WILMINGTON, Del., March 6, 2026 /PRNewswire/ – Valcare Medical, Inc., a pioneer in transcatheter mitral valve repair solutions, today announced the appointment of two new members to its Board of Directors: Jeffrey B. Jump and Jacques Séguin, MD, PhD. These renowned experts in the structural heart and medical device industry will strengthen the Board’s expertise and provide strategic guidance as the company advances enrollment in its AMEND™ TS Early Feasibility Study (EFS) and prepares for subsequent clinical trials.

The AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System delivers a closed, D-shaped, semi-rigid annuloplasty ring via a percutaneous approach. Designed to replicate the anatomical remodeling and proven outcomes of traditional surgical annuloplasty, the gold standard in open-heart mitral valve repair, the AMEND System uniquely preserves options for future interventions if needed, distinguishing it from other transcatheter technologies.

“We are thrilled to welcome these exceptional industry leaders to our Board,” said Steve Sandweg, CEO of Valcare Medical. “Their deep expertise in structural heart innovation, clinical development, and commercialization will be invaluable as we progress our clinical programs and drive toward transforming treatment for patients suffering from severe mitral regurgitation.”

Valcare Medical Board of Directors

Jeffrey B. Jump, a veteran medical device executive with over 45 years of international experience and 20 years at the board level. He most recently founded and served as Chairman and CEO of MedAlliance, sold to Cordis for $1.2 billion. He previously led publicly listed Biosensors International as CEO for 13 years, growing it from startup to the world’s fourth-largest cardiac drug-eluting stent supplier, while also serving as President and Board Director. Jump currently chairs Casper Medical, TexRay, and Transluminal/Circlage, and serves on the boards of Valcare Medical and Compahya SA.

Jacques Séguin MD, PhD, Professor of Cardiac Surgery at Paris University, was responsible for developing the self-expandable TAVR procedure CoreValve, a company he founded and headed which was subsequently acquired by Medtronic in 2009. After that, he was founder at ReCor Medical, a renal denervation company acquired by the Japanese company Otsuka in 2018. Jacques is currently founder, investor and board member of many innovative medtech companies.

Chris Richardson, has over 30 years of experience in the medical device industry, and an extensive record of successfully leading medtech startups from clinical study phase through regulatory approval, commercial launch, and acquisition. Prior to joining the Valcare Medical Board, Richardson served as President and CEO of Keystone Heart which was acquired by Venus Medtech in 2018. He also served as International President and Chief Commercial Officer of Direct Flow Medical, a transcatheter aortic valve company, and General Manager of Evalve (MitraClip), which was acquired by Abbott Vascular in 2009.

Alessandro Piga, Co-Founder and Managing Director of TechWald Holding S.p.A., serves as Executive Chairman of the Board. At TechWald, Alessandro focuses on investments in high-potential early-stage MedTech companies. With more than 40 years extensive leadership experience across Fortune 500 medical device firms – such as Johnson & Johnson, St. Jude Medical, and W. L. Gore – including roles as CEO, General Manager, and Country Manager, he brings proven board and executive insight to Valcare Medical.

Steve Sandweg, CEO of Valcare Medical, contributes over 30 years of sales leadership and commercial experience in cardiovascular and structural heart technologies. His career includes progressively senior roles at Boston Scientific, Medtronic, Direct Flow Medical, Keystone Heart, and EBR Systems, where he most recently served as General Manager and Chief Commercial Officer, respectively.

About the AMEND TS Early Feasibility Study

The AMEND TS EFS (NCT06951672) is a prospective, single-arm study assessing the safety and performance of the AMEND Transseptal System in patients with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation who are suitable for transcatheter annuloplasty. The study plans to enroll fifteen patients across seven U.S. investigational sites.

