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Humacyte Announces Publication of Preclinical Data on Use of the CTEV as a Coronary Artery Bypass Graft (CABG)

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– Results were published in JACC: Basic to Translational Science – – Publication evaluated coronary tissue engineered vessel (CTEV) as a conduit for CABG in a nonhuman primate model – – All implanted CTEVs remained patent through six months, demonstrated adaptive remodeling, and recellularized with host coronary artery cells – – Humacyte plans to advance CTEV into first-in-human study in CABG – DURHAM, N.C., Sept. 18, 2025 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the publication of new preclinical data as part of a study evaluating the coronary tissue engineered vessel (CTEV) as a coronary artery bypass graft conduit in a non-human primate model. In the study, published in JACC: Basic to Translational Science, a specialist journal launched by the Journal of the American College of Cardiology (JACC), the CTEV was observed to sustain blood flow, recellularize with the animals’ host cells, and remodel to reduce the initial size mismatch between the CTEV and the animals’ native artery. “Innovation in CABG has been stagnant for far too long,” said Alan Kypson, MD, FACS, Cardiothoracic Surgeon, UNC REX Hospital. “Our results suggest that we may be on the verge of a new option — one that remodels to match the native artery and recellularizes with host cells, potentially providing superior patency relative to saphenous vein grafts. The CTEV has the potential to address a significant unmet clinical need in coronary bypass surgery and ultimately improve patient outcomes.” Cardiovascular disease is the leading cause of death worldwide, comprising one in every three deaths in the United States in 2023. The most common form is coronary artery disease (CAD), which affects 1 in 20 adults aged 20 and older. Coronary artery bypass grafting, a procedure that improves blood flow to the heart by using the internal mammary artery and saphenous vein to bypass narrowed or blocked coronary arteries, remains the current standard of care. However, saphenous vein grafts – used in 80%-90% of CABG cases – demonstrate poor long-term patency, with approximately 50% failing at 10 years. Many patients also lack usable autologous veins or arteries due to prior harvest, ablation, or poor quality, highlighting the unmet clinical need for alternative conduits. For the past half century, no novel CABG conduits have gained routine clinical use. The recent JACC study, titled “Acellular Tissue Engineered Vessels as Coronary Artery Bypass Grafts”, follows five adult baboons undergoing CABG to the right coronary artery with the CTEV. All CTEVs remained patent throughout the 6-month study. At the end of follow-up, the CTEV was observed to have recellularized with host cells to form a multi-layered tissue, including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the right coronary artery (RCA). The results suggest that the CTEV may be a durable alternative CABG conduit. The CTEV is 3.5mm blood vessel produced in the same bioengineering manufacturing system as Humacyte’s acellular tissue engineered vessel (ATEV™). The CTEV is also referred to as the small-diameter ATEV, or sdATEV. Humacyte also announced that it plans to advance the CTEV into its first-in-human study in CABG. To support human study, the Company anticipates filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) during the 4th Quarter of 2025. The Company’s current plans for filing an IND are based on the outcome of a meeting held early this year with the FDA, including agreements reached with the agency. “We’re pleased that this new publication of preclinical data demonstrates the promise of CTEVs as an alternative for native vessel grafts in CABG,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “As one of the leading causes of early death, coronary artery disease poses unique challenges for patient care. We are looking forward to proceeding into the first-in-human study of the CTEV in CABG and hopefully offering surgeons another option for treating this disease.” The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in extremity vascular trauma was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs and our CTEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs and our CTEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Form 10-Q for the quarter ended June 30, 2025, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

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Novo Nordisk A/S: Ozempic® reduces the risk of heart attack, stroke and death by 23% compared to dulaglutide in the first head-to-head real-world study

