Company Information

Tutogen Medical, Inc., a Florida corporation, was formed in 1985 and with its consolidated subsidiaries (collectively, the “Company” or “Tutogen”, develops, manufactures and markets sterile biological implant grafts made from human (allograft) and animal (xenograft) tissue. Tutogen utilizes its Tutoplast^® Process of tissue preservation and viral inactivation to manufacture and deliver sterile bio-implants used in dental, spinal, urology, ophthalmology, head and neck, and general surgery procedures.

One of the Company's wholly owned subsidiaries, Tutogen Medical GmbH, designs, develops, processes, manufactures, markets, and distributes specialty surgical grafts and services to over 20 countries through a worldwide distribution network. Another subsidiary, Tutogen Medical (United States), Inc., was formed in 1994 to process, market and distribute allografts for the U.S. market.

The Company's worldwide corporate headquarters is located in Alachua, Florida.The Company has a manufacturing facility in Alachua, Florida, as well as international executive offices, processing and manufacturing facilities in Neunkirchen, Germany, and a sales office in Boulogne, France.

            

 

Company Profile

Tutogen's primary bio-implants are allografts which are donated human tissues, treated by our proprietary Tutoplast^® process of tissue preservation and viral inactivation.  The Tutogen product portfolio consists of traditional grafts (conventional allograft material), xenografts (animal tissue products) and specialty grafts (precision machined implants).

The Tutoplast^® process is a proprietary tissue processing system designed to significantly reduce the amount of cells, bone marrow and lipid components from allograft bone and connective tissue while preserving the extracellular matrix (collagen and mineral components). The validated Tutoplast^® process inactivates and removes bacteria, viruses and prions, producing a cleaner and safer implantable graft.

Tutogen procures tissue from a network of licensed/accredited recovery sites, all of which are subject to the same stringent donor screening procedures. All recovered tissue undergoes the proprietary Tutoplast^® processing procedures.

Tutogen Medical, Inc. manufacturing operations are U.S. FDA registered, AATB accredited (U.S.), licensed in all states that have an applicable HCT/P requirement, certified to ISO 9001:2000 and 13485:2003, and licensed by BfArM/AMG (Germany) and AFSSAPS (France).

Tutogen adheres to strict quality control policies and procedures in all of its activities. These policies and procedures are routinely reviewed in order to stay abreast with changing regulatory requirements and state-of-the-art technologies.

Quality Assurance and Quality Control are central to our operations. Staff members who have no direct responsibility for processing review and approve the records independently. Our goal is to provide the highest quality and safest tissue for transplant.