Serica Presents New Data Showing Potential to Reduce Failure in Rotator Cuff Repair Using a Bioresorbable Silk-Based Implant in Animal Model


MEDFORD, Massachusetts, and DUNDEE, Scotland, July 2 /PRNewswire/ --

- A second study indicates initial safety, efficacy of silk-based
implant for ACL repair in animal model.

Serica Technologies today reported first data on the use of a
non-mammalian derived silk-based long-term bioresorbable implant for rotator
cuff tendon (RCT) repair, which demonstrated potential to reduce primary
repair failure following surgery, in an animal model. Data presented at the
British Orthopaedic Research Society (BORS) meeting in Scotland showed that
the SeriCuff(TM) Scaffold helped to re-establish the tendon footprint and
resulted in significantly increased repair strength three months following
surgery, in a sheep rotator cuff repair model.

"There is documented high incidence of re-tear following rotator cuff
tendon repair, which is necessitating the development of new clinical
strategies for tendon footprint augmentation," said Gregory H. Altman, Ph.D.,
President and CEO, Serica Technologies. "Our device is showing potential as a
preventative measure to rotator cuff re-ruptures in mid to large RCT tears,
thereby avoiding the need for surgical revision."

In a podium presentation, "Infraspinatus Tendon Footprint Reinforcement
with a Bioengineered Long-Term Bioresorbable Silk Fibroin Tendon Overlay in a
Sheep Rotator Cuff Repair Model," Rebecca Horan, PhD, the study's lead
investigator and Serica's Senior Director, Research and Development, reported
that 10 sheep were implanted with the SeriCuff device. The animals were able
to walk following surgery, with return to a normal gait at an average of six
days. Pain scores diminished throughout the first two weeks after surgery. A
42% increase in repair strength was reported with the SeriCuff device
reinforced repair at three months, and the device supported the formation of
Sharpy's fibers in the remodeling tendon tissue.

In a second study presented at the meeting, "Clinical, Mechanical and
Histopathological Evaluation of a Bioengineered Long-Term Bioresorbable Silk
Fibroin Graft in a One Year Goat Study for Development of a Functional
Autologous Anterior Cruciate Ligament," Horan also reported on the
SeriACL(TM) Graft, a non-mammalian derived long-term bioresorbable
multi-bundled silk-based implant for repair of the anterior cruciate ligament
(ACL) in the knee.

In this study, 43 goats were implanted with the SeriACL Graft and
pre-clinical results demonstrated the safety of the device, with initial
indications of efficacy.

About the Technology

Serica is developing natural silk biomaterials designed to help stabilize
soft connective tissue structures -- such as ligaments and tendons --
following surgical repair. The company's grafts for ACL and rotator cuff
tendon repair, as well as its surgical meshes and gels, are comprised of the
fiber of the B. mori silkworm. Silk has a proven track record of safety over
centuries of human use and Serica's technology seeks to provide predictable
and controlled bioabsorption by the body, which is a major advantage in many
tissue repair and reconstructive surgical procedures.

Serica's biomaterials are intended to act as "scaffolds" to provide
support and relief to damaged tissues, and promote restored function. These
implants are designed to allow the natural tissue to heal and resume normal
function, as the implant is slowly resorbed by the body during the recovery
period.

In clinical studies, Serica's 100 percent silk-based products are shown
to be bioresorbed at slower rates than other common structural proteins, such
as collagen, to facilitate healing. Its products require no re-hydration or
advance preparation for surgical implantation.

Serica Technologies, Inc., formerly Tissue Regeneration, Inc., is a
growth-stage medical device company pioneering silk-based biomaterial
platforms for tissue rejuvenation. Incorporated in 1998, Serica's proprietary
products currently in preclinical and clinical development are being studied
in the areas of orthopedic and sports medicine, aesthetic and reconstructive
plastic surgery and other structural tissue repair needs. Serica's team of
engineers and scientists are located in a state-of-the-art 22,000-square-foot
office, R&D and manufacturing facility in Medford, MA. For more information
about Serica Technologies, please visit http://www.sericainc.com.

Web site: http://www.sericainc.com

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