Preclinical startup LifeServe Innovations has pivoted and switched the target market of its airway access devices to bedside critical care users.
Previously, the young company had planned to target emergency users, such as EMTs and battlefield medics, for its tracheostomy devices that drew their design inspiration from the way a snake bites its prey.
Now, LifeServe is aiming its device at helping anesthesiologists in critical care bedside situations perform tracheotomies, surgical procedures in which a hole is created in a patient’s windpipe through the neck.
The reason for the change is simple: It represents a larger target market, according to 23-year-old CEO Rick Arlow, who’s enrolled in an M.D./Ph.D. program at Case Western Reserve University.
Arlow maintains that LifeServe’s devices can help doctors perform bedside airway-access procedures more quickly, easily and safely than tracheotomy kits on the market now. And certainly performing the procedure at the bedside of a patient who’s experiencing obstructed breathing is quicker and cheaper than a surgeon doing it in an operating room
LifeServe has raised about $100,000 through grants thus far, and is in talks on an investment round of $400,000 to $500,000, Arlow said. The money would be used to fund the process of obtaining Food & Drug Administration 510(k) clearance to commercialize the devices.
Even with FDA clearance, the company will still need to show its devices provide clinical value, so getting buy-in from doctors will be critical for LifeServe. The company has yet to test the device on live humans, having only so far tried it on cadavers.
Arlow, a former volunteer emergency medical technician, still hopes at some point to sell LifeServe’s devices to emergency users, but that market is no longer priority No. 1 for the company.