Jul 10,2023 TOP STORY

Better Therapeutics Receives FDA Authorization for AspyreRx™ to Treat Adults with Type 2 Diabetes

Better Therapeutics received FDA authorization for AspyreRx™, a prescription-only digital therapeutic (PDT) treatment indicated to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes (T2D). AspyreRx was reviewed through the FDA’s De Novo pathway and its authorization creates a new class of diabetes digital behavioral therapeutic devices. AspyreRx is expected to launch commercially in Q4 2023?.

REGULATORY FDA

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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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Dec 01,2022

Alex Therapeutics presents major Eila clinical trial recruitment milestone

Alex Therapeutics, together with Pfizer, has reached the first major milestone in a clinical study of a digital therapeutic for the CBT-based treatment of tobacco dependence in Germany. The Eila study, number X9001304, is a prospective, comparative, randomized, single-blind, multicenter, pragmatic clinical study with approximately 1,000 participants in Germany, designed to assess the safety and effectiveness of the Eila® DTx compared to the standard of care. The medical device was developed by Alex Therapeutics and adapted to the requirements of the German healthcare system together with Pfizer. The partnership initially focuses on Germany, one of the world’s largest unified healthcare markets. 

CLINICAL STUDY

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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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Jun 04,2021

Alex Therapeutics recieves Vinnova funding to develop tobacco cessation product in India

Alex Therapeutics received application approval and funding from Vinnova (Sweden Government's Innovation Agency) to develop and clinically validate a tobacco cessation digital therapeutic (DTx) program in India. The project was in response to the European Call for Proposals for Joint R&D Projects with India in Health and AI launched in 2020 and will run from 2021 to 2024. Together with the Public Health Foundation of India (PHFI), Alex Therapeutics will adapt and clinically validate its nicotine addiction DTx treatment, developed using the Alex Therapeutics DTx platform, to the Indian Market. 

COLLABORATION PARTNERSHIP

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Oct 16,2020

Welltok Addresses Mental Health Crisis With New Connect Partners

Welltok announced the addition of three new Connect Ecosystem Partners to address the mental health crisis compounded by COVID-19. Welltok selected eMindful, Happify Health and SilverCloud Health to round out its ecosystem of curated programs that the nation’s largest employers and health plans can select to support the total wellbeing of millions. These innovative programs complement Welltok’s existing mental health category partners including: Workit Health (substance use disorder care), Livongo (behavioral health programs covering wellness through clinical conditions), Total Brain (brain performance self-monitoring and self-care) and meQuilibrium (resilience training).

COLLABORATION PARTNERSHIP

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May 04,2021

Vicore enters into collaboration with Alex Therapeutics to develop new prescription digital therapeutic for patients with IPF

The agreement with Alex Therapeutics marks the initiation of a new clinical program for Vicore (VP04) – the joint development and commercialization of a clinically validated digital therapeutic (DTx) will provide cognitive behavioral therapy (CBT) for patients suffering from IPF. VP04 expands Vicore’s existing small therapeutic programs in IPF and other severe respiratory diseases. The digital therapeutic will be designed to provide CBT to IPF patients, in parallel to routine consultations with medical professionals, to help improve their quality of life and support them through the psychological impacts of disease and its diagnosis. Working closely with patient groups and healthcare providers, Vicore and Alex Therapeutics expect to begin the clinical trial of VP04 in 2022.

COLLABORATION PARTNERSHIP

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Jul 05,2023 TOP STORY

Peer-Reviewed Publication Reports Stanza Preliminary Efficacy Data

Swing Therapeutics announced the publication of the randomized phase II trial (SMART-FM) with Stanza, which appeared this week in The Journal of Behavioral Medicine. This peer-reviewed paper reports clinically significant improvement in well-being and fibromyalgia severity in patients who received an earlier generation of Stanza, Swing Therapeutics’ digital behavioral therapy for fibromyalgia. SMART-FM, a pilot randomized controlled trial, evaluated the impact of the self-guided, smartphone-based digital therapy for patients with fibromyalgia. Sixty-seven patients with fibromyalgia were randomized to receive a prototype version of the Stanza digital therapy or the control, a digital symptom tracking application. At Week 12, 73% of treated participants using the digital therapy reported improvement in well-being (measured by Patient Global Impression of Change) versus 22% of participants in the control arm.

CLINICAL STUDY

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Jun 14,2023

Ampersand Health Expands into Dermatology & Partners with Barts Health

Ampersand Health introduces the My Derm app to support people with inflammatory skin conditions. The app offers personalized self-management, remote monitoring by clinical teams, and therapy techniques. Barts Health is implementing the My Derm app as part of a broader transformation programme that seeks to improve outcomes for patients while reducing outpatient waiting times in line with the NHS’s Elective Recovery Plan.

COLLABORATION PARTNERSHIP

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Jun 02,2023

Q&A: Nox Health on its $3.9M bid for Pear Therapeutics' assets

Nox Health, a tech-enabled sleep health company, made the highest bid of $3.9 million for the assets of Pear Therapeutics' Somryst at a recent bankruptcy auction. Somryst is an FDA-cleared prescription digital therapeutic that utilizes cognitive behavioral therapy for insomnia. Nox Health aims to integrate Somryst into its comprehensive sleep management program, offering proven outcomes for patients with chronic insomnia and complementing its existing offerings in sleep health. The company plans to make Somryst accessible to physicians and patients while continuing to invest in its improvement.

COLLABORATION MERGERS & ACQUISITION

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