Financial

Milestone Pharmaceuticals Refreshes Board of Directors

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– Two New Independent Directors, Stuart Duty and Andrew Saik, Appointed – Third New Independent Director to Be Appointed to Board in Near Term MONTREAL and CHARLOTTE, N.C., July 15, 2024 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) (“Milestone” or the “Company”), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced steps to refresh its Board of Directors (“Board”). Stuart Duty and Andrew Saik have been appointed to its Board, effective immediately, and will stand for election at the Company’s 2024 Annual Meeting of Shareholders (the “Annual Meeting”). The Company will appoint a third independent director to its Board in the near term. In conjunction with the announcement, the Company entered into a Cooperation Agreement (the “Agreement”) with Alta Fundamental Advisers LLC (“Alta”), one of the Company’s shareholders. Mr. Duty has over 30 years of experience in investment banking and operations primarily in the biotechnology and specialty pharmaceuticals sectors. Most recently, he served as a Senior Managing Director at Guggenheim Securities, LLC from 2012 to 2023 where he advised senior executives and boards on a range of financing activities and strategic transactions. Mr. Saik has over 25 years of accounting and finance experience, including as Chief Financial Officer of biopharmaceutical companies Arvinas, Inc., Intercept Pharmaceuticals, Vyne Therapeutics Inc., PDS Biotechnology, Inc. and Vertice Pharma, LLC, where he has led numerous capital structure transformations. “We welcome Stuart and Andrew to our Board and look forward to benefitting from their varied perspectives and experiences,” said Robert J. Wills, PhD, Chairman of the Milestone Board of Directors. “We believe Stuart and Andrew will provide important insights to the Board and are great additions as we approach this particularly exciting time for Milestone.” The Company also announced that Debra K. Liebert and Richard C. Pasternak, MD, will not stand for reelection at the Annual Meeting. Dr. Wills added, “We want to thank Debra and Richard for their years of service and significant contributions as members of the Board. Their invaluable insights in the boardroom brought us closer to realizing our mission of providing a new treatment option for patients with paroxysmal supraventricular tachycardia and atrial fibrillation. We wish them all the best for the future.” Pursuant to the Agreement, Alta has agreed to customary standstill, voting and other related provisions. The Agreement will be included as an exhibit to the Company’s current report on Form 8-K, which will be filed with the U.S. Securities and Exchange Commission (the “SEC”). About Stuart Duty Stuart Duty brings over 30 years of experience in investment banking and operations primarily in the biotechnology and specialty pharmaceuticals sectors. Mr. Duty most recently served as a Senior Managing Director at Guggenheim Securities, LLC from 2012 to 2023, where he advised senior executives and boards on a range of financing activities and strategic transactions, including significant in-country and cross-border transactions in the U.S., Japan, China, Canada and many European countries. Prior to joining Guggenheim, he was a Managing Director, Co-Head, Healthcare Investment Banking at Piper Jaffray from 2007 to 2012, returning to the firm after serving in the same role from 1999 to 2002. Mr. Duty served as Chief Operating Officer of Oracle Partners from 2002 to 2007. Earlier in his career, he served as a Managing Director, Healthcare Investment Banking at Montgomery Securities, as Director, Business Development at Curative Technologies and as a healthcare investment banking analyst at Kidder Peabody. Mr. Duty has served on the board of directors of Achieve Life Sciences, Inc. (Nasdaq: ACHV) since March 2023, where he serves as the chair of the audit committee and sits on the nominating and corporate governance committee, and on the board of directors of EyePoint Pharmaceuticals (Nasdaq: EYPT) since November 2023, where he sits on the audit committee. Mr. Duty holds a BA in Biochemistry from Occidental College and an MBA from Harvard Business School. About Andrew Saik Andrew Saik brings over 25 