SANTA CLARA, Calif.–(BUSINESS WIRE)–Next-generation IVL catheter delivers pulses at 2 Hz, improving efficiency in calcium modification treatment of coronary artery disease.
Author: Ken Dropiewski
Anteris Advances Global PARADIGM Trial Expansion with German Regulatory Clearance
MINNEAPOLIS and BRISBANE, Australia, Oct. 19, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) announced today that it has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM) for the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). This clearance enables Anteris to initiate patient recruitment at leading German centers and represents an important step in expanding the PARADIGM Trial’s European footprint. Germany is Europe’s largest and most established transcatheter aortic valve replacement (TAVR) market, with an extensive network of experienced structural heart centers and investigators. Activating sites in this high-volume environment is anticipated to increase access to eligible patients and accelerate enrollment in the PARADIGM Trial. “Germany’s scale, clinical expertise and established TAVR infrastructure create an important opportunity to advance enrollment and extend PARADIGM’s reach across leading international TAVR markets,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. The Company continues to execute its global clinical strategy through coordinated site activation and patient enrollment across the United States and Europe. Germany’s inclusion strengthens the trial’s European presence and adds meaningful scale to the PARADIGM Trial. ENDS About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1,000 patients 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. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare 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® 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, including statements regarding the expectation that this regulatory clearance enables patient recruitment in Germany. Forward-looking statements include all statements that are not historical facts. 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, 2025 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: Global Investor Relationsinvestors@anteristech.comDebbie OrmsbyAnteris Technologies Global Corp.+61 1300 550 310 | +61 7 3152 3200Investor Relations (US)mchatterjee@bplifescience.comMalini Chatterjee, Ph.D. Blueprint Life Science Group+1 917 330 4269 Website www.anteristech.comX @AnterisTechLinkedIn https://www.linkedin.com/company/anteristech
Remote Heart Monitoring at KFSH Reduces Heart Failure Admissions by 46%
KFSH Virtual Care Remote Patient Follow-Up
A KFSH physician follows up with a patient remotely
RIYADH, Saudi Arabia, Oct. 19, 2026 (GLOBE NEWSWIRE) — King Faisal Specialist Hospital and Research Centre (KFSH) has reduced hospital admissions for decompensated heart failure by 46.4% among patients fitted with an implantable pulmonary artery pressure sensor, according to a center analysis of 130 recipients who completed six months of follow-up, compared with the same patients’ experience before implantation. The CardioMEMS sensor allows KFSH’s Heart Center of Excellence to monitor pulmonary artery pressure remotely and identify early signs of worsening heart failure. Clinical teams can then adjust treatment while the patient remains at home, rather than waiting for symptoms to require an emergency visit or admission. Remote monitoring is part of a wider set of technologies that extend specialist oversight beyond the hospital. The center also uses artificial intelligence to support electrocardiogram analysis and offers leadless pacemakers for selected pediatric and congenital heart disease patients. A round-the-clock virtual cardiac service handles urgent concerns after discharge through defined escalation pathways. For patients whose heart failure advances, KFSH provides a full continuum of specialist care, including ventricular assist devices, extracorporeal membrane oxygenation, and heart transplantation. In 2024, KFSH performed the world’s first fully robotic heart transplant, and in 2025 the world’s first robotic-assisted implantation of a HeartMate 3 heart pump. Fewer admissions mean more time at home for patients and fewer disruptions to their families and work. They also preserve specialist hospital capacity for patients who require inpatient treatment, in a center that records more than 70,000 outpatient visits each year. The results reflect KFSH’s approach to heart failure as a long-term condition that is best managed continuously, with technology keeping specialist teams in contact with patients between visits. King Faisal Specialist Hospital and Research Centre was ranked first in the Middle East and Africa and 12th globally among the world’s top 250 academic medical centers for 2026, and was named the most valuable healthcare brand in Saudi Arabia and the Middle East for 2026 by Brand Finance. KFSH was also recognized by Newsweek among the world’s best hospitals, best smart hospitals, and best specialized hospitals for 2026. For more information, please contact Media Coverage at KFSH: mediacoverage@kfshrc.edu.sa A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/89c2fcf4-e51b-4a27-951c-7b5ed78bdc8a
