Jean Boulle Group’s VDYNE Heart Valve Technology International Feasibility Study and Breakthrough Device Designation from the FDA.
Luxembourg 26 April 2023
The Jean Boulle Group is pleased to note the announcement by its medtech device company VDYNE regarding the launch of its global feasibility study for the pioneering Transcatheter Tricuspid Valve in twenty sites across the EU and Canada. The announcement also confirms that the VDYNE tricuspid valve has been designated as a Breakthrough Device by the U.S. Food and Drug Administration. Successful procedures have been completed to implant of the VDYNE Tricuspid Valve in patients.
Commenting on the announcement Jean-Raymond Boulle II, Director of Jean Boulle Medtech and VDYNE, said: “I want to congratulate the VDYNE team on their continued success. The Company has consistently delivered on its promises to roll out its novel interventional valve replacement technology and thereby improve the quality of life for patients with limited treatment options available.”
VDYNE is now the second heart valve technology company founded by the Jean Boulle Group to have attracted a multibillion-dollar medical technology company as a strategic investor. The first related to the sale of Tendyne™ to Abbott Laboratories (NYSE: ABT) for US$250 million in cash plus future payments of US$ 150 million tied to regulatory milestones. Following the sale, TendyneTM received CE Mark approval from the European Union on the 3rdFebruary 2020.
The announcement made by VDYNE is reproduced below:
VDYNE Announces First Patient Enrolled in VISTA Global Feasibility Study of the VDYNE Transcatheter Tricuspid Valve for the Treatment of Tricuspid Regurgitation
Maple Grove, Minneapolis USA, — VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing transcatheter valve technologies for the treatment of tricuspid regurgitation, announced today that it has initiated its global feasibility study – called VISTA – to evaluate the VDYNE transcatheter tricuspid valve for the reduction of moderate to severe tricuspid valve regurgitation.
The first patient enrolled in the Company’s VISTA study was treated by Dr David Muller and Dr Paul Jansz at St. Vincent’s Hospital in Sydney, Australia. The patient was successfully implanted with the VDYNE tricuspid valve and left the operating theater in a stable condition with no paravalvular leaks and was discharged from hospital six days after the surgery.
“We are very pleased to offer a minimally invasive, non-surgical, therapy to a highly complex patient with multiple co-morbidities, who was suffering from the debilitating effects of tricuspid regurgitation” said Dr David Muller. He added: “The implant was completed with a short device treatment time of only two hours enabling the patient to quickly transition out of the operating theater with no residual valve regurgitation and no complications. VDYNE’s tricuspid valve offers the promise of improving the quality of life of patients with limited or no treatment options”.
Tricuspid regurgitation is a condition when the tricuspid valve’s flaps (or leaflets) do not close properly. The tricuspid valve controls the flow of blood from the heart’s right atrium to the right ventricle. When the right ventricle of the heart endeavours to pump blood from the heart to the lungs for re-oxygenation, an impaired tricuspid valve allows blood to flow back or “leak” from the right ventricle into the right atrium leading to shortness of breath, fatigue, abnormal heart performance and an enlarged heart. VDYNE’s minimally invasive delivery system delivers a prosthetic valve via a transfemoral catheter to replace the body’s “leaky valve”. The novel design of the VDYNE valve and delivery system is expected to provide a treatment solution for a large range of tricuspid anatomies as compared to existing technologies.
“The commencement of the VISTA global feasibility study marks the next step in the Company’s clinical development and follows the treatment of a diverse group of patients under compassionate use. With the benefit of FDA confirmation of Breakthrough Device Designation, VDYNE is also in the advance stages of preparing to initiate an early feasibility study in the United States”, commented David McIntyre, Chairman of VDYNE.
The VISTA global feasibility study is a single arm study assessing forty (40) patients suffering from moderate to severe tricuspid regurgitation in twenty (20) sites across the European Union, Canada and Australia.
The VDYNE tricuspid valve was also previously granted U.S. Food and Drug Administration (“FDA”) Breakthrough Device Designation and is indicated for percutaneous tricuspid reduction of symptomatic tricuspid valve regurgitation in patients who have been determined to be at prohibitive risk for tricuspid valve surgery by a heart team.
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. For more information please email email@example.com
For more information please contact:
The Jean Boulle Group
Audrey Richardson +352 222 512
Aura Financial +44 207 321 0000
Michael Oke/Bea Hopkins +44 7834368299/+44 7903537129
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.