Q&A: Why digital therapeutics need to be led with evidence

In August, Swing Therapeutics has been dubbed the FDA Breakthrough Device for its smartphone-based fibromyalgia management digital therapeutics. Now, the company has extended rounds to its $ 10.3 million series to support a new clinical trial targeting a potential FDA de Novo.

Startup CEO sits down with Mike Rosenbluth MobiHealthNews Swing’s first product to focus on fibromyalgia and discuss what is needed to encourage suppliers to adopt digital therapeutic.

MobiHealthNews: Can you tell me a little bit about how your digital therapeutic works for fibromyalgia?

Mike Rosenbluth: We are studying two different digital interventions to test against one another. The first is ACT, or Acceptance and Committed Therapy. This is a 12-week program. Thus, a patient will communicate with it every day and spend about 15 to 20 minutes on it.

People with fibromyalgia and other chronic pain disorders may try to figure out how to reduce the symptoms in their life naturally and how to change their life to make their symptoms more manageable. This can lead to a lot of avoidance where people don’t really have a meaningful life for them anymore. And so, what the ACT is trying to do is help people to accept, not to say that you have resigned from this disease, but to say that it exists, and that you can live your best life alongside the symptoms as well as the pain.

So, [it’s] Really trying to think about how you can change your relationship with pain – which is a lot easier said than done – but trying to get to a point where you are living a fulfilling life where the symptoms of the disease are rather annoying. Than a central part of your life.

The second intervention we are testing is a digital symptom tracker. This is where you will track your symptoms every day and people with chronic pain and various ailments often find it helpful to see their symptoms over time. They will also have access to general health education articles and fibromyalgia health articles.

MHN: Why did you decide to start with fibromyalgia?

Rosenblath: When I founded the company with Jazz Venture Partners, we were really interested in autoimmune and chronic pain disorders, realizing that a lot of healthcare resources had been spent in this area. Although many treatments are effective, there is a real gap in care for these patients and a real opportunity to do better for these patients.

We ended up talking to a lot of doctors and a lot of patients and really pointed to fibromyalgia as a place to start. We are a super proof driven company. There is level 1A evidence all around Behavioral therapy, but there is a real lack of access to them. We thought that by using software-based approaches, we could really treat patients in a way that could help them and scale it.

If you talk to practicing physicians, they acknowledge that these treatments work and that they are beneficial, but in general, the referral route is not there. So, if you are a primary care physician or you are a rheumatologist, you do not have a pain psychologist at Rolodex whom you would usually refer to unless you are at a specialized clinic or mayo clinic or some chronic pain center, which most people do not have access to. It’s really burdensome on the patient to find these things out, which is really hard.

And align with that Purchase of non-pharmacological, for chronic pain management [which] Quite specific. So, there aren’t many trained specialists who can do it, and many of them don’t take out insurance, and it’s inconvenient to get it. In most cases, patients are told, “There are some medications that can be helpful, we encourage you to exercise, and I can do it for you.”

MHN: So, you recently announced your Series A. Can you tell me a little bit about how you are going to use this investment?

Rosenblath: So, our first priority is to study our Prosper-FM. This is our main study, to study these two different digital interventions. And it uses, if the result is positive, to file for FDA clearance. I have always believed that to change the quality of care, you need to lead with evidence. I think this is probably our fifth clinical study that we have conducted in various forms.

We are planning to launch a telemedicine clinic. Those plans are working now, and so, we’ll talk more about that later But the general idea is that as we get to know more about this patient population, we realize that a digital therapeutic can be really powerful, and would be even more powerful to provide these patients with a care specialist who can truly understand their disease.

MHN: What do you think needs to happen to get into the mainstream of digital therapeutics?

Rosenblath: I will say [there are] Three areas. One, I think, is the maturity and clarity of the path of retribution. I think this is obviously a challenge – not only for adoption, but also for continued investment and success in this area. If we can demonstrate an economically sustainable and effective business model, I think it is critical.

Around the second, how do you actually get it into the hands of patients? Innovating business models and trying to figure out how physicians can get more comfortable with prescribing new treatment methods, things they may not be familiar with.

And then, I think the third is only in the vicinity of this promise to be able to change the standard of proof and care of evidence and integrate with the guidelines. I think once you start looking at these technologies and methods in the guidelines, I think it can also help change the behavior of physicians and payers.

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