Other News

Traferox Technologies Inc. Receives FDA Clearance for the X°Port Heart Preservation System

Coronary/Structural Heart by 0 comments

X°Port Heart Preservation System

X°Port Heart Preservation System, now FDA-cleared

MISSISSAUGA, Ontario, Sept. 22, 2026 (GLOBE NEWSWIRE) — Traferox Technologies, Inc. today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the X°Port® Heart Preservation System, a device that enables static 10°C heart preservation during transport prior to transplantation. “The FDA clearance of X°Port Heart marks an important milestone for Traferox and for the continued advancement of 10°C organ preservation,” said Rick Mangat, Chief Executive Officer of Traferox. “The strong clinical evidence supporting 10°C heart preservation, together with the successful adoption of 10°C preservation across leading lung transplant programs, has demonstrated the potential of this approach to improve donor organ preservation and transport. We look forward to working with transplant centers across the US to support the continued adoption of 10°C preservation in routine clinical practice”. The clearance comes as clinical evidence supporting 10°C heart preservation continues to grow. Published, peer-reviewed evidence has linked 10°C heart preservation to improved early outcomes, including reductions in severe primary graft dysfunction and improved post-transplant survival compared to conventional ice storage1 and other hypothermic temperatures2, including in transplants involving higher-risk donor hearts. Vanderbilt University Medical Center was the first US institution to investigate 10°C heart preservation clinically, building on the success of 10°C preservation in lung transplantation. As the largest heart transplant center in the US, Vanderbilt has since completed more than 150 procurements using 10°C preservation and reported improved outcomes despite the use of higher-risk donor hearts1. “10°C preservation has changed how we approach donor heart preservation,” said Dr. Ashish Shah, Surgical Director of Vanderbilt’s heart transplant program. “It is the standard in our institution for performing heart transplantation.” X°Port Heart builds on the US commercial launch of X°Port Lung in Q3 2025, which has since been adopted by 7 of the 10 highest-volume US lung transplant centers and more than half of all lung transplant programs in the US. This growing clinical adoption reflects the demand for preservation technologies that combine strong clinical evidence with practical benefits for transplant programs. “The introduction of X°Port Heart reflects our commitment to advancing organ preservation through technologies grounded in robust science, designed for intuitive clinical integration, and built to deliver sustainable value for healthcare systems,” said Joe Kletzel, President of Traferox. “With X°Port Heart, we are expanding that commitment to heart transplantation while building on the strong foundation established with the market leading X°Port Lung Preservation System and the newly launched TorEx Lung Perfusion System. Together, these technologies reflect our broader vision to provide transplant programs with clinically meaningful, practical solutions across the continuum of organ preservation.” With the FDA clearance of X°Port Heart, Traferox will begin making 10°C heart preservation available to transplant centers across the United States. IMPORTANT SAFETY INFORMATION Indications for UseThe X°Port Heart Preservation System is indicated for static hypothermic preservation of donor hearts at 4-10°C for up to 4 hours using a del Nido (or equivalent) cold storage solution. ContraindicationsThere are no known contraindications. Please refer to the Instructions for Use for complete indications, warnings, precautions, and operating instructions. About Traferox Technologies Inc.Traferox Technologies, Inc. is a medical device company headquartered in Mississauga, Ontario, Canada, dedicated to advancing organ transplantation through innovative preservation and organ assessment technologies. Founded in 2021 as a spin-out of University Health Network’s Toronto General Hospital, Traferox develops and commercializes technologies that expand access to transplantation through scientifically validated, clinically practical solutions that are easy to adopt and deliver sustainable value for healthcare systems worldwide. The company’s growing portfolio includes technologies for donor lung and heart preservation and assessment, with a mission to improve transplant outcomes and increase access to life-saving organs for patients around the world. DisclosuresAshish Shah is Professor and the Chair of the Department of Cardiac Surgery, Alfred Blalock Endowed Director in Cardiac Surgery, Medical Director Cardiac Surgery OR Pod & Heart Transplant Surgery, at Vanderbilt University Adult Hospital. He is also a strategic advisor to Traferox Technologies. Media ContactTraferox Technologies, Inc.Media & Investor InquiriesEmail: info@traferox.comWebsite: www.traferox.com 1 Ahmad, A., et al. (2026). Improved outcomes and donor utilization in heart transplantation with 10 °C static cold storage. The Journal of Heart and Lung Transplantation, 45(8), 1229–1237. https://doi.org/10.1016/j.healun.2026.02.0042 Williams, A. M., et al. (2026). Donor heart preservation at 10 °C outperforms 4–8 °C with improved early graft function in adult heart transplantation: A Vanderbilt and Duke multicenter study. Circulation: Heart Failure. Advance online publication. https://doi.org/10.1161/CIRCHEARTFAILURE.126.014240 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4d14d97f-3105-495f-af34-3890b2c177e7

