Editor's note: This article has been updated to clarify FDA classification of the Sprint Peripheral Nerve Stinulation system.
Cleveland, Ohio-based SPR Therapeutics announced today that it has received FDA clearance for a new version of its percutaneous, wearable pain management device.
With this 510(k) approval, the Sprint Peripheral Nerve Stimulation (PNS) system is now available as a single lead (Sprint endura) or dual lead (Sprint extensa) offering, with the latter allowing for the non-surgical placement of two lead wires that are connected to a single device. In addition, the updated platform now supports rechargeable batteries and a Bluetooth-enabled controller for patient use.
“Our Sprint PNS platform is designed to deliver the least invasive and most user-friendly [percutaneous electrical nerve stimular] therapy experience for physicians and their patients,” Maria Bennett, founder, president, and CEO of SPR Therapeutics, said in a statement. “With the ease of use and dual lead capabilities we’ve built into the Sprint System we look forward to advancing the early use of neurostimulation as a non-opioid alternative for more patients while we continue to generate data that demonstrate significant and sustained pain relief following our 60-day therapy.”
SPR Therapeutics’ percutaneous electrical nerve stimulator is a non-narcotic alternative for chronic and acute pain relief indicated for up to 60 days of use in the back or extremities. By connecting a wearable stimulater to a 0.2mm wire placed through the skin, the system activates target nerve fibers to relieve patients’ pain. The therapy requires no permanent implants, invasive surgery, tissue destruction, or opioid prescription.
Despite its commercial name, the Sprint PNS system is classified by the FDA as a percutaneous electrical nerve stimulator (PENS). Devices classified by the agency as a PNS are intended for long-term implantation within the body.
The company has described the system as being ideal for shorter outpatient procedures, as the placement is completely reversible if necessary. A 2014 clinical investigation found use of SPR's system to be associated with a 72 percent reduction in average pain among those presenting with moderate-to-sever post-amputation pain.
Preliminary results from a multicenter study of the system that were included in today’s announcement also showed significant pain or pain interference reduction among two-thirds of participating chronic post-amputation pain patients after eight weeks of treatment. In addition, the same reduction was reported by four out of five patients who completed the full 12-month study period, according to the company. The majority of these patients were using the dual lead version of the company’s offering.
SPR Therapeutics enjoyed a $25 million Series C financing round led by Frontcourt Ventures and an unnamed family office in September 2017, and has received a total of $9 million from the US Department of Defense in contracts. The company’s primary competition in the wearable pain management device space is Neurometrix’s Quell, which is worn above the skin.