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Body Builders
There's enough biomedical research and industry in the state to put together a Bionic Floridian.
In a sprawling, glass-walled laboratory in the north-central Florida town of Alachua, a technician dressed in blue scrubs and protective headgear loads small, white chunks of material into a stainless steel machine called a Fadal.
Fadals were designed to mill and manufacture parts for the auto and aerospace industries -- or any industries requiring intricate, precise designs cut from chunks of metal. But these pieces aren't metal. They're human tissue -- harvested from the recently deceased, then rushed in coolers to the 130,000-sq.-ft. complex of Regeneration Technologies Inc.
RTI's business is turning donated human tissue -- including bone, cartilage, tendon, ligament and cardiovascular tissue -- into precision implants for orthopedic and other surgeries. There in the lab, the technician taps a code into his computer. The Fadal machine spins. It chooses the drill bit needed to create a sugar-cubed sized implant called a spinal allograft.
RTI later puts this implant, along with all the other products manufactured from the same donor, through a sterilization process called BioCleanse. The spinal allograft will be freeze-dried, shipped to a medical-distribution company and then to an operating room, where a surgeon will implant it into a patient suffering from neck or back pain due to spinal disk degeneration. Because it's made of human tissue, it will remodel with the patient's own bone, and, over time, heal the spine.
When it comes to life-altering medical research in Florida, the talk is often "if only." If only Scripps Research Institute could get clearance to build in Palm Beach County. If only the state would pony up $200 million over the next 10 years for embryonic stem-cell research.
But some 70 biotech companies, 80 pharmaceutical companies and 400-plus medical device companies in Florida, along with its university research institutes, already are bettering the human body. At the University of Miami's Biomechanics Research Lab, athletes are hooked up to machines, their motions captured in 3-D by cameras, by reflective body markers, by gait-analyzing plates built into the floor. At the University of Florida, scientists use CT scans, computer modeling and other mechanical-engineering technologies to create longer-lasting artificial knees.
Statewide, the industry has enough biomed to put together a Bionic Floridian. Florida Trend did it with some of the newest biologics coming out of Florida's biotech companies and universities; with some of the classic cardio and orthopedic devices produced by Florida companies; and with the products that portend the industry's future -- a meshing of hardware and biologics.
The pages that follow use only a fraction of the devices and research going on in Florida companies and universities. In some cases, the body part is an actual product your surgeon could order from the company. In others, it's in FDA trials and not yet approved for humans. In others, it's still a researcher's dream -- effective in mice but years away from human use.
Unlike TV's $6-million bionic man, Steve Austin, Trend's Bionic Floridian may not be "better than he was before, stronger, faster..." but he does have a strong jaw, a good heart and no cavities.
The Bionic Floridian
SKULL
Who: Walter Lorenz Surgical
Where: Jacksonville
Walter Lorenz Surgical has been supplying surgeons with craniomaxillofacial products for more than 30 years. The company's Hard Tissue Replacement-Patient Matched Implants (HTR-PMIs) replace missing or depressed sections of the skull in cases of large or complex skull defects, such as in patients who've suffered trauma, tumor removal or congenital abnormalities. The synthetic implants are created with a patient's own CT scan and have a rigidity similar to bone.SHOULDERS
Who: Florida Orthopaedic Institute
Where: Tampa
Dr. Mark Frankle, an orthopedic surgeon at Tampa General Hospital who also serves on the University of South Florida's biomedical engineering faculty, has developed a shoulder prosthesis for patients with severely torn rotator cuffs. The Reverse Shoulder Prosthesis, made of titanium, looks more like a hip. A deeper socket and bigger ball provide improved stability and give patients a better-functioning shoulder.BONES
Who: University of Central Florida
Where: Orlando
Molecular biology professor Kiminobu Sugaya and mechanical, materials and aerospace engineering professor Sudipta Seal are combining coatings, nanotechnology and stem-cell technology to create a better transplant bone. Their biocompatible bone is coated with the patient's own stem cells. The hope is this bone will incorporate into the patient's own tissue much faster than artificial bone -- and that it will help build new bone-marrow tissue.SKIN
Who: Nanotherapeutics
Where: Gainesville
The UF nanotechnology spinoff that works on new ways of delivering drugs also has a skin-care line that delivers nutrients like coenzyme Q-10 into the deepest layers of the skin. The company says its Lunaderm product restores elasticity and reduces the appearance of wrinkles. (Non-cosmetic work continues: The National Institutes of Health this year awarded Nanotherapeutics a major grant to develop disposable inhalers of antibiotics for post-exposure protection against pneumonic plague and tularemia -- two deadly bioterrorism agents.)HEART
Who: Cordis Corp., a Johnson & Johnson company
Where: Miami Lakes
Probably the most successful medical-device company in the state, Cordis Corp. makes the first drug-eluting stent approved by the FDA. The company's CYPHER stent has been a breakthrough for patients with coronary artery disease. The device, which combines a proven metal stent with anti-rejection medication called Sirolimus, reopens clogged heart arteries with only minimally invasive surgery.CELLS
