Augmenix’ SpaceOAR System Experiences Rapid U.S. Adoption

Technology that Reduces Prostate Cancer Radiotherapy Complications to be Highlighted at ASTRO 2015

WALTHAM, Mass.--(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 57^th Annual American Society of Therapeutic Radiology and Oncology Meeting (ASTRO 2015), taking place October 18-21 in San Antonio, Texas.

“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.”

“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.

“It’s an exciting time at Augmenix,” said John Pedersen, Augmenix CEO. “Just months after our published clinical study results and FDA clearance, accelerated acceptance of the SpaceOAR System by leading radiotherapy centers across the country speaks to the fact that the technology fills an important need in the market. Given the strong clinical evidence and the recent momentum, we anticipate a high level of interest from clinicians and industry at the upcoming ASTRO meeting and look forward to showcasing the SpaceOAR technology at this important industry event.”

Augmenix will showcase the SpaceOAR System in booth #508 and is sponsoring an Industry Expert Theater, which will take place on Monday, October 19 at 12:30 p.m. The symposium presentation will include:

• Dr. John Sylvester, radiation oncologist at 21^st Century Oncology, who will present the SpaceOAR U.S. Pivotal study results;
• Dr. Marcio Fagundes, medical director at Provision Center for Proton Therapy, who will discuss spacer use in proton radiotherapy;
• and Dr. Robert Timmerman, professor and vice chair of the Department of Radiation Oncology and Professor of Neurosurgery at UT Southwestern, who will discuss spacer use in dose escalated SBRT.

The Augmenix Products
Using a minimally invasive procedure, the SpaceOAR System is injected as a liquid into the space between the prostate and rectum where it expands the space and then solidifies into a soft hydrogel. The hydrogel remains stable for three months while protecting the rectum during radiotherapy and then liquefies and is completely absorbed. The SpaceOAR System is FDA cleared, CE marked and TGA approved. Augmenix also markets TraceIT® Hydrogel, the world’s first absorbable hydrogel tissue marker with CT, MRI and ultrasound visibility. TraceIT Hydrogel is FDA cleared and CE marked for use throughout the body, and is finding utility as a marker to improve radiation targeting of tumors. See the SpaceOAR System and TraceIT Tissue Marker IFUs for complete information regarding potential risks, complications and warnings.

About Augmenix, Inc.
Augmenix, Inc. is a privately held company based in the Boston area focused on the development and commercialization of radiation oncology products using its proprietary hydrogel technology. The company was founded by Incept LLC in 2008 and is funded by several leading venture capital groups. More information about Augmenix can be found at http://www.Augmenix.com.