Angina Pectoris

OSLO, Norway, April 29, 2025 /PRNewswire/ -- Navamedic ASA (OSE: NAVA) today announced it has signed a renewed distribution agreement with TopRidge Pharma Limited (TopRidge) for Imdur®, valid until June 2032, including options for new products to be added to the agreement. "It is a pleasure to announce that we have agreed with our great partner TopRidge Pharma, to revise and renew the distribution agreement for Imdur until 2032. Imdur is our second largest single brand and is currently marketed by us in the Nordics, the Netherlands, the Baltics, Greece and Cyprus. Although there is generic competition in this field, the original product is highly valued by the patients who often stay on the treatment for a long period of time." says Kathrine Gamborg Andreassen, Chief Executive Officer of Navamedic. Imdur® (isosorbide mononitrate), is a prescription medication used to prevent angina pectoris due to heart disease. It was first launched in Europe in 1985. Navamedic commenced distribution of the product as part of a strategic partnership and long-term distribution agreement with TopRidge Pharma Limited in 2016. "Imdur® remains an important product to Navamedic, and we appreciate the efforts made by TopRidge to update the Marketing Authorisations and to secure steady supplies to our markets. With the renewal of this agreement, we look forward to exploring further collaboration opportunities for additional products in the future," Gamborg Andreassen concludes. The effective date of the agreement is 1 January 2025, and the revised terms of the agreement are implemented from this date even though the signature date is 29 April 2025. For further information, please contact: Kathrine Gamborg Andreassen, CEO, Navamedic Mobile: +47 951 78 680 E-mail: [email protected] Lars Hjarrand, CFO, Navamedic Mobile: +47 917 62 842 E-mail: [email protected] About Navamedic Navamedic ASA is a Nordic pharmaceutical company dedicated to enhancing people's quality of life by being a reliable supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies. Our growing product portfolio has been carefully selected to meet current public health concerns, such as obesity, Parkinson's disease, antibiotics and metabolism, to empower people to live healthier and more fulfilling lives. What sets us apart is our deep-rooted commitment to understanding the needs and requirements of the countries where we are present. Our local insight and competence enable us to understand the specific needs of each country where we operate and ultimately to gain market access. This makes us a preferred partner for international companies expanding their footprint across the Nordics and Benelux regions, through either in-licensing or out-licensing. Navamedic has been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is headquartered in Oslo, Norway. For more information, please visit Navamedic.com. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orchestra BioMed’s Virtue® Sirolimus AngioInfusion Balloon™ (“Virtue SAB”) is the only non-coated drug-eluting balloon system under clinical investigation worldwide and has been awarded multiple FDA Breakthrough Device DesignationsThe Virtue Trial will be the first U.S. IDE head-to-head randomized evaluation of a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon (AGENT™) for the treatment of coronary in-stent restenosis (“ISR”)Robust non-inferiority trial is designed to provide a clear pathway to regulatory approval as well as potentially showcase clinical advantages of Virtue SABWith the amended IDE approved by the FDA, Orchestra BioMed is currently targeting initiation of the Virtue Trial during the second half of 2025 NEW HOPE, Pa., April 29, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its Investigational Device Exemption (“IDE”) amendment to initiate an updated design of the Company’s planned Virtue SAB in the Treatment of Coronary ISR Trial (“Virtue Trial”). The IDE provides FDA regulatory clearance for Orchestra BioMed to initiate a U.S. pivotal clinical trial comparing its highly differentiated, next-generation Sirolimus-AngioInfusion Balloon, Virtue SAB to the Boston Scientific AGENT paclitaxel-coated balloon, currently the only drug-coated balloon (“DCB”) FDA-approved for a coronary indication. Data from the Virtue Trial will be used to support regulatory approval in the U.S. Virtue SAB and SirolimusEFR are investigational technologies owned by Orchestra BioMed, which also controls and is responsible for all regulatory filings, clinical operations, and drug and device supplies for the Virtue Trial. The Differentiation of Virtue SAB, An FDA Breakthrough Designated DeviceVirtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose, overcoming certain limitations of DCBs. SirolimusEFR™ enables tissue uptake and extended release of the required therapeutic levels of sirolimus (> 1ng/mg tissue concentration), the “gold-standard” drug for preventing arterial restenosis, through the critical healing period of approximately 30 days.