Augmenix Touts SpaceOAR Trial Data
Augmenix announced Thursday clinical trial results of its SpaceOAR system for prostate radiotherapy treatment in men.
The multicenter, single-blind pivotal study evaluated the system’s safety and efficacy and enrolled 222 patients. The spacer was able to increase the space between the prostate and rectum on average from 1.6 mm to 12.6 mm, which reduced the rectum volume receiving radiation by 73 percent when compared against the control arm.
While the prostate’s proximity to the rectum means that it is difficult to deliver radiation treatment to the area without harming the rectum, the SpaceOAR overcomes this hurdle by temporarily positioning the rectal wall away from the prostate during radiotherapy, the Waltham, Mass., devicemaker says.
A hydrogel is administered as a liquid using a small needle, but soon solidifies into a soft gel capable of expanding the space between the prostate and rectum, maintaining this space until radiotherapy is finished. Afterward, the spacer turns back into a liquid, is absorbed and departs the body through urination.
The ability to protect the rectum from radiation may allow for radiation dose escalation to increase cancer kill rates and entail fewer radiation treatment sessions.
The product received FDA clearance in April, and is CE Marked and TGA approved. — Jason Scott