years of accounting and finance experience at biopharmaceutical companies. Mr. Saik is currently Chief Financial Officer at Arvinas, Inc. (Nasdaq: ARVN). Prior to joining Arvinas, Mr. Saik served as Chief Financial Officer at Intercept Pharmaceuticals from 2021 to 2023, where he led a restructuring of the company’s balance sheet that included the sale of its international business and recapitalization of the company’s debt. Mr. Saik served as Chief Financial Officer of Vyne Therapeutics Inc. from 2020 to 2021. He was Chief Financial Officer and served on the board of directors of PDS Biotechnology, Inc. (formerly Edge Therapeutics) from 2017 to 2020. Before joining PDS, he was Chief Financial Officer at Vertice Pharma, LLC, a Warburg Pincus-backed company, from 2015 to 2017. Mr. Saik was Chief Financial Officer of Auxilium Pharmaceuticals, Inc. from 2014 to 2015, where he helped lead the execution of Auxilium’s growth strategy culminating in the sale of the company. Before joining Auxilium, he was Senior Vice President, Finance and Treasurer at Endo Pharmaceuticals from 2013 to 2014. Earlier in his career, Mr. Saik served in senior financial management roles with increasing responsibility at Valeant Pharmaceuticals International from 2001 to 2012, including as Senior Vice President, Finance. He was a Finance Manager at Nexgenix from 1999 to 2001 and began his career at Atlantic Richfield as Finance Consultant from 1996 to 1999. Mr. Saik holds a BA from the University of California, Los Angeles and an MBA from the University of Southern California. 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 etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws (“forward-looking statements”). Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of upcoming clinical trial milestones and related data; the company’s cash runway; and the company’s plans to maintain a dialogue with its shareholders. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with SEC and the Canadian securities regulatory authorities, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with the SEC and the Canadian securities regulatory authorities, which is available under Milestone’s profile on EDGAR at www.sec.gov and on SEDAR at www.sedarplus.ca. Except as may be expressly required by applicable law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available or based on future events or otherwise. Participants in the Solicitation This press release is neither a solicitation of a proxy or consent nor a substitute for any proxy statement or other filings that may be made with the SEC and Canadian securities regulatory authorities. Milestone, its directors, certain of its executive officers, and other members of management and employees may be deemed under U.S. securities laws and Canadian securities laws to be participants in the solicitation of proxies with respect to a solicitation by Milestone. Information about Milestone’s executive officers and directors and other participants in the solicitation, including their respective interests, by security holdings or otherwise, is available in the Company’s proxy statement on Schedule 14A for its 2023 annual meeting of shareholders, filed with the SEC on April 28, 2023 (available here). To the extent holdings of Milestone securities reported in the proxy statement have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC and if applicable, on the System for Electronic Disclosure by Insiders (“SEDI”) in accordance with insider reporting requirements of Canadian securities laws. Updated information regarding the identity of potential participants and their direct or indirect interests, by security holdings or otherwise, in Milestone will be set forth in the Company’s definitive proxy statement for the Annual Meeting and other documents to be filed with the SEC and Canadian securities regulatory authorities, when they become available. These documents are or will be available free of charge at the SEC’s website at www.sec.gov and either through the Company’s profile on SEDAR at www.sedarplus.ca or updated filings on SEDI at www.sedi.ca. Contact:Kim Fox, Vice President, Communications kfox@milestonepharma.com 704-803-9295  Investor RelationsChris Calabrese, ccalabrese@lifesciadvisors.comKevin Gardner, kgardner@lifesciadvisors.com

