At DeviceTalks Minnesota 2019, SPR Therapeutics founder, president & CEO Maria Bennett spoke with DeviceTalks program manager Sarah Faulkner about the company’s FDA-cleared peripheral nerve stimulation system for pain management.
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Sarah: Could you tell us a little bit about how SPR Therapeutics got started?
Maria: SPR Therapeutics is a neurostimulation company and we have commercialized a percutaneous peripheral nerve stimulation system for the treatment of pain management in both acute and chronic pain. The company was founded about 10 years ago, but the technology began in my graduate work at Case Western Reserve. At that time, we knew that nerve stimulation was effective in simulating muscles and restoring function in those who had lost function either due to spinal cord injury or to stroke.
In particular, we were looking at stroke patients that had shoulder dysfunction or separation. And we said, ‘Wouldn’t it be cool if we could stimulate those muscles of the shoulder and reduce that dislocation or reduce that subluxation that they have.’
So through that research, we found that we could stimulate those muscles. We reduced the subluxation in the shoulder, but the most compelling impact on the patients that we saw was the reduction in pain. This separation in the shoulder was causing significant pain amongst these individuals. And because of that lack of mobility that they had, they could not exercise, they could not participate in their physical therapy in order to help reduce that pain. Electrical stimulation did that for them.
Sarah: Can you shed a little light on the need that SPR Therapeutics’ product is addressing?
Maria: If any of us were to walk into our doctor’s office today with some sort of pain, the first course of treatment is typically some sort of anti-inflammatories and possibly physical therapy. Unfortunately, if you’re in pain, it’s really hard to be compliant with your physical therapy. Then you move down a course of more invasive therapies and those can be anything from injections to radiofrequency ablation. And then there’s the far end of the spectrum in which there are surgeries for fully implantable devices such as neurostimulation devices and spinal cord stimulation devices.
Neurostimulation for pain has been used for decades and it’s a very effective technique but it’s really focused on back and upper leg pain. And it’s a very expensive technology. So there’s this gap in the middle of the treatment continuum for a non-opioid non-disruptive non-surgical treatment that we feel that we fit.
It is a technology that is percutaneously placed for 60 days and most patients experience significant pain relief and improvement in their quality of life during those 60 days. It’s removed after 60 days. And our data has shown that many patients not only have that significant pain relief at the end of 60 days but for many months to years following the treatment. So why not try that technology before going to those more destructive or other types of technologies that have more significant side effects or more costly? We really are filling a gap early on in the treatment continuum. And that has resonated with physicians.
I should also say the other technologies aren’t specific to the type of pain that patients have. So, for example, if you take a medication, it’s going to go throughout your body. Our technology is placed directly in proximity to the target nerve that is causing the pain. And so we can be very specific to treating the type of pain and then ultimately be very effective as well.
Sarah: Without giving away any secrets, can you tell us about how the Sprint PNS system works?
Maria: The implanted lead is constructed of very fine wire about the size of a human hair. It is seven strands of stainless steel that are helically wound and then coated and inserted via a needle into the area that we are targeting. Again, using the shoulder as an example, it is placed percutaneous through the skin and a portion of the wire is in proximity to that target nerve.
The rest of the wire is exiting the body and that is connected to an external stimulator that is then attached to a pad and adhered to the skin. The patient is able to put that pad wherever it is comfortable for them. They’re able to control the stimulator and use it throughout their therapy.
Anytime that any of us are in pain is because there’s been some sort of insult to the nerve. It could be a disease, it could be an injury. The first thing that we probably do, if we hit our thumb with a hammer is you start to rub that thumb, right? What you’re doing is providing some external stimulation to the overactivity that has been caused by the insult to the nerve.
What electrical stimulation does is it calms down that overactivity. And if it does it for a long enough period of time, then it’s able to give positive feedback to the brain. So we can specifically treat the area of pain and we can do it in a minimally invasive nature. The procedures that we have used were thoughtfully designed so that they were similar to ultrasound-based interventional procedures that anesthesiologists use today. So, the patient goes home with the system for those 60 days and does not need to return to the physician’s office until at the end of those 60 days when they have the lead removed.
Sarah: What were some key design considerations that your team took into account when developing the device?
Maria: For the patients, we wanted something that was not going to be cumbersome for them – something easy, user-friendly for them to use at home and hopefully have minimal or no need for caregiver support. Then once they’re home they’re able to go about their activities of daily living while using the device. They can turn it up when they need to if they want to feel it more or they can turn it down perhaps at night while they’re sleeping. We built a lot of flexibility into the device for the patients to adjust things as they need to once it’s preset by their physicians.
Once their physicians find those therapeutic parameters that work for that patient during the time at which they placed the lead, then the patients go home and can have that flexibility with their device and don’t need to have the routine visits back and forth to the physician’s office.
Sarah: Regulating therapies for pain management, especially as it relates to the opioid crisis, has been a priority of the FDA in recent years. What has your experience with regulatory agencies been like?
Maria: Everybody talks about the FDA likes it’s just a building. It’s people. So it’s about building relationships with the reviewers and understanding what they’re looking for. As you get to know these reviewers and as you get to understand what they’re looking for in terms of evidence necessary to clear or approve devices, then it becomes a much more productive partnership.
Originally we thought that we would be going for a specific indication based upon our body of evidence specific to shoulder pain. But as we went through the review process, we were able to provide FDA with all of the clinical data that we had across multiple different indications, which led us to this general indication clearance that at first, we didn’t know how that would play out commercially. But it has turned out to be a tremendous benefit to us.
So we’ve got the regulatory hurdle behind us – we’ve got the clearance – and now we can continue to drive data to satisfy the commercial aspects like reimbursement coverage. We’re very fortunate that there’s an existing code for our device. We have been successful in achieving both Medicare and private payer coverage. But each state, each payer, is unique and they’re looking for different bodies of evidence, different dialogue and experience from the commercial setting. And so now we’re making sure that we have the right partners within our company to have those conversations with medical directors at the payers, but also have the right amount of data to put to the problem.
Sarah: You have an interesting background in that you have experience across the product lifecycle from product inception to R&D to commercialization. How has your experience shaped the way you lead SPR Therapeutics as its CEO?
Maria: When I was in graduate school I always appreciated the professors that had been in the industry and I’ve been fortunate that I’ve been able to experience many different aspects of the product lifecycle, both at a small and large company. As I built out SPR, I made sure to hire people that are better than me. And I’ve got a team of people in Cleveland and in our Chapel Hill office in North Carolina that are brilliant scientists, engineers, commercialization experts that are now leading the efforts with their experience.
Because of my previous experience, I’m able to provide vision and strategy for the company. I’m also very fortunate that I have a supportive board of directors. So, in building a company I would say the key is not only financing that company but also ensuring that you have control over the vision of the company and making sure that the board of directors and advisors are all aligned. I don’t necessarily want them always to agree with me, but just be aligned with the vision. If they always agree with me, we wouldn’t grow.
We’re building this company to compete. As long as we continue to build value within this organization, we’re going to see opportunities that were presented to us to continue to grow and be competitive in the marketplace.
Want to see these interviews live? Join us at DeviceTalks West – Dec. 9-10 in Santa Clara, CA.
Read the full article at massdevice.com.