The goal of the presently proposed Commercialization Readiness Pilot (CRP) Program project is to prepare for commercialization of an implantable system (developed in Phase II) that is capable of delivering a novel peripheral nerve stimulation (PNS) therapy shown to be highly effective in treating intractable pain in a majority of amputees in previous studies (including Phase I). Approximately 1.8 million individuals in the U.S. are living with an amputation, and about 185,000 individuals undergo an amputation each year. Post- amputation pain has a high incidence (95%) and frequently causes further disability, depression, and reductions in quality of life. Existing long-term pain therapies are inadequate long-term and are expensive (totaling up to $2.7-13 Billion/year in the U.S.). The previous Phase I project successfully demonstrated the feasibility of relieving post-amputation pain in 88% of subjects during in-clinic testing with a method of peripheral nerve stimulation (PNS) that selectively activates target fibers using a single electrode inserted remote from the nerve. In an additional 2-wk home trial of temporary percutaneous stimulation, all subjects that completed the trial experienced clinically significant pain relief (average=76%) while receiving 24hr/day stimulation, confirming that pain relief can be sustained as long as stimulation is delivered. The Phase II project is in the final year of the early-stage development of an implantable pulse generator (IPG) designed to be capable of delivering the novel PNS therapy long-term for post-amputation pain relief. The therapy is designed to use a flexible, self-anchoring electrode that avoids the need for open surgery and precise lead placement, and minimizes the risk of complications (fracture & migration) that previously limited use of existing PNS systems. These risks are further reduced by an IPG that is sufficiently thin to be placed in the residual limb, eliminating the need for the lead to cross the hip joint and avoiding the repeated flexing and bending that frequently causes failures with existing commercial systems. The proposed CRP project is needed to advance the system from an early stage (Phase II) to its final late- stage (commercial) design to enable rapid clinical adoption among pain physicians by enhancing the system implantation tools (Aim 1) to reduce complexity and the need for support staff, while leveraging a familiar procedural approach in which the vast majority of these physicians are already proficient. The project is also needed to advance system production from early-stage (intended in the Phase II project for low-volumes in which each IPG is manufactured by skilled technicians in a time-intensive process) to late-stage development of sustainable, quality controlled, high volume production in line with Good Manufacturing Practices (GMP) to enable successful commercialization.
Each aim will be considered successful if all verification/validation tests are passed. If successful, the final product will have the potential to meet the needs of amputees and their physicians through a commercially viable and sustainable therapy following FDA approval.
Approximately 1.8 million persons in the United States are living with amputations, and almost all have post-amputation pain, which is often severe and leads to disability, depression, and general suffering. Post-amputation pain can greatly reduce quality of life and interfere with the simple activities of daily living, but none of the present treatment options are adequate in managing the pain. The goal of this project is to complete late-stage development of a system designed to deliver a novel electrical stimulation therapy, reduce post-amputation pain, improve pain disability, and increase quality of life.