Augmenix Announces Positive SpaceOAR® Clinical Trial Results Demonstrating Superior Outcomes at 3-Years

Application of SpaceOAR hydrogel results in lower long-term rectal
injury and higher patient quality of life scores

WALTHAM, Mass.–(BUSINESS WIRE)–Today Augmenix, Inc. (http://www.spaceoar.com/),
a medical technology company that develops, manufactures, and sells
proprietary absorbable hydrogels that separate and protect organs at
risk during prostate radiotherapy, announced the 3-year results from the
SpaceOAR System Prostate Cancer US Pivotal Clinical Trial. These results
were presented at the 2016 American Society for Radiation Oncology
Annual Meeting in Boston, MA as a Late Breaking Abstract, an honor
reserved for highly significant and timely findings in clinical
oncology, radiobiology or medical physics. Entitled “Continued Benefit
to Rectal Separation for Prostate RT: Final Results of a Phase III
Trial”, the study results presented by Daniel Hamstra, MD, PhD, a
radiation oncologist at Texas Oncology in Irving, TX demonstrated
significantly lower rectal toxicity and higher patient quality of life
(QOL) scores when the SpaceOAR System was applied prior to radiotherapy
as compared to the trial control patients.


The leading side effects of prostate cancer radiotherapy are
collectively known as “rectal toxicity” (diarrhea, rectal bleeding,
urgency, pain, etc.), which results from unintended radiation injury to
the rectum (the Organ At
Risk, OAR). These complications can last
for years, significantly impacting QOL. The SpaceOAR System was
developed to push the rectum away from the high dose region during
treatment, and then to be completely absorbed by the body after
radiotherapy is complete.

The prospective, randomized, multi-center, patient-blinded clinical
trial evaluated rectal and urinary toxicity and QOL impact on prostate
radiotherapy patients treated either with SpaceOAR hydrogel, or with no
hydrogel (Controls). Previously published initial study results
demonstrated spacer safety, and a significant 74% reduction in the
volume of rectum receiving 70 Gray radiation at 15 months. Presented
today were the patient results three years after the start of prostate
radiotherapy.

Following radiotherapy through 3 years no SpaceOAR patients (0%)
experienced grade 2 or worse late rectal toxicity, compared to 5.7% in
the Control patients (p=0.012). Additionally, at 3 years the average
SpaceOAR patient bowel QOL was slightly better than before radiotherapy
(+0.48 points), while the Control patients QOL had significantly
declined (-5.3 points, p=0.05). The percent of men with significant 10+
declines in bowel QOL at 3 years was 20.5% and 5.4% in the Control and
SpaceOAR groups (p=0.02), respectively. Unexpectedly, the SpaceOAR
patients also showed benefits in urinary complications and QOL, relative
to Controls. In the three years after radiotherapy, grade 1 urinary
incontinence was experienced in 19.6% and 4.3% of the Control and
SpaceOAR patients, respectively (p=0.003). Additionally, like bowel QOL,
at 3 years the average SpaceOAR patient urinary QOL was slightly better
than before radiotherapy (+0.6 points), while the Control patient QOL
had declined (-3.3 points, p=0.05).

“The low level of rectum radiation dose seen in the men who received the
spacer in this trial is unprecedented, and it is great to see that the
spacer rectum protection is resulting in long-term patient benefits,”
said Dr. Hamstra. “The idea that three years after treatment patients
can be having the same bowel and urinary QOL is wonderful. Essentially
patients can complete their treatment and be confident that life can
return to normal.”

“Patient quality of life is the new standard for long-term outcomes.
This is the first study ever, showing that prostate radiotherapy
patients can complete their treatment, and then get their lives back,”
said John Pedersen, Augmenix CEO. “Further, this validation of the
spacer concept supports our strategy to improve radiotherapy procedures
all over the body.”

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. The SpaceOAR System is FDA Cleared, CE marked and is also
approved in Australia and Canada. Augmenix also markets TraceIT®
Hydrogel, the world’s first absorbable hydrogel tissue marker with CT,
MRI and ultrasound visibility. TraceIT Hydrogel is FDA cleared as an
absorbable tissue marker, and is CE marked and approved in Australia as
an absorbable tissue marker and spacer. See the Instructions for Use for
complete information on potential risks, warnings and precautions.

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
Eileen Gardner, RN, 781-902-1625
egardner@augmenix.com