VDyne, Inc

VDyne, Inc. is a clinical-stage medical device company based in Minneapolis, Minnesota, dedicated to developing transcatheter valve solutions for the treatment of tricuspid regurgitation (TR), a common and significantly undertreated heart condition. The company describes TR as the "forgotten valve disease," noting that while more than 70 million patients are affected globally — including over 1.5 million in the United States — fewer than 8,000 tricuspid interventions are performed annually in the US. VDyne aims to change that by raising awareness of tricuspid valve disease and by developing a new, minimally invasive system to address this unmet medical need. The company's core technology is the VDyne Valve System, a transcatheter tricuspid valve replacement (TTVR) platform. VDyne states that its proprietary technology is "quite literally — turning twenty years of transcatheter valve delivery on its side," using a minimally invasive side-delivery approach intended to enable physicians to treat more TR patients than ever before. The VDyne Valve System is an investigational product only and is not approved for commercial sale or use for the treatment of any health condition; it is presently undergoing human (clinical) feasibility studies. VDyne is undertaking multiple clinical studies in the United States, Europe, and Australia. Its clinical program includes the VISTA global clinical study and US early feasibility study, and the TRIVITA US IDE pivotal study of the TriNova TTVR system, for which the company announced FDA approval to initiate and later reported the first patient treated. The company has also presented VISTA study data at the 2025 EuroPCR conference. VDyne is led by Chief Executive Officer Mike Buck, who was appointed Chairman and CEO to lead the next phase of its TTVR program. The leadership team also includes Neela Saikrishnan (Senior Vice President, Product Development & Operations), Vinny Podichetty, MD (Vice-President Clinical Affairs), Rick Theisen (Vice-President Operations), Tony Hyk (Chief Financial Officer), and other functional leaders. The board of directors is chaired by Mike Buck and includes Greg Pearl, MD, Jean-Raymond Boulle II, and Lucian Lozonschi, MD. The company is privately held and has raised financing, including a $21 million round announced to enable first-in-human clinical studies.

VDyne, Inc. is a clinical-stage medical device company based in Minneapolis, Minnesota, focused on transcatheter valve solutions for tricuspid regurgitation (TR). The company was founded to address what it describes as the "forgotten valve disease" — a condition affecting more than 70 million patients globally, including over 1.5 million in the United States, yet one for which fewer than 8,000 tricuspid interventions are performed annually in the US. VDyne's approach centers on the VDyne Valve System, a transcatheter tricuspid valve replacement (TTVR) platform. The company states that its proprietary technology is "quite literally — turning twenty years of transcatheter valve delivery on its side," using a minimally invasive side-delivery technology intended to enable physicians to treat more TR patients than ever before. The VDyne Valve System is an investigational product only and is not approved for commercial sale or use for the treatment of any health condition. The company has progressed through financing and clinical milestones. It announced a $21 million financing round to enable first-in-human clinical studies for the treatment of tricuspid regurgitation. It subsequently announced the first patient enrolled in the VISTA US Early Feasibility Study, followed by the first patient enrolled in the VISTA Global Clinical Study. VDyne received FDA approval to initiate the TRIVITA IDE pivotal trial of its transcatheter tricuspid valve replacement system, and later announced the first patient treated in the TRIVITA US IDE pivotal study of the TriNova TTVR. The company also announced it would present VISTA study data at the 2025 EuroPCR conference. VDyne appointed Mike Buck as Chairman and CEO to lead the next phase of its TTVR program. The company is undertaking multiple clinical studies in the United States, Europe, and Australia, and is based in Minneapolis, Minnesota.

• VDyne announces $21M financing round to enable first-in-human clinical studies for treatment of tricuspid regurgitation

• First patient enrolled in VISTA US Early Feasibility Study for the treatment of tricuspid regurgitation

• First patient enrolled in VISTA Global Clinical Study for the treatment of tricuspid regurgitation

• VDyne receives FDA approval to initiate the TRIVITA IDE pivotal trial of its transcatheter tricuspid valve replacement system

• Mike Buck appointed Chairman and CEO to lead next phase of TTVR program

• VDyne to present VISTA study data at 2025 EuroPCR Conference

• First patient treated in TRIVITA US IDE pivotal study of the TriNova TTVR

Clinical-stage medical device company developing minimally invasive transcatheter tricuspid valve replacement to address the undertreated tricuspid regurgitation market.

• VDyne Valve System

  Investigational minimally invasive transcatheter tricuspid valve replacement system using side-delivery technology; not approved for commercial sale or use.

• TriNova TTVR System

  Transcatheter tricuspid valve replacement system studied in the TRIVITA US IDE pivotal study.

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