Active recruitment underway for study to compare AxoGen’s proprietary processed human nerve allograft to nerve tubes for bridging gaps in peripheral nerve tissue.
ALACHUA, FL - June 23, 2015 – AxoGen, Inc. (NASDAQ: AXGN), a leading medical technology company focused on restoring quality of life through nerve repair, announced today that the first subject has been enrolled in the “RECON Study” to support an Investigational New Drug Application for Avance® Nerve Graft. The RECON Study is a multicenter, prospective, randomized study to evaluate recovery outcomes of surgical repairs of peripheral nerve discontinuities. This Phase 3 clinical trial will compare AxoGen’s Avance® Nerve Graft, an off-the-shelf processed human nerve allograft, to nerve tubes for bridging gaps in peripheral nerve tissue and will support the FDA biologic license application (“BLA”) being pursued by the Company.
The first patient was enrolled at Virginia Commonwealth University Medical Center by Principal Investigator, Jonathan Isaacs, MD. A second clinical study location, Hospital of the University of Pennsylvania with Principal Investigator, L. Scott Levin MD, FACS, has also started recruiting for potential subjects.
Avance® Nerve Graft is currently commercially available in the United States and several other countries. The RECON Study has been initiated under an Investigational New Drug Application for Avance® Nerve Graft, supporting the regulatory transition of the product to a licensed biologic. In May, the Company announced that the FDA had provided clearance for AxoGen to proceed with the RECON Study after conducting a review of the Study protocols and characterization of Avance® Nerve Graft.
“The commencement of the RECON Study is an important milestone in moving Avance® Nerve Graft to be the first FDA licensed biologic implant for peripheral nerve repair,” said Karen Zaderej, President and CEO of AxoGen. “The rigor of the BLA transition process offers an opportunity for AxoGen to develop a significant amount of data on a biological implant for nerve repair while simultaneously allowing us to continue to advance the commercial adoption of Avance® Nerve Graft.”
About the RECON Study
A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities (RECON), is a Phase 3 clinical trial developed under a Special Protocol Assessment to support the transition to a licensed biologic. Enrollment of 150 subjects is expected to take 2 years with subjects being followed for 12 months after surgery.
For more information about the RECON Study, visit ClinicalTrials.Gov at https://clinicaltrials.gov/ct2/show/NCT01809002?term=avance+nerve+graft&rank=3
About AxoGen, Inc.
AxoGen (NASDAQ: AXGN) is a leading medical technology company dedicated to peripheral nerve repair. AxoGen’s portfolio of regenerative medicine products is available in the United States, Canada and several other countries and includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix (“ECM”) coaptation aid for tensionless repair of severed nerves, and AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments.
Avance® Nerve Graft is processed in the United States by AxoGen. AxoGuard® Nerve Connector and AxoGuard® Nerve Protector are manufactured in the United States by Cook Biotech Incorporated, and are distributed worldwide exclusively by AxoGen. AxoGen maintains its corporate offices in Alachua, Florida and is the parent of its wholly owned operating subsidiary, AxoGen Corporation.
For more information about AxoGen or to sign up for our news alerts, please visit www.AxoGenInc.com.
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ALACHUA, FL - June 23, 2015 – AxoGen, Inc. (NASDAQ: AXGN), a leading medical technology company focused on restoring quality of life through nerve repair, announced today that the first subject has been enrolled in the “RECON Study” to support an Investigational New Drug Application for Avance® Nerve Graft. The RECON Study is a multicenter, prospective, randomized study to evaluate recovery outcomes of surgical repairs of peripheral nerve discontinuities. This Phase 3 clinical trial will compare AxoGen’s Avance® Nerve Graft, an off-the-shelf processed human nerve allograft, to nerve tubes for bridging gaps in peripheral nerve tissue and will support the FDA biologic license application (“BLA”) being pursued by the Company.
The first patient was enrolled at Virginia Commonwealth University Medical Center by Principal Investigator, Jonathan Isaacs, MD. A second clinical study location, Hospital of the University of Pennsylvania with Principal Investigator, L. Scott Levin MD, FACS, has also started recruiting for potential subjects.
Avance® Nerve Graft is currently commercially available in the United States and several other countries. The RECON Study has been initiated under an Investigational New Drug Application for Avance® Nerve Graft, supporting the regulatory transition of the product to a licensed biologic. In May, the Company announced that the FDA had provided clearance for AxoGen to proceed with the RECON Study after conducting a review of the Study protocols and characterization of Avance® Nerve Graft.
“The commencement of the RECON Study is an important milestone in moving Avance® Nerve Graft to be the first FDA licensed biologic implant for peripheral nerve repair,” said Karen Zaderej, President and CEO of AxoGen. “The rigor of the BLA transition process offers an opportunity for AxoGen to develop a significant amount of data on a biological implant for nerve repair while simultaneously allowing us to continue to advance the commercial adoption of Avance® Nerve Graft.”
About the RECON Study
A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities (RECON), is a Phase 3 clinical trial developed under a Special Protocol Assessment to support the transition to a licensed biologic. Enrollment of 150 subjects is expected to take 2 years with subjects being followed for 12 months after surgery.
For more information about the RECON Study, visit ClinicalTrials.Gov at https://clinicaltrials.gov/ct2/show/NCT01809002?term=avance+nerve+graft&rank=3
About AxoGen, Inc.
AxoGen (NASDAQ: AXGN) is a leading medical technology company dedicated to peripheral nerve repair. AxoGen’s portfolio of regenerative medicine products is available in the United States, Canada and several other countries and includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix (“ECM”) coaptation aid for tensionless repair of severed nerves, and AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments.
Avance® Nerve Graft is processed in the United States by AxoGen. AxoGuard® Nerve Connector and AxoGuard® Nerve Protector are manufactured in the United States by Cook Biotech Incorporated, and are distributed worldwide exclusively by AxoGen. AxoGen maintains its corporate offices in Alachua, Florida and is the parent of its wholly owned operating subsidiary, AxoGen Corporation.
For more information about AxoGen or to sign up for our news alerts, please visit www.AxoGenInc.com.
Help employers find you! Check out all the jobs and post your resume.