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History of Regeneration Technologies, Inc.

»Jamie Grooms and the Allograft Industry
»The New Business Model at U.F. Tissue Bank
»Precision-Tooling Allograft
»Negotiating a Distribution Channel
»Spinning Off as a Private Company
»Building the Company
»The Future of RTI

Jamie Grooms and the Allograft Industry
After earning a biology degree from Old Dominion University, Jamie Grooms began working with a tissue bank in the Northeast, which introduced him to "allograft" tissue. Allograft is tissue recovered from another person, and most allograft recovered and used today comes from deceased donors via a network of not-for-profit tissue banks. Mr. Grooms rapidly moved on to Osteotech, Inc. (Nasdaq:OSTE), a company that was then at the forefront of tissue technology. At Osteotech he had the opportunity to bring innovation to the processing and manufacturing areas, and after two years he was recruited to CryoLife (NYSE:CRY), the largest and most successful company in the allograft industry at that time.

At CryoLife Mr. Grooms started working on tissue sterilization ideas and the machining of bone. It was here that he first came to realize that bone could be machined into very small, precisely sized screws and dowels, complete with threads, notches and slots that allowed them to be used with instrument sets. He realized these new allografts could take the place of metal pins, screws and dowels used in surgical procedures and, if he could commercialize them, patients would be able to regenerate their own natural tissue, instead of having metal in their bodies the rest of their lives. He tried and failed to convince CryoLife of the commercial viability of the technology, so he began looking for an opportunity to put his experience and knowledge to use.

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The New Business Model at U.F. Tissue Bank
In 1992 Mr. Grooms took the position of director of a small tissue bank at the University of Florida's (UF) Department of Orthopedics, hoping to work on his ideas for precisely shaped bone screws and dowels. At that time the tissue bank had only six employees, and was recovering tissue from only 50 donors a year.

Mr. Grooms knew that to make his ideas a reality, he would have to develop a new business model that would dramatically increase tissue donation, as tissue donation had been flat in the U.S. for many years. He also knew he would need to apply science and technology to tissue processing technologies to make them safer and more efficient. Importantly, he knew that to accomplish these goals he would need to create a successful and self-sustaining business model, and hire people who could effect these goals.

He recruited key people from national tissue and blood banking organizations. Together they developed a novel new hospital service plan that promoted tissue donation at every death, instead of using the traditional model that concentrated primarily on organ donors. They began doubling tissue donation each year, and by 1995 they had raised the level of tissue donation in North Florida to the highest percentage in the U.S. Today it is the most successful model in the country, recovering more than 2,000 tissue donors from a population base of 3.2 million, compared to other top programs which recover only 500 - 600 donors out of population bases three times greater.

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Precision-Tooling Allograft
Anxious to begin work on his concept of precision tooling bone tissue into screws, pins and dowels, Mr. Grooms recruited machinists and scientists to work with him on tissue processing. In 1995, Mr. Grooms and UF moved the tissue bank into a separate not-for-profit structure, the University of Florida Tissue Bank (UFTB). By 1996, several new allograft implants had been developed, including a ligament attachment screw and a threaded bone dowel for use in spinal surgeries. The tissue bank had grown to 15 employees, but did not yet have the processing facilities or distribution network to cover its R&D costs. With all available credit tapped, the company's future depended on getting its products launched on a large scale as soon as possible.

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Negotiating a Distribution Channel
Mr. Grooms realized that the company would not survive without capital to build production of its new allografts and without a network to distribute them. He found a single answer to both problems. He learned that Medtronic Sofamor Danek (NYSE:MDT), the largest spinal orthopedics distributor in the U.S., was facing stiff competition from a rival company's new metal spinal surgery dowel, and wouldn't be able to get FDA approval for its own metal version for another three years. Although UFTB's threaded bone dowels had not yet been perfected, Mr. Grooms convinced Medtronic that the bone dowels would surpass strength requirements, and the companies began negotiating for distribution rights.

In mid-1996 Mr. Grooms was introduced to Richard Allen, a principal in a technology and business consulting firm working in technology development and licensing. Mr. Allen and Mr. Grooms worked together on negotiations with Medtronic and, in July 1996, Medtronic infused $2.5 million into the tissue bank in return for distribution rights to the bone dowel and other spinal grafts. The tissue bank used the funding to build out its production facilities. With production and distribution now in place, the company was poised to explode into high growth.

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Spinning Off as a Private Company
During 1997 Mr. Grooms and Mr. Allen worked on the strategic plan, business plan and financial forecasts for a spin-off company that would privatize the new business and bring in the capital needed for it to flourish. After negotiations with officials from the University of Florida, they won approval for a largely equity-based spin-out, contingent upon receiving a certain level of venture backing. They then packaged the business plan for venture capital groups and took to the road in search of funding. In February, 1998, they formally spun off Regeneration Technologies, Inc. (RTI) from UFTB, bringing in $6.5 million in venture funding primarily from Lehman Brothers, Inc. and Adler and Company.

By 1999, capitalizing on the funding provided, the company had launched a dozen graft products, including new versions of threaded dowels, pins, interbody fusion grafts and the new Osteofil injectible and Opteform molded bone pastes. The company also completed development of its BiocleanseTM tissue sterilization system, a system that allowed sterilization of allograft bone tissue without affecting the biomechanical properties of the bone.

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Building the Company
The company's revenue grew from $35 million in 1998 to $73 million in 1999 and to $122 million in 2000, while profits grew from $0.18 per share in 1999 to $0.22 per share in 2000. In August, 2000 RTI completed its IPO, bringing in $75 million, of which $25 million went to UF for approximately 25% of its total equity holdings. The company joined the Nasdaq exchange under the ticker symbol RTIX.

The company expanded its market beyond orthopedic applications, into oral maxillofacial, urinary and cardiovascular surgeries, and its innovations continuously raised the bar of science and safety in the allograft industry.

After the IPO the company went through two years of challenges mounted largely by a consortium of large not-for-profit tax-exempt companies that had dominated the industry before RTI appeared. The attacks slowed the company's growth by attempting to disrupt the tissue supply and by lobbying legislators in an attack on RTI's innovative tissue sterilization systems. RTI emerged successfully, however, with the FDA eventually endorsing the company's safety and sterilization systems, which led to rekindled growth.

In the fourth quarter of 2001 Mr. Grooms, with the Board's approval, brought in a new president and CEO, Brian Hutchison, to take over operations of the company. Mr. Grooms recruited Mr. Hutchison from his position as Executive Vice President of Stryker Corporation (NYSE:SYK), one of the largest and most successful orthopedics manufacturers in the world, and his hiring left RTI in strong hands. Shortly after the hiring of Mr. Hutchison, Mr. Allen stepped down as CFO, allowing Mr. Hutchison to hire for the position. And after a short transition period as Chairman of the Board, Mr. Grooms resigned that position to allow Mr. Hutchison to assume both executive positions.

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The Future of RTI
RTI continues to be a leader in science and safety, and the largest and most successful allograft tissue processing company in the world. It has built a solid reputation within the medical device industry, and is projecting growth of approximately 30% per year. Its BioCleanse system now allows it to process and deliver allograft tissue labeled sterile per AAMI and ISO standards, providing the most complete measure of sterilization in the industry. And it is expanding distribution through new marketing relationships while growing in its current markets.

Both Mr. Grooms and Mr. Allen remain on excellent terms with RTI's leadership, and both are still significant stockholders in the company. Mr. Grooms continues to represent RTI on the Board of Directors of Organ Recovery Systems, Inc., a company in which RTI maintains a substantial ownership interest.