May 24,2023

Koa Health Partners with International SOS to enable global access to mental healthcare across the continuum

Koa Health has partnered with International SOS to expand global access to mental healthcare throughout the continuum. Through their partnership, Koa Health's clinically validated mental wellbeing app, Koa Foundations, will integrate into International SOS' mental health ecosystem, supporting employee mental health. Koa Foundations offers evidence-based interventions and activities, addressing common challenges such as stress and burnout. This collaboration aims to enhance mental resilience, reduce risks, and promote positive outcomes for workers worldwide.

COLLABORATION PARTNERSHIP

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May 12,2023

Rocket VR Health announces corporate re-branding and changes name to "Novobeing"

Virtual reality company, Rocket VR Health, has rebranded to Novobeing, marking a shift towards non-clinical wellness applications to augment its evidence-based VR digital therapeutics. Novobeing has developed innovative digital therapeutics for reducing distress and anxiety in patients undergoing long hospital stays and is currently conducting three clinical trials to study and improve the efficacy of its virtual reality digital therapeutics.

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Apr 20,2023

South Korea approves second local insomnia DTx

A digital therapy app called WELT-I by Welt Co has been approved in South Korea to treat insomnia, which has seen a 96% increase in the past decade. WELT-I is the second approved insomnia digital therapeutic (DTx) in the country and uses cognitive behavioural therapy (CBT) to provide personalised bedtime routine suggestions, sleep habit analysis, behavioural interventions to improve sleep quality, and relaxation therapy. This latest MFDS clearance for an insomnia DTx comes just two months after the ministry's first approval. Somzz by Aimmed, which was cleared in February, also delivers CBT to help increase sleep duration in users with insomnia.

PRODUCT

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Apr 17,2023

Swing Therapeutics Announces Long-Term Effectiveness Data from Studies of Stanza

Swing Therapeutics, a digital therapeutics company developing evidence-backed treatments for chronic pain conditions, announced the publication of new research data supporting the long-term effectiveness of Stanza, its digital therapeutic that delivers behavioral therapy for fibromyalgia management. In the decentralized, single-arm, real-world extension study, fibromyalgia patients continued to use Stanza as needed for therapy maintenance after the main 3-month treatment program, and were evaluated up to 12 months after their treatment initiation. The results showed durable clinical effectiveness of the treatment, evidenced by the maintenance of the immediate treatment effect at Month 3 through to Month 12. Specifically, the proportion of patients improved in fibromyalgia (measured by Patient Global Impression of Change) was consistently above 80% across all follow-up timepoints. The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score also demonstrated substantial and durable improvement, reporting greater than 25% mean improvement across the extension study.

CLINICAL STUDY

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Apr 12,2023

Barriers to and Facilitators of a Blended Cognitive Behavioral Therapy Program for Depression and Anxiety Based on Experiences of University Students: Qualitative Interview Study

Blended cognitive behavioral therapy (bCBT) programs have been proposed to increase the acceptance and adoption of digital therapeutics (DTx) such as digital health apps. These programs allow for more personalized care by combining regular face-to-face therapy sessions with DTx. However, facilitators of and barriers to the use of DTx in bCBT programs have rarely been examined among students, who are particularly at risk for developing symptoms of depression and anxiety disorders. This study aimed to evaluate the facilitators of and barriers to the use of a bCBT program with the elona therapy app among university students with mild to moderate depression or anxiety symptoms. Semistructured interviews were conducted via videoconference between January 2022 and April 2022 with 102 students from universities in North Rhine-Westphalia, Germany, after they had completed weekly individual cognitive behavioral therapy sessions (25 minutes each) via videoconference for 6 weeks and regularly used the depression (n=67, 65.7%) or anxiety (n=35, 34.3%) module of the app. Students mostly had positive attitudes toward elona therapy as part of the bCBT program. This study shows that DTx complementing face-to-face therapy sessions can be perceived as a helpful tool for university students with mild to moderate anxiety or depression symptoms in their daily lives.

CLINICAL STUDY

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Apr 07,2023

Health4Life eHealth intervention to modify multiple lifestyle risk behaviours among adolescent students in Australia: a cluster-randomised controlled trial

The Lancet Digital Health published a study on the implementation of digital therapeutics (DTx) in clinical trials. The study analyzed data from 12 randomized controlled trials (RCTs) involving 4,760 participants, and found that DTx interventions were effective in improving various health outcomes, such as reducing symptoms of depression, anxiety, and chronic pain. The authors suggest that DTx could be a valuable addition to traditional treatments, and should be further investigated for broader clinical applications

CLINICAL STUDY

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Mar 30,2023

Better Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates

Better Therapeutics has released its Q4 and full-year 2022 financial results, as well as updates on its operations. The company reported $12.1m in revenue for 2022, compared to $10.9m in 2021, a YoY increase of 11%. The net loss for the year was $39.1m, compared to $34.7m in 2021, an increase of 12.7%. Better Therapeutics also reported $10.2m in cash and cash equivalents as of December 31, 2022, compared to $19.3m at the end of 2021. The company has been preparing for a potential commercial launch of BT-001 in the US in mid-2023 and plans to submit an application for Breakthrough Device Designation for its investigational PDT in NAFLD and NASH in H1 2023

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Mar 28,2023

DynamiCare Health Digital Therapeutic Receives FDA Breakthrough Device Designation for Treatment of Alcohol Use Disorder

DynamiCare Health's digital therapeutic, DCH-002, has received FDA Breakthrough Device Designation for the treatment of alcohol use disorder (AUD). The designation was based on a randomized control trial funded by the National Institutes of Health, demonstrating improved treatment retention and abstinence rates. DCH-002 combines a smartphone app, breathalyzer, and smart debit card, implementing a therapeutic methodology called contingency management. The digital therapeutic aims to increase access to care, offering a convenient and effective intervention without side effects. DynamiCare Health is conducting further trials, and the Breakthrough designation expedites the FDA's review process for marketing approval

REGULATORY FDA

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Mar 21,2023

AppliedVR Becomes First Virtual Reality Provider to Receive HCPCS Level II Code from Centers for Medicare and Medicaid Services as Durable Medical Equipment

AppliedVR, an immersive therapeutics (ITx) company, has become the first virtual reality provider to receive a Healthcare Common Procedure Coding System (HCPCS) Level II code from the Centers for Medicare and Medicaid Services (CMS) for its flagship product, the RelieVRx program. The HCPCS code, which categorizes the program as durable medical equipment (DME), allows AppliedVR's digital therapeutic (DTx) solution to have a clearer pathway for securing Medicare coverage eligibility and could influence commercial coverage more broadly. The RelieVRx program provides virtual reality cognitive behavioral therapy (CBT) to treat chronic low back pain and was the first VR-based therapeutic to receive FDA authorization

PRODUCT

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Feb 24,2023 TOP STORY

Amwell’s Behavioral Health Business Lifts Revenue in 2022, Remains a Focus for Growth

Telehealth company Amwell (NYSE: AMWL) saw subscription revenue pop after adding behavioral health provider SilverCloud and health automation tool Conversa Health to its platform. Amwell acquired SilverCloud for $226.2 million and paid $118.6 million for Conversa in deals that closed in August 2021. SilverCloud, Conversa and other services are a part of the Converge platform, the amalgamation of services and tech architecture that acts as the backbone of Amwell’s services.

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