Continue Reading →

Edgewise Therapeutics Unveils the Differentiated Mechanism of Action (MoA) of its Cardiac Sarcomere Modulator EDG-7500

Coronary/Structural Heart by 0 comments

– The MoA that targets the Regulatory Light Chain (RLC) has shown in preclinical models to improve cardiac relaxation while preserving systolic function and cardiac reserve – – Company to host webcast to discuss these findings today at 8:30 a.m. Eastern Time – BOULDER, Colo., Sept. 22,…

Continue Reading →

CVRx Appoints John Landry as Chief Financial Officer

Financial by 0 comments

Landry Brings Two Decades of Medtech and Public Company Finance ExperienceMINNEAPOLIS, Sept. 21, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that John Landry has been appointed Chief Financial Officer, succeeding Jared Oasheim, whose resignation was previously announced. Mr. Landry will join the Company on October 12, 2026, and assume the CFO role on the day after the Company files its Form 10-Q for the quarter ending September 30, 2026.   Mr. Oasheim will remain with the Company for a transition period consistent with his previously disclosed transition agreement. “John is exactly the kind of finance leader we need for this next chapter,” said Kevin Hykes, President and CEO of CVRx. “Over the past two decades, he has played a key role in building and financing high growth medical device companies introducing novel therapies like Barostim. He is a hands-on operational leader who has significant commercial and capital markets experience, and who is well known within the investment community. John’s experience driving growth while managing expenses is particularly relevant as we scale Barostim and reach more heart failure patients. “I want to thank Jared for the significant impact he has had at the company since 2015. He led us through our IPO and helped build the financial foundation we stand on today,” Hykes added. “We’re grateful for his contributions and wish him success in his next chapter.” Mr. Landry brings more than two decades of financial leadership experience in the medical device industry. He currently serves as CFO of Nyxoah SA (Euronext Brussels/Nasdaq: NYXH), where he raised several rounds of capital and drove operational efficiencies to fund the company’s U.S. commercial expansion. Before that, he spent 12 years at Vapotherm, Inc. (formerly NYSE: VAPO), most recently as Senior Vice President and CFO, where he led the company’s IPO and built its finance, investor relations and public company reporting functions from the ground up. Earlier in his career, Mr. Landry held finance leadership roles at Salient Surgical Technologies (acquired by Medtronic in 2011), Bottomline Technologies, Hussey Seating Company and Coopers & Lybrand. He holds a B.S. in Accountancy from Bentley College, is a CPA (inactive) and serves on the board of Liberate Medical, Inc. “Barostim is changing how physicians treat heart failure and the positive impact it is having on patients’ lives is what drew me to this role,” said John Landry. “I’ve spent most of my career in the medical device industry helping to build the infrastructure and operating discipline needed as companies scale their commercial efforts. I’m excited to join the CVRx team and see a real opportunity to bring that same operating discipline to support the business as we execute our commercial growth strategy.” About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark KlausnerICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com

