Cohera Medical has treated the first patient in a clinical study of its Sylys surgical sealant, designed to reduce leaks in large and small bowel anastomoses.
Anastomotic leaks, which are the cause of one third of the mortalities following colorectal surgery, occur in 3% – 15% of colorectal procedures.
Currently underway in Europe, the study is being conducted in two hospitals in the Netherlands to investigate the safety of the product and its ability to reduce anastomotic leaks following bowel repair.
Amsterdam Academic Medical Centre nephrologist Dr Bemelman said; "We look forward to enrolling more patients in the study and being part of this important research."
Cohera Medical president and chief executive officer Patrick Daly said the treatment of the first patient will be the company’s second class 3 product in humans.
"Our Sylys product has the potential to transform the healing process following bowel repair and associated complications in colorectal surgeries," Daly said.
"We are privileged to work with such a renowned group of doctors who recognize the need for this product on a daily basis."
Sylys is currently indicated for investigational use only and has not yet been approved for medical use by the Food and Drug Administration (FDA) in the US.
The company’s first product, TissuGlu surgical adhesive, is used while performing large flap surgeries such as abdominoplasty, andeliminates or reduces fluid accumulation and the need for post surgical drains.