It’s time to rethink nerve repair.™

AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen's portfolio of products 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, 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 and Avive™ Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a soft tissue covering to reduce inflammation and scar tissue formation. Along with these core surgical products, AxoGen also offers AxoTouch™ Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.

Company Overview

  • Only company focused on peripheral nerve repair solutions
  • Addressing a $1.6B+ current market opportunity
  • Comprehensive product portfolio addresses all surgical peripheral nerve reconstruction needs
  • Pioneering sales and market strategy, solid execution plan
  • Poised for strong growth
  • 75% gross margins
  • Barriers to competitive entry & growing body of clinical data
  • Long term expansion potential beyond current market

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 comorbidities associated with an additional surgical site. Further, they offer surgeons an opportunity to protect compressed nerves or reconstruct injured nerves. Our technologies are used by several surgical specialties and in peripheral nerves throughout the body.

Based on research and analysis, the U.S. market for the repair of transected peripheral nerves in the extremities exceeds $1.6 billion. AxoGen is actively targeting this market and expanding focus in OUS markets.

AxoGen and Extremity Market Charts

Our Current Focus

  • Upper Extremity
  • Lower Extremity
  • Carpal Tunnel Revision
  • Oral and Maxillofacial

AxoGen’s future expansion opportunities include Facial Reconstruction, Podiatry, Breast Reconstruction, Prostatectomy, and Pain Management

Market Research Reports

Analysis by an independent third party research group concluded that the US market for the repair of transected peripheral nerves in the extremities alone exceeds $1.6 billion. For further information on the analysis, read this report.

Our Products

AxoGen’s proprietary products and 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(R) Transparent

  • Avance® Nerve Graft is a processed human nerve allograft for bridging severed nerves without the comorbidities associated with an additional surgical site. 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 diameters up to 5mm and a variety of lengths up to 70 mm, provides the flexibility to be used across joints and handles similarly to an autograft nerve without the comorbidities associated with an additional surgical site.

 

CONNECTOR_H_C-2

  • AxoGuard® Nerve Connector is a minimally processed, extracellular matrix derived from porcine small intestine submucosa (SIS) designed as a coaptation aid for tensionless repair of transected or severed peripheral nerves. AxoGuard® Nerve Connector 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) and the potential for fascicular mismatch. AxoGuard® Nerve Connector is strong and flexible, easy to suture and semi-translucent which allows visualization of the underlying nerve.

 

PROTECTOR_H_C-2

  • AxoGuard® Nerve Protector is a minimally processed, intact extracellular matrix derived from porcine small intestine submucosa (SIS) designed to wrap and protect injured peripheral nerves. 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.

  • Avive™ Soft Tissue Membrane is a minimally processed human umbilical cord membrane that can be used as a resorbable soft tissue covering to separate tissue layers.  Avive™ Soft Tissue Membrane is provided sterile and in several sizes to help surgeons meet a variety of surgical needs. Up to 8x thicker than amniotic sac membrane alone, Avive™ Soft Tissue Membrane stays in place for at least 8 weeks, and is minimally processed to preserve the natural properties of umbilical cord amniotic membrane. Avive™ Soft Tissue Membrane is easy to suture or secure or may simply be laid on the injured tissue for flexibility of use. Additionally, Avive™ Soft Tissue Membrane is stored at room temperature and is Chorion free- reducing the likelihood of immune response.

AcroVal

  • AcroVal™ Neurosensory & Motor Testing System (NSMTS) is a nerve function evaluation system designed to be used as a tool for surgeons and other allied health professionals in the measurement, mapping, and monitoring of patients with peripheral nerve injuries and conditions. AcroVal™ NSMTS consists of three different accessory devices designed to evaluate neurosensory function and hand strength:
    • Pressure Specified Sensory Device™ / PSSD™
    • AcroGrip™ Device
    • AcroPinch™ Device

 

AxoTouch-logo

  • The AxoTouch™ Two-Point Discriminator tool is a set of two aluminum discs that can be used to measure the innervation density of any surface area of the skin. The discs are useful for measuring sensation after a nerve injury, following the progression of a repaired nerve, and during the evaluation of a person with a possible nerve injury, such as nerve division or nerve compression. The discs can be rotated between a single prong for testing one-point and any of the other spaced prongs for testing two-point intervals with ease.

Our Clinical Research

AxoGen invests in and supports clinical studies and programs to further the understanding and outcomes of peripheral nerve repair.

  • 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 a pilot comparative study. Enrollment is now completed.
  • 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). The primary objective of this study is to evaluate the difference in functional recovery outcome between the study groups.
  • 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. Enrollment is now completed.

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 international, federal, state and local regulations as Healthcare Products. AxoGen meets the regulations for human tissue products and medical devices as required by the appropriate international and domestic regulatory agencies (i.e. FDA).  Additionally, AxoGen is an accredited tissue bank with the American Association of Tissue Banks (AATB) and AxoGen is an ISO 13485 registered company and a Verified-Accredited Wholesale Distributor (VAWD).

  • AxoGuard® Nerve Protector and AxoGuard® Nerve Connector
      • FDA 510(k) clearance
  • Avance® Nerve Graft
      • The AxoGen Quality System meets the requirements set forth under 21 CFR § 1271 for Human Cells, Tissues and Cellular and Tissue-Based Products, including Good Tissue Practices (“GTP”)
      • November 2010: The US FDA has issued an Enforcement Discretion Letter allowing continued sales of Avance® Nerve Graft under the controls applicable to a HCT/P pursuant to section 361 of the Public Health Service Act and 21 CFR Part 1271 of FDA’s regulations, in accordance with a transition plan with the FDA in which  AxoGen transitions to compliance with the Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), the current good manufacturing practice regulations in 21 CFR  § 210 and 211 and the applicable regulations and standards in 21 CFR § 600-610, AxoGen conducts a phase 3 clinical trial to demonstrate safety, purity and potency of the Avance® Nerve Graft and AxoGen continues to comply with the regulations and standard for 21 CFR § 1271.
  • Avive™ Soft Tissue Membrane
      • Avive™ Soft Tissue Membrane is processed and distributed in accordance with US FDA requirements for Human Cellular and Tissue-based Products (HCT/P) under 21 CFR Part 1271 regulations, US State regulations and the guidelines of the American Association of Tissue Banks (AATB).
  • AcroVal™ Neurosensory & Motor Testing System (NSMTS)
      • FDA 510(k) clearance
  • AxoTouch™ Two-Point Discriminator
      • Class 1 medical device under 21 CFR Part 882.1200 and is exempt from premarket notification

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”, “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, AxoGuard® Nerve Protector and AxoTouch™ Two-Point Discriminator, 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.