Organization and Business |
12 Months Ended |
|---|---|
Dec. 31, 2021 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Organization and Business | Organization and Business Axogen is the leading company focused specifically on the science, development, and commercialization of the technologies for peripheral nerve regeneration and repair. Axogen is passionate about providing the opportunity to restore nerve function and quality of life for patients with peripheral nerve injuries. Axogen provides innovative, clinically proven, and economically effective repair solutions for surgeons and healthcare providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve or the inability to properly reconnect peripheral nerves can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.
Axogen’s platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard® Nerve Connector, a porcine (pig) submucosa extracellular matrix (“ECM”) coaptation aid for tensionless repair of severed peripheral nerves; Axoguard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard® Nerve Cap, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; Avive® Soft Tissue Membrane, a processed human umbilical cord intended for surgical use as a resorbable soft tissue conduit and Axotouch® Two-Point Discriminator, used to measure the innervation density of any surface area of skin. Axogen's portfolio of products is available in the U.S., Canada, Germany, United Kingdom ("UK"), Spain, South Korea, and several other countries.
Axogen suspended the market availability of Avive Soft Tissue Membrane ("Avive") effective June 1, 2021, and management continues discussion with the U.S. Food and Drug Administration (the "FDA") to determine the appropriate regulatory classification and requirements for Avive. The suspension was not based on any safety or product issues or concerns with Avive. Axogen seeks to return Avive to the market, although the Company is unable to estimate the timeframe or provide any assurance that a return to the market will be achievable.
Avance Nerve Graft and Avive Soft Tissue Membrane are processed in the U.S. by Axogen pursuant to a License and Services Agreement, as amended, (the "CTS Agreement') with Community Blood Center (doing business as Community Tissue Services) ("CTS") at the CTS processing facility in Dayton, Ohio. The Axoguard product line is manufactured by Cook Biotech Incorporated ("Cook Biotech"), in West Lafayette, Indiana. The Axotouch Two-Point Discriminator is contract manufactured by Viron Technologies, LLC (doing business as Cybernetics Research Laboratories) (“CRL”) in Tucson, Arizona. CRL supplies the Axotouch Two-Point Discriminator unpackaged, and they are packaged at Axogen’s distribution facility in Burleson, Texas.
In March 2020, the World Health Organization declared the outbreak of the 2019 novel coronavirus and any and all variants thereof ("COVID-19") a pandemic. The global impact of COVID-19 has had a negative effect on the global economy, disrupting the financial markets and significantly impacting the medical industry. The Company implemented certain cost mitigation initiatives in 2020 such as a reduction in pay levels, temporary suspension of tissue processing and deferral of certain projects, among other efforts. As economic activity began to normalize, the Company lifted these cost mitigation initiatives. Although COVID-19 had a significant impact on the Company's revenue growth in 2020, the Company was able to increase revenue in 2021 as compared to 2020. The rapid development and fluidity of the situation surrounding COVID-19 prevent any prediction as to the ultimate impact COVID-19 will have on the Company's business as new variants continue to spread, causing global supply chain disruptions, labor shortages, and inflationary conditions.
|