SPR Therapeutics, a medical device company, has received a $1.45 million grant from the National Institutes of Health (NIH) to develop a fully-implantable peripheral nerve stimulation (PNS) system to treat post-amputation pain.
This small business innovation research (SBIR) phase II grant from the NIH complements a $2.8 million research grant from the Department of Defense that is funding ongoing clinical trials to assess the safety and efficacy of SPR's PNS therapy in the management of phantom and residual limb pain following amputation.
"Access to this technology opens the door to the treatment of many currently unaddressed chronic peripheral pain conditions, such as post-amputation pain, for which appropriate treatment options do not exist," said interventional pain physician Steven P. Cohen, director of pain research at Walter Reed National Military Medical Center and Professor of Anesthesiology & Critical Care Medicine and Physical Medicine & Rehabilitation at The Johns Hopkins School of Medicine and the Uniformed Services University of the Health Sciences.
According to the National Limb Loss Information Center there are approximately 1.7 million people in the United States living with limb loss. Post-amputation pain presents a significant treatment challenge and occurs in up to 85% of those with major limb amputation. Using SPR's unique method of percutaneously stimulating peripheral nerves, researchers in Winston-Salem, North Carolina reported significant relief of phantom and residual limb pain in amputees and improvement in quality of life. As published in Neuromodulation, pain was reduced by 76%, on average.
This novel approach to PNS involves the percutaneous (through the skin) insertion of a very small medical wire, or lead. Ultrasound guidance is used to position the lead remote from the nerve, decreasing risk of nerve injury and making the procedure very amenable to the interventional pain management physician. Placement of the lead remote to the nerve also allows SPR's system to preferentially activate the targeted sensory nerve fibers without activating pain or motor fibers, which is a challenge with other PNS approaches. Conventionally, PNS has involved the placement of multiple electrodes in close proximity to the nerve often requiring a neurosurgical procedure to dissect away tissue from around the nerve. Conversely, SPR's PNS system was designed with the goal of avoiding the neurosurgical procedure and instead using ultrasound guided insertion of the lead through a small needle. SPR's intent is to enable the large number of interventional pain specialists that manage chronic pain patients to implant the system on an outpatient basis.
The NIH grant funding will be used to develop SPR's second-generation implantable pulse generator (IPG) for patients who require long-term stimulation to manage their chronic pain following amputation and other types of neuropathic pain conditions. Currently available IPGs have not been optimized for use in the periphery and as such they are typically implanted in the trunk or abdomen. The planned project will result in development of a small implantable device that can be comfortably placed within the residual limb of an amputee. Reviewers of the NIH grant application indicated that the system "addresses a significant problem, and brings forward an innovative idea over existing methods of PNS. The minimally invasive remote placement of the stimulating electrode was considered a particularly advantageous approach." The project is supported by Grant Numbers R43NS066523 and R44NS066523 from the National Institute of Neurological Disorders And Stroke.
"We are very pleased to have received this grant award from the National Institutes of Health. The peer-reviewed and funded grant serves as continued validation of our therapy and the unmet need that our technology addresses in the field of pain management," said Maria Bennett, president and CEO of SPR Therapeutics.
SPR's technology platform is being developed to address a wide spectrum of chronic and post-surgical pain indications affecting millions worldwide. SPR's PNS Systems are investigational devices limited by U.S. law to investigational use. The grant award from the National Institutes of Health will support development of the implantable system for the next phase of the clinical research being conducted at several premier research centers in the United States to include the Carolinas Pain Institute and Center for Clinical Research in Winston-Salem, North Carolina and Walter Reed National Military Medical Center in Bethesda, Maryland.
SPR Therapeutics is a medical device company that has developed a proprietary peripheral nerve stimulation platform to address a critical unmet need for non-narcotic, less invasive, longer lasting, and cost effective treatments for post-operative and chronic pain.