Financial

UnitedHealthcare and Cigna Coverage for Cleerly LABS Advanced Plaque Analysis Begins October 1st

DENVER–(BUSINESS WIRE)–Cleerly, the leader in AI-based advanced cardiovascular imaging, today announced that groundbreaking coverage policies from UnitedHealthcare and Cigna for Cleerly® LABS™ advanced plaque analysis will go into effect on October 1st, 2025. These landmark decisions mark a new era in cardiac care, bringing AI-guided quantitative coronary CT angiography (AI-QCT)/Coronary […]

Medera Strengthens Leadership Team with Three Key Executive Appointments

Clinical operations, regulatory affairs, technical expertise, and corporate leadership additions support advancing gene therapy pipeline for cardiovascular diseasesBOSTON, Sept. 30, 2025 (GLOBE NEWSWIRE) — Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, and its clinical development division, Sardocor, today announced the appointments of three senior executives to strengthen its leadership team. The expanded team includes Fubao Wang, Ph.D., as Chief Regulatory Officer and Chief Technical Officer, Sardocor; James Kim as Chief Corporate Officer, Medera; and Niharika (Niha) Kamat, M.S., as Vice President of Clinical Operations, Sardocor. “These exceptional leaders bring decades of combined experience in gene therapy, clinical operations, regulatory affairs, and corporate finance that will be instrumental as we advance our innovative cardiac gene therapy programs through ongoing clinical trials,” said Ronald Li, Ph.D., CEO and Co-Founder of Medera. “Their proven track records in bringing complex therapies from development through regulatory approval, combined with deep capital markets expertise, align perfectly with our mission to transform treatment for patients with incurable cardiovascular diseases.” Fubao Wang, Ph.D. – Chief Regulatory Officer and Chief Technical Officer, Sardocor Dr. Wang brings over 28 years of pharmaceutical and biotech industry experience across multiple prophylactic and therapeutic areas and product modalities including gene editing, cell and gene therapy, RNA therapeutics, biologics, and vaccines. His product development and regulatory experience encompasses CMC, pre-clinical, early-stage, and late-stage clinical development, global regulatory strategy, submission, approval, and post-approval regulatory maintenance. Dr. Wang served most recently as Senior Vice President, Head of Regulatory Affairs at Prime Medicine and AskBio, and previously as Vice President, Head of Regulatory CMC at Sarepta Therapeutics, Associate Vice President, US site head of CMC Dossiers at Sanofi, and Director of Global and Emerging Markets Regulatory Affairs at Merck. Dr. Wang holds a B.S. in Biology and M.S. in Microbiology from Nankai University, China; Ph.D. in Molecular Biology from University of Heidelberg, Germany, and was trained as a Post-Doctoral Fellow in Molecular Biology and Genetics at Stanford University. James Kim – Chief Corporate Officer, Medera Mr. Kim brings over 20 years of experience in the biopharmaceutical industry as a senior executive and investment banker. In 2024, Mr. Kim served as Chief Financial Officer at TriArm Therapeutics, a private biotechnology company specializing in CAR-T therapies. Prior to his role at TriArm, Mr. Kim was a Managing Director at Stifel, Raymond James, Cantor Fitzgerald, and Jefferies, focused on biopharmaceutical coverage. He has advised on and executed over 100 transactions, totalling approximately $13 billion in mezzanine, public equity, and debt financings, as well as $12 billion in business development and M&A transactions. Mr. Kim holds a Bachelor of Science in Economics from The Wharton School at the University of Pennsylvania. Niharika (Niha) Kamat, M.S. – Vice President of Clinical Operations, Sardocor Ms. Kamat brings nearly 20 years of leadership experience across the medical device, pharmaceutical, and biotechnology sectors, with deep expertise in global Phase 1-3 trials across cardiovascular, liver, hemophilia, and rare disease indications. Prior to joining Sardocor, she served as Head of Clinical Operations at Tenaya Therapeutics, where she led First-in-Human gene therapy trials in cardiovascular disease, implemented dose escalation strategies, and built a high-performing Clinical Operations team. Her earlier roles include leading gene therapy programs for hemophilia at Catalyst Biosciences and nearly a decade at Gilead Sciences managing small molecule trials across all phases in infectious diseases, as well as contributing to cardiovascular medical device development at Abbott Vascular. Ms. Kamat holds a Master’s degree in Bioengineering from the University of Texas at Arlington and a Bachelor’s degree in Biomedical Engineering from Mumbai University. With these strategic leadership appointments, Medera strengthens its position to advance its pipeline of innovative cardiac gene therapies while building the regulatory, clinical operations, and corporate expertise necessary to bring these potentially transformative treatments to patients with significant unmet medical needs. About Medera Inc. Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via its two preclinical and clinical business units, Novoheart and Sardocor, respectively. Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart’s versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart’s technology platform for their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor’s lead therapeutic candidates that are currently in clinical trials. Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-associated Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor’s pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases. For more information, please visit www.medera.bio. Contacts: Ally StubinPublic RelationsICR HealthcareAlly.stubin@icrhealthcare.com646.667.1861 Stephanie CarringtonInvestor RelationsICR HealthcareStephanie.carrington@icrhealthcare.com646.277.1282

