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.

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May 22,2024

Study Finds Spark Direct Effective in Improving Mood Among Adults With Depression

Big Health announced the successful results of a randomized controlled trial showing that their digital CBT program for depression, Spark Direct, significantly improves mood and quality of life in adults. The study, involving 61 adults with moderate to moderately-severe depression, highlighted Spark's ease of use (95% satisfaction) and its effectiveness in enhancing motivation and providing actionable coping strategies. Participants using Spark experienced mood improvements 2.5 times greater than those in the control group, with benefits sustained for an additional five weeks post-program. Quality of life improvements for Spark users were nearly double that of the control group. Spark Direct, which utilizes cognitive-behavioral techniques, covers mental health education, behavioral activation, mindfulness, and long-term skill maintenance.

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May 09,2024

Woebot Health Wins MedTech Breakthrough's Mental Health Innovation Award

Woebot Health has received the "Mental Health Innovation Award" in the 8th annual MedTech Breakthrough Awards. This recognition highlights their Woebot Health Platform, which utilizes clinically proven techniques and artificial intelligence to provide accessible chat-based mental health support. The platform includes Woebot, a digital companion offering personalized support through chat-based conversations based on evidence-based approaches like Cognitive Behavioral Therapy, Interpersonal Psychotherapy, and Dialectical Behavioral Therapy. The CEO of Woebot Health, Michael Evers, expressed excitement about the award and emphasized the importance of innovative digital solutions in improving mental health care.

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May 06,2024 TOP STORY

Otsuka America, Inc’s. Data and Technology Company will Support Rejoyn™ Commercialization & Personalized Patient Engagement

Otsuka America, Inc. (OAI) has announced the launch of Otsuka Precision Health, Inc. (OPH), aimed at delivering tailored interventions along patients’ health journeys. OPH will prioritize enhancing the patient experience, focusing on nephrology, mental health, and beyond. The recent FDA clearance of Rejoyn™, the first prescription digital therapeutic for adjunctive treatment of major depressive disorder (MDD) symptoms, is a proof-point for the possibilities of what OPH can bring to the market to enable a better patient experience, claims the Company. OPH will serve to commercialize Rejoyn™. Rejoyn™ will also be showcased at the 2024 American Psychiatric Association (APA) Annual Meeting in New York City from May 4 to May 8, reflecting OPH's dedication to mental health advancements.

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Apr 23,2024

Curio Digital Therapeutics Inc. Announces the FDA Clearance of MamaLift Plus

Curio Digital Therapeutics announces the FDA clearance of MamaLift Plus, marking the first prescription digital therapeutic for postpartum depression (PPD). MamaLift Plus is an eight-week prescription digital therapeutic intended for patients 22 years and older, to be used under healthcare provider supervision. It offers neurobehavioral interventions including Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT). Clearance is based on the SuMMER study, a national, sham-controlled, pivotal randomized controlled trial (RCT), where MamaLift Plus demonstrated efficacy in improving symptoms of depression. The study achieved its primary endpoint with 86.3% of participants experiencing a clinically meaningful improvement.

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Apr 10,2024

Dario Publishes Two New Peer-Reviewed Studies Demonstrating Impact of Digital Behavioral Health

DarioHealth announced two new studies published in Journal of Internet Medicine (JMIR) including a Randomized Controlled Trial (RCT) demonstrating the impact of a digital stress reduction program for teens. The study results from RCT trial involved 303 teens engaged in a self-guided Digital Mental Health Intervention (DMHI) during a 12-week period. Participants in the DMHI group experienced significant improvements in perceived stress, brooding, and loneliness compared to the control group, highlighting the potential of digital stress management programs as viable alternatives to traditional in-person interventions. The second study investigated the impact of relaxation tools such as breathing exercises and Cognitive Behavioral Therapy-based videos, and evaluated on a group of 490 people engaged in Dario's digital behavioral health solution with moderate and higher levels of stress at the beginning of a 10-week period. The study reveals a significant reduction in stress levels among participants who engaged in both digital CBT-based videos and breathing exercises, demonstrating the effectiveness of digital relaxation tools in personalized behavioral health programs.

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Mar 19,2024 TOP STORY

Almee Receives Breakthrough Device Designation From the FDA

Alex Therapeutics and Vicore Pharma announced FDA Breakthrough Device Designation status for Almee, a 9-week digital cognitive behavioral therapy (CBT) delivered in a patient-facing tool, to be used as an adjunct treatment of anxiety symptoms related to Pulmonary Fibrosis. Almee has shown effectiveness in reducing anxiety symptoms and improving health-related quality of life in the COMPANION study as reported earlier this year, driving a 2.7-point increase in GAD-7 (generalized anxiety disorder scale) score and a 4.4 improvement in KBILD (King’s Brief Interstitial Lung Disease) score. As next steps, Vicore is seeking to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis.

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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.  

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Feb 01,2024

Evidence From First Mahana Tinnitus Study Accepted for Presentation at Upcoming American Audiology Society (AAS) Annual Meeting

Mahana Therapeutics, a leading provider of digital therapeutics, announced that positive results from a large US-based Pilot Clinical Trial, have been accepted for presentation at the upcoming American Audiology Society (AAS) Scientific and Technology Meeting, on February 15-17, 2024 in Scottsdale, Arizona. The pilot study, one of the largest US-based of its kind with 97 participants, explored the acceptability, safety, and clinical outcomes of Mahana Tinnitus™, which provides Digital Cognitive Behavioral Therapy (CBT) for adults with bothersome tinnitus. Key results from the abstract now available online include: 61% of participants in the Intent To Treat (ITT) population experienced a clinically meaningful improvement in TFI score after 6 weeks, and 65% reported a global impression of change, with improvements reported across tinnitus-related domains, like sleep, distress, and coping.

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Jan 04,2024

Alex Therapeutics Reports Positive Results from the Randomized-Controlled Trial of its Digital Therapy for Anxiety

Alex Therapeutics and Vicore Pharma today announced positive results of the COMPANION study, investigating the efficacy of Almee, a 9-week digital CBT intervention accessed through a smartphone or tablet. Almee, developed by Alex Therapeutics in partnership with Vicore Pharma, is an app that offers personalized treatment for anxiety based on cognitive behavioral therapy (CBT). The COMPANION study enrolled 108 participants from across the United States in a randomized, controlled, parallel-group clinical investigation evaluating the impact of Almee on the psychological symptom burden in adults diagnosed with PF. The study met its primary endpoint, change from baseline in GAD-7 anxiety scores, with a statistically significant 2.7-point improvement compared to control, where a change in GAD-7 score of more than 1.8 is considered clinically meaningful. Quality of life, measured by the K-BILD, was a key secondary endpoint and improved by 4.4 points compared to control, and the K-BILD psychological domain improved by 6.5 points.

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