Feb 14,2017

Servier and GAIA Extend Their Partnership to Provide Patients around the World with Deprexis

Servier, an independent international pharmaceutical company, and GAIA, a global pioneer in digital therapy, announced that they have signed a partnership to extend the marketing of deprexis®, an internet-based cognitive behavioral therapy to treat depression. deprexis® has been licensed to Servier for the German market since July 2015. It is available for patients in Germany under the label deprexis24®. The current agreement extends the exclusive marketing rights of Servier to all countries except US and Japan. Other countries will launch versions in local languages in the coming months.

COLLABORATION PARTNERSHIP

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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.

CLINICAL STUDY

#cbt

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Mar 31,2024 TOP STORY

Otsuka and Click Therapeutics Announce the FDA Clearance of Rejoyn for the Adjunctive Treatment of Major Depressive Disorder Symptoms

Otsuka Pharmaceutical and Click Therapeutics announce that the U.S. FDA has cleared Rejoyn™ (developed as CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms, and it is a six-week treatment program designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for the brain and brief therapeutic lessons. The clearance of Rejoyn is based on data from the Mirai study, a 13-week pivotal, multicenter, remote, double-blinded, randomized, controlled trial of 386 participants, aged 22 to 64, diagnosed with MDD who were on antidepressant medication for the treatment of depression. In the trial, individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline. Following the FDA's approval, it is expected to be available for download from app stores in the latter half of 2024, upon healthcare professionals' prescriptions for their patients.

REGULATORY FDA

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Mar 20,2024

Grow Therapy, Big Health Deal Highlights Path Forward for Digital Therapeutics

Burgeoning outpatient mental health digital platform Grow Therapy has partnered with digital therapeutics producer Big Health. The deal aims to drive more patients to Big Health’s suite of mental health-focused digital therapeutics. Additionally, Grow Therapy providers and patients can access high-tech tools that support patients between therapy sessions. The deal also highlights a solution to an existential problem for digital therapeutics as a business: patient acquisition. By leveraging Grow Therapy's extensive network of clinicians and health plans and Big Health's suite of digital therapeutics, the partnership aims to provide stability and volume to both companies.

COLLABORATION PARTNERSHIP

#institution

#mobile app

#telehealth

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Sep 12,2023

PayrollPlans Announces Pioneering Partnership with Woebot Health and Curai Health to Provide Virtual Mental Health and Primary Care Solutions to Underserved Workers

PayrollPlans, Woebot Health, and Curai Health unveil a partnership to deliver a virtual benefit solution with AI-driven primary care and mental health services to over 2 million Small-to-Medium Enterprises employing over 70 million underserved American workers. PayrollPlans is a proprietary digital ecosystem that integrates into payroll software used by Independent Payroll Processors and their Small-to-Medium Enterprise clients. Through this partnership, Woebot Health and Curai Health enable employers to provide their employees with enhanced access to unlimited and affordable mental health and primary care services, a core tenet of the PayrollPlans mission. Woebot Health will deliver its AI-powered mental health tool Woebot for Adults, an accessible, reliable, and scalable mental health ally. When coupled with Curai Health’s AI-enabled virtual clinic, their specially trained clinicians will provide convenient virtual primary care, improved health outcomes, and reduced costs. 

COLLABORATION PARTNERSHIP

#institution

#virtual care

#chatbot

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Mar 05,2024 TOP STORY

The DTx Solution for Borderline Personality Disorder, priovi Secures Permanent Reimbursement in Germany with the Phase 3 Trial Results

priovi, the world’s first and only fully automated digital therapy for borderline personality disorder (BPD) developed by GAIA Group, has been available for clinical use in Germany since March 2023, and now its effectiveness has been confirmed in a large clinical trial (RCT) with 580 patients. Thanks to the positive results, the Federal Institute for Drugs and Medical Devices (BfArM) in Germany granted permanent reimbursement for priovi's digital therapy intervention. The study, which included 580 patients, showed a significant and clinically relevant reduction in borderline symptoms as well as a decrease in both depression and anxiety symptoms in the intervention group, compared to the control group. In addition, the number of suicide attempts was significantly lower in the priovi group. Patients also reported a high level of satisfaction while using the program and their satisfaction scores increased with time.

