“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,” said Karen Zaderej, chairman, CEO and president of Axogen.
Headquartered in Alachua, Florida, Axogen is the leading company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. The company is passionate about helping to restore peripheral nerve function and quality of life to 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.
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 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; and Avive® Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a resorbable soft tissue covering to separate tissue layers and modulate inflammation in the surgical bed.
The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, and several other European and international countries.
“Axogen has been collaborating with ARMI for several years, since I met ARMI founder Dean Kamen and CTO Tom Bollenbach when the organization was just getting started,” Zaderej said adding, “ARMI’s vision was complementary to Axogen’s vision of revolutionizing the science of nerve repair, so we agreed to work together in a coordinated effort to advance regenerative medicine, and then ARMI and Axogen leaders continued the conversation and met at conferences like TERMIS. Our partnership, sharing the goal of advancing regenerative medicine, continues to this day.”
“The science of regenerative medicine allows us to help restore both sensory and motor function to an underserved patient population,” she explained, continuing, “As a company, and as individuals, we are excited to play a role in revolutionizing the science of nerve repair and helping to improve quality of life for so many patients who would otherwise struggle with the results of peripheral nerve damage. Our Avance Nerve Graft is changing the way peripheral nerves are repaired.”
Zaderej explained the current and future state of nerve repair this way, “Many surgeons still repair peripheral nerves by harvesting a nerve from another part of the body and using it to bridge a gap in an injured peripheral nerve. A healthy nerve, typically the sural nerve from the leg, is surgically removed and sutured into the nerve gap. This procedure is known as an autograft and requires an additional surgical site and may result in numbness where the nerve was removed and, as a result, the patient must trade feeling in one part of their body for the chance to regain feeling or function in another. As an off-the-shelf processed human nerve allograft, our Avance Nerve Graft eliminates the need for an additional surgical site while also eliminating the need for a patient to give up feeling in another part of their body. Also, the sural nerve is typically small in diameter, which often results in a size mismatch to the nerve being repaired. Since processed nerve allograft is available in a range of sizes, it can more readily be sized to match the nerve being repaired. Processed nerve allograft is donated human peripheral nerve that is used to bridge the nerve gap, providing a biologically active bridge of nerve tissue to support and guide the regeneration of the nerve..”
Avance Nerve Graft, Axogen’s flagship product, is used to repair injured peripheral nerves throughout the body. To date, Avance has been used primarily in the upper extremities to restore movement and feeling in the hands and arms, however Axogen regularly researches new nerve repair applications for Avance and pursues those where the company believes it can make a meaningful difference by providing a surgical solution to a challenging health care issue.
Loss of sensation after mastectomy and breast reconstruction is one such challenge. Late last year, Axogen announced the launch of an expanded application in breast reconstruction neurotization. “At Axogen, we believe the ideal breast reconstruction restores Size, Shape, Symmetry, Softness, and now, Sensation.”
“We worked with surgeons to develop the ReSensation® surgical technique, which incorporates this vision into an effective and reproducible solution for reconstructive plastic surgeons. The ReSensation breast neurotization technique is designed to restore sensation in a flap reconstruction after a mastectomy,” noted Zaderej, adding. “Free flap reconstruction uses a woman’s own tissue, typically taken from the abdomen, to rebuild the breast mound. ReSensation makes it possible to connect the nerves in the newly formed breast (using allograft nerve grafts) with nerves in the chest that were transected during the mastectomy,” she explained.
“Historically, the sensory nerves were not repaired in breast reconstruction procedures following a mastectomy, and reconstructive plastic surgeons had very limited options for restoring sensory function. Women simply accepted the loss of sensation as a trade-off for removing the cancer. These surgeons can now offer breast cancer patients the option of an autologous or free flap breast reconstruction that includes neurotization. Women no longer need to accept a permanent loss of sensation in their breasts as an inevitable side effect of a mastectomy,” Zaderej noted.
“The field of regenerative manufacturing is still emerging. Every company and organization in the TERM field faces some level of challenge with its manufacturing processes, scaling for growth, or standards confusion. ARMI is helping to advance these processes and support expansion of this important technology for improved patient care,” she said.
“Axogen is an active and involved member of ARMI, which allows us to stay abreast of developments in the regenerative medicine field. ARMI membership provides opportunities to collaborate with other players in the field and leverage the skills, experiences, and capabilities of a diverse group of ARMI members. Available funding opportunities to support the development of new technologies is also of interest,” she concluded.