In the emerging field of regenerative medicine, AxoGen is a company with a lot of nerve

When it comes to AxoGen’s market potential in the Florida medical world, the human body offers millions of nerves for this company to showcase its products. Firmly positioned in the emerging field of regenerative medicine, the company is in the business of peripheral nerve repair—and there are a lot of people who need help.

Traumatic injuries, especially in the extremities and oral/maxillofacial area, cost $1.6 billion annually in the U.S. alone. Sufferers range from members of the military to healthy babies with birth canal injuries to active adults having accidents. Sadly, the list is long.

“We saw that there was really a tremendous unmet need in these injuries with peripheral nerves,” says Karen Zaderej, president and CEO. “And we really weren’t satisfied with the current solutions. We can provide solutions with our suite of products that gives patients new options for their repair. And we are excited about that.”

NASDAQ was also excited to have the Alachua, Fla.-based company join the exchange in August. Traded as AXGN, its current market capitalization is about $75 million. Not bad for a company that started with four employees.

Zaderej explained that surgeons don’t change treatments on a whim; they rely on data. “We have a real internal mandate to educate the surgical community in terms of new options and repair techniques,” she cites, adding that AxoGen also wants to educate patients about new treatment choices.

While its current core market focuses on surgeries for extremities, especially hands and lower extremities, in the short term the company is looking to new clinical applications for existing products. In April, AxoGen started working with surgeons on trigeminal nerve (jaw) injuries as a result of dental procedures. In November, the company is scheduled to sponsor an educational forum for oral and maxillofacial surgeons in Chicago.

It’s obvious that first and foremost AxoGen is a health care company in the business of helping people. Zaderej is animated when discussing new clinical applications for her company’s products. On the horizon: breast cancer. After reconstruction, women don’t have normal nerve sensation in their new breast(s). AxoGen would like to change that and is currently working with several surgeons on the technique to hook up the nerves. “We think you need to have sensory function to feel normal again,” comments Zaderej. While this type of procedure is in the early stages, Zaderej thinks in a year or two in it will be available to patients on a broad basis.

Another disease with nerve consequences is prostate cancer. The company just completed a critical study. Common side effects for men who have their cancerous prostates removed are erectile dysfunction and incontinence. “We have conducted a pilot study that repairs the nerve when you can’t spare them. Nerves are right on the surface of the prostate, and the surgeon has to decide to either leave cancer behind or take out the nerve,” Zaderej explains. She believes the nerve can be repaired and the patient’s quality of life is maintained while achieving cancer- free status: “We will see those results in about a year.”

AxoGen’s suite of products includes Avance Nerve Graft/The Natural Connection; AxoGuard Nerve Protector/Wrap & Protect and AxoGuard Nerve Connector/Align & Connect. These off- the-shelf products enable surgeons to conduct allograft procedures, as opposed to autograft procedures in which the patient must undergo two incisions to harvest nerves and cells from another part of his or her body to fix the injured nerve. There are a lot of advantages to keeping the surgery to one incision site.

AxoGen Corp. was born into the Florida medical sector when it was founded in 2002 and, as the result of a reverse merger with LecTec Corp. in 2011, became today’s AxoGen Inc. It was spun out of the Sid Martin Biotechnology Incubator at the University of Florida.

Zaderej is a fan of the Gainesville area. Recruited in 2006, she was amazed at the resources offered to her by the incubator and views them as problem-solvers for companies. Whenever a business need arose, small or large, the staff was on hand with solutions. It enabled AxoGen to focus on its product development.

“I wasn’t really familiar with the resources that were available in the Gainesville area. And I have been amazed and impressed with the support infrastructure here for starting a company,” Zaderej. “I tell people all the time this is an area they should look to.” She also mentions the resources at UF, especially in the area of research.

Being a health care company in the exciting regenerative field, research is essential. It’s the “process of replacing or regenerating human cells, tissues or organs to restore or establish normal function.” This area of medicine holds the promise of regenerating damaged tissue and/or by stimulating the body’s own repair mechanisms to heal previously irreparable tissues or organs.

In terms of economic impact, some estimates place the Florida medical market, specifically the regenerative medicine market, at $17 billion in the coming year.

“Regenerative medicine is really going back to the building blocks of the body. It is individualized treatment,” concludes Zaderej. “There are many things on the horizon that will happen over the next five years.”