clinicalPre-clinical studies demonstrated the No-laps can effectively prevent stomal prolapse without obstructing stool passage↗
▶Ep 14 · 0:27
clinicalForce testing proved significant force is required to accidentally dislodge the device↗
▶Ep 14 · 0:27
clinicalThe No-laps is compatible with use of ostomy appliances↗
▶Ep 14 · 0:27
clinicalThe device has been successfully used in three emergency human cases↗
▶Ep 14 · 0:27
clinicalThe team plans to proceed with human clinical trials in the de novo pathway for FDA approval↗
▶Ep 14 · 0:27
clinicalThe team is currently working on pre-clinical studies using a porcine model↗
▶Ep 14 · 0:27
clinicalThe final design will include six different sizes↗
▶Ep 14 · 4:48
quotewhen we were uh looking up like the market and seeing what is available, we were kind of shocked by how few options there are, especially non-operative, um, for such a common problem in both the pediatric and adult population↗
▶Ep 14 · 4:48
clinicalThe No-laps device is made of medical-grade silicone↗
▶Ep 14 · 7:44
quotewe're realizing how um challenging that the road is from idea innovation to like clinical translation↗