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SPR Therapeutics Awarded $10M From U.S. Department of Defense

October 2, 2018

Latest awards will advance further research and development of the SPRINT PNS System for chronic and acute pain

CLEVELAND, Oct. 02, 2018 (GLOBE NEWSWIRE) — SPR Therapeutics, Inc., a leader in neurostimulation technology for pain management, has been awarded two new grants and one new contract from the U.S. Department of Defense totaling $10M to further develop its percutaneous Peripheral Nerve Stimulation (PNS) therapy, the company announced today. The SPRINT® PNS System offers a non-opioid pain relief therapy that is FDA-cleared for the treatment of acute and chronic pain.

In addition to a previous contract and grants from the National Institutes of Health and Department of Defense, these latest awards from the Defense Department bring the total amount of grants and contracts to $30M to support the advancement of SPR’s neurostimulation technology for pain.

“We are honored to receive this additional Department of Defense funding to advance research in support of broader use of our SPRINT percutaneous Peripheral Nerve Stimulation therapy for pain,” said Maria Bennett, Founder, President and CEO of SPR Therapeutics. “The management of chronic and post-operative pain continues to be a challenge among U.S. Military, Veterans and the general public. In the midst of the opioid crisis and the need for non-opioid pain treatment options, product refinements and data from additional studies of percutaneous PNS will support the independent, appropriate and effective use of our SPRINT PNS System for pain management.”

The largest of the awards, a grant totaling $6M, will support a randomized controlled trial (RCT) comparing the SPRINT PNS System to conventional medical management, to reduce pain and opioid use while enabling improvements in function among Service members, Veterans and civilians with chronic back pain. Chronic back pain interferes with function and daily activities (such as walking, work and personal care), and decreases quality of life. As the leading cause of morbidity in the U.S. military, back pain is the most commonly diagnosed injury or reason for seeking medical care and has the highest 5-year risk of permanent disability.

A second RCT, supported by a $3M grant, will focus on improving pain management following surgery for combat and non-combat related orthopedic trauma. Designed based on encouraging results of a previous study, it will further evaluate the use of percutaneous PNS to relieve pain, reduce or eliminate use of opioids, and accelerate functional recovery.

A $1M contract will fund continued advancement of the company’s PNS platform while enhancing the system’s ability to support independent use by healthcare providers. These improvements are intended to enable a wider range of interventional pain management physicians to offer the system with minimal training and enable simpler self-management of therapy, thereby allowing more patients to receive effective, non-opioid pain relief.

“The need among pain management physicians for non-opioid, minimally invasive and user-friendly treatment options is great. The funding provided by the Defense Department will provide additional data and insight regarding the SPRINT System’s ability to improve quality of life, enable faster post-operative recovery and provide long-term pain relief,” said Dawood Sayed, M.D., President, The American Society of Pain and Neuroscience.

About the DoD Awards
The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office for the awards. This work will be supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program and the Peer Reviewed Orthopaedic Research Program under Grant Nos. W81XWH-18-1-0800 and W81XWH-18-1-0799, respectively.  The contract is supported by the Defense Health Agency (DHA) Small Business Innovation Research (SBIR) Program, US Army Medical Research Material Command/Clinical Rehabilitative Medicine/US Army Research Institute of Surgical Research under SBIR Phase II Contract No. W81XWH-18-C-0329.  Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

About SPRINT® PNS System 
The SPRINT Peripheral Nerve Stimulation (PNS) System is the only percutaneous PNS device that is FDA-cleared for both chronic and acute pain, including post-operative and post-traumatic pain. The next generation device, endura™ (single-lead) and extensa™ (dual-lead) is the first and only dual-lead percutaneous PNS system. The SPRINT PNS System lead(s) are placed by a physician during an outpatient procedure without surgery, incisions, tissue destruction or anesthesia, and are connected to a wearable stimulator that delivers stimulation for up to 60 days of therapy. The lead is then removed. In multiple studies, SPRINT has demonstrated significant and sustained pain relief post-60-day treatment. Physicians have used SPRINT to treat post-amputation pain, shoulder pain, lower back pain, complex regional pain syndrome (CRPS), and post-operative pain following joint replacement (partial listing). For additional information regarding safety and efficacy visit sprtherapeutic.wpengine.com.

About SPR Therapeutics
SPR Therapeutics, Inc. is a privately-held medical device company headquartered in Cleveland, Ohio, focused on developing, manufacturing and commercializing non-opioid, minimally invasive treatment options that improve quality of life. The company’s SPRINT technology is the only percutaneous Peripheral Nerve Stimulation (PNS) System FDA-cleared to treat both chronic and acute pain. More information can be found at: sprtherapeutic.wpengine.com.

SPR Contact:
Mark Stultz
Senior Vice President
mstultz@sprtherapeutics.com
612-770-0390

Media Contact:
Helen Shik
Shik Communications
ShikPR@sprtherapeutics.com
617-510-4373

Photos accompanying this announcement are available at

http://www.globenewswire.com/NewsRoom/AttachmentNg/e8f37077-eae8-49ef-9466-1f6a1a1987dc

http://www.globenewswire.com/NewsRoom/AttachmentNg/496f31de-7959-4e83-9061-0023e29ac557

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The SPRINT PNS System is indicated for up to 60 days for: (i) Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; (ii) Symptomatic relief of post-traumatic pain; and (iii) 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. Physicians should use their best judgment when deciding when to use the SPRINT PNS System. For more information see the SPRINT PNS System IFU. Most common adverse events are skin irritation and erythema. Results may vary. Rx only.

View References for support of all claims.

The SPRINT® PNS System, MicroLead™, OnePass Introducer™, Rethink Your Pain Strategy™, Outsmart Pain™, Sustained Pain Relief Starts Here™, Life. Get Back to It.™ and SPR® are registered or common law trademarks of SPR Therapeutics, Inc.


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