Icon (Close Menu)

Logout

Medical Device Awaits Funding, FDA Approval

2 min read

Spencer Jones hopes that it won’t be long before the Food & Drug Administration approves his medical device allowing an IV line to break away easily under tension and snap shut, preventing complete IV failure.

“We feel positive” that it will be approved, said Jones, the chief technology officer for Site Saver Inc. of Fayetteville, which does business as Lineus Medical.

In the meantime, his company is in the middle of raising $1.25 million to help fund the launch of the product, SafeBreak Vascular, and for its manufacture. Jones, who is also the founder of the company, said it has raised more than half of that sum.

SafeBreak fits into a patient’s IV line and separates into two pieces if the line is accidentally pulled or caught on something. The product works with all types of medical tubing, including feeding tubes and urinary catheters. If the line is broken, SafeBreak’s valves stop the flow of fluids from the IV to the patient. The IV pump sounds an alarm to alert medical professionals to the break.

“It’s a simple device, but at the same time, there are complex engineering things that we had to solve,” said Jones, who once worked as a registered nurse and was a member of the 2015 class of Arkansas Business’ 20 in Their 20s. For example, SafeBreak has to completely seal and be sterile. “Those real specific clinical features we couldn’t get wrong,” Jones said. “We had to get that right.”

Before the current funding round, the company, which was founded in 2015, had raised a total of $2.2 million — $850,000 in 2015 and $1.365 million toward the end of 2016.

Jones said the product has been presented at “countless conferences” over the past two-and-a-half years. “The response has been pretty overwhelming,” he said.

The breakaway device “will save a lot of IV lines, trouble and waste for the hospitals” and will improve patient care, Jones said.

The product will have a starting list price of about $8 and be manufactured in New Jersey.

Jones said the company has three full-time employees, but will probably hire a vice president of sales and a quality and regulatory expert next year.

Send this to a friend