Transcatheter mitral valve repair and replacement was incredibly high-profile in 2015--resulting in a handful of big-ticket startup acquisitions by major industry players including Medtronic ($MDT), Edwards Lifesciences ($EW) and Abbott Laboratories ($ABT). Now, 4Tech hopes it is in the lead for a follow-on market to TMVR--transcatheter tricuspid valve repair (TTVR).
|TriCinch TTVR system--Courtesy of 4Tech|
The Galway, Ireland-based startup has raised a $29 million Series B financing for clinical testing and to get a CE mark for its TriCinch system, which it says is the first transcatheter device developed for this TTVR to treat tricuspid regurgitation. That may be a bit of a stretch, though. Notably, TAVR and TMVR player Edwards reported data at a conference last October on its own transcatheter device for tricuspid regurgitation.
4Tech notes that this market is roughly two-thirds of the mitral valve patient population--with more than 3 million patients in the U.S. and Europe. Now, the only effective treatment for tricuspid regurgitation requires open-heart surgery, obviously a more risky route than a transcatheter procedure.
It is led by an executive team that includes Carine Schorochoff as President and CEO; she cofounded the company in 2010 alongside Francesco Maisano, Dr. Hugo Vanermen, and Israeli device entrepreneur Yossi Gross. Prior to 4Tech, she was a director of marketing for Medtronic's first transcatheter valve in Europe.
Heading up R&D as Global VP of Therapy Development is Hardip Thakerar, who was the Global VP of Therapy Development at Twelve--the transcatheter mitral valve replacement startup that nabbed the biggest price-tag among similar deals last year when it was acquired for up to $458 million by Medtronic in August.
"Current standards of care for treating TR leave clinicians and patients with few desirable options," said Schorochoff in a statement. "Our vision is to bring the promise of transcatheter technology to this difficult but often overlooked disease, which we believe will result in meaningful improvements in patient quality of life while at the same time reducing healthcare costs."
Tricuspid regurgitation results in blood backflows into the right side of the heart. Outside of surgery, the condition is typically managed with diuretic medication. It often results in recurring complications and frequent rehospitalizations as well as lead to end-stage dialysis--that makes it quite costly to healthcare systems focused on reducing readmissions.
The new financing will go to support an ongoing 6-month trial in end-stage patients and, ultimately, to obtaining a CE mark in Europe for the TriCinch system. It is not approved in the U.S. and the company didn't indicate its plans for this market, which is typically more costly and difficult for medical devices to enter. 4Tech does have a small, 24-patient Phase I trial that's registered with ClinicalTrials.gov. It started in June 2013 and is slated to have primary endpoint data in December 2016.
The financing was led by Valiance and RMM, with participation from new and existing investors including NeoMed Management and an undisclosed group of angel investors "with a strong track record in aortic and mitral structural heart disease."
"With its unique TriCinch system, 4Tech is well-positioned to capitalize on the growing trend toward the transcatheter treatment of heart valve disease," said Valiance founder and CDO Jan Pensaert, founder and CEO of Valiance. "We believe the company has the potential to transform the way tricuspid valve disease is treated in the future. Furthermore, 4Tech is leading the evolution of a new and potentially large market segment."
- here is the announcement