The company has also raised $37m capital in a Series D growth equity financing round for commercial expansion of its SPRINT PNS System and to fund additional clinical research
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
SPR Therapeutics has secured approval from the US Food and Drug Administration (FDA) for the expanded indication of the SPRINT Peripheral Nerve Stimulation (PNS) System.
The new indication enables the use of the system in areas of the head, neck, and the front of the torso.
The approval is based on real world safety data obtained from more than 5,500 patients using the SPRINT PNS System commercially.
The FDA had previously approved the use of the system to the back and extremities.
SPR’s SPRINT PNS System is a 60-day treatment that is designed to provide a drug-free, surgery-free option for patients who suffer from chronic pain.
SPR Therapeutics founder, president and CEO Maria Bennett said: “This is a tremendous milestone for SPR and the SPRINT System.
“We look forward to the opportunity to bring effective pain relief to even more patients seeking alternatives to other more invasive treatment options.”
According to the medical device company, the SPRINT PNS System is developed to bring an innovative shift in the treatment of pain and is indicated for symptomatic relief of chronic, and intractable pain, post-surgical and post-traumatic acute pain.
It is also indicated for symptomatic relief of post-traumatic pain and symptomatic relief of post-operative pain.
However, the system is not intended to treat pain in the region innervated by the cranial and facial nerves.
Separately, SPR Therapeutics has raised $37m funding in a Series D growth equity financing round for commercial expansion of its SPRINT system.
The company intends to utilise the proceeds to speed up the uptake of its system, to fund additional clinical research, and to advance next generation technology.
Bennett said: “This additional funding will allow us to accelerate the already strong adoption we are seeing of our SPRINT PNS System within the interventional pain management community.
“There is clear interest from physicians and patients in avoiding the use of opioids and permanent implants when possible. Our goal is to ensure that all patients have access to our SPRINT System as an effective, non-opioid, treatment.”