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Swing Therapeutics Receives FDA Breakthrough Device Designation for Digital Therapeutic for the Management of Fibromyalgia, Launches Real-World Study

SAN FRANCISCO–()–Swing Therapeutics, a digital therapeutics company developing evidence-backed treatments for autoimmune and chronic pain conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s digital therapeutic for the management of fibromyalgia. The company is also launching a real-world study of its digital therapeutic, which is based on a clinically validated program that it exclusively licensed from the University of Manitoba. The company launched with $9 million in seed funding from JAZZ Venture Partners, a leading investor in several other pioneering digital therapeutic companies.

Swing’s program digitally delivers acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT). The company is extending and modernizing a foundational online therapy program that, through a clinical trial, showed improvement in function and symptoms for people living with fibromyalgia. Swing is leveraging existing clinically validated approaches to treatment as well as completing its own clinical trials specifically to show the safety and efficacy of its proprietary program. The company has completed a pilot study of its digital therapeutic, which has shown promise for improving the symptoms of people living with fibromyalgia, and it recently launched a real-world study, and is planning a multicenter, randomized controlled pivotal trial to support FDA clearance.

“Currently, most people living with chronic pain conditions like fibromyalgia are offered medications and some suggestions for modifying their lifestyle. Behavioral therapies have evidence supporting their effectiveness for pain management, but are not widely available or easily accessed by the average individual. Swing is tackling the challenge of making these therapies more available in a digital format. I look forward to following Swing as the company continues to build evidence to support its approach,” said David Williams, Ph.D., Associate Director of Chronic Pain and Fatigue Research Center at the University of Michigan, and advisor to Swing Therapeutics.

Swing’s simple-to-use, daily digital therapeutic includes engaging lessons and interactive exercises that help patients apply well-established principles to their unique circumstances and gradually develop the ability to manage their condition. The self-guided program is designed to foster understanding and acceptance of the participants’ own symptoms, while teaching powerful condition management skills. The program being studied also incorporates a tool to help users triage symptom flares—a common occurrence with fibromyalgia. The core program lasts 12 weeks, with a maintenance mode for extended use.

“We founded Swing to address the real unmet needs of people with underserved chronic conditions, so they can live their best lives. This mission guides us each day. We believe that our engaging digital patient-centered program will significantly increase access to proven approaches that previously very few people have been able to experience,” said Mike Rosenbluth, Ph.D., founder and CEO of Swing Therapeutics. “Our team is committed to creating valuable digital therapies and demonstrating strong clinical evidence to support their use. The results of our initial studies are encouraging, and with the support of the FDA, we look forward to optimizing the product as we advance through our pivotal trial.”

“Our focus is on advancing breakthroughs at the frontiers of technology and science to unlock human potential,” said Zack Lynch, Managing Partner at JAZZ Venture Partners. “Swing’s mission to expand treatment options for people living with chronic conditions is aligned with this vision. We are excited to support the company as it works to bring innovative approaches to patients.”

Swing Therapeutics Seeking Enrollees for Real-World Study for Management of Fibromyalgia

Swing Therapeutics is currently initiating a clinical trial called REACT-FM (Real-World Evidence from Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia). If you suffer from fibromyalgia and are interested in participating in a study assessing an investigational digital program for fibromyalgia management, go to react-fm.com/welcome/003 to learn more.

About Fibromyalgia

Fibromyalgia is a chronic and debilitating pain condition that effects an estimated 10 million Americans. The condition is characterized by widespread pain and other physical and cognitive symptoms that include fatigue, disrupted sleep, reduced physical function, memory problems and difficulty concentrating (“brain fog”), and is often accompanied by anxiety and depression. Because fibromyalgia manifests differently across the affected patient population and can be masked by other accompanying conditions, it is difficult to diagnose and treat.

About Swing Therapeutics

Swing Therapeutics was founded in 2019 with the goal of developing digital treatments in disease areas where patients are not well-served, and where digital interventions may be effective. Its focus is on tackling autoimmune conditions and chronic overlapping pain conditions (COPCs) like fibromyalgia where central pain sensitization is a significant factor. The company is investing in research to support the development and validation of its pipeline of prescription-based digital therapies. Swing Therapeutics’ near-term goal is to validate its digital program for the treatment of fibromyalgia and bring it to market as an FDA-cleared, prescription-based digital therapeutic. For more information visit www.swingtherapeutics.com.

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