Bonding To Bone
University of Florida materials scientist Larry Hench was just trying to help injured Vietnam veterans when he combined calcium, phosphorous, sodium, silica and oxygen in the late 1960s and created BioglassT.
The original intent of BioglassT was to replace metal and plastic implants then being used to mend bones shattered in battle. The body's rejection of the implants was causing many veterans to lose limbs to amputation.
More than a quarter century later, BioglassT remains the only known man-made substance capable of forming a physiochemical bond with human bone and soft tissue. All clinical trials to date have established that BioglassT is non-toxic in humans and enhances the body's healing response. There have been no reported cases of infection or adverse reactions to the presence of BioglassT products.
These unique capabilities have made BioglassT a mainstay of the dental industry, where it is used to combat the bone loss inherent in extractions and periodontal disease. Also, BioglassT can help clinicians save natural teeth and avoid some of the pain, discomfort and cost associated with denture replacements.
BioglassT also has been used to replace bones in the middle ear damaged by such things as childhood infections.
Now, USBiomaterials, the company to which UF has licensed the BioglassT rights, is aggressively pursuing even more applications for this amazing material.
"Technological advances have given us a greater understanding of what occurs at the interface between human tissue and BioglassT," says USBiomaterials President James L. Meyers. "This has given us new insights into Bioglass'T potential applications."
USBiomaterials' current flagship product is PerioGlasT, a surface-active bone grafting product that accelerates the repair and regeneration of the alveolar bone lost to periodontal disease. The company recently received FDA clearance for broader applications, including ridge augmentation procedures and filling extraction sockets after teeth are pulled.
When teeth are extracted (some 50 million procedures are performed every year), the jawbone begins to recede. Previously, clinicians would leave the extraction site void, leading to further bone loss. PerioGlasT can be used to repair extraction sockets, adhering to bone and promoting regeneration.
Periodontal disease also leads to loss of bone. PerioGlasT repairs the alveolar bone and tissue loss due to disease. It is activated in the presence of water, saline or the patient's blood. PerioGlasT stops bleeding at the site and can be sculpted by the clinician as needed to conform to the defect.
USBiomaterials also manufactures a version of PerioglasT for uses in veterinary medicine under the trade name ConsilT.
It is estimated that Americans spend more than $2 billion a year on dental implants and reconstructive orthopedic devices. Experts believe bioceramic products could capture much of this market, and eliminate the costs of repeat surgeries needed in many cases to remove and replace metal or plastic devices that wear out or malfunction.
USBiomaterials CEO Mento A. Soponis says, "The opportunities beyond periodontology and otolaryngology are very promising, especially in the areas of orthopedics and wound healing."
The experience with BioglassT in dental applications indicates that it not only bonds well with human tissue, but that it actually enhances the healing process.
USBiomaterials is scheduled to introduce a BioglassT bone grafting product called OsteoglasT in Europe this year. OsteoglasT will be used in spinal surgeries to enhance fusion between two or more vertebrae.
The company also has plans to seek FDA approval this year for a BioglassT-based toothpaste for hypersensitive teeth. Company officials are currently negotiating with several major toothpaste manufacturers to add BioglassT to their formula.
"We have found that BioglassT goes beyond the moment of brushing to effectively block the tubules that cause hypersensitivity," Meyers says. "It may also help to restore the mineral coating on teeth."
To date, USBiomaterials' innovations have garnered seven U.S. patents. Nine other applications have been filed with the U.S. Patent Office and more are being prepared.
Meyers and Soponis say USBiomaterials' business strategy is to fund external research on BioglassT applications at UF and other university research centers around the country, then to partner with leading health-care product manufacturers to reach a particular segment of the market.
Several UF researchers continue to explore potential applications for BioglassT in such fields as dentistry, orthopedics and wound healing.
Soponis says the company, which is currently privately owned by about 300 shareholders, "is maturing into a candidate for a public offering." He says the pace of current product development and the condition of the stock market are key elements in any decision to go public.
And what of BioglassT inventor Larry Hench? After a long and successful career at UF, Hench moved to Great Britain last year and assumed a position as a chaired professor of ceramic materials at the Imperial College of Science, Technology and Medicine in London. He still holds an appointment at the University of Florida as an emeritus graduate research professor of materials science engineering. He also serves as a consultant to USBiomaterials.