“We decided early on that we wouldn’t be just another app,” said Debra Reisenthel, president and CEO of Palo Alto Health Sciences, the digital behavioral health company behind FDA-approved Freespira Breathing Exercise to help people with panic disorder who suffer panic attacks. “We want clinicians to recommend us.”
She secured approval from the U.S. Food and Drug Administration in 2013 for an app that functions like a digital drug that seeks to help get breathing under control for the 2.7 percent of the U.S. population who suffer from panic disorder, according to data from the National Institute for Mental Health. Now she wants to pursue indications for children aged 9 to 18.
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Palo Alto Health Sciences was one of a group of young companies exhibiting in the Startup Showcase in the HX360 Innovation Pavilion at the HIMSS conference in Las Vegas this week.
She has taken an evidence-based approach to validate the effectiveness of its app. Hyperventilating can cause some of the symptoms most people would associate with a heart attack like chest pain and shortness of breath. That frequently leads to emergency room visits that aren’t necessary, but are often repeated because of the emotional toll these panic attacks take.
Many of the people who have panic disorder are prescribed drugs such as Valium to manage their condition. The app Reisenthel developed guides users through a breathing exercise taken twice a day over four weeks. A sensor samples and measures the carbon dioxide levels in exhaled breath and transmits that data to the App running on a tablet. Breathing information is displayed on the tablet. The app provides verbal and visual prompts, which guide users to adjust their breathing pattern to optimize CO2 levels and respiration rate.
The goal of the test is to normalize carbon dioxide levels and respiratory patterns to help people avoid hyperventilating. A dashboard for therapists and physicians lets them monitor their patients’ progress.
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Highmark Blue Shield is piloting the app and collecting clinical data to validate whether the app can lower costs for this patient population. Johns Hopkins Medical Center has done a feasibility study of the app and a randomized control trial is next.
“It’s not easy to do cognitive behavioral therapy with a 9-year-old,” she acknowledged.
One trend Reisenthel has noticed is that a fair number of patients have been coming to the website who have no desire to see a therapist but want to use the device themselves. To address this interest and stay within the parameters of its FDA approval, Reisenthel said it hired behavioral health nurses to train patients on the breathing exercise.