Freudenberg Medical Opens Second Production Facility in Costa Rica

$25 million investment to meet growing global demand for medical devices and precision components. Expansion to quadruple manufacturing footprint for high-volume minimally invasive catheters. Leveraging VR and AI for seamless tech transfers and optimized factory layouts. Grand Opening of Freudenberg Medical’s second operation in Costa Rica. Pictured: Keith Kiernan, Chief […]

AstraZeneca launches direct-to-consumer platform to expand access to medications for US patients, including those living with chronic conditions

AstraZeneca Direct is designed to offer greater convenience WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announces the launch of AstraZeneca Direct, an online platform designed to create a simple, convenient way for eligible patients to access their prescribed medications at a transparent cash price with home delivery. AstraZeneca Direct will support people living […]

Cigna Approves Coverage for Cleerly’s AI Cardiovascular Imaging Technology

DENVER–(BUSINESS WIRE)–Cleerly, a leader in AI-based cardiovascular imaging, today announced that Cigna will begin covering Cleerly LABS Advanced Plaque Analysis effective October 1, 2025. The coverage decision makes Cigna the latest major insurer to recognize the clinical and economic value of Artificial Intelligence Enabled CT Based Quantitative Coronary Tomography (AI-QCT)/Coronary […]

AVS Quadruples Capacity in Preparation for U.S. Commercial Launch with New Headquarters in Waltham, Mass.

New global HQ features over 37,000 square feet that includes R&D and manufacturing BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today the opening of its new global headquarters at 180 Third Avenue in Waltham, Mass. The new 37,811 […]

Cardiosense Appoints Eric Meizlish as CEO to Advance AI-Enabled Cardiac Care

Appointment highlights Cardiosense’s growth trajectory following FDA clearance, clinical milestones, and expanded leadership team CHICAGO–(BUSINESS WIRE)–Cardiosense, a digital health company pioneering AI-enabled solutions for cardiac disease management, today announced the appointment of Eric Meizlish as Chief Executive Officer (CEO). Meizlish, a seasoned healthcare technology executive with experience scaling innovative health platforms, will […]

BioCardia Announces Pricing of Up To $12 Million Public Offering

$6 million upfront with up to an additional $6 million of potential aggregate gross proceeds upon the exercise in full of short-term warrantsSUNNYVALE, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ:BCDA] (“BioCardia” or the “Company”), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the pricing of a public offering of an aggregate of 4,800,000 shares of its common stock and short-term warrants to purchase up to 4,800,000 shares of common stock, at a combined public offering price of $1.25 per share and accompanying short-term warrant. The short-term warrants will have an exercise price of $1.25 per share, will be exercisable upon issuance and will expire two years thereafter. The closing of the offering is expected to occur on or about September 19, 2025, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be $6 million. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be $6 million.  No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes, which include, but are not limited to, advancing our investigational biotherapeutic candidates and our biotherapeutic delivery partnering business. The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-290283), which was declared effective by the Securities and Exchange Commission (the “SEC”) on September 18, 2025. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph® vascular navigation product platforms. Forward-Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the completion of the offering, the satisfaction of customary closing conditions related to the offering, the exercise of the short-term warrants prior to their expiration and the intended use of net proceeds from the offering. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor Relations Email: mpeto@BioCardia.com Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial Officer Email: investors@BioCardia.com Phone: 650-226-0120