Coronary/Structural Heart by 0 comments

Ozempic® (once-weekly injectable semaglutide) was associated with a 23% reduced risk of heart attack, stroke and death in people with type 2 diabetes and cardiovascular disease on Medicare versus dulaglutide1Data also highlighted Ozempic® was associated with a 26% lower risk of death versus dulaglutide1This study is the first to directly compare these glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications in everyday real-life use. It fills a significant gap in understanding their effects on heart health in older people at high risk, which could help support informed treatment decisions and health policies.1 Bagsværd, Denmark, 18 September 2025 – Novo Nordisk today announced results from the REACH real-world study, which demonstrated that compared to dulaglutide, Ozempic® (once-weekly injectable semaglutide) was associated with a reduced risk of major adverse cardiovascular events such as a heart attack or stroke by 23%1. The data span nearly 60,000 US Medicare patients (aged ≥66 years) living with type 2 diabetes, atherosclerotic cardiovascular disease (ASCVD) – a condition where fatty deposits build up in blood vessels, reducing blood flow and increasing the risk of heart attacks, strokes and related problems – and multiple health conditions2. The results were presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting on 15–19 September in Vienna, Austria1. “As we age, the risk of experiencing a heart attack, stroke or dying from a cardiovascular event increases. At the same time, there are limited clinical data for people living with diabetes and cardiovascular disease aged 66 years or older. These data, showing a 23% risk reduction of a heart attack, stroke and death, fill an important gap and reinforce the well-established clinical evidence of semaglutide,” said Filip Krag Knop, senior vice president and incoming chief medical officer at Novo Nordisk. “This is great news for older patients as well as healthcare professionals, as these results build on the importance of our randomised clinical trial data assessing the effectiveness of treatments in a real-life setting. This also supports what we already know from our clinical development programmes that not all GLP-1 RAs are the same.”Beyond these essential benefits, once-weekly semaglutide was also associated with a 25% risk reduction of heart attack, stroke, hospitalisation for unstable angina or heart failure, and death from any cause (five-point MACE)1. Ozempic® is the only GLP-1 RA that has proven risk reduction of cardiovascular and kidney events in people with type 2 diabetes3-6. These results provide the first direct comparison of cardiovascular outcomes between Ozempic® and dulaglutide in US Medicare beneficiaries and add to the body of evidence for Ozempic®. About REACH REACH is a comprehensive series of studies assessing the cardiovascular disease-related outcomes of the once-weekly GLP-1 RA class, including semaglutide, compared to glucose-lowering therapies such as DPP4 inhibitors, SGLT2 inhibitors and others. It also includes within-class comparisons of GLP-1 RAs from multiple administrative claims and electronic health record databases. The study presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting is a real-world evidence analysis evaluating cardiovascular risk reduction with GLP-1 RAs – semaglutide and dulaglutide – in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD). This study draws from Medicare fee-for-service claims data, using a target-trial emulation framework, including 58,336 matched patients (29,168 patients in each treatment group) aged ≥66 years with type 2 diabetes and ASCVD who initiated once-weekly semaglutide or dulaglutide. Direct cardiovascular outcome comparisons between GLP-1 RAs are lacking. These results address a critical gap for insights, particularly in an older Medicare population with multiple comorbidities underrepresented in randomised clinical trials. About Ozempic®Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from cardiovascular events in adults with type 2 diabetes and chronic kidney disease. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media:   Ambre James-Brown  +45 3079 9289 globalmedia@novonordisk.com   Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com   Investors:   Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com   Sina Meyer  +45 3079 6656 azey@novonordisk.com   Max Ung +45 3077 6414  mxun@novonordisk.com    Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com   Alex Bruce  +45 34 44 26 13 axeu@novonordisk.com   Frederik Taylor Pitter  +1 609 613 0568 fptr@novonordisk.com   _______________________References1.      Tan M, et al. Late-breaking oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; Sep 15-19 2025; Vienna, Austria.2.      Dai D, et al. Cancer Control. 2022;29:10732748221140691.3.      Marso SP, et al. N Engl J Med. 2016;375:1834-1844.4.      Perkovic V, et al. N Engl J Med. 2024;391:109-121.5.      Ozempic® (once-weekly semaglutide): US Prescribing Information. 2025 [online]. Available at: https://www.novo-pi.com/ozempic.pdf Last accessed: September 2025.6.      EMA. Ozempic® (once-weekly semaglutide) Summary of Product Characteristics. 2025 [online]. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic. Last accessed: September 2025.
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PR250918-EASD-REACH

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

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– 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

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Pulse Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced that the Compensation Committee of its Board of Directors has granted equity awards to four new employees as equity inducement awards outside […]

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TEAM Technologies Acquires TAG3 Engineering, Adding Front End Design and Product Innovation to its Suite of Capabilities to Service the Medical Device Industry

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KNOXVILLE, Tenn.–(BUSINESS WIRE)–TEAM Technologies (“TEAM Tech”), a leading end-to-end outsourced manufacturer of mission-critical medical devices, announces the acquisition of TAG3 Engineering LLC (“TAG3” or the “Company”), a full-service MedTech design, development, and manufacturing firm located in Sunrise, Florida. TAG3 brings expanded U.S.-based front end innovation capabilities to TEAM Tech’s portfolio […]