About Valcare Medical

Valcare Medical, Inc. is dedicated to revolutionizing mitral regurgitation treatment by delivering transcatheter solutions that match the efficacy and durability of surgical annuloplasty while eliminating the risks of open-heart surgery. The company’s flagship investigational AMEND™ Transcatheter Mitral Valve Repair Annuloplasty System is designed to restore normal mitral valve geometry and function via a percutaneous approach. Valcare Medical is a privately held company headquartered in Wilmington, Delaware.

For more information, visit www.valcaremedical.com or follow us on LinkedIn.

CAUTION: The Valcare AMEND System is an investigational device. Limited by Federal (U.S.) law to investigational use only. Not available for sale.

SOURCE: Valcare Medical

WILMINGTON, Del., February 11, 2026 /PRNewswire/ — Valcare Medical, Inc., a pioneer developer in transcatheter mitral valve repair solutions, today announced the successful first U.S. transseptal implantation of its AMEND™ Transcatheter Mitral Valve Repair (TMVr) Annuloplasty System as part of the ongoing AMEND TS Early Feasibility Study (EFS).

The milestone procedure was performed by Dr. Paul Sorajja, a nationally recognized expert in interventional cardiology and structural heart disease, at Banner – University Medical Center in Phoenix.

“For many patients with mitral regurgitation, open-heart surgery is either too risky or simply not an option due to age or other health conditions,” said Dr. Sorajja. “The AMEND transseptal approach offers physicians a percutaneous alternative designed to deliver a surgical-style repair option for their patients with less pain, faster recovery, and the potential for excellent long-term outcomes.”

The AMEND™ System delivers a closed, D-shaped, semi-rigid annuloplasty ring through catheter in a transseptal approach. It is specifically designed to mimic the anatomical remodeling and clinical results achieved by traditional surgical annuloplasty—the technique used in most open-heart mitral valve repairs. Unlike other transcatheter mitral repair technologies, the AMEND System is designed to preserve future treatment options if clinically required later.

“Annuloplasty has served as the foundation of more than 95% of surgical mitral valve repairs for decades,” said Steve Sandweg, CEO of Valcare Medical. “Applying this proven surgical technique through a percutaneous, transcatheter approach represents a significant step forward. We are grateful to Dr. Sorajja, Banner Health, and all participating investigators and their teams for helping bring this important therapy one step closer to patients suffering from significant functional mitral regurgitation.”

About the AMEND TS Early Feasibility Study

The AMEND TS EFS (NCT06951672) is a prospective, single-arm study evaluating the safety and performance of the AMEND Transseptal System in patients with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation who are anatomically suitable for transcatheter annuloplasty. The study will treat 15 patients in seven investigational sites in the United States.

About Valcare Medical

Valcare Medical, Inc. is committed to transforming the treatment of mitral regurgitation by providing transcatheter solutions that deliver the efficacy and durability of surgical annuloplasty while avoiding the risks and invasiveness of open-heart surgery. The company’s flagship technology, the investigational AMEND™ Transcatheter Mitral Valve Repair Annuloplasty System, is designed to restore normal mitral valve geometry and function through a percutaneous approach. Valcare Medical is a privately held company in Wilmington, Delaware. For more information, visit www.valcaremedical.com or follow us on LinkedIn.

CAUTION: The Valcare AMEND System is an investigational device. Limited by Federal (U.S.) law to investigational use only. Not available for sale.

SOURCE Valcare Medical

HERZLIYA, Israel and WILMINGTON, Del., March 13, 2025 /PRNewswire/ — Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMEND™ Trans-Septal System for investigational device exemption (IDE) application to commence an Early Feasibility Study (EFS).

The AMEND™ Trans-Septal System is a trans catheter device intended for treatment of mitral insufficiency with a semi rigid, closed, D-shaped annuloplasty ring that mimics today’s surgical gold standard.

