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