Annual report pursuant to Section 13 and 15(d)

Organization and Business

v3.10.0.1
Organization and Business
12 Months Ended
Dec. 31, 2018
Organization and Business  
Organization and Business

2.Organization and Business

 

Axogen is a global provider of innovative surgical solutions for physical damage or transection to peripheral nerves.  Axogen is focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Axogen’s products are designed to restore nerve function and are used to treat patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. 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 portfolio of products includes Avance® Nerve Graft, an 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 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 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 resorbable soft tissue covering to separate tissues and modulate inflammation in the surgical bed.  Along with these core surgical products, Axogen also offers the Axotouch® Two-Point Discriminator and Acroval® Neurosensory and 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 peripheral nerve function. The Company’s portfolio of products is available in the United States, Canada, and other European and international countries.

 

Avance® Nerve Graft and Avive® Soft Tissue Membrane are processed in the United States by Axogen at its processing facility in Dayton, Ohio.  Axoguard® Nerve Connector and Axoguard® Nerve Protector are manufactured in the United States by Cook Biotech Incorporated and are distributed worldwide exclusively by Axogen.  The Acroval® Neurosensory and Motor Testing System and Axotouch® Two Point Discriminator are contract manufactured by Viron Technologies, LLC (formerly Cybernetics Research Laboratories) (“Viron”) Tucson, Arizona.   Viron supplies the Acroval® and Axotouch® unpackaged and they are packaged at Axogen’s distribution facility in Burleson, Texas.  Axogen maintains its corporate offices in Alachua, Florida and is the parent company of its wholly owned operating subsidiaries, AC, APC and Axogen Europe GmbH.