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To ensure the widespread availability of neural technology for the restoration of function for those with neurological impairments, and ensure the long-term support of those receiving the technology.

Why a non-profit?

Due to the relatively small market size of many neurological conditions like spinal cord injury, and the relatively high costs associated with moving technology from research through FDA approval, the ecomonics did not support traditional commercialization in this case. This is why the IFR was formed. To act as a surrogate corporate partner, performing all the actions necessary to reach FDA approval without the free market pressures of a company. The IFR is able to seek funding from philanthropy, foundation support and other grant mechanism to fill the gap between potential reimbursement and true cost. The IFR will continue to evaluate the individual programs for potential transfer to a for-profit venture, but as the mission also includes long-term support of the patient, the transfer would have to provide a satisfactory means of dealing with this issue.

Pathway from Research to Availability

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It all starts with a great idea. Available to many researchers are federal and foundation grants that provide funding for a truly innovative and important idea to evolved. This has been the case with neural technology. From the seed of an idea, an entire field of research has been created. The science and technology was developed first on a bench and then in animal models prior to being demonstrated to be safe in humans. These FDA feasibility trials are also considered research and, as such, have access to federal research grant mechanisms.

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The jump from research to commercialization marks the transition from innovation to demonstrating the same or similar outcome across a much larger population. This system is typically reliant on a company to fund the transfer of technology, protocol, and all other aspects of the delivery from a research environment to a commercial-ready state. Once the technology and outcome reach the level of controls needed for FDA approval, the device can be sold outside of a research trial.

The IFR is unique. The research is conducted by teams within the Cleveland FES Center and CWRU, and the conversion to product availability is lead by the Institute for Functional Restoration.

The Functional Electrical Stimulation (FES) Center is a pioneer in research to restore functions lost because of spinal cord injury. Established in 1991, the research center combines the efforts and expertise of three partner institutions: Case Western Reserve University, the Cleveland VA Medical Center and MetroHealth Medical Center. The technology developed by the FES Center can activate essential functions like bladder control and breathing, create sensation in the skin and even restore limb movement. The Institute for Functional Restoration (IFR) will build in the successful work of the FES Center and lead these products through FDA clinical trials to make them available to patients outside of the limited reach of the FES Center’s research studies. By combining philanthropic support with business expertise, the IFR will provide the essential step of financial support to propel these innovations into the marketplace

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Dr. P. Hunter Peckham.

For the past 40 years, Dr. Peckham has pursued functional restoration of those with neurological impairments through electrical stimulation. As the founder and Executive Director of the IFR, Dr. Peckham is ensuring that these advancements become an option for those with SCI. Learn more.