Xeltis today released early data on its bioresorbable heart valves built on endogenous tissue restoration technology, touting potential benefits of the regenerative approach to heart valve replacement.
The Swiss medical device company’s technology is designed to promote endogenous tissue restoration using polymers structured as a resorbable “porous matrix.” The aim is to gradually replace the polymer structure with naturally regrown tissue, and the company is currently testing the system in pulmonary and aortic valves.
“Our objective is to change the paradigm for heart valve treatment. If you think about it, today, what we do is kind of plumbing – we replace a faulty valve with another synthetic valve, made of animal tissue. Our objective is to allow the natural restoration of heart valves, letting the body heal itself, in a way. I think this is very exciting, and we’re going to see more and more data that supports the technology,” CEO Laurent Grandidier told MassDevice.com in an interview.
Early preclinical data on the company’s aortic valve was presented today at the EuroPCR 2017 conference in Paris, and showed good hemodynamic performance fully functional valves in vivo at 6-months post implantation, according to a company press release.
“The next big milestone will be when we start implanting aortic valves in patients in a clinical trial. That will take a bit of time, most likely a year and a half, maybe 2 years, but that’s where that program is leading,” Grandidier said. The company is still developing preclinical data on its aortic valve built on the same technology, he added.
The company also announced that the 1st feasibility clinical trial for its Xplore-I pulmonary valve is underway in Europe and Asia, with patient enrollment completed in December last year.
In January, the FDA approved an Investigational Device Exemption for an early feasibility study of the Xplore-I in 10 patients, the company said. Grandidier said the company has data that is consistent and satisfies all the US requirements to begin a trial.
“We have 2 main programs – the pulmonary valve and the aortic valve. The current strategy may change, but the strategy we have today is to go in parallel as much as we can in the US and Europe, which is not that usual for startups in our space. We have made the decision to really push the regulatory pathway on both sides of the Atlantic in parallel,” Grandidier said. “One of the next big milestones will be the start of our US clinical trial. It’s already public that 2 of centers that will be participating in the trial are Columbia in New York and the Children’s Hospital in Philadelphia. These are prestigious, pre-eminant centers, and we’re very proud. This will be a big moment in the life of the company. Being able to go through the FDA regulatory requirements to start a clinical trial in the US is an achievement.”
The results of the feasibility studies will lead to clinical trials of the devices, with hopes to begin clinical trials in Europe this year, Grandidier said. Clinical trials in the US could take a year or more to start, but he said that the company was looking to being the study there as soon as possible.
