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.

REGULATORY FDA

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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.

CLINICAL STUDY

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Nov 06,2023 TOP STORY

Smileyscope Therapy is the First Virtual Reality Device to Receive FDA Class II Clearance for Acute Pain

Smileyscope has made history by becoming the first virtual reality (VR) device to receive FDA Class II clearance for acute pain. This approval recognizes Smileyscope's innovative Procedural Choreography™ technique, which uses positive virtual stimuli to reduce pain and anxiety during medical procedures. With this milestone, Smileyscope aims to revolutionize pain and anxiety management, partnering with hospitals and clinicians globally to enhance patient experiences and improve clinical workflows. FDA clearance included critical, independent evaluation of Smileyscope's patented Procedural Choreography™. Procedural Choreography is Smileyscope's proprietary technique that takes negative real-world stimuli (e.g. a needle) and replaces it with psychologically-preferable positive virtual stimuli (e.g. a friendly fish).

REGULATORY FDA

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Oct 09,2023 TOP STORY

New Research Demonstrates Clinical Effectiveness of Digital Treatment at Improving Insomnia and Comorbid Mental and Physical Health Issues

Big Health announced today the publication of two, peer-reviewed studies demonstrating the effects of its flagship digital insomnia treatment Sleepio in individuals with co-morbid insomnia and clinically significant anxiety as well as in stroke survivors. Published in the peer-reviewed Journal of Affective Disorders, researchers found that Sleepio’s clinically validated impact on insomnia also significantly reduced participants’ anxiety symptoms — 84% of improvements in anxiety were due to improvements in sleep. Also, the peer-reviewed Journal of Sleep Research published results from the INSPIRES study, a randomized controlled trial (RCT) comprising 84 stroke survivors demonstrating that Sleepio was effective at improving sleep, compared with sleep hygiene control, for at least eight weeks post-intervention. Results also showed that, among participants who had insomnia disorder at baseline, 71% in the Sleepio study arm achieved remission post-intervention compared to 30% of control participants.

CLINICAL STUDY

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Jul 14,2023

Big Health Expands into Adolescent Mental Health Through Acquisition of Limbix

Big Health, the leader in digital therapeutics, acquires Limbix to address the youth mental health crisis. The acquisition expands Big Health's portfolio to include SparkRx, a digital therapeutic for adolescent depression, and an anxiety product in development, alongside its flagship programs for patients aged 18+: Sleepio, for insomnia, and Daylight, for anxiety. The addition of SparkRx allows Big Health to provide effective treatments across a broader age range and increase nationwide access through strategic distribution agreements.

COLLABORATION MERGERS & ACQUISITION

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Apr 21,2022

Alex Therapeutics presents results from digital therapeutic pilot study showing nearly 50% reduction in anxiety

The Pilot study was a 4-week, single-arm, decentralized, open-label clinical investigation in 10 patients with self-reported anxiety related to idiopathic pulmonary fibrosis (IPF). The primary objective of the study was to test the functionality, user experience, and safety of the DTx, which were all found to be positive. Additionally, the trial provided encouraging early indications of efficacy. The patient-reported Generalized Anxiety Disorder (GAD-7*) results showed an average score reduction of 4.2. A reduction in the GAD-7 score of  ≥2 points is regarded as clinically meaningful. The full DTx, AlmeeTM, to which patients in this pilot were given limited access, has been developed by Alex Therapeutics in collaboration with Vicore Pharma.

CLINICAL STUDY

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Feb 14,2023

Digital mental health tech for children and young people recommended by NICE in first rapid healthtech guidance

Four digital technologies that can help children and young people with mild to moderate symptoms of anxiety or low mood, including SilverCloud Health, have been recommended for use in the NHS once they achieve regulatory approval. These four technologies, using games, videos and quizzes, represent a promising step forward for new treatment options for children and young people, with early evidence showing they could help improve symptoms of anxiety or low mood.

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Dec 15,2022

Rx.Health and Wise Therapeutics collaborate to provide game-based digital therapeutic to anxiety patients

Rx.Health, the leading evidence-based automated care coordination platform, has announced a partnership with Wise Therapeutics, a leading provider of game-based digital therapeutics for mental health. This partnership will enable Rx.Health's health plan and health system users to deploy Wise's mobile game to their patient populations as an integrated digital therapeutic for anxiety.

COLLABORATION PARTNERSHIP

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Jun 01,2020

Blue Note Therapeutics Receives Breakthrough Device Designation from FDA for Prescription Digital Therapeutic to Treat Cancer-Related Anxiety and Depression

Blue Note Therapeutics, Inc., a prescription digital therapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to BNT001, the company’s lead prescription digital therapeutic (PDT) candidate for the treatment of symptoms of anxiety and depression related to cancer in adult patients.

REGULATORY FDA

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Jul 29,2020

CVS Health Adds Big Health’s Digital Therapeutics for the 24-Hour Problem of Mental Health to Its Point Solutions Management Program

Big Health, the global leader in digital therapeutics dedicated to helping millions back to good mental health, today announced that its Daylight digital therapeutic for worry and anxiety is now available to employers and other plan sponsors through CVS Caremark’s Point Solutions Management program. Together, Sleepio and Daylight address the 24-hour problem of mental health, spanning poor sleep, worry and anxiety, with clinically proven, instantly accessible digital therapeutics. Point Solutions Management is a full-service offering that leverages the CVS Caremark PBM infrastructure to enable plan sponsors to more efficiently administer apps, online trackers and other digital point solutions that support their members’ health and well-being.

COLLABORATION PARTNERSHIP

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