NovaBone Products LLC announced today that results of an
independent clinical study of 20 spine fusion surgery patients showed
that the Company's FDA-cleared synthetic bone graft product,
NovaBone(R), stimulated new bone formation on an 'equivalent basis'
compared to 'BMP-2' (bone morphogenic protein) when each was used in a
composite as described below.
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 of 65 years of age. All patients were having
a primary fusion. Each patient was given a bone graft substitute as
follows to enhance spine fusion:
Right Side: NovaBone(R) + bone marrow + local bone + BMP-2
Left Side: NovaBone(R) + bone marrow + local bone
"We have drawn two conclusions from the results of our study,"
said Craig M. Chebuhar, M.D., an orthopaedic spine surgeon with
Pinnacle Orthopaedics and Sportsmedicine, Marietta, Ga., who was
principal investigator for the independent clinical study. "First,
that using local bone graft and bone marrow aspirate with NovaBone(R)
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(R) may be as
effective as a similar composite graft with BMP-2 for posterolateral
"We believe the results of this study will give NovaBone(R) 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," said Arthur C. Wotiz,
president and chief executive officer of NovaBone Products LLC. "At
the very least, we can make a very strong case that NovaBone(R) is a
great extender for the more expensive BMP-2 product. Beyond this, we
believe NovaBone(R) has three important advantages: it has superior
technical characteristics to other synthetics; it can be used in
combination with autograft or BMP-2; and it is significantly less
expensive than these other options."
Founded in 2002, NovaBone Products LLC is a privately held company
headquartered in Jacksonville, Fla. The core technology underlying the
Company's NovaBone(R) product was invented at the University of
Florida and is licensed exclusively to NovaBone Products LLC.