Conavi Medical Announces New Grants of Stock Options
TORONTO, Oct. 19, 2026 (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, today announced that it has granted an aggregate of 1,600,000 stock options to purchase common shares of the Company to officers of the Company pursuant to the Company’s Omnibus Equity Incentive Plan (the “Plan”). The stock options are exercisable at a price of C$0.20 per common share and have a term of ten years from the date of grant. The options vest over four years, with 25% vesting on the first anniversary of the grant date and the remaining 75% vesting in equal monthly instalments over the subsequent 36 months, subject to the terms of the Plan. The grant of these stock options remains subject to the approval of the TSX Venture Exchange. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented hybrid imaging system is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging beams to enable simultaneous hybrid imaging of coronary arteries. The hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration. For more information, visit http://www.conavi.com/. Forward looking information This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging and the ability of Conavi’s hybrid imaging system to meet market needs. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the annual information form of the Company dated February 26, 2026 (available on the Company’s profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. Contact Mark Quick, Chief Financial Officer | 416-483-0100Christina Cameron, Investor Relations | 416-483-0100 ext. 121 | IR@conavi.com
Haemonetics Announces FDA Approval of PerQseal® Elite Vascular Closure System
BOSTON, Oct. 19, 2026 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced U.S. Food and Drug Administration (FDA) approval of the PerQseal® Elite vascular…
Groundbreaking therapy for advanced heart failure: Repairon Strengthens Executive Leadership with Appointment of Detlef Schumann, Ph.D. as Chief Operating Officer
Biotech executive brings global leadership and operations experience to speed clinical development, expand operations, and carry out strategic growth plans.GÖTTINGEN, Germany and PROVIDENCE, R.I., Oct. 19, 2026 (GLOBE NEWSWIRE) — Repairon, a biotechnology company developing regenerative cardiac therapies, today announced the appointment of Detlef Schumann, Ph.D. as Chief Operating Officer. Schumann will report to CEO Lothar Germeroth, Ph.D. and oversee global operations and strategic growth initiatives. Dr. Schumann brings extensive executive leadership experience across biotechnology, pharmaceuticals, and medical devices, combining deep scientific and technical expertise in cell therapy, advanced therapy medicinal products (ATMPs), regenerative medicine, and medical devices with a strong track record in operational excellence, organizational development, GMP manufacturing, automation, strategic partnerships, and M&A. He has developed and implemented international growth strategies, with particular expertise in EMEA, Japan and Singapore. As CEO of TETEC Tissue Engineering Technologies AG, he established sustained growth through the restructuring and scaling of GMP-compliant ATMP manufacturing operations and highly specialized CDMO services. He served as Managing Director of CeGaT GmbH, Vice President for Technology Innovation at B. Braun Aesculap, and held senior research and business development positions at DSM Biomedical. Dr. Schumann holds a degree in pharmacy and a doctorate in regenerative medicine and pharmaceutical technology from the University of Regensburg, Germany. His academic research experience includes postdoctoral fellowships at MIT/Harvard and the National University of Singapore. Repairon’s CEO, Lothar Germeroth, remarked that “the addition of Detlef Schumann to our senior leadership team is crucial for the company’s forthcoming expansion. His experience and leadership will have a direct impact on scaling up production, executing pivotal clinical trials, increasing focus on Far East markets, and managing and growing our revenue-generating activities in Germany. Fueled by the positive clinical outcomes of our Phase I-II clinical study, as the first company to demonstrate the restoration of heart muscle in ischemic advanced heart failure patients, we look forward to developing Repairon’s BioVAT product. “Contributing to the clinical, regulatory, and commercial