FDA Clearance of an Expanded Indication for the SPRINT® PNS System Now Enables Treatment in Areas of the Head, Neck, and Torso

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The clearance was based on real world safety data collected from over 5,500 patients using the SPRINT PNS System commercially, both on-label and off-label.

Metadata
Provider: 
GlobeNewswire, Inc.GlobeNewswire, Inc.
Retrieved on: 
Tuesday, October 19, 2021
Information
Tags: 
SPRINT, Neck, Pain, Head, Risk, Chronic pain, Pain management, OH, PNS, Human, SPR, FDA, NP-hardness, CEO, Therapy, GLOBE, Patient, Torso, Extremities, Shoulder, Founder, Medtech, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Low back pain, Knee, Safety, Pharmaceutical industry, Dentistry
Geotags: 
Cleveland, MINNEAPOLIS, OHIO, NC, ROCHESTER, MN, CHAPEL HILL
Organisation: 
SPR THERAPEUTICS, INC.
Summary
Key Points: 
  • The clearance was based on real world safety data collected from over 5,500 patients using the SPRINT PNS System commercially, both on-label and off-label.
  • The expanded indication allows access to the many millions of patients with certain types of head, neck and torso pain.
  • The SPRINT PNS System is not intended to treat pain in the region innervated by the cranial and facial nerves.
  • Our SPRINT PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain.



CLEVELAND, Ohio, Oct. 19, 2021 (GLOBE NEWSWIRE) -- SPR Therapeutics® has obtained clearance from the U.S. Food and Drug Administration (FDA) of a broader indication for use for its SPRINT Peripheral Nerve Stimulation (PNS) System. Prior clearance limited use of the SPRINT PNS System to the back and extremities, but the new indication allows the device to be used in areas of the head, neck, and the front of the torso. The clearance was based on real world safety data collected from over 5,500 patients using the SPRINT PNS System commercially, both on-label and off-label.

Even without this expanded indication the pace of SPRINT System growth has more than doubled in the past year, 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. The expanded indication allows access to the many millions of patients with certain types of head, neck and torso pain.

“I have had great success in utilizing the SPRINT PNS System for many of my patients and I’m 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 authorization support from the SPRcare® market access team,” said Dr. Matthew Pingree of Rochester, MN.

“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.”

About the SPRINT® PNS System
The SPRINT® PNS System, by SPR® Therapeutics, marks an innovative shift in the treatment of pain. Our breakthrough, restorative, 60-day treatment is a First-Line™ PNS option uniquely designed to recondition the central nervous system to provide significant and sustained relief from chronic pain — without a permanent implant, nerve destruction or the risk of addiction. The system has been studied extensively for low back pain, shoulder pain, post-amputation pain, and chronic and acute post-operative pain, and is cleared for use up to 60 days. Recognized by leading pain management centers, the breakthrough neuromodulation treatment offers a patient-preferred alternative to more invasive options.

The SPRINT PNS System is indicated for up to 60 days for:   Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; Symptomatic relief of post-traumatic pain; Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the region innervated by the cranial and facial nerves.

For additional information regarding safety and efficacy, visit www.SprintPNS.com.

About SPR Therapeutics, Inc.
SPR Therapeutics is a privately-held medical device company, providing patients with a non-opioid, minimally invasive pain treatment option. Our SPRINT® PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain. Backed by the largest body of clinical evidence, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and built an incredibly strong foundation for commercial growth. Headquartered in Cleveland, OH with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s Senior Management team includes experienced industry veterans with nearly 200 years of collective pain market and MedTech expertise, all driven by our purpose - to improve the quality of patients’ lives by providing them with a minimally-invasive, drug-free, surgery-free solution to manage their acute and chronic pain.

More information can be found at www.SPRTherapeutics.com.


SPR Contacts:
Mark Stultz
Senior Vice President
[email protected]        
612.770.0390        

Dave Folkens
Public Relations Contact
[email protected]
612.978.6547

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