Continue Reading →

Nyxoah Announces Chief Financial Officer Transition

Financial by 0 comments

REGULATED INFORMATIONINSIDE INFORMATION Nyxoah Announces Chief Financial Officer Transition Loïc Moreau, Nyxoah’s President International and former CFO, to serve as interim CFO Company reaffirms full year 2026 financial guidance Mont-Saint-Guibert, Belgium – September 21, 2026, 22:01h CET / 4:01h ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that John Landry, Chief Financial Officer, will step down from his role effective October 2, 2026 to pursue another professional opportunity. Loïc Moreau, the Company’s President International and former CFO, will serve as Interim CFO effective upon Mr. Landry’s departure while the Company conducts a search for a permanent successor. “We are fortunate to have Loïc available to step into the interim CFO role. He knows this Company deeply, having previously served as our CFO prior to becoming President International, and that continuity gives us full confidence in a smooth transition as we continue to execute on our growth strategy and path to profitability,” commented Olivier Taelman, Chief Executive Officer. “I want to thank John for his contribution to Nyxoah and wish him success in his next endeavor.” Loïc Moreau joined Nyxoah in 2022 as Chief Financial Officer and transitioned to the role of President International in 2024. He is a seasoned finance leader with more than 20 years of experience, having held senior roles at GSK, including in M&A/Corporate Development and as Country CFO across multiple geographies. Prior to GSK, he began his career in External Audit at EY and in Corporate Finance at PwC. Reaffirmation of Financial Guidance Nyxoah is reaffirming the financial guidance for the full year 2026 that it previously issued: The Company expects worldwide net revenue for the full year 2026 to be in the range of €36 million to €40 million.The Company expects gross margin for the full year 2026 to be in the range of 60% to 62%.The Company expects total operating expenses for the full year 2026 to be in the range of €99 million to €102 million. The Company expects non-GAAP cash operating expenses for the full year 2026 to be in the range of €88 million to €90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash expenses such as depreciation, amortization, and share-based compensation. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study in 2024 and received approval from the FDA in August 2025, with the treatment of CCC patients included in the warning section of our indications for use. For more information, please visit http://www.nyxoah.com. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the transition of the Chief Financial Officer role; the Company’s leadership and organizational structure; Nyxoah’s financial guidance for the full year 2026; the Company’s results of operations, financial condition, liquidity, performance, prospects, growth, future revenue and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah Rémi Renard, Head of Investor Relations & Corporate CommunicationIR@nyxoah.com
Attachment

ENGLISH_Nyxoah Announces CFO Transition PR

Continue Reading →

SELUTION SLR™ Drug-Eluting Balloon Approved by FDA for In-Stent Restenosis: First and Only Sirolimus Drug-Eluting Balloon in the US

Coronary/Structural Heart Regulatory by 0 comments

MIAMI LAKES, Fla.–(BUSINESS WIRE)– #Cordis–Cordis, a global leader in interventional cardiovascular and endovascular technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR), marking a major milestone in expanding treatment options for one of the most complex challenges in interventional cardiology. Physicians now have immediate access to the

Continue Reading →

StimCardio’s NeuroPulse Study Reports Substantial Reduction in Recurrent Atrial Fibrillation Events Via Non-Invasive Wearable Neuromodulation Following Ablation

Rhythm by 0 comments

90% freedom from atrial arrhythmias at six months with neuromodulation vs. 80.8% with sham Randomized, double-blind, sham-controlled results presented as late-breaking clinical science at HRX Live 2026 and simultaneously published in peer-reviewed Heart Rhythm ATLANTA and LOS ANGELES,…

Continue Reading →

JACC: Clinical Electrophysiology Publishes 12-Month Outcomes from Field Medical’s First-in-Human Field PULSE Trial: 94.2% Per-Vein PVI Durability with Optimized Waveform

Rhythm by 0 comments

Late-breaking HRX data advance Field Medical’s “instantaneous ablation” workflow and expand the clinical evidence for high-voltage focal PFA with the FieldForce™ PFA System ATLANTA and CARLSBAD, Calif., Sept. 20, 2026 /PRNewswire/ — Field Medical, Inc., advancing high-voltage focal…

Continue Reading →

HFSA’s 2026 Annual Scientific Meeting to Feature Late-Breaking Trials That Could Reshape Heart Failure Treatment

Coronary/Structural Heart by 0 comments

October 9-12, 2026 | Phoenix, Arizona — New data spans pharmacotherapy, imaging and diagnostics, and device therapy for patients with cardiomyopathy WASHINGTON, Sept. 18, 2026 /PRNewswire/ — The Heart Failure Society of America (HFSA) today announced the Late-Breaking Clinical Research…

Continue Reading →

Roche announces grand opening of its Innovation Center Boston to drive advancements in Cardiovascular, Renal and Metabolic diseases

