|Trinity TAVR--Courtesy of Transcatheter Technologies|
Venus Medtech aims to have the first transcatheter aortic valve implantation system cleared by the China Food and Drug Administration (CFDA). It also has a transcatheter pulmonic valve that is finishing clinical trials, which would also be a first for the CFDA.
Now, the startup, which nabbed $37 million in financing from Goldman Sachs last month, has acquired German startup Transcatheter Technologies to add into the mix a third-gen TAVR technology, Trinity, which would allow the valve to repositioned after implantation. With this addition, Venus Medtech is aiming to have top-tier tech that would potentially have appeal in markets outside of China--not only in TAVR but also in TMVR, which last year was the object of rapid-fire deal-making.
In the U.S., there is no FDA-cleared TAVR system that can be repositioned after implant. St. Jude Medical ($STJ) is in late-stage testing for one, but has hit some stumbling blocks there for its Portico, which already has a CE mark. Transcatheter aortic valve replacement (TAVR) and transcatheter aortic valve implantation (TAVI) are interchangeable terms--and acronyms--that describe the same procedure and devices.
"Second generation TAVI systems cannot be repositioned once they are fully implanted. Trinity, however, is designed to solve this substantial issue and reduce the chance of PVL and AV block," said Transcatheter Technologies co-founder and CEO Dr. Wolfgang Goetz in a statement. "Once Trinity is completely expanded and anchored above the annulus, a cardiologist can fully evaluate the valve's function to determine whether it needs to be repositioned, retrieved, or kept in the same position. This feature is unique to Trinity, positioning Trinity as a third-generation TAVI system." Paravalvular leak (PVL) and atrio-ventricular (AV) block are complications associated with TAVR procedures.
|Final position of Trinity TAVR--Courtesy of Transcatheter Technologies|
Transcatheter Technologies, based in Regensburg, Germany, was founded in 2009 with the aim of making noninvasive heart valve implantation safer--thereby expanding the number of patients who can benefit from this procedure. Financial terms of the acquisition were undisclosed.
Added Goetz, "Our third-generation transcatheter aortic valve implantation (TAVI) system--Trinity--is designed to be the world's first 'truly repositionable' TAVI system and has already completed two-years of follow-up."
The German company said that in clinical testing Trinity's novel sealing cuff did not result in paravalvular leakage (PVL), while it also reduced the risk of atrio-ventricular (AV) block due to the supra-annular positioning.
In addition to TAVI, Transcatheter Technologies also has a novel transcatheter mitral valve system based on a transseptal access route, Tresillo. This tech was the reason for a series of large, rapid-fire deals last year as several major medical device players worked to stake their claim in TMVR. The startup also has Tumbao, a novel endovascular aortic repair and sealing system.
"Transcatheter Technologies has developed not one, but three, next-generation technologies that will play a significant role in treating structural heart disease patients in China and the rest of the world," said Healthios Capital Markets Managing Director Christoph Brandenberger. "Dr. Goetz has demonstrated that he can quickly develop and cost-effectively validate clinically meaningful technology."
- here is the acquisition announcement