Augmenix, Inc. Announces SpaceOAR® Hydrogel is Now Covered by Geisinger and TRICARE
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 negatively affect patient health and quality of life during radiotherapy, and for years afterwards.
SpaceOAR hydrogel reduces the radiation dose delivered to the anterior rectum and reduces the risk of injury. In a clinical study, SpaceOAR hydrogel demonstrated a 99% procedural success rate, a 73.5% reduction in radiation dose to the rectum, and significantly less quality of life impact at a median follow up of 3 years. (1) Injected as a liquid into the space between the prostate and rectum, SpaceOAR hydrogel gently pushes the structures apart and then solidifies into a soft hydrogel, which maintains space for approximately three months during radiation therapy then liquefies and is completely absorbed by the body.
SpaceOAR Hydrogel, is cleared by the U.S. Food and Drug Administration (FDA) and is currently being used in many leading cancer centers throughout the United States. It has also received CE Mark approval in Europe, is approved in Australia and Japan, and is licensed in Canada. To date, over 25,000 patients worldwide have benefited from the SpaceOAR hydrogel procedure.
See the Instructions for Use for complete information on potential risks, warnings, and precautions. For more information, visit SpaceOAR.com.
About Augmenix, Inc.
Augmenix, Inc. is a privately held company based in the Boston area and focuses on the development and commercialization of radiation oncology products using its proprietary hydrogel technology. Focusing initially on protection during prostate radiation therapy, their next-generation products will address spacing and marking applications throughout the body to improve radiotherapy and interventional oncology procedure outcomes. SpaceOAR is a registered trademark of Augmenix, Inc. More information about Augmenix and the SpaceOAR hydrogel can be found at http://www.SpaceOAR.com.
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.
Risks associated with the implantation of SpaceOAR hydrogel:
In addition to the risks associated with any medical procedure there are potential complications that may be associated with the use of the SpaceOAR System that include, but are not limited to: pain or discomfort associated with SpaceOAR hydrogel; needle penetration or injection of SpaceOAR hydrogel into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding, constipation; and rectal urgency.
April Renzella, 781-902-1621
Source: Augmenix, Inc.