Olympe Imagerie to deploy Nanox.ARC at Paris-area Hospital Privé Jacques Cartier MASSY for lung cancer screening applications
Author: Ken Dropiewski
Bioxodes presents BIOX-101 clinical data showing breakthrough potential for stroke in webcast with Prof Dr Robin Lemmens
Gosselies, Belgium, 14 November 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has held a webcast on the breakthrough potential of its lead candidate BIOX101 to treat intracerebral hemorrhage (ICH) and discussed the data with Prof Dr Robin Lemmens, KU Leuven, the Principal Investigator of its Phase 2a BIRCH clinical trial. Prof Lemmens, a world-renowned stroke expert and head of the stroke unit at the University Hospital Leuven, underscored the urgent need to address the large unmet medical need in intracerebral hemorrhage, and provided his insights from the successful Phase 2a clinical study with BIOX-101. Bioxodes CEO Marc Dechamps presented the company’s strategy in bringing BIOX-101 to market, possibly as early as late 2030.
Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio
INSIDE INFORMATIONREGULATED INFORMATION Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio Financings are comprised of equity investments, including from Cochlear, Resmed and Nyxoah’s Chairman and Management, and a convertible bond. Mont-Saint-Guibert, Belgium – November 13, 2025, 2025, 10:11pm CET / 4:11 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA) through neuromodulation, today announced a €22 million private placement of equity, a U.S. $5.6 million registered direct offering, and a €17 million registered direct offering combined with a convertible bond financing of up to €45 million. The private placement consists of the issuance of 5,481,678 new ordinary shares at a subscription price per share of €4.00 (approximately U.S. $4.6304 at current exchange rates) with gross proceeds totaling €22 million (approximately U.S. $25 million at current exchange rates). The closing of the private placement is expected to occur on or about November 17, 2025, subject to customary closing conditions. Degroof Petercam acted as the sole book runner for this private placement. The ordinary shares are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Additionally, the registered direct offering consists of the issuance of 1,215,964 new ordinary shares at a price per share of U.S. $4.6304 with gross proceeds totaling approximately U.S. $5,6 million. The closing of the registered direct offering is expected to occur on or about November 18, 2025, subject to customary closing conditions. The registered direct offering is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333- 268955) which was declared effective by the Securities and Exchange Commission (the “SEC”) on January 6, 2023. The offering is being made only by means of a prospectus which is part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Additionally, the Company entered into a subscription agreement with an international financial services firm for the issuance of convertible bonds for an aggregate maximum principal amount of up to €45 million (approximately U.S. $52 million at current exchange rate). The financing consists of a first tranche of up to €22.5 million with an option to issue a second tranche of €22.5 million at Nyxoah’s discretion, during the 30 days beginning seven months from the closing date subject to certain conditions. The closing for the first tranche of bonds is expected to occur in December 2025, subject to customary closing conditions. The first tranche of bonds will be issued at 92 per cent of their principal amount and carry an interest rate of 6.5 per cent per annum, payable every quarter in arrears. The bonds have a three-year maturity from issuance with quarterly amortization payments of principal and interest. The default conversion price for the first tranche of bonds, which can be modified on a downward basis, shall be equal to EUR 5.00, which represents 125 per cent of the placement price of the Shares being issued pursuant to the private placement. The net proceeds from the convertible bonds together with the net proceeds of the private placement, will be used (i) to support commercialization activities in the United States and advance the commercialization of the Genio system in the Company’s initial target markets outside the United States; (ii) to continue gathering clinical data and to support physician-initiated clinical research projects related to OSA patient treatments; (iii) to further finance research and development activities related to Genio system upgrades, re-designing the Company’s products for manufacturability and cost reduction initiatives; (iv) to continue to build a pipeline of new technologies and explore potential collaboration opportunities in the field of monitoring and diagnostics for OSA; and (v) for other general corporate purposes, including, but not limited to, working capital, capital expenditures, investments, acquisitions, should the Company choose to pursue any, and collaborations. This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. 