How temporary neurostimulation can treat chronic pain long-term

Maria Bennett, co-founder and CEO of Cleveland-based SPR Therapeutics, has been studying pain relief using electrical stimulation for 25 years with the goal of treating the pain in the back and extremities using a non-surgical medical device.

“The idea around the product actually started back in my graduate studies,” Bennett told Medical Design & Outsourcing. “I was working with a team of scientists and physicians that identified shoulder pain as a significant unmet need in patients following stroke. We had used electrical stimulation to stimulate nerves, which is the core piece of the technology to activate shoulder muscles and other muscles in the body. Especially those that were inactive or unused for long periods of time such as those affected by a stroke or spinal cord injury.”

Stroke survivors may experience shoulder pain that can result in a limited range of motion and subluxation, according to the American Heart Association. Shoulder pain is often treated with medication and range-of-motion exercises to maintain the correct anatomic position of the shoulder joint as much as possible. Nerve block injections with anesthetic and Botox have also been used for pain management following a stroke, according to the heart association.

A notion takes hold

“We thought, ‘Wouldn’t it be a cool idea to activate these muscles of the shoulder and try to restore some movement in the shoulder for those patients and reduce the subluxation that occurs from those muscles being inactive? Wouldn’t that be kind of neat if we can set that shoulder back into place, so to speak, in those patients?’” Bennett said.

Bennett and her research team found that electrical stimulation could provide that benefit, reducing pain and improving patients’ quality of life. The initial neurostimulator her team produced could be used for a short period of time, up to 60 days, and it wasn’t implantable like other available neurostimulators that are in use.

Bennett set out to develop that technology even further, joining a small, Cleveland-based startup that was venture-backed and based on helping patients who had suffered spinal cord injuries. Though the research was costly, she moved on to expand the clinical work that was behind the technology. She ultimately went to work at Boston Scientific but continued thinking about the end result of the product she wanted to create.

After her stint at Boston Scientific, Bennett moved back to Cleveland to join former colleagues who founded the electrical stimulation company NDI Medical. NDI Medical sold its urinary incontinence-treatment product to Medtronic in 2008 for $42 million. A colleague approached her after the sale and proposed the idea of getting back into pain management to build upon the work Bennett did in graduate school.

“So, in 2009, I spent time validating the market and making sure there was an unmet need for a short-term neurostimulation device that could be used to treat different kinds of pain, specifically in the peripheries, but also low-back pain. I also did clinical validation and worked with some of my previous clinical colleagues,” Bennett said. “We had to think about this device going widespread commercially down the road.”

Bennett officially founded SPR Therapeutics in 2010.

“For the first several years, we focused on research and development of the technology and advancing it toward FDA clearance,” she said. We received FDA clearance in 2016 and then transitioned the organization into a commercial organization. Now we’re selling our device across nearly 20 U.S. territories and are continuing to execute on our commercial expansion strategy.”

How the technology works

The core device and product is called the Sprint peripheral nerve stimulation system. It’s a neurostimulator that activates a nerve that has been injured, either through trauma or disease, and is causing pain.

“The nerves that feed the brain signals are hyperactive,” Bennett said. “They have all these pain signals that are communicating to the brain that you’re in pain. What electrical stimulation does is that it calms down that overactivity. It starts to reset it to a healthy state in which it starts to send positive signals to the brain that you’re no longer in pain or that pain has been reduced.”

The technology is designed to treat everything from joint pain, such as shoulder or knees, to post-amputation pain. It uses a very fine lead the size of hair-like wire strands that is placed through the skin and in proximity to the target nerve. A physician, usually an interventional pain specialist, places the lead using a needle guided by ultrasound and turns on the device to deliver electrical stimulation. The physician can also see the activation of muscle and adjust the stimulation for the patient’s comfort. The rest of the wire exits the skin and is connected to an external stimulator, according to Bennett.

Patients can also control the level of stimulation using a device that’s similar to a key fob. When placing the lead in an outpatient procedure, a clinician can program the neurostimulator device through the fob or through a separate program on a tablet.

Commerically, SPR Therapeutics is approaching 4,000 patients that have used the device across the U.S., according to Bennett. Company sales reps are working with hospitals and surgery centers in about 20 U.S. territories. The company’s key areas of focus are on chronic back, shoulder, knee and nerve-related pain.

Keeping an elective procedure essential during COVID-19

Early in the COVID-19 pandemic, the Centers for Medicare and Medicaid Services released guidance recommending that healthcare providers postpone adult elective surgeries and procedures to preserve personal protective equipment such as masks and gowns while protecting patients and staff from exposure to the coronavirus.

“I think, like many other business owners, it was a very uncertain time,” Bennett said. “I was very fortunate to have our very supportive board of directors and our team that rallied very quickly to say, ‘How are we going to respond and how do we retool ourselves in a virtual environment while also keeping the strength of the organization afloat with our resources to ensure that we can continue to execute on our commercial strategy?’”

In keeping with the telehealth and telework landscape of the pandemic, SPR Therapeutics provided educational webinars to customers and additional training for the company’s sales representatives in order to keep the brand top of mind with physicians and the internal team “sharp” during the slow down period.

“The webinars were successful,” Bennett said. “It drove the opportunity for new customers coming out of the slow down period. We were able to come out of May with our largest month of sales in the history of the company. We’ve grown month-over-month steadily since then and are closing the gap of what we thought we could achieve for revenue for 2020. There will be a very small difference between where we thought we’d be.”

SPR Therapeutics experienced a percent growth in monthly product revenue of 660% from April to May 2020.

The Paycheck Protection Program also enabled SPR Therapeutics to avoid layoffs or furloughs.

“Being a medtech company is never a straight path. There are lots of twists and turns that we have to be prepared for,” Bennett said. “Now we’re almost 11 years old and have had a lot of twists and turns, but we’ve been able to adapt by having open and transparent communication amongst the team and plan for contingencies.  I am very proud of what our team has accomplished and look forward to the many opportunities we have to continue to provide an opportunity for pain relief for the millions of pain sufferers.”

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