Augmenix Announces the Publication of the SpaceOAR® Hydrogel Pivotal Clinical Study Results: Application Technique and Patient Tolerance in Men Undergoing Prostate Cancer Radiotherapy

Study Demonstrates Safety, Excellent Patient Tolerance, and Improved
Patient Outcomes

WALTHAM, Mass.–(BUSINESS WIRE)–Augmenix,
Inc., a privately held company developing minimally invasive
hydrogel products to improve outcomes following cancer radiotherapy,
today announced the publication of the SpaceOAR®
System US Clinical Trial results of the application technique, and
impact on prostate intensity modulated radiation therapy (IMRT).
Designed to act as a temporary spacer, the absorbable hydrogel pushes
the rectum away from the prostate and reduces rectal radiation injury in
men undergoing prostate cancer radiotherapy.

Published in the March issue of Urology
Practice, an official journal of the American Urological Association
(AUA) that focuses on clinical trends, challenges and practice
applications, the paper describes outcomes in a randomized, controlled
Level 1 clinical trial evaluating IMRT in prostate cancer patients with
(SpaceOAR) and without (Control) the prostate-rectum spacing hydrogel.

“The simple concept of an absorbable spacer improving prostate
radiotherapy outcomes makes so much sense,” said Lawrence I Karsh, MD,
Director of Research and Attending Urologist, The Urology Center of
Colorado and a study investigator. “I insist on the best care for my
patients, and knowing this tool is now available increases my confidence
in achieving excellent radiotherapy outcomes.”

Between 2010 and 2013, 222 patients with stage T1 or T2 prostate cancer
were enrolled in 20 centers across the US. Either local, monitored or
general anesthesia was used in an outpatient procedure to implant the
hydrogel spacer. Patient tolerance of the spacer implantation procedure
was deemed excellent, with only 10% of the SpaceOAR patients
experiencing mild transient effects (e.g. transient perineal
discomfort). The hydrogel spacer increased the prostate-rectum space by
an average of 11mm (1.6 to 12.6mm), resulting in a significantly reduced
radiation dose to the rectum with no signs of altering the prostate dose
or increasing dose elsewhere. Median rectal (v70) radiation dose was
decreased by 78% in SpaceOAR patients relative to control (p<0.0001).

As anticipated, the reduced rectal radiation improved outcomes. Patients
in the SpaceOAR group experienced 76% less acute rectal pain events, a
71% reduction in the incidence of late rectal toxicity, and significant
reductions in late rectal toxicity severity. In addition, patients in
the SpaceOAR group experienced lower rates of decline in bowel quality
of life. The hydrogel spacer was absorbed when evaluated 12 months after
implantation and there were no implant infections, rectal wall
complications or other issues related to the implant.

“It’s rare you find a product concept with all the arrows pointing in
the right direction” said Amar Sawhney, Ph.D., company founder and
Chairman of the Board. “Safely reducing rectal injury during prostate
cancer radiotherapy will enable radiation delivery in fewer hospital
visits, improving patient convenience, increasing facility throughput
and saving healthcare dollars.”

The device received clearance from the U.S. Food and Drug Administration
(FDA) in April 2015 and since then, more than 100 cancer treatment
centers in 29 states and Washington, DC have adopted it. Augmenix will
showcase the SpaceOAR System at the 111th AUA Annual Meeting, taking
place May 6 – 10 in San Diego, CA.

The Augmenix Products
Using a minimally invasive procedure,
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. See the Instructions for Use for a complete list of
warnings, precautions and risks. The SpaceOAR System is 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, and is
finding utility as a marker to improve radiation targeting of bladder
tumors.

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.

Contacts

Augmenix, Inc.
Eileen Gardner
Director of Marketing
egardner@augmenix.com