Augmenix, Inc. recently announced that the FDA has approved the SpaceOAR System, the first product in the US receiving clearance as a spacer that protects the rectum in men undergoing prostate cancer (PCa) radiotherapy.
Many advancements have been achieved in PCa radiotherapy, however, because of the prostate-rectum proximity, it is hard to deliver radiation properly to the prostate without harming the rectum, which is defined as an Organ At Risk (OAR). The SpaceOAR System is designed to be positioned at the anterior rectal wall to protect it from radiation exposure.
“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. Our focus at Augmenix will now turn toward working judiciously with providers to make the SpaceOAR System available to patients in the coming months,” noted John Pedersen, the company’s CEO.
The product is placed using a small needle: hydrogel is administered into the patient as a liquid that solidifies and becomes a soft gel that expands the space between the prostate and rectum, protecting the latter from radiation. The hydrogel assures protection until the radiotherapy is completed and then it re-liquefies, becoming absorbed and eliminated through the patient’s urine.
John Sylvester, a PI in the clinical trial for SpaceOAR, added: “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. Shielding the rectum from radiation may enable the utilization of dose escalation (more prostate radiation for improved cancer kill rates) and hypofractionation (fewer radiation treatment sessions), both of which should have substantial patient benefits and help reduce healthcare costs.”
Prostate cancer is the second most deadly cancer in men and estimates suggest it will be responsible for 220,800 new cases of cancer and 27,540 deaths in 2015 in the United States.
This FDA clearance was granted after a clinical trial showing that SpaceOAR hydrogel achieved a significant reduction in rectal radiation dose and late rectal toxicity.