​ Virtue SAB has been previously granted FDA Breakthrough Device Designation for the treatment of coronary ISR as well as for coronary small vessel disease and peripheral artery disease below-the-knee. In the multi-center SABRE pilot study, Virtue SAB demonstrated best-in-class clinical results for the treatment of coronary ISR, including 12-month target lesion failure of 2.8% and 6-month late lumen loss of 0.12mm. “Virtue SAB has the potential to be one of the most compelling technologies in interventional cardiology. It’s the only product in development that optimizes both the arterial tissue uptake and retention of sirolimus to achieve pharmacokinetics that match or even exceed those of proven ‘limus-eluting stents,” said Dean J. Kereiakes, M.D., FACC, MSCAI, Chairman of The Christ Hospital Heart & Vascular Institute, Medical Director of The Christ Hospital Research Institute, Professor of Clinical Medicine at The Ohio State University, Professor of Medicine at University of Cincinnati and Co-Principal Investigator on the Virtue Trial. Dr. Kereiakes continued: “Virtue SAB is designed to consistently deliver a large liquid dose of an extended-release formulation of sirolimus to overcome certain limitations of traditional DCBs, including lower doses due to surface area and coating integrity constraints, drug loss in transit leading to inconsistent dosing, and the risk of emboli from large coating particulates. As the coronary treatment landscape continues to shift toward more rapid adoption of DCBs, I’m excited about the potential of Virtue SAB to set a new standard of care.” “Drug-coated balloons are emerging as a new standard of care in the treatment of various coronary and peripheral indications, and I believe utilization of this class of technology will continue to grow and evolve over time as the science is expanding. In a field largely reliant on paclitaxel drug-coated balloons, Virtue SAB stands out as the only device with a completely different mechanism of action; namely to provide delivery of a large liquid dose of an extended-release formulation sirolimus," commented Allen Jeremias, MD, MSc, Associate Director of the Cardiac Catheterization Laboratory at St. Francis Hospital & Heart Center, and Co-Principal Investigator on the Virtue Trial. “Having had the opportunity to work with several DCBs, I anticipate continued momentum for this class, and am eager to see how Virtue SAB, particularly with its anti-restenotic, anti-inflammatory and cytostatic SirolimusEFR formulation, performs in a head-to-head trial against a paclitaxel-coated balloon.” Showcasing Distinctive and Sustainable Advantages of Virtue SAB Through a Head-to-Head Trial “We believe there is a multibillion-dollar U.S. market for coronary drug delivery balloons based on the significant unmet clinical need, market demand, and established reimbursement,” said David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. “We made a deliberate, strategic decision to pursue a head-to-head trial with the commercially available AGENT paclitaxel-coated balloon, underscoring our confidence in Virtue SAB as a fundamentally differentiated solution for the treatment of atherosclerosis. We believe this approach offers the most direct path to regulatory approval while also providing the best opportunity to demonstrate what we believe are distinctive and sustainable advantages of our proprietary technology.” Mr. Hochman continued, “The superior safety and efficacy of sirolimus over paclitaxel was made clear by the performance of drug-eluting stents. Published meta-analysis involving 76 trials show ‘limus-eluting stents have significantly better clinical performance than paclitaxel-eluting stents in terms of target lesion revascularization and major adverse cardiac events.1 We believe this is due to their ability to maintain sufficient drug tissue concentration through the critical healing period of approximately 30 days, because stents that failed to do this did not perform well clinically.2,3,4 Virtue SAB is the only drug delivery balloon that has demonstrated comparable drug tissue levels to clinically successful drug-eluting stents in large published preclinical studies, without the need to leave a permanent metal implant in the artery. Our pilot clinical results with Virtue SAB also highlight the potential for optimal clinical outcomes with robust sirolimus delivery. We’re excited to showcase the full potential of Virtue SAB in this landmark trial and are proud of our team and grateful to our clinical collaborators for their work in achieving this important milestone.” The Virtue Trial is a prospective, multi-center, randomized trial comparing clinical outcomes of Virtue SAB to AGENT Paclitaxel DCB in the treatment of coronary ISR, a difficult-to-treat and serious complication of coronary stenting. The primary endpoint is a non-inferiority comparison of Target Lesion Failure (TLF) defined as a composite of cardiac death, nonfatal target vessel myocardial infarction and ischemia-driven target lesion revascularization at 12 months. The trial will randomize 740 patients across up to 75 centers in the U.S. With the amended IDE approved by the FDA, Orchestra BioMed is currently targeting initiation of the Virtue Trial during the second half of 2025, bringing the Company one step closer to delivering a next-generation solution for