IN: Hanger Goes in a New Direction

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Traditionally, Hanger Orthopedic Group has focused on patient care facilities, along with distribution of O&P products through SPS, its distribution subsidiary.

Now, catching the wave of emergent technologies, Hanger is adding another dimension with Innovative Neurotronics (IN), Bethesda, Maryland.

Although Hanger has developed products previously, these have been used within Hanger's own patient care centers rather than being made available to the general market.

Innovative Neurotronics (IN), Bethesda, Maryland, a wholly owned subsidiary of Hanger Orthopedic Group, is changing that. Focusing on functional electrical stimulation (FES), in May 2006, IN launched its first product, the WalkAide® System, for treatment of foot drop due to stroke, multiple sclerosis, cerebral palsy, brain injury, spinal cord injury, and other neuromuscular pathologies. The new product has been approved by the US Food & Drug Administration (FDA) and has recently achieved ISO certification and the CE Mark, opening up worldwide marketing opportunities.

The WalkAide is the first of IN's Myo-Orthotic Technology" products, being developed at major research centers and universities worldwide and carried through final development and commercialization. The company focuses on products involving neuromuscular rehabilitation, although FES technology has broad applications in many other medical areas, said IN President Jeff Martin in an interview with The O&P EDGE. For instance, the technology is used in heart pacemakers developed in the 1960s.

After more than a decade in development by a team of researchers at The University of Alberta, Canada, the WalkAide System counters the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. The system allows a qualified clinician to analyze the patient's leg and foot movements, which are identified by a patented sensor technology called an accelerometer and transmitted via a Bluetooth® connection. Once the device is fit on the patient, electrical signals are sent to the peroneal nerve, which controls the movement of the ankle and foot, prompting the muscles to raise the foot at the appropriate time and allow the patient to walk more normally. Worn around the leg, just below the knee, the wireless AA battery-operated device is about the size of a deck of cards.

Further, WalkAide may improve circulation, reduce atrophy, improve voluntary control over time and increase joint range of motion in patients with foot drop, according to IN.

The device is making an impact: IN won Frost & Sullivan's prestigious 2006 US Orthopedics Product of the Year Award for the WalkAide System. Frost & Sullivan, a global leader in market research and growth consulting, recognized the WalkAide as particularly innovative and superior to other offerings in this sector.

Marketing Plans

"We have a well-defined plan for rolling out this technology," Martin said. "We want to make this technology accessible to as many patients as possible, and we are looking at the international stage." IN has been contacted by about 30 companies worldwide interested in distributing the WalkAide, Martin said. "Right now we're in active negotiations with a number of companies for distribution," he added.

Besides orthotists, the company is planning to communicate the benefits of the WalkAide to healthcare professionals throughout the rehab continuum, including neurologists, physiatrists, orthopedists, and physical therapists. "We have a responsibility to market the WalkAide to specialists involved in the continuum of care, so they understand what this technology is, what it can do for their patients, and what it can't do—so we need a very broad communication plan," Martin said. Now that the company feels there are enough clinicians in place who are trained regarding the application of the product, IN is beginning to market to consumers/patients as well, he continued.

IN does not fund research, Martin explained. "We are looking for emergent, late-stage technologies to take to final development and commercialization—that's where our focus is." The company is actively exploring other product possibilities, but Martin could not discuss further due to confidentiality agreements and other considerations.

Neuroplasticity: Brain's Amazing Ability

An exciting result of the WalkAide is due to the brain's amazing ability to reorganize itself by forming new neural connections throughout life. Neuroplasticity allows the neurons in the brain to compensate for injury and disease and to adjust their activities in response to new situations or to changes in their environment.

Brain reorganization takes place by mechanisms such as "axonal sprouting" in which undamaged axons grow new nerve endings to reconnect neurons whose links were injured or severed, according to . Undamaged axons also can sprout nerve endings and connect with other undamaged nerve cells, forming new neural pathways to accomplish a needed function. Previously thought to be characteristic of the brains only of young children, neuroplasticity is seen as a possibility for adults as well, opening up an exciting vista of what might be possible in helping stroke and SCI patients, as well as others, regain function.

Patient Regains Function 40 Years Post-Stroke

For instance, traditionally stroke patients have been discharged three months post-stroke, since it is generally accepted that their recovery potential plateaus around 12 weeks. However, a 57-year-old WalkAide user, who suffered a stroke at age 17, was able, after a period of time, to remove the WalkAide and walk without it, Martin said.

A study published in the September 2006 issue of the peer-reviewed journal Neurorehabilitation and Neural Repair examined the potential for improvement when the WalkAide is used for one full year by patients with foot drop. The results are encouraging, according to the company. At the traditional three-month mark, when rehabilitation is typically stopped, the walking speed of patients wearing the WalkAide increased by 15 percent. However, with continued usage of the WalkAide system through six months, the patients' walking speed increased by 32 percent. Even more encouraging, after 12 months, the patients' walking speed had increased by nearly 50 percent. The study also showed the number of steps taken per day by WalkAide users increased significantly over the year. Patients suffering from foot drop due to spinal cord injury, traumatic brain injury, and other pathologies such as multiple sclerosis and cerebral palsy, were included in the study and also experienced the same positive results.

The efficacy of the WalkAide in stimulating neuroplasticity to help patients regain function is being explored further, Martin said. Clinical trials have been completed at three centers in Canada, with clinical trials currently underway at five centers in the US.

As FES and other technologies continue to emerge and develop, the O&P and broader rehabilitation field will likely see more exciting developments to the benefit of consumers and healthcare providers alike.

Innovative Neurotronics Earns ISO Certification

Innovative Neurotronics Inc. (IN Inc.), Bethesda, Maryland, a wholly owned subsidiary of Hanger Orthopedic Group Inc., also based in Bethesda, announced that it has achieved ISO 13485:2003 and ISO 9001:2000 certification from BSI Inc., the world's leading quality management systems registrar. The achievement of ISO certification verifies that IN Inc. has implemented comprehensive quality management systems (QMS) in product development, operations, shipping, and customer service.

"Innovative Neurotronics is committed to developing and delivering the highest quality products based on emerging neuromuscular technologies," IN Inc. President Jeff Martin said. "Achievement of the ISO 9001 and 13485 certifications validates this commitment. We will continue to instill confidence in our patients, referral sources, research alliances, and international partners by regularly monitoring our business operations and delivering on promises of service excellence."

Developed by the International Organization for Standardization (ISO), a network of the national standards institutes of 161 countries, the ISO 13485:2003 standard is an internationally recognized quality management system standard for medical devices. Certification supports the CE marking process for products sold within the 25-nation European Union and also is a requirement to obtain marketing approvals by several countries, including Canada and Japan.

Also developed by the International Organization for Standardization, the ISO 9001:2000 certification is an international reference for quality management requirements in business-to-business dealings. It signifies a global benchmark in customer satisfaction and product quality.

IN Inc. decided to pursue the ISO quality management certifications as part of its commitment to expand its business capabilities and broaden its neuromuscular stimulation offerings, the company said.

"Achievement of both ISO certifications is a significant milestone in our plans for international expansion," said Hanger President and COO Tom Kirk. "It facilitates our mission of bringing emerging Myo-Orthotics TM technology products to the European Union and beyond. Patients and healthcare providers across the globe can rest assured they are receiving high quality devices from IN Inc."

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