RTI Biologics Announces Positive Clinical Results for BioCleanse®-Processed BTB Allografts Used in ACL Reconstruction

  RTI Biologics Announces Positive Clinical Results for BioCleanse®-Processed
  BTB Allografts Used in ACL Reconstruction

Company to highlight implant at American Academy of Orthopaedic Surgeons’ 2013
                       Annual Meeting in Chicago, Ill.

Business Wire

ALACHUA, Fla. -- March 20, 2013

RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic and
other biologic implants, is pleased to announce the results of a recent
randomized prospective clinical study of BioCleanse^®-processed bone-patellar
tendon-bone (BTB) allografts used in anterior cruciate ligament (ACL)
reconstruction surgery. The study was published in the peer reviewed journal,
Knee Surgery, Sports Traumatology, Arthroscopy, in December 2012.

The article compares the clinical outcomes of BTB allografts processed using
RTI’s patented BioCleanse Tissue Sterilization Process with a control group
consisting of aseptically-processed allografts from the three U.S. tissue
banks that provide this type of allograft. According to the American
Association of Tissue Banks’ 13^th edition of Standards for Tissue Banking,
aseptic processing refers to the processing of tissue using methods to
prevent, restrict or minimize contamination with microorganisms from the
environment, processing personnel, and/or equipment. A total of 67 patients
undergoing ACL reconstruction at six independent investigation sites were
evaluated at six, 12 and 24 months. After randomization, 24 patients received
aseptic BTB allografts and 43 patients received BioCleanse-sterilized
allografts.

“These results indicate that the sterilization process, BioCleanse, did not
demonstrate a statistical difference in clinical outcomes for the BTB
allograft at two years,” authors find. “The BioCleanse process may provide
surgeons with allografts clinically similar to aseptically-processed allograft
tissue with the benefit of addressing donor-to-recipient disease.”

According to Millennium Research Group’s “U.S. Markets for Orthopedic Soft
Tissue Solutions 2011” report, more than 457,400 ACL reconstructions are
performed annually in the U.S., with 21 percent of those using allograft
implants. According to the authors, the use of allograft tissue in ACL
reconstruction has been noted to decrease operating time, eliminate donor site
morbidity and increase the tissue available for multi-ligament cases. The one
disadvantage compared with autografts (the use of one’s own tissue) or metal
and synthetic implants, is that disease can be transmitted as a result of an
aseptically-processed allograft.

However, RTI’s BioCleanse Tissue Sterilization Process, a patented, validated,
automated process provides surgeons with a safe option for allografts. The
system sterilizes tissue to SAL 10^-6 using a complex, proprietary combination
of mechanical and chemical processes, working in conjunction with each other.
The mechanical component applies oscillating positive and negative pressure in
the presence of the chemical agents (including detergents and sterilants),
which gently perfuse the tissue. This combination removes blood and lipids,
and inactivates or removes pathogenic microorganisms. Repeated water rinses
throughout the process remove debris, and final water rinses remove residual
chemicals, leaving the tissue biocompatible. The BioCleanse process does not
use excessive heat or irradiation to sterilize tissue.

“This study provides further evidence that BioCleanse-processed implants are a
safe alternative to autografts,” said Roger Rose, RTI’s executive vice
president and chief commercial officer. “BioCleanse sterilizes tissue without
the potentially harmful side effects of other methods.”

The safety of allograft tissue is contingent on three stages: donor screening,
laboratory testing and tissue preparation validated to address potential
disease transmission. Some companies rely only on donor screening, laboratory
testing and aseptic processing for the safety of their implants.

“When we launched BioCleanse in March 2000 it was the first of its kind in
terms of allograft tissue sterilization for our industry,” said Brian K.
Hutchison, president and CEO. “The low-temperature chemical sterilization
process inactivates or removes bacteria, fungi, spores and viruses from tissue
without compromising the biocompatibility or structural integrity of the
tissue. The positive results of this clinical study prove just that. Surgeons
and patients can rest assured knowing that RTI provides allografts that will
maintain their biomechanical integrity the same as aseptically-processed
implants, while addressing the risk of donor-to-recipient infection.”

Where possible, RTI has advanced beyond the use of aseptic processing, which
does not ensure the removal or inactivation of microorganisms inherent to the
donor or tissue, to better protect recipients from the risk of
donor-to-recipient disease transmission. RTI’s proprietary, validated
sterilization processes have a proven track record of more than four million
implants distributed with zero incidence of implant-associated infection. To
learn more, visit www.rtibiologics.com/safety/sterilization-processes.

The article entitled, “Aseptically processed and chemically sterilized BTB
allografts for anterior cruciate ligament reconstruction: a prospective
randomized study,” can be downloaded for free at
http://link.springer.com/article/10.1007%2Fs00167-012-2309-7. Authors are:
Peter A. Indelicato, University of Florida, Gainesville, Fla.; Michael G.
Ciccotti, Thomas Jefferson University, Philadelphia, Pa.; Joel Boyd, TRIA
Orthopaedic Center, Minneapolis, Minn.; Laurence D. Higgins, Brigham and
Women’s Hospital-Ortho, Boston, Mass.; Benjamin S. Shaffer, George Washington
University, Washington, D.C.; and C. Thomas Vangsness Jr., University of
Southern California, Los Angeles.

To learn more about RTI’s BioCleanse-processed BTB allografts, as well as the
company's full biologic portfolio, visit the RTI Biologics booth, #3823, at
the American Academy of Orthopaedic Surgeons’ 2013 Annual Meeting in Chicago,
Ill., March 19-23.

About RTI Biologics Inc.

RTI Biologics Inc. is a leading provider of sterile biologic implants for
surgeries around the world with a commitment to advancing science, safety and
innovation. RTI prepares human donated tissue and xenograft tissue for
transplantation through extensive testing and screening, precision shaping and
using proprietary, validated processes. These allograft and xenograft implants
are used in orthopedic, dental and other specialty surgeries.

RTI’s innovations continuously raise the bar of science and safety for
biologics – from being the first company to offer precision-tooled bone
implants and assembled technology to maximize each gift of donation, to
inventing validated sterilization processes that include viral inactivation
steps. These processes — BioCleanse®, Tutoplast® and Cancelle® SP DBM — have a
combined record of more than four million implants distributed with zero
incidence of implant-associated infection. These processes have been validated
by tissue type to inactivate or remove viruses, bacteria, fungi and spores
from the tissue while maintaining biocompatibility and functionality.

RTI’s worldwide corporate headquarters are located in Alachua, Fla., with
international locations in Germany and France. The company is accredited by
the American Association of Tissue Banks in the United States and is a member
of AdvaMed.

Contact:

RTI Biologics Inc.
Jenny Highlander, APR, 386-418-8888
Manager, Corporate Communications
jhighlander@rtix.com
 
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