Who: Florida Atlantic University
Where: Boca Raton
Professor Herb Weissbach, director of FAU's Center for Molecular Biology and Biotechnology, was part of an international team that used the fruit fly to study aging. The team found that certain genetic alterations could almost double the lifespan of the fly. More specifically, they identified a gene with the information to produce a complex protein that protects cells against oxidative damage. The protein, or enzyme, called MsrA (methionine sulfoxide reductase), can also repair cell damage. MsrA exists in all cells, including human cells. Today, Weissbach and other colleagues at FAU continue to study how it might protect cells -- and possibly prolong life.EYES
Who: University of Florida
Where: Gainesville
Chemical engineering professor Anuj Chauhan is working to create soft contact lenses that contain tiny, drug-filled particles capable of releasing medications slowly and steadily into the eye. Chauhan hopes his drug-delivery research will someday allow patients with cataracts, glaucoma and other eye diseases to avoid the eye drops that can seep into the blood stream and cause side effects ranging from impotence to heart problems.JAW
Who: Mydea Medical, a division of Mydea Technologies
Where: Orlando
Mydea takes MRI or CT scan data and uses them to produce physical medical models. Sometimes the models from this "direct digital manufacturing" process are used for surgical planning. Other times, like in the case of this custom jaw, they're used as "rapid tooling"; for implants. The implants, made from materials such as stainless steel and titanium, fit perfectly because they're made from the patient's own digital scan.TEETH
Who: Oragenics
Where: Alachua
Scientists at the UF spinoff have come up with a genetically engineered bacteria that prevents tooth decay -- at least in the lab and in the mouths of rats. This year, the company launched clinical trials to see if the engineered bacteria can be safely used in human mouths. If so, in the future people could receive a painless, five-minute treatment from their dentist and be free from cavities for life.HANDS
Who: Ortheon Medical
Where: Winter Park
Hand-tendon repair and finger replacements are so difficult to perform, and so specialized, that they're generally done in only major surgical centers, by hand specialists. But Ortheon was founded to bring a technology called Teno Fix to the general-surgery market. Surgeons insert the small, anchoring coil into a damaged tendon, where it gathers collagen fibers as it turns, harnessing the strength of the tendon. The technology is designed to give patients a speedier return to normal motion than under standard tendon-repair surgeries.TENDONS
Who: Regeneration Technologies Inc. (Nasdaq-RTIX)
Where: Alachua
Regeneration Technologies uses donated ligaments and tendons to create allograft implants that replace torn ligaments in knees, shoulders and other parts of the body.HIP
Who: Exactech (Nasdaq-EXAC)
Where: Gainesville
Exactech sells hip, knee, shoulder and biologic devices to orthopedic surgeons around the world. Exactech is hoping to elevate its presence in the hip market with the use of diamond technology. It's partnered with Utah diamond technology company Diamicron Corp. to investigate the promise of polycrystalline diamond compact for use in hip implants. Preliminary tests show the implants offer better mechanics and wear than currently available technology.KNEES
Who: BioMotion Foundation
Where: West Palm Beach
The non-profit research foundation developed a type of knee that makes knee-replacement surgery available to younger, more active patients. More than 250,000 people a year get knee replacements, but the vast majority are older than 65. The replacements weren't available to young people with serious problems because they wear out in about 15 years. BioMotion's "3-D Knee" is expected to last twice that long. And it has a 150-degree range of motion: Similar to normal knees and superior to the 115-degree range offered by most artificial knees. The foundation partnered with Austin, Texas-based Encore Medical Corp. to sell the knees.LEGS
Who: University of Miami, Biomechanics Research Lab
Where: Miami
The Biomechanics Lab has earned a reputation for breakthroughs with amputees in athletics, figuring out, for example, how to make a running prosthesis faster. UM scientists' work helped Paralympic gold medalist Danny Andrews of Miami set a world record in the 400-meter relay last year.IMMUNE SYSTEM
Who: VaxDesign
Where: Orlando
New biotech company VaxDesign is working with the U.S. Defense Advanced Research Projects Agency and other funders on "engineered vaccines." Traditionally, vaccines are developed the same way they have been for more than 100 years -- using whatever pathogen the vaccine is meant to fight. VaxDesign is bypassing the pathogen and instead manipulating the body's own dendritic cells -- the cells that initiate immune response -- to program the immune system to fight against disease. The company is also working on an artificial immune system, replicating in the lab skin, lungs and other points of pathogen entry in order to test vaccines much more quickly, reliably -- and cheaply -- than is possible today.SPINE
Who: U.S. Spine
Where: Boca Raton
U.S. Spine is working on an artificial disc hoped to mimic the human disc in both structure and function. As the body ages, the spinal discs in between vertebrae wear out and collapse, creating pinched nerves and tremendous pain. The Spartacus restores the collapsed space, freeing pinched nerves and preserving natural movement. The device is made from a proprietary polymer and fiber matrix and behaves as a shock absorber for the spinal column. It has no moving parts but is designed to rotate, bend and stretch naturally. The company expects to begin human clinical trials on Spartacus in 2007 and hopes to release it in 2010.
