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Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc.

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Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc. Mont-Saint-Guibert, Belgium – September 15, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) and Nyxoah, Inc. (collectively, “Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced that it has filed a lawsuit against Inspire Medical Systems, Inc. (“Inspire”) alleging that the Inspire IV and Inspire V devices infringe the following three patents held by the Company; U.S. Patent Nos. 8,700,183, 9,415,215, and 9,415,216. The suit was filed in the United States District Court for the District of Delaware, seeking injunctive relief and damages for infringement. “We will defend our intellectual property portfolio and the proprietary, minimally invasive Genio® system, which does not rely on traditional pacemaker hardware but is a differentiated solution offering bi-lateral stimulation, full body MRI compatibility and an upgradable technology platform that does not require re-surgery for battery replacements,” said Olivier Taelman, Chief Executive Officer. “At Nyxoah, we remain committed to putting patients first and offering physicians an alternative, trusting them to make the best decision for their patients suffering from OSA. We’re excited about the positive feedback we have received from both physicians and patients in the first month post-US commercial launch and look forward to introducing the Genio system to more physicians and OSA patients so they can choose the best solution for their needs.” About NyxoahNyxoah 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 and U.S. FDA approval of a Premarket Approval application. 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 managements’ current expectations regarding the Genio system; planned and ongoing clinical studies of the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio system; the Company’s commercialization strategy and entrance to the U.S. market; the Company’s intellectual property portfolio; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth 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. Additionally, 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, 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, or adverse litigation outcomes 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: NyxoahJohn Landry, CFOIR@nyxoah.com
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ENGLISH_Nyxoah PR_FINAL

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Conavi Medical Submits Next Generation Novasight Hybrid Intravascular Imaging System to US FDA for 510(k) Clearance

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TORONTO, Sept. 16, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, announced that it has submitted its next generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration (“FDA”) for 510(k) clearance for coronary applications.

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PatenSee Receives FDA Breakthrough Device Designation for Non-Contact Vascular Access Management for Patients Undergoing Hemodialysis

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Designation supports accelerated development of AI-driven platform to improve outcomes and reduce clinical burden. DETROIT and OR YEHUDA, Israel, Sept. 16, 2025 /PRNewswire/ — PatenSee, a clinical-stage medical device company, announced that the U.S. Food and Drug Administration (FDA)…

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PaceMate Names New Head of AI As It Readies Cardiac Monitoring Platform for AI Expansion

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Sean Shoffstall Will Lead Transformation of One of the Most Robust Cardiovascular Dataset on the Planet Into AI Use Cases That Drive Precision Patient Outcomes TAMPA, FL, UNITED STATES, September 16, 2025 /EINPresswire.com/ — PaceMate, the remote cardiac monitoring platform that leading healthcare providers trust, today announced the appointment of Sean […]

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Visura Technologies Announces Positive Data from TEECAD Product Registry Presented at the American Society of Echocardiography 2025 Conference

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Data strongly supports the technology for effective, efficient and safe probe placement versus blind intubation   Sept. 8, 2025 – MINNEAPOLIS – Visura Technologies, Inc., announced today positive data from the TEECAD product registry, demonstrating the product’s ability for physicians to successfully visualize and safely and effectively navigate the esophageal […]

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Johnson & Johnson Announces Launch of its Shockwave Javelin Peripheral Intravascular Lithotripsy Catheter in Europe to Transform Treatment of Difficult-to-Cross Calcified Lesions

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  SANTA CLARA, Calif. – September 15, 2025 – Today, Johnson & Johnson announced the European launch of its Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium in extremely narrowed vessels to expand treatments in patients suffering from peripheral artery disease (PAD). The first-of-its-kind Forward IVL […]

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Dr. Sean Raj, MD, MBA, Named Chief Medical Officer of SimonMed Imaging, Expanding Role Alongside Chief Innovation Officer

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SCOTTSDALE, Ariz., Sept 14, 2025 – SimonMed Imaging (“SimonMed”), one of the nation’s leading outpatient medical imaging providers and radiology practice, is proud to announce the appointment of Dr. Sean Raj, MD, MBA, to Chief Medical Officer, in addition to his ongoing role as Chief Innovation Officer. A nationally recognized […]

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EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke