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 receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. ADDITIONAL INFORMATION The following information is provided pursuant to article 7:97 of the Belgian Code on companies and associations. The investors that have participated in the private placement include, among others, (either directly or through entities controlled by them) Robert Taub, who is the chairman of the board of directors, Jürgen Hambrecht and Daniel Wildman (permanent representative of Wildman Ventures LLC), who are independent directors, Olivier Taelman, CEO and director of the Company, John Landry, CFO of the Company and Scott Holstine, Chief Commercial Officer of the Company. Together, these investors have subscribed to 356,250 new shares for EUR 1.425 million in gross proceeds at an issue price equal to EUR 4.00. As Robert Taub, Jürgen Hambrecht, Daniel Wildman, Olivier Taelman, John Landry and Scott Holstine qualify as related parties of the Company, the board of directors applied the related parties procedure of article 7:97 of the Belgian Code on companies and associations in connection with the participation of the aforementioned related parties in the private placement. Within the context of the aforementioned procedure, prior to resolving on the private placement, a committee of three independent directors of the Company consisting of Rita Johnson-Mills, Virginia Kirby and Kevin Rakin (the “Committee”) issued an advice to the board of directors in which the Committee assessed the participation of the six aforementioned investors in the private placement. In its advice to the board of directors, the Committee concluded the following: “Based on the information provided, the Committee considers that the proposed Transaction is in line with the strategy pursued by the Company, will be done on market terms, and is unlikely to lead to disadvantages for the Company and its shareholders (in terms of dilution) that are not sufficiently compensated by the advantages that the Transaction offers the Company”. The Company’s board of directors approved the principle of the private placement and did not deviate from the Committee’s advice. IMPORTANT INFORMATION THIS ANNOUNCEMENT IS NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN ANY JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW. THIS ANNOUNCEMENT IS FOR GENERAL INFORMATION ONLY AND DOES NOT FORM PART OF ANY OFFER TO SELL OR PURCHASE, OR THE SOLICITATION OF ANY OFFER TO SELL OR PURCHASE, ANY SECURITIES. THE DISTRIBUTION OF THIS ANNOUNCEMENT AND THE OFFER, SUBSCRIPTION, SALE AND PURCHASE OF SECURITIES DESCRIBED IN THIS ANNOUNCEMENT IN CERTAIN JURISDICTIONS MAY BE RESTRICTED BY LAW. ANY PERSONS READING THIS ANNOUNCEMENT SHOULD INFORM THEMSELVES OF AND OBSERVE ANY SUCH RESTRICTIONS. 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 closings of the private placement, the registered direct offering and the convertible bond financing; the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company’s commercialization strategy and entrance to the U.S. market; 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. These risks and uncertainties include, but are not limited to, the satisfaction of the closing conditions required for the closing of each of the private placement, the registered direct offering and the convertible bond financing and the consummation of the respective closings, 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, 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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Financing PR
Adagio Medical Reports Third Quarter 2025 Results
Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the third quarter […]
Esaote and Schiller Americas announce strategic partnership to expand the sales channel in the cardiology imaging space
FISHERS, Ind., Nov. 13, 2025 /PRNewswire/ — Esaote, one of the world’s leading medical imaging companies, is proud to announce a new strategic partnership with Schiller Americas, a global leader in cardiopulmonary diagnostics. This collaboration strengthens both companies’ presence in…
Humacyte Announces Six Presentations Scheduled for the Upcoming 52nd Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITHsymposium)
DURHAM, N.C., Nov. 13, 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 details of six presentations on the Company’s acellular tissue engineered vessel (ATEV™) that are scheduled for the 52nd Annual Symposium on Vascular and Endovascular Issues, Techniques And Horizons (VEITHsymposium), to be held November 18-22, 2025 in New York, NY. The VEITHsymposium is a premier educational event for vascular surgeons, interventional radiologists, interventional cardiologists, and other vascular specialists.
