Medical device firm Augmenix has presented the 222-patient pivotal study, which is designed to assess the safety and efficacy of the SpaceOAR system in men undergoing prostate radiotherapy.
The SpaceOAR system is specified to reduce the radiation dose delivered to the rectum during prostate radiotherapy, by creating space between the prostate and rectum.
It has been developed to minimize the risk of rectal damage during prostate radiotherapy and is a soft, gel-like material that temporarily moves the rectum away from the prostate during a course of radiotherapy, decreasing the likelihood of rectum radiation injury.
Augmenix CEO John Pedersen said: "In just two months since receiving FDA clearance, the SpaceOAR System has already been incorporated into several clinical practices across the country."
The results from the multi-center, randomized and single-blind study demonstrated product safety and effectiveness, according to the firm.
In the study, Patients have well tolerated the spacer application, increasing prostate-rectum space from 1.6mm to 12.6mm.
The extra space decreased the average rectal V70 radiation dose from 12.4% to 3.3%, a 73% relative decline compared to the control group (no spacer).
Augmenix said that the decreased radiation resulted in additional key patient benefits compared to the control group, including reduced reports of rectal pain during radiation treatment by 76% and reduction in rectal toxicity by 71% in the year following radiotherapy.
Image: Augmenix’s SpaceOAR system. Photo: courtesy of Augmenix, Inc.