STUDY SHOWS DECELLULARIZED CADAVERIC ALLOGRAFT EFFECTIVE IN REPAIR OF PERIPHERAL NERVE DAMAGE IN MAXILLOFACIAL SURGERY
Data show AVANCE® Nerve Graft effective in surgery to repair damaged lingual and inferior alveolar nerves; results presented today at The American College of Oral and Maxillofacial Surgeons 30th Annual Scientific Conference and Exhibition
TAMPA, May 6, 2009 – Treatment with a decellularized cadaveric allograft supports nerve repair and restoration of function in peripheral nerves, according to results from a study involving patients with damaged lingual and inferior alveolar nerves. Study findings were presented today in an oral presentation at The American College of Oral and Maxillofacial Surgeons (ACOMS) 30th Annual Scientific Conference and Exhibition in Tampa, Florida.
In the study, eight patients were treated with secondary neurorrhaphy surgery using AVANCE Nerve Graft to repair either a lingual (five patients) or inferior alveolar (three patients) nerve injury. The length of the defects ranged from 2-4 cm. All repairs were performed between two weeks and seven months after initial injury. All patients underwent standardized preoperative and postoperative neurosensory testing with Level A directional sensation; Level B static touch with Semmes Weinstein monofilaments; and Level C pinprick sensation. The study results were presented by John C. Nale, MD, DMD, a resident at the University of Florida School of Dentistry.
Findings further showed that results were maintained in follow-up examination. Four patients demonstrated return of directional sensation and one was able to sense light static touch after surgery. Two patients had no return of sensation to Level C testing and one patient did not participate in follow up monitoring.
“Autogenous grafts have been the accepted standard for secondary nerve repair for several years. The use of autogenous grafts requires a transplant from a second surgical site that can result in significant donor site numbness in patients. Hollow conduits are also used to treat shorter defects, but their results in longer continuity defects have not been promising,” said Dr. Nale. “Based on the findings of this study, a decellularized cadaveric allograft seems to be a viable option for the reconstruction of lingual and inferior alveolar nerves without any donor site numbness while also reconstructing longer continuity defects as compared to conduit treatment.”
In 2007, AxoGen began distribution of AVANCE Nerve Graft for use in the repair of peripheral nerve damage. Clinical data related to the use of AVANCE Nerve Graft have shown good to excellent recovery of function in treating peripheral nerve damage. AVANCE Nerve Grafts are decellularized allograft nerves recovered from cadaveric donors. AVANCE is developed using a proprietary process designed to remove cellular components associated with a risk of tissue rejection while maintaining structural and neurotropic components designed to support nerve regeneration. AVANCE Nerve Graft is also treated to remove chondroitin sulfate proteoglycans (CSPGs), which inhibit nerve axon regeneration in peripheral nerves. To date, more than 500 AVANCE Nerve Grafts have been implanted in humans with no reports of tissue rejection or other adverse events.
Peripheral nerves provide the pathway for both motor and sensory signals between the central nervous system and muscles or organs throughout the body. These nerves support movement and register sensation including pain, cold or heat. On average, more than three hundred thousand people suffer traumatic injuries or have surgical procedures that disrupt or stop the function of peripheral nerves each year.
About AxoGen
AxoGen, Inc. is a privately held company working to develop new and more effective products to treat peripheral nerve damage. With the focus of bringing the science of nerve repair to life, AxoGen is working to introduce new technologies to improve the standard of care for patients with injured peripheral nerves. With licensed technologies from the University of Florida, the University of Texas, and Emory University, researchers at AxoGen have developed an innovative technology platform making it possible to process allograft nerves while preserving the three dimensional scaffold and key components of the tissue. Based in Alachua, Florida, AxoGen has received funding from private investors including Accuitive Medical Ventures, Cardinal Partners, De Novo Ventures, Springboard Capital II, LLC, SynoGen, and Emergent Growth Fund of Gainesville, FL.
AxoGen is a registered tissue bank with the FDA.