Financial by 0 comments

The center will be a hub for Roche and Genentech, bringing together expertise in Cardiovascular, Renal and Metabolism, as well as for data science and AI specialists to drive innovation in drug discovery and developmentIt will expand Roche’s and Genentech’s presence in Boston, reflecting a long-term commitment to one of the world’s leading life sciences hubsThis is part of Roche and Genentech’s USD 50 billion investment in US manufacturing and R&D, building on recent investments and manufacturing milestones in Holly Springs, North Carolina, and Hillsboro, Oregon Basel, 17 September 2026 – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the grand opening of the Roche Genentech Innovation Center Boston, expanding Roche and Genentech’s US research presence in one of the world’s leading life sciences communities. Located at Harvard’s Enterprise Research Campus in Allston, the Roche Genentech Innovation Center Boston will serve as Roche’s Cardiovascular, Renal and Metabolism (CVRM) hub, establishing a significant end-to-end R&D presence in CVRM. With the new center, Roche and Genentech are expanding their footprint within the Greater Boston innovation ecosystem, leveraging local talent and anchoring an entrepreneurial hub at Harvard’s Enterprise Research Campus. It brings together scientists from across discovery research, clinical development, artificial intelligence and data science disciplines, and creates an end-to-end research environment spanning early-stage discovery through late-stage clinical development. The Innovation Center is part of Roche and Genentech’s investment commitment in US manufacturing and R&D and builds on recent investments and manufacturing milestones in Holly Springs, North Carolina, and Hillsboro, Oregon. Together, these investments expand an end-to-end US footprint spanning research, development and manufacturing and reflect the companies’ long-term commitment to American scientific innovation. Roche and Genentech have around 25,000 employees in the United States, with 15 R&D centers and 13 manufacturing sites across Pharma and Diagnostics. Thomas Schinecker, CEO Roche Group:“Scientific innovation has always been the foundation of Roche and Genentech’s success, and the United States remains one of our most important innovation hubs. This investment in Boston is an important part of our commitment to expand our US manufacturing and R&D footprint. By investing in scientific talent, new capabilities and infrastructure, we are strengthening our ability to discover and develop the next generation of medicines for patients.” Maura Healey, Governor of Massachusetts:“Massachusetts leads the world in life sciences because we bring together the best researchers, workers, universities and companies to solve big challenges and improve people’s lives,” said Governor Maura Healey. “Roche and Genentech’s decision to expand their presence here is another powerful vote of confidence in Massachusetts and in the people who make our state a global center for discovery and innovation. We’re proud to welcome this new Innovation Center and the groundbreaking research that will help shape the future of medicine.” Michelle Wu, Mayor of Boston“Boston will continue to lead in life science and innovation because of the extraordinary companies that chose to bring their ideas, talent and investment to our City. We are thrilled to welcome Roche and Genentech’s new Innovation Center to Allston, which will create hundreds of jobs, drive new investment and further strengthen Boston’s life sciences ecosystem. We look forward to working together to move innovation forward and help shape the next generation of scientific innovation.” This new investment highlights Roche’s dedication to advancing healthcare through academic and scientific collaboration in Boston’s life sciences ecosystem. These drug discovery efforts have included work to combat antibiotic resistant bacteria as well as the use of AI in cancer research to identify targeted approaches to treatment and to analyse the effectiveness of new cancer drugs in clinical trials. Roche and Genentech have signed a 10-year lease for the 95,000 square metre center, which will have capacity for up to 500 people across research, clinical development, data science and other areas. About the Enterprise Research CampusHarvard’s Enterprise Research Campus, the first phase of which is underway and developed by Tishman Speyer and Breakthrough Properties, has been intentionally designed to foster innovation and collaboration. Located adjacent to Harvard’s Science and Engineering Complex and near Harvard Business School, the ERC will be a dynamic mixed-use development integrating research and laboratory space, residential buildings, a hotel, conference center, retail units, and a variety of community-centered outdoor spaces. The first phase of construction is expected to be complete in 2026. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. Roche Global Media RelationsPhone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan SchmitzPhone: +41 79 529 70 35Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +41 79 398 38 53Yvette PetillonPhone: +41 79 961 92 50 Irène StephanPhone:  +41 79 377 83 75Albert ThottiyilPhone: +41 79 775 66 12
Attachment

Media Release Roche Genentech Innovation Center Grand Opening English

Continue Reading →
1 … 17 18 19 20 21 … 1,394