Berlin, Germany, April 2023 – HelloBetter, one of the world’s leading providers in developing and commercializing software-based medicines called prescription digital therapeutics (PDTx), has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its DTx HelloBetter Panic. Securing Breakthrough Device Designation represents the next step in HelloBetter’s long term strategy to access the US market, after the 2022 launch of the US-brand HelloGina.
If left untreated, people struggling with Panic disorder bear a heavy burden, in terms of their ability to function and an overall reduced quality of life. Lack of treatment poses the risk of the disorder escalating into a more severe state, increasing the risk of complications, including mortality. Yet, in spite of these considerable risks, it is still very difficult in the United States to access care for Panic disorder. There are simply not enough trained professionals and treatment options are very limited and not very flexible. Also for many, stigma still poses significant obstacles to patients seeking treatment. As a result, patients often do not even start treatment or struggle to complete it.
HelloBetter Panic has the potential to become an easily accessible and flexible treatment option for patients nationwide. The programme is based on the principles of Cognitive Behavioral Therapy (CBT), which is an evidence-based psychotherapeutic treatment form that involves efforts to change a patient’s thinking and behavior patterns. A randomized-controlled trial demonstrated that HelloBetter Panic represents a viable alternative to the current standard of care. After completion of the therapy programme, symptom severity of panic disorder and agoraphobia with panic disorder had reduced by a third on average. After six months, symptom severity had reduced even more – by an average of 52 per cent compared to baseline. In April 2022, HelloBetter Panic entered the standard of care in Germany after being approved by the Federal Institute for Drugs and Medical Devices (BfArM, the German equivalent of the FDA.) HelloBetter Panic was the first panic DTx to be granted ‘permanent’ approval status for reimbursement in the Statutory Health Insurance system in Germany after demonstrating a clinically significant impact on symptom severity in a rigorous randomized-controlled clinical trial.
“We believe that PDTx can make effective, evidence-based treatments for panic disorder available to many people who today often suffer in silence,” said Hannes Klöpper, HelloBetter’s Chief Executive Officer. “Patients and clinicians deserve access to safe, effective, and innovative treatment options, and we look forward to working closely with FDA under the Breakthrough Devices Program to gain marketing authorization of HelloBetter Panic.”
The Breakthrough Devices Program is intended for medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is designed to expedite development of the device and the prioritized review of the subsequent regulatory submissions. It is available for devices, like PDTs, which may be subject to FDA review under a premarket approval (PMA) application, premarket notification (510(k)), or De Novo classification request.
HelloBetter Panic has not yet received marketing authorization from FDA and is not available for sale in the United States.
HelloBetter is a European leader in the field of digital therapeutics (DTx) for mental health and a global pioneer in digital mental health research. Founded in 2015, HelloBetter has the strongest evidence base globally, with a total of 33 randomized controlled trials published in peer-reviewed journals. In Germany, six of their therapy programmes are part of the standard of care and as such available to all adults for free as prescription digital therapeutics or DiGA. In 2022, HelloBetter entered the US market with its HelloGina brand which offers a sexual wellness program for people with vaginismus.