1st April 2026
The Jean Boulle Group is pleased to note the announcement made by Medtech device company VDyne (“the Company”) that the U.S. Food & Drug Administration (“FDA”) has approved an investigational device exemption (IDE) for the Company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system.
The IDE approval enables the start of the Company’s pivotal study at leading clinical centers to evaluate the safety and effectiveness of the VDyne system in patients. This development marks further progress towards the Company’s goals to achieve CE Mark and full FDA approval.
Commenting on the announcement, Mr Jean-Raymond Boulle, Chairman and CEO of the Jean Boulle Group said:
“I congratulate the VDyne team on reaching another important phase in the development of the Company’s transcatheter tricuspid valve replacement system. The pivotal study is a large-scale, controlled clinical trial designed to produce definitive evidence of a medical device’s safety and effectiveness.”
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 in January 2020 and approval for use in US patients from the Food and Drug Administration (FDA) in May 2025.
The announcement below was issued today by VDyne:
PRESS RELEASE
VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System
MAPLE GROVE, Minn., USA – April 1, 2026
VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system.
The IDE approval enables initiation of a U.S. pivotal study at leading clinical centers to evaluate the safety and effectiveness of the VDYNE system in patients with severe tricuspid regurgitation (TR).
“This is a defining milestone for VDYNE and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation,” said Mike Buck, Chief Executive Officer. “Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care.”
Significant unmet clinical needs exist in the treatment of TR with 1.5 million people in the US suffering from TR with a small percentage of those patients eligible to receive surgical treatment.2 Severe TR is linked to poor prognosis and high mortality (10% at one year), yet current treatment options remain extremely limited3.
VDYNE’s TTVR system is designed as a patient-tailored, minimally invasive solution to address the complexities of tricuspid valve anatomy and disease. Since first-in-human use in November 2023, the system has been used globally through clinical studies and compassionate use, providing important insights into procedural performance and clinical outcomes.
About VDYNE, Inc.
VDYNE, Inc. is a privately held medical device company focused on developing innovative transcatheter valve replacement technologies for the treatment of tricuspid regurgitation. Headquartered in Maple Grove, Minnesota, VDYNE is dedicated to transforming care for patients suffering from right heart valve disease.
The VDYNE Tricuspid Valve Replacement System is currently under clinical investigation and not commercially available in the United States or any other country.
About Tricuspid Regurgitation
Tricuspid regurgitation (TR) occurs when the tricuspid valve fails to close properly, allowing blood to flow backward into the right atrium. This condition can lead to fatigue, fluid retention, and reduced quality of life and is associated with significant mortality and morbidity.
Contact:
Investor Relations
VDYNE, Inc.
investor@vdyne.com
[1] TRIVITA Trial: VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients with Symptomatic Severe Tricuspid Valve Regurgitation
[2] Demir OM, Regazzoli D, Mangieri A, Ancona MB, Mitomo S, Weisz G, Colombo A, Latib A. Transcatheter Tricuspid Valve Replacement: Principles and Design. Front Cardiovasc Med. 2018 Sep 19;5:129. doi: 10.3389/fcvm.2018.00129. PMID: 30283790; PMCID: PMC6156134.
[3] Kolte D, Elmariah S. Current state of transcatheter tricuspid valve repair. Cardiovasc Diagn Ther. 2020 Feb;10(1):89-97. doi: 10.21037/cdt.2019.09.11. PMID: 32175231; PMCID: PMC7044094.
ENDS
For more information on Jean Boulle Group, please contact:
Michael Oke Michael@aura-financial.com
Khushi Hunt Khushi@aura-financial.com
+44 (0)207 321 0000
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.