Wednesday, December 16 – Arlington, VAPatients, caregivers, and clinicians have faced unprecedented challenges in 2020. Given the global need to address growing mental health concerns, provide remote care for patients with chronic conditions, and enhance healthcare delivery processes, it is crucial to address increasing gaps in care by providing patients with access to appropriate evidence-based digital therapies in their home environments.

Digital therapeutics (DTx) can easily reach high-risk, rural, and underserved populations who often lack access to healthcare services even during the best of times. In order to encourage the integration of these technologies into current healthcare models, the Digital Therapeutics Alliance (DTA) undertook the following initiatives in 2020:

  • Published the paper, Digital Therapeutics: Reducing Rural Health Inequalities, to demonstrate how DTA member company products are able to meet patient and clinician needs in underserved communities.
  • Undertook a Covid-related international campaign in six languages requesting that global policymakers provide their citizens with access to DTx products during and after the pandemic.
  • Developed legislative specifications for the formal recognition of DTx products under U.S. Medicare and Medicaid.
  • Launched an ‘Urgent Access’ campaign to provide healthcare decision makers with clarity on how to identify, assess, and utilize DTx products across their patient populations.

Central to these industry efforts are companies dedicated to providing high-quality care to patients and their caregivers. DTA is therefore incredibly proud to highlight the many ways that DTA members have worked tirelessly in 2020 to serve the needs of patients, caregivers, and clinicians globally.    

DTA Member Highlights, 2020:

The Association of Diabetes Care & Education Specialists (ADCES) won the 2020 ClearMark Award for best brochure in partnership with Lilly Diabetes. This award recognizes their patient first approach to communicating complex diabetes information with individuals and their families. Link

Akili Interactive‘s EndeavorRx became the first prescription treatment delivered through a video game after obtaining U.S. FDA clearance in June. EndeavorRx improves attention function in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Link

Astellas advanced activities under collaboration with Welldoc and continued evaluation of further collaborative efforts to provide patients with access to digital therapeutics in multiple markets.

Bayer organized its first “Virtual Digital Health Forum: Agents of Change” to discuss the three pillars of how we change the experience of healthcare: Equity, Access and Sustainability. Link

BehaVR partnered with Sumitomo Dainippon Pharma to expand on virtual reality’s capability to personalize the patient experience and address critical unmet needs in social anxiety disorder (SAD) using real-time biometrics and machine learning. Link

Better Therapeutics announced key findings from their clinical trial demonstrating that a software-only product configuration delivering behavioral therapy can produce meaningful outcomes in patients with type 2 diabetes. Link

Big Health demonstrated that patients who use Sleepio for sleep improvement yielded 28% lower healthcare costs than those who did not during an 18-month health economic evaluation. Link

Boehringer Ingelheim entered into a collaboration with Click Therapeutics to develop and commercialize a prescription-based digital therapeutic with the goal of helping schizophrenia patients achieve certain positive clinical outcomes. Link

Cognoa was named to the 2020 Global Digital Health 100 list by The Journal of mHealth recognizing their innovative work in autism spectrum disorder diagnosis and treatment. Link

Curelator prepared a submission for FDA clearance of N1-Headache, enabling them to shift from clinical research platform to a more interventional, commercial version of N1-Headache which will be launched early in 2021. Link

DarioHealth released key findings in two studies showing that the use of Dario’s platform promotes behavioral modification, enhanced individual engagement, and improved clinical outcomes for patients with diabetes and hypertension. Link

Dreem published a study on the Dreem headband’s clinical validation against polysomnography, published in SLEEP, and new findings showing that their multimodal sleep improvement solution demonstrates significant efficacy and engagement in a real world study. Link

Duke DCRI published a groundbreaking study in The Lancet: Digital Health proving the efficacy of a video game by Akili Interactive Labs to treat inattention associated with ADHD. DCRI team has also continued to work with a number of DTA member companies to design and execute their clinical evidence strategies. Link

Freespira, Inc (formerly Palo Alto Health Sciences) raised $10 million to continue commercialization of the Freespira digital therapeutic for treating Panic Disorder, panic attacks, and PTSD with health plans, employers, and the VA. Link

Global Kinetics developed an enhanced care model that combines the Parkinson’s KinetiGraph system (PKG) with Remote Physiologic Monitoring (RPM) reimbursement codes in the U.S., leading to greater opportunity for clinician adoption.