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89bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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SAN FRANCISCO, July 12, 2024 (GLOBE NEWSWIRE) — 89bio, Inc. (the “Company” or “89bio”) (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 125,000 shares of the Company’s common stock to six new employees (the “Inducement Grants”) on July 9, 2024 (the “Grant Date”). The Inducement Grants have been granted pursuant to the Company’s 2023 Inducement Plan (the “Plan”). The Inducement Grants were granted as an inducement material to these individuals entering into employment with 89bio in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Grants have an exercise price per share that is equal to the closing price of 89bio’s common stock on the Grant Date. The Inducement Grants will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the employee’s start date, and thereafter the remainder of the shares vest in 12 equal quarterly installments, subject to each employee’s continued employment with 89bio through the applicable vesting dates. About 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn. Investor Contact:Annie Chang89bio, Inc.investors@89bio.com PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com Media Contact:Sheryl SeapyReal Chemistrysseapy@realchemistry.com

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Adona Medical, a Shifamed Portfolio Company, Raises $33.5 Million in Series C Financing

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Funding to support next stage of product development and early clinical experience of company’s novel interatrial shunt and remote monitoring solution for patients with heart failure LOS GATOS, Calif., July 10, 2024 /PRNewswire/ — Adona Medical, a Shifamed portfolio company that aims to deliver advanced solutions for heart failure, announced today it has secured $33.5 million in Series C financing. The funds will be used to further product development and to initiate clinical use of the company’s adjustable interatrial shunt with integrated bi-atrial pressure monitoring. The financing was led by Cormorant Asset Management and TCP Health Ventures, with participation from Excelestar Ventures, the PA MedTech VC Fund II, Unorthodox Ventures, AMED Ventures, and other new and existing investors.

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The Adona Medical interatrial shunt features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter.

“Heart failure is a complex condition that benefits from an individualized treatment paradigm, yet many of the device-based treatment options available today offer a one-size-fits-all approach,” said Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center, Minneapolis Heart Institute Foundation. “Adona’s innovative shunt and sensor pairing aims to provide a more individualized management strategy and is designed so that shunt flow can be adjusted to best suit the needs of each individual patient, both initially and as their condition evolves over time. I look forward to working with the Adona team as they move into clinical use later this year.”

“Despite advancements in heart failure therapies, challenges remain that limit patient applicability and physician adoption with first-generation devices,” said Bihua Chen, Founder and Managing Member of Cormorant Asset Management. “We are pleased to lead this round as we believe Adona’s technology has the potential to disrupt the field and benefit the millions of patients suffering from heart failure.”
The Adona device includes a shunt that features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter. In addition, the implantable device features integrated sensors designed to capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction. These daily readings can provide physicians with a more complete understanding of a patient’s hemodynamic status and can augment shunt therapy by enabling more informed medical management. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally.1″Adona is committed to improving outcomes for patients with heart failure. We’ve developed multiple innovative technologies that we believe will elevate the impact that is achievable with device-based interventions,” commented Brian Fahey, Co-Founder and Chief Executive Officer of Adona Medical. “The team has made tremendous progress in advancing our solution for heart failure management and we are grateful for the strong ongoing support from our investors as we take the next steps in our journey.”About Adona Medical, Inc.Adona Medical, a privately held portfolio company of Shifamed, LLC, is a pre-clinical stage medical technology company developing next-generation interatrial shunting and remote patient monitoring solutions for patients with advanced heart failure. The Adona Medical heart failure management platform is an investigational device and is not approved for use in the U.S. or anywhere in the world. To learn more, please visit www.adonamed.com.About Shifamed, LLCFounded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.MEDIA CONTACT:Jennie KimSPRIG Consulting, LLC[email protected]References:
Benjamin et al. Circulation 2018.
SOURCE Adona Medical

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R3 Vascular Appoints Josh Smale as its Vice President of Global Clinical and Scientific Affairs

