; PMCID: PMC6055567.[3] Data on file: D062749[4] Gagne PJ, Tahara RW, Fastabend CP, et al. Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction. J Vasc Surg Venous Lymphat Disord. 2017;5:678-687.[5] Divakaran S, Meissner MH, Kohi MP, et al. Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries. J Vasc Interv Radiol. 2022;33(12):1476-1484.e2. doi:10.1016/j.jvir.2022.08.018 Regulatory disclosures Developed by Vesper Medical, Inc., a wholly owned subsidiary of Philips, the Duo Venous Stent System is being marketed under the Philips brand. Its FDA approval order, along with related regulatory information, can be found here: PMA approval for Duo Venous Stent System. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. For further information, please contact:Joost MalthaPhilips Global Press OfficeTel. : +31 (6) 1055 8116Email : joost.maltha@philips.com About Royal PhilipsRoyal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,100 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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University Hospitals Transforms Patient Care with Aidoc’s AI-Enabled Solutions Across Its Entire Health System

Aidoc aiOS™ integration across 13 hospitals focuses on enhancing clinical outcomes and streamlining workflow with access to 17 FDA-cleared AI algorithmsCLEVELAND, June 12, 2024 /PRNewswire/ — University Hospitals (UH) has announced a major advancement in its AI strategy with the deployment of Aidoc’s comprehensive AI platform (aiOS™) across 13 of its hospitals and dozens of its outpatient locations. This initiative marks a significant leap forward in leveraging cutting-edge technology for superior patient outcomes.

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Image of University Hospitals Medical Center Campus in Cleveland, Oh. (PRNewsfoto/Aidoc)

University Hospitals Logo (PRNewsfoto/Aidoc)

Driven by a commitment to provide the highest standard of care, UH sought a standardized, hyper-accurate AI platform that could be seamlessly integrated across its network of academic hospitals and outpatient locations. Having utilized AI in various small-scale applications, UH chose to expand its capabilities with Aidoc to empower care teams with the information they need to address some of today’s most pressing medical issues.

Patients at UH will benefit from faster diagnosis and treatment of acute conditions such as pulmonary embolism, aortic dissection, vertebral compression fracture and pneumothorax. When a patient arrives at a UH facility and undergoes a CT scan for an injury or pain, Aidoc’s AI analyzes the scan using its comprehensive algorithms. The technology identifies both expected and unexpected findings, helps physicians prioritize urgent cases and ensures all flagged conditions are reviewed by the care team. Aidoc’s AI facilitates communication between the care team to enhance collaboration and speed up treatment.
Key Benefits of Aidoc for University Hospitals
Seamless integration across the entire health network
Immediate access to critical patient information
Expedited care and improved patient outcomes
Access to all 17 FDA-cleared AI algorithms for triage, quantification and care coordination
“Today’s care delivery is incredibly complex with numerous moving parts,” shared Dr. Donna Plecha, Chair of Radiology at University Hospitals.” Aidoc’s AI technology assists our radiologists in evaluating various patient images, allowing our clinicians to access precise, actionable data quickly. The AI technology enables our care teams to be more accurate and efficient leading to even more exceptional care for our patients.”The agreement leverages Aidoc’s proprietary aiOS™, a groundbreaking platform that addresses common AI implementation challenges such as integrating with existing IT systems, ensuring EHR compatibility, and managing data and reporting. This comprehensive approach ensures that UH can provide leading-edge care while maintaining operational efficiency and clinical excellence.”We are thrilled to collaborate with University Hospitals to drive healthcare innovation through our AI solutions,” said Elad Walach, CEO, Aidoc. “University Hospitals’ visionary approach to healthcare and dedication to integrating technology sets a new standard for patient care. UH is not only enhancing care coordination and streamlining workflows but also ensuring every patient receives the precise, timely and exceptional care they deserve. UH’s commitment to medical ingenuity and excellence is truly transformative.”By integrating Aidoc’s AI platform, University Hospitals ensures seamless deployment and minimal technical challenges, allowing for a collaborative approach to continuous monitoring and governance. This partnership not only enhances patient safety and care but also enables UH to maintain high standards in AI performance and reliability. Through this collaborative effort, UH can focus more on patient care, ensuring every patient receives the best possible treatment with the aid of AI technology.About University Hospitals Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 21 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, the Technion Israel Institute of Technology and National Taiwan University College of Medicine. The main campus also includes the UH Rainbow Babies & Children’s Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women’s Hospital, Ohio’s only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org.About AidocAidoc is a pioneering force in clinical AI. We focus on aiding and empowering healthcare teams to optimize patient treatment, which results in improved economic value and clinical outcomes. Our clinically proven AI solutions eliminate silos, increase efficiencies, and improve outcomes by delivering critical information when and where care teams need it leading to immediate collective action. Built on Aidoc’s proprietary aiOS™, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Used in more than 1,000 medical centers worldwide, Aidoc has the most FDA clearances (17) in clinical AI and its AI-based solutions cover 75 percent of patient populations, enabling physicians to make informed decisions based on real-time data. Aidoc AI is always on, running in the background to change the foreground. Visit Aidoc.com to see how we are connecting all points of care with always on AI.Photo – https://mma.prnewswire.com/media/2436134/Aidoc_UH.jpgLogo – https://mma.prnewswire.com/media/2015772/4756850/Aidoc_Always_On_AI_Logo.jpgLogo – https://mma.prnewswire.com/media/2436135/University_Hospitals_Logo.jpgSOURCE Aidoc