The EFS study will evaluate the safety and functionality of the AMEND™ Trans-Septal System in the treatment of subjects with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) that are anatomically suitable for transcatheter mitral annuloplasty. The EFS will enroll up to 15 subjects in 7 investigational centers in the United States. The study is expected to begin treating patients in the first half of 2025, paving the way for a pivotal study anticipated in 2027.

The primary and secondary endpoints of this trial include safety and device performance assessments such as technical success of ring delivery, implantation, and delivery system retrieval. Patient outcomes such as stroke, myocardial infarction, non-elective cardiovascular surgery for device related complications, and all-cause mortality are to be reported at 30 days and 6 months post implantation.

Additional secondary endpoints will include changes in NYHA functional class, 6-Minute-Walk-Test, quality of life at 30 days and 6 months in addition to reduction of MR grade from baseline by at least 1 grade at 30 days, 6 months and 1 year.

“I am pleased and eager to begin the AMEND™ Trans-Septal System EFS to further evaluate this promising novel technology. The AMEND™ annuloplasty ring has the potential to improve mitral repair for a patient population that are considered poor candidates for currently available therapies,” stated Dr. Scott Lim, AMEND EFS Study Chairman and Professor of Medicine & Pediatrics at the University of British Columbia, and Professor Emeritus with Tenure at the University of Virginia. “Furthermore, the AMEND System provides a non-invasive approach to the gold standard surgical repair, and I am excited for its potential to treat patients suffering from severe mitral regurgitation.”

“The FDA’s approval to begin the AMEND EFS is a critical milestone for Valcare Medical on the path to achieving eventual Pre-Market Approval in the United States. This study will build upon clinical data from the AMEND First-in-Human Study, which will be presented as a Late Breaker Clinical Trial during this year’s CRT Conference in Washington DC next month,” said Steve Sandweg, President and Chief Executive Officer for Valcare Medical. “I am incredibly proud of the entire Valcare Medical Team for achieving this important milestone.”

About Valcare Medical
At Valcare Medical, our mission is to transform mitral valve therapy through the development of advanced, minimally invasive solutions. Our goal is to eliminate the need for open-heart surgery in patients with severe mitral regurgitation. We aim to minimize patient risk and maximize procedural outcomes by providing strong clinical evidence for the effectiveness of our technologies. We aspire to improve patients’ quality of life while increasing life expectancy by offering a safer and more effective alternative to traditional surgical methods.

The AMEND™ Trans-Septal System is an investigational device, limited by US federal law for investigational use only. The product is not available for sale or commercial distribution.

SOURCE Valcare Medical

TAMPA, Fla., July 25, 2024 /PRNewswire/ — Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, announces the expansion of the AMEND™ TS EU Pilot Study to Italy. The Italian Ministry of Health has approved the extension to include multiple centers throughout Italy, building upon the initial cases conducted in Portugal earlier this year.

The AMEND TS EU Pilot Study will evaluate the safety and performance of the AMEND Trans-Septal System as the primary technique in a comprehensive mitral repair approach comprising mitral annuloplasty as a standalone therapy or in combination with additional approved technologies to achieve a surgical-level repair.

The innovative AMEND mitral valve repair device is a closed, D-shaped semi-rigid annuloplasty ring with proprietary anchoring capabilities. AMEND is designed to replicate the efficacy of the traditional annuloplasty rings used to treat mitral regurgitation during open-heart surgery but is implanted via a less invasive, percutaneous approach.

Following the Ministry of Health approval, the Maria Cecilia Hospital in Cotignola (RA), part of GVM Care and Research, Italian Healthcare Group, became the first hospital in Italy to enroll and treat a patient in the AMEND TS EU Pilot Study.

“We are honored to be the first Italian site to treat a patient with AMEND in the EU Pilot Study,” said Dr. Fausto Castriota, who serves as the Director of the Interventional Cardio-Angiology Unit at Maria Cecilia Hospital. “This marks a significant achievement not only for our hospital but also for the broader medical community as we strive to find innovative treatment solutions for patients suffering from severe mitral regurgitation who are unable or unwilling to have surgery.”

