NEWS: Curebase closes $40M Series B with strategic investment by Gilead. Read about it in TechCrunch, Fierce Biotech, andEndpoints News.

Press release

Curebase, Flow Neuroscience Announce Joint Clinical Trial  for the use of an at-home tDCS device for treating depression

SAN FRANCISCO and MALMO, Sweden, May 17, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and Flow Neuroscience, creator of Europe's only medically approved transcranial direct current stimulation (tDCS) device and behavioral therapy app for depression, are launching a clinical trial in which participants will test the effectiveness of Flow's at-home headset in reducing depressive symptoms.

The Flow headset is the first portable tDCS device to be medically approved for home use in the U.K. and European Union. The brain stimulation technique used in the Flow headset, typically delivered only in-clinic, has been validated in longitudinal clinical trials, using double-blinded RCT studies, as an effective and safe treatment for depression. Providing a non-pharmaceutical alternative, the Flow headset works by delivering gentle electrical currents to an area called the dorsolateral prefrontal cortex to restore activity usually lowered in those with depression. The self-managed treatment's unique safety system and design allows for a remote solution that is immediately accessible to support patients in reducing their depression at home. Similarly, the remote capability of the Flow device enables reach, supporting decentralized clinical trials and further depression research at scale.  

The trial will include 270 participants in London and Houston across two research centres, UTHealth and UEL. The University of Texas led by Dr. Sudhakar Selvaraj with co-researcher Professor Jair Soares and the University of East London led by Professor Cynthia Fu with co-researcher Professor Allan Young, King's College London. Testing the efficacy of using tDCS to treat depression through a portable device, the trial will see participants follow a treatment plan of ten weeks where they will have five stimulation sessions per week in the first three weeks and two stimulation sessions per week in the next seven weeks.

Powered by Curebase's decentralized clinical trial platform, initial data will be collected from participants at home securely as researchers can schedule virtual interviews as well as gather all electronic clinical outcome assessment (eCOA) data to select eligible participants. In addition, the company's patient management system will amplify efficiency as both researchers and participants can work effectively in the decentralized trial setup with scheduled virtual check-ins, collecting patient reported outcomes (ePROs) and sending reminders.

"Flow's brain stimulation treatment has been shown in Europe to be an effective and safe alternative to medication for people battling depression," said Tom Lemberg, founder and CEO of Curebase. "We are excited to be partnering with Flow Neuroscience on this important clinical trial."

Major depressive disorders (MDD) affect 17.5 million adults in the U.S. and costs the economy $326 billion in 2018, up 38% from 2010, according to the latest research from Analysis Group. MDD can have a devastating impact on individuals, families and communities. Similarly, in the U.K. one in five adults reported having depressive symptoms in 2021. This is more than double from previous years, with younger populations and women amongst some of the most affected and mental health services are now reported to be at breaking point.

As this unmet need grows, so does the demand need for more treatment options. Decentralization allows for more large-scale trials to be executed faster so that researchers and companies can bring alternatives at a higher rate than ever before. Both the remote Flow technology and the Curebase platform in this trial have the unique capabilities to bring renewed hope to finding alternatives to treat depression.

The trial began in Mayis slated to begin in February, with data results expected in the fall. Flow is applying to the U.S. Food and Drug Administration (FDA) for approval of its at-home device and app as a treatment for depression.

"This is a pinnacle moment as we embark on collecting large-scale data for the use of brain stimulation delivered via a portable device to treat depression." Flow co-founder and CTO, Erik Rehn comments. "As we have the ability to carry out this clinical trial remotely, powered by Curebase's platform and the Flow device, we will be able to reach more participants efficiently and bring results for new treatment options faster than would be possible with in-clinic trials using in-clinic devices. These results will pave the way for FDA approval of the Flow at-home brain stimulation treatment for major depressive disorder, enabling access to a non-pharmaceutical option for this debilitating condition."

Curebase's decentralized clinical trial model ensures more diverse studies through the inclusion of underrepresented populations. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.

About Flow Neuroscience

Flow Neuroscience is the creator of Flow, a physical and behavioural at-home treatment for depression that comprises a brain stimulation headset and therapy app. It is the first and only medically approved treatment for depression of its kind in Europe. Classified as a Class IIa medical device, Flow was developed from the fields of clinical psychology, neuroscience and innovative technology. Flow empowers and motivates individuals to take control and self-manage their depression with effective, non-pharmacological, digital alternatives. Based in Malmö, Sweden, Flow was founded in 2016 by clinical psychologist Daniel Mansson and neuroscientist Erik Rehn. Their team consists of prominent researchers in the field of psychiatry and brain stimulation.

About Curebase

At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.

