Press Release
Luxembourg, 16 May 2025
The Jean Boulle Group is pleased to note the announcement made by its Medtech device company VDYNE (“the Company”) that it will present joint data from the Company’s VISTA-Global Early Feasibility Study and the VISTA-US Early Feasibility Study (together the “Studies”) at the EuroPCR cardiovascular conference to be held in Paris, France. These human patient VDYNE Studies evaluated the performance of the Company’s Transcatheter Tricuspid Valve Replacement System which was developed by VDYNE for the treatment of tricuspid regurgitation. The EuroPCR conference on interventional cardiovascular medicine attracts thousands of cardiologists, surgeons, imagers, nurses and allied professionals.
Commenting on the announcement Jean-Raymond Boulle II, Director of Jean Boulle Medtech and VDYNE, said: “This is an exciting moment not only for VDYNE but also for the global cardiovascular community who will be gathering in Paris next week. These clinical trial results will determine the impact of treatment options for millions of patients affected by tricuspid regurgitation. We look forward to publicising the results.”
Transcatheter valve implant devices are implanted in a beating heart and enable a significantly less invasive “keyhole” procedure compared to the familiar treatment than involves open heart surgery. VDYNE is the second heart valve technology discovered and founded by a scientific team assembled by the Jean Boulle Group. Each has attracted significant investment attention from multibillion-dollar medical technology corporations. The first company was Tendyne™, acquired by Abbott Laboratories (NYSE: ABT) for US$250 million, supplemented by an additional US$150 million contingent upon regulatory milestones. Post-acquisition, Tendyne™ received CE Mark approval from the European Union on January 30, 2020. The Tendyne™ valve is in the advanced stages of the only outstanding regulatory milestone which is the U.S. Food and Drug Administration approval process, which is expected imminently.
The announcement made by VDYNE is reproduced below:
VDYNE to Present VISTA Study Data at 2025 EuroPCR Conference VDYNE Expected to Initiate US Pivotal Study
Maple Grove, Minneapolis USA, May 13, 2025 — VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing transcatheter valve replacement technologies for the treatment of tricuspid regurgitation, announced today that the Company will present joint data from the Company’s VISTA-Global Early Feasibility Study (EFS) and the VISTA-US Early Feasibility Study at the EuroPCR meeting to be held in Paris, France.
The presentation, titled “Transcatheter Tricuspid Valve Implantation Using the VDYNE System” will be presented on behalf of all VISTA study investigators by Dr. Joerg Kellermair from the Johannes Kepler University, Linz, Austria at 8:30am (Central European Summer Time) on Thursday, May 22nd, 2025.
“VDYNE is thrilled to provide the first release of clinical data that has been collected across the Company’s global VISTA studies in more than thirty (30) sites around the world” said Dr. Vinny Podichetty, Vice President – Clinical Affairs at VDYNE. “Dr. Kellermair’s presentation will showcase a significant body of clinical data and provide an insight into our broadening clinical experience and strong patient outcomes with our novel valve and side-delivery technology. This is an incredible milestone for the Company ahead of the forthcoming commencement of our U.S. pivotal study”.
The VISTA-Global and VISTA-US Early Feasibility Studies are two prospective, single-arm, multi-center global studies in fifteen (15) countries evaluating the safety and performance of the VDYNE Tricuspid Valve Replacement System (VDYNE Valve System) in patients with symptomatic severe tricuspid regurgitation. Endpoints include device and / or procedure related Major Adverse Events at thirty (30) days for safety, and reduction in tricuspid regurgitation, changes in New York Heart Association (NYHA) class status, 6-minute walk distance and Kansas City Cardiomyopathy (KCCQ) Questionnaire for efficacy.
Since introducing the Company’s final design into the clinical setting in November 2023, VDYNE has treated more than sixty (60) cases under the VISTA-US Study, the VISTA-Global Study and other protocols. VDYNE is presently advancing its registrational study to support CE Marking, and with the benefit of having been previously granted U.S. Food & Drug Administration (FDA) FDA Breakthrough Device Designation, the Company expects to shortly initiate a pivotal study to support pre-market approval of the VDYNE Valve System in the United States.
About VDYNE Inc
VDYNE is a privately held medical device company pioneering an innovative interventional valve replacement technology for the treatment of tricuspid regurgitation. VDYNE is based in Maple Grove, Minneapolis.
The VDYNE Tricuspid Valve Replacement System is under clinical investigation and is not commercially available in the United States of America, or elsewhere.
About Tricuspid Regurgitation
Tricuspid regurgitation occurs when the tricuspid valve does not close properly, and blood flows backwards from the right ventricle into the right atrium instead of progressing through the heart to the lungs for re-oxygenation. This regurgitation is a debilitating condition that impacts the general health and quality of life of a significant portion of the patient population. More importantly, surgical intervention to treat tricuspid regurgitation has high rates of mortality and morbidity. There are presently no approved minimally invasive valve replacement treatment alternatives.
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For more information please contact:
The Jean Boulle Group
Audrey Richardson +352 222 512
Aura Financial +44 207 321 0000
Michael Oke/Rita Cunha Vaz +44 783 436 8299/+351 939 988 080
For VDYNE please email investor@vdyne.com or visit https://www.vdyne.com/
Notes to editors
About Jean Boulle Group
The Group is principally active in sectors including medical technology, therapeutics, natural resources, agriculture, energy, luxury and philanthropy. Since its foundation by Jean-Raymond Boulle the Group has completed transactions worth more than US$5 billion and successfully listed investee companies on the following stock exchanges: AIM (England), TSX (Canada), ASX (Australia) and SEM (Mauritius). Its investments span early-stage private funding for innovative technologies through to acquisitions, special situations and strategic investments in publicly traded companies. The Group often co-invests alongside state investment and pension funds and uses its specific industry knowledge to discover, evaluate and develop new enterprises.
About Jean Boulle Medtech
Jean Boulle Medtech Ltd. (“JBM”) has a uniquely successful record of developing innovative transcatheter valve implant devices for use in cardiology. In 2021 VDYNE closed a US$21 million, heavily subscribed Series C financing led by JBM. Subsequently, VDYNE received a further cash investment of approximately US$6.5 million from JBM and US$47 million cash investment from a new major strategic industry investor in its proprietary VDYNE technology. JBM was the founding investor of Tendyne Holdings, Inc. which developed the first and most successful Transcatheter Mitral Valve Implant in existence today.