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A Non Profit Organisation based in Colorado- USA.,

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Presentation on theme: "A Non Profit Organisation based in Colorado- USA.,"— Presentation transcript:

1 A Non Profit Organisation based in Colorado- USA.,
Founded in 1980 Founded by Dr.William H Hiatt DDS a Periodontist. Independent Tissue Processing Company without any affiliation to any other tissue bank Develops & Produce Irradiated allogenic cancellous bone and marrow for human transplantation. Approved by FDA Current Good Practices (cGTP) 21CFR 1271, the requirement of American Association of Tissue Banks “ Standard for Tissue Banking”

2 GLOBAL REGISTRATIONS/ACCREDITATION
Approval # OMB No: American Association of Tissue Bank Certificate # First Tissue Bank to obtain ISO certificate to distribute to European Union. Korean Approvals

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4 Rocky Mountain Tissue Bank Grafts: RMTB
RMTB grafts are "Donated Human Tissue" which have been prepared from a donor that has met the donor suitability criteria. Suitability is based on a documented Medical Director review of screening and testing records. These records include but are not limited to donor profile, informed consent, medical/social history, procurement documentation, microbiological testing, serology testing, hospital records (if applicable), autopsy report (if applicable), as well as all processing records. All Donors have been screened and shown negative for the presence of active infectious disease, malignancies, degenerative neurological disease of unknown etiology, and diseases of unknown etiology. Blood samples have been tested for relevant communicable diseases and shown negative for HIV 1 & 2, Hepatitis B Surface Antigen, Hepatitis B core (total). Hepatitis C antibody, HTLV 1 & 2, syphilis (RPR), nucleic acid test (NAT) for HIV 1 & HCV. Communicable disease testing was performed by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvements Amendments of 1998 (CLIA) and 42 CFR part 493.

5 Dental Procedures by Dr. Stuart Orton-Jones - Irradiated Bone Grafting
Indications:    -Sinus Augmentation -Sinus Lift -On-Lay Grafts -Periodontal Defects -Segmental Osteotomies - Tunnel Grafting - Socket Preservation -  Block Grafting Dental Procedures by Dr. Stuart Orton-Jones - Irradiated Bone Grafting Dental procedures by Dr. David Resnick - RMTB Bone Block Grafting To View Surgical Videos Click Above Links with internet connection Our Processing provides you the greatest assurance of allograft quality and safety.

6 Clinical Updates on Allografts
Socket Preservation and Sinus Augmentation Using a Medical Grade Calcium Sulfate Hemihydrate and Mineralized Irradiated Cancellous Bone Allograft Composite Robert Bagoff, DDS  Sachin Mamidwar, MS, MBBS Ioana Chesnoiu-Matei, DDS, MS John L. Ricci, PhD Harold Alexander, PhD Nick M. Tovar, PhD De Novo Bone Formation After the Sinus Lift Procedure Albert M. Price   Martha Nunn   Frank G. Oppenheim   Thomas E. Van Dyke Click Above Links with internet connection

7 Irradiated Allogenic Cancellous Bone and Marrow Graft Material
RM·CanPar (Cancellous Bone Particulate) CANCELLOUS PARTICULATE VIALS Irradiated Allogenic Cancellous Bone and Marrow Particulate Randomly sized. RM-Canpar 0.25mg RM-Canpar 0.50mg RM-Canpar 1.0 gm RM-Canpar 2.0 gm RM-Canpar 3.0 gm - Also available as RM-Corpar Cancellous Particulate Vials with Cortical Bones with same above quantities packing.

8 Irradiated Allogenic Cancellous Bone and Marrow Graft Material
CORTICAL / CANCELLOUS “BONE BLOCKS” Irradiated  Allogenic Cortical/Cancellous Bone Blocks D W L D W L 5 x 10 x 10 mm RM·BB x 10 x10 mm RM·BB 5 x 10 x 20 mm RM·BB x 10 x 20 mm RM·BB 5 x 10 x 30 mm RM·BB x 10 x 30 mm RM·BB D = Depth W = Width L = Length

9 Irradiated Allogenic Cancellous Bone and Marrow Graft Material
RM·BB (Bone Block) CORTICAL PARTICULATE VIALS- “BONE BLOCKS” Irradiated Allogenic Crushed Cortical Particulate Randomly sized 2-3 mm. RM·CorPar g RM·CorPar g

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11 Instructions for Use & Storage with Compliance – Mandatory Requirements
1. In the Rocky Mountain Tissue Bank processing, protocol, every effort is made to ensure the safety of our tissue. However, current technologies may not preclude the transmission of infectious agents. 2. The use of this tissue is limited to hospitals, physicians, dentists or other qualified medical professionals. 3. Allograft has been irradiated with betweeen 25 kGy and 38 kGy of irradiation. 4. Do Not Re-sterilize. 5. Store at Room Temperature. 6. It is the responsibility of the transplant facility and/or the clinician to maintain the allograft in the appropriate storage conditions prior to transplantation. 7. The Particulate grafts transport tube should be opened and inner sterilized vial placed in sterile surgical field; or the Bone Block outer pouch is opened and inner pouch is placed in sterile field. 8. Once the container seal has been compromised, the tissue shall be either transplanted or discarded. 9. No Special Handling is required. 10. No additional preparation is necessary for transplantation, such as diluting or reconstitution. 11. For Single Patient Use Only. **ADVERSE OUTCOMES ATTRIBUTED TO THE TISSUE MUST BE REPORTED PROMPTLY TO ROCKY MOUNTAIN TISSUE BANK. ***A PATIENT TRACKING FORM ACCOMPANIES EVERY TISSUE GRAFT, COMPLETE AND RETURN IT TO ROCKY MOUNTAIN TISSUE BANK IMMEDIATELY AFTER TISSUE IS TRANSPLANTED. ****IT IS THE RESPONSIBILITY OF THE TRANSPLANT FACILITY AND THE CLINICIAN TO MAINTAIN RECIPIENT RECORDS FOR THE PURPOSE OF POST-TRANSPLANT TRACING.

12 Marks Biotech Inc., 104/5, Second Floor, S-1, The Brown Building,
Radha Avenue 6th Street, Valasaravakkam, Chennai or Mani Krishnan

13 mani.krishnan@marksbiotech.com Or call +91 98198 93250
For more information and communication write back to : Or call


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