02 Feb Donated Tissue Provides Surgeons Improved Ways to Repair and Reconnect Damaged or Severed Nerves

MedicalResearch.com Interview with:

Karen Zaderej

Karen Zaderej
CEO, AxoGen

Karen Zaderej joined AxoGen in May 2006. She has served as President, Chief Executive Officer and a member of the Board of Directors of AxoGen, Inc. since May 2010. Prior to her current role, she served as Chief Operating Officer from October 2007 to May 2010 and as Vice President of Marketing and Sales from May 2006 to October 2007. From October 2004 to May 2006, Karen worked for Zaderej Medical Consulting, a consulting firm she founded that helped medical device companies build and execute successful commercialization plans. From 1987 to 2004, Karen worked at Ethicon, Inc., a Johnson & Johnson company, where she held senior positions in marketing, business development, research & development, and manufacturing. Karen is a Director of SEBio, a non-profit supporting the life science industry in the southeastern United States. Karen earned an MBA from the Kellogg Graduate School of Business at Northwestern University and a Bachelor of Science degree in Chemical Engineering from Purdue University.

MedicalResearch.com: Please tell us about yourself and how you became CEO at AxoGen.

Response: I met Jamie Grooms, co-founder of AxoGen, in 2005 and we had one of those meetings that change your life. Jamie is a serial entrepreneur and loves to start businesses. He had tried to make nerves in the past but had been unsuccessful. When he saw new technology at the University of Florida that explained some of the issues in regenerating nerves, he decided to found a company focused on nerve repair. In parallel, I had been in business development and strategic marketing for Johnson & Johnson and we had looked at the nerve repair market. We determined there was a significant unmet need in nerve repair, but we could not find any technology at that time that solved the surgical need. Several years later, I left J&J and started a consulting business focused on market development and commercialization of early stage med tech companies. Jamie and I met, and I found the technology I had been looking for years earlier. We had an exciting conversation about the potential to improve the lives of patients with nerve injuries. I saw the possibility to create an entire new segment in med tech, one dedicated to nerve repair. With that great potential in front of me, I closed my consulting business, moved to Florida, and joined the AxoGen team.

MedicalResearch.com: Tell me about AxoGen and its signature products.

Response: AxoGen was founded in 2002 and has become a global leader in innovative surgical solutions for peripheral nerve injuries. We are the only company dedicated specifically to peripheral nerve repair solutions. We are passionate about restoring nerve function and quality of life to patients with peripheral nerve injuries by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care providers.

Our 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, AxoGuard^® Nerve Connector, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed 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 can be used as a soft tissue covering to reduce inflammation and scar tissue formation. 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 health care 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. AcroVal^™ and AxoTouch^™ are available in the U.S. The remaining AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.

MedicalResearch.com: What is unique about Avive? How is it used in surgery?

photo of Avive Soft Tissue Membrane
From surgeon who uses Avive Soft Tissue Membrane:
Avive™ provides a novel solution to a challenging problem. Following traumatic injury, we are often concerned with potential scarring, adhesions and tethering of the nerve. Avive™ offers a material with the ability to reduce inflammation and scarring with handling properties that are ideal for applications in nerve surgery.” – Dr. Bauback Safa
The Buncke Clinic, San Francisco

Response: Avive^™ Soft Tissue Membrane is processed from human umbilical cord that delivers the benefits of amnion to reduce inflammation and scar tissue formation. Avive^™ Soft Tissue Membrane offers a naturally resorbable anatomical covering to modulate inflammation and keep potentially adherent surfaces apart. Up to eight times thicker than amniotic sac membrane alone, 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. Avive^™ Soft Tissue Membrane 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.

MedicalResearch.com: What future research/products is AxoGen developing?

Response:  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.

MedicalResearch.com: Is there anything else you would like to add?

Response:  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. We invite you to learn more about AxoGen and our products for peripheral nerve repair by visiting axogeninc.com.

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

[wysija_form id=”5″]

Last Updated on February 3, 2017 by Marie Benz MD FAAD