Espoo, Finland, 8 February 2021 – HVR Cardio International Ltd Oy (“HVR Cardio”), the cardiovascular device company developing new transformative solutions for mitral valve repair based on its groundbreaking helix technology platform, today announced that it has reached major milestones in its research and development work.
- HVR Cardio’s transcatheter mitral valve repair solution, CathHELIX®, has demonstrated excellent efficacy and safety results in a 90-day study in a mitral regurgitation animal model
- HVR Cardio’s surgical mitral valve repair solution, HVR Cardio Annuloplasty Ring (MAR), has demonstrated excellent 5-year results in a clinical evaluation of long-term safety and performance
Having reached these major R&D milestones for both CathHELIX® and MAR, HVR Cardio is now focused on its next goal of achieving first-in-human results for CathHELIX® and market approval for MAR.
Olli Keränen, CEO and Founder of HVR Cardio, commented:
“CathHELIX® and MAR are both based on our unique helix technology and protected by our strong patent portfolio. We believe these products have the potential to transform the way patients with mitral valve disease are treated.
“The FDA designated CathHELIX® as a Breakthrough Device in 2019. It is the front runner in transcatheter mitral valve repair, which represents the largest business opportunity in heart valve devices. MAR is a first-in-class product for surgical mitral valve repair and is backed by more than 800 patient months of clinical data.
“We are pleased to report today’s positive results, which represent major milestones for the Company, and are looking forward to progressing to the next exciting phases of first-in-human testing for CathHELIX® and market approval study for MAR.”
For more information, please contact:
Oli Keränen, CEO of HVR Cardio
Tel: +358 50 356 7090
Instinctif Partners (media relations)
Melanie Toyne-Sewell / Katie Duffell
Tel: +44 20 7457 2013
About HVR Cardio International Ltd Oy
HVR Cardio International Ltd Oy is an innovative cardiovascular device company developing transformative solutions for mitral valve repair based on its groundbreaking helix technology platform.
Mitral regurgitation, or leaking valve, is the most common heart valve disorder in people aged over 60. Mitral regurgitation, if left untreated, often leads to heart failure and death. HVR Cardio is developing both transcatheter and surgical solutions for repairing the leaking mitral valve. HVR Cardio’s IP is protected by over 50 patent families.
HVR Cardio’s transcatheter mitral valve repair solution, CathHELIX®, targets the largest business opportunity in structural heart and has received Breakthrough Device Designation from the FDA. The advantages of CathHELIX® include, among others, the ability to utilise an annuloplasty ring without any external fixation in the mitral valve repair. CathHELIX® also leaves future treatment options open.
HVR Cardio’s first-in-class surgical mitral valve repair solution, MAR, has already demonstrated strong safety and efficacy results in 11 mitral regurgitation patients with over 800 patient months of clinical follow-up data. Based on the clinical and preclinical results to date, MAR may provide significant benefits in terms of operation time, consistency, and left ventricle reverse remodeling (recovery of the heart).