Press Release

Wed, Oct 13, 2004

Bone adhesive from BSI pave way to new treatments

A compound that initially was developed as a binder for highway paving may prove to revolutionize bone and ligament orthopedic surgical operations...

A compound that initially was developed as a binder for highway paving may prove to revolutionize bone and ligament orthopedic surgical operations and also may have uses in a host of undiscovered opportunities.

Privately held Bone Solutions (BSI; Dallas) said this week that its magnesium-based, bio-absorbable adhesive compound has successfully tested against leading products in the orthopedic cement/filler markets, providing what it said is “significantly superior” strength compared to these products and thus potentially eliminating the need for screws, plates and other traditional tools used widely in orthopedic surgeries.

The company said that early animal studies have demonstrated that the compound is able to attach tendon to bone and bone to bone – suggesting, it said, the potential to alter the way knee and shoulder surgeries are performed in humans and animals. It estimated that the potential market for all the potential orthopedic applications exceeds $1.5 billion.

“We believe this has the potential of revolutionizing certain orthopedic surgical procedures, starting with the ACL market, and that of extremities, since our ‘solution’ reduces the time it takes for hand, shoulder or ankle injuries to heal,” said Thomas Lally, founder, chairman and president. “It also could prove invaluable to the sports medicine industry – including both humans and animals,” he told Medical Device Daily.

According to Lally, the company’s studies have thus far shown that the bone adhesive could take the place of screws used in orthopedic surgery. “It might not be any quicker [than the screws], but it will hold whatever you put in there [a ligament or tendon] right in the center and you won’t get any shearing as you can with a screw.”

Additionally, Lally said that while most current formulations of injectable calcium phosphate compounds are biocompatible, most are not absorbable, or take too long to be absorbed – thereby hindering new bone growth in the repair process. “On the other hand, BSI’s inorganic compound not only has powerful adhesive qualities and is bioabsorbable and non-toxic, but it also is injectable. Most importantly, being magnesium-based, it overcomes many of the limitations of today’s calcium-based cements and fillers.”

Lally, the inventor of the BSI technology, originally developed the product for highway paving, but discovered, as he said, “by accident,” that it had excellent medical potential.

At an investment meeting later this month, the company will disclose results of recent testing done at Ohio State University (Columbus) by Alicia Bertone, PhD, a professor of veterinary medicine and equine orthopedic surgery. “The BSI compound of magnesium oxide and biodegradable magnesium monophosphate adhered bone and tendon within bone tunnels sufficiently to significantly augment, or potentially be used independently in, ACL reconstruction,” Bertone said in a statement. “Indeed, our tests showed powerful adhesive properties exceeding 1000 neutons, equivalent to 225 pounds of force, which could be sufficient to contain even fracture fragments in comminuted fracture repair,” she added.

The company also envisions potentially using the product in numerous other applications, according to CEO Tony Copp, PhD. “Since our formulation is PH-neutral, we believe it may also act as a delivery system for stem cells, growth hormones, proteins and other biologics.” The company, which is “angel”-funded, is seeking additional early-stage investment funding and new strategic relationships in order to complete regulatory testing and commence commercialization of the technology across multiple markets, though the primary focus is in the adhesive bone technology. “We’re waiting for that next jump in our appreciation, which we feel [we will get] after we get some of these in vivo tests done,” Lally said.

Lally believes that with the right amount of funding, hiscompany can compete with the larger players in the orthopedic sector because his technology is unique. He said he thinks the company has enough money to get through the basic animal studies to the threshold of the 510(k) studies required by the FDA.

The company estimated that it would take another $2 million to cover the costs of FDA testing for human applications and staff working capital.

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