atherosclerotic disease. About Coronary In-Stent Restenosis (ISR)Coronary ISR is a serious complication of coronary stenting, which can increase the risk of life-threatening heart problems. It is characterized by a re-narrowing of a coronary artery segment that was previously treated with a stent. According to the National Cardiovascular Data Registry, coronary ISR occurs in up to 10% of stented patients during the first year and continues at a rate of up to 3% per year thereafter, resulting in an estimated over 325,000 coronary ISR lesions annually worldwide that may require treatment. If left untreated, coronary ISR may lead to stable angina, unstable angina, acute coronary syndrome, acute myocardial infarction, or death. About Virtue SABVirtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. Forward-Looking StatementsCertain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the timing of the initiation and of the Virtue Trial, the number of patients to be enrolled in the Virtue Trial, and the potential safety and efficacy of the Company’s product candidates, including the ability of Virtue SAB to overcome certain limitations of DCBs. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s product candidates; the timing of, and the Company’s ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactJeremy FefferLifeSci AdvisorsJfeffer@lifesciadvisors.com Media ContactKelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com References 1Xinlin Zhang, et. al. PLOS ONE 2014 May 20;9(5):e97934. 2https://slideplayer.com/slide/5787004. 3 Tada, et. Al., Am Heart J. 2013 Jan;165(1):80-6. 4Leon M LBT III, Session 3014 ACC 2011.

A biotech incubated by RA Capital has secured a $57.5 million Series B to begin a mid-stage trial for its cardio drug this quarter and get to a readout in late 2026. Imbria Pharmaceuticals has now raised a total of about $150 million in equity financing, CEO Alvin Shih exclusively told Endpoints News . The Boston startup, which has eight employees, has not previously disclosed its fundraising. Imbria’s financial backers include RA, SV Health Investors, Deep Track Capital, AN Ventures and Catalio Capital Management. The money is expected to help the company prove whether its oral medicine, code-named ninerafaxstat , can treat patients with non-obstructive hypertrophic cardiomyopathy, or HCM, in a Phase 2b study. The biotech now has a runway into the second half of 2027, according to Shih, who joined Imbria as a board member last year and is now CEO. Anne Prener, a former partner at SV Health, was president and CEO of Imbria from 2020 until September, according to her LinkedIn. Shih has spent the past few quarters trying to secure funding in a challenging market. “It has not been easy. The environment is very difficult, but I would say raising money for my previous company — Catamaran [Bio] in the cell therapy space — was impossible,” he said, referring to the CAR-NK cell therapy biotech that closed last year . “This was just difficult.” Imbria will also benefit from the expertise of Cytokinetics, which chipped into the startup’s Series B. “Their involvement validates our approach,” Shih said. The California drug developer’s aficamten is in late-stage development in similar cardio fields as Imbria’s ninerafaxstat; however, Cytokinetics doesn’t have any operational control over ninerafaxstat, Shih confirmed. Eventually, and maybe with the help of a partner, Imbria plans to continue testing the twice-daily drug in other cardio indications like heart failure with preserved ejection fraction, or HFpEF. The drug has already gone through a Phase 2a in HFpEF. Imbria said the drug met the trial’s primary endpoint in a presentation at last month’s annual American College of Cardiology conference. “It’s become an epidemic,” Shih said. “HFpEF is the fastest-growing segment of heart failure, and it’s clear that even with GLP-1s, you haven’t totally fixed the problem, and so patients are going to need additional therapeutics.” Ninerafaxstat is a partial fatty acid oxidation (pFOX) inhibitor. Shih said the goal is to make the heart less reliant on fatty acids, which is common in heart failure patients, and more reliant on glucose, which could boost metabolism and make for a more well-oiled mitochondrial engine. With better energy generation, cardiac function should improve. Shih said the experimental oral drug has demonstrated improvement in “cardiac energetics,” key functional outcomes and quality of life outcomes, including on the Kansas City Cardiomyopathy Questionnaire, a self-administered survey for heart failure patients. “That is what is going to be the approvable endpoint in both HCM and HFpEF,” Shih said. RA Capital got the idea from a decades-old drug called trimetazidine , which has been commercialized in Europe to treat angina but is not approved by the FDA. “It’s known to have some activity in the cardiac mitochondria, but what they wanted to do was to optimize the molecule and they ended up creating a new molecule that results in trimetazidine as one of its metabolites, but also has other active metabolites,” Shih said. It’s “sort of getting more bang for the buck on the mechanism, which is in the mitochondria.”