Medical device firm Augmenix has unveiled positive SpaceOAR clinical trial results, demonstrating superior outcomes at three years.
The results showed significantly lower rectal toxicity and higher patient quality of life (QOL) scores when the SpaceOAR System was applied before radiotherapy as compared against trial control patients.
The SpaceOAR system has been developed to push the rectum away from the high dose region during treatment.
It will then be completely absorbed by the body following the completion of radiotherapy.
The US prospective, randomized, multi-center and patient-blinded clinical trial assessed rectal and urinary toxicity and QOL impact on prostate radiotherapy patients treated either with SpaceOAR hydrogel or with no hydrogel (controls.)
Initial study results demonstrated spacer safety and 74% reduction in the volume of rectum receiving 70 Gray radiation at 15 months.
By minimally invasive procedure, the SpaceOAR system will be injected as a liquid into the space between the prostate and rectum, where it will expand the space and then solidifies into a soft hydrogel.
The hydrogel will remain stable for three months, while protecting the rectum during radiotherapy. Later, it will be completely liquefied and absorbed.
SpaceOAR system secured FDA and CE mark approvals. It is also approved in Australia and Canada.
Augmenix CEO John Pedersen said: “Patient quality of life is the new standard for long-term outcomes. This is the first study ever, showing that prostate radiotherapy patients can complete their treatment, and then get their lives back.
“Further, this validation of the spacer concept supports our strategy to improve radiotherapy procedures all over the body.”
Image: SpaceOAR separates the prostate and rectum during radiation treatment. Photo: courtesy of Business Wire.