Bone graft technology – which has been riddled with complications and several stumbles – just took a step forward with the first human implantation of Osteotech's (Eatontown, New Jersey) MagniFuse Posterior Cervical (PC) Bone Graft, a new type of tissue-based product that aims to solve the common problems of graft site migration and the ability to visualize the implant post-surgery.
In launching MagniFuse, Osteotech is addressing a market the company values at more than $750 million. Although the initial use is targeted for posterolateral spine and deformity correction procedures, MagniFuse was broadly cleared by the FDA a year ago for use in spine, pelvis and extremities providing a slew of potential applications if proved successful.
"Other bone graft materials on the market are liquid, putty or collagen spun, wrapped around other materials and it takes a fair amount of work to prepare," Robert Wynalek, president, Osteotech Domestic, told Medical Device Daily. "The other challenge is packing that material. MagniFuse has a higher active biologic material to provide growth, but contained in a resorbable mesh bag. It's very easy to handle and deliver. Instead of packing in a putty or a mix, surgeons have a pre-configured implant sized to the specific procedure. It simplifies the whole grafting procedure. Surgeons say it's far more intuitive because implants are shaped specifically to the geometry and size of the defect. No manipulation is required. It's a turnkey type of grafting."
Osteotech is aiming to redefine the bone-grafting market with this streamlined approach delivered in MagniFuse while at the same time improving the cost effectiveness of a procedure that is typically replete with potential complications.
MagniFuse looks like a rectangular packet of material that can be pressed into a bone void created by injury or degeneration. The resorbable self-contained delivery system has a scaffold that creates a highly exposed surface area comprised of 100% bone material that is shaped and oriented to provide guided bone healing. The formulation is derived from allograft source material that contains a higher concentration of multiple natural human growth factor and reduced graft site migration once implanted, as evidenced in animal studies.
This first human implant was performed on a patient who had degenerative problems with his cervical spine. The surgeon performed a two-level posterior fusion using MagniFuse along with rod and screw fixation earlier this month. The goal is to stop motion between two or more vertebrae that cause neck pain or damage to the nerves that extend into the upper extremities.
"In using MagniFuse for the first time, I found the product to be unique from a biologic perspective and easy to work with from a surgical placement perspective," said Orin Atlas, MD, an orthopedic spine surgeon and chief of spine surgery at Virtua-Burlington Medical Center (Mt. Holly, New Jersey). "MagniFuse required minimal hydration and the self-contained delivery system made it easily conformable to the defect once implanted at the surgical site. This graft has a completely unique delivery system and is unlike any other product on the market."
"The patient is doing very well," Wynalek said. "Dr. Atlas reported the case was very simple."
After implantation, fusion is usually assessed between nine and 12 months. Ideally, however, surgeons want to visualize the implant right after surgery.
"Radiographs allow the surgeon to see that the graft material is sitting where he put it," Sam Owusu-Akyaw, CEO of Osteotech, told MDD. "It's designed to be radiopaque. No other product can do it."
When asked what makes MagniFuse radiopaque, Owusu-Akyaw said, "That's the secret sauce."
Osteotech will be going head-to-head against Stryker's (Kalamazoo, Michigan) OP-1 Implant and Medtronic's (Minneapolis) Infuse Bone Graft Implant. It's entering a tough market. Last year the FDA issued a safety notification regarding recombinant human bone morphogenic protein (rhBMP) stating that it received at least 38 reports of complications during the last four years in cervical spine applications of the product. Among the complications are swelling of neck and the throat tissues, which the agency says "resulted in compression of the airway and/or neurological structures in the neck." Severe cases of difficulty in swallowing have also been reported (MDD, July 3, 2008).
Earlier this year, Medtronic was sued by a patient who allegedly was seriously injured by Infuse in an off-label surgical procedure. The suit claims Medtronic improperly promoted the off-label use (MDD, Jan. 15, 2009). At the time of this suit, the FDA reported it had received more than 200 complaints related to the off-label use of Infuse.
Osteotech reports no adverse bone-healing effects in its animal studies including "... no ectopic bone formation, radiculopathy, or cancellous bone bed osteolysis as seen with single growth factor products," according to company promotional documents.
"The key aspect with MagniFuse is the mesh bag and delivery containment system," Wynalek said. "The bag is easy to implant. It will resorb around six months. The densely packed scaffold stays in place where implanted and you form bone exactly where the graft is placed. It's an important healing element and a problem with Infuse, which elutes quickly and you have issues with bone forming not exactly where you have it placed."
Wynalek said preclinical studies compared MagniFuse with Medtronic's Infuse and found them to be equivalent. "We were very excited by that one because we're the only company that did a head-to-head comparison with that product," he said.
But none of these data have been published.
MagniFuse is being launched in a controlled release in the U.S. so that Osteotech can continue to insure positive outcomes and to collect more data.
"We are very confident the outcomes will be great because of the animal data," said Owusu-Akyaw. "Hospitals are trying to reduce costs. We have positioned this product as the most cost effective bone graft material."
Although Owusu-Akyaw wouldn't reveal a price point, he said it would be less than Medtronic's Infuse and can be reimbursed via existing codes.
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