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By Stacy Lawrence

Staff Writer

Device-based approaches to pain management are seeing a renaissance of interest as the ongoing opioid crisis highlights the perils and limitations of existing drug treatments. Cleveland, Ohio-based SPR Therapeutics LLC is among the latest beneficiaries of that momentum with its new $25 million series C financing.

The start up's Sprint peripheral nerve stimulation (PNS) system also coincides with another major medical device trend, minimally invasive procedures. It's the first FDA-cleared device to treat chronic and acute pain that's a minimally invasive, peripheral nerve stimulation system.

The Sprint system has a percutaneously implanted lead that is accompanied by a wearable stimulator; it's designed for 30 to 60 days of use but has been shown to have long-term pain reduction effects after removal.

"We're in an unfortunate, but opportune, situation with pain management and the opioid crisis. Physicians, patients, payers and the FDA, everybody across the board, is really looking for safe and effective alternatives that can fill a gap within the treatment continuum," Maria Bennett, the CEO, president and founder of SPR, told BioWorld MedTech.

"There's this continuum of care for any sort of pain patient that starts with anti-inflammatories and physical therapy. And then you've got your treatments of last resort, which are typically surgeries or potentially implantable neuromodulation systems. And there's really nothing in between these except for potentially an opioid prescription," she added.

The Sprint system is expected to offer an alternative prior to opioids in a wide variety of pain indications. The FDA clearance is broadly for the relief of chronic and acute pain, including post-operative and post-traumatic pain.

The company has done research in a number of more specific indications, including shoulder pain after stroke, post-amputation pain, lower back pain and post-surgical pain after knee replacement. It may pursue additional FDA clearances in specific indications at a later date, if it finds that to be commercially advantageous.

Starting with stroke

SPR Therapeutics, which was founded in 2010, is based on research that Bennett was involved in at the Cleveland-based Case Western Reserve University while she was working on her master's degree in biomedical engineering.

Another novel Case Western Reserve pain management device start up that is also based in Cleveland, Ohio, Neuros Medical Inc, also recently garnered a $20 million series AA round. (See BioWorld MedTech, Aug. 9, 2017.)

The early research behind SPR was focused on using peripheral nerve stimulation to alleviate shoulder pain after stroke.

"The top comorbidity for post-stroke patients is shoulder pain. You will see a stroke patient with a change in their gait or maybe in their speech or cognitive abilities, but they have a significant amount of shoulder pain because of this weakening of the shoulder muscles and dislocation that occurs," explained Bennett.

"We found that we could stimulate the area of the shoulder with our technology and stimulate that for just a few weeks. Then we would remove the technology and found that patients had a significant reduction in their shoulder pain, as well as a significant improvement in their quality of life," she said.

She continued, "Part of our secret sauce was that we did not have to leave this technology permanently implanted. After we removed the technology, we actually saw that patients had a carryover of pain relief for many months to years. So, this was something new and game-changing for the field of neurostimulation and pain management."

The lead for the Sprint system is implanted within a few millimeters of the peripheral nerve associated with the pain. In published data on thousands of leads, SPR has had zero infections due to the coiled design of the lead, Bennett said.

On average, the Sprint system provided greater than 50 percent pain reduction for 72 percent of patients in a study. And at 12 months post-treatment, 78 percent of patients reported that they continued to experience clinically significant pain relief.

In mostly small studies, the system offered more than 50 percent of pain relief for anywhere from about two-thirds up to 90 percent of patients, depending on the specific indication.

The persistent effect of the system is thought to derive from its ability to interrupt pain signals to the brain, thereby disrupting the self-perpetuating process that is thought to lead from short term to chronic pain.

"We're specifically targeting the nerve that's causing the pain. We're able to actually activate those fibers that are carrying those negative signals as pain signals to the brain. So, when somebody is in a state of chronic pain, the brain has been sensitized to that state – this is basic science – it is well documented," said Bennett

"What we're able to do by stimulating the nerves, we were able to calm down that over-activity or that negative feedback and almost reset it to a healthy state," she concluded.

Costs of innovation

The recent financing, which was jointly led by an undisclosed family office and Frontcourt Ventures, brings the total equity financing raised by SPR to $35 million. In addition, it's garnered nearly $23 million from non-dilutive funding from sources including the U.S. Department of Defense (DOD) and the National Institutes of Health (NIH).

These agencies have supported both clinical study activity and product development activity. The DOD is specifically interested in the post-amputation pain application for use with veterans; in May, DOD awarded SPR Therapeutics a $6 million, four-year contract to continue to advance sprint in individuals with combat or trauma-related amputations with moderate to severe neuropathic pain. More than 85 percent of people with amputations report residual or phantom limb pain.

With the FDA clearance of the Sprint system coming last July, SPR started working on a launch early this year. The financing will enable the start up to start fielding reps, focusing first on its existing physician connections.

Bennett noted that during this early launch phase, interventional pain specialists have embraced the technology, particularly since the percutaneous procedure to implant the lead is already familiar, since it's similar to nerve blocks.

The Sprint system is 10 percent to 15 percent the cost of a traditional spinal cord stimulation implantable pain device – and it is reimbursable under an existing code. Several hospitals have already been approved for purchasing, and a five-person launch team has just been hired.

Summed up Bennett, "We want to change the way that pain management is treated, changing the lives directly of patients and giving clinicians options and alternatives to treat those patients."



Published  September 14, 2017

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