Media Contact:

Shawn Malloy

media@curebase.com

315-882-5310

Curebase, Flow Neuroscience Announce Joint Clinical Trial  for the use of an at-home tDCS device for treating depression

SAN FRANCISCO and MALMO, Sweden, May 17, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and Flow Neuroscience, creator of Europe's only medically approved transcranial direct current stimulation (tDCS) device and behavioral therapy app for depression, are launching a clinical trial in which participants will test the effectiveness of Flow's at-home headset in reducing depressive symptoms.

The Flow headset is the first portable tDCS device to be medically approved for home use in the U.K. and European Union. The brain stimulation technique used in the Flow headset, typically delivered only in-clinic, has been validated in longitudinal clinical trials, using double-blinded RCT studies, as an effective and safe treatment for depression. Providing a non-pharmaceutical alternative, the Flow headset works by delivering gentle electrical currents to an area called the dorsolateral prefrontal cortex to restore activity usually lowered in those with depression. The self-managed treatment's unique safety system and design allows for a remote solution that is immediately accessible to support patients in reducing their depression at home. Similarly, the remote capability of the Flow device enables reach, supporting decentralized clinical trials and further depression research at scale.  

The trial will include 270 participants in London and Houston across two research centres, UTHealth and UEL. The University of Texas led by Dr. Sudhakar Selvaraj with co-researcher Professor Jair Soares and the University of East London led by Professor Cynthia Fu with co-researcher Professor Allan Young, King's College London. Testing the efficacy of using tDCS to treat depression through a portable device, the trial will see participants follow a treatment plan of ten weeks where they will have five stimulation sessions per week in the first three weeks and two stimulation sessions per week in the next seven weeks.

Powered by Curebase's decentralized clinical trial platform, initial data will be collected from participants at home securely as researchers can schedule virtual interviews as well as gather all electronic clinical outcome assessment (eCOA) data to select eligible participants. In addition, the company's patient management system will amplify efficiency as both researchers and participants can work effectively in the decentralized trial setup with scheduled virtual check-ins, collecting patient reported outcomes (ePROs) and sending reminders.

"Flow's brain stimulation treatment has been shown in Europe to be an effective and safe alternative to medication for people battling depression," said Tom Lemberg, founder and CEO of Curebase. "We are excited to be partnering with Flow Neuroscience on this important clinical trial."

Major depressive disorders (MDD) affect 17.5 million adults in the U.S. and costs the economy $326 billion in 2018, up 38% from 2010, according to the latest research from Analysis Group. MDD can have a devastating impact on individuals, families and communities. Similarly, in the U.K. one in five adults reported having depressive symptoms in 2021. This is more than double from previous years, with younger populations and women amongst some of the most affected and mental health services are now reported to be at breaking point.

As this unmet need grows, so does the demand need for more treatment options. Decentralization allows for more large-scale trials to be executed faster so that researchers and companies can bring alternatives at a higher rate than ever before. Both the remote Flow technology and the Curebase platform in this trial have the unique capabilities to bring renewed hope to finding alternatives to treat depression.

The trial began in Mayis slated to begin in February, with data results expected in the fall. Flow is applying to the U.S. Food and Drug Administration (FDA) for approval of its at-home device and app as a treatment for depression.

"This is a pinnacle moment as we embark on collecting large-scale data for the use of brain stimulation delivered via a portable device to treat depression." Flow co-founder and CTO, Erik Rehn comments. "As we have the ability to carry out this clinical trial remotely, powered by Curebase's platform and the Flow device, we will be able to reach more participants efficiently and bring results for new treatment options faster than would be possible with in-clinic trials using in-clinic devices. These results will pave the way for FDA approval of the Flow at-home brain stimulation treatment for major depressive disorder, enabling access to a non-pharmaceutical option for this debilitating condition."

Curebase's decentralized clinical trial model ensures more diverse studies through the inclusion of underrepresented populations. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.

About Flow Neuroscience

Flow Neuroscience is the creator of Flow, a physical and behavioural at-home treatment for depression that comprises a brain stimulation headset and therapy app. It is the first and only medically approved treatment for depression of its kind in Europe. Classified as a Class IIa medical device, Flow was developed from the fields of clinical psychology, neuroscience and innovative technology. Flow empowers and motivates individuals to take control and self-manage their depression with effective, non-pharmacological, digital alternatives. Based in Malmö, Sweden, Flow was founded in 2016 by clinical psychologist Daniel Mansson and neuroscientist Erik Rehn. Their team consists of prominent researchers in the field of psychiatry and brain stimulation.

About Curebase

At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.

