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

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By Business Wirevia The Motley Fool

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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.

ALACHUA, Fla.–(BUSINESS WIRE)– RTI Biologics Inc. (RTI) (NAS: 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’ 13th 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 …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

RTI Biologics Launches New Line of Biologic Implants at Americas Hernia Society's 15th Annual Hernia

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RTI Biologics Launches New Line of Biologic Implants at Americas Hernia Society’s 15 th Annual Hernia Repair Conference, March 13-16



Company will host symposium luncheon on March 13

ALACHUA, Fla–(BUSINESS WIRE)– RTI Biologics Inc. (RTI) (NAS: RTIX) , a leading provider of orthopedic and other biologic implants, is launching a new line of biologic implants used in hernia repair procedures at the Americas Hernia Society‘s 15th Annual Hernia Repair Conference held at JW Marriott Grande Lakes, Orlando, Fla., March 13-16. The implants will be distributed directly by the company’s new Surgical Specialties business unit.

Tutopatch™ bovine pericardium and Tutomesh™ fenestrated bovine pericardium are non-crosslinked acellular collagen matrices that offer a safe and natural biologic option for hernia repair. The implants offer equivalent strength1 to the leading implant in the market and are sterilized through RTI‘s Tutoplast® Tissue Sterilization Process. The Tutopatch and Tutomesh implants are clinically proven and have been implanted by surgeons in Europe for more than 10 years.

Cortiva™ allograft dermis offers high mechanical strength2,3, rapid cellular repopulation4,5,6 and features a faster rehydration time compared with other dermis grafts (rehydrating in 30 seconds on average)7. Dermis is collagenous connective tissue with three-dimensional intertwined fibers. The Cortiva implant is also sterilized through RTI‘s Tutoplast Tissue Sterilization Process rendering non-crosslinked acellular dermal matrix that retain mechanical properties of native dermis.

“We are excited to begin direct distribution of Tutopatch and Tutomesh bovine pericardium and Cortiva allograft dermis through our newly developed distribution force for Surgical Specialties,” said Brian K. Hutchison, RTI president and CEO. “Surgeons in need of biologics for hernia repair can expect safe, quality implants from a provider they trust. We will be filling out our hernia portfolio in the coming months with the introduction of our porcine dermis implant.”

The Tutoplast Tissue Sterilization Process is a validated chemical sterilization process that thoroughly penetrates tissue, removing antigenicity and inactivating pathogens. Terminal sterilization using low dose gamma irradiation achieves a sterility assurance level (SAL) of 10-6.

AHS Luncheon Symposium

In addition to launching …read more
Source: FULL ARTICLE at DailyFinance