AxoGen, Inc. Announces Presentation of New Clinical Data For Avance® Nerve Graft

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Peripheral nerve repair clinical data shared by study investigators at major hand and nerve surgery meetings

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"Avance® Nerve Graft provides service men and women and their civilian counterparts with a viable option for nerve reconstructions." Dr. Bauback Safa, The Buncke Clinic

AxoGen, Inc. (NASDAQ: AXGN), the only company completely focused on peripheral nerve repair, today announced that new data from the CHANGE Study and the Ranger® Study was presented by study investigators at the recent combined annual meetings of the American Association for Hand Surgery (AAHS), American Society for Peripheral Nerve (ASPN) and American Society for Reconstructive Microsurgery (ASRM).

During the AAHS, meeting, Dr. Jim Higgins of The Curtis National Hand Center based in Baltimore, MD, presented results from a clinical study entitled “Outcomes from a Multi-Center, Prospective, Randomized, Blinded, Comparison Study of Processed Nerve Allografts and Hollow-Tube Conduit for Nerve Reconstructions in the Hand”. The study, named “CHANGE”, offers the first multi-center prospective outcomes data comparing Avance® Nerve Graft with hollow tubes for nerve repair. The study found that, in the pilot phase, repairs with Avance® Nerve Graft had a better response rate (returning of function), a higher rate of returning patients back to baseline (pre-injury) sensory function and had fewer adverse events when compared with hollow tube conduit products. Four major US hand practices participated in the study including The Curtis National Hand Center, University of Kentucky, Indiana Hand to Shoulder Center and Georgia Hand Center.

Additionally data from the Ranger® Study, the largest multicenter, observational registry in peripheral nerve repair, was presented as part of the AAHS, ASPN and ASRM Scientific Programs. At the AAHS meeting, in a presentation titled “Outcomes from the Addition of an Autograft and Tube Conduit Contemporary Control Cohort for Ranger®: A Registry Study of Processed Nerve Allograft Repair Outcomes,” Ranger® Study investigator Dr. Bauback Safa of The Buncke Clinic in San Francisco presented the first dataset from the contemporary control cohort of hollow tube conduits and nerve autograft, establishing in-study controls for hollow tube conduits and nerve autograft. This cohort, dubbed “MATCH”, further adds to the robustness of the Ranger® Study and provides clinical evidence on comparative outcomes for nerve repairs with hollow tubes and nerve autografts.

Additional data from the Ranger® Study on mixed and motor nerve repairs with processed nerve allograft were presented during the ASPN scientific poster session. The presentation detailed specific functional outcomes for return of muscle function and range of motion following reconstruction with Avance® Nerve Graft.

Finally, Dr. Safa presented the Ranger® Study cohort for Military and Combat-Like Injuries treated with Avance® Nerve Graft. Data from the study found that the Avance® Nerve Graft can provide meaningful levels of recovery, even in these devastating traumatic injuries. While presenting the results, Dr. Safa concluded, “In many instances military and combat-like injuries result in devastating trauma with no adequate source of autograft tissue. Avance® Nerve Graft provides these service men and women and their civilian counterparts with a viable option for nerve reconstructions”.

AxoGen CEO Karen Zaderej said, “As thought leaders continue to present the growing body of positive clinical evidence on Avance® Nerve Graft at these important conferences, specialists are gaining awareness of the patient and procedural benefits we are bringing to peripheral nerve repair. The depth and robustness of the CHANGE Study and the Ranger® Study provide an evidence-based platform for understanding the utilization and outcomes for Avance® Nerve Graft. These recent advancements exemplify AxoGen’s commitment to providing real world clinical evidence in peripheral nerve repair.”

About the Ranger® Study
The Ranger® Study is an active database with 18 contributing centers designed to continuously monitor and collect injury, repair, safety and outcomes data for peripheral nerve injuries repaired with processed nerve allograft (Avance® Nerve Graft). In 2013, contemporary control groups (MATCH) were added to the registry to allow for comparisons of outcomes between nerve autograft and hollow tubes.

About AxoGen, Inc.
AxoGen (NASDAQ: AXGN) is a medical products company based in Alachua, Florida. Founded in 2002, AxoGen is the only company to focus entirely on peripheral nerve repair. AxoGen’s portfolio of products is available in the United States, Canada and several European countries and includes Avance® Nerve Graft, the only off-the-shelf commercially available processed 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, West Lafayette, Indiana, and are distributed exclusively by AxoGen. AxoGen is the parent of its wholly owned operating subsidiary, AxoGen Corporation.

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Cautionary Statements Concerning Forward-Looking Statements
This Press Release contains "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations or predictions of future conditions, events or results based on various assumptions and management's estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as "expects", "anticipates", "intends", "plans", "believes", "seeks", "estimates", "projects", "forecasts", "continue", "may", "should", "will" variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without limitation, statements regarding product commercialization and marketing efforts for its portfolio of peripheral nerve repair products, Avance® Nerve Graft, AxoGuard® Nerve Connector and AxoGuard® Nerve Protector, product development, financial performance, sales growth, product adoption, market awareness of our products, data validation and the intent to list on a national securities exchange. The forward-looking statements are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the statements. Forward-looking statements in this release should be evaluated together with the many uncertainties that affect AxoGen's business and its market, particularly those discussed in the risk factors and cautionary statements in AxoGen's filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made, and AxoGen assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: AxoGen, Inc.

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Greg Freitag, CFO & General Counsel
AxoGen, Inc.
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