development of one of the most significant tissue engineering technologies in cardiovascular medicine is a fabulous opportunity and a significant responsibility,” said Detlef Schumann. “I look forward to applying all my skills, experience, and energy to build Repairon and develop BioVAT for the benefit of millions of advanced heart failure patients worldwide.” High medical need in advanced heart failure: Approximately 5% of the global population suffers from chronic heart failure of any severity, and it remains one of the most common causes of death. In the US, heart failure represents the most common cause of hospitalization and mortality in the senior population, and over 6 million people are affected. As heart failure progresses to advanced stages, patients experience weakness with discomfort during all physical activities and at rest, sometimes even requiring constant bed rest. For these severely ill patients, the only treatment options currently available are mechanical pump devices or heart transplantation. About Repairon: Repairon GmbH is a German biotech company based in Göttingen, Germany, focused on developing regenerative cell therapies for cardiac medicine. The company was founded in 2014 based on research by Wolfram-Hubertus Zimmermann, MD and his team at the University Medical Center Goettingen, who have developed several tissue engineering technologies with proven applicability for organ repair and drug development. Repairon’s lead therapeutic candidate, the human engineered heart muscle patch, is currently being evaluated in the BioVAT-HF Phase 2 clinical trial as a biological ventricular assist tissue (BioVAT) for end-stage heart failure. Company contact:Dr. Lothar GermerothRepairon GmbH37079 Göttingen – GermanyEmail: germeroth@repairon.deUS contact:Frank AhmannRepairon USAProvidence, RI Email: f.ahmann@repairon.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/64985d27-8653-4e2b-a6b9-38b0d3a46954
Jupiter Endovascular Announces Publication of SPIRARE II Pivotal Trial Results Showing Vertex Thrombectomy System Normalized Hemodynamics in 50% of Pulmonary Embolism Patients
MENLO PARK, Calif.–(BUSINESS WIRE)– #EuroIntervention–Jupiter Endovascular announced pivotal trial publication showing that its Vertex Thrombectomy System normalized hemodynamics in 50% of PE patients.
BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter
SUNNYVALE, Calif., Oct. 19, 2026 (GLOBE NEWSWIRE) — BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for marketing clearance of its Helix catheter (“Helix”) intended for therapeutic and diagnostic agent delivery. In May 2026, the Company and FDA met and reviewed our initial De Novo pre-submission package. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns regarding the product’s safety data, performance, or compatibility with general classes of agents. In August 2026, FDA confirmed and accepted the meeting minutes. In September 2026, the De Novo pre-submission was revised, incorporating the advice from FDA CDRH as detailed in the meeting minutes, re-submitted and has now been accepted by FDA. BioCardia expects FDA substantive review with written feedback, followed by a meeting with BioCardia to discuss approval via the De Novo pathway, this quarter. The extensive clinical data and safety profile from fifteen clinical trials including nearly five hundred patients presents an opportunity for FDA to ensure that follow-on catheters demonstrate a similar level of safety and clinical experience to obtain clearance. Marketing clearance of Helix by FDA has the potential to expand BioCardia’s opportunities to partner with developers of investigational cells, genes, and protein therapeutics requiring targeted delivery to the heart. About the Helix Transendocardial Delivery Catheter The Helix transendocardial delivery catheter is an enabling platform for minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart intramyocardially. It enables agents to be delivered precisely within the heart with superior retention over other therapeutic delivery modalities, and to many regions of the heart that other delivery methods cannot reach. The Helix includes a specialized small distal helical needle which engages the heart tissue from within the chamber of the heart and provides stability within the dynamic beating heart to safely enable agent delivery. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also acts as a biotherapeutic delivery partner supporting therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2026, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. MEDIA CONTACT:Miranda Peto, Investor Relations mpeto@biocardia.com (650) 226-0120 INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@biocardia.com (650) 226-0120
Nanox Selected as One of TIME’s Best Inventions of 2026 for its Nanox.ARC X
