Until the early
1990s, if an orthopedic surgeon wanted to repair a damaged
vertebra or some other bone using natural tissue, he or she
had to whittle a replacement piece right in the operating
“Doctors did their best carpentry work on the operating
room back table,” says Jamie Grooms, the former president
of Regeneration Technologies Inc. “The better carpenters
had a better success rate.”
Often that tissue came from the patient’s own body,
known as autograft. Usually it was a piece of the hip, acquired
through a separate surgery and necessitating a longer, more
painful recovery. Occasionally, it would be bone obtained
from a deceased person, known as allograft. Either way, preparing
the implant was an often lengthy and imprecise process.
“If you needed bone, usually you’d use the patient’s
bone. The morbidity involved in taking the iliac crest (hip
bone) was real and permanent,” says Dr. Peter Gearen,
chair of the UF Department of Orthopaedics and Rehabilitation.
“It was a tough surgical situation. The opportunity
to take a graft right off the table was a great improvement.”
Grooms had worked in all phases of the tissue banking industry
by the time he was hired in 1992 to direct a small tissue
bank in the Department of Orthopaedics and Rehabilitation
that had only six employees and was recovering tissue from
fewer than 50 donors a year.
During his eight years in the business, Grooms had become
convinced that bone could be machined into very small, precisely
sized screws and dowels, complete with threads, notches and
slots that would accommodate operating room instruments.
“I believed these new allografts could take the place
of metal pins, screws and dowels,” Grooms says. “So
patients would be able to regenerate their own natural tissue,
instead of having metal in their bodies the rest of their
But almost nobody else believed with him.
“I proved the principle that you could thread bone and
it would hold the thread,” Grooms says. “I presented
it to numerous companies, and they all thought it was a bad
idea. It was one kid’s belief. I had no data.”
So Grooms hired Kevin Carter, whom he calls “the ultimate
machinist,” and they started machining bone themselves
at the UF Tissue Bank.
“I would bring Kevin metal implants and say ‘Let’s
make this in bone,’ and he would,” Grooms says.
Finally, Grooms convinced the medical device company Sofamor
Danek to apply its marketing and distribution capabilities
to his concept and in 1996 the first precision-shaped allograft,
a threaded cortical dowel, hit the market.
Backed by Sofamor Danek’s marketing, demand for the
dowels took off, and in 1998 the UF Tissue Bank spun off its
allograft technology to a new company, Regeneration Technologies
Inc., or RTI.
Current RTI Chairman and CEO Brian Hutchison says that first
dowel changed orthopedic surgery forever.
“It demonstrated something everyone in orthopedics thought
was possible but had never proved,” Hutchison says.
“We finally had a biological solution that fit physiologically,
immunologically and clinically.”
Today, RTI offers hundreds of different machined bone products,
plus bone paste and soft tissue like ligaments. Last year
RTI processed more than 165,000 implants.
Hutchison says other companies have now followed RTI’s
lead, but that RTI has worked hard to stay ahead of the pack
through innovations like its BioCleanse Tissue Sterilization
RTI spent several years developing the BioCleanse process,
which eliminates bacteria, fungi and spores, as well as viruses
such as HIV and hepatitis, without compromising the tissue’s
strength and biocompatibility. Since March 2003 RTI has been
labeling its bone implants “sterile,” meaning
they meet the same sterility assurance level as metal and
“This label gives surgeons assurance that the tissue
they implant is as free from bacteria, viruses, fungi and
spores as metal or synthetic implants and other medical products,”
Hutchison says. “In addition we believe BioCleanse tissue
heals faster and better because the process cleans the bone
without destroying its structure. At the end of the healing
process, we don’t want the patient to feel as if they
ever had surgery.”
Perhaps the greatest challenge in the human tissue industry
is maintaining a positive public perception about tissue donation
so there will be a sufficient supply of tissue to meet the
demand for implants.
