Company Summary and Mission
AxoGen, Inc. (AXGN.OB) provides surgeons with solutions to repair and protect peripheral nerves. The company has created and licensed a unique combination of patented nerve repair technologies to change the standard of care for patients with peripheral nerve injuries.

Company Highlights

• Pioneer in peripheral nerve reconstruction and regeneration solutions
• Avance^® Nerve Graft is the first commercially available allograft nerve for bridging nerve discontinuities
• Bringing the science of nerve repair to life with thousands of surgical implants world wide including use in military hospitals for service men and women.

Company Profile

AxoGen is a regenerative medicine company focused on the science, development and commercialization of technologies for peripheral nerve regeneration and reconstruction to help patients suffering from traumatic injuries or undergoing surgeries that impact the function of their peripheral nerves. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Damage to a peripheral nerve can result in the loss of muscle or organ function, the loss of sensory feeling or pain and can significantly impact the patient's quality of life.

AxoGen's stock is traded on the Over the Counter Bulletin Board Exchange with the ticker symbol AXGN.

Our Market

AxoGen is a pioneer in the regenerative medicine market with a portfolio of products for peripheral nerve reconstruction. Our technologies provide an option for surgeons to reconstruct injured nerves without the loss of donor nerve function associated with an autograft. Further, they offer surgeons an opportunity to protect compressed nerves or reconstruct injured nerves where autograft is limited or unavailable. Our technologies are used by several surgical specialties and in peripheral nerves throughout the body.

Our Products

AxoGen's proprietary products & technologies are designed to overcome fundamental challenges in nerve reconstruction and offer off-the-shelf solutions to surgeons for a wide variety of peripheral nerve injuries.

• Avance^® Nerve Graft is a processed nerve allograft for bridging nerve discontinuities. Avance^® Nerve Graft follows the guiding principle that the human body created the optimal nerve structure. The human nerve allograft is decellularized and processed resulting in a surgical implant with the natural structural pathways to guide axon regeneration. Avance^® Nerve Graft is provided in a variety of sizes up to 70 mm in length, provides the flexibility to be used across joints and handles similarly to an autograft nerve without the potential complications, pain and loss of function associated with the surgical removal of an autograft.
  
  
• AxoGuard^® Nerve Protector can reinforce a coaptation site, wrap a partially severed or compressed nerve, and isolate tissue. AxoGuard^® Nerve Protector can be used to wrap injured nerves up to 40 mm in length, easily conforms to and wraps the injured nerve, and minimizes the potential for soft tissue attachments and nerve entrapment by physically isolating the nerve. Further, it is strong, flexible and easy to suture.
  
  
• AxoGuard^® Nerve Connector is a coaptation aid allowing for close approximation of severed nerve ends. It can be used to bridge gaps up to 5 mm in length and alleviates tension at the repair site. Further, it reduces the number of required sutures (vs. direct repair), the potential for fascicular mismatch, and the risk of neuroma by containing regenerating axons. The AxoGuard^® Nerve Connector is strong and flexible, easy to suture and semi-translucent which allows visualization of the underlying nerve.

Our Clinical Research

AxoGen's aggressive clinical programs are designed to support adoption of the Company's products.

• A Multicenter Retrospective Study of Avance^® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair (RANGER). The RANGER study, the Avance^® Nerve Graft registry, has completed the first data milestone and continues to enroll additional cases.
  
  
• A Multicenter, Prospective, Randomized, Comparative Study of Hollow Nerve Conduit and Avance^® Nerve Graft Evaluation Recovery Outcomes of the Nerve Repair in the Hand (CHANGE). The CHANGE study is being run as a pilot comparative study and enrollment is nearing completion.
  
  
• Cavernous Nerve Reconstruction Using Avance^® Nerve Graft in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer. This study is being conducted to assess the technical feasibility of robotic assisted implantation of Avance^® Nerve Graft and the long term outcomes for continence and potency in men undergoing radical prostatectomy.

Our Pipeline

AxoGen will continue to work with leading researchers in an effort to further translate research into products that improve the standard of care for patients with peripheral nerve injuries. We believe this approach provides a path to continue on the leading edge in our field and to increase our overall potential for success and growth. AxoGen is engaged in a major initiative to build and further expand sales and marketing capabilities, and to increase acceptance and clinical adoption from the medical community.

Regulatory Information

AxoGen's products are subject to regulation by the FDA, as well as other federal and state regulatory bodies. In addition, Avance^® Nerve Graft complies with the standards of the American Association of Tissue Banks (AATB).

• AxoGuard^® Nerve Protector and AxoGuard^® Nerve Connector
• FDA 510(k) clearance


• Avance^® Nerve Graft
• AxoGen is in compliance with Good Tissue Regulations under 21 CFR Part 1271
• November 2010: Enforcement Discretion letter from FDA allowing continued sales as a 361 HCT/P based upon agreed transition to a Licensed Biologic

Safe Harbor Statement

This Fact Sheet 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", "may", "should", 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 development, product potential or financial performance. 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 Fact Sheet 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.