KFAR SABA, ISRAEL – March 03, 2016 – Colospan Ltd., a company developing revolutionary solutions for colorectal surgery, announced that it has recruited 20 patients for its clinical trial, thus completing the number of required patients for this trial.
The trial is a prospective, multi-center, single-arm, open-label study designed to evaluate the safety, tolerability and performance profile of the Colospan CG-100 device in patients undergoing colorectal surgery. CG-100 aims to provide a superior, effective and safe alternative for stoma pouches which are prone to complications, entail health risks and seriously impact the patient’s wellbeing. As an internal device, CG-100 does not require the rigorous care and limitations imposed by the stoma pouch. It also does not require a separate operation for removal, and can be easily extracted at any time by the physician.
The trial participants were recruited in medical centers throughout Europe and Israel, and the results will be gathered over the next few months. The trial is designed to explore the company’s technology, as part of the development efforts. It will examine the product’s safety for treating humans, as well as its functionality and clinical effect. This data will be the basis for defining the product’s characteristics, usability and the type of patients suitable for treatment.
“Colospan’s device is extremely simple to insert and extract,” said Dr. Ilia Pinsk, a senior colorectal physician from Soroka Medical Center in Beer Sheva Israel. “It’s a whole different world when we don’t have to operate on the patient again just to extract the device. The CG-100 adds only 10 minutes to the total procedure time. I can say with confidence that the CG-100 upgrades and eases my work.”
“We were pleased to witness the eagerness of patients to join our clinical trial,” said Boaz Assaf, CEO, Colospan Ltd. “I believe the risks, limitations and lifestyle implications of the diverting stoma are so daunting that patients are happy to embrace our solution, even in the framework of a clinical trial. Its advantages of reducing risks, no operation for removal and no bulky external pouch have great appeal for patients.”
Colospan Ltd. is a clinical stage medical device company active since December 2010. Colospan Ltd focuses on developing novel proprietary technology for colorectal surgery. The company is dedicated to meeting the first and foremost challenge in colorectal surgery by addressing the profound clinical and economic pains associated with anastomotic leaks. Colospan Ltd focuses on developing a safe, effective alternative for the ostomy pouch, to improve medical procedures, reduce health risks and upgrade patients’ wellbeing.
Bringing together clinical, technical and marketing expertise since its inception, Colospan’s competitive advantage stems from the synergy between these domains. Its team consists of seasoned professionals in marketing, sales and development of surgical devices colorectal surgery. It also boasts a distinguished scientific advisory team comprising KOL physicians from Europe and the United States specializing in the colorectal surgery.