1. Changing Lives through Tissue Donation Bruce W. Stroever, President & CEO Musculoskeletal Transplant Foundation

2.  MTF is an AATB accredited, non-profit tissue bank located in NJ  MTF provides over 400,000 grafts per year throughout the US  Partnered with Gift of Life Michigan for over 20 years in the recovery, processing and distribution of tissues to hospitals in Michigan

3. MTF is a non-profit service organization dedicated to providing quality tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families. MTF Mission Statement

4. Two Novel Tissue Forms  Flex HD – Acellular dermis  Trinity Evolution – Viable cryopreserved cellular bone matrix

5. Acellular Dermis Used primarily for:  Abdominal wall repair  Reconstruction following mastectomy Essentially a sheet of human collagen processed from human skin

6. What Makes a Good Hernia Repair Material?  Strong enough to withstand physiological stress over a period of time  Conforms to the abdominal wall  Promotes strong host ingrowth, which mimics normal healing  Resists formation of bowel adhesions and erosion into visceral structures  Doesn’t induce allergic or foreign body reaction  Resists infection

7. What Makes a Good Hernia Repair Material?  Strong enough to withstand physiological stress over a period of time  Conforms to the abdominal wall  Promotes strong host ingrowth, which mimics normal healing  Resists formation of bowel adhesions and erosion into visceral structures  Doesn’t induce allergic or foreign body reaction  Resists infection

8. Revascularization Gross examination of acellular dermal matrix after 8 weeks in rabbit study revealed neovascularization around graft perimeter Source: FlexHD Acellular Dermal Matrix. Histology: In Vitro and In Vivo Studies

9. Acellularity Before ProcessingAfter Processing Processing removes cells and maintains matrix integrity Intact matrix structure allows for cell infiltration and revascularization Source: FlexHD Acellular Dermal Matrix. Histology: In Vitro and In Vivo Studies

10. Preserved Collagen Elastin, in conjunction with collagen, contributes to the strength and structure of the dermal matrix scaffold Source: FlexHD Acellular Dermal Matrix. Histology: In Vitro and In Vivo Studies Magnification shows collagen fibrils in normal skin (left) and acellular dermis (right).

11. Abdominal Wall Repair  Wound dehiscence  Trauma  Infected sites Source: T.N. Robinson et al, Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. Surgical Endoscopy 2005; 19:1556-1560. Source: DermaMatrix Acellular Dermis brochure General - Applications Abdominal Wall Repair

12. Plastic - Applications Source: DermaMatrix Acellular Dermis brochure Breast Reconstruction – Post Mastectomy

13. 10 months Post-Op Pre-op *All images and patient data owned by E. Parra-Davila, MD, permitted use by MTF only. Do not redistribute Case Studies: Repair and Reconstruction

14. A Major Concern of the Surgeon is the Size of the Graft  Use of dermatomes – 8cm maximum width  Shift to free hand dissection – 20 x 24cm  Skill of the recovery team is key to producing large grafts

16. Viable Cryopreserved Cellular Bone Matrix  Trinity Evolution

17. Trinity Evolution: Inception  Background:  Stem cells are critical in facilitating bone repair  Bone marrow aspirates containing live stem cells often taken from the patient during surgery and combined with bone graft for fusion/bone healing applications  Limitations include limited volume and second surgery site  Trinity Evolution concept:  Novel tissue form containing viable stem cells inside an allograft bone matrix

18. Bone Formation Osteoconductive (Scaffold) Osteoinductive (Growth Factors) Osteogenic (Living Cells) Autograft Allograft Synthetics BMP DBM Trinity Evolution

19. Structure & Function What are the key characteristics of Trinity Evolution? Osteoconductive MatrixOsteoinductive FactorsOsteogenic Cells

20. Stem Cell Characterization CD166 positiveOsteocalcin positive Trinity Evolution contains stem cells that are capable of forming bone

21. Production in the Core  3 teams work around-the- clock  Processing completed within 96 hours post mortem  Processing technology maintains:  Cell viability  Cell location within the matrix

22. Cryopreservation at MTF

23. Clinical Applications To expedite the bone healing process for spinal and orthopaedic needs

24. Spinal Fusion

25. Critical Issues for Fresh/Viable Allografts  Time Time Time – the current shelf life of Trinity Evolution is about 6 months  All paperwork and testing must be expedited for tissue to be usable  Sterile Technique  These tissues are processed at risk  More than 15% of all donors are rejected following recovery  No graft sterilization is possible

26. Thank You