Peripheral/Endo

Xeltis receives CE mark for aXess™, its aXess hemodialysis conduit™, as it moves to commercialization

CE mark awarded for aXess™ at record speed, underpinned by strong EU pivotal trial data Xeltis advances ahead of schedule to commercializationaXess™ reduces the need for vascular access interventions enabling more streamlined kidney care delivery EINDHOVEN, The Netherlands, April 21, 2026 (GLOBE NEWSWIRE) — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that it has received the CE mark for aXess™, its restorative vascular access conduit for hemodialysis treatment, marking a significant regulatory milestone and the Company’s transition from a clinical-stage to a commercial-stage organization. The CE mark was granted following evaluation of all data including Xeltis’ European clinical pivotal trial results and was achieved in just 84 working days from submission, well ahead of schedule, reflecting the strength and completeness of the clinical evidence package. Built on Nobel Prize-winning science, aXess™ leverages Restorex™ materials, which triggers the body’s natural healing response to transform into the patient’s own tissue to form a living vessel for reliable vascular access. aXess™ is designed to reduce long-term catheter dependence and access issues – helping shift the hemodialysis journey for patients with end-stage kidney disease from repeated interventions toward more seamless care delivery and improved quality of life. Achieving CE mark approval represents a pivotal commercial inflection point for Xeltis, signaling the transition from clinical validation to market entry. The successful and timely completion of the CE marking process serves as a clear signal to clinicians, investors and strategic partners of the product’s readiness for real-world use. With CE marking in place, Xeltis can commercialize across European markets, enabling clinicians to confidently deploy aXess™ and allowing patients to benefit from an innovation that meets high standards of safety, performance and clinical evidence. Eliane Schutte, Chief Executive Officer of Xeltis, commented: “Receiving CE mark approval for aXess™ is a defining moment for Xeltis and a strong validation of our revolutionary restorative technology platform and the outstanding dedication of the entire Xeltis team. For patients undergoing hemodialysis, this milestone means we can offer a more reliable, long-lasting access option that can improve quality of life while reducing the burden of ongoing procedures. Achieving CE mark in just 84 working days underscores the strength of our clinical data and marks our transition from a clinical-stage company to a commercial organization.” Steve Phillips, Chief Strategy Officer of DaVita, said: “At DaVita, we’re committed to advancing technologies that meaningfully improve outcomes and elevate the care experience for people living with kidney disease. This milestone for Xeltis represents meaningful progress toward better clinical results and a more patient centered care experience.” Fred Colen, Chairman of the Board of Xeltis, added: “The Xeltis Board of Directors is very pleased with the performance of the Xeltis team under the leadership of CEO Eliane Schutte, to deliver on the promise of the exceptional Xeltis Technology Platform, to obtain the European CE Mark approval in record time, under the stringent European MDR regulations. Approval to start commercialization for its first application, access for dialysis patients addressing key limitations of existing treatment options in clinical use, is further testament to the promise of this technology.” Ferdinando Lamagna, Spokesperson at The British Standards Institution said: “At BSI, it is a pleasure to support MedTech organizations that bring meaningful innovation to the sector and ultimately benefit patients. Xeltis demonstrated a high level of preparation and a collaborative approach throughout the conformity assessment process, which progressed in an efficient and well-structured manner, with effective coordination between the parties. As a result, certification of this Class III implantable device was achieved within a notably short timeframe, taking into account the scope and complexity of the assessment, including a full Clinical Evaluation Consultation Procedure per MDR Article 54. We congratulate the Xeltis team on this important achievement and look forward to continuing our collaboration to support innovation in patient care.” The Xeltis team will be presenting its 12-month data at The 48th Charing Cross Symposium, London, UK, from 21-23 April 2026. Contacts XeltisEliane Schutte, CEOAlexander Goemans, CFOinfo@xeltis.com Optimum Strategic CommunicationsNick Bastin, Eleanor Cooper, Aoife Minihan +44 (0) 208 078 4357xeltis@optimumcomms.com   About XeltisXeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary Restorex™ platform utilizes an advanced polymer implant which regenerates the patient’s own tissue before gradually being absorbed and leaving new, living and long-lasting vessels in place. Xeltis’ most advanced product currently under commercial development is aXess™, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors. Visit the Xeltis website for more details: https://xeltis.com/

Reflow Medical Announces 12-Month Results from DEEPER REVEAL Trial: Sustained Outcomes with the Spur® Stent System in CLTI

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announces that 12-month results from the DEEPER REVEAL clinical trial (NCT05358353) were presented for the first time today at the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting in Toronto, Canada. […]

Microbot Medical® Commences Full Market Release (FMR) of the LIBERTY® Endovascular Robotic System in the U.S. at the Society of Interventional Radiology (SIR) Annual Scientific Meeting