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MOUNTAIN VIEW, Calif., July 09, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce the appointment of Josh Smale as its Vice President of Global Clinical and Scientific Affairs. Prior to joining R3 Vascular, Mr. Smale served as Vice President of Clinical Affairs for the Peripheral Intervention business unit of Becton Dickinson (BD) where he was responsible for all aspects of clinical evidence generation and dissemination for the company’s complex and diverse device portfolio. Prior to his tenure at BD, Mr. Smale served in roles of increasing responsibility for Bard Peripheral Vascular, Inc. (BPV) which was acquired by BD, and as Regulatory Affairs Manager for SenoRX, Inc. which was acquired by BPV. He also served as Regulatory Affairs Manager for Endologix, Inc. and in various roles at BPV. Mr. Smale holds a Bachelor of Science in Engineering with an emphasis on Molecular and Cellular Engineering, and Biochemical Engineering from Arizona State University. He also served on the board of the Peripheral Intervention business unit of BD, has received numerous awards, is the co-author of several publications, and holds five Vena Cava Filter patents. Commenting on the appointment of Mr. Smale, Christopher M. Ownes, President and CEO of R3 Vascular, said, “On behalf of the R3 management team, I am very pleased to welcome Josh Smale as Vice President of Global Clinical and Scientific Affairs. Josh has a proven track record and more than 20 years of relevant medical device experience specializing in clinical and regulatory affairs strategy, clinical evidence generation and dissemination, and physician education. Among other key clinical and scientific affairs programs, Josh will lead our clinical trial efforts, including our pivotal ELITE trial for our next generation Magnitude drug eluting bioresorbable scaffold. We look forward to his contributions as we work towards establishing R3 Vascular as the leader in the development and manufacturing of fully bioresorbable vascular scaffolds.” Mr. Smale said, “I am very excited to join R3 Vascular and work closely with Chris Owens, Kamal Ramzipoor, and the rest of the R3 Vascular team to build upon the success of the company and support the adoption of its breakthrough technology for treating below-the-knee peripheral arterial disease (BTK PAD). R3 Vascular’s novel next generation bioresorbable scaffolds will transform the field of peripheral interventions by providing a new standard of care and improving the health of patients around the world.” Mr. Smale joins R3 Vascular’s leadership team which, among others, includes Christopher M. Owens, President and Chief Executive Officer and Kamal Ramzipoor, R3 Vascular’s Founder and Chief Technology Officer (CTO). In May of 2024, R3 Vascular announced the closing of its $87 million Series B financing round. About R3 Vascular Inc.R3 Vascular is a privately-held medical device company that develops a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com. Media Contact:David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c861cb09-8ed9-4401-8f89-6e69934fd0d3

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Octagos Health Secures Over $43 Million Investment to Advance AI-Driven Cardiac Device Monitoring

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HOUSTON, July 9, 2024 /PRNewswire/ — Octagos Health, an industry-leading provider of AI-driven cardiac device monitoring solutions, today announced a successful equity raise of over $43 million in investment capital. The Series B investment round was led by funds managed by Morgan Stanley Expansion Capital, with continued participation from Mucker Capital and other strategic investors. This funding will accelerate Octagos Health’s mission to use artificial intelligence to revolutionize cardiac care and provide comprehensive patient monitoring services. 

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Octagos Health provides an AI-driven platform that offers continuous monitoring and data analysis for patients with cardiac devices (pacemakers, defibrillators, ambulatory monitors, consumer wearables, and other modalities). Atlas AI, the company’s proprietary technology, ensures high accuracy and sensitivity in detecting clinically relevant events, automating physician workflows, and enabling healthcare providers to make informed decisions and improve patient outcomes. The platform’s comprehensive capabilities include seamless integration with electronic health records (EHR) and customizable reporting features, making it a preferred choice for cardiology practices. 

“By combining AI, patient services, and bidirectional EHR integration, the Octagos Health platform enables cardiologists to efficiently monitor patients, improve patient care, and enhance clinic economics.”

