BEDFORD, Mass.--(BUSINESS WIRE)--Augmenix, Inc., a medical technology company that develops, manufactures, and sells proprietary absorbable hydrogels that separate and protect organs at risk during radiotherapy, today announced that the first patients have been treated with SpaceOAR® hydrogel at the Chaim Sheba Medical Center in Tel Hashomer, Israel. SpaceOAR hydrogel is an absorbable prostate-rectum spacer that reduces rectal injury during prostate radiotherapy.
“We are excited to offer our patients this new, innovative technology to significantly reduce risks of prostate cancer radiotherapy,” said Zvi Symon, M.D. from the Chaim Sheba Medical Center. “SpaceOAR hydrogel will provide meaningful long-term benefits, improving overall quality of life for our patients."
“We are extremely pleased to bring our innovative SpaceOAR hydrogel to physicians and patients in Israel," commented John Pedersen, CEO of Augmenix. "Our growing body of clinical evidence demonstrates that SpaceOAR hydrogel significantly reduces the risk of rectal and urinary toxicities and loss of sexual function associated with prostate cancer radiotherapy. SpaceOAR hydrogel is making a significant difference in the lives of men around the world.”
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.
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 quality of life (QOL) domains (bowel, urinary and sexual). Fully 20% (1 in 5 patients) of men in the Control arm had clinically significant declines in all three QOL areas compared to only 2.5% (1 in 40 patients) of men in the SpaceOAR hydrogel arm (p=0.002).1 Among men who were potent at baseline, the analysis showed that SpaceOAR hydrogel treated men were better able to maintain erections sufficient for intercourse through 3 years of follow-up (p=0.03). Of the men treated with SpaceOAR hydrogel, 66.7% could achieve erections sufficient for intercourse at three years compared to 37.5% in the Control arm, a 77.8% improvement.2
ABOUT SPACEOAR SYSTEM
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 hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR hydrogel 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. See the Instructions for Use for complete information on potential risks, warnings and precautions.
ABOUT AUGMENIX, INC.
Augmenix, Inc. is a privately held U.S. company based in the Boston, Massachusetts area 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 FDA cleared and is currently being used in the majority of leading cancer centers in the United States. It is also CE marked, approved in Australia and licensed in Canada. SpaceOAR is a registered trademark of Augmenix, Inc. More information about Augmenix and the SpaceOAR hydrogel can be found at http://www.Augmenix.com.
ABOUT CHAIM SHEBA MEDICAL CENTER
Chaim Sheba Medical Center is the largest medical center in Israel and the Middle-East and one of the most comprehensive and advanced hospitals in the world. Adjacent to Tel Aviv, it is renowned for its compassionate care and leading-edge medicine. It is also a major medical-scientific research center that collaborates internationally with the medtech and pharmaceutical industries to develop new treatments and technologies, and a foremost global center for medical education. Visit www.eng.sheba.co.il for more information.
1) Hamstra D, et al. Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys; 2017 Volume 97, Issue 5, Pages 976–985.
2) Hamstra D, et al. Evaluation of sexual function on a randomized trial of a prostate rectal spacer. J Clin Oncol 35, 2017 (suppl 6S; abstract 69)
