Jan 08,2024 TOP STORY

Transforming Corporate Health: Fitterfly's Success in Tackling Diabetes and Weight Issues

While corporate wellness plans have been offered by employers for a long time, the focus has been primarily around giving access to quality care in the form of consultations, insurance or annual checkups. None of these have shown great adoption or outcomes. To change this scenario, Fitterfly launched digital therapeutic programs as pilot programs with 400 employees from five large corporate groups in January 2023. The primary focus was delivering health outcomes using technology and coaching for diabetes, obesity, dyslipidemia and PCOS, and metabolic health issues. Notably, 88% of participants experienced a 1.1 point reduction in HbA1c levels, indicating better diabetes management. Nutritional changes were also significant, with a 30% reduction in calorie intake, a 36% reduction in carbohydrates, and a 29% reduction in fats. At the end of the weight management program, 85% of employees achieved an average weight loss of around 3.5 kg. With the program extended to fitness and mental wellbeing, 66% of participants showed improvement in musculoskeletal fitness scores and 77% in cardiovascular function. 92% of them showed improvement in sleep quality, 98% in stress scores, and 96% in overall quality of life.

PRODUCT

#coaching

#mobile app

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Jan 09,2024

Feel Therapeutics Brings Michel Vounatsos as Chairman Of The Advisory Board, and Secures New Funding

Feel Therapeutics announced today that Michel Vounatsos, former CEO of Biogen, has joined as a Chairman of their Advisory Board. Additionally, Feel has secured new funding from Satori Neuro, Metavallon VC, and existing investors such as SOSV, SeedtoB, and others, to fuel its expansion plans. Along with the new funding, Amy Kruse, Chief Investment Officer of Satori Neuro, has joined the Board of Directors.

FUNDING FUNDING ROUND
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Jan 09,2024

Transforming Corporate Health: Fitterfly's Success in Tackling Diabetes and Weight Issues

While corporate wellness plans have been offered by employers for a long time, the focus has been primarily around giving access to quality care in the form of consultations, insurance or annual checkups. None of these have shown great adoption or outcomes. To change this scenario, Fitterfly launched digital therapeutic programs as pilot programs with 400 employees from five large corporate groups in January 2023. The primary focus was delivering health outcomes using technology and coaching for diabetes, obesity, dyslipidemia and PCOS, and metabolic health issues. In the Diabetes programs delivered via Fitterfly App, personalised diet, fitness, stress and sleep management plans were shared with the employees based on several scientific assessments. Notably, 88% of participants experienced a 1.1 point reduction in HbA1c levels, indicating better diabetes management. Nutritional changes were also significant, with a 30% reduction in calorie intake, a 36% reduction in carbohydrates, and a 29% reduction in fats.

PRODUCT

#coaching

#dtx

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Jan 04,2024

BlueSkeye AI Launches Groundbreaking Technology Using Mobile Devices to Analyze Facial Expressions and Vocal Behavior for Clinical Use at CES 2024

UK startup Blueskeye AI is launching its Health Foundation Platform at the Consumer Electronics Show in Las Vegas held in between January 9-12 in Las Vegas. The Health Foundation Platform makes it easy and quick for health tech companies to integrate clinical grade AI which analyses medically relevant expressed behavior into their products. Their technology uses mobile phones or tablets running advanced machine learning algorithms to analyze facial expressions and vocal behavior to provide digital health companies and their customers with deeper, more measurable and reliable customer insights more securely and faster than ever before. The powerful clinical grade AI can be integrated rapidly into digital therapeutics platforms, clinical trial or treatment companion apps, extending their capabilities, making them more powerful and allowing additional services to be offered. The Platform can also assess fatigue, pain, muscular atrophy, anxiety and depression. It could even identify the early signs of conditions which have an effect on the face or voice, such as, Autism, ADHD, Parkinson's or Alzheimer's. The Platform's core technology is already in use in the UK's NHS Trusts where the company is undertaking a clinical trial of its use for assessing anxiety and depression amongst pregnant women.

