The Strong New Choice MILLION. From A Provider. You Already Know

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Transcription:

The Strong New Choice MILLION From A Provider You Already Know

MILLION With more than three million implants distributed with zero incidence of implantassociated infection, the Tutoplast Tissue Sterilization Process has a proven 40-year history of reliability and safety.

Non-crosslinked acellular dermal matrix A Leading Biologics Provider Worldwide RTI provides sterile biologic implants for surgeries around the world with a commitment to advancing science, safety and innovation. Major Medical Device Companies Distribute Our Implants to Hospitals Every Day Spine/Orthopedics Sports Medicine General Surgery Reconstructive Surgery Urology Ophthalmology

All The Benefits of Tutoplast 1, 2 Quality You Know You Know and Trust Only Better* Ready In Seconds MAINTAINS THE BENEFITS OF TUTOPLAST STERILIZED DERMIS - INCLUDING LIMITED STRETCH Cortiva rehydrates faster just 0 seconds 11 High Mechanical Strength, 4 Equivalent Revascularization 1 Ultimate Tensile Strength Angiogenesis 80 70 60 50 40 0 20 81.2 N (± 2.9N) Abdominal Wall UTS is 0N 80.8 N (± 22.8N) Tutoplast 4 2 1 Scores per 200x objective field at 0 to 4 scale; = 10 to 20 vascular profiles 4 Weeks 8 Weeks Pre-clinical studies demonstrate revascularization as early as 7 days post implantation. 1 AlloDerm RTU ** requires a two minute soak FASTER REHYDRATION 50 40 0 20 10 1, 5, 6 Rapid Cellular Repopulation Absolute Cell Counts in Implants at 4 Weeks Lymphocytes Macrophages Fibroblasts Multi-step preservation and sterilization process (SAL10-6 ) Removes antigenicity and inactivates pathogens Histological Evaluation at 8 Weeks 1 200x Magnification Arrows denote blood vessels. Maintains structure, biomechanics and remodeling characteristics Implants have 5-year room temperature shelf life no refrigeration Referenced in 900+ publications (see Clinical References 7-10 for examples) Tutoplast Clinical Efficacy 12 Laparoscopic Paraesophageal Hernia Repair With Acellular Dermal Matrix, Including Tutoplast Sterilized Dermis Age Patient Demographics & Results 60. +/- 1.9 yr BMI 0. +/- 5. Operative Time 182 +/- 56 min Length of Stay 2.6 days (range 1 to 8) Recurrences Clinical 2/46 (4.%) Radiographic 2/26 (7.7%) Dysphagia 6/46 (1%) Early Complications 9/46 (19.6%) 10 9 8 7 6 5 4 2 1 Ready in Seconds 11 Tutoplast 0 Seconds 5 Minutes Tutoplast Sterilized Dermis 2 Minutes ALLODERM RTU Why RTI Biologics? Multiple tissue types, sizes and shapes from one provider Consignment or stock inventory 10 Minutes ALLODERM * This refers to reduced rehydration time. Data on file at RTI Biologics, Inc. ** AlloDerm is a trademark of LifeCell

Always The Right Size Ordering Information Code Description Code Description DH0508 5 x 8 cm Cortiva allograft dermis DH2416 4 x 16 cm Cortiva 1mm allograft dermis DH0416 4 x 16 cm Cortiva allograft dermis DH2616 6 x 16 cm Cortiva 1mm allograft dermis DH1010 10 x 10 cm Cortiva allograft dermis DH2816 8 x 16 cm Cortiva 1mm allograft dermis DH1015 10 x 15 cm Cortiva allograft dermis DH2508 5 x 8 cm Cortiva 1mm allograft dermis DH115 1 x 15 cm Cortiva allograft dermis DH2710 7 x 10 cm Cortiva 1mm allograft dermis DH0204 2 x 4 cm Cortiva allograft dermis DH2412 4 x 12 cm Cortiva 1mm allograft dermis DH0510 5 x 10 cm Cortiva allograft dermis DH2612 6 x 12 cm Cortiva 1mm allograft dermis DH0710 7 x 10 cm Cortiva allograft dermis DH2812 8 x 12 cm Cortiva 1mm allograft dermis DH0412 4 x 12 cm Cortiva allograft dermis DH2820 8 x 20 cm Cortiva 1mm allograft dermis DH1620 16 x 20 cm Cortiva allograft dermis DH015 10 x 15 cm Cortiva 1mm allograft dermis DH0616 6 x 16 cm Cortiva allograft dermis DH620 16 x 20 cm Cortiva 1mm allograft dermis DH0816 8 x 16 cm Cortiva allograft dermis DH0612 6 x 12 cm Cortiva allograft dermis DH0420 4 x 20 cm Cortiva allograft dermis DH0620 6 x 20 cm Cortiva allograft dermis DH1220 12 x 20 cm Cortiva allograft dermis Clinical References 1. Data on file 4 & 8 week rat model comparing Cortiva 1mm to 1mm Tutoplast 2012 2. IMS Hospital Usage of biologics report that substantiates that Tutoplast is a market leader in hospital acquisition of allograft dermis.. Data on file Doc #7042. Benchtop Testing comparing Cortiva to Tutoplast 201. 4. 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. 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;10(5 Suppl 2): 9S-17S. 7. Kapan S, Kapan M, Goksy E, et al. Comparison of PTFE, pericardium bovine and fascia lata for repair of incisional hernia in rat model, experimental study. Hernia. 200 7:9-4 8. Van Tuil C, Saxena AK, Willital GH. Experience with management of anterior abdominal wall defects using bovine pericard. Hernia. 2006 10:41-47. 9. D Ambra L, Berti S, Feleppa C, et al. Use of bovine pericardium graft for abdominal wall reconstruction in contaminated fields. World Journal of Gastrointestinal Surgery. 2012 July 27; 4(7): 171-176. 10. Cavallaro A, Lo Menzo E, Di Vita M, et al. Use of biological meshes for abdominal wall reconstruction in highly contaminated fields. World Journal of Gastrointestinal Surgery. 2010 April 21; 16(15): 1928-19. 11. Data on file Rehydration study comparing Cortiva to Tutoplast 201. 12. Roth JS, Diaz DF. Laparoscopic Paraesophageal Hernia Repair with Acellular Dermal Matrix Cruroplasty. JSLS, Journal of the Society of Laparoendoscopic Surgeons. (2011) 15:55-60. 1. Greenspan DC, Hernandez R, Faleris J. Histology of Surgically Implanted Tutoplast Processed Dermis. Unpublished data, 2008 Call 877-612-4287 to coordinate implant availability with your local representative. 11621 Research Circle Alachua, FL 2615 Toll Free: 877-612-4287 Fax: 86-518-6649 E-mail: rticustomerservice@rtix.com www.rtibiologics.com Ask about our full portfolio of Surgical Specialties implants. 201 RTI Biologics, Inc. 7405 R0 02/20/1