SpaceOAR System Receives Shonin Approval in Japan

Augmenix Inc., a developer and manufacturer of proprietary absorbable hydrogels that separate and protect organs at risk during radiotherapy, has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its SpaceOAR System in Japan. SpaceOAR hydrogel is an absorbable prostate-rectum spacer that reduces rectal injury during prostate radiotherapy.
 
“SpaceOAR hydrogel is a major advance to significantly reduce risks of prostate cancer radiation therapy and positively impact patients’ quality of life,” said Keiichi Nakagawa, M.D., Ph.D., University of Tokyo Hospital. “We are very excited to have this technology available in Japan and look forward to its use in treating our prostate cancer patients.”
 
SpaceOAR is CE marked in the European Union, cleared by the U.S. Food and Drug Administration, approved in Australia, and licensed in Canada.
 
“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,” said John Pedersen, CEO of Augmenix. “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.”
 
Radiation therapy in the treatment of prostate cancer can cause unintended injury to adjacent healthy tissue, which can lead to bowel, urinary and sexual symptoms that can affect patient health and quality of life. With SpaceOAR hydrogel, physicians can place a hydrogel barrier to separate the prostate from surrounding healthy tissue. The minimally invasive procedure can be performed in a hospital, surgery center, outpatient clinic or doctor’s office. SpaceOAR hydrogel is initially implanted as a liquid that solidifies into a soft gel that pushes the prostate and rectum apart. It remains stable for three months and then is gradually absorbed by the body following radiation therapy.
 
In January 2017, Augmenix announced three-year post-treatment data from a prospective, randomized, multi-center, patient-blinded clinical trial showing that patients treated with SpaceOAR hydrogel technology prior to prostate cancer radiotherapy demonstrated significant rectal (bowel), urinary, and sexual benefit through three years of follow up. Overall patient wellness at three years was assessed by looking at the percent of patients with clinically significant declines in all three QOL areas (bowel, urinary and sexual). Fully 20 percent (one in five patients) of men in the Control arm had clinically significant declines in all three QOL areas compared to only 2.5 percent (one in 40 patients) of men in the SpaceOAR arm (p=0.002). Among men who were potent at baseline, the analysis showed that SpaceOAR treated men were better able to maintain erections sufficient for intercourse through three years of follow-up (p=0.03).

Of the men treated with SpaceOAR, 66.7 percent could achieve erections sufficient for intercourse at three years compared to 37.5 percent in the control arm, a 77.8 percent improvement.
 
Radiation therapy in the treatment of prostate cancer can cause unintended radiation injury to adjacent healthy tissue (organs at risk). This injury can lead to a range of bowel, urinary and sexual symptoms that can affect patient health and quality of life during radiotherapy, and for years afterward. In recent years, radiation oncologists have considered use of “spacing” techniques to reduce the risk of radiation injury to surrounding tissue during radiotherapy. SpaceOAR hydrogel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR System is injected as a liquid into the space between the prostate and rectum where it pushes the structures apart and then solidifies into a soft hydrogel. The hydrogel remains stable for three months during radiation therapy then liquefies and is completely absorbed by the body.
 
Augmenix Inc. is a privately held company based in the Boston, Mass., area and focused on the development and commercialization of radiation oncology products using its proprietary hydrogel technology. Focusing initially on protection during prostate radiation therapy, Augmenix next-generation products will address spacing and marking applications throughout the body to improve radiotherapy and interventional oncology procedure outcomes. The company’s lead product, SpaceOAR System, is currently being used in the majority of leading cancer centers in the United States.