Jun 11,2024 TOP STORY

Mahana Secures Permanent Reimbursement in Germany for its Cara Care for Irritable Bowel Syndrome (IBS) Digital Therapeutic

Mahana Therapeutics has secured permanent reimbursement in Germany for its digital therapeutic, Cara Care for Irritable Bowel Syndrome (IBS). Following price negotiations with Germany’s National Association of Statutory Health Insurance Funds (GKV-SV), Cara Care for IBS is now widely accessible to IBS patients insured by statutory health insurers. The reimbursement is based on the therapeutic's proven clinical efficacy, cost-effectiveness, and quality of life improvements. Cara Care, which can be prescribed for 90 days for patients aged 18 to 70, uses a personalized treatment plan including cognitive behavioral therapy (CBT), dietary therapy, and gut-directed hypnosis. Clinical trials have demonstrated significant improvements in symptom severity and quality of life for users, solidifying its value in the German healthcare system.

PRODUCT

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Mar 12,2024 TOP STORY

Mahana Therapeutics Acquires Cara Care to Become a Global Leader in the Digital Treatment of Chronic Conditions

Mahana Therapeutics announced that it has acquired Berlin-based HiDoc Technologies GmbH, operating as Cara Care in digital digestive healthcare. This combination creates a global company offering a comprehensive digestive health portfolio currently addressing Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Celiac Disease and Heartburn, with a pipeline focused on Tinnitus, Pruritus, and Vulvodynia. The acquisition of Cara Care is expected to accelerate Mahana’s market entry in Europe where the reimbursement of digital programs is outpacing the United States. Cara Care’s IBS prescription-based digital program is currently being prescribed, and reimbursed, to the patients in Germany. The combined entity is now poised to expand its commercialization efforts beyond Germany to France and the United Kingdom as reimbursement of digital programs continues to improve across Europe. Mahana’s and Cara Care's self-guided, digital chronic condition management programs employ a proprietary cognitive behavioral therapy (CBT) platform that complements consumer health and pharmacological treatments to address high unmet needs associated with digestive, hearing, dermatology, and women’s health chronic conditions. Financial terms of the acquisition were not disclosed.  

COLLABORATION MERGERS & ACQUISITION

#product & service

#pdt

#cbt

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Oct 24,2023

Positive Real World Evidence of Mahana IBS Presented at the American College of Gastroenterology (ACG) Annual 2023 Scientific Meeting

Mahana Therapeutics announced the results from the analysis presented by Mythili Pathipati, M.D. of Mass General Hospital at ACG 2023 Scientific Meeting in Vancouver on October 24, 2023 demonstrating that nearly 60% of users who completed Mahana IBS in the real world setting reported clinically meaningful reduction in severity of IBS symptoms. The real world analysis evaluated results from 843 patients using Mahana IBS over a 2-year timeframe from August 2021 to August 2023. In addition to evaluating IBS symptom severity and anxiety, the real world analysis assessed factors associated with adherence and response to Mahana IBS. Key results from the Real World Analysis include: 38% (n=324) of subjects were adherent as defined by completion of the first five sessions of the program, and statistically significant reductions in pain, bloating and IBS interference and improvements in bowel satisfaction were observed.

CLINICAL STUDY

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Sep 29,2022

metaMe Health partners with Launchit Ventures to market Regulora®, an FDA-cleared Prescription Digital Therapeutic for adults with IBS, in Canada

Launchit Ventures, Inc., a HealthTech solutions provider and global commercialization partner developing new technology-led business solutions faster and with less risk, and metaMe Health, Inc., an FDA approved Prescription Digital Therapeutics (PDT) company and developer of Regulora®, today announced a global partnership to bring Regulora® to the Canadian market for the treatment of abdominal pain due to IBS. Launchit Ventures will work to obtain regulatory authorization in Canada and will develop a commercialization strategy and execution plan to make Regulora® available to patients with IBS in Canada markets.

