Apr 26,2023

Mahana Therapeutics Achieves Key Quality Control Credentials

Mahana Therapeutics has achieved important quality control credentials with SOC 2 Type II report certification and Cyber Essentials accreditation.This comprehensive third-party audit and certification verifies that the company meets the highest standards of security and compliance in its data management practices. The company also achieved Cyber Essentials accreditation in the United Kingdom.

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Feb 14,2023

Delivering holistic care for physical health conditions through digital talking therapies

Could digital talking therapies tools help to provide more well-rounded care to people with physical health conditions? Health Innovation Network project manager Gemma Dakin discusses the potential benefits of these digital tools and work being done to increase their usage. Talking therapies use techniques such as guided self-help or cognitive behavioural therapy (CBT) to help people self-manage their symptoms and find improve their wellbeing. They are most suited to treating mental health problems of relatively low severity; there is a growing nationally-recognised evidence base suggesting they can improve the quality of life for people with physical health conditions ranging from diabetes to lower back pain. Featuring SilverCloud Health, Mahane Therapeutics, Limbic and Minddistrict as examples.

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Dec 08,2020

CBT digital therapeutic for IBS patients receives FDA De Novo clearance

The FDA has granted a De Novo clearance to San Francisco-based Mahana Therapeutics' Parallel, a prescription digital therapeutic for patients with irritable bowel syndrome (IBS) that delivers cognitive behavioral therapy (CBT). The three-month digital treatment logs a patient's symptoms and uses them to deliver relevant guidance. In addition, the digital CBT teaches patients skills and habits to help them manage their condition.

REGULATORY FDA

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Dec 14,2020

Bold Health's CBT app for IBS goes head-to-head with Headspace

Bold Health, a London-based company developing digital therapeutics for gastrointestinal conditions, is backing a new University of Pennsylvania-led study that will directly compare the company's cognitive behavior therapy (CBT) app for irritable bowel syndrome (IBS) to Headspace's consumer mindfulness and meditation app. Researchers will be randomly assigning 300 participants with IBS to receive either Bold Health's Zemedy app or the Headspace mindfulness app for free. Each group will have the app for eight weeks, after which those who received the Headspace app will also be given access to Zemedy.

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#mobile app

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Aug 06,2019

Digital IBS therapy maker metaMe Health closes $3.8M seed round

Chicago-based metaMe Health, a startup focused on behavioral digital treatments gastrointestinal conditions, has raised $3.8 million in seed funding. LionBird Ventures led the round, which also saw contributions from Hemi Ventures and other unnamed backers. The company’s lead product is Regulora, a treatment tackling the cognitive, behavioral and affective factors that can trigger irritable bowel syndrome (IBS). The startup said that the seed funding will support continued development of Regulora, particularly through the initiation of a large, randomized controlled trial of IBS patients.

FUNDING SEED

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Jan 18,2022

Mahana Therapeutics Selected for Prestigious Digitalhealth.London Accelerator Program

Mahana Therapeutics, a leading developer of prescription digital therapeutics designed to empower people living with chronic health conditions, announced that Mahana has been selected for the DigitalHealth.London’s Accelerator programme.The program will help Mahana Therapeutics better engage with the NHS to accelerate adoption of Mahana IBS in clinical practice. Mahana IBS has the potential to deliver significant cost savings for the NHS and provide a new way of treating IBS for millions of people affected. Mahana IBS delivers cognitive behavioral therapy (CBT) to empower adults with irritable bowel syndrome (IBS) to lessen the severity of symptoms.

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#cbt

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Jan 20,2022

Berlin-based Cara Care app approved as German DiGA

The German Federal Institute für Drugs and Medical Devices (BfArM) has added a new digital therapeutic to its digital health applications (DiGA) directory for public reimbursement. Cara Care is the first DiGA that addresses gastroenterological issues and widespread digestive health problems such as Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), food and reflux intolerances.

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Mar 22,2022

Digital IBS therapy startup metaMe to bring PDT to market

Digital IBS care startup metaMe Health is launching its recently FDA-approved prescription digital therapeutic using a partnership with operations and commercialization company Indegene. Regulora, which scored an FDA 510(k) late last year, delivers gut-directed hypnotherapy to help alleviate pain associated with IBS in adults. As part of the commercialization deal, Indegene will focus on bringing the prescription digital therapeutic to market and promoting it to providers, payers and patients.

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Aug 29,2022

Australian startup Mindset Health launches hypnosis-based DTx app for smoking cessation

Australia-based digital therapeutics startup Mindset Health has unveiled its latest digital therapeutics offering to help people quit smoking within a month. Founded in 2018, Mindset Health is building a range of hypnosis-based DTx apps. Its first product, Nerva, is a digital hypnotherapy solution for treating irritable bowel syndrome.

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#mobile app

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Mar 09,2021

Mahana Therapeutics Obtains CE Mark for Parallel™ in the UK

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.

REGULATORY CE MARK

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