Konica Minolta Healthcare Partners with Leading Teleradiology Provider, Implements Exa Teleradiology Powered by NewVue
The company will highlight Exa Teleradiology at RSNA 2025 The company will highlight Exa Teleradiology at RSNA 2025
Anteris Announces Results for the Third Quarter of 2025
MINNEAPOLIS, Minn. and BRISBANE, Australia , Nov. 12, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended September 30, 2025, and provided a corporate update. Third Quarter 2025 Highlights Continued FDA engagement during the Quarter to advance the IDE for the PARADIGM Trial, with FDA approval to commence U.S. recruitment* announced in November 2025Advanced European regulatory activities to initiate the PARADIGM Trial across multiple countries, with the first PARADIGM patients treated in Denmark following regulatory approval from the Danish Medicines Agency in October 2025Progressed site and operational readiness across the United States, Europe and Canada ahead of anticipated trial enrolmentStrengthened operational and quality systems while advancing manufacturing scale-up to support clinical activities including ISO 13485 certification for DurAVR® THV productionReceived approval from the Company’s stockholders for ASX Limited’s grant to the Company of a waiver from ASX Listing Rule 7.1 “Third Quarter activities were critical to set the company on its path for the rest of the year and into 2026. The company made significant progress on the regulatory front with approvals to start the PARADIGM pivotal study being achieved in both Europe and the U.S. in Q4 as a result,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations DurAVR® THV Commercialisation Update Activities supporting the launch of the PARADIGM Trial During the third quarter of 2025, the company maintained positive engagement with the United States Food and Drug Administration (FDA) to advance the Investigational Device Exemption (IDE) for the PARADIGM Trial, submitting a formal response to address requests for additional information, including a completed simulated use study. FDA approval to commence patient recruitment* in the United States was subsequently announced in November 2025. Anteris also advanced European regulatory activities aimed at securing approval to commence the PARADIGM Trial in countries including Germany, France and the Netherlands, with the first European approval secured in Denmark in October 2025. In parallel, cross-functional teams completed site and operational readiness activities, namely investigator training, study material preparation, and logistical set up, ahead of anticipated enrolment and pending receipt of regulatory clearance and Institutional Review Board (IRB) approval. The first PARADIGM patients were enrolled and treated in Denmark following regulatory approval from the Danish Medicines Agency in October 2025. The Company continued strengthening its operational infrastructure during the quarter, advancing quality management system (QMS) buildout to support upcoming clinical activities and future ISO 13485 certification. Key quality procedures and standard operating documents were released to establish the framework for a mature, compliant system and to mitigate audit risk. In parallel, manufacturing scale-up activities progressed, including cross-training of inspection personnel, expansion of clean room capacity, and ongoing process development initiatives for projected DurAVR® THV demand. The financial results for Anteris for the quarter ended September 30, 2025, are reviewed below. All amounts in $ refer to U.S. dollars. The Company’s net operating cash outflows for the nine months ended September 30, 2025, were $59.3 million, in line with the increase in clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. Reflecting this clinical focus, the key areas of the Company’s operating expenditure for the three months ended September 30, 2025, were as follows: R&D expenses were $16.8 million. The key activities undertaken were the preparatory activities linked to the PARADIGM Trial, including regulatory work regarding the IDE and extensive engagement with planned investigators at clinical trial sites by the Clinical Specialist Team, who work directly with physicians in the Cath Lab to support appropriate use of the device and procedural success. Additionally, there were further costs associated with upscaling of manufacturing capabilities, including completion of design validation processes and documentation, and continued portfolio development aimed at driving long-term growth beyond the current products. Selling, general and administrative expenses were $5.8 million. The Company held $9.1 million of cash and cash equivalents as of September 30, 2025. Anteris refers to the detailed Financial Information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1,000 patients across the United States, Europe and Canada in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval (PMA) in the United States, with CE Mark approval anticipated to progress in parallel to the PMA. For further information about the PARADIGM Trial, please refer to ClinicalTrials.gov (ClinicalTrials.gov ID NCT07194265). *Subject to Institutional Review Board (IRB) approval About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts, including the objectives of, plans for and size of Anteris’ studies and trials. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Investor Relations Investor Relations (US)investors@anteristech.com mchatterjee@bplifescience.comDebbie OrmsbyMalini Chatterjee, Ph.D.Anteris Technologies Global Corp. Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200 +1 917 330 4269 Website www.anteristech.comX@AnterisTechLinkedIn https://www.linkedin.com/company/anteristech
Hone Health Integrates Prenuvo Whole-Body MRI Scans to Power Preventive, Data-Driven Longevity Care
[New York, NY – November 6, 2025] – Hone Health, the leader in longevity intelligence and personalized care, is teaming up with Prenuvo, the leader in whole body MRI for proactive health screening, giving patients access to comprehensive health insights and physician-guided care within a single platform, allowing patients to […]
XCath Endovascular Robotic System Successfully Performs its First-In-Human Brain Aneurysm Procedures
HOUSTON–(BUSINESS WIRE)–XCath, a medical device company dedicated to pioneering neuro-endovascular surgical robotics, announced today the successful first-in-human use of its EVR robotic system to treat three patients with complex brain aneurysms. The landmark procedures were performed at The Panama Clinic in Panama City, Panama, led by Vitor Mendes Pereira, M.D., […]



