Augmenix announced last Thursday that its SpaceOAR hydrogel system, the first U.S. product capable of protecting the rectum in male patients undergoing prostate cancer radiotherapy, has won FDA de novo clearance.
The company plans to launch the product later this year.
The prostate’s proximity to the rectum means that it is difficult to deliver radiation treatment to the prostate without harming the rectum, the Waltham, Mass., devicemaker said. SpaceOAR overcomes this hurdle by temporarily positioning the rectal wall away from the prostate during radiotherapy.
The 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 company added.
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, said Dr. John Sylvester, a principal investigator in the SpaceOAR multicenter clinical trial.
In that trial, patients treated with SpaceOAR reported positive outcomes and experienced a significant reduction in rectal radiation dose and severity of late rectal toxicity when compared to the control arm, the devicemaker said.
The American Cancer Society and National Cancer Institute data indicates that prostate cancer is the second-most frequently diagnosed cancer in men, with 220,800 new cases and 27,540 deaths in the U.S. forecast for 2015. Prostate cancer treatment options generally consist of surgery, radiotherapy or active surveillance, with no immediate treatment.
SpaceOAR received the CE Mark in 2010 and is available for sale in Europe and Australia. — Jason Scott