Svelte Medical Systems said it raised $22 million to complete a clinical trial of its coronary stent platforms, taking its total raise to $65 million since 2007.
Venture capital shops New Science Ventures and CNF Investments led the latest round for New Providence, N.J.-based Svelte, which the medical device company said it plans to use to complete its Direct II clinical trial as it gears up for commercialization.
"We appreciate the confidence our investment partners have in us and will work hard to achieve the milestones necessary to realize commercialization of our drug-eluting stent platforms. There are no products presently in the coronary stent market specifically designed to facilitate the trans-radial approach and direct stenting. The low profile of our system, coupled with specialized balloon and drug carrier technologies designed to reduce arterial injury and inflammation, will enhance patient outcomes to address this unmet need," president & CEO Jack Darby said in prepared remarks.
The Direct II trial is comparing the Svelte stent, which elutes the anti-stenosis drug sirolimus using a bioabsorbable carrier made of amino acids, with Medtronic‘s (NYSE:MDT) Resolute stent, which uses a polymer-based drug carrier. The 159-patient study is slated to enroll subjects at up to 20 clinical sites in Europe and Brazil, with primary endpoints of target vessel failure and in-stent late loss. Patients will receive 6-month clinical and angiographic follow-up and further monitoring for 5 years.
Svelte said it plans to commercialize its integrated delivery system and rapid-exchange system stents in Europe in 2015, after results from the Direct II trial become available next year.