A product that began as a rapid-set cement product used for patching highways has received FDA 510(k) clearance as a bone void filler. Bone Solutions (Dallas) says the regulatory milestone represents a critical step towards establishing a platform for its magnesium-based technology.
The product, OsteoCrete, is resorbable (doesn't stay in the body forever), injectable, osteoconductive (stimulates bone growth), and non-toxic, the company noted.
"This is a significant milestone in our strategy to generate a pipeline of products from our patented magnesium-based technology for surgeries at hospitals, clinics and other private surgical centers within the orthopedic industry," said Tony Copp, PhD, EVP/COO of Bone Solutions.
Copp told Medical Device Daily that Bone Solutions expects to generate five to 10 additional products from this platform. He said this first FDA clearance was "the big hurdle" for the company because Bone Solutions is the first in the magnesium-based solutions for bone fillers or even bone cements. Most of the world uses calcium-based products, he said, but Bone Solutions expects its technology to prove superior.
The OsteoCrete bone void filler device utilizes a similar material composite noted in the patent that the FDA cleared for long-bone and pelvis applications, the company said. Interestingly, the technology began as a rapid-set cement product with major binder qualities for patching highways that would stay tough in bitterly cold temperatures.
Copp said that Tom Lally, president of Bone Solutions, had applied the technology while he was working in the transportation sector. He noted that unlike other pothole fillers that get washed out by the rain, the product can be injected into the hole one time and the cement will expand into the boundaries and adhere to the boundaries in a powerful way, then hardens "very quickly."
According to Copp, Lally saw early on that this rapid-set cement product had major binding qualities that were missing in most medical products on the market. The company proceeded to begin the formal testing process to seek FDA clearance for the solution as a bone filler.
"[Bone Solutions'] OsteoCrete, now FDA-cleared for long-bone and pelvis applications, establishes a new landscape for expanding breakthroughs in orthobiologics," Lally said. "Most of today's leading devices in bone repair or replacement are calcium-based and do not exhibit the combination of features including compressive strength, expandability yielding a major binding quality."
Lally noted that OsteoCrete is resorbable, as it is replaced with bone during the window of healing. He also said the product is injectable, osteoconductive, and is non-toxic. "Because of the deficiencies of today's calcium-based bone void fillers and cements, which result in lower surgical success rates, the industry spends millions of dollars annually on new R&D in an attempt to invent better calcium-based products, or better-reinforcing metallic devices such as nails, pins, plates, and screws – some of which are not bioabsorbable," Lally said.
He added that Bone Solutions' magnesium-based technology along with other ingredients provides "significant compressive strength and possesses Ph-neutral qualities that make it ideal as a delivery system for possible future applications."
According to Bone Solutions, rigorous laboratory and animal testing of OsteoCrete was completed at Ohio State University (Columbus). Separate animal research with the product confirmed its biocompatible, osteoconductive, bioresorbable compressive strength qualities. The results of these studies are now published in the Journal of Cranialfacial Surgery and in the American Journal of Sports Medicine.
Bone Solutions says it believes that its magnesium-based technology has the potential to improve the success rates of long-bone and pelvis surgeries that could "revolutionize future bone and ligament surgical operations for human applications worldwide." The company believes that future research with its magnesium-based platform will, at a minimum, augment – and potentially replace – some of the screws, pins and plates now used for major knee and shoulder surgeries, for more rapid recoveries.
"Our patented magnesium-based technology is well-positioned as a platform for new approaches and new devices to be introduced into orthopedic surgery repair," Copp said. "Our strategy has been to first seek FDA clearance of OsteoCrete as a bone void filler by applying existing FDA guidance protocols for bone void fillers. In the future, we intend to seek further clearance of OsteoCrete for applications in cranial surgery, maxillofacial surgery, non-load-bearing spine applications, and as a bone anchor and bone cement. In the meantime, we intend to commence sales efforts for OsteoCrete as a bone void filler for human markets in long-bone and pelvis applications."
Copp said the company hopes this product will "open up a whole vista of research of magnesium-oriented solutions."
He added that Bone Solutions has had conversations with several players in the orthopedic industry about its platform technology. "We're thinking about what relationships we need to seek out to help us commercialize," he said. "Not only for our first product, but for the next five or six products that we're already thinking about."
The company's goal is to start selling OsteoCrete by 1Q10. It also is filing for a CE mark.