Media Contact:

Shawn Malloy

media@curebase.com

315-882-5310

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Curebase Technology Key to metaMe Health's FDA Clearance of Regulora

Curebase serves as technology and decentralized trial execution partner for MetaMe Health's digital therapeutic dtx

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Curebase Named to the 2021 CB Insights Digital Health 150 -- List of Most Innovative Digital Health Startups

Curebase recognized for achievements in Clinical Trials Tech

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Curebase CEO, Tom Lemberg, Featured in Drug Discovery and Development's "9 Predictions for Pharma in 2022"

Curebase CEO offers expert insight into the dawn of dynamic clinical trial designs

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Forbes 30 Under 30 Names Curebase CEO Tom Lemberg to it's 2022 List

Founder and CEO of Curebase receives Forbes 30 Under 30 prestigious honor for leading positive, global change in healthcare

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Curebase's Enhanced Telemedicine Feature Expands Patient Access to Edesa Biotech Derm Study

Edesa Biotech uses Curebase's eClinical platform for enhanced telemedicine that allows providers to view, measure, and record patient symptoms via the built-in application

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Curebase, LEVEL Announce Clinical Trial to Determine Whether Cannabinoids Can Help Veterans Sleep Better

Decentralized clinical trials leverages Curebase eclinical software platform, Veterans' advocacy groups

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Curebase, Checkable Medical Announce Joint Clinical Trial to Assess Effectiveness of At-home Strep Test Kit

Curebase and Checkable Medical launch first-ever at-home strep test decentralized clinical trial

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Curebase, Digital Therapeutics Alliance Announce Partnership to Accelerate Adoption of DTx Products

Curebase and DTA partner to develop a joint white paper to provide clinical trial regulatory guidance and best practices for DTx clinical evidence generation

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Curebase Solutions Supports Another InBios FDA Emergency Use Authorization for COVID-19 IgG Antibody Rapid Test

Curebase's decentralized clinical trial approach helps secure FDA Emergency Use Authorization for InBios' new COVID-19 IgG Antibody Rapid Test

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Curebase Hires Katri Langel as Senior Director of Program Development for Europe

Katri Langel, international IT and clinical research expert, joins Curebase as Senior Director of Program Development for Europe

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Curebase Hires Wayne Bowden as Vice President of Business Development

Curebase names clinical trials veteran, Wayne Bowden, as Vice President of Business Development to lead new growth and expansion efforts

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It's a virtual world: Curebase, AppliedVR team up on virtual reality-based, at-home clinical trials

AppliedVR will test its virtual-reality-based digital therapeutics dtx across five studies using the decentralized clinical trials software from Curebase

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Curebase Secures Jane Myles as Vice President of Clinical Trial Innovation

Curebase has named tenured clinical research expert Jane Myles as vice president of clinical trial innovation

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Curebase, Adaptive Biotechnologies Announce Collaboration to Expand Clinical Study Access

Curebase decentralized clinical trial model will be used to study effectiveness in infections disease study

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Introducing ‘BYOP’ Clinical Trials

Curebase is promoting the concept of 'bring-your-own-physician' clinical trials.

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Curebase Names Paul Donnelly as Senior Vice President of Enterprise Strategy

Industry veteran, Paul Donnelly, brings more than two decades of success building healthcare companies to Curebase

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Startups Cash In as Venture Funding for Digital Health Rises

Curebase featured in Wall Street Journal among startups realizing venture capital boom in digital health

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Curebase, InBios Announce Results of Virtual Clinical Trial of InBios COVID-19 Rapid Detection Test Using Curebase Platform

Curebase decentralized trials platform used to study efficacy of diagnostic test

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Curebase Nabs $15M for Siteless Trials that Revolve 'Around the Patient's Lifestyle'

Curebase has raised a $15 million series A for a new approach to decentralized trials that goes beyond the current drop of virtual trial platforms.

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Cofactor Genomics Begins Multi-Site Clinical Trial for Immunotherapy Prediction Assay

Curebase is participating as a CRO partner with Cofactor Genomics in first multicenter clinical trial of its OncoPrism immunotherapy response prediction assay

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Non-Traditional Clinical Trial Sites Powered by the Curebase System Support Emergency Use Authorization of New Rapid COVID-19 Test

Operationalizing drive-through COVID testing locations as clinical research sites provided a safe and convenient way to enroll and consent potential participants in key diagnostic validation study

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CLM Tests Drug Plus Digital Combo for High Blood Pressure

CLM drug and DTx digital therapeutics study with Curebase

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Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.

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Remote Care Powered CURE-19 Platform Enables At Home COVID-19 Clinical Trials

Curebase launches the CURE-19 Platform to provide a resource for researchers seeking to better understand COVID-19 as the pandemic begins

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