Augmenix said last week that a pivotal study of its SpaceOar system was published online in the International Journal of Radiation Oncology•Biology•Physics.
The 222-patient pivotal study was designed to evaluate safety and efficacy of the SpaceOar System in men undergoing prostate radiotherapy, the company said.
The SpaceOar is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer, Augmenix said. SpaceOar is delivered through a small needle as a liquid, which then solidifies into a soft gel that expands the space between the prostate and rectum during radiotherapy. The substance then liquefies and is absorbed and cleared from the body in the patient’s urine, Augmenix said.
“Spacer application in the study was well tolerated, the gel lasted through radiation treatment and was shown to completely absorb, leaving nothing behind. From the urologist perspective, a product that reduces the complications in patients selecting prostate radiotherapy is a tremendous advance that should be considered when patients are weighing treatment options,” study investigator Dr. Lawrence Karsh, of Denver’s Urology Center of Colorado, said in a press release.
The study reported a 73% reduction in the average rectal V70 radiation dose necessary when the device was used, from 12.4% to 3.3%, the company said. The study also reported a 76% reduction in reports of rectal pain, a 71% reduction in rectal toxicity in the year following radiotherapy and a 46% reduction of patients reporting declines in bowel quality.
“In the field of prostate radiotherapy, the rectum dose reduction seen in this trial is unprecedented. This new ability to safely reduce rectum radiation may enable advanced protocols, like prostate stereotactic body radiation therapy, resulting in significant cost savings, as well as in prostate dose escalation, potentially decreasing cancer recurrence,” study investigator Dr. Richard Hudes of Chesapeake Urology said in a prepared statement.
The same study was used to help Augmenix win a nod from the FDA for the device in April, the company said. The device also has CE Mark approval in the European union, Augmenix said.
“In just 2 months since receiving FDA clearance, the SpaceOAR System has already been incorporated into several clinical practices across the country. We are encouraged by the overwhelming interest from clinicians to receive SpaceOAR hydrogel training and will strive to meet demand and provide support to new customers,” CEO John Pedersen said in prepared remarks.