PRODUCT

#software

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Jan 04,2024

First FDA-Approved Self-Neuromodulation Device for PTSD Officially Launches in the US

GrayMatters Health, a developer of digital self-neuromodulation therapies for mental health care, announced that it has officially launched Prism for posttraumatic stress disorder (PTSD) in the United States. Prism for PTSD—the first self-neuromodulation device to receive US Food & Drug Administration (FDA) clearance as a prescribed adjunct to standard of care (SOC) for PTSD—is now accessible at 2 US clinics, with several more clinics currently in the process of installing and training with Prism for PTSD. During Prism therapy, a computer simulation and EEG headset create an immersive environment to train individuals to gain control over amygdala-based biomarker activity associated with PTSD. The core GrayMatters Health technology, the world’s first digital EEG-fMRI-Pattern (EFP) biomarker of brain-area-specific activity, plays a pivotal role in Prism for PTSD. Developed through advanced statistical models, this technology registers fMRI amygdala data with EEG.

PRODUCT

#pdt

#connected device

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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

#cbt

#mobile app

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Jan 04,2024 TOP STORY

Click Therapeutics and Boehringer Ingelheim Announce FDA Breakthrough Device Designation for Prescription Digital Therapeutic to Treat Negative Symptoms of Schizophrenia

Click Therapeutics announced that the investigational CT-155 prescription digital therapeutic (PDT), co-developed by Boehringer Ingelheim and Click Therapeutics, has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). CT-155 is a novel software accessible on mobile devices that is being studied for use adjunctive to standard of care pharmaceutical therapy and is designed to treat the negative symptoms of schizophrenia. It is one of multiple digital therapeutics under joint-development by the companies for the treatment of schizophrenia. “Our unique therapeutic approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “This designation brings us one step closer to that reality by enhancing our ability to work with the FDA on market authorization and accelerate access to this future treatment option,” said Austin Speier, Chief Strategy Officer of Click Therapeutics. CT-155 is the first investigational PDT developed as part of the collaboration between Click Therapeutics and Boehringer Ingelheim, which has been in effect since September 2020. The collaboration has since expanded to include an additional investigational prescription-based digital therapeutic for use alone and in combination with pharmaceutical therapy to help people with schizophrenia achieve positive clinical outcomes, which was announced in December 2022.

REGULATORY FDA

#pdt

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Dec 18,2023 TOP STORY

EndeavorRx Secures FDA Label Expansion for Pediatric ADHD Patients Aged 13-17

Akili announced that it has received authorization from the FDA to expand the label for EndeavorRx from 8 to 12 year-old patients with primarily inattentive or combined-type ADHD who have a demonstrated attention issue to include older children aged 13 - 17. This increased age range is expected to more than double the number of pediatric patients with ADHD who are now eligible for EndeavorRx – the only FDA-authorized, game-based digital therapeutic – with a prescription from a healthcare provider. (Akili also offers a non-prescription product for adults with ADHD, using the same technology, EndeavorOTC™.) The clinical study on which the FDA’s label expansion authorization for EndeavorRx is based involved 162 adolescents with a verified diagnosis of inattentive or combined-type ADHD who all received EndeavorRx for 4 weeks and subsequently demonstrated significant improvements in Test of Variables of Attention-measured attentional control. In the same study, adolescents using EndeavorRx also saw significant improvement in clinician-rated ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores.

PRODUCT

#pdt

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Aug 11,2022

Frontiers in Digital Health Publication Presents Feel Therapeutics Program as a New Strategy for Effectively Monitoring and Improving Anxiety and Depression

Feel Therapeutics announced the publication in Frontiers in Digital Health of a landmark clinical feasibility study showing the effectiveness of Feel’s intervention program for anxiety and depression. The study presented the results from real-world-data to evaluate different aspects of the Feel Program, which is a 16-week, fully-remote, digital mental health support program created by Feel Therapeutics to bring objective data and precise support into the management of mental health. In this study, 48 participants suffering from mild or moderate Major Depressive Disorder (MDD) and Generalized Anxiety Disorders (GAD) symptoms participated in the Feel Program and were assessed across three key metrics: feasibility of the program, participant engagement, and symptom improvement. The results demonstrated a high average precision level (87%) in identifying emotional events passively through the wearable device. Furthermore, the study showed high engagement rates of >60 minutes per week of app usage, and 4 out of 5 participants were very likely to recommend the program.

CLINICAL STUDY

#coaching

#rpm

#connected device

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Jun 06,2022

Feel Therapeutics Receives Funding from SeedtoB Capital

Feel Therapeutics, a San Francisco, CA-based developer of digital biomarkers and therapeutics, raised an undisclosed amount in funding from SeedtoB Capital. The company intends to use the funds to accelerate their progress on the path to making data-driven mental health interventions accessible to those who need them.

FUNDING FUNDING ROUND
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