“The source of all allograft is tissue that has been
donated by people upon their death, with the consent of their
family or loved ones,” Hutchison says. “RTI honors
the gift of tissue donation by treating the tissue with respect,
by finding new ways to use the tissue to help patients and
by helping as many patients as possible from each donation.”
Hutchison admits RTI has had detractors, mostly non-profit
tissue banks who decry the company’s for-profit approach.
He says he has worked hard to foster more professionalism
and cooperation in the industry.
“There has been too much fighting within the industry,”
Hutchison says. “I have spent a lot of time building
relationships. The potential for this industry is huge. None
of us has to fail for the rest of us to be successful.”
Today, the fruits of the university’s relationship with
RTI can be seen all over the Gainesville campus.
During the company’s early, lean years, the University
of Florida Research Foundation, or UFRF, took licensing fees
for the bone-shaping technology in hundreds of thousands of
shares of then practically worthless stock, leaving the company
cash to spend on operating expenses.
“We took a gamble,” says UF Vice President for
Research Win Phillips. “If the company succeeded, our
investment would pay off; if it didn’t, our shares would
The company did succeed and after RTI went public in August
2000, UFRF was able to sell its stock for more than $60 million,
half going to the Department of Orthopaedics and Rehabilitation
and half to the College of Medicine. The university is using
much of that money to help pay for the construction of two
buildings on campus — the Genetics and Cancer Research
Building and the Orthopaedic Surgery and Sports Medicine Institute.
Gearen says that when Grooms interviewed to become director
of the Department of Orthopaedics and Rehabilitation tissue
bank in 1992 he laid out a vision that included spinning the
department tissue bank off to become a direct support organization
of the university, then a for-profit company, then a publicly
traded company. Gearen even remembers discussion of a new
“He knew what he wanted to do,” Gearen says, “and
everything he outlined came to fruition.”
The Department of Orthopaedics and Rehabilitation is using
$27 million of its RTI royalties to construct the Orthopaedic
Surgery and Sports Medicine Institute, a 120,000-square-foot
building that will house all of the orthopaedic clinics and
other non-surgical functions of the department. It is scheduled
to open later this year.
“This building will offer us the opportunity to significantly
improve the efficiency and quality of patient care,”
Gearen says, “as well as make it much easier for patients
to receive services.”
Also included in the institute are radiology and physical
therapy facilities, making a visit to the orthopaedic clinic
a “one-stop” experience for most patients, Gearen
says. The building will also house a state-of-the-art Human
The College of Medicine contributed more than $27 million
of its RTI royalties to the construction of the 280,000-square-foot
Genetics and Cancer Research Building. The building will house
the university’s Genetics Institute, Shands Cancer Center,
Interdisciplinary Center for Biotechnology Research and C.A.
Pound Human Identification Laboratory. The facility will include
research laboratories, animal-research facilities, faculty
and administrative offices and a rooftop greenhouse. It is
expected to be completed in the spring of 2006.
“Think about it,” Gov. Jeb Bush marveled at the
April groundbreaking for the Genetics and Cancer Research
Building. “Money generated by the licensing of UF research
is now being rolled back into this research building. This
is exactly how we want university technology transfer to occur.”
Gearen credits Grooms with “recognizing when his personal
ability to run a for-profit company had reached its limits”
and recruiting Hutchison from the medical device company Stryker.
“RTI’s evolution from a start-up company to a
wonderfully run business is a testament to Jamie and Brian,”
Gearen says. “Jamie’s ego did not prevent him
from recognizing when he was in over his head on the business
end. Usually that doesn’t happen.”
Grooms is now president and CEO of another Gaines-ville start-up
called Axogen, which is developing technologies for using
allograft nerve tissue to repair nerve damage.
RTI maintains close ties to the university, with Gearen serving
on the board of directors, and Hutchison says he looks forward
to future collaborations with the university.
“If there are opportunities to work with the university,
we want to do it,” Hutchison says. “A lot of great
ideas come out of there and we want to partner on those ideas.”
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