The Christ Hospital Heart & Vascular Institute Performs First-of-Its-Kind J-Valve Surgery

CINCINNATI (October 26, 2023) – The Christ Hospital Heart & Vascular Institute, in partnership with Genesis MedTech, a leading medical device company, have announced the first enrollment in its North American Early Feasibility Study using its dedicated TAVR system, J-Valve™ Transfemoral (TF) System. The procedure was successfully performed by Dean Kereiakes, MD, Santiago Garcia, MD and the team at The Lindner Research Center at The Christ Hospital Health Network earlier this month.

Developed by JC Medical, the J-Valve™ TF System has been granted Breakthrough Device designation for the proposed indication of treating severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients determined eligible for the device and to be at high risk for surgical aortic valve replacement. The procedure is performed through a minimally invasive transfemoral approach, without the need for open-heart procedure or extracorporeal circulation. The innovative design and features of the J-Valve™ TF System can potentially help patients that suffer from aortic valve regurgitation with no approved options for treatment in the United States.

"We are pleased to report that the first Early Feasibility case using a 34mm J-Valve yielded favorable results,” said Dr. Kereiakes, President of The Christ Hospital Heart and Vascular Institute and National Co-Principal Investigator for the study. “The J-Valve™ TF System could potentially revolutionize the treatment of aortic regurgitation, allowing larger annular sizes to be treated."

“This valve clearly addresses an unmet clinical need and has the potential to help many patients” added Dr. Garcia, principle investigator for the study at The Christ Hospital Health Network. “Unlike cardiac surgery, our patient did not have general anesthesia and went home the next day.”

The completion of the first successful implantation under the FDA-approved Early Feasibility Study marks a significant milestone for Genesis MedTech. Dr Mark A. Turco, CEO JC Medical and President of Vascular Intervention North America at Genesis MedTech shared, "This achievement demonstrates our dedication to advancing medical technology in the structural heart disease sector. Collaborating with leading TAVR sites across the US and Canada, we hope to demonstrate results that will highlight the unique ability of a dedicated TAVR valve like J-Valve in treating patients with a life-threatening disorder." The North American EFS is part of a broad clinical program that will investigate the treatment of patients with aortic regurgitation.

About The Christ Hospital Health Network

The Christ Hospital Health Network consists of an acute care hospital located in Mt. Auburn, a remote hospital location in Liberty Township, five ambulatory outpatient centers and dozens of medical offices throughout the region. For more than 130 years, The Christ Hospital has provided compassionate care to those it serves. Made up for more than 1,300 physicians and more than 6,500 team members, our mission is to improve the health of our community by providing exceptional outcomes in an affordable way. The Network was recognized by U.S. News & World Report as the #1 hospital in the Cincinnati Region and named to Newsweek’s World’s Best Hospitals list in 2023. It is also a Press Ganey Guardian of Excellence Award recipient, which recognizes top-performing healthcare organizations that achieve the 95th percentile or above of performance in patient experience.

ABOUT GENESIS MEDTECH & JC MEDICAL

Based in Burlingame California, JC Medical Inc., under Genesis MedTech Group, is a structured heart company that is primarily engaged in the design and development of transcatheter valve replacement products for the minimally invasive treatment of structural heart diseases. Genesis MedTech Group is a medical device company headquartered in Singapore. Founded by a group of professionals and entrepreneurs with MedTech experience globally and in Asia, the company's product portfolio focuses on multi-therapy medical device products for emerging markets with sales and distribution through its established commercial network. Genesis MedTech Group covers the entire industry value chain of research and development, production, quality management, supply chain, marketing, and sales.