Augmenix Announces Positive Three-Year Long-Term Data Highlighting Benefits of SpaceOAR® Hydrogel Spacer for Patients with Prostate Cancer

Results published in the International Journal of Radiation Oncology
Biology and Physics
show on average no long-term declines in
bowel and urinary quality of life for patients and 78% reduction in late
rectal toxicity.

WALTHAM, Mass.–(BUSINESS WIRE)–Augmenix, Inc., a medical technology company that develops,
manufactures, and sells proprietary absorbable hydrogels that separate
and protect organs at risk during prostate radiotherapy, announced that
the International Journal of Radiation Oncology Biology and
Physics
(IJROBP), also known as the Red Journal, has
published long-term outcomes data from the company’s Phase 3 clinical
trial for SpaceOAR System, the first absorbable hydrogel spacer designed
to separate the rectum and prostate during prostate cancer radiotherapy.


The Red
Journal publication
reports three-year post-treatment data in the
Phase 3 prospective, randomized, multi-center, patient-blinded clinical
trial of the SpaceOAR System. The study evaluated radiation dose to
critical structures (prostate, rectum, bladder, penile bulb), rectal and
urinary toxicity and quality of life (QOL) impact on prostate cancer
patients treated with and without SpaceOAR System during radiotherapy.
For QOL, the Expanded Prostate Cancer Index Composite (EPIC) was
utilized. The SpaceOAR System is the only product that is FDA cleared to
provide a barrier between the prostate and rectum to decrease toxicity
and minimize changes in QOL following prostate radiotherapy. It is
injected as a liquid and then solidifies into a soft hydrogel that
pushes the rectum out of the high-dose prostate radiation field for
three months during radiation therapy. The hydrogel is absorbed by the
body in the months following treatment.

During radiotherapy the spacer resulted in a 73.5% reduction in rectal
V70 radiation dose, and a 49% reduction in median penile bulb radiation
dose in patients treated with SpaceOAR (SpaceOAR) compared to men who
did not receive SpaceOAR hydrogel (Control). In the three years
following radiation treatment the SpaceOAR group demonstrated a 78%
reduction in late rectal toxicity complications, compared to Control
patients. No patients in the SpaceOAR group (0%) experienced grade two
or worse rectal toxicity, compared to 5.7% in the Control group. Results
also showed a 75% reduced risk of mild urinary incontinence among
patients treated with SpaceOAR compared to Control. At three years, the
average SpaceOAR patient bowel and urinary QOL measure was the same as
before radiotherapy, while the Control patients QOL measures had
significantly declined.

Overall patient wellness at three years was also assessed by looking at
the percent of patients with clinically significant declines in all
three QOL areas (bowel, urinary and sexual). Fully 20% (one in five) of
the Control patients had clinically significant QOL declines in all
three QOL areas compared to only 2.5% (one in forty) of the SpaceOAR
patients.

“These results further validate the safety and efficacy of the SpaceOAR
System and highlight the long-term benefits it can provide to prostate
cancer patients who are treated with radiotherapy,” said Daniel Hamstra,
MD, PhD, radiation oncologist at Texas Center for Proton Therapy. “By
creating a space between the rectum and prostate, SpaceOAR can help
prevent risks of injury to surrounding healthy tissue during radiation,
representing an important advantage for thousands of men treated for
prostate cancer each year.”

“Following radiation therapy, patients often experience a decline in
urinary, bowel and sexual function which in some cases can be extreme.
These data show that the benefits seen in the use of SpaceOAR are
durable and support the use of SpaceOAR hydrogel spacing during
radiotherapy for prostate cancer with the potential to help many
patients return to and maintain pre-treatment quality of life,” said
John Pedersen, CEO of Augmenix.

About SpaceOAR System

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 affect patient health and quality of life during radiotherapy,
and for years afterward. In recent years, radiation oncologists have
considered use of “spacing” techniques to reduce the risk of radiation
injury to surrounding tissue during radiotherapy. SpaceOAR System is
intended to temporarily position the anterior rectal wall away from the
prostate during radiotherapy for prostate cancer and in creating this
space it is the intent of SpaceOAR System to reduce the radiation dose
delivered to the anterior rectum. The SpaceOAR System is injected as a
liquid into the space between the prostate and rectum where it pushes
the structures apart and then solidifies into a soft hydrogel. The
hydrogel remains stable for three months and then liquefies and is
completely absorbed by the body after radiation treatment is over. The
SpaceOAR System is FDA cleared and is currently being used in the
majority of leading cancer centers in the United States. It is also CE
marked, approved in Australia and licensed in Canada. 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. Focusing initially
on protection during prostate radiation therapy, the Augmenix
next-generation products will address spacing and marking applications
throughout the body to improve radiotherapy and interventional oncology
procedure outcomes. The company was founded by Incept LLC in 2008 and is
funded by several leading venture capital groups. More information about
Augmenix and the SpaceOAR System can be found at http://www.Augmenix.com.

SpaceOAR is a registered trademark of Augmenix, Inc.

Contacts

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