Nanox.ARC X recognized among the “world’s most groundbreaking innovations” and for its approach to making advanced medical imaging more accessible Marks Nanox’s second appearance on TIME’s Best Inventions list, and its first inclusion on the main list PETACH TIKVA, Israel, Oct. 15, 2026 (GLOBE NEWSWIRE) — Nanox Imaging Ltd. (NASDAQ: NNOX) (“Nanox”), a leader in innovative medical imaging technology, today announced that the Nanox.ARC X has been selected as one of TIME’s Best Inventions of 2026. See the full list here: https://time.com/collection/best-inventions/2026 TIME’s annual Best Inventions list recognizes “the products, software, and services shaping our world—from breakthroughs in science and technology to innovations making the world better, smarter, and more fun.” Nanox.ARC X is an FDA-cleared digital tomosynthesis system that captures X-ray images from multiple angles at once and delivers up to 200 coronal images per scan. It produces a 3D view of the body at up to 80% less radiation than CT for equivalent body parts and uses a standard 110V power outlet in a standard X-ray room. The Nanox.ARC X builds on Nanox’s proprietary digital Nanox.SOURCE X-ray technology and advanced tomosynthesis capabilities, combining them in a fully integrated, single-unit system with a significantly reduced physical footprint compared to a CT system. Plug-and-play installation, a simplified operator workflow, and remote upgrade capability allow the system to be deployed and maintained across a range of settings, including small and medium imaging centers, outpatient clinics, and hospitals. “It is an honor to be recognized once again on TIME’s Best Inventions list,” said Erez Meltzer, Chief Executive Officer and Acting Chairman of Nanox. “This recognition is a meaningful acknowledgment of the innovation behind our technology and the vision that continues to guide us: making advanced medical imaging more accessible to healthcare providers and patients around the world. We believe it reflects the progress we have made in translating that vision into reality and reinforces our commitment to advancing a more accessible future for medical imaging.” Nanox.AI’s FDA-cleared AI solutions received a “Special Mentions” recognition in TIME’s Best Inventions of 2024 list. Nanox.ARC X is the latest generation of the Nanox.ARC system. Nanox has announced Nanox.ARC distribution agreements across the United States, Europe and Latin America. Nanox will showcase Nanox.ARC X at the RSNA 2026 Annual Meeting in Chicago, booth 1759. About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC, a cost-effective, 3D multi-source digital tomosynthesis imaging system designed for ease of use and scalability; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provide access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT, which combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit www.nanox.vision Forward-Looking Statements This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of Nanox’s liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; (iv) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (v) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (vi) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vii) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (viii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (ix) Nanox’s ability to conduct business globally; (x) changes in global, political, economic, business, competitive, market and regulatory forces; (xi) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xii) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xiii) potential litigation associated with our transactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Contacts Media Contact:Ben ShannonICR HealthcareNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com
Precision Neuroscience™ Appoints Nevro Founder Konstantinos Alataris as President and Katherine Neuenfeldt as Senior Vice President, Commercial Strategies
NEW YORK, Oct. 15, 2026 (GLOBE NEWSWIRE) — Precision Neuroscience Corporation (Precision), a brain–computer interface (BCI) company, today announced that Konstantinos Alataris, Ph.D., founder and former chief executive officer of Nevro, has joined as president, and Katherine Neuenfeldt, who led the U.S. launch and market access strategy for Nevro’s Senza spinal cord stimulation system, has joined as senior vice president, commercial strategies. Following Precision’s $250 million Series D financing, the two executives will advance the company’s BCI toward commercialization, drawing on their experience developing, launching, and securing reimbursement for implantable medical devices. “Precision has established a leading position in BCI technology, and our recent financing gives us the resources to take the next step,” said Michael Mager, co-founder and