ALACHUA, Fla--(BUSINESS WIRE)--Mar 12, 2013--RTI Biologics Inc. (RTI) (Nasdaq: 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 15 th 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 strength 1 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 strength 2,3, rapid cellular repopulation 4,5,6 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 the implant line at the AHS conference, RTI will also host a luncheon presentation and discussion on Wednesday, March 13 from 12 to 1 p.m. featuring David Nocca, M.D., Ph.D. from the Department of Digestive Surgery at the University Hospital of Montpellier in Montpellier, France. Nocca will present “Biosurgical Technology and Technique-Based Considerations for Ventral Hernia Repair.” Tutopatch and Tutomesh bovine pericardium and Cortiva allograft dermis are currently available for distribution. For further information, visit the RTI booth, #207, at the Annual Hernia Repair Conference or contact an RTI representative at (877) 612-4287.
1 Data on file at RTI Biologics, Inc.
2 Data on file – Doc #7042. Benchtop Testing comparing Cortiva to Standard Tutoplast Sterilized Dermis 2013.
3 Hollinsky C, Sandberg S. Measurement of the tensile strength of the ventral abdominal wall in comparison with scar tissue. Clinical Biomechanics. 22 (2007) 88 – 92.
4 Data on file – 4 & 8 week rat model comparing Cortiva1mm to Standard1mm Tutoplast Sterilized Dermis 2012.5.
5 Deeken CR, Melman L, Jenkins ED, et al. Histologic and biomechanical evaluation of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral incisional hernia repair. J Am Coll Surg.
2011 May; 212(5):880-8.
6 Novitsky YW, Rosen MJ. The biology of Biologics: Basic Science and Clinical Concepts. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2): 9S-17S.
7 Data on file – Rehydration study comparing Cortiva to Standard Tutoplast Sterilized Dermis 2013.
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.