“We are extremely pleased with the Italian Ministry of Health’s recent approval for our EU Pilot Study and grateful to Dr. Castriota, his team, and the clinical trial unit for their outstanding collaboration and support,” said Steve Sandweg, CEO of Valcare Medical, Inc. “This expansion marks an important milestone for Valcare’s clinical strategy and will help expedite enrollment in our EU study.”

About Valcare Medical
At Valcare Medical, our mission is to transform mitral valve therapy through the development of advanced, minimally invasive solutions. Our goal is to eliminate the need for open-heart surgery in patients with severe mitral regurgitation. We aim to minimize patient risk and maximize procedural outcomes by providing strong clinical evidence for the effectiveness of our technologies. We aspire to improve patients’ quality of life while increasing life expectancy by offering a safer and more effective alternative to traditional surgical methods.

The AMEND device is investigational and limited to investigational use only. The products are not available for sale or commercial distribution.

CONTACT: info@valcaremedical.com

TAMPA, Fla., July 2, 2024 /PRNewswire/ — Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts. The SAB will provide expert insight and guidance while helping the Company further advance its research and development initiatives for the AMEND mitral valve repair device. The AMEND mitral annuloplasty ring has been designed to treat patients suffering from severe mitral regurgitation not deemed suitable for surgery.

“We are excited to be joined and supported by some of the world’s leading pioneers in mitral valve therapies,” said Dr. David Meerkin, Valcare Medical CMO. “Their combined experience and collective insights will greatly assist Valcare at this critical point as we significantly broaden and deepen our clinical experience.”

Members of the Valcare Medical Scientific Advisory Board include:

Dr. Isaac George, MD joined New York Presbyterian/Columbia University Medical Center in the Department of Surgery in July of 2001 as a resident in general surgery following his graduation from Duke University School of Medicine. Prior to receiving his MD, Dr. George completed a B.S. in Mechanical Engineering at Massachusetts Institute of Technology in 1997. Dr. George also completed a fellowship program in cardiothoracic surgery in 2011 as well as a fellowship program in interventional cardiology in 2012. Dr. George is an Associate Professor of Surgery and Medicine, and the Surgical Director of Structural Heart of the NYP health system. He is one of the few physicians in the world trained in both cardiac surgery and interventional cardiology. He is an expert in the most current and innovative procedures including Transcatheter Aortic Valve Replacement (TAVR), transcatheter valvular mitral valve repair (Mitraclip, Edge to Edge), transcatheter mitral and tricuspid valve replacement and surgical TAVR removal/explantation.

Dr. Scott Lim, MD, is a Professor of Medicine & Pediatrics at the University of Virginia and the University of British Columbia. He has developed a career focusing on novel therapies for heart valve, structural, congenital, and heart failure therapies. He has served as national primary investigator on transcatheter aortic, mitral, and pulmonary valve trials, as well as worked with multiple early-stage novel cardiac device therapies, particularly in mitral and tricuspid valve disease. In addition to authoring more than 250 scientific publications, 500 presentations, and 50 book chapters, Dr. Lim has been the founding editor through 5 editions of the most popular textbook on congenital heart disease, the Field Guide to Congenital Heart Disease & Repair. He has also spent more than two decades leading a charitable organization to teach cardiac disease care to physicians in developing countries.

Dr. Paul Sorajja, MD is the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center at the Minneapolis Heart Institute Foundation, and a cardiologist at Minneapolis Heart Institute® where he serves as the Director of the Center for Valve and Structural Heart Disease. Dr. Sorajja’s expertise is interventional cardiology, with a focus on bringing the latest innovative technologies to patients with valvular and structural heart disease. He was part of the team that performed the first transcatheter mitral valve replacement (TMVR) in the US and has the largest worldwide experience with the therapy. Dr. Sorajja currently serves as a national investigator for TMVR and for clinical trials in percutaneous treatment for tricuspid regurgitation. He has served on multiple national practice committees for valvular heart disease and hypertrophic cardiomyopathy. Dr. Sorajja has published more than 250 manuscripts as well as several books. He routinely lectures at national and international medical conferences and has received awards for his expertise in medical education. Dr. Sorajja is also highly active in developing intellectual property in these areas.

