The US Food and Drug Administration (FDA) has granted approval for Augmenix’s SpaceOAR System as a spacer to protect the rectum in men undergoing prostate cancer (PCa) radiotherapy.
The system has been developed to temporarily position the anterior rectal wall away from the prostate during radiotherapy for PCa, allowing to create space to protect the anterior rectum from exposure to radiation.
Augmenix CEO John Pedersen said: "For years, hydrogel products have been used safely to protect the most sensitive parts of the body as sealants and adhesion barriers, and now prostate cancer patients will also be able to benefit.
"FDA clearance of the SpaceOAR System represents a significant development in advancing the safety, precision and flexibility with which prostate cancer radiotherapy can be delivered."
The hydrogel, which is placed through a small needle, will be administered as a liquid. It quickly solidifies into a soft gel that expands the space between the prostate and rectum.
According to the company, the hydrogel spacer maintains this space until radiotherapy is complete and the spacer then liquefies that is absorbed and cleared from the body in the patient’s urine.
The approval was granted after completion of the multicenter and randomized clinical trial of the system, and results are expected to be released later this year.
SpaceOAR clinical trial principal investigator Dr John Sylvester from Florida-based Lakewood Ranch Oncology said: "SpaceOAR hydrogel is a valuable new tool for urologists and radiation oncologists and should be instrumental in the adoption of advanced prostate cancer radiotherapy protocols."
The SpaceOAR System is already received CE mark and TGA mark approval. Augmenix also produces TraceIT hydrogel, an absorbable tissue marker with CT, MRI and ultrasound visibility.
Image: Augmenix announces FDA clearance of SpaceOAR System. Photo: courtesy of Business Wire.