SPR bags $25M to market nonopioid pain-relief device

Dollars
The financing comes about one year after SPR received FDA clearance for its pain device.

SPR Therapeutics has raised $25 million to commercialize its FDA-cleared nonopioid pain-relief device. The series C tees SPR up to push a neurostimulation technology it wants to position as a drug-free way to relieve chronic and acute pain.

A prominent family office and Frontcourt Ventures led the round, which comes four years after SPR put together a $5 million series A to step up its push toward the market.

Cleveland, Ohio-based SPR’s Sprint is a minimally invasive peripheral nerve stimulation system for the management of chronic, post-traumatic and postsurgical pain in the back and extremities. The device is designed to relieve pain by stimulating a peripheral nerve linked to the affected area. This entails placing a percutaneous electrode near to the nerve and connecting it to a wearable device that delivers stimulation.

SPR picked up 510(k) clearance from the FDA in June 2016 on the grounds it is equivalent to the BiowavePENS System. One notable difference between Sprint and other neurostimulation devices is all the components are removed at the end of the 30-day treatment period.

The FDA filing pointed to multiple studies on chronic or intractable, postsurgical and post-traumatic pain to demonstrate the safety of the device. Those trials saw transient cases of skin irritation, erythema, a blister and a mild skin tear but none were classed as serious.

Sprint has suffered some setbacks in the clinic, though. A clinical trial in patients with poststroke shoulder pain failed to show the device is effective, although SPR thinks there are mitigating circumstances for that finding and points to other studies to make its case for Sprint.

"Two randomized, controlled trials comparing percutaneous PNS to standard of care have demonstrated clinically and statistically significant improvements relative to the control groups, the most recent of which compared to physical therapy," John Chae, M.D., chief medical Advisor to SPR, said.

"The third study demonstrated clinically-significant improvements in the majority of patients who received percutaneous PNS. However, the effect size for the primary outcome measure between the control group and the treatment group would have required a larger trial than the research grant was funded to support."

SPR now plans to leverage readouts from more positive clinical trials, such as its postamputation study, and fresh funding to escalate promotion of Sprint, while also funneling cash into research to expand use of the device into new indications. Postsurgical acute pain and chronic low back pain are on SPR’s hit list.

Nick Valeriani has signed up to support these efforts from a seat on SPR’s board of directors. The appointment gives SPR access to a medtech expert who rose to the position of worldwide chairman of medical devices and diagnostics during a 34-year spell at Johnson & Johnson.