Ozics And The Future Of Mending Bones (written by Jennifer Hicks, Forbes contributor)
The worldwide orthopedic market had global revenues of more than $36b in 2008. The market is dominated by six global companies that hold 80% of that global revenue. Osteoporosis has been on a relentless march. Worldwide, an osteoporotic fracture is estimated to occur every three seconds. Osteoporosis is estimated to affect 200 million women worldwide: approximately one-tenth of women aged 60, one-fifth of women aged 70, two-fifths of women aged 80 and two-thirds of women aged 90. Osteoporosis affects an estimated 75 million people in Europe, USA and Japan. And here is the statistic that demonstrates the size of the market potential for mending bones: by 2050, 30% of the EU population will be over the age of 65. *
The Ozics Group, a Swiss biotech firm, believes it has found a way to manage osteoporosis with a newly discovered innovative material that is the perfect marriage of science and device design. The technology platform, known as Ozics CompO6™, enables minimally invasive transcutaneous repair of load-bearing fractures such as osteoporotic proximal femoral fractures – commonly known as hip fractures to you and me.
Now, let me paint a picture for you. For decades, the primary method to treat fractures has been to use metallic hardware such as plates, screws and pins or a total joint prosthesis combined with standard bone cement known as Poly-Methyl-Methlacrylate (PMMA). PMMA is supplied as a powder and a liquid that have to be mixed together to form a dough-like resin. Then, it’s applied surgically with a spatula or syringe and it hardens on the bone. In recent biomechanical studies** both in the US and Switzerland, PMMA bone cement has been shown to enhance fixation strength in femoral fractures when it was used around metallic fixation screws. However, it still has no bonding abilities, so no bonding to the bone, it only fills the void without any true integration to the bone.
This is where Ozics’ CompO6™ Bone Replacement composite takes a step forward in the next line of advanced medicine for osteoporosis. Unlike conventional PMMA bone cement – it forms a solid bond with the bone. CompO6™ is a composite material of polymer and ceramic including hydroxyapatite. When that mixture comes into contact with a watery solution it forms an apatite-rich layer over the bone, think of it as a bio-compatible ceramic that’s chemically related to bone. (Quick science lesson: Apatite is a mineral found in the bone, so it’s about as natural as it comes Without apatite, there can’t be any bond to the bone.)
Within minutes after delivery of CompO6™, a solid bond between the implant surface and the bone is formed. The paste-like material from CompO6™ flows into the interstitial spaces of the cancellous bone (cancellous bone is softer, less dense and typically found at the end of long bones, around joints and within the interior of vertebrae), forming a mechanical lock with the bone. The load-bearing feature of CompO6™ allows patients to regain pain-free mobility with less rehabilitation shortly after the minimally invasive application. The first set of clinical trials for CompO6™ will be in 2012.
According to Dr. Auvo Kaikkonen, President and CEO, Ozics Group, CompO6™ will initially be targeted for the treatment of osteoporotic spinal fractures. “We believe the unique innovative material that Ozics has created will revolutionize fracture management and eventually be used prophylactically before the fracture has occurred ,” said Dr. Kaikkonen. “CompO6™ will be the first injectable load-bearing fracture fixation implant offering which will improve patients’ fracture care.”
Ozics is not alone. Other companies, such as BoneSupport (Sweden),Orthovita (US – acquired by Stryker in May 2011), BoneSolutions (USA),IlluminOss Medical (USA) and PolyNovo (Australia) have also been working on new ways to mend bones. Several companies are developing similar bone mending products for small bone fractures but with no load-bearing characteristics.
Everyone talks about disruptive technology and they all see something different. In the end, the technology that can be the most disruptive is one that can improve the quality of life for an aging population. In this case, Ozics’ CompO6™ Bone Replacement composite is live matter that generates bioactivity around the bone and simply revolutionizes the way bone fractures are treated. Ozics’ discovery will also have a domino effect in the fracture and osteoporosis industry by enabling other physicians, such as interventional radiologists and geriatricians, to treat these patients without the need of an expensive surgical facility to perform the procedure.
Disruptive in the healthcare industry can also boil down to changing the status quo. There were around 1.6m hip fractures in the US and EU in 2010. It costs around €13,000 in treatment for a 3-5 day hospital stay and extended rehabilitation time significantly increases cost to around €30,000 in EU.
That’s an industry that needs a little disruption.
Sources:
* International Osteoporosis Foundation
**AO Development Institute, Davos, Switzerland. Dec;24(12):2230-7 2006.Biomechanical evaluation of a new augmentation method for enhanced screw fixation in osteoporotic proximal femoral fractures. von der Linden P, Gisep A, Boner V, Windolf M, Appelt A, Suhm N.
** Orthopaedic Research Laboratories, University of Michigan, Ann Arbor 48109-0486, USA 1997 Nov;11(8):577-83. Hip screw augmentation with an in situ-setting calcium phosphate cement: an in vitro biomechanical analysis.Moore DC, Frankenburg EP, Goulet JA, Goldstein SA.