Peijia Medical and inQB8 Medical Report FIH Implantation of MonarQ TTVR System

December 2, 2022—inQB8 Medical Technologies, LLC, in partnership with Peijia Medical Limited, recently announced a successful transcatheter tricuspid valve replacement (TTVR) procedure with the MonarQ transcatheter tricuspid valve (TTV) in a 75-year-old female with severe torrential tricuspid regurgitation. The MonarQ device is in the early phases of development; it will not be available for clinical trials until further notice and is not available for sale.

Headquartered in Winchester, Massachusetts, inQB8 Medical Technologies is a privately held medical device incubator focused on developing solutions for major cardiovascular diseases, including structural heart issues, aortic disease, and heart failure. inQB8 accelerates projects through prototyping, bench, and preclinical testing until they are ready to be acquired or advanced as separate stand-alone cardiovascular start-ups.

In June 2021, Peijia Medical announced a strategic partnership with inQB8 and agreed to acquire the MonarQ TTVR technology, which inQB8 continues to develop on its behalf.

Peijia Medical, which is headquartered in Suzhou, China, is focused on the high-growth interventional procedural medical device market in China and aims to become a medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases.

According to inQB8, the transjugular TTVR procedure was performed on November 21, 2022, on compassionate grounds at the Heart Center at Rigshospitalet University Hospital in Copenhagen, Denmark. The procedural team included interventional cardiologists Professor Lars Søndergaard, MD, and Professor Ole De Becker, MD; cardiothoracic surgeon Morten Smerup, MD; echocardiographer Jacob Moller, MD; anesthesiologist Hasse Moeller-Sorensen, MD; and inQB8 Cofounder, Executive Chairman, and CMO Arshad Quadri, MD, who is a cardiac surgeon.

Prof. Søndergaard commented in the press release, “We are grateful to have had the opportunity to work with Dr. Quadri again, along with the team from inQB8, to provide an exciting new treatment option to this patient for whom no other alternatives were available.”

He continued, “Due to multiple risk factors and anatomical restrictions, neither traditional tricuspid valve surgery nor edge-to-edge transcatheter tricuspid repair were options for this patient. Through careful review and consideration within our team, we determined that TTVR with the MonarQ system could offer the potential to alleviate symptoms and provide an improved quality of life for this patient. The valve was implanted successfully with excellent function.”

Dr. Quadri added, “I am delighted to be working with Dr. Lars Søndergaard and his experienced team at Rigshospitalet on this next chapter of transcatheter valve development. The MonarQ TTV has a unique biodynamic attachment system that utilizes and preserves the heart’s natural motion to secure the implant to the native leaflets, distribute systolic loads, and minimize paravalvular leaks over a wide range of native annulus sizes.”

Brent Ratz, Cofounder and CEO of inQB8, stated, “By addressing not only the anatomic requirements but also the physiologic needs of the tricuspid valve, Dr. Quadri and I believe that the MonarQ TTVR system will turn the page on the treatment of tricuspid valve regurgitation, an extremely insidious and disabling disease of this forgotten valve.”

Michael Zhang, PhD, Chairman & CEO of Peijia Medical, commented, “In the past few years, the need for a TTVR solution has become increasingly clear. As Peijia looks to expand its presence globally and build its structural heart portfolio, our combined investment in inQB8 and the MonarQ TTVR technology was a natural choice.”

JianFong Tan, PhD, CTO of Peijia Medical, added, “The successful first-in-human of MonarQ implantation marks an exciting first step in bringing this life-saving and life-enhancing technology to more and more patients around the world.”