Palette Life Sciences 510(k) has bagged clearance for Barrigel, the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect it during radiation therapy treatment for prostate cancer. 

The Barrigel clearance is based on data from the first-ever FDA-reviewed randomised controlled trial using hypofractionated radiotherapy for treating prostate cancer with a rectal spacer. Barrigel is indicated for prostate cancer patients with T1-T3b disease.

“We are proud of US FDA clearance of Barrigel and we look forward to working with urologists and radiation oncologists to help improve outcomes for the approximately 250,000 men in the US diagnosed with prostate cancer each year, and 1.4 million men diagnosed globally,” said Per G Langö, CEO and Board Director, Palette Life Sciences. 

Barrigel is made from safe, proven, non-animal stabilized hyaluronic acid (NASHA), the first material documented for prostate spacing. NASHA has a long history of safety, efficacy and biocompatibility in a wide variety of medical applications, including paediatrics. NASHA can withstand high levels of radiation without any compromise to its functional capabilities. Further, NASHA will decompose and disappear naturally following radiation therapy.

Barrigel has previously been approved for rectal spacing in Australia and Europe and is being developed for future market introduction in Japan.