Palette Life Sciences Announces FDA 510(k) Clearance for Barrigel® Rectal Spacer, Proven Safe and Effective at Minimizing the Harmful Long-Term Side Effects of Prostate Radiation Therapy
Groundbreaking technology introduces increased control to achieve optimal coverage proven to significantly reduce the risk of toxicity to the rectum
SANTA BARBARA, CALIF. / STOCKHOLM, SWEDEN – June 9, 2022— Palette Life Sciences, a fully-integrated global life sciences company dedicated to improving patient outcomes, today announced U.S. 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.
“We are extremely proud of today’s U.S. 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 U.S. diagnosed with prostate cancer each year, and 1.4 million men diagnosed globally,” said Per G. Langö, Chief Executive Officer and Board Director of Palette Life Sciences. “Data show that personalized medicine such as precision radiation therapy offers patients the greatest chance of survival and using Barrigel can decrease potential damage to healthy tissue during this treatment.”
“The Barrigel Prostate Trial found that 98.5% of men who were treated with Barrigel met the primary endpoint of achieving at least a 25% reduction in radiation to the rectum. Patients who met the primary endpoint averaged an 85% reduction in radiation to the rectum, and Barrigel is proven superior in the reduction of acute and long-term Grade 2+ GI toxicity at 3 and 6 months compared to control.” said Dr. Martin King, Assistant Professor of Radiation Oncology at Harvard Medical School, Dana-Farber Cancer Institute in Boston and Medical Director of the Barrigel Prostate Trial.
“Radiation therapy is a cornerstone of prostate cancer treatment, but radiation exposure to surrounding healthy tissue, including the rectum, can profoundly impact the quality of life of these cancer survivors,” said Dr. Peter F. Orio III, Associate Professor of Radiation Oncology at Harvard Medical School. “There is a trend to use hypofractionated radiotherapy, which uses a shorter course of radiation to allow patients to complete their treatment in four to six weeks compared to conventionally fractionated radiotherapy, which takes almost nine weeks to complete. Quicker courses of radiation are more convenient to the patient and have been proven to provide equal cancer control rates, but can come at the cost of causing additional toxicity to patients, especially to the rectum, as a greater amount of radiation must be delivered each day in their course of therapy. Barrigel, injected between the prostate and the rectum, supports higher radiation doses while lowering the risk of toxicity to the rectum, resulting in less treatment-related side effects for these men.”
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 pediatrics. NASHA can withstand high levels of radiation without any compromise to its functional capabilities. Further, NASHA will decompose and disappear in a natural way following radiation therapy.
“NASHA provides a natural alternative to synthetic materials, providing safe and effective experience to patients and providers,” said Travis Gay, Chief Commercial Officer of Palette Life Sciences. “Its unique characteristics enable Barrigel to provide the control and coverage necessary to sculpt an anatomy-specific implant. NASHA is the foundation of our expansive product portfolio of minimally invasive treatments in radiotherapy and interventional oncology procedures, urology/urogynecology disorders and colorectal conditions.”
Barrigel has previously been approved for rectal spacing in Australia and Europe and is being developed for future market introduction in Japan.
About the Study
The Barrigel Prostate Trial included 201 adult patients with up to unfavorable intermediate prostate cancer who were randomized into two study cohorts. The Barrigel cohort included 136 patients while the Control group was comprised of 65 patients. All patients will continue to be followed for three years.
Barrigel was proven effective at achieving a clinically significant reduction in radiation dose to the rectum. The hypofractionated regimen of radiation provided 60 Gy in 20 fractions (3 Gy/fraction). For full study results, please visit Barrigel.com.
1. Data from Palette Life Sciences 510(k) K220641. 2. Data on file. Palette Life Sciences.
About Palette Life Sciences
Palette Life Sciences is a fully integrated life sciences company. Palette Life Sciences’ products improve patient outcomes in urology and urogynecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures. The company’s portfolio of available products includes Barrigel®, Deflux®, Solesta®, and Lidbree™. Palette Life Sciences moves rapidly to leverage novel applications of existing technologies to create breakthrough medical solutions. This focus enables the company to serve those often overlooked by traditional medical companies and improve patient quality of life. Led by experienced healthcare executives, Palette Life Sciences is headquartered in Stockholm, Sweden, with offices in Santa Barbara, California, Dallas, Texas, Sydney, Australia and Tokyo, Japan. Learn more at http://www.palettelifesciences.com.
Palette has a license to worldwide commercialization and development rights for Barrigel™ from Galderma S.A.