Augmenix Announces First Commercial Use Of SpaceOAR™ System For Prostate-Rectum Separation In Prostate Cancer Patients

Main Category: Prostate / Prostate Cancer
Also Included In: Medical Devices / Diagnostics;  Radiology / Nuclear Medicine;  Urology / Nephrology
Article Date: 12 Aug 2010 - 3:00 PDT


Augmenix, Inc. announced that Prof. Michael Eble and Dr. Michael Pinkawa of the Aachen University Hospital, Aachen, Germany, performed a commercial implantation of the company's CE Mark approved SpaceOAR™ System. The SpaceOAR hydrogel (from spacing Organs At Risk) is designed to be a tissue compatible, absorbable spacer to reduce radiation injury to healthy tissues.

"The potential for radiation injury to nearby healthy tissues is always a concern for Radiation Oncologists, and the SpaceOAR hydrogel is a simple, easy-to-use tool that should reduce undesirable rectal radiation in prostate cancer patients. I look forward to using SpaceOAR hydrogel in my prostate cancer population and in other pelvic tumors such as vaginal, cervical, and endometrial cancers," said Dr. Pinkawa, Radiation Oncologist.

Since the prostate lies directly over the rectum, prostate radiation treatment always results in some rectal radiation which can lead to pain, rectal bleeding, urgency, and other serious complications. This injury potential forces a treatment compromise, between delivering enough radiation to kill the cancer and having acceptable complication rates. The Augmenix technology can alter that compromise by moving the organs at risk away from the high intensity radiation zone.

SpaceOAR System is a synthetic hydrogel composed of approximately 90% water, with the remaining solids being cross-linked polyethylene glycol (PEG). Injected as a liquid, the material solidifies in the body to form an absorbable hydrogel that maintains space between the prostate and rectum during radiation therapy, and then gradually liquefies and is absorbed. In a procedure lasting only minutes, Dr. Pinkawa used transrectal ultrasound guidance to inject the hydrogel through a 18 gauge needle using only a local perineal block.

SpaceOAR System is the first implantable, absorbable product designed specifically to protect vulnerable tissues during radiotherapy. "We look forward to bringing this product to market, and to provide Radiation Oncologists and Urologists with a new tool that protects healthy tissues", said Amar Sawhney, Augmenix CEO. "I am extremely enthusiastic about this technology and truly believe it will offer a new level of hope to men facing treatment for prostate cancer and potentially other malignancies", said Jeff Michalski, MD, Vice Chairman and Professor, Washington University, St. Louis, MO.

Source: Augmenix, Inc.

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