Fossa medical, established in 2001 in Boston started out with the aim of exploring concepts for kidney stone removal. The company has succeeded in obtaining finances to complete designs, file patents, complete animal trials/clinical studies and obtain FDA clearance for their Stone Sweeper device.
The stone sweeper device is a technological miracle that works to widen the ureter in order to facilitate the removal of kidney stones. The device has received clearance from the United States Food and Drug Administration (FDA). Before submitting the 510 k application, the co-founders of Fossa, Gloria Kolb and Dr. Michael Mitchell conducted animal trials (on pigs) with excellent outcomes for passively dilating the ureter and removing kidney stones. It is these results that made the FDA approval procedure easier!
The idea of this device occurred to the two co-founders four years ago while discussing about the possibility of such a device. Then followed the brainstorming sessions and discussions about a device that would leave no room for inefficiencies and mistakes in the operating room. The stone sweeper thus designed is a stone removal system that includes a stent that is inserted through the urethra and into the ureter. Once in place, a sheath is removed, allowing a series of baskets along the length to expand. This allows two things: the ureter to dilate and the stones to be caught or swept into the baskets for direct removal.
Kolb, who is known for her hip implants and medical instruments that she once designed for Johnson & Johnson, has designed an equally innovative kidney stone removal device. Kolb and Mitchell have already garnered as much as $400,000 from investors and another $50,000 from various business plan competitions, to commercialize the kidney stone sweeper and other devices. The aim is to raise another $4 million to bring the device to the estimated 2 million Americans who suffer from kidney stones each year.