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“By combining AI, patient services, and bidirectional EHR integration, the Octagos Health platform enables cardiologists to efficiently monitor patients, improve patient care, and enhance clinic economics. The funding will help us accelerate our growth across the US and expand into other critical areas of cardiac care, including ambulatory monitors, consumer wearables, and sleep.  Our goal is to build a comprehensive AI-based clinical decision support engine for healthcare. We are thrilled to have Morgan Stanley Expansion Capital as our lead investor and the continued support of Mucker Capital. In a short period, we have grown from first servicing my cardiology clinic to becoming one of the largest cardiac remote monitoring companies that provides software and services,” said Dr. Shanti Bansal, cardiologist, CEO of Octagos Health and Houston Heart Rhythm. 
“This investment will enable us to accelerate enhancements to our platform, in addition to scaling our commercial team and operations. We are currently the only company that helps cardiology practices migrate their historical data from legacy software providers and fully integrates with any EHR system. We do this while enabling customized reporting supported by patient and practice decision-support analytics,” said Eric Olsen, COO of Octagos Health. “We are excited to partner with Octagos Health and support their vision of transforming cardiac care,” said Melissa Daniels, Managing Director of Morgan Stanley Expansion Capital. “Octagos Health has demonstrated exceptional growth and innovation in a critical area of healthcare. We believe their platform and vertically integrated software and services significantly improve patient care and streamline cardiac monitoring processes for healthcare providers.” “Octagos Health is poised for scale – industry leading gross margins, a very sticky product that doctors and clinical staff love, and a market ready for disruption with artificial intelligence. This is the new wave for diagnostic care,” said Will Hsu, Co-Founder and Partner at Mucker Capital. “This funding will help Octagos Health continue to add additional data sources from various diagnostic and consumer devices and further differentiate their offering.” About Octagos Health Octagos Health is a leading provider of cardiac monitoring solutions, dedicated to improving patient outcomes through advanced technology and comprehensive monitoring services. The company’s AI-driven platform offers continuous monitoring and data analysis for patients with implantable cardiac devices, enabling healthcare providers to make informed decisions and deliver timely care. Octagos Health’s solutions are designed to seamlessly integrate with electronic health records and provide customizable reporting features, making it an essential tool for modern healthcare institutions. For more information, please reach out to [email protected]. You can also follow us on LinkedIn. About Morgan Stanley Expansion Capital Morgan Stanley Expansion Capital is the growth-focused private investment platform within Morgan Stanley Investment Management. Morgan Stanley Expansion Capital targets growth equity and credit investments within technology, healthcare, consumer, and other high-growth sectors. For nearly four decades, Morgan Stanley Expansion Capital has successfully pursued growth investment opportunities and has completed investments in over 200 companies, leveraging the global brand and network of Morgan Stanley.About Mucker Capital Founded in Santa Monica, CA in 2011, Mucker Capital provides Pre-Seed, Seed, and Series A capital and support for startups in Southern California and in other, similarly underfunded ecosystems outside Silicon Valley.SOURCE Octagos Health, Inc.

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Neha Motwani Elected to Longeveron® Board of Directors

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MIAMI, July 09, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease, today announced that Neha Motwani, a senior healthcare investment banker, has been elected to the Longeveron Board of Directors at the Company’s recent Annual Meeting of Stockholders. “I am delighted to welcome Neha, with her tremendous healthcare industry experience, to the Board of Directors,” said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. “Her extensive knowledge of biopharma company operations, financing and capital markets will bring significant value to Longeveron as we continue to advance Lomecel-B™, our proprietary, scalable, allogeneic cellular therapy. With five positive clinical trials across three indications, we believe Lomecel-B™ has the potential to be an important therapy for some of the most difficult diseases and conditions associated with aging.” Neha Motwani has over 25 years of healthcare investment banking experience, most recently serving as Managing Director, Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer and Company, Stifel Financial and Cowen and Company, where, collectively, she completed transactions raising approximately $7.0 billion. Ms. Motwani earned her B.A. in political science from Columbia University. “I am delighted to join the Board of Directors of Longeveron at this exciting phase of the Company’s clinical development,” said Ms. Motwani. “I look forward to working with this talented team to continue their mission to advance their novel cellular therapy, Lomecel-B™ for the potential treatment of HLHS, a rare and devastating congenital heart condition, and diseases of the aging.” 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. The Lomecel-B™ HLHS program has received three distinct and important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Investor Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00f0eb5c-76f5-49b1-9994-ee363513547b

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Valcare Medical, Inc. Announces Formation of Scientific Advisory Board with Renowned Mitral Valve Experts

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TAMPA, Fla., July 2, 2024 /PRNewswire/ — Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts. The SAB will provide expert insight and guidance while helping the Company further advance its research and development initiatives for the […]

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Methodist University Hospital named Best in Cardiac Care by Money magazine

