California-based medical device company TS3 has raised $100,000 of the $3 million it will seek during the next six to nine months, Founder and CEO Mallik Thatipelli said. The money will fund the healthcare startup’s peripheral artery disease tech that aims to replace subintimal dissection. This would especially help the 40 percent of PAD patients with chronic total occlusion lesions, who are often at risk of amputation.
Specifically, the money will go toward animal testing, FDA regulatory filing and limited market release, Thatipelli said. He said the 6-month-old company plans to raise the first $1 million in debt notes, then the following $2 million in equity financing, looking specifically at venture capitalists as investors.
The CentraPass, the company’s device, drills a very narrow pathway down the center of the blood vessel, Thatipelli said, rather than going through the wall of the blocked blood vessel, to create a channel for a guidewire (then a stent and balloon). The process, he said, is more predictable and user-friendly than subintimal dissection. Plus it’s more likely to keep the guidewire from the periphery, lessening the chance of perforation, he said.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
“Subintimal dissection is not a predictable technique. You’re creating a channel in the blood vessel wall, so that may end up in perforation,” he said.
“Because there is no capital expenditure and there are no complex physics” the device would be significantly cheaper than those of competitors, Thatipelli said.
Big players in the PAD medical device space include Volcano’s Pioneer Plus (once Medtronic’s tech), Bard’s Crosser series and Boston Scientific’s Truepath CTO (a vascular drill which also requires no capital equipment), among others.
TS3 plans to apply for FDA 510(k) clearance and the CE Mark in mid-2014. The company hopes to have the FDA clearance by the end of 2014 and begin large-scale manufacturing in 2015.
Health Benefit Consultants, Share Your Expert Insights in Our Survey
Share some of the trends you are seeing among your clients across healthcare, including chronic conditions, behavioral health, healthcare navigation, and more.
After this initial product is launched, Thatipelli said the company will focus on second- and third-generation devices. Then, it will move toward creating other minimally invasive vascular devices.
Follow MedCity News on Facebook and Twitter for more updates.
