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Nd Pharma & Biotech BONE MATRIX

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ND PHARMA & BIOTECH

ND PHARMA & BIOTECH
DEMINERALIZATED BONE MATRIX
BIOLOGICAL IMPLANTS
STERILE

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    Nd Pharma & Biotech BONE MATRIX Nd Pharma & Biotech BONE MATRIX Document Transcript

    • 2010 ND Pharma & Biotech DEMINERALIZED BONE MATRIX MATRIZ OSEA DESMINERALIZADA ND Pharma & Biotech is the leading provider of sterile biological implants for surgeries around the world. ND Pharma & Biotech prepares human donated tissue and bovine tissue for transplantation through extensive testing and screening, precision shaping and proprietary, validated sterilization processes. ND Pharma & Biotech Departamento Científico 01/01/2010
    • These allograft and xenograft implants are used in dental, head and neck, ophthalmology, spine, sports medicine, urology and other specialty surgeries. Our 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 fully validated sterilization processes that include viral inactivation steps. Two such processes, the Totalcleanse® Tissue Sterilization Process and the Allplast® process, sterilize tissue, are clinically successful and are scientifically proven to eliminate donor-to-recipient disease transmission risk while preserving tissue strength and biocompatibility. These processes have a proven record of more than a million implants distributed with zero incidence of infection. In addition, ND pastes are sterilized through the demineralization process; a validated viral inactivation step. The company is leading the evolution of biologics once again by offering a bovine based biological matrix, providing surgeons an expanded supply of safe, sterile tissue for their patients. 2
    • Biologic Implants There are five categories of implants that we prepare for implantation: •Sports Medicine ◦ACL repair and other knee procedures ◦Foot and ankle procedures ◦Shoulder repair ◦Joint repair •Spinal Implants ◦Cervical and Lumbar procedures •Dental ◦Dental Bone Grafting ◦Dental Implant procedures •Bone Graft Substitutes ◦General Orthopedic procedures ◦Trauma repair ◦Oncology procedures •Surgical Specialties ◦General Orthopedic procedures ◦Hernia repair ◦Breast reconstruction ◦Ophthalmology ◦Urology 3
    • Allografts The source of all allografts is tissue that has been donated by people upon their death, with the consent of their family or loved ones. ND PHARMA & BIOTECH processes donated tissue for implantation by surgeons into patients who are in need of tissue regeneration and healing. ND PHARMA & BIOTECH honors the gift of tissue donation by: •finding new ways to utilize the tissue to help patients, •increasing the use of the tissue that has been donated, and •helping as many patients as possible from each donation. Xenografts ND PHARMANATURAL® Biological Matrix provides surgeons an expanded supply of safe, sterile tissue. Bovine bone sterilized through the Allcleanse® process can be used in any application where a natural biologic scaffold is needed and provides an option for procedures previously limited by tissue availability and material constraints. Natural Biological Matrix is a safe and natural alternative to autograft, allograft and synthetic resorbable materials. Studies show Sterling grafts are equivalent to allograft biomechanically and remodel with patients' own bone comparably to allograft. 4
    • Biologics vs. other materials Allograft vs. other options: When you recommend surgery for your patients, in most cases you have options. Will you use allograft, autograft or metal/synthetic implants? Autograft: While autograft is osteoconductive (provides a scaffold for new bone to attach to) and osteoinductive (stimulates growth of new bone), it must be harvested from the patient’s body in a painful and potentially dangerous second surgery. In some cases, the patient may not even have sufficient quantities of tissue suitable for transplant; when they do and autograft is harvested, complications may occur such as morbidity at the harvest site, infection, nerve and artery damage, joint instability acute or recurrent pain. In addition, this second surgery means additional time under anesthesia. Metals/synthetics: Metals can be tooled for specific applications and are designed for use with instrument sets for faster and more precise surgeries. The patient spends less time on the operating table, and the surgeon has a uniform process that can be repeated easily. However, metals and synthetics do not promote bone remodeling and since the material is stiffer than the adjoining bone, can actually cause weakening and fragility of surrounding bone or even cause it to disappear in these areas. In many cases, there is no metal or synthetic option, such as for tendons or other soft tissue used in sports medicine repair. Allograft: When properly processed, the patient’s body remodels with allograft the same way it does with autograft. There is no rejection of allograft, and no “typing” required. Allograft has all the advantages of autograft, such as remodeling, without the complications and danger of a second surgery site. Additionally, unlike autograft, which must be shaped in the operating room, allograft can be pre-shaped and precision tooled like metals, decreasing the amount of time required in surgery. Great strides have been made in allograft safety with the invention of technologies such as ND PHARMA & BIOTECH Totalcleanse®, the risk of disease transmission through allograft transmission is essentially eliminated. 5
    • © ND Pharma & Biotech 2010 POLIGONO DE VALDREDO 33157 CUDILLERO, ASTURIAS SPAIN 6