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Oral semaglutide (Rybelsus®) is now the first and only oral GLP-1 RA approved for type 2 diabetes, with proven cardiovascular benefits1This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus®) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk1In addition, new results from SOUL will be presented at one of the largest diabetes conferences (EASD) later this week, showing that oral semaglutide significantly reduced hospitalisations compared with placebo2 Bagsværd, Denmark, 15 September 2025 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial. SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsus® on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD)1. Rybelsus® is now the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) – mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and digestion – available in the EU for type 2 diabetes with a proven cardiovascular benefit1. “Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that,” said Emil Kongshøj Larsen, executive vice president, International Operations at Novo Nordisk. “This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.” New results from the SOUL trial will be shared later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting, 15–19 September. These include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events compared with placebo2. Additional SOUL results will be presented at the same meeting, which highlight that the cardiovascular benefits of oral semaglutide were consistent regardless of body mass index (BMI) and body weight of participants3. In the US, a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus®. Novo Nordisk has also submitted an application in the US for a once-daily 25 mg oral formulation of semaglutide (Wegovy® in a pill) in adults living with obesity or overweight and cardiovascular disease. A decision is expected at the turn of this year, and if approved, Wegovy® would become the first oral GLP-1 RA indicated for chronic weight management. Rybelsus® is the first and only oral GLP-1 RA approved for the treatment of type 2 diabetes, following its launch in 2019. It is supported by a strong clinical and real-world evidence base, demonstrating superior blood glucose reduction and body weight reduction versus multiple comparators, as well as an established safety profile in people with type 2 diabetes4-8. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial, with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide versus placebo, when added to standard of care, on cardiovascular outcomes in people with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease (CKD). The SOUL trial was initiated in 2019. The primary outcome was time-to-first occurrence of major adverse cardiovascular events (MACE; a composite objective consisting of cardiovascular death, heart attack and stroke) 1. The SOUL trial demonstrated a superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo in people with type 2 diabetes and cardiovascular disease and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with a proven cardiovascular benefit1. About Rybelsus® Rybelsus® (oral semaglutide) is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise7, 9. Rybelsus® is administered once daily and is approved for use in the following therapeutic dosages: 1.5 mg, 3 mg, 4 mg, 7 mg, 9 mg, 14 mg, 25 mg and 50 mg4, 5. Rybelsus® offers superior blood glucose lowering versus multiple comparators4, 5, together with consistent weight reduction4, 5, 10, reduction in cardiometabolic risk factors10 and reduction in major adverse cardiovascular events (MACE) 1. Rybelsus® is now the first and only oral GLP-1 RA available in the EU for type 2 diabetes with a proven cardiovascular benefit1. It is currently available in 48 countries11, and more than 2.4 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide12. About Wegovy®Semaglutide 2.4 mg is marketed under the brand name Wegovy®. In the EU, Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy® major adverse cardiovascular events (MACE) risk reduction, improvements in heart failure with preserved ejection fraction (HFpEF)-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis13. In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older with obesity and in adults with obesity or with overweight in the presence of at least one weight-related comorbid condition, as well as for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in combination with a reduced calorie diet and increased physical activity14. 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 9289globalmedia@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.comInvestors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comSina Meyer +45 3079 6656azey@novonordisk.comMax Ung+45 3077 6414 mxun@novonordisk.com Christoffer Sho Togo Tullin+45 3079 1471cftu@novonordisk.comAlex Bruce +45 34 44 26 13axeu@novonordisk.comFrederik Taylor Pitter +1 609 613 0568fptr@novonordisk.com _______________________References1.      McGuire DK, et al. N Engl J Med. 2025;392(20):2001-2012.2.      Buse JB, et al. Oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; 15-19 Sep 2025; Vienna, Austria.3.      Inzucchi SE, et al. Oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; 15–19 Sep 2025; Vienna, Austria. 4.      Rosenstock J, et al. JAMA. 2019;321(15):1466-1480.5.      Rodbard HW, et al. Diabetes Care. 2019;42(12):2272-2281.6.      Pratley R, et al. Lancet. 2019;394(10192):39-50.7.      Rybelsus® (oral semaglutide): US Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf. Last accessed: September 2025.8.      Aroda VR, et al. Lancet. 2023;402(10403):693-704.9.      Rybelsus® (oral semaglutide): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus. Last accessed: September 2025.10.      Husain M, et al. N Engl J Med. 2019;381(9):841-851.11.      Novo Nordisk Data on File. LEA portal Product Planning, 25th Aug 2025.12.      Novo Nordisk Data on File. IQVIA Jun’25 Patients R3M Vol. data. 2025.13.      Wegovy® (semaglutide): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information_en.pdf. Last accessed: September 2025.14.      Wegovy® (semaglutide): US Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s015lbl.pdf. Last accessed: September 2025.
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PR250915-Rybelsus-label-update-SOUL