Successful Execution of the Limited Market Release (LMR) Includes Adoption by Globally Recognized Healthcare Systems in the U.S. Market and Demonstrates Broad Market Scalability in Key Endovascular ProceduresHINGHAM, Mass., April 13, 2026 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY® Endovascular Robotic System, announced today that it has successfully executed its limited market release (LMR) and will commence its full market release (FMR) in the U.S. as planned. To date, LIBERTY has been adopted by multiple healthcare systems with dozens of hospitals in their networks, including globally recognized hospitals such as Emory Healthcare and Tampa General Hospital. Microbot considers this achievement a reflection of the highly effective execution of the LIBERTY System’s LMR and positions the Company to commence the FMR of the LIBERTY System as originally planned, at the Society of Interventional Radiology (SIR) Annual Scientific Meeting, being held in Toronto, ON, Canada, from April 11-15. The LIBERTY system is creating an entirely new category as the only FDA-cleared, single-use, remotely operated robotic system. It has been successfully used commercially across a variety of procedures, including Prostate Artery Embolization (PAE), Uterine Fibroid Embolization (UFE), Genicular Artery Embolization (GAE), Y90 mapping, Y90 deliveries, and peripheral arterial interventions. Physicians have highlighted LIBERTY’s precision, short learning curve, fast setup, the ability to use their preferred wires and catheters, as well as the potential to improve efficiency by reducing procedure time and number of instruments used to perform such procedures. In preparation for the FMR, the Company has further enhanced its commercial team core capabilities by adding salespeople in key locations and broadening its sales footprint from four to eight sales territories, with a goal of having 12 territories across the U.S. by the end of 2026. “We successfully achieved our goals for the limited market release of the LIBERTY System, including its adoption by leading hospitals across multiple peripheral procedures, giving us the momentum to commence, as planned, the full market release at the SIR conference,” commented Harel Gadot, Chairman, President & CEO. “It’s exciting to see the level of enthusiasm among our existing customers, first when they initially use LIBERTY, utilizing it across multiple procedures, and then as they expand it to other hospital sites within their network. The variety of case types shows the system’s flexibility, and its ease of use is generating high customer satisfaction. I also believe the level of customer adoption during the limited market release in such a short time further demonstrates a shorter sales cycle compared to traditional surgical robots, which is another key differentiator and one we believe will lead to accelerated adoption.” SIR represents over 8,000 practicing interventional radiology physicians, trainees, medical students, scientists, and clinical associates. This will be the first opportunity for the Company to showcase the LIBERTY system at the conference, which features its primary addressable U.S. target market. SIR, along with the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) have recently adopted new guidelines, which were published in CardioVascular and Interventional Radiology (CVIR), and endorsed by at least eight other medical societies. These guidelines cover updated evidence, address new exposure sources such as CT-guided procedures and radioembolization, and radiation protection during pregnancy for female practitioners, as well as addresses musculoskeletal risks for interventional radiology staff. This follows a recent American Medical Association (AMA) policy adopted late last year to strengthen protections for health care professionals from occupational exposure to ionizing radiation. “This year’s SIR conference is a pivotal moment for Microbot Medical, and the timing of the conference represents an optimal opportunity for our team to leverage the market feedback to commence the full market release of the LIBERTY System,” added Mr. Gadot. “Our targeted end users will be in attendance, and we plan to engage with them directly, enhancing our opportunities over the coming months as we broaden our presence in existing territories and expand into new ones.” The Company plans to meet with physicians and other stakeholders, to showcase the LIBERTY system at booth #423, and to further educate physicians on the system’s full capabilities to accelerate market adoption in the U.S. LIBERTY is the only FDA cleared, single-use, remotely operated robotic system for peripheral endovascular procedures. It is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain, addressing key clinical and operational challenges faced by interventional radiology teams. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the world’s first FDA cleared single-use, remotely operated robotic solution designed for precision, efficiency and safety. Backed by a strong intellectual property portfolio and a commitment to innovation, Microbot is driving the future of endovascular care. Learn more at www.microbotmedical.com and connect on LinkedIn and X. Safe Harbor Statements to future financial and/or operating results, future adoption of products, future growth in research, technology, clinical development, commercialization and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “contemplates,” “continues,” “could,” “forecasts,” “intends,” “may,” “might,” “possible,” “potential,” “predicts,” “projects,” “should,” “would,” “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the commercialization of the LIBERTY® Endovascular Robotic System, and in the development of future versions of or applications for the system, uncertainty in the results of regulatory pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, particularly any changes in personnel or processes or procedures at the FDA and announcements of tariffs on imports into the U.S., disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, Iran and other neighboring countries, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical® can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical® disclaims any intent or obligation to update these forward-looking statements, except as required by law. Contacts: IR@microbotmedical.comMedia@microbotmedical.com

InterVene Completes First 30 Cases Using the Recana® Thrombectomy Catheter System, Plans for Broader Commercial Launch

REDWOOD CITY, Calif.–(BUSINESS WIRE)–InterVene, Inc., a privately held medical device company advancing interventional care for venous disease, today announced the successful completion of 30 cases using the Recana® Thrombectomy Catheter System. The cases were performed across the company’s limited US market release and its European first-in-human study. “We’ve had the privilege of partnering with some of the most experienced and knowledgeable physicians to reach this important milestone,” sa

Endospan Receives FDA Approval for the NEXUS® Aortic Arch Stent Graft System

TEL AVIV, Israel–(BUSINESS WIRE)– #aortaEd–Endospan, a privately-held company pioneering solutions for the endovascular repair of aortic arch disease, today announced that the U.S. Food and Drug Administration (FDA) has approved the NEXUS® Aortic Arch Stent Graft. FDA approval was supported by the one-year results of the TRIOMPHE Investigational Device Exemption (IDE) Study evaluating the NEXUS® System shown to effectively treat aortic arch disease, including chronic aortic dissections, in patients at

Merakris Therapeutics Provides FDA Update and Reports Interim Findings for MTX-001 in Venous Leg Ulcers

RESEARCH TRIANGLE PARK, N.C., April 07, 2026 (GLOBE NEWSWIRE) — Merakris Therapeutics today provided an update on recent communications with the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug (IND) application for MTX-001, an investigational biologic being developed for venous leg ulcers (VLUs).