Neuros Medical Seeks to Commercialize Nerve Block as Treatment for Pain

by David Pope, editorial director

Neuros Medical Inc., headquartered in Willoughby, OH (about 20 miles east of downtown Cleveland) was launched in 2008 to bring to market Nerve Block, a selective and reversible neurostimulation technique for completely blocking transmission of impulses in targeted nerves. The company’s initial goal is to develop an implanted device for blocking chronic pain that arises in the peripheral nervous system, such as amputation residual-limb pain, post-surgical pain, traumatic neuromas, and migraine. The neurostimulation technique also can be used to block spasticity, or muscle spasms, that occur as a result of spinal-cord injury, stroke, cerebral palsy, Tourette’s syndrome, and multiple sclerosis.

Jon Snyder, founder, CEO, and president of Neuros, has more than 20 years of experience with biomedical and healthcare companies including Cyberonics, Imalux, Steris, and Cardinal Health. He returned to Cleveland in early 2008 to become CEO-in-residence at BioEnterprise, a nonprofit initiative set up to help Ohio companies launch bioscience technologies. The CEO-in-residence program is funded by Ohio’s Third Frontier Project. Snyder also joined Arboretum Ventures, based in Ann Arbor, MI, as a venture partner and manager of its Cleveland office. Part of his role at BioEnterprise was to search for biomedical inventions to commercialize. It did not take long to find one across the street at Case Western Reserve University. With help from BioEnterprise’s staff, Snyder put together a business plan for developing and marketing the promising Nerve Block technology invented at CWRU, and incorporated Neuros Medical in October 2008.
Case Technology Ventures, an early-stage investment fund set up by the university, and JumpStart Inc., a Cleveland-based venture development organization, provided early funding of $375,000. Joseph Jankowski, CWRU’s associate vice president for technology management, joined the Neuros board of directors. In November 2009 Neuros announced a $1.8 million series A round led by North Coast Angel Fund, which was joined by Glengary LLC, Ohio Tech Angel Fund, Queen City Angels First Fund III, and individual investors. Claiborne Rankin of the North Coast Angel Fund and Mark Teague of Glengary LLC became directors of Neuros.

The Nerve Block technique acquired by Neuros uses two phases of electrical stimulation to temporarily depolarize the nerve membrane in the targeted nerve region. Repeated biphasic pulses make the nerve membrane incapable of conducting action potentials in that region. Animal studies indicate that the block is immediately and completely reversible. In a mixed nerve with both motor and sensory nerve fibers, it is possible to block the larger motor nerve fibers while allowing the sensory nerve fibers to continue functioning. This is done by using low-amplitude pulses. To block pain signals, the stimulus amplitude is progressively increased until both the motor and sensory nerve fibers are prevented from transmitting action potentials.

Kevin Kilgore and Niloy Bhadra of CWRU’s department of biomedical engineering are credited with the development of the nerve block technique. Kilgore is an adjunct assistant professor and Bhadra is a research assistant professor. In addition, Kilgore holds positions at MetroHealth Medical Center, the Louis Stokes VA Medical Center, and is associate director at the Cleveland Functional Electrical Stimulation (FES) Center. Bhadra, who was an orthopedic surgeon before changing to biomedical engineering research, earned a Ph.D. from CWRU in 2005 for his research on biphasic, high-frequency nerve block. He also is a principal investigator at the Cleveland FES Center. Kilgore and Bhadra serve as technical advisors to Neuros.

The nerve block technology stems in part from research at CWRU in the 1990s by Warren Grill before he moved to Duke University [Grill is NBR’s senior technical editor]. Kilgore, Grill, and two other researchers are listed on a fundamental patent for reversibly blocking nerve activity that was filed in 2002 and issued to CWRU in 2008. Kilgore and Bhadra have submitted additional applications for patents.

Shortly after the series A fund raising, Neuros appointed Zi-Ping Fang chief technology officer. Fang, who has a Ph.D. in biomedical engineering from CWRU and post-doctoral training in neuroscience, is responsible for the company’s technology and clinical development efforts. Fang has more than 25 years of experience in clinical research and neurostimulation technology and served previously with Nevro Corp. A clinical advisory board has been formed with Amol Soin of the Ohio Pain Clinic and Michael Stanton-Hicks of the Cleveland Clinic as members.

Battelle’s medical devices and diagnostics group has been selected to develop the prototype under the guidance of Neuros’ CTO Fang. “A prototype will be produced in 2010, developed with and manufactured by Battelle,” according to Snyder, Neuros’ president and CEO. The prototype is designed for use in patients in clinical studies.
Headquartered in Columbus, OH, Battelle is the world’s largest independent research and development organization, conducting more than $5 billion in contract research annually. The Battelle medical devices group has experience in the design, development, and manufacture of devices, as well as in the design and management of clinical studies. Its services are compliant with FDA’s quality and regulatory requirements and with ISO 9001 and 13485 standards. Following the completion of a medical study managed by Battelle, the FDA requested a special presentation as an example of the design and execution of a high-quality medical device clinical study. The Battelle medical device group also developed the algorithms for processing brain signals from the BrainGate interface developed by Cyberkinetics Neurotechnology Systems, Inc. Battelle also developed patient-training techniques to enable paralyzed patients to learn to communicate through the BrainGate interface.

Neuros plans to have its safety and efficacy clinical trial completed in the first quarter of 2011. The initial target market is the patient with chronic residual-limb pain following limb amputation. About 70 percent of the 1.7 million patients in the U.S. who have undergone amputation experience residual-limb pain. In addition, the high incidence of amputation in military casualties in Iraq and Afghanistan has created an urgency for developing better treatments, and the Nerve Block device may find a role in providing pain relief to wounded veterans.

The next target for Neuros’ Nerve Block platform is likely to be patients with chronic pain due to damage to nerves caused by surgery or injury. Migraine pain relief is another promising area. If patient clinical studies show that Nerve Block can prevent uncontrolled muscles spasms without affecting sensory nerve activity, a wide range of clinical applications will be possible.