Stimatix GI reported that the AOS-C1000(TM), a unique colostomy management device, met primary and secondary endpoints in pre-clinical in-vivo animal studies. The study was conducted under the direction of Dr. Ron Greenberg, Senior Surgeon, Department of Surgery, Sourasky Medical Center, Tel Aviv Israel. Primary endpoints of repeatable stoma sealing for continence control as well as secondary endpoints regarding tissue pathology and survival were met confirming the AOS-C1000(TM) as capable of enabling repeatable colostomy site (stoma) sealing for continence control.
Developed by Stimatix GI (http://www.stimatix-gi.com), a privately funded medical device company focused on continence solutions, the AOS-C1000(TM) Colostomy Management System is designed to allow individuals to discretely manage their colostomy without the need to wear a traditional ostomy pouch. The AOS-C1000(TM) is intended to improve quality of life and offer an elegant, non-surgical, and simple to use solution for round-the-clock continence control.
The AOS-C1000(TM) Colostomy Management System hermetically seals the colostomy site without the use of adhesives, prevents leakage and odor . Waste matter is stored inside the body eliminating the need to wear a suspended pouch. As designed, the AOS-C1000(TM) provides the individual complete control over continence, restoring confidence and improving quality of life.
With the worldwide ostomy patient population estimated at 1.5 million people, generating $2 Billion in associated expense, there has been no major breakthrough in colostomy care for over 50 years. The colostomy site, referred to as the stoma, an artificial opening in the abdomen, is the result of a surgical procedure in which the colon or ileum is cut and brought through the abdominal wall. Medical conditions that may require a stoma include cancer, ulcerative colitis, and Crohn's disease.
"This pre-clinical result is great news for individuals with colostomies," stated David Hanuka, CEO of Stimatix GI. "Stimatix GI's pre-clinical results mark a breakthrough in ostomy care, a field that has not witnessed any major change in more than five decades. People with colostomies face numerous obstacles including integrating back into society, difficulties with bag management, and skin irritation. Stimatix GI's vision is to set a new standard in stoma care and enhance quality of life by restoring control and confidence to individuals with colostomies."
Stimatix GI is preparing for first-in-man clinical trials to commence during the second half of 2011 and recently announced that it is raising $2.6 million towards this end.