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Kestra Medical Technologies Appoints Dr. Elizabeth Kwo to Board of Directors

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KIRKLAND, Wash., Sept. 17, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced the appointment of Elizabeth Kwo, M.D. as an independent director to its board following her election at the company’s annual general meeting of shareholders held earlier this month. “I am pleased to welcome Dr. Kwo to the Kestra board of directors,” said Brian Webster, President and CEO of Kestra Medical Technologies. “As a physician, healthcare executive, and entrepreneur, she brings extensive experience building and scaling digital health platforms and advancing data-driven care models to improve patient outcomes. Her expertise and perspective will be invaluable as we accelerate adoption of our lifesaving Cardiac Recovery System platform.” Dr. Kwo currently serves as Chief Commercial Officer of Everly Health, Inc, a diagnostics-driven digital healthcare company. She previously served as Deputy Chief Clinical Officer for Anthem, VP and GM of Provider Networks at American Well, and Entrepreneur in Residence at Harvard Medical School’s Office of Technology Development. She has also founded multiple venture-backed companies, including the educational platform New Pathway and digital healthcare company InfiniteMD. Dr. Kwo is board certified in preventive care and occupational medicine and remains active as a practicing physician. She earned her M.D. from Harvard Medical School, an M.P.H. from the Harvard T.H. Chan School of Public Health, an M.B.A. from Harvard Business School, and a B.A. from Stanford University. “I’m honored to join Kestra’s board of directors at such a pivotal time,” said Dr. Kwo. “Kestra’s commitment to protecting patients through innovation in cardiac recovery deeply resonates with me. I look forward to contributing my experience in digital health and care-model innovation to help advance the company’s mission and expand its impact for patients and providers.” About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com

Media contact
Rhiannon Pickus
rhiannon.pickus@kestramedical.com

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Arch Strengthens its Position as a Leading Kidney Therapeutics Company with the Acquisition of a Breakthrough Platform to Develop New Drugs Targeting Chronic Kidney Disease (CKD)

