It’s time to rethink nerve repair.™
AxoGen (NASDAQ: AXGN) is a leading medical technology company dedicated to peripheral nerve repair. 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. 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 an additional 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.
- 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 a secondary 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.
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, click here .
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® 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 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.
- 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.
- 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.
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.
- 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 performs a phase 3 clinical study and AxoGen continues to comply with the regulations and standard for 21 CFR § 1271.
From time to time, in reports filed with the Securities and Exchange Commission, in press releases, and in other communications to shareholders or the investment community (such as information contained in this website), the Company may provide forward-looking statements concerning possible or anticipated future results of operations or business developments. 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, regulatory environment, sales and marketing strategies, liquidity, capital resources or operating 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 Company communications should be evaluated together with the many uncertainties that affect the Company’s business and its market, particularly those discussed in the risk factors and cautionary statements in the Company’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 the Company assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.