CEO of Precision. “Bringing a new Class III medical device to market takes more than technical skill and capital. We have to be able to build products that physicians can rely on and that insurers will pay for. Konstantinos and Katherine have done exactly that with implantable devices in the nervous system. Their experience will be critical as we move from demonstrating what our technology can do to making it available to patients.” Alataris has served on Precision’s board of directors since May 2025 and will continue in that role alongside his responsibilities as president. Alataris founded Nevro in 2006 and led the development and commercial launch of its high-frequency spinal cord stimulation technology for chronic pain. Nevro received European CE marking for its spinal cord stimulation system in 2010, went public on the New York Stock Exchange in 2014, and received FDA approval for the system in 2015, achieving a multi-billion dollar market capitalization. Beyond Nevro, Alataris has held executive and board roles across medical device, biotechnology, and pharmaceutical companies, including serving as president and CEO of Zosano Pharma, co-founding Nēsos, and chairing the scientific advisory board of Iota Biosciences until its acquisition by Astellas Pharma. He currently serves on the boards of Oryzon Genomics SA (BME: ORY), a clinical-stage biopharmaceutical company developing epigenetic therapies for cancer and central nervous system (CNS) disorders, and Delsona Therapeutics, a Columbia University spinout developing focused ultrasound therapeutics. He is also a partner and co-chairman at Forepont Capital, a New York-based private equity firm. Previously, he was a vice president at healthcare investment firm Bay City Capital. “Precision has demonstrated that it is possible to achieve high-performance neural control without penetrating the brain — something many believed couldn’t be done. That is a testament to the vision and dedication of co-founders Michael Mager and Ben Rapoport and the entire team,” Alataris said. “The next chapter is turning today’s breakthroughs into everyday medicine: reliable, repeatable, exceptional performance that neurosurgeons and patients can depend on, case after case. That is the work I wanted to help lead. Moving from the board into an operating role was a natural progression, an opportunity to roll up my sleeves and help bring the promise of Precision’s technology to patients.” Neuenfeldt leads Precision’s commercial strategy and market access efforts. She joined Nevro when the company had roughly 60 employees and led marketing for its successful 2015 U.S. launch of HF10 therapy. Later, as vice president of market access, she built and led a 40-person commercial team spanning national accounts, pricing and contracting, analytics, patient access, and reimbursement. Her team drove insurance coverage, adoption, and market differentiation for Nevro’s products globally. She previously spent six years at Medtronic Cardiovascular, where she led the U.S. launch of its flagship Endurant AAA stent graft, and most recently served as senior vice president of commercial strategies at Presidio Medical. “Joining Precision allows me to bring my experience launching disruptive medical devices backed by rigorous clinical evidence to a mission that is deeply personal to me,” Neuenfeldt said. “A device can be safe and effective, and a physician can want to use it, but if payers don’t cover it, patients won’t have access. For BCI technologies to reach people living with ALS, spinal cord injury, and brainstem stroke, we need to lay the groundwork for insurance coverage now, including generating clinical evidence that demonstrates meaningful benefits for patients.” The appointments follow Precision’s $250 million Series D financing, which brought its total capital raised to $430 million. Since its founding in 2021, Precision has built the largest clinical footprint in BCI, with more than 100 patient procedures across 18 medical institutions. The company has demonstrated high-resolution neural recording across 4,096 electrodes and real-time decoding of intended movement, received FDA clearance for its Layer 7™ cortical surface array, and published peer-reviewed research, including in Nature Biomedical Engineering. It has also established a commercial partnership with Medtronic and built a wholly owned MEMS manufacturing facility in Texas. About Precision NeurosciencePrecision Neuroscience is developing breakthrough treatments and technology for millions of people worldwide. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and high-bandwidth. To learn more about how Precision is connecting human and artificial intelligence, visit www.precisionneuro.io. Media Contactmedia@precisionneuro.io
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