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| Tryton Medical raised $20 million to support its side branch stent.--Courtesy of Tryton Medical |
Startup Tryton Medical has raised $20 million in venture capital to submit its side branch stent to the FDA and market it in Europe. It hopes to have the first coronary stent approved to treat bifurcation lesions in the U.S. Nearly one-third of patients undergoing coronary angioplasty have bifurcation lesions, according to the company.
The company is building an access registry, which it expects to submit to the FDA along with its pivotal trial data. The pivotal study showed the benefit of the Tryton Side Branch Stent in a post-hoc analysis of patients with complex bifurcation lesions involving significant side branches. Tryton enrolled its first patient in the registry last month and expects to enroll 133 patients in Europe and the U.S. The stent has already been used in more than 10,000 patients globally. It is marketed in countries in Europe, the Middle East and Africa.
Pivotal trial data did not meet a noninferiority primary endpoint of target vessel failure as compared with conventional provisional treatment, or balloon angioplasty, in the side branch. Tryton reported data from that study last October; it enrolled 704 patients in 11 countries and is the largest coronary bifurcation study ever conducted, the company said. The Tryton stent did meet a secondary endpoint, superiority in reducing the diameter of side branch stenosis.
Coronary artery disease often results in plaque buildup at the site where one artery branches from another. Approaches that are currently used are difficult and time intensive; in addition, the left side branch is often not stented. This leaves it vulnerable to higher rates of narrowing after implantation, Tryton noted. Left main disease is when plaque narrows the base of the coronary tree; more than 75% of left main lesions are bifurcation lesions.
The Tryton Side Branch Stent System uses a single wire balloon stent to deploy a cobalt chromium stent in the side-branch artery alongside a conventional drug-eluting stent that is placed in the main artery.
Existing investors participating in the financing included RiverVest Venture Partners and 3x5 Special Opportunity Fund; they were joined by new investor Canepa Advanced Healthcare Fund and an undisclosed investor. As part of the financing, Alejandro Sanchez from Canepa will join the company's medical board.
- here is the release