PRESS RELEASE
Luxembourg, 30 May 2025
Jean Boulle Medtech (the “Company”), founder of Tendyne Holdings, Inc. (“TendyneTM”), is pleased to announce that its former investee company TendyneTM has received approval from the U.S. Food and Drug Administration (FDA) for the use of the transcatheter mitral valve replacement system to treat U.S. patients with mitral valve disease.
Following CE Mark approval from the European Union in February 2020, the FDA approval is the final milestone which triggers payments to Jean Boulle Medtech shareholders by Abbott (NYSE: ABT) (“Abbott”). Abbott paid an initial US$250 million under the terms of the acquisition and agreed to two future payments totalling US$150million contingent upon meeting certain regulatory requirements, as well as completing a designated number of successful transcatheter mitral valve replacements in patients.
Implanted in a beating heart, the Tendyne™ valve enables a significantly less invasive procedure for mitral valve treatment than open heart surgery. Traditional open-heart valve surgery is highly invasive, requiring the surgeon to make a 6 to 8 inch incision along the middle of the chest, cutting through the breastbone and stopping the heart in an operation lasting approximately 8 hours, with significant intensive care required during recovery in hospital and subsequent weeks at home. By comparison the Tendyne™ valve procedure lasts around 1.5 hours with patients expected to be discharged from hospital within 3 days.
In September 2015 the Jean Boulle Group announced that an agreement had been reached for Abbott to acquire TendyneTM from Jean Boulle Medtech Ltd and other TendyneTM shareholders for a total consideration of US$400million excluding Abbott’s existing 10% of the company.
Commenting on today’s announcement, Mr Jean-Raymond Boulle, Chairman and CEO of the Jean Boulle Group said:
“I am delighted that the TendyneTM team behind the breakthrough mitral heart valve have achieved 100% success in their mission. Abbott Industries can now treat many more patients suffering from life threatening conditions.
“The added benefits associated with reductions in the cost of treatment and care from this technology further amplify the impact of innovation in medicine. Today’s success story will inspire further innovation and investment in patient care by those who – like the Jean Boulle Medtech team – are dedicated to persistence in discovery.
“The Jean Boulle Medtech team also created the VDYNE transcatheter tricuspid valve implantation system which presented U.S. and global data studies at the EuroPCR cardiovascular conference in Paris, France on 16 May 2025. VDYNE has treated more than 70 cases in 40 countries since November 2023 and is advancing its device designation to follow to the success of TendyneTM in the EU and US.”
The full Press Release issued by Abbott on 27 May 2025 can be found here: https://abbott.mediaroom.com/2025-05-27-Abbott-Receives-FDA-Approval-for-Tendyne-TM-,-First-of-Its-Kind-Device-to-Replace-the-Mitral-Valve-Without-Open-Heart-Surgery
ENDS
For more information please contact:
Jean Boulle Medtech
Audrey Richardson +352 222 512
audrey@jeanboullegroup.com www.jeanboullegroup.com
Jean Boulle Group
Michael Oke/Rita Cunha Vaz +44 783 436 8299/+351 939 988 080
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 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.
Relevant press releases from Abbott:
Abbott Laboratories Press Release 27 May 2025: Abbott Receives FDA Approval for Tendyne™, First-of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery
Abbott Laboratories Press Release 30 January 2020: Tendyne™ Device Receives World’s First CE Mark for Transcatheter Mitral Valve Implantation Available
Abbott Laboratories Press release 23 May 2018 ABBOTT’S INVESTIGATIONAL TENDYNE™ DEVICE FOR MITRAL VALVE REPLACEMENT DEMONSTRATES POSITIVE OUTCOMES AT 30 DAYS IN GLOBAL STUDY
Abbott Laboratories Press Release 30 January 2020: Tendyne™ Device Receives World’s First CE Mark for Transcatheter Mitral Valve Implantation Available