Limbix Health, Inc

Limbix is developing a pipeline of prescription digital therapeutics (PDTs) for adolescent mental health disorders. We are passionate about creating evidence-based digital programs to increase young people’s access to clinically effective mental health treatment. Our first product, SparkRx, is a CBT-based digital therapeutic to treat symptoms of depression in teens and young adults.

Mission/Vision

To give all young people access to affordable, effective mental health care by giving providers immediate, safe, and evidenced based treatment options they can prescribe to their patients

Type of Organization

Startup - Newly established businesses, investable

Size of Organization

10-50

Organization Mailing Address

548 Market St
PMB 91609
San Francisco, CA 94104
United States

http://limbix.com

SparkRx

http://SparkRx.com

SparkRx is a digital therapeutic that provides evidence-based digital intervention for adolescents aged 13-22 with symptoms of depression. It provides clinicians with an immediate, safe and discreet adjunct treatment option they can offer their patients, overcoming common barriers to accessing mental health care.

SparkRx is self-guided over 5-weeks and is designed to provide the core components of face-to-face behavioral activation therapy. The program is delivered via a smartphone app, and includes features such as psychoeducation, mood tracking, activity scheduling, problem solving and mindfulness.

SparkRx has been studied nationwide in randomized controlled trials. Limbix continues to build the clinical evidence base for SparkRx ahead of applying for FDA clearance via the 510(k) pathway.

SparkRx is available prior to clearance in October 2021 under the FDA’s Enforcement Policy for Digital Health Devices During the COVID-19 Public Health Emergency. It is available for a limited time at no costs to patients. SparkRx must be recommended by a healthcare provider.

Category of Innovation

Digital Health - A digital health solution is a technology-based solution whose user is caring for or providing care for themselves (think of a personal app) or another individual (such as a doctor using a tool to help their patient)

Intended End User

Patient - Individuals who receive health care

Provider - Individuals or organizations responsible for providing care to patients (e.g. doctors, nurses, hospital/clinic administrators, etc.)

Impactful Innovation Stage (Click Here for Details)

Adoption

Problem (i.e. barrier, issue, complication, etc.) being solved for the end user

Adolescent depression has increased 50% since COVID and suicide is the #2 cause of death in teens, yet effective care is limited by long waitlists and large out-of-pocket costs for therapy, limited pharmacological options, and stigma surrounding mental health.

Idea/solution to the problem, if applicable

SparkRx was designed to address the barriers to accessing mental health treatment by offering a self-guided, immediate, and clinically validated adjunct treatment option. It can be used as a valuable resource for patients on increasingly long waitlists for therapy, or for those looking for an adjunct to antidepressants medications.

Level of adoption (i.e. list of customers/users, testimonials, etc.), if applicable

Limbix has partnered with a number of hospital systems including Boston Children’s via the Mass Challenge HealthTech Accelerator and Children’s Hospital Los Angeles via the KidsX Accelerator to further validate our product. We are in the process of working with a top 5 national health plan and an integrated health system to get SparkRx in the hands of hundreds of patients with symptoms of depression.Our team was also awarded a Small Business Innovation (SBIR) grant from the National Institutes of Health to evaluate the feasibility, safety, and efficacy of SparkRx.

Impact (i.e. measurable outcomes), if applicable

In randomized controlled trials, participants who received SparkRx showed a clinically meaningful reduction in depression symptoms (>5 reduction PHQ-8). Participants that consistently engaged with treatment saw a statistically significant reduction in depression symptoms compared to control.

Funding Stage

Series A

List of Funding Sources (if applicable)

Sequoia Capital, GSR Ventures, Storm Ventures, Bixink, JAZZ Venture Partners, Maverick Capital, Digital Garage and Innovation Global

Certifications?

Yes

HIPAA-compliant

Has your company attested to any codes of conduct?

Yes