Augmenix touted data today 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.
Data from the trial demonstrated that the SpaceOar device reduced the median radiation dose to the penile bulb by 49%. Men treated with the system were also better able to maintain erections after 3 years compared to those in the control arm.
“Loss of sexual function represents one of the most devastating consequences of radiation therapy for prostate cancer,” radiation oncologist Dr. Daniel Hamstra said in prepared remarks. “These results show that by reducing the levels of radiation that reach the penile bulb the treatment with SpaceOar may be able to help more men maintain sexual function and potency after treatment.”
Healthcare practitioners inject the SpaceOar system in the space between patients’ prostate and rectum prior to radiation therapy and the soft gel pushes the rectal wall away from the prostate. The hydrogel remains stable for 3 months before it liquefies and is absorbed by the body.
“Our Phase III clinical trial previously demonstrated that SpaceOar offers a significant benefit in reducing the risk of rectal complications and damage associated with radiation therapy in the treatment of prostate cancer,” Augmenix CEO John Pedersen added. “The important findings from this new analysis indicate that SpaceOar could also help to reduce the risk that radiation therapy could adversely affect sexual performance for millions of men treated for prostate cancer in the years ahead.”
In November, the company won a category 1 current procedural terminology reimbursement code from the American Medical Association for periprostatic implanation of biodegradable material.
The reimbursement win was supported by the American Society for Radiation Oncology and the American Urological Association, the company said. The CPT code is expected to become effective on January 1, 2018, replacing the device type’s current category 3 code.