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Only ranking hospital in western Tennessee
MEMPHIS, Tenn., July 3, 2024 /PRNewswire/ — Methodist Le Bonheur Healthcare announced Methodist University Hospital earned top recognition by Money magazine as one of the Best U.S. Hospitals for Cardiac Care. The Memphis-based healthcare system’s academic flagship landed 15th out of 75 and is the only ranked hospital located in western Tennessee.
Money analyzed 125,000 data points to build their list of exceptional cardiology programs with highly trained cardiologists, cardiovascular surgeons and other heart specialists.
“This elite honor recognizes the robust, comprehensive and individualized care we provide to our heart patients,” said Oluwaseun Akinseye, MD, medical director of cardiovascular services at Methodist University Hospital. “We stand firm in our commitment to meet the needs of our patients, and our multidisciplinary team delivers on that promise day after day.”
In addition to performing the Volunteer State’s first Medtronic PulseSelect™ Pulsed Field Ablation (PFA) earlier this year, Methodist University and its sister hospitals treat a variety of heart conditions including aortic stenosis, arrhythmia, coronary artery disease, heart disease, heart failure, peripheral artery disease and structural heart disease.
For more information about services offered throughout Methodist Le Bonheur Healthcare, please visit MethodistHealth.org.
About Methodist Le Bonheur Healthcare
Based in Memphis, Tennessee, Methodist Le Bonheur Healthcare has been caring for patients and families regardless of their ability to pay for more than 100 years. Guided by roots in the United Methodist Church and founded in 1918 to help meet the growing need for quality healthcare in the greater Memphis area, MLH has grown from one hospital into a comprehensive healthcare system with 13,000 Associates supporting six hospitals, including nationally ranked Le Bonheur Children’s Hospital, ambulatory surgery centers, outpatient facilities, a hospice residence and physician and specialty practices serving communities across the Mid-South. From transplants and advanced heart procedures to expert neurology services and compassionate cancer care, Methodist Le Bonheur Healthcare offers clinical expertise with a focus on improving every life we touch.
About Money
Founded in 1972, Money Magazine helped everyday people live richer lives by learning personal finance strategies that improved their bottom line. Over that time their mission has evolved to guide people to financial victories through up-to-date information, education, and tools as a digital-only destination. With the rising costs of healthcare, Money sees the direct correlation between quality of care and the lessened financial impact on the consumer, the better the care, the lower the overall, long-term costs.
SOURCE Methodist Le Bonheur Healthcare

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Ultromics granted Category III CPT reimbursement code for EchoGo® Heart Failure

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OXFORD, England, July 2, 2024 /PRNewswire/ — Ultromics announced today that the American Medical Association (AMA) has issued a Category III Current Procedural Terminology (CPT) code for EchoGo® Heart Failure, a crucial advancement in enhancing the accessibility of Ultromics’ ground-breaking technology in hospital outpatient settings.

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The American Medical Association (AMA) has issued a Category III CPT® code (0923T) for reimbursing EchoGo® Heart Failure.

EchoGo® Heart Failure uses AI to detect heart failure with preserved ejection fraction (HFpEF) from a single, routinely acquired echocardiographic video. The technology leverages large datasets and advanced algorithms to identify patterns and correlations that may go undetected by traditional diagnostic methods. The AI insights aid clinicians in diagnosis, monitoring, and expediting treatment responses, significantly enhancing the detection and management of patients with this challenging subtype of heart failure.

