AxoGen, Inc., based out of Florida, has spent the past several years establishing themselves as a leader in the field of nerve repair. Their latest advance, Avive Soft Tissue Membrane, made its formal commercial bow just a few weeks ago. The product offers a new solution to surgeons addressing traumatic injury, promising reduced inflammation and scarring in the recovery process.
To learn more, Surgical Products interviewed Karen Zaderej, who has served as president and CEO for AxoGen since 2011. She also sits on the board of directors. Zaderej shared insights on Avive Soft Tissue Membrane, addressed other solutions available from AxoGen, and provided a preview of future advances.
Can you tell us about Avive Soft Tissue Membrane?
Avive Soft Tissue Membrane is 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. Up to eight times thicker than traditional amnion, Avive Soft Tissue Membrane stays in place for at least sixteen weeks and is minimally processed to preserve the natural properties of umbilical cord amniotic membrane. It 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.
The first clinical implants of Avive recently took place. Can you tell us about the procedure?
The first implant of Avive Soft Tissue Membrane took place at the Buncke Clinic located in San Francisco, California on November 14, 2016. Avive Soft Tissue Membrane was implanted into a patient who had suffered a crush injury where the median nerve appeared to be inflamed. Avive Soft Tissue Membrane was used to cover the median nerve to reduce both inflammation and separate the nerve and surrounding soft tissues.
One week later, the second clinical implant of Avive Soft Tissue Membrane took place at Doctors Hospital in Modesto, California. A patient suffered a distal radius fracture requiring tenolysis. Avive Soft Tissue Membrane was placed around the median nerve to address inflammation and separate the tendons and the nerve following distal radius fracture.
How specifically does the product improve patient outcomes in nerve surgery?
Post-operative scar tissue formation and tissue attachment is inherent following traumatic injury or surgical intervention and can lead to soft tissue irritation and inflammation, or neuritis. There are several further complications that can result from that, including recurrent pain and an altered range of motion. Minimally processed from human umbilical cord, Avive Soft Tissue Membrane delivers the benefits of amnion to modulate inflammation and offers a resorbable anatomical covering to keep tissue surfaces apart.
How do you see Avive fitting into the overall mission of AxoGen?
At AxoGen we are dedicated to peripheral nerve repair. We work every day to provide innovative, clinically Proven, and economically effective repair solutions for surgeons and healthcare providers. In addition to Avive, 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. We also have 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.
Along with these core surgical products, AxoGen also offers AcroVal Neurosensory & Motor Testing System and AxoTouch Two-Point Discriminator. 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 other European and international countries.
Where do you go from here? What other innovations do you expect to see in the near future?
AxoGen has a five-year strategic plan that includes multi-dimensional growth. We will continue to launch impactful new products to solve additional needs in peripheral nerve repair, while also exploring new markets and applications for our current products. For example, the potential to improve quality of life for women who undergo breast reconstruction by restoring sensory function of the breast is an area of opportunity we will investigate further in the next year.
We will also continue to invest in and support clinical studies and programs to further the understanding and outcomes of peripheral nerve repair. In fact, we have clinical research underway in several key areas, evaluating outcomes for patients being treated for a variety of types of peripheral nerve injuries.
Anything else you’d like to add?
The body communicates with the brain using a system called peripheral nerves. These nerves enable sensation and muscle movement. Peripheral nerve injuries affect people of all ages. Injury to these nerves can cause tingling, burning, pain, loss of feeling, or loss of movement. Dealing with a peripheral nerve injury can be frustrating and confusing. At AxoGen, patient safety is our first priority, and we’ve made it our mission to bring life-improving solutions to people who struggle with peripheral nerve injuries.
As the leader in this market, we provide special training and educational opportunities to surgeons, help build awareness of peripheral nerve injuries and the treatment options available, invest in research and development projects to move the science of peripheral nerve repair forward, conduct clinical studies to build the data resources necessary to improve peripheral nerve treatment, and support organizations dedicated to improving lives through tissue donation awareness and advocacy.