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Arch acquires a new CKD platform that has the potential to produce next-generation CKD drugs for the pharmaceutical industry Based on a novel mechanism of action involving IL-32 and directly implicated in CKD, discovered in pre-clinical studies led by Dr. Justin Chun The Company has filed both composition and method of use patents relating to the CKD platform. The Arch CKD program will be led by Dr. Justin Chun, who joins the Company as a Principal Scientist CKD is largely an unmet medical need, currently affecting more than 800 million people worldwide and approximately 35 to 38 million in the U.S. TORONTO, Sept. 17, 2025 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), today announced it has acquired a pre-clinical platform developing new drugs to treat chronic kidney disease (CKD). The platform includes recently filed patents protecting new compositions and methods targeting a novel mechanism of action involving interleukin-32 (IL-32), which is directly implicated in the progression of CKD. Farris Smith, Strategic Advisor to Arch and former CFO of Novo Nordisk Canada, said, “This new chronic kidney disease program expands the commercial potential of Arch’s kidney drug development pipeline. The assets underlying the CKD program could provide novel, on-target treatment options for a significant unmet need in a major pharmaceutical market. Combined with Arch’s existing acute kidney injury programs, Arch is better positioned for potential new partnership opportunities that can accelerate development and drive long-term value for the Company.” Richard Muruve, CEO of Arch Biopartners, said, “Our entry into the CKD drug development business is a natural evolution for our team that has a strong core competency in nephrology. Today’s news makes Arch Biopartners’ kidney drug portfolio more vital to patients and more valuable to the pharmaceutical industry.” Arch obtained the new CKD assets through the acquisition of all outstanding shares of Lipdro Therapeutics Inc. (Lipdro), a private Alberta based company and arm’s length to the Company, in return for 250,000 common shares of Arch at a deemed price of $1.85 per common share and a royalty on net sales in the future, and subject to final approval by the TSX Venture Exchange. Dr. Justin Chun, MD, PhD, founder and 100% owner of Lipdro, joins the Company as a Principal Scientist to lead development of the new Arch CKD platform. The common shares, when issued to Dr. Chun following today’s announcement, will be subject to a four month hold period. The therapeutic platform acquired by Arch specifically targets interleukin-32 (IL-32), a non-classical cytokine involved in regulating inflammation and immune responses. In pre-clinical studies, Dr. Chun and his scientific team discovered that IL-32 is directly implicated in the pathogenesis of diabetic CKD. New drug compositions were subsequently invented through a collaboration involving the National Research Council of Canada (NRC), Lipdro, and Arch scientists, and exclusively licensed to Arch by the NRC. Additional therapeutic approaches involving IL-32 were developed and patented by Dr. Chun and Arch scientists and assigned to Arch. Dr. Daniel Muruve, Chief Science Officer at Arch Biopartners and Professor, Cumming School of Medicine, University of Calgary, said, “We are excited to welcome Dr. Chun to the Arch science team as a Principal Scientist and leader of the IL-32 CKD program. His deep scientific knowledge as a nephrologist and his leading expertise in working with patient-derived kidney organoids will be invaluable as Arch develops novel therapeutics targeting chronic kidney disease.” These patents are a significant addition to Arch’s kidney drug asset portfolio. The IL-32 CKD program deepens the Company’s portfolio for developing new treatments for kidney diseases and injury. The new program introduces a novel therapeutic approach for diabetic CKD, the most common cause of kidney failure globally. The therapeutic platform is based on a mechanistic understanding of disease pathways and builds on Arch’s expertise in renal inflammation and organ protection. Dr. Chun said, “Targeting the underlying mechanisms of inflammation and fibrosis that drive CKD is critical for preventing irreversible structural organ damage and slowing the progression toward kidney failure. In this context, our discovery of IL-32 as an intracellular, unconventional cytokine that links metabolic dysregulation to chronic inflammation represents a promising therapeutic target and opens new avenues for halting the progression of CKD, including diabetic kidney disease.” An overview of the IL-32 mechanism of action related to diabetic-CKD is summarized by Dr. Chun and his collaborators in the following abstract published in the Journal of the American Society of Nephrology: “IL-32 Is a Lipid Droplet-Associated Mediator of Tubular Injury in Diabetic Kidney Disease” Chronic Kidney Disease (CKD) CKD affects more than 800 million people worldwide1,2 and approximately 35 to 38 million in the U.S.3. Diabetes is the leading cause, responsible for an estimated 30% to 40% of all CKD cases4. Diabetic CKD leads to kidney failure, and several other major comorbidities, including