Dr. Azeem Latib, MD, Director of Structural Heart Interventions, Montefiore Health System, New York. Azeem is a world-leading expert in interventional cardiology, with a clinical focus on complex coronary interventions as well as transcatheter aortic, mitral, and tricuspid interventions. Following his clinical interests, Dr. Latib’s research centers on transcatheter aortic, mitral, and tricuspid interventions with a focus on device innovation. In addition, he performs research on drug-coated balloons, drug-eluting stents, and challenging lesion subsets.

Dr. Federico DeMarco, MD, PhD is the head of the Structural Heart Program and of the Interventional, Valvular and Structural Heart Interventions Unit in Centro Cardiologico Monzino in Milan. He trained in Interventional Cardiology at the Institut Cardiovasculaire Paris Sud in Massy, France, between 2005 and 2007, and until 2015 he worked as a senior staff interventional cardiologist at Niguarda Hospital in Milan. From 2015 to 2022 he helped build the largest Structural Heart Interventions program in Italy in Policlinico San Donato in Milan. His interventional experience is extensive, spacing from complex coronary interventions to TAVR, transcatheter mitral and tricuspid valve repair and replacement, PFO and LAA occlusion, peripheral interventions, and a wide variety of other endovascular interventions. He has been collaborating with multiple companies since 2012, both on product design and development with engineers and on early clinical experience with various device trials and first in man procedures. He authored and co-authored over 150 peer-reviewed publications and book chapters on coronary, aortic and mitral interventions and has a strong interest in new endovascular technology.

“We are honored to have these accomplished mitral valve experts join Valcare Medical’s Scientific Advisory Board,” said Steve Sandweg, Valcare Medical CEO. “Each of these individuals has made significant contributions and helped pioneer breakthroughs in the treatment of mitral valve disease. We look forward to leveraging the vast expertise of our SAB to help drive Valcare’s clinical and regulatory strategy.”

The innovative AMEND mitral valve repair device is a closed, D-shaped semi-rigid annuloplasty ring with proprietary anchoring capabilities. AMEND has been designed to replicate the efficacy of the traditional annuloplasty rings used to treat mitral regurgitation during open-heart surgery, but is implanted via a less invasive, percutaneous approach.

The AMEND device is investigational and limited to investigational use only. The products are not available for sale or commercial distribution.

TAMPA, Fla., May 14, 2024 /PRNewswire/ — Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, announces the successful completion of the first two enrollments in the AMEND TS European pilot study. Dr. Bruno Melica and the team from Vila Nova de Gaia Hospital, Portugal, performed the procedures.

The purpose of the study is to build upon the positive results from the first in human experience in which 33 patients were successfully treated with the AMEND Trans-Septal System. The AMEND TS EU Pilot Study will evaluate the safety and performance of the AMEND Trans-Septal System as the primary technique in a comprehensive mitral repair approach comprising mitral annuloplasty as a standalone therapy or in combination with additional approved technologies to achieve a surgical-level repair.

The innovative AMEND mitral valve repair device is a closed, D-shaped semi-rigid annuloplasty ring with proprietary anchoring capabilities. AMEND is designed to replicate the efficacy of the traditional annuloplasty rings used to treat mitral regurgitation during open-heart surgery, but is implanted via a less invasive, percutaneous approach.

“We are thrilled to have successfully implanted the AMEND annuloplasty ring in the initial two patients enrolled in the AMEND TS EU pilot study,” commented Dr. Bruno Melica, Interventional Cardiologist at Vila Nova de Gaia Hospital, Portugal. “These procedures mark a significant advancement in addressing an unmet need for patients at high risk for mitral valve surgery.”

