Source – Big Health
In a move to further consolidate its position in the digital therapeutics (DTx) sector, Big Health has made an agreement to acquire Limbix, a company offering an app designed for adolescents and young adults showing signs of depression. By adding Limbix to its portfolio, Big Health expands its range of mental health products, which already includes two other DTx apps: Sleepio for insomnia and Daylight for anxiety. Limbix’s app for teen depression, called SparkRx, will now join Big Health’s offerings in the US market since its launch in October 2021. The terms of the acquisition have not been disclosed.
SparkRx functions as a digital cognitive behavioral therapy (CBT) program, accessible via smartphones. According to Big Health, the app’s effectiveness is backed by a clinical trial published in the Frontiers In Digital Health journal, demonstrating a “clinically meaningful” reduction in depression symptoms. The app employs standard CBT techniques such as mood tracking, behavioral activation, problem-solving, and mindfulness.
As of now, neither SparkRx nor Sleepio and Daylight have formal FDA approval under the software-as-a-medical device (SaaMD) pathway. However, they have been made available under the FDA’s enforcement discretion policy for mental health DTx during the COVID-19 pandemic.
“Limbix and Big Health share significant alignment in our cultures and in our focus on delivering first-line digital therapeutics for a range of mental health conditions. As the industry leader, Big Health is a natural home for SparkRx, our upcoming product pipeline and our team to accelerate giving young people tools they can use themselves to meaningfully benefit from clinically-proven digital depression treatments.”
– Ben Lewis, co-founder and CEO of Limbix
Big Health’s CEO, Arun Gupta, emphasized that FDA approval does not guarantee commercial success in the current DTx landscape. Instead, he advocates a broader approach to market access, focusing on direct patient access and clinician referrals based on solid clinical and health economic evidence to demonstrate their value.
Gupta revealed that this approach has already yielded positive outcomes, with increased coverage and reimbursement of products like Sleepio, which is now recommended by the NHS in Scotland for first-line care of individuals with insomnia.
With the acquisition of Limbix, Big Health plans to market SparkRx to its employer, public sector, health systems, and health plan clients, as well as through distribution agreements with pharmacy benefit managers (PBMs).
“We must continue to rise to the challenge of the mental health crisis – our acquisition of Limbix is a strategic milestone in advancing our mission to help millions back to good mental health. Our portfolio of evidence-based, clinically validated digital treatments will enable a record number of adult and adolescent patients to get immediate access to safe and effective non-drug options.”
– Arun Gupta, CEO and Executive Chairman of Big Health
Founded in 2016, Limbix has raised $30 million through a Series A funding round and is actively building a pipeline of products targeting adolescents, as stated by Big Health.