This is the only artificial intelligence CPT code specific to supporting HFpEF diagnosis through echocardiography and was released on July 1st this year on the AMA’s website, becoming effective January 1st, 2025. The new CPT code, 0923T, will replace the previous HCPCS outpatient code for EchoGo® Heart Failure, C9786.  EchoGo® Heart Failure is also covered in the hospital inpatient setting, using the New Technology Add-on Payment (NTAP) code XXE2X19.
Ross Upton, PhD, Chief Executive Officer and founder of Ultromics, stated, “This recognition by the AMA underscores the significant impact our technology is having in the field of heart failure care. HFpEF represents a significant and growing patient population, accounting for 50% of heart failure cases worldwide, and may go undiagnosed in up to 64% of cases.1  We believe that EchoGo® Heart Failure will transform diagnostic pathways for these patients, enable earlier intervention, improve quality of life, and deliver benefits to payors and healthcare systems.”In the US, CPT codes are used by public and private health insurance programs and offer doctors and healthcare professionals a method to identify medical services and procedures for reimbursement. Category III CPT codes are temporary codes assigned to new and developing technologies, procedures, and services.Additional Data on EchoGo® Heart FailureEchoGo® Heart Failure was granted FDA 510(k) clearance in December 2022 and has been awarded FDA Breakthrough Device Designation.2Recent data on the tool was published last year in JACC: Advances, showing superior efficacy of EchoGo® Heart Failure in identifying HFpEF over the current clinical standard.Specifically, the AI-based system was able to correctly assign a diagnosis to 74% of patients who had returned non-diagnostic results on the commonly used HFA-PEFF and H2FPEF clinical scores.3 This improvement could translate to more patients receiving accurate and timely diagnoses and management.EchoGo® Heart Failure demonstrated high sensitivity and specificity, detecting 88% of patients who had HFpEF, and 82% of patients that did not.3 These results exceed what is usually observed in routine clinical practice.For the study, investigators retrospectively assessed independent data on 6,756 patients who underwent a comprehensive TTE at Mayo Clinic in Rochester, Minnesota, between January 2009 and December 2020. It was then independently tested in geographically distinct areas within Mayo Clinic Enterprise sites across the United States on a dataset that included 1,284 patients.The authors concluded, “EchoGo® Heart Failure’s exceptional discrimination capabilities, combined with its ability to identify patients with higher mortality risks, hold great promise for improving patient outcomes and enabling faster access to treatment.”References:1. Borlaug et al., Heart Failure With Preserved Ejection Fraction: JACC Scientific Statement. J Am Coll Cardiol 2023;81:1810–1834.2. Ultromics receives FDA Clearance for its Breakthrough Device EchoGo Heart Failure: An AI-based platform that enables precision detection of heart failure with preserved ejection fraction. News release. Ultromics. December 2, 2022.3. Akerman AP, et al. Automated Echocardiographic Detection of Heart Failure with Preserved Ejection Fraction Using Artificial Intelligence. JACC Adv. 2023:1;2(6):100452–2.About Ultromics:Ultromics is a pioneer in precision heart failure detection. Our ground-breaking platform, EchoGo®, is transforming the way heart failure is diagnosed using artificial intelligence and cardiac ultrasound as a modality.  The technology empowers clinicians to make precise, efficient, and accurate assessments of heart failure, leveraging the largest known heart disease dataset in echocardiography. The model was trained on thousands of patients to accurately detect disease and was validated against 5-year patient outcomes.  The technology has been built in collaboration with Mayo Clinic and the NHS England. Ultromics’ mission is to stop heart failure in its tracks with its precision detection platform.Photo – https://mma.prnewswire.com/media/2452704/Ultromics.jpgSOURCE Ultromics

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Valcare Medical, Inc. Announces Formation of Scientific Advisory Board with Renowned Mitral Valve Experts

