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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Sep 18,2023

AimMed challenges to develop DTx for Galaxy Watch

At a workshop organized by the Korean Society of Pharmaceutical Science and Technology last Friday, Jung Kyung-ho, a director at AimMed, said the company signed a memorandum of understanding with Samsung Electronics to develop Somzz exclusively for Galaxy Watch. According to Jung, the MOU calls for developing digital healthcare services based on wearable devices and cooperating in related business. Somzz is the first DTx in Korea developed by AimMed. In February, it won approval from the Ministry of Food and Drug Safety as a software medical device that materialized behavioral therapy for insomnia as a mobile application (app). AimMed is registering Somzz with application stores, including the App Store and Google Play. The process is expected to take about a month. However, it will take a little longer for patients to be able to prescribe Somzz at the point of care. "You may think that the development period for digital therapeutic devices is shorter than that of new drugs, but it takes seven years -- three years to receive approval and four years to be officially listed for reimbursement. It also requires 1 billion won ($770,000) to 1.5 billion won a year to license and maintain a digital therapeutic device, and the cost could rise to 2 billion won," Jung said.

COLLABORATION PARTNERSHIP

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Aug 18,2023

Welt, Aimmed face delays in launching Korea's first approved DTx devices

Korea approved two digital therapeutics (DTx) devices this year but there has been no news about the market launch since the Ministry of Food and Drug Safety (MFDS) granted the approval for these innovative devices from Aimmed and Welt in February and April this year respectively. As the developers of the first approved DTx devices in Korea, both Welt and Aimmed are exploring uncharted territory. However, even after receiving approval, both companies have to prepare for the pilot project to accumulate real-world evidence of the DTx device, as required by the National Evidence-based Healthcare Collaborating Agency (NECA). Welt CEO Sean Kang expressed his frustration with the slow launch saying that it was being delayed as they were required to jump through several hoops to undergo a pilot project.

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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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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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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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Feb 15,2023

Aimmed’s Somzz becomes Korea’s first approved DTx device for insomnia

The Ministry of Food and Drug Safety (MFDS) said that Aimmed’s Somzz for treating insomnia was the first digital therapeutics (DTx) device to receive domestic marketing approval at a press briefing on Wednesday. The MFDS reviewed the results of six-month clinical trials conducted by Aimmed at three domestic clinical trial institutions for Somzz and confirmed that the DTx device statistically improved the insomnia severity assessment scale before and after its use. Somzz is a software medical device that implements cognitive behavioral treatment (CBT) to treat insomnia patients in the form of a mobile application. It improves insomnia by increasing sleep efficiency through sleep habit training, real-time feedback, and behavioral intervention provided by the mobile app for 6 to 9 weeks.

PRODUCT

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Jan 26,2023

For many with mental health conditions, medication is the only option. That has to change.

Digital therapeutics is gaining traction as a major application in the field of mental health for several reasons. Firstly, mental health encompasses a variety of highly prevalent conditions like anxiety, depression, chronic pain, insomnia, and PTSD that affect around one in three individuals. Secondly, the existing treatments for these conditions, such as commonly prescribed medications, have inadequate efficacy and may result in significant side effects. Thirdly, during the pandemic, mental health has become a top three priority for governments, health systems, and employers to address more effectively. Additionally, patient preferences are also contributing to this trend, with 75% of individuals expressing a preference for non-pharmaceutical treatments.

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Dec 20,2022

HelloBetter Sleep: First online therapy programme for organic and nonorganic insomnia available on prescription in Germany

HelloBetter Sleep has secured approval as HelloBetter’s sixth DiGA (prescription digital therapeutic) by the German Federal Institute for Drugs and Medical Devices (BfArM) and is now included in the DiGA directory. HelloBetter Sleep is the only prescription digital therapeutic that is approved not just for the treatment of nonorganic insomnia (ICD-10 F51.0), but also organic insomnia (ICD-10 G47.0) in Germany. All statutory as well as many private health insurers will cover the costs of HelloBetter Sleep in full, making it available free of charge to 73 million people in Germany. Over the last 14 months, HelloBetter has managed to secure six regulatory DiGA approvals – more than any other company.

PRODUCT

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Mar 26,2020

Pear Therapeutics Obtains FDA Authorization For Somryst, A Prescription Digital Therapeutic For The Treatment Of Adults With Chronic Insomnia

Pear Therapeutics, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted authorization for Somryst™, the first prescription digital therapeutic (PDT) intended for use in the treatment of patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms, and it is the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed as part of FDA’s Software Precertification Pilot Program to help build and test FDA’s Digital Health Precertification Working Model 1.0.

REGULATORY FDA

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