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Tutogen Medical, Inc. Sells donated human tissues includes dura mater, bone

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Is a World Leader in safe bioimplants for tissue repair, with offices in

Parsippany, NJ  and Erlangen, Germany and tissue processing facilities in

Alachua, FL and Neunkirchen, Germany.  The company's main products are

allografts which are donated human tissues preserved for reimplantation in

humans.

Symbol: TTGN

Tutogen Medical, Inc. (formerly Biodynamics International, Inc.), is a world

leader in safe bioimplants for tissue repair, with offices in Parsippany, NJ

and Erlangen, Germany and tissue processing facilities in Neunkirchen Germany

and Alachua, FL. The Company's main products are allografts which are donated

human tissues, preserved with the Company's patented Tutoplast® process of

tissue preservation and viral inactivation. The Company is expanding it's

technology to xenografts, (tissues from animals) and to tissue engineered

grafts with a biological base

Tutoplast® processed dura mater serves as a scaffold for the ingrowth of host

tissues so that during the course of healing, the implant is replaced. 

Therefore, neither explantation nor re-operation is required.  The Tutoplast®

process removes antigens which minimizes the potential for immune reaction

Tutoplast® processed Bone / Clean Bone are solvent dehydrated, gamma-

irradiated whole and crushed human bone.  The Tutoplast® Bone / Clean Bone are

indicated for areas requiring additional bone pieces, such as filling of bone

defects and plastic reconstruction of resected or damaged bone areas.

Tutoplast® processed Pericardium is indicated for implantation with a specific

spectrum of indications.  Collagenous connective tissue with multidirectional

fibers retains the mechanical strength and elasticity of native pericardium,

while providing the basic formative structure to support replacement by new

endogenous tissue. 

Tutoplast® processed fascia lata serves as a scaffold for the ingrowth of host

tissues so that during the course of healing, the implant is replaced.  

Therefore, neither explantation nor re-operation is required.  The Tutoplast®

process removes antigens which minimizes the potential for immune reaction. 

Competitive Advantage

Safety - Tutogen's competitive advantage is it's patented Tutoplast® process

for tissue preservation and viral inactivation. The process is based on

solvent dehydration, as distingished from freezing or cryopreservation. It

preserves the tissue's integrity, and the implants are remodeled by the body's

own cells in the course of normal healing. The process has an outstanding

safty record. Since its introduction more than 25 years ago, more than 750,000

procedures have been performed using Tutoplast® processed tissues. There are

no known complications from disease transmission or tissue rejection

attributable to the implants. Tutoplast® processed implants have been descibed

in a substantial number of published scientific papers. Tutoplast® implants

meet FDA requirements for marketing in the United States and are recognized

for their outstanding quality.

Worldwide Distribution - Currently, some 80% of TTGN's revenues come from

outside the United States. TTGN has a worldwide distribution network with

representation in more than 40 countries. A major effort is under way to

increase penetration in major European markets and especially in the U.S.

Market. With its tissue processing facility in the U.S., TTGN is in a unique

position to accomplish this objective.

Strategy for Growth

The present market for bioimplants is approximately $1.2 billion worldwide.

The broader market of biomaterials for tissue repair is approximately $4

billion, 55% in the U.S. The market is driven by the aging population, the

more active life styles and the increasing emphasis on life enhancement in

addition to curing disease. Market growth in the segments in which Tutogen

competes is estimated to be in double digits.

The Company's strategy for growth is to leverage the exsting allograft

business, the worldwide distribution organization and the Tutoplast®

technology into a major franchise in biomaterials for tissue repair.

Product development strategy in the short run will focus on maximizing the

potential of the allograft business through specialty products in soft tissues

and hard tissues (bones). In addition, the product scope with be broadened

through the development of xenografts (tissues from animals). There is

scientific evidence that Tutoplast® processed xenografts are equivalent to

Tutoplast® processed allografts. TTGN is also pursuing the developement of

tissue engineered biomaterials with major market potentail, in as much as

Tutoplast® processed tissues are expected to represent ideal carriers for

tissue engineered products. Major unfilled needs are in fields such as bone

repair, cartilage repair and vascular grafts for bypass surgery.

Tutogen is an investment opportunity in biomaterials for tissue repair with a

line of proven products and a technology upside.

Website at http://www.tutogen.com/start.htm

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