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Got Nerve?


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Edward Bonfiglio joined the military two months after his high school graduation. At age 18, the New Jersey-native found his calling within the ranks of the U.S. Navy Corpsman.

“I always knew I wanted to do something with medicine,” he said.

As a first responder, Bonfiglio served two tours in Iraq and one in Afghanistan, accompanying Marine troops into battle and providing emergency medical assistance on the frontlines.

But on August 10, 2009, his life changed forever.

Bonfiglio’s unit was ambushed during a routine foot patrol in Afghanistan. They were stuck in a firefight for nearly an hour, before deciding to push out and gain new ground. During the maneuver, Bonfiglio got shot in the left thigh. He felt his leg go numb. He stumbled. He collapsed.

“My leg just dropped out from underneath me,” he said. “I immediately knew that something was wrong.”

Bonfiglio’s friend Michael Whalen, pulled him under cover and applied pressure to the wound while the rest of his unit radioed in for emergency medical assistance.

The area was so hostile that the medical support airlift they requested was guarded by two fighter helicopters and an accompanied by a thick, billowing smoke screen—to protect the helicopter landing from enemy triggers. Bonfigilio was rolled onto a stretcher and carried into the helicopter on the shoulders of his brothers-in-arms.

The tables had flipped for the Navy Corpsman who had bandaged and sutured so many of his fellow servicemen.

“It was weird being a patient, instead of the one taking care of the wounded,” he said wryly.

At the hospital, it became clear that the bullet had severed Bonfigilio’s sciatic nerve, an injury that left a colossal 5 centimeter gap in his nerve and stole his ability to feel or function below his knee.

His outlook was bleak: leg amputation and a life with prosthetic limb seemed inevitable. “I didn’t think I’d ever be able to use my leg again,” he said.

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Bonfigilio is just one of the more than 1.4 million people who suffer from traumatic peripheral nerve injuries in the United States. The injuries can be caused by something as simple as lacerating one’s hand on a wineglass, or as violent as suffering an IED explosive to the leg.

More than 700,000 of those injuries result in surgical intervention in extremities alone, said

Jill Schiaparelli, senior vice president of business strategy & marketing for AxoGen, Inc.

When you include oral and carpal tunnel revision surgeries for nerve repair, that number skyrockets to 900,000, she said.

Dr. Nirav Gupta, an orthopedic surgeon at Ocala Regional Medical Center, has seen his share of nerve damage. Patients suffering from nerve damage can suffer a wide range of symptoms, depending on the severity of the injury, he said.

He has seen patients experience everything from a mild tingling sensation to chronic pain to a complete loss of limb function. “Nerve damage can devastating,” Dr. Gupta said. Treatment choices are limited.

“Traditionally, when a nerve is injured and a portion of the tissue is missing, surgeons have had to extract nerve tissue from the back of the patient’s ankle to repair the damage,” Schiaparelli said.

This method, known as “autografting,” often requires a second surgery and can result in increased pain, a higher risk of complications and a longer prescribed recovery time for the patient.“Nobody likes to have surgery in one area, let alone two,” Dr. Gupta said dryly. His desire to offer more treatment choices to his patients drove him to test AxoGen’s nerve graft products in 2010. He hasn’t really gone back since.

“AxoGen is really revolutionary; mainly because you don’t have to harvest the graft tissue from the patient,” he said. “They offer a unique product line not really available by anyone else.”

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A surgeon at Walter Reed National Military Medical Center used AxoGen’s Avance® Nerve Graft to repair the gap in his sciatic nerve in Bonfiglio’s leg. Doctors were amazed by the results, he said.

It was one of the biggest nerve grafts they had ever attempted. Recovery was painful, but rewarding: a few months after the procedure he started to regain mobility in his toes.

In conjunction with intense physical therapy training sessions, Bonfigilio gradually graduated from a wheelchair, then a pair of crutches and finally a cane.

He’s thankful that he had an ‘Option B.’

“AxoGen gave me a second chance to actually save my leg,” he said.

Today, Bonfigilio is pursuing a Bachelor of Science in Kinesiology at Penn State and dreams of competing on the U.S. Paraolympics team.

He said that he’s going to try out for powerlifting, shot put and disc next year. If Bonfiglio’s drive and commitment is any indication: we just might see him competing in Brazil 2015.

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The Problem:

Each year, more than 1.4 million people suffer traumatic peripheral nerve injuries in the U.S.

The injuries can be caused by something as simple as cutting one’s hand on a wineglass, or as violent as suffering an IED explosive to the leg.

Depending on the level of severity, patients can experience anything from a mild tingling sensation to chronic pain to complete lack of limb mobility or function.

 

Conventional Treatment:

Traditionally, when a nerve is injured and a portion of the tissue is missing, surgeons have had to harvest nerve tissue from the patient’s body to perform a successful nerve repair. The method, known as “autografting,” often requires a second surgery and can result in increased pain, a higher risk of complications and a longer prescribed recovery time for the patient.

 

The Technology:

AxoGen has developed a way to process donated human tissue called “allografts.” Their Avance® Nerve Graft product helps bridge nerve gaps while maintaining the tissue’s pliability and natural microarchitecture. The product doesn’t require a second surgery like conventional autograft repair and provides an off-the-shelf choice for surgeons. It spans larger gap lengths and offers better nerve size matching than traditional methods. Avance® is the only commercially available processed nerve allograft.

 

The Company:

AxoGen, Inc. was founded in 2002. The company moved into the UF Sid Martin Biotechnology Incubator soon a few years later; it has seen double-digit growth ever since. Last month, AxoGen raised $18M and started trading on the NASDAQ stock market. its products have been used on thousands of patients worldwide.

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