cardiovascular disease. Many current renal therapies are based on unanticipated ‘off-target’ actions of drugs originally designed to control blood pressure, blood sugar, and cardiovascular complications5,6 rather than targeting specific biological pathways in the kidney that drive disease7,8. Arch’s newly acquired ‘on-target’ CKD platform stands apart from many drugs in use today and may represent the next generation of CKD candidates for clinical development in the pharmaceutical industry. About Dr. Justin Chun Dr. Chun, MD, PhD is an Associate Professor and Clinician Scientist at the Cumming School of Medicine, University of Calgary, and Assistant Director of the Precision Medicine in Nephrology Program at the Snyder Institute for Chronic Diseases. He also co-directs the Human Organoid Innovation Hub, where his research focuses on using patient-derived kidney organoids and primary kidney cells to study glomerular diseases and diabetic kidney disease. About Arch Biopartners Arch Biopartners Inc. is a therapeutic biotech company developing novel drugs for acute and chronic kidney diseases. The Company is advancing an integrated pipeline that includes new treatments targeting inflammation- and toxin-induced kidney injury. The company’s programs include a pre-clinical chronic kidney disease platform targeting IL-32 (announced today), LSALT peptide, a first-in-class DPEP1 inhibitor in Phase II for preventing cardiac surgery-associated acute kidney injury, and cilastatin, a repurposed drug in Phase II for preventing toxin-induced kidney damage. These assets represent distinct, mechanism-based approaches to treating and preventing common causes of kidney damage. Together, they target serious unmet needs in kidney care across both chronic and acute indications, affecting millions of patients worldwide. For more details about the Company’s science and ongoing clinical trials, please visit: www.archbiopartners.com/our-science Follow Arch on LinkedIn, Bluesky, and X (formerly Twitter) for news as it happens. The Company has 66,106,366 common shares outstanding. For more information, please contact: Aaron BensonDirector of CommunicationsArch Biopartners, Inc. 647-428-7031 Send a message and subscribe for email alerts at: www.archbiopartners.com/contact-us Citations: Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl (2011). 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. Epub 2022 Mar 18. PMID: 35529086; PMCID: PMC9073222Francis, A., Harhay, M.N., Ong, A.C.M. et al. Chronic kidney disease and the global public health agenda: an international consensus. Nat Rev Nephrol 20, 473–485 (2024). doi: 10.1038/s41581-024-00820-6Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2023. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2023Ma X, Liu R, Xi X, Zhuo H, Gu Y. Global burden of chronic kidney disease due to diabetes mellitus, 1990–2021, and projections to 2050. Front Endocrinol (Lausanne). 2025;16 doi: 10.3389/fendo.2025.1513008Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int 102(5S):S1-S127. doi: 10.1016/j.kint.2022.06.008. PMID: 36272764Francis, A., Harhay, M.N., Ong, A.C.M. et al. Chronic kidney disease and the global public health agenda: an international consensus. Nat Rev Nephrol 20, 473–485 (2024). doi: 10.1038/s41581-024-00820-6Zoccali C, Vanholder R, Massy Z. et al. The systemic nature of CKD. Nat Rev Nephrol 13, 344–358 (2017). doi: 10.1038/nrneph.2017.52.Baigent, ColinAnker, Stefan D. et al. Impact of diabetes on the effects of sodium–glucose cotransporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials. The Lancet. 2022;400(10365):1788–1801. doi: 10.1016/S0140-6736(22)02074-8. Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of the Company’s future performance, liquidity, and capital resources, as well as the ongoing development of its drug candidates targeting chronic kidney disease and the dipeptidase-1 (DPEP-1) pathway, including the outcome of its clinical trials relating to LSALT peptide (Metablok) or cilastatin, the successful commercialization and marketing of its drug candidates, whether the Company will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe, and other countries, its ability to raise capital to fund its business plans, the efficacy of its drug candidates compared to the drug candidates developed by competitors, its ability to retain and attract key management personnel, and the breadth of, and its ability to protect, its intellectual property portfolio. These statements are based on management’s current expectations and beliefs, including certain factors and assumptions, as described in the Company’s most recent annual audited financial statements and related management discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, the actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company undertakes no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including the Company’s most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedarplus.ca. The scientific and medical content of this release has been approved by the Company’s Chief Science Officer Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Cytokinetics Announces Pricing of Upsized $650.0 Million Convertible Senior Notes Offering; Refinances a Portion of 2027 Convertible Notes