Milestone Pharmaceuticals to Host KOL Event for Investors “Learnings from the Field: Expert Perspectives on PSVT in the Community Setting” on June 20, 2024

MONTREAL and CHARLOTTE, N.C., June 12, 2024 (GLOBE NEWSWIRE) — Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will host Part I of its virtual investor educational series on Thursday, June 20, 2024, at 8:00 AM ET. To register for “Learnings from the Field: Expert Perspectives on Managing PSVT in the Community Setting,” click here. The event will feature George Mark, MD, FACC and Vivek Sailam, MD from The Heart House and Cooper University Health Care, who will discuss the burden of paroxysmal supraventricular tachycardia (PSVT) on patients and their practice, current treatments and unmet needs, and expectations for how the treatment landscape will evolve in coming years. A live question and answer session will follow the formal presentation. About George Mark, MD, FACC George Mark, MD, FACC is a cardiac electrophysiologist at The Heart House and Cooper University Health Care who specializes in treating rhythm disorders of the heart. His practice includes medical device implantation for the prevention of sudden cardiac death and cardiac ablation to treat abnormal heart rhythms. Dr. Mark graduated from Wesleyan University with a degree in Molecular Biology and Biochemistry and received his medical degree from Temple University. Dr. Mark remained at Temple for his residency in Internal Medicine, where he served for a year as Chief Medical Resident. Dr. Mark completed his fellowship training in Cardiovascular Diseases and Clinical Cardiac Electrophysiology at Thomas Jefferson University Hospital. About Vivek Sailam, MDVivek Sailam, MD is a clinical cardiologist at The Heart House and Cooper University Health Care with more than 16 years of experience. He completed his internal Medicine Residency at Hahnemann University and pursued additional training in cardiovascular disease. His dedication and expertise have been acknowledged with awards such as South Jersey Top Docs, Guardian Angel Award, and NJ Top Docs. Dr. Sailam has contributed to the medical field through publications in the NY Times 2021. Beyond medicine, Dr. Sailam is passionate about Community Health programs: “Walk with a Doc, Workout with a Doc, Eat with a Doc, Shop with a Doc,” nutrition, fitness, and racing automobiles, finding his balance and inspiration outside the clinic or hospital. About Paroxysmal Supraventricular Tachycardia An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is CARDAMYST (etripamil) nasal spray, a novel calcium channel blocker that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor Relations Chris Calabrese, ccalabrese@lifesciadvisors.com Kevin Gardner, kgardner@lifesciadvisors.com Source: Milestone Pharmaceuticals Inc.

