Medical Device Daily Associate
NovaBone Products (Jacksonville, Florida) reported that the results of an independent clinical study of 20 spine fusion surgery patients showed the company's FDA-cleared synthetic bone graft product, NovaBone, stimulated new bone formation on an “equivalent basis“ compared to bone morphogenic protein (BMP-2) when each was used in a composite.
The study evaluated 20 consecutive patients undergoing elective, single-incision, 360-degree lumbar fusion. Patients ranged in age from 34 to 85, with an average age of 65 years. All patients were having a primary fusion.
Each patient was given a bone graft substitute to enhance spine fusion as follows:
Right Side: NovaBone + bone marrow + local bone + BMP-2.
Left Side: NovaBone + bone marrow + local bone.
“We have drawn two conclusions from the results of our study,“ said Craig Chebuhar, MD, an orthopedic spine surgeon with Pinnacle Orthopaedics and Sportsmedicine (Marietta, Georgia), the principal investigator for the independent clinical study. “First, that using local bone graft and bone marrow aspirate with NovaBone and BMP-2 results in excellent fusion rates for single-incision, 360-degree lumbar fusion. Secondly, that composite bone grafting using local bone graft, bone marrow aspirate and NovaBone may be as effective as a similar composite graft with BMP-2 for posterolateral fusion.“
Art Wotiz, president and CEO of NovaBone, said, “We believe the results of this study will give NovaBone a significant advantage among competing products in the bone grafting market — a $625 million opportunity in the U.S. alone in 2003, according to Millennium Research Group.“ At the very least, he added, “we can make a very strong case that NovaBone is a great extender for the more expensive BMP-2 product.“
Wotiz said he believes NovaBone has three important advantages over existing compounds. First, he said it has superior technical characteristics to other synthetics. Secondly, it can be used in combination with autograft or BMP-2. And lastly, he said, it is “significantly less expensive“ than these other options.
Wotiz told Medical Device Daily that NovaBone was formed in July 2002 to acquire the rights to the bone-grafting aspects of this technology, originally developed at the University of Florida (Gainesville) and then acquired by USBiomaterials (Alachua, Florida).
When implanted in an osseous defect, Wotiz said the compound “greatly accelerates“ the body's natural healing processes. The net effect of the use of NovaBone is osteostimulation — i.e., new bone is induced to form, but only in the presence of existing bleeding bone. Unlike morphogenic proteins and autograft or allograft, he said that NovaBone would not induce bone formation away from the bone implantation site, thus eliminating the possibility of ectopic bone growth.
Wotiz said that the company believes that NovaBone, which is cleared by the FDA for use in periodontal, craniofacial/maxillofacial and orthopedic applications, may eventually supplant BMPs, which are currently the hot new bone graft substitute.
While bone morphogenic proteins are popular, the company noted that they have a high cost and that ectopic bone growth may occur if any BMPs migrate from the implant site.
Additionally, Wotiz pointed out that the incremental benefits and long-term effects of BMP use are unknown at this time, whereas the synthetic NovaBone product “has been implanted over 700,000 times in human beings over the last 10 years. Its safety record is unassailable, and it's well-known what's going to happen when you use this product over a long period of time.“
Aside from fusions, the compound also is indicated for use in trauma defects, bony defects, arthroplasty bone stock defects, long bone acute fractures, as a graft extender and for osteolysis/particulate disease.
Wotiz noted that NovaBone Products has the rights to use the material in orthopedic applications “from head to toe.“ The company also sells the compound as PerioGlas, an oral/periodontal bone-grafting material for use by dentists, periodontists and oral surgeons. Indications for use include extraction sites, ridge augmentation, cystic defects, sinus lifts, periodontal defects and dental implants.
Additionally, the material is used as a cranio-maxillo-facial bone graft particulate under the name NovaBone-C/M.
Currently, the company is looking for marketing partners, and Wotiz said he believes with the right partner the company can maintain its independent status and still take a “significant share of the overall bone graft substitute market.“
He said he and his associates have thus far self-funded the company. While he said that NovaBone could successfully obtain venture capital if it so chose, he believes it can fund its own growth with good sales figures.
Wotiz said that Chebuhar recently submitted an abstract of his study to the North American Spine Society (LaGrange, Illinois) to be considered for inclusion at next year's annual meeting.