WALTHAM, MA, 15 October 2015 – (BUSINESS WIRE) Augmenix, Inc., a privately held company developing minimally invasive hydrogel products to improve outcomes following cancer radiotherapy, today announced robust commercial uptake of its innovative SpaceOAR® System. An absorbable hydrogel, SpaceOAR technology is designed to create space and protect the rectum in men undergoing prostate cancer radiotherapy. The device received clearance from the U.S. Food and Drug Administration (FDA) in April 2015 and since then, more than 40 cancer treatment centers in 19 states have adopted it. Augmenix will showcase the SpaceOAR System at the 57th Annual American Society of Therapeutic Radiology and Oncology Meeting (ASTRO 2015), taking place October 18-21 in San Antonio, Texas.

“For decades, attempts to limit rectum radiation injury in men receiving prostate cancer radiotherapy included advances in planning and delivery, along with improvements in prostate localization and enhanced image guidance. As we observe increasing interest worldwide in high-dose, ultra-hypofractionated treatment delivery regimens, the rectal tolerance to these high radiation dose levels represents a significant clinical concern,” said Michael J. Zelefsky, MD, Memorial Sloan Kettering Cancer Center. “The concept of an absorbable hydrogel implant pushing the rectum away from the prostate is a totally new approach and a potential game changer. The use of SpaceOAR for this clinical setting may reduce long-term rectal toxicity and become a critical adjunct to the safe implementation of high-dose SBRT.”

Despite advancements in prostate cancer radiotherapy, the close proximity of the prostate to the rectum (defined as the Organ At Risk, or OAR) limits the total amount of radiation that can be delivered safely to the prostate without fear of rectum radiation injury. In fact, in 1996 and 2003, the published median volume of rectum receiving 70Gy radiation (or V70, a predictor of long-term rectal complications) was 21.7 percent and 18.2 percent, respectively (RTOG 9406 and 0126 studies). In comparison, the median rectum V70 radiation in the recently published SpaceOAR study was 2.3 percent. The unprecedented low rectal radiation doses made possible by the SpaceOAR System will enable advanced prostate cancer radiation protocols that should result in fewer rectal complications (including rectal pain during treatment and declines in bowel quality of life), higher prostate radiation doses and faster treatment times, translating into better patient outcomes, reduced cancer recurrence and healthcare savings. These benefits are helping to drive rapid adoption of the technology for use in intensity modulated radiation therapy (IMRT), Stereotactic Body Radiation Therapy (SBRT), low-dose rate brachytherapy (LDR), high-dose rate brachytherapy (HDR) and proton radiotherapy procedures.

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