Anteris Provides Data Update on First in Human Study of DurAVR™ THV Presented at New York Valves 2024

BRISBANE, Australia & MINNEAPOLIS–(BUSINESS WIRE)–Anteris Technologies Ltd (ASX: AVR), a structural heart company developing DurAVR™ THV, a new class of TAVI and the world’s only balloon-expandable, single-piece biomimetic aortic replacement valve shaped to mimic the native human valve, today announced […]

Foldax® Reports Positive Clinical Results for TRIA Mitral Surgical Heart Valve Using Novel LifePolymer Material

SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced positive 30-day results from a prospective, multicenter, single-arm, clinical study of the TRIA™ mitral surgical heart valve with LifePolymer™ conducted in India. At […]

Longeveron® Announces Completion of Successful Investigator Meeting for On-going Phase 2b Clinical Trial Evaluating Lomecel-B™ as a Potential Treatment for HLHS, a Rare Pediatric Cardiac Disease

With current HLHS treatment, only 50-60% of infants survive to adolescenceIn ELPIS I Phase 1 clinical trial, children experienced 100% transplant-free survival up to five years of age after receiving Lomecel-B™ compared to approximate 20% mortality rate observed from historical control dataELPIS II Phase 2b clinical trial on track for completing enrollment by end of 2024Multiple nationally recognized children’s treatment centers participating in ELPIS II MIAMI, June 11, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for rare, life-threatening and chronic aging-related conditions, today announced the successful completion of an investigator meeting for ELPIS II, the on-going Phase 2b clinical trial evaluating Lomecel-B™ as a potential adjunct treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric congenital heart birth defect. The investigator meeting was organized to discuss the progress to date and operational implementation of the clinical trial, inviting the principal investigator and site staff from premiere infant and children’s treatment institutions across the country. ELPIS II is on track to complete enrollment by the end of 2024. Healthcare institutions participating in the ELPIS II Phase 2 clinical trial include: Three additional nationally recognized pediatric cardiothoracic institutions participated in the investigator meeting as part of their preparation for participating as investigative sites in ELPIS II. “While we have made significant advances in diagnosing HLHS before a baby is born, we don’t yet know the cause, and current HLHS treatment requires infants to undergo a complex three-stage surgical reconstruction over the first 3-4 years of their life,” said Ram Kumar Subramanyan, division chief of Pediatric Cardiothoracic Surgery at Children’s Nebraska, and a Principal Investigator in ELPIS II. “Even with this comprehensive treatment, only 50% to 60% of infants survive to adolescence due to right ventricular failure. There is clearly an important unmet medical need to improve right ventricular function in these infants to positively impact both short- and long-term patient outcomes. Lomecel-B’s™ Phase 1 clinical data is highly encouraging and suggests it has the potential to be a new, additive treatment option for physicians and their patients dealing with HLHS. The community is very much looking forward to the results of ELPIS II.” “We believe the data generated to date in HLHS support potential for Lomecel-B™ as a regenerative medical therapy to help these infants,” said Nataliya Agafonova, MD, Chief Medical Officer of Longeveron. “In the ELPIS I Phase 1 clinical trial, participating infants experienced 100% transplant-free survival up to five years of age after receiving Lomecel-B™ compared to approximate 20% mortality rate observed from historical control data. ELPIS II is designed to further our understanding of Lomecel-B’s™ safety and efficacy in this patient population. With the collaboration of our outstanding investigative sites, we remain on track to complete enrollment of the clinical trial by the end of this year.” Longeveron’s lead investigational therapeutic candidate is Lomecel-B™, a proprietary, scalable, allogeneic, adult human bone marrow-derived medicinal signaling cell therapy. ELPIS II is enrolling 38 pediatric patients, with enrollment completion anticipated by year end 2024. The clinical trial is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH). ELPIS II builds on the positive clinical results of ELPIS I. About Hypoplastic Left Heart Syndrome (HLHS) HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, infants born with this condition have severely diminished systemic blood flow, which requires them to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. While these infants can now live into adulthood, early mortality is still extremely high in this population due to right ventricle failure, which is not meant for the increased load demanded for systemic circulation (blood circulation throughout the body). As such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term outcomes. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, the potential for Lomecel-B™ to be a beneficial treatment for patients with HLHS. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com