Palette Life Sciences, a fully-integrated global life sciences company, announced US Food and Drug Administration (FDA) 510(k) clearance of 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 randomized controlled trial using hypofractionated radiotherapy for treating prostate cancer with a rectal spacer. Barrigel is indicated for prostate cancer patients with T1-T3b disease.