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Orthopedic and Dental Industry News Complete Archive »

BioMimetic Therapeutics Releases Promising GEM OS1 Orthopedic Data BY ARIELLA P. GOLOMB, MD, NOVEMBER 8, 2006

GEM OS1 is BioMimetic Therapeutics' developmental product for open fracture reduction or fractures requiring surgery in orthopedic applications. The therapy consists of both particulate Beta-tricalcium phosphate (β-TCP) with recombinant human Platelet-Derived Growth Factor (rhPDGF-ββ). BioMimetic has a similar, already-marketed product, GEM 21S, for the treatment of periodontal disease. (We've previously discussed promising GEM 21S data on our blog.)

Earlier this week, BioMimetic shared data from it's "first-in-man" GEM OS1 clinical experience in foot and ankle orthopedic applications in Canada. In a presentation Nov. 4th at the Dewar Orthopaedic Society Meeting, Dr. Tim Daniels concluded from this data that to date, GEM OS1 is a safe alternative to autogenous bone graft (associated with pain and morbidity at the harvest site) and additional randomized clinical trials are warranted to prove efficacy.

The results from the data showed that all nine of the 24 week follow-up patients achieved full weight bearing status. At 12 weeks, an independent radiographical assessment of 29 patient CT scans concluded that 85% of the patients had some degree of fusion, and 67% had moderate or complete osseous bridging. By comparison, recent 12 week data has shown that 48% of patients receiving autograft developed a greater than 50% fusion mass on CT scan. According to the researchers none of the study adverse events were attributable to the device and there was no evidence of ectopic or otherwise abnormal bone formation.

The applicability of these study results is limited given it was an open label study and the comparison group is derived from historical, published autograft foot and ankle fusion rates. However, a challenging patient population was chosen. The study group was comprised of individuals who are considered high-risk for poor healing (including smokers, diabetics, morbidly obese patients and those requiring revision surgery.) 44% had multiple risk factors.

This trial was designed to establish safety in a foot and ankle indication and optimize study design prior to larger multi-center clinical trials. However, based on the Canadian Ministry of Health's approval, this trial will be extended from 20 to 60 patients (55 have already been enrolled), likely enough for Canadian product approval.

The Canadian foot and ankle study is similar to a study underway in the US. Earlier this week, the Company also announced that an expansion of the US Orthopedic current program into pivotal trials was recommended by an independent Data Monitoring Committee. The initiation of the US pivotal trial is expected 1H:07. Management commented that the 250 to 450 patient trial is being designed to be a non-inferiority trial to autograft, with a likely primary endpoint of percentage of patients completely fused at a specific time point (around 9 months) as confirmed by CT scans. A European pivotal clinical study for GEMOS1 foot and ankle indications is also planned for 1H:07.

Data from a Swedish distal radius fracture GEM OS1 clinical study is expected "within the next several months." The Company also discussed large animal data from a rotator cuff study which is an exciting potential tendon and ligament application for the GEM technology.

Earlier this week, the Company also reported its quarterly financial results with a 3Q:06 net loss of $4.2 million, or $(0.27) per share, compared to analyst's expectations of $(0.42) and a net loss of $(0.82) in 3Q:05. Revenues for 3Q:06 were $0.7 million, and include $0.4 million in GEM 21S sales to Osteohealth Company and $0.2 million in sublicensing income. Revenues in 3Q:05 were $1.3 million, but all attributable to R&D cost compensation from the Company's marketing partner. 3Q:06 R&D expenses were $2.8 million, compared to $1.8 million in 3Q:05. These expenses were attributable to GEM OS1 clinical trials as well as activities relating to GEM 21S EU marketing approval.

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