Happify Health launched Kopa to support people with chronic conditions by driving engagement with tools and support to navigate the clinical, social, psychological, and physical challenges of their condition. Link

Headspace expanded access to its mindfulness content to help people manage anxious thought, build mental resilience, and navigate through the uncertainty faced during the Covid-19 pandemic. Link

Health Catalyst was able to expand and meet the urgent needs of health care systems and technology platforms across the U.S. in direct response to the Covid-19 pandemic.

Hello Sunday Morning demonstrated the effectiveness of Daybreak to drive alcohol behaviour change following a study that showed large reductions in alcohol consumption and psychological distress among Australians who downloaded the product in Spring 2020. Link

HERINGS collaborated with Korea’s National Evidence-based Healthcare Collaborating Agency (NECA) on HDT-204, a product with a focus on early detection of recurrence of lung cancer.

JOGO Health partnered with Harvard Medical School to study the efficacy of their digital therapeutic product for chronic lower back pain.

Kaia Health closed a $26 million series B financing round allowing them to launch more therapies and double down on their rigorous clinical approach. Link

Kaiku Health was acquired by Elekta, furthering the development of personalized digital interventions in order to help improve the lives of cancer patients globally. Link

Lucine closed a €5.5 million seed funding round to develop a digital therapeutic to relieve and treat patients with chronic pain. Link

Mahana Therapeutics obtained U.S. FDA de Novo authorization for Parallel, the first DTx to receive this authorization in the gastrointestinal space. Link

MedRhythms received U.S. FDA Breakthrough Device designation for its product to treat chronic stroke walking deficits. Link

Novartis acquired DTx company Amblyotech, expanding their refractive disorder pipeline in ophthalmology. Link

Orexo accelerated the launch of Deprexis and Vorvida in the U.S. market to meet the patient need for access to low-risk clinically-validated digital health devices during the ongoing Covid-19 pandemic and employ the recent U.S. FDA “Enforcement Policy” providing an accelerated pathway to market for digital therapies focused on psychiatric conditions. Link

Pear Therapeutics launched via an end-to-end virtual care experience their product Somryst™, the only FDA-authorized prescription digital therapeutic for patients with chronic insomnia. Link  Somryst was awarded Best Digital Health Product by the Prix Galien USA. Link

Propeller Health launched the first co-packaged asthma medication and digital health solution in collaboration with Novartis in the EU. Link 

Roche successfully communicated with the U.S. FDA on a development program for a digital therapeutic product for people with autism spectrum disorder.

S3 Connected Health created and rolled out Enodatis, a clinical support tool for respiratory care of Covid-19 patients, in a record ten-days across Ireland and the UK to support clinicians with triage, monitoring, and treatment of patients in-hospital. Link

S-Alpha Therapeutics closed a $2.7M seed funding round to develop a digital therapeutic in the area of ophthalmology. Link

Sanofi partnered with Health2Sync to improve diabetes care and management in Taiwan, as well as to accelerate digital adoption and transformation for clinics and hospitals. Link

SilverCloud Health developed “Challenging Times,” a Covid-19 specific program to support mental health and increased access to its mental health services for frontline workers and their families in response to the pandemic.  Link 

Sumitomo Dainippon Pharma collaborated with BehaVR in the U.S. aimed at leveraging virtual reality experiences to address social anxiety; and with Save Medical Corporation in Japan, to co-develop a product for patients with diabetes. Link

Voluntis partnered with Bristol-Myers Squibb to co-develop a product to support cancer patients by providing real-time recommendations for self-management of symptoms related to their therapy. Link

Welldoc received FDA clearance for an additional feature on their product BlueStar, allowing real-time adjustments to insulin. Link

Welt established DTx guidelines with the South Korean Ministry of Food and Drug Safety (MFDS), translated it into English for DTA members, and signed an MOU with the National Center for Mental Health (NCMH) to define DTx for the Korean government.

As we collectively look ahead to 2021, this community of companies will be instrumental in offering tremendous relief to patients and caregivers, using technology to strengthen patient-clinician relationships and provide actionable insights to healthcare decision makers. Together, our goal is to transform global healthcare by building a stronger system that is designed around patient needs and improves outcomes through the delivery of evidence-based therapies.

 

About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding and adoption of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more please visit: www.dtxalliance.org.