Mahana Therapeutics Obtains CE Mark for Parallel™ in the UK
First Prescription Digital Therapeutic to Reduce the Symptom Severity of Irritable Bowel Syndrome Also Receives NICE Recommendation
SAN FRANCISCO, March 9, 2021 /PRNewswire/ -- Mahana Therapeutics, an emerging leader in prescription digital therapeutics, announced today that it has obtained a CE mark for its flagship product Parallel™. Parallel is the first prescription-only digital therapeutic (PDT) intended to reduce the severity of irritable bowel syndrome (IBS) symptoms in adult patients. The programme was developed in collaboration with expert researchers under the leadership of Professor Rona Moss-Morris, Ph.D, of King's College, London, and Professor Hazel Everitt, Ph.D, of the University of Southampton. Parallel has also been recommended for Evaluation in Practice by the National Institute for Health and Care Excellence (NICE).
IBS is a disorder of the gut-brain interaction. Parallel, formerly known as Regul8, was developed by a team of leading UK psychologists to teach adults cognitive behavioural therapy (CBT) skills to influence gut-brain communication. Parallel's three-month programme works by helping patients change certain behaviours and thoughts that can contribute to IBS and has been clinically proven to reduce the severity of IBS symptoms.
"We entered into this collaboration with Mahana because of our shared commitment to developing clinically validated, cost-effective treatment options that address IBS symptoms," said Professor Rona Moss-Morris, Professor of Psychology as Applied to Medicine and Head of Psychology at King's College, London, who led the development of the initial Parallel programme. "I am excited and proud that the result of our work together has met the high health and safety standards needed to obtain a CE mark."
In the UK alone, IBS affects up to 22 percent of the population and costs the NHS more than £200 million annually. More than half of IBS patients don't feel that their prescription drugs alone provide effective relief from IBS. Those suffering from IBS often experience a range of symptoms, both physical and psychological. Parallel is intended to be used in conjunction with other IBS treatments to reduce the severity of these symptoms.
"I see many patients in my clinical practice who continue to struggle with ongoing IBS symptoms despite trying medications,'' said Professor Hazel Everitt, GP and Professor of Primary Care Research, Faculty of Medicine, University of Southampton. ''This led me to undertake research to provide rigorous evidence for new options. Randomised controlled trials, including the one I led, have shown that CBT designed specifically for IBS can meaningfully reduce the severity of IBS symptoms. Our collaboration with Mahana was born from the vision that innovative, clinically validated approaches, alongside the latest practice guidelines, could make a real difference to patients. Digital therapeutics like Parallel could give providers a new tool to help their IBS patients reduce symptom severity and improve the quality of their daily lives."
This news comes on the heels of Mahana obtaining FDA authorization for Parallel in the United States. It also follows a year of significant milestones, including the announcement of a worldwide exclusive license to Parallel and a collaboration agreement with King's College, London.
"Mahana was founded with the needs of patients at its heart," said Steven Basta, Mahana's CEO. "Earning a CE mark certification represents an exciting new phase for our work to deliver innovative treatment options to patients struggling with IBS symptoms."
About Mahana Therapeutics
Mahana Therapeutics is an emerging leader in prescription digital therapeutics. Parallel™, Mahana's debut product, is the first digital therapeutic authorized for marketing by the U.S. FDA and CE Marked for the European Union to reduce the severity of symptoms of irritable bowel syndrome (IBS), a condition that affects one in 10 people worldwide. Guided by a commitment to rigorous clinical evidence and drawn from experience as patients ourselves, Mahana's team of experienced entrepreneurs, physicians, psychologists, engineers, and designers are dedicated to using software to treat and manage chronic conditions that affect so many. For more information, visit www.mahanatx.com or follow us @mahanatx.
About Parallel™
Parallel™ was formerly known as Regul8. Parallel was originally developed by Rona Moss-Morris, Ph.D, Head of Psychology Department, King's College, London (KCL), in collaboration with Trudie Chalder, Ph.D, Professor of Cognitive Behavioural Psychotherapy; Alice Sibelli, Ph.D., MSc, CPsychol L; and Hazel Everitt, Ph.D, Professor of Primary Care Research, University of Southampton. Initial clinical funding support was provided by the UK National Institute for Health Research (NIHR).
Parallel Indication For Use and Important Safety Information
Parallel is a prescription-only digital therapeutic device intended to provide cognitive behavioural therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a three-month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
Safety Information and Warnings
- PARALLEL is intended for patients whose primary language is English.
- PARALLEL is intended only for patients who have a desktop or laptop with a web browser and internet connectivity and are familiar with the use of web-based applications.
- PARALLEL is not to be used to communicate any emergency, urgent or critical information. Parallel does not include features that can send alerts or warnings to your clinician. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.
- PARALLEL is not a substitute for your medications. You should continue to take your medications as directed by your provider.
- PARALLEL is not intended to be used as standalone therapy for IBS and does not replace care by your provider.
- PARALLEL is meant to be used in conjunction with other IBS treatments you may be using.
This press release does not include all the information needed to use Parallel safely and effectively. Please see the full Patient & Clinician Brief Summary Instructions for Parallel for more information.
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