Press Release

Luxembourg, 24 April 2024

The Jean Boulle Group is pleased to note the announcement made by its Medtech device company VDYNE that it has initiated the United States early Feasibility Study (VISTA-US) for the evaluation of the performance of the Transcatheter Tricuspid Valve Replacement System for the treatment of tricuspid regurgitation. The announcement also confirms the first patient has been enrolled in the VISTA-US study and was successfully implanted with the VDYNE tricuspid valve and treated by Drs. Paul Sorajja, Vinayak Bapat and Nadira Hamid at the Minneapolis Heart Institute Foundation (“MHIF”).

Commenting on the announcement Jean-Raymond Boulle II, Director of Jean Boulle Medtech and VDYNE, said: “I would like to offer my congratulations to the VYDNE team on this significant step in the Company’s clinical developments. The VISTA-US clinical trial aims to enrol up to thirty patients to advance the development of the technology to help the millions of patients affected by tricuspid regurgitation that currently have limited treatment options available.”

VDYNE is the second heart valve technology venture founded by the Jean Boulle Group to attract significant investment from a multibillion-dollar medical technology corporation. 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 February 3, 2020.

The announcement made by VDYNE is reproduced below:

VDYNE Announces First Patient Enrolled in VISTA US Early Feasibility Study of the VDYNE Transcatheter Tricuspid Valve for the Treatment of Tricuspid Regurgitation

Maple Grove, Minnesota, USA, April 9, 2024 — VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing transcatheter heart valve replacement technologies for the treatment of tricuspid regurgitation, announced today that it has initiated its United States early feasibility study, called VISTA-US, to evaluate the clinical safety and performance of the VDYNE Transcatheter Tricuspid Valve Replacement System for the treatment of tricuspid regurgitation.

The first patient enrolled in the VISTA-US study was treated by Drs. Paul Sorajja, Vinayak Bapat and Nadira Hamid at the Minneapolis Heart Institute Foundation (“MHIF”) in Minneapolis, Minnesota, USA. The patient was successfully implanted with the VDYNE tricuspid valve with regurgitation reduced to none and no paravalvular leakage immediately post-procedure.

“Following our previous experience with the VDYNE Valve System under a compassionate use protocol, we are very pleased to initiate VDYNE’s VISTA-US feasibility study,” said Dr. Paul Sorajja, Roger L. and Lynn C. Headrick Family Chair for the MHIF Valve Science Center. He added, “The VDYNE System’s unique deployment and securement features, together with a streamlined implantation procedure enabled the patient to quickly transition from the procedure to the recovery ward. We look forward to helping advance this new therapy for patients suffering from tricuspid regurgitation.”

The initiation of the Company’s VISTA-US study expands the ongoing clinical studies aimed at assessing the safety and effectiveness of the VDYNE Transcatheter Tricuspid Valve Replacement System. The Company previously initiated a global (non-US) feasibility study – called VISTA – which is a single arm study enrolling up to forty (40) patients suffering from moderate or greater tricuspid regurgitation in up to twenty (20) sites across Europe and Australia. To date the Company has successfully completed eleven (11) clinical cases under VISTA across seven (7) clinical sites in Australia and Europe and is targeting commencing an expanded clinical study to support CE Marking at the end of 2024.

“With both a global and US feasibility study now underway, more than 25 clinical cases completed, and a fast device procedure time, VDYNE is well-placed in its goal of advancing the VDYNE Valve System as a treatment option for the millions of patients afflicted by the debilitating effects of tricuspid regurgitation. We are very grateful to the team at MHIF and all our physicians in the United States, Australia and Europe for their expertise and assistance,” commented David McIntyre, Chairman of VDYNE.

The VISTA-US clinical trial aims to enrol up to thirty (30) patients with severe tricuspid regurgitation of primary or secondary etiology at a maximum of ten (10) clinical sites across the United States. The VDYNE Valve System has previously been granted FDA Breakthrough Device Designation.

The VDYNE Valve System is the world’s only transcatheter tricuspid valve replacement system incorporating “side-delivery” which, prior to implantation, compresses the valve vertically (instead of horizontally) thereby allowing the Company to deliver a broad range of valve sizes through a single 28 french catheter. VDYNE believes that its proprietary side-delivery system has the potential to be used in a broad range of patient anatomies with a fast, easy-to-use implantation procedure.

 

About VDYNE, Inc.

VDYNE is a privately held medical device company pioneering an innovative interventional valve replacement technology designed to treat tricuspid regurgitation. VDYNE is based in Maple Grove, Minnesota.

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 heart 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.

For more information please email investor@vdyne.com

ENDS

For more information please contact:

 

The Jean Boulle Group

Audrey Richardson +352 222 512

audrey@jeanboullegroup.com

https://jeanboullegroup.com/

Aura Financial +44 207 321 0000

Michael Oke/Bea Hopkins +44 7834368299/+44 7903537129

boulle@aura-financial.com

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 natural resources, medical technology, therapeutics, and philanthropy. Since its foundation by Jean-Raymond Boulle the Group has completed transactions worth more than US$5 billion. Its investments span early-stage private funding for innovative technologies through to acquisitions, special situations and strategic investments in publicly traded companies on leading stock exchanges. 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 medical 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 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 most successful Transcatheter Mitral Valve Implant in existence today.