Freespira is an at-home behavioral health treatment with FDA indications for PTSD and panic disorder symptoms. Its clinically validated solution combines a medical device with high-touch support to deliver symptom relief for the patient in 28 days.
Joseph, you have a decade of experience working in novel technologies for neuroscience treatments. How did that journey lead you to Freespira?
My background is predominantly in medical devices, initially focused within the cardiovascular space, like pacemakers and stents. However, the past decade has been spent working in the neuroscience markets, specifically dealing with novel mental health treatments. I joined BrainsWay, a start-up company using neuromodulation to address neuroscience disorders, which was finally commercially available to patients after its initial development 40 years ago. I was fascinated by the opportunity to move beyond traditional psychotherapy and medication to a non-pharmaceutical and non-invasive treatment model.
The multi-modality approach to mental health is also what attracted me to join Freespira. Our mission is simple yet ambitious: to shift the paradigm for behavioral healthcare in the United States and beyond. We have seen that the sooner people engage in care, the better their quality of life and overall health outcomes. We believe in providing patients with choices early in their diagnosis by encouraging them to engage in validated treatments tailored to their needs.
What does Freespira’s treatment entail and how does it benefit patients?
Freespira is an at-home behavioral treatment with FDA indications for panic disorder and PTSD symptoms. It combines a medical device with live support to deliver rapid, lasting symptom relief in just 28 days.
Patients with conditions like PTSD and panic disorder often suffer from breathing dysfunction due to CO2 hypersensitivity. Freespira addresses breathing dysfunction by training patients to stabilize their breathing with our Capnometry Guided Respiratory Intervention. But the impact of these disorders runs deeper than just breathing. Many patients develop avoidance behaviors to manage triggers, which can limit their ability to engage in normal family activities. For example, one veteran with PTSD avoided taking his daughter to the movies for several years due to his PTSD symptoms, which were triggered when sitting in dark, enclosed spaces like a movie theatre. After completing treatment with Freespira, he was finally able to enjoy that experience with her again. Stories like this highlight how mental health treatments restore individual well-being, family connections, and quality of life.
What key issues cause patients to go untreated in the U.S. mental healthcare system?
The first major issue is access. Right now, half of Americans live in areas with a shortage of mental health providers. This often leads to long waits to get an appointment or a significant lack of specialists available to the patients in that community. The second issue is affordability. Mental health patients frequently rely on out-of-network providers, which adds financial strain. Medicaid patients face even steeper barriers as fewer specialists accept Medicaid. Lastly, many traditional treatments for these conditions come with challenges that cause patients to stop treatment and leave many without viable options – prolonged exposure therapy for PTSD can be distressing and lengthy, and medications used to treat these conditions have significant side effects.
While many still associate PTSD with combat, we are seeing the fastest growth in the private sector population. Natural disasters, school shootings, and other traumatic events are contributing to this rise, especially among adolescents and young adults, whose preferences and expectations around access to care differ significantly from older generations.
How is the market for novel digital therapeutics evolving?
The market is evolving slower than I would like. There are challenges, particularly in how the industry categorizes digital therapeutics. Often, they are lumped together with general wellness apps or fitness trackers. This broad categorization makes it challenging to differentiate validated therapeutic devices from other modalities. Our goal is to bridge that gap by emphasizing that Freespira has undergone the rigorous FDA clearance process for medical devices, unlike many digital health products.
Another challenge we face is that mental health is often seen as a single category, but conditions like depression, panic disorder, and PTSD are each fundamentally different. Therefore, educating payors and patients is a significant part of our strategy. We concentrate on markets where we already have established reimbursement pathways – regions like New England, the Mid-Atlantic and parts of the Midwest – and we partner with health plans to conduct direct-to-member outreach campaigns.
Given that Freespira is not automatically covered by insurance, how do you encourage adoption amongst practitioners, especially as it can be perceived as a more experimental therapy?
Our approach is unique in that we focus less on practitioners and more on working directly with health plans to secure reimbursement. We have adopted a proactive approach by offering success-based contracts in which health plans only pay for patients who achieve agreed-upon outcomes. What is particularly innovative is our proprietary algorithm, which allows us to identify diagnosed and undiagnosed members in their populations, quantify the costs, and share quarterly updates on clinical outcomes. Twice a year, we also provide cost savings analyses, showing how better care reduces overall healthcare expenses.
Innovative health plans are realizing the importance of giving patients faster access to care, whether through behavioral health specialists or alternative pathways like Freespira. This flexibility resonates with forward-thinking payers,, though we are still in the early stages of seeing this approach take root.
Beside health plans, which key industry voices influence the uptake of novel mental health treatments?
Pharmaceutical companies, especially those in oncology, are essential. They are recognizing that mental health plays a critical role in patient care and outcomes, and many are developing wraparound digital products to monitor and support mental health during treatment. For instance, data shows that within 30 days of a breast cancer diagnosis, 50-70% of patients exhibit PTSD symptoms, yet less than 4% are receiving treatment a year later. This neglect creates lasting emotional and physical challenges for patients and their families and can lead to escalating comorbidities, including chronic physical conditions.
With the association between anxiety and chronic conditions like cardiovascular disease or diabetes becoming irrefutable, this bi-directional relationship underscores the need to address mental health alongside physical health to improve patient survivability and overall well-being.
With the changing U.S. healthcare landscape in mind, how will Freespira achieve commercial growth in 2025?
We plan to build on the success with our current clients to encourage other payers to expand coverage for Freespira. Pivotal to this will be leveraging the momentum created by the newly passed CMS physician fee schedule for 2025, including codes and reimbursement structures for digital mental health treatments.
From an industry perspective, this is a game-changer—a clear signal from CMS that these therapies must be integrated into the overall treatment paradigm for mental health. This gives venture capitalists confidence in the sector and sends a strong message to commercial payers to take these products seriously. In 2025, we aim to capitalize on this by teaming up with larger organizations, such as pharmaceutical companies or behavioral health groups, to treat patients with chronic conditions or broader mental health issues.
