Augmenix said yesterday it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its SpaceOAR system.
The SpaceOar is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer, the Belford, Mass.-based company said.
The device 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.
“SpaceOAR hydrogel is a major advance to significantly reduce risks of prostate cancer radiation therapy and positively impact patients’ quality of life. We are very excited to have this technology available in Japan and look forward to its use in treating our prostate cancer patients,” Dr. Keiichi Nakagawa of the University of Tokyo Hospital said in a prepared statement.
“We now have extensive clinical data showing that SpaceOAR hydrogel helps to significantly reduce the risk of rectal and urinary toxicities and loss of sexual function associated with radiation therapy for men with prostate cancer. We are very pleased that the Shonin approval will enable physicians in Japan to offer SpaceOAR hydrogel as an option for men with prostate cancer who want to reduce their risk of radiotherapy side effects including rectal toxicity, incontinence and loss of sexual function,” Augmentix CEO John Pedersen said in a press release.
With the approval, the company’s SpaceOAR has CE Mark approval in the European Union, FDA clearance and approval in Australia and is licensed in Canada, the company said.
In February, Augmenix released data from a Phase III trial evaluating its SpaceOar hydrogel in men undergoing prostate radiotherapy. The study showed that the company’s device, placed between the prostate and rectum, helps men maintain sexual function and potency following radiation therapy.
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