SPR Therapeutics has obtained clearance from the US Food and Drug Administration (FDA) of a broader indication for the usage of its SPRINT peripheral nerve stimulation (PNS) system. Prior clearance limited use of the SPRINT PNS system to the back and extremities, but this new indication will allow the device to be used to treat pain in certain areas of the head, neck, and the front of the torso too.
The new clearance was based on real-world safety data collected from more than 5,500 patients using the SPRINT PNS system commercially, both on-label and off-label, a press release from SPR Therapeutics states.
The SPRINT system is a 60-day treatment option that uses PNS to recondition the central nervous system, providing significant and sustained relief from chronic pain.
Even without this expanded indication, the pace of the SPRINT system’s growth has more than doubled in the past year—the release adds—having been used to treat nearly 7,000 patients to date, many of whom are seeking a pain management solution that does not require tissue destruction or a permanent implant.
“I have had great success in utilising the SPRINT PNS system for many of my patients and I am pleased that the expanded indication allows me to now treat these areas of high interest in an on-label manner, while also allowing many more patients to receive prior authorisation support from the SPRcare market access team,” said Matthew Pingree (Mayo Clinic, Rochester, USA).
“This is a tremendous milestone for SPR and the SPRINT system,” said Maria Bennett, CEO, president and founder of SPR Therapeutics. “We look forward to the opportunity to bring effective pain relief to even more patients seeking alternatives to other, more invasive treatment options.”
SPR Therapeutics also recently announced it had raised US$37 million in an oversubscribed Series D growth equity financing—which it intends to use to accelerate the commercial expansion of the SPRINT PNS system, and fund additional clinical research and advance next-generation technologies.