The sudden excitement around catheter-delivered mitral valve technologies seen mid-year suggests that this market is poised to develop along the same lines as transcatheter aortic valves did a decade ago. Some companies, though, are looking beyond this area to the tricuspid valve. Edwards Lifesciences is working on a tricuspid repair device, as befits the world’s leading transcatheter valve company – but so is the much smaller 4Tech Cardio.
“Mitral disease and tricuspid disease are often associated,” says Carine Schorochoff, 4Tech’s chief executive. “If one was developing a transcatheter solution for the mitral valve, there would certainly be a need for a solution for the tricuspid.”
4Tech believes it has just such a solution. Called the TriCinch, the device is used to repair a diseased tricuspid valve, rather than replace it, just like Edwards’ tricuspid technology, Forma (Edwards looks to tricuspid valves and beyond, October 8, 2015).
Quality of life
Both devices are in early human trials, with Edwards’ Forma having been implanted in at least 12 patients to date, and 4Tech’s TriCinch in 10. Results from the first seven patients in the trial of Edwards’ device, reported at the Transcatheter Cardiovascular Therapeutics meeting in October, showed that Forma caused moderate reduction in the severity of tricuspid regurgitation in three patients and mild reduction in four patients.
TriCinch’s feasibility trial, called Prevent, is aimed at securing a CE mark for the device. It was begun two years ago and is being conducted with a rigour fairly unusual for a start-up with a new kind of technology.
“We didn’t go through compassionate cases,” Ms Schorochoff says. “We felt this approach was probably an easy route, but not the best for the patient because with compassionate cases you have the freedom to report or not report your successes and failures.”
Instead 4Tech is conducting a fully documented study. This means that enrolment has necessarily been slow, but with the opening of several new sites this should now speed up and the remaining 14 patients should be enrolled by the end of next year.
The Prevent trial’s primary outcomes are the 30-day adverse event rate, reduction in tricuspid regurgitation both immediately postoperatively and at time of discharge, but Ms Schorochoff emphasises that what really matters is keeping patients out of hospital and improving their quality of life.
“That’s what we’ve been able to demonstrate in a few cases where we have been able to follow up at six months and one year,” she says. Full study data should emerge mid-2017.
Before then the company will have started a first US trial. This is planned to begin in 2016 and will evaluate a next-generation device; its protocol will be similar to the European study, enrolling 20-30 patients and evaluating feasibility and safety and having an early look at efficacy.
Just like mitral?
The patients enrolled in both 4Tech’s and Edwards’ studies are extreme cases, but if successful the technologies will probably come to be used in less ill patients, expanding the market. This is what happened with transcatheter aortic valves – the initial trials were in patients who were otherwise untreatable, being too sick to withstand surgery. So impressive were the results seen with the products that their use was soon expanded to milder cases, and the market is now worth more than $1.5bn, according to analysts from Morgan Stanley.
The market for catheter-based tricuspid valves may not reach these heights – but an indication of its potential could come with the development of mitral technologies.
“The end in mind is with this large transcatheter mitral market that is under development at the moment,” says Ms Schorochoff. “This market will be there in three to four years … and 50% of these patients will have associated tricuspid disease.”
Other upcoming transcatheter tricuspid technologies include US company Mitralign’s Trialign tricuspid repair device, which has just kicked off a 15-patient early feasibility study, Scout.
Of course, if the tricuspid market evolves exactly as the mitral one has, it will see an identical frenzy of large medtech companies buying up start-ups with promising devices (Boston arrives late to the mitral valve party, October 9, 2015). While 4Tech is not banking on a buyout, it is certainly aware of the possibility.
“The nature of the business model is that start-ups, if they have a meaningful solution, will be acquired,” Ms Schorochoff says. Though 4Tech could take the device to market singlehandedly, she says “it’s much better to focus on innovation, and once the device is proven hand it over to a large group that can run the larger trials, fight for reimbursement and commercialise appropriately.”
She adds that some large medtech companies are “looking at us quite closely”, and are considering contributing to the series B venture round 4Tech is currently raising. This ought to bring in around $20-25m and is due to close in short order. 4Tech closed a $10m series A round in 2011.
The B round should fund the company to 2017, by which time full data from the European trial will have emerged. Perhaps by then larger companies will be ready to add a tricuspid technology to their pipelines. Edwards has its internally developed device, but if TriCinch excels in the Prevent trial one of the other vascular players – Medtronic, Abbott or Boston Scientific, perhaps – may well step in.
|Company||Product||Trial name||Design||Trial ID|
|4Tech||TriCinch||Prevent||24 patients, data expected mid-2017||NCT02098200|
|Edwards||Forma||-||At least 12 implants completed||-|
|Mitralign||Trialign||Scout||15 patients, primary completion date May 2018||NCT02574650|