ND PHARMA & BIOTECH DEMINERALIZATED BONE MATRIX BIOLOGICAL IMPLANTS STERILE

1. 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.
2010
ND Pharma & Biotech
Departamento Científico
01/01/2010

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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.

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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

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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.

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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.

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© ND Pharma & Biotech
2010
POLIGONO DE VALDREDO
33157
CUDILLERO, ASTURIAS
SPAIN