“The enrollment of the first two patients in the AMEND EU Pilot Study marks an important milestone in Valcare’s mission to provide a surgical-style result for high-risk patients suffering from severe functional mitral regurgitation,” said Steve Sandweg, CEO, Valcare Medical, Inc. “We are grateful to Dr. Melica and his team for their incredible support and collaboration during this study and look forward to continuing this important journey together.”

The AMEND TS EU Pilot Study will enroll a total of 20 patients in several European sites and follow each patient for a period of 12 months. Following completion of the EU pilot study, Valcare plans to continue working with the FDA on a future IDE submission.

The AMEND device is investigational and limited to investigational use only. The products are not available for sale or commercial distribution.

About Valcare Medical:

Valcare Medical is dedicated to providing innovative minimally invasive technologies for the treatment of mitral regurgitation.

For media inquiries, please contact:
info@valcaremedical.com

TAMPA, Fla., April 24, 2024 /PRNewswire/ — Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced a comprehensive corporate restructure by a group of investors led by Techwald Next, aimed at accelerating the company’s plans to initiate the AMEND mitral annuloplasty clinical studies in Europe and the United States.

As part of the restructuring, TechWald has appointed Steve Sandweg to serve as Chief Executive Officer. Sandweg brings a successful 25-year history in the medical device space having worked for both Fortune 500 and startup companies in the cardiovascular and structural heart space. Sandweg most recently served as Chief Commercial Officer for EBR Systems, Inc, developer of the world’s only wireless cardiac pacing system for heart failure. Prior to that, Sandweg worked for Keystone Heart where he served as General Manager, and Direct Flow Medical serving as Director, US Clinical Field Operations.

Sandweg began his cardiovascular and structural heart career with Medtronic Corp. in 2006 where he held positions of increasing responsibility with Medtronic’s peripheral vascular, coronary, and structural heart business units. While with Medtronic, Sandweg played a key role in helping execute several strategic product launches including Endeavor and Resolute, the company’s first drug eluting stents and Corevalve/EVOLUT, the company’s first transcatheter aortic valve devices.

“I’m excited and honored to be joining such a remarkably talented team,” Sandweg said. “The corporate restructure offers a unique opportunity for us to increase focus and accelerate performance. Following the success of our first in human experience in which 33 patients were treated with AMEND and showed promising results (17 treated under clinical protocol and followed out to 6 months), we are eager to now begin enrolling patients in the AMEND Plus European pilot study and continuing our work with the FDA on a future IDE submission.”

In addition to the appointment of Sandweg, the company also appointed a new Board of Directors led by Executive Board Chair, Chris Richardson. Richardson has over 30 years of experience in the medical device industry, and an extensive record of successfully leading medtech startups from clinical study phase through regulatory approval, commercial launch, and acquisition.

Prior to joining the Valcare Medical Board, Richardson served as President and CEO of Keystone Heart which was acquired by Venus Medtech in 2018. He also served as International President and Chief Commercial Officer of Direct Flow Medical, a transcatheter aortic valve company, and General Manager of Evalve (MitraClip), which was acquired by Abbott Vascular in 2009.

“We’re fortunate to have Steve come on board at this important stage in Valcare’s development,” said Chris Richardson. “Steve has the experience and operational track record the company needs at this time to execute on its ambitious plan to transform the standard of care for patients suffering from severe mitral regurgitation.”

Valcare’s AMEND mitral valve repair device is an innovative, clinically proven, D-shaped, semi-rigid closed ring with proprietary anchoring capabilities. AMEND is designed to provide clinical standard-of-care surgical treatment via a transcatheter-based procedure. The AMEND platform also serves as the foundation for Valcare’s future mitral replacement and tricuspid repair solutions.

The AMEND device is limited to investigational use and is not commercially available.