Medical startup Lineus Medical of Fayetteville is moving out of research and development mode and into product launch mode.
A result of the transition is a new CEO. Vance Clement, previously the company’s chief operations officer, recently assumed the CEO role.
Spencer Jones, the previous CEO who founded the company in May 2015, is now chief technical officer.
“The board made the move so that Spencer could continue to focus on his strengths such as product development, clinical issues and intellectual property,” Clement said. “We moved people to their area of strength to match the company’s current focus.”
Lineus Medical’s SafeBreak Vascular product attaches to an IV line. When force is applied to the line, the two pieces break away from each other, creating “a controlled separation,” preventing damage to the IV line and not requiring the insertion of a new one, according to the company’s website.
Jones invented SafeBreak while working as an overnight nurse at CHI St. Vincent Hospital in Little Rock in 2015. He purchased an existing patent for the SafeBreak IV, refined the device and has been working for the past three years to bring it to market.
Lineus Medical concluded a Series A funding round of $1.36 million last fall. Since the company’s founding three years ago, the company has raised nearly $3 million.
Clement said the company has submitted the product to the U.S. Food and Drug Administration (FDA) for clearance through the regulatory agency’s premarket notification program, more commonly known as the 510(k).
Technically, Clement said, the FDA does not “approve” medical devices for sale via the 510(k) process — they “clear” them for sale in the US.
Clement said clearance times vary significantly, but according to the latest data available, 95% of medical services submitted to the FDA were cleared within 12 months, 85% within nine months and 58% within six months.
“We are well ahead of the average time and money it takes to get this class of device cleared by the FDA,” Clement said. “Big-picture wise, everybody wants the product [cleared] yesterday. In comparison to similar companies, we’re still ahead of the curve.”