CLINICAL STUDY

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Feb 12,2024

Curavit Successfully Completes a Virtual Clinical Trial for Sana's Investigative Digital Therapeutic to Treat Symptoms of PTSD

Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), has announced the successful completion of a decentralized trial for the Sana Health's device. Sana has submitted the trial data for Breakthrough Device Designation consideration from the U.S. Food and Drug Administration (FDA) for its wearable, virtual-reality-style mask that uses audiovisual stimulation to reduce symptoms of post-traumatic stress disorder (PTSD). More than 45 patients were recruited from a Veteran's hospital participated in the 28-day study. The trial was carried out with a grant from CDMRP funds, disbursed through the Military Operational Medicine Research Program (part of the DoD). It was designed to gather evidence on the Device's ability to allow patients suffering from PTSD to gain additional relief whilst on waiting lists for further specialty care. Previously, the Sana Device received FDA Breakthrough Device Designation for treatment of Fibromyalgia in 2021.

PRODUCT

#conneted device

#virtual reality

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Feb 06,2024

U.S. Department of Veterans Affairs Taps Mynd Immersive to Create Landmark VR Application for Vietnam Veterans

In a significant development, Mynd Immersive, a leading provider of XR-based, digital therapeutics, announced today that it had signed a 3-year Cooperative Research and Development Agreement with the U.S. Department of Veterans Affairs (VA) to develop "Virtual Vietnam: A Path to Peace," a landmark virtual reality (VR) project for aging Vietnam Veterans. Mynd Immersive is now deployed in nearly 100 long-term Veteran care facilities across the United States. In a large, multi-year study with Stanford, Mynd has been shown to improve mood, reduce feelings of isolation and improve the relationship between older adults and their caregivers. This new collaboration will enlist the input of Veterans across the nation. Their firsthand experiences and perspectives will guide virtual journeys that are respectful, therapeutic, and empowering.

COLLABORATION PARTNERSHIP

#r&d

#virtual reality

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Jan 16,2024

Banner Health reduces generalized anxiety with digital therapeutics

Banner Health, a large nonprofit health system based in Phoenix, faced challenges in behavioral health due to a surge in demand accelerated by the pandemic, a shortage of licensed clinical professionals, and Phoenix experiencing the largest growth in behavioral healthcare needs. To address this, Jeff Johnson, VP of Innovation and Digital Business, proposed using digital therapeutics to provide care for mild and moderate depression and anxiety. For diabetes, Banner aimed to enhance patient and staff efficiencies by addressing the fragmented experience caused by varied data collection methods. They evaluated digital therapeutic products thoroughly, seeking solutions that aligned with both business and clinical needs. The digital therapeutic for behavioral health, SilverCloud, showed positive results, reducing anxiety disorder scores, and Banner is exploring its impact on healthcare utilization and cost containment.

COLLABORATION PARTNERSHIP

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Jan 08,2024 TOP STORY

GlobalSpace Technologies unveils GoRoga - India's first Anti-Stress wearable

GlobalSpace Technologies Limited unveiled GoRoga, India's first anti-stress wearable under the Make in India initiative. Manufactured and patented as RogaLife in the USA, the complete solution has been developed in collaboration with GlobalSpace Technologies Ltd and is now available for the first time, in India. GoRoga aims to be the ultimate anti-stress companion for those suffering from moderate to severe stress and anxiety. Crafted through the FDA-approved NIBS (neuroscience-researched non-invasive brain stimulation) technology, this non-invasive Anti-Stress wearable plugs into a phone while the sticky pads hook to the ears to activate cortisol for the reduction of stress via the release of serotonin and multiple another feel good harmones. A dedicated mobile app also offers comprehensive tracking, progress scores, and personalized insights. It takes just 20 minutes per day, recommended up to a maximum of 60 minutes per day for 3 to 4 weeks, to get on the path of lasting tranquility. Backed by rigorous research, user testing, and the personal triumph of our co-founder, GoRoga has a reliable stamp of safety and efficacy.

PRODUCT

#connected device

#mobile app

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