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Altimmune Appoints Accomplished Commercial Executive Linda M. Richardson as Chief Commercial Officer

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GAITHERSBURG, Md., Sept. 15, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced the appointment of Linda M. Richardson to the role of Chief Commercial Officer, effective September 16, 2025. Ms. Richardson joins the Company with more than 30 years of experience in sales and marketing, commercial, corporate and business development across a range of therapeutic areas, including metabolic disease, hepatology, cardiovascular and addiction medicine. During her career, she has led multiple product launches, built successful commercial franchises and contributed to a variety of business development transactions. “Linda joining Altimmune marks a key strategic addition to our executive team as we approach the initiation of Phase 3 development of pemvidutide in MASH. To add a leader with her pedigree positions Altimmune, and pemvidutide, for future commercial success,” said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “Her deep expertise and strong track record will be instrumental to our strategic business execution and growth.” Ms. Richardson added, “I believe that pemvidutide represents a rare opportunity in the area of hepato-metabolic disease and is differentiated from other marketed and development-stage therapies with significant potential to improve the lives of patients with MASH. Additionally, there are sizeable opportunities in Alcohol Use Disorder and Alcohol-associated Liver Disease where we continue to investigate the potential utility of pemvidutide in these highly prevalent and underserved indications. I am pleased to bring my experience to Altimmune and thrilled to begin leading Altimmune’s commercial-readiness efforts.” Ms. Richardson served as Chief Commercial Officer and Executive Vice President at Intercept Pharmaceuticals, a liver disease company, departing in early 2024 following the Company’s acquisition by Alfasigma. Prior to joining Intercept, she was Chief Strategy and Commercial Officer at Chimerix. Earlier in her career, she held a variety of senior-level marketing and commercial positions, including at Sanofi, where she was Global Commercial Head of Lixisenatide, the Company’s GLP-1 program and Marketing Lead for MULTAQ and AUVI-Q, Reliant Pharmaceuticals, where she launched Lovaza for hypertriglyceridemia, and at GSK. She holds a bachelor’s degree in English from the University of Pennsylvania. Inducement GrantIn connection with being named as Chief Commercial Officer, Ms. Richardson will receive, in the aggregate, options to purchase 278,000 shares of Altimmune’s common stock, and 96,000 restricted stock units (“RSUs”). The options will have an exercise price equal to the closing price of Altimmune’s common stock on September 16, 2025 (the “Grant Date”). Based on the closing price of Altimmune’s common stock on September 12, 2025, Altimmune would issue approximately 168,112 options as inducement awards under its 2018 Inducement Grant Plan, and the balance as incentive stock options under its 2017 Omnibus Incentive Plan. The final allocation of options between the 2018 Inducement Grant Plan and 2017 Omnibus Plan are subject to adjustment based on the closing price of Altimmune’s common stock on the Grant Date. One-fourth of the shares underlying the options will vest on the one-year anniversary of the Grant Date and thereafter 1/36th of the shares underlying the options will vest monthly, such that the shares underlying the options will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to Ms. Richardson’s continued employment with Altimmune on such vesting dates. One-fourth of the RSUs will vest on the one-year anniversary of the Grant Date and thereafter the RSUs will vest in three substantially equal annual installments, such that the RSUs will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to Ms. Richardson’s continued employment with Altimmune on such vesting dates. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). About AltimmuneAltimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead product candidate is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), Alcohol-associated Liver Disease (ALD) and obesity. For more information, please visit www.altimmune.com. Forward-Looking StatementsAny statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, the timing of key milestones for the Company’s clinical assets, future plans or expectations for pemvidutide for the treatment of MASH, AUD, ALD and obesity, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements, or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on X Company Contact:Greg WeaverChief Financial OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Media Contact:Jake RobisonInizio Evoke CommsPhone: 619-849-5383jake.robison@inizioevoke.com  This press release was published by a CLEAR® Verified individual.

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