89bio, Inc. Announces Agreement to be Acquired by Roche

– 89bio stockholders to receive up to $20.50 per share in cash, comprised of $14.50 per share in cash at closing and a non-tradeable contingent value right (CVR) to receive up to an aggregate of $6.00 per share in cash; transaction represents total equity value of up to approximately $3.5 billion – – Transaction reflects pegozafermin’s potential best-in-disease profile for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH) – – 89bio to join the Roche Group as part of Roche’s Pharmaceuticals Division – SAN FRANCISCO, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) — 89bio, Inc. (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 it has entered into a merger agreement to be acquired by Roche at a price of $14.50 per share in cash at closing, representing a premium of approximately 79% to 89bio’s closing stock price on September 17, 2025, the last trading day before the announcement of the transaction, and a premium of 52% to 89bio’s 60-day volume-weighted average price (VWAP). In addition, 89bio stockholders will receive a non-tradeable CVR to receive certain contingent payments of up to an aggregate of $6.00 per share in cash upon achievement of specified milestones, for a total transaction equity value of up to approximately $3.5 billion on a fully diluted basis. The merger agreement has been unanimously approved by 89bio’s Board of Directors, and 89bio’s Board of Directors unanimously recommends that 89bio stockholders tender their shares in the tender offer. “Our mission at 89bio has always been to develop innovative therapies to help patients with serious liver and cardiometabolic diseases, a commitment demonstrated by the strategic design and successful execution of the development program for pegozafermin over the years,” said Rohan Palekar, Chief Executive Officer of 89bio. “We are thrilled to be joining with Roche to combine the promise of pegozafermin with Roche’s established global development, manufacturing, and commercialization capabilities, to accelerate and maximize potential benefit for patients in need and unlock significant shareholder value. I am tremendously proud of the entire team at 89bio and would like to express my deepest thanks and gratitude to them, our Board, investigators, clinical trial participants, numerous vendors, and MASH and SHTG communities for helping us reach this pivotal moment.” “We are excited about this agreement and to further develop this promising therapy, which we hope will provide people with moderate to severe MASH a new treatment option,” said Boris L. Zaïtra, Head of Roche Corporate Business Development. “By adding pegozafermin to our cardiovascular, renal, and metabolism portfolio and with our Diagnostics expertise in cardiovascular and metabolic diseases, we are aiming to transform the standard of care and positively impact patients’ lives.” Transaction TermsUnder the terms of the merger agreement, an affiliate of Roche will commence a tender offer to acquire all of 89bio’s outstanding shares for a price of $14.50 per share in cash at closing, representing an aggregate payment of $2.4 billion. In addition, 89bio’s stockholders will receive a non-tradeable CVR to receive up to an aggregate of $6.00 per share in cash, for a total transaction equity value of up to approximately $3.5 billion on a fully diluted basis. Each non-tradeable CVR will entitle its holders to receive the following contingent cash payments, conditioned upon the achievement of certain milestones, within specified time periods: $2.00 per share in cash, upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients (by March 31, 2030)$1.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US $3.0 billion in any calendar year (by December 31, 2033)$2.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US $4.0 billion in any calendar year (by December 31, 2035) The closing of the transaction is subject to customary closing conditions, including the tender of shares representing at least a majority of 89bio’s outstanding shares (other than shares held by 89bio, Roche or any of their respective subsidiaries, and any dissenting shares), the completion of regulatory review and other customary closing conditions. Upon the successful completion of the tender offer, Roche will acquire all remaining 89bio shares that are not tendered into the tender offer through a second-step merger at the same price of $14.50 per share in cash at closing, plus a non-tradeable CVR to receive up to an aggregate of $6.00 per share in cash, payable upon achievement of the specified milestones. The closing of the transaction is currently expected to take place in the fourth quarter of 2025, subject to satisfaction of the closing conditions described above. Until that time, 89bio will continue to operate as a separate and independent company. Moelis & Company LLC and Centerview Partners LLC are serving as financial advisors to 89bio and Gibson, Dunn & Crutcher LLP is serving as legal counsel to 89bio. Citi is acting as financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche. 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 in Phase 3 trials for its lead candidate, pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, 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. Additional Information and Where to Find ItThe tender offer described in this communication has not yet commenced. This communication is for information purposes only and is neither an offer to buy nor a solicitation of an offer to sell any securities of 89bio, Inc. (“89bio”), nor is it a substitute for the tender offer materials that Roche Holdings, Inc. (“Roche”) and its wholly owned acquisition subsidiary, Bluefin Merger Subsidiary, Inc. (“Merger Sub”), will file with the Securities and Exchange Commission (the “SEC”). The solicitation and the offer to buy shares of 89bio’s common stock will only be made pursuant to a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Roche and Merger Sub intend to file with the SEC. In addition, 89bio will file with the SEC a Solicitation/ Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Once filed, investors will be able to obtain the tender offer statement on Schedule TO, the offer to purchase, the Solicitation/Recommendation Statement of 89bio on Schedule 14D-9 and related materials with respect to the tender offer and merger, free of charge at the website of the SEC at www.sec.gov or from the information agent named in the tender offer materials. Investors may also obtain, at no charge, the documents filed with or furnished to the SEC by 89bio under the “Investors & Media” section of 89bio’s website at www.89bio.com. STOCKHOLDERS AND INVESTORS ARE STRONGLY ADVISED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT OF 89BIO ON SCHEDULE 14D-9 AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding the ability to complete and the timing of completion of the transactions contemplated by the Agreement and Plan of Merger dated as of September 17, 2025 by and among 89bio, Roche and Merger Sub (the “Merger Agreement”), including the parties’ ability to satisfy the conditions to the consummation of the tender offer and the other conditions to the consummation of the subsequent merger set forth in the Merger Agreement, and the possibility of any termination of the Merger Agreement. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “anticipate,” “goal,” “opportunity,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the Securities and Exchange Commission (SEC)), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: risks associated with the timing of the closing of the proposed transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed transaction will not occur; uncertainties as to how many of 89bio’s stockholders will tender their shares in the offer; the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the possibility that competing offers will be made; the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction; the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; unanticipated difficulties or expenditures relating to the proposed transaction, the response of business partners and competitors to the announcement of the proposed transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction; risks related to non-achievement of the CVR milestones and that holders of the CVRs will not receive payments in respect of the CVRs; and other risks and uncertainties identified in 89bio’s Annual Report on Form 10-K for the year ended December 31, 2024 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor & Media Contacts: Ryan Martins89bio, Inc.ryan.martins@89bio.com Annie Chang89bio, Inc.investor@89bio.com Eva Bilange89bio, Inc.eva.bilange@89bio.com Sheryl SeapyReal Chemistrysseapy@realchemistry.com