By Bob Marshall, Chief Editor, Med Device Online
Have you ever accidently struck your thumb or finger with a hammer? What was your immediate reaction? I mean after the few choice expletives! Most, if not all of us, will grab and rub the impacted appendage. Why do we do this? It is our instinctive attempt to stabilize and soothe the nerve we have just violently stimulated with the hammer.
The triggered nerve is dutifully sending messages through the central nervous system to the brain, which responds with a corresponding magnitude of pain. The concept of this simple analogy was shared with me by Maria Bennett, founder and CEO of SPR Therapeutics, during a recent interview. She used our innate, real-world, mechanical attempt to soothe an activated nerve to explain what her device does electronically. The SPRINT PNS System has a lead that is placed percutaneously and is used to selectively activate and soothe nerve fibers to reduce or eliminate pain.
A Stimulating Path To Relieving Pain
When I stopped by SPR Therapeutics to talk with Bennett, I asked her how she got her start in the medical device industry. She explained:
I basically started back in graduate school when I was attending Case Western Reserve here in Cleveland and pursuing a master’s degree in biomedical engineering. I was connected with a physician using electrical stimulation for restoration of function following a stroke while I was working on my master’s thesis. Specifically, the doctor was trying to treat subluxation, or dislocation of the shoulder due to paralysis or muscle weakness resulting from the stroke. While the potential to restore functionality was interesting, the most significant impact on the patient’s life when treating the shoulder with electrical stimulation was the reduction of pain.
Bennett would continue her work with a small startup neuro-stimulation company focused on restoring function for those affected by spinal cord injuries. Unfortunately, in spite of having great technology, the company was not commercially viable. This led Bennett to an opportunity with Boston Scientific in Minneapolis, where she led large clinical studies for several devices. Then, the call came: an opportunity to return to Cleveland and re-focus on neuro-stimulation.
Bennett joined NDI Medical in 2004 as its VP of Clinical Affairs and helped to develop the company’s first device, a neuro-stimulator to treat urinary incontinence. The device was acquired by Medtronic in 2008 for $42M. Following that success, NDI Medical’s CEO offered Bennett the opportunity to focus on her earlier interest, applying electrical stimulation to provide pain management. Once Bennett agreed to lead the effort, SPR Therapeutics was spun out of NDI Medical in 2009 with Bennett at the helm.
Just Say “No” To Drugs
As Bennett took up her mantle, we were becoming nationally aware of a crisis on our hands in the form of pain management via prescription opioids. These drugs can be used acutely to treat moderate to severe pain, and often are prescribed following surgery or injury. But, according to the Centers for Disease Control and Prevention (CDC), recent years have seen a dramatic increase in the acceptance and use of prescription opioids for the treatment of chronic conditions, such as back pain or osteoarthritis, despite serious risk of addiction and a lack of evidence regarding the drugs’ long-term effectiveness.
The CDC quantified the risk of addiction and escalation: As many as 1 in 4 people who receive prescription opioids — long-term and in primary care settings — struggle with addition. Every day, more than 1,000 people in the U.S. are treated in emergency rooms for misusing prescription opioids. And, sadly, more than 40 people die every day from overdoses involving prescription opioids. The CDC suggests that to reverse this epidemic, we need to improve the way we treat pain.
Regulatory Clearance Aided By Expert Advice And Solid Clinical Data
I asked Bennett about her initial challenges in getting the ball rolling at SPR Therapeutics. “Up until the last year, the most significant challenge was obtaining FDA clearance. There were lots of stops and starts along the way. It was not a straight path by any means, and there were lots of discussions we had to have with the FDA,” Bennett said. “I would say, ultimately, finding a very good consultant — [who] worked with us directly, had experience previously working in the Office of Device Evaluation at the FDA, and was able to help us develop the right strategy — was key to obtaining clearance.”
Bennett also described another helpful element in achieving FDA clearance.
The FDA had just issued a guidance document on patient-reported outcome measures. For our application, this guidance takes us beyond a user’s pain decreasing from 10 to 4 on a numerical scale to how that reduction impacts their quality of life. Have you been sleeping better? Are you back to work? Have you been getting along with your family better? Are you walking? Are you more productive? So, we had collected patient-reported outcomes in our series of clinical trials, including these specific impacts on quality of life due to the pain reduction, and that really seemed to move the needle in achieving our 510k clearance. It also helped SPR Therapeutics to build a significant portfolio of intellectual property.
The next challenge for Bennett and SPR Therapeutics was transforming the organization from an R&D focus to a commercial focus. “We weren’t going to pull the trigger too soon, because we didn’t know what the FDA would say about our submission, and we didn’t want to spend time and resources until we knew,” Bennett explained. “Once clearance was obtained, we said, okay, now we’re going to take the next six months and put the commercial infrastructure in place — including the quality system, the people, and the capital. With that focus completed, it’s execution time!” It also doesn’t hurt that SPR Therapeutics recently secured $25M in Series C financing to support commercialization of the SPRINT PNS System.
I asked Bennett about the extent of her commercial operations, and whether she was planning to outsource manufacturing of the device. “We will likely use an outsourced manufacturer to produce this device in volume. Right now, our parent company, NDI Medical, is the named manufacturer of record, and final assembly and packaging is done here,” she said. “I don’t, however, see internal production playing out in high volume. When we get there, we would be best served to work with a contract manufacturer, and we have been talking to a number of them and looking forward to developing a relationship as we move into the next stage of larger volume production.”
What’s Next For SPR Therapeutics?
Before we finished, I asked Bennett what concerns keep her up at night and where SPR Therapeutics is going next. She replied:
Today’s challenge is reimbursement, or third-party payment for the device. We’re fortunate to have existing coding for the device that can be billed, and it will be up to individual payers to decide if they will be covering the treatment. Reimbursement is another area where we worked with a number of consultants. A key message here is working with experts in the field. We’re still a very small organization of about 30 people. We are not going to have all of the answers, but it is prudent to work with experts in the field [who] do have those answers. We currently have a number of reimbursement consultants advising us on this next major milestone for the organization. We also continue to collect data in our go-forward clinical studies to ensure we can answer questions not just on quality of life improvements, but also on the health-economic questions [payers] may have in deciding whether or to provide reimbursement.
With FDA clearance, a solid foundation of clinical data (and ongoing studies), a commercialization plan, series C financing, and existing coding for reimbursement, it seems Bennett and SPR Therapeutics have all of the bases covered. Hopefully the SPRINT PNS System will become one of the solutions for pain relief and reducing dependence on prescription opioids.