COLLABORATION PARTNERSHIP

#institution

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Nov 30,2021

metaMe Health Receives FDA Clearance for Regulora®, the First FDA-authorized Treatment Specifically for Abdominal Pain Due to Irritable Bowel Syndrome (IBS)

metaMe Health, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated with irritable bowel syndrome (IBS) in adults. Regulora® is a prescription Digital Therapeutic (PDT) that is self-administered through an Apple or Android smartphone and provides behavioral therapy based on Gut-Directed Hypnotherapy (GDH) through a convenient smartphone app that can be used at home. GDH helps patients with their IBS symptoms by promoting healthier control of digestive tract function and delivering therapy designed to influence pain sensation

REGULATORY FDA

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Nov 02,2019

metaMe Health Announces First Subject Enrolled in Pivotal Study of a Digital Therapeutic for Treatment of IBS

metaMe Health, Inc., a Chicago-based prescription digital therapeutics company committed to the treatment of gastrointestinal (GI) conditions such as Irritable Bowel Syndrome (IBS), today announced that the first subject has enrolled in a pivotal study to evaluate the efficacy and safety of an all-digital, self-administered behavioral therapy for the treatment of adult subjects with symptomatic IBS.  This trial is a randomized, controlled, parallel-group study that will enroll subjects from across the United States. metaMe expects to enroll approximately 380 patients, aged 18 years and older, to the study, in partnership with the digital clinicial trials company Curebase. Initial results are expected by the second half of 2020.

CLINICAL STUDY

#cbt

#mobile app

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Mar 14,2019

metaMe Health Wins Worldwide Healthcare Access Challenge

metaMe Health was named a winner of the prestigious Sandoz Healthcare Access Challenge (Sandoz HACk) for the company’s lead product Regulora®, a fully digital behavioral intervention for the treatment of Irritable Bowel Syndrome (IBS).  The global competition was sponsored by Sandoz, a Novartis division headquartered outside Munich, Germany. Winners were announced at a recent award ceremony held in conjunction with South by Southwest (SXSW). Winners will receive both seed funding to bring their ideas to life as well as ongoing support from Sandoz experts. metaMe was the only winning company that represented the United States.  

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Jan 01,2020

Mahana Therapeutics gears up to launch IBS treatment app with $61M series B, reaching to total of $81M funding

Not long after the FDA cleared the smartphone version of Mahana IBS, investors led by JAZZ Venture Partners and Gurnet Point Capital contributed $61 million in series B funding to help commercialize the startup’s IBS program and support its continued work to develop digital therapeutics for other chronic diseases. JAZZ also led Mahana’s previous funding rounds alongside Lux Capital; in total, the San Francisco-based company has raised $81 million since its founding.

FUNDING FUNDING ROUND
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Sep 12,2023

Real World Evidence of Mahana IBS Accepted for Presentation at Upcoming American College of Gastroenterology (ACG) Annual 2023 Scientific Meeting ‍

Mahana Therapeutics, a leading provider of prescription digital therapeutics, announced today that analysis performed by Mass General Hospital led by Kyle Staller, M.D., has been accepted for presentation at the upcoming ACG 2023 Scientific Meeting in Vancouver on October 24, 2023.  The abstract presentation entitled “Efficacy of a Digital Prescription Mobile Application for Adults With Irritable Bowel Syndrome” will be presented by Dr. Mythili Pathipati on Tuesday, October 24, 2023 at 8:30 AM during the Functional / Esophagus Plenary Session 2A.

CONFERENCES
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Aug 22,2023 TOP STORY

Mahana Therapeutics Signs Agreement with Consumer Health Division of Bayer to Commercialize Digital Therapeutics

Mahana Therapeutics announced today that the company has entered into a multi-million-dollar distribution and marketing partnership with the Consumer Health division of Bayer to commercialize digital therapeutics. Earlier this year, Bayer announced the launch of a new business unit, Precision Health, focused on delivering new digitally enabled precision health products to market. Bayer is prioritizing development of products that enable people to take greater control of their own personal health through digital solutions that facilitate more informed choices based on personal insights and novel delivery mechanisms. David Evendon-Challis, Head of R&D and Chief Scientific Officer for the Consumer Health division of Bayer added, “Digital therapeutics are a perfect addition to our portfolio of care and tap into new tech-savvy consumers looking for drug-free treatments as well as help eliminate gaps in care provision. We’re excited to partner with Mahana Therapeutics and enter the field of digital therapeutics in consumer health.”

COLLABORATION PARTNERSHIP

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#cbt

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