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TAMPA, Fla., July 2, 2024 /PRNewswire/ — Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts. The SAB will provide expert insight and guidance while helping the Company further advance its research and development initiatives for the AMEND mitral valve repair device. The AMEND mitral annuloplasty ring has been designed to treat patients suffering from severe mitral regurgitation not deemed suitable for surgery.
“We are excited to be joined and supported by some of the world’s leading pioneers in mitral valve therapies,” said Dr. David Meerkin, Valcare Medical CMO. “Their combined experience and collective insights will greatly assist Valcare at this critical point as we significantly broaden and deepen our clinical experience.”
Members of the Valcare Medical Scientific Advisory Board include:
Dr. Isaac George, MD joined New York Presbyterian/Columbia University Medical Center in the Department of Surgery in July of 2001 as a resident in general surgery following his graduation from Duke University School of Medicine. Prior to receiving his MD, Dr. George completed a B.S. in Mechanical Engineering at Massachusetts Institute of Technology in 1997. Dr. George also completed a fellowship program in cardiothoracic surgery in 2011 as well as a fellowship program in interventional cardiology in 2012. Dr. George is an Associate Professor of Surgery and Medicine, and the Surgical Director of Structural Heart of the NYP health system. He is one of the few physicians in the world trained in both cardiac surgery and interventional cardiology. He is an expert in the most current and innovative procedures including Transcatheter Aortic Valve Replacement (TAVR), transcatheter valvular mitral valve repair (Mitraclip, Edge to Edge), transcatheter mitral and tricuspid valve replacement and surgical TAVR removal/explantation.
Dr. Scott Lim, MD, is a Professor of Medicine & Pediatrics at the University of Virginia and the University of British Columbia. He has developed a career focusing on novel therapies for heart valve, structural, congenital, and heart failure therapies. He has served as national primary investigator on transcatheter aortic, mitral, and pulmonary valve trials, as well as worked with multiple early-stage novel cardiac device therapies, particularly in mitral and tricuspid valve disease. In addition to authoring more than 250 scientific publications, 500 presentations, and 50 book chapters, Dr. Lim has been the founding editor through 5 editions of the most popular textbook on congenital heart disease, the Field Guide to Congenital Heart Disease & Repair. He has also spent more than two decades leading a charitable organization to teach cardiac disease care to physicians in developing countries.
Dr. Paul Sorajja, MD is the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center at the Minneapolis Heart Institute Foundation, and a cardiologist at Minneapolis Heart Institute® where he serves as the Director of the Center for Valve and Structural Heart Disease. Dr. Sorajja’s expertise is interventional cardiology, with a focus on bringing the latest innovative technologies to patients with valvular and structural heart disease. He was part of the team that performed the first transcatheter mitral valve replacement (TMVR) in the US and has the largest worldwide experience with the therapy. Dr. Sorajja currently serves as a national investigator for TMVR and for clinical trials in percutaneous treatment for tricuspid regurgitation. He has served on multiple national practice committees for valvular heart disease and hypertrophic cardiomyopathy. Dr. Sorajja has published more than 250 manuscripts as well as several books. He routinely lectures at national and international medical conferences and has received awards for his expertise in medical education. Dr. Sorajja is also highly active in developing intellectual property in these areas.
Dr. Azeem Latib, MD, Director of Structural Heart Interventions, Montefiore Health System, New York. Azeem is a world-leading expert in interventional cardiology, with a clinical focus on complex coronary interventions as well as transcatheter aortic, mitral, and tricuspid interventions. Following his clinical interests, Dr. Latib’s research centers on transcatheter aortic, mitral, and tricuspid interventions with a focus on device innovation. In addition, he performs research on drug-coated balloons, drug-eluting stents, and challenging lesion subsets.
Dr. Federico DeMarco, MD, PhD is the head of the Structural Heart Program and of the Interventional, Valvular and Structural Heart Interventions Unit in Centro Cardiologico Monzino in Milan. He trained in Interventional Cardiology at the Institut Cardiovasculaire Paris Sud in Massy, France, between 2005 and 2007, and until 2015 he worked as a senior staff interventional cardiologist at Niguarda Hospital in Milan. From 2015 to 2022 he helped build the largest Structural Heart Interventions program in Italy in Policlinico San Donato in Milan. His interventional experience is extensive, spacing from complex coronary interventions to TAVR, transcatheter mitral and tricuspid valve repair and replacement, PFO and LAA occlusion, peripheral interventions, and a wide variety of other endovascular interventions. He has been collaborating with multiple companies since 2012, both on product design and development with engineers and on early clinical experience with various device trials and first in man procedures. He authored and co-authored over 150 peer-reviewed publications and book chapters on coronary, aortic and mitral interventions and has a strong interest in new endovascular technology.
“We are honored to have these accomplished mitral valve experts join Valcare Medical’s Scientific Advisory Board,” said Steve Sandweg, Valcare Medical CEO. “Each of these individuals has made significant contributions and helped pioneer breakthroughs in the treatment of mitral valve disease. We look forward to leveraging the vast expertise of our SAB to help drive Valcare’s clinical and regulatory strategy.”
The innovative AMEND mitral valve repair device is a closed, D-shaped semi-rigid annuloplasty ring with proprietary anchoring capabilities. AMEND has been designed to replicate the efficacy of the traditional annuloplasty rings used to treat mitral regurgitation during open-heart surgery, but is implanted via a less invasive, percutaneous approach.
The AMEND device is investigational and limited to investigational use only. The products are not available for sale or commercial distribution.
About Valcare Medical
At Valcare Medical, our mission is to transform mitral valve therapy through the development of advanced, minimally invasive solutions. Our goal is to eliminate the need for open-heart surgery in patients with severe mitral regurgitation. We aim to minimize patient risk and maximize procedural outcomes by providing strong clinical evidence for the effectiveness of our technologies. We aspire to improve patients’ quality of life while increasing life expectancy by offering a safer and more effective alternative to traditional surgical methods.
Contact: [email protected]
SOURCE Valcare Medical

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