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SOUTH SAN FRANCISCO, Calif., Sept. 16, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (“Cytokinetics”) (Nasdaq: CYTK) today announced the pricing of its offering of $650.0 million aggregate principal amount of 1.75% convertible senior notes due 2031 in a private placement (the “offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The aggregate principal amount of the offering was increased from the previously announced offering size of $550.0 million. Key elements of the transaction include: Primarily a refinancing transaction of the 3.50% convertible senior notes due 2027 (the “2027 notes”), which extends the maturity of the refinanced debt to 2031Achieved a lower coupon of 1.75% and a higher conversion price of approximately $68.42 compared to the 2027 notesRetiring approximately $399.5 million of the 2027 notesAny remaining proceeds will be used to support the potential commercial launch of aficamten and for general corporate purposes, including potentially to retire the remaining 2027 notes before or at maturity of those notes that are not exchanged and refinanced pursuant to this transaction The issuance and sale of the notes are scheduled to settle on September 19, 2025, subject to customary closing conditions. Cytokinetics also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $100.0 million aggregate principal amount of notes. The notes will be senior, unsecured obligations of Cytokinetics. The notes will accrue interest at an annual rate of 1.75%, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2026. The notes will mature on October 1, 2031, unless earlier converted, redeemed or repurchased by Cytokinetics. Before July 1, 2031, noteholders will have the right to convert their notes only in certain circumstances. From and after July 1, 2031, noteholders may convert all or any portion of their notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. Cytokinetics will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Cytokinetics’ election. The initial conversion rate is 14.6156 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $68.42 per share of common stock. The initial conversion price represents a premium of approximately 37.5% over the last reported sale price of $49.76 per share of Cytokinetics’ common stock on September 16, 2025. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events. Cytokinetics’ may not redeem the notes at its election at any time before October 6, 2028. The notes will be redeemable, in whole or in part (subject to certain limitations), at Cytokinetics’ option at any time, and from time to time, on a redemption date on or after October 6, 2028 and, in the case of any partial redemption, on or before the 40th scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if (i) the notes are “freely tradable” (as defined in the indenture for the notes) as of the date Cytokinetics sends the related redemption notice and all accrued and unpaid additional interest, if any, has been paid in full as of the first interest payment date occurring on or before the date such notice is sent and (ii) the last reported sale price per share of Cytokinetics’ common stock exceeds 130% of the conversion price for a specified period of time. If a “fundamental change” (as defined in the indenture for the notes) occurs, then, subject to a limited exception, noteholders may require Cytokinetics to repurchase their notes at a cash repurchase price equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. Use of Proceeds: Cytokinetics estimates that the net proceeds from the offering will be approximately $632.0 million (or approximately $729.4 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and Cytokinetics’ estimated offering expenses. Cytokinetics intends to use: approximately $402.5 million of the net proceeds from the offering to pay the cash portion of the consideration in the note exchange transactions as described below; andthe remainder of the net proceeds of this offering will be used (a) to support the potential commercial launch of aficamten, (b) to continue and expand the development program for aficamten, (c) to advance its development and research pipeline, and (d) for general corporate purposes, including potentially to retire the remaining 2027 notes before or at maturity of those notes that are not exchanged and refinanced pursuant to this transaction and working capital. Cytokinetics expects to use approximately $402.5 million of the net proceeds from the offering and to issue 2,168,806 shares of its common stock in exchange for approximately $399.5 million aggregate principal amount of the 2027 notes in privately negotiated transactions (each, a “note exchange transaction”) entered into concurrently with the pricing of the offering. The terms of each note exchange transaction will depend on a variety of factors, including the market price of Cytokinetics’ common stock and the trading price of the 2027 notes at the time of such note exchange transactions. No assurance can be given as to how much, if any, of the 2027 notes will be exchanged or the terms on which they will be exchanged. This press release is not an offer to exchange the 2027 notes, and the offering of the notes is not contingent upon the note exchange transactions. In connection with any note exchange transaction, Cytokinetics expects that holders of the 2027 notes who agree to have their 2027 notes exchanged and who have hedged their equity price risk with respect to such 2027 notes (the “hedged holders”) will, concurrently with, or shortly after, the pricing of the notes, unwind all or part of their hedge positions by buying Cytokinetics’ common stock and/or entering into or unwinding various derivative transactions with respect to its common stock. The amount of Cytokinetics’ common stock to be purchased by the hedged holders or the notional number of shares of Cytokinetics’ common stock underlying such derivative transactions may be substantial in relation to the historic average daily trading volume of Cytokinetics’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Cytokinetics’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price for the notes. Cytokinetics cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or its common stock. The offer and sale of the notes, any shares of common stock issuable upon conversion of the notes and any shares of common stock issuable in connection with any note exchange transaction have not been, and will not be, registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws. This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any state or jurisdiction. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. Forward-Looking Statements This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the completion of the offering, the expected amount and intended use of the net proceeds and the timing or amount of any exchanges of the 2027 notes by Cytokinetics and the potential impact of the foregoing or related transactions on the market price of Cytokinetics’ common stock or the price of the notes. Forward-looking statements represent Cytokinetics’ current expectations regarding future events and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those implied by the forward-looking statements. Among those risks and uncertainties are market conditions, the satisfaction of the closing conditions related to the offering and risks relating to Cytokinetics’ business, including in its Annual Report on Form 10-K for the period ended December 31, 2024, filed with the SEC on February 27, 2025 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2025 and June 30, 2025, filed with the SEC on May 6, 2025 and August 7, 2025, respectively, and other filings that Cytokinetics makes from time to time with the SEC. Cytokinetics may not consummate the offering or the note exchange transactions described in this press release and, if the offering is consummated, cannot provide any assurances regarding its ability to effectively apply the net proceeds as described above. The forward-looking statements included in this press release speak only as of the date of this press release, and Cytokinetics does not undertake to update the statements included in this press release for subsequent developments, except as may be required by law. Contact:Cytokinetics, Inc.Diane WeiserSenior Vice President, Corporate Affairs(650) 624-3060

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NobleStitch™ Suture-Mediated PFO Closure Demonstrates Superior Long-Term Safety and Outcomes in Largest Cohort to Date

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New data show zero device-related complications or atrial fibrillation, no recurrent stroke or TIA, with a cohort 40% larger than Gore and Amplatzer device studies FOUNTAIN VALLEY, Calif., Sept. 16, 2025 /PRNewswire/ — NobleStitch™, the deviceless suture-mediated patent foramen ovale…

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InspireMD Announces the Appointment of Dan Dearen to its Board of Directors

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MIAMI, Sept. 17, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of Dan Dearen to its Board of Directors. Mr. Dearen brings nearly 40 years of leadership experience in the medical device and life sciences sectors, with a proven track record of guiding MedTech companies through critical financial milestones and delivering shareholder value through execution.

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