metaMe Health

What metaMe Health does

metaMe Health is a Chicago-based, privately held prescription digital therapeutics (PDT) company developing FDA-cleared software applications for gastrointestinal conditions. Its flagship product, Regulora, received FDA authorization in 2021 as the first prescription digital therapeutic specifically indicated for abdominal pain associated with irritable bowel syndrome (IBS) in adults. The product delivers self-administered gut-directed hypnotherapy (GDH) through iOS and Android mobile applications, replacing traditional in-person hypnotherapy sessions with at-home smartphone-based treatment. The company is led by CEO Tim Rudolphi, an ex-Takeda executive, with Chief Product Officer and founder Danny Bernstein, and operates with 11-50 employees from its headquarters at 222 Merchandise Mart Plaza, Suite 1230, Chicago.

The company's technology platform centers on the standardized delivery of clinically validated GDH protocols through HIPAA-compliant mobile applications, with SOC 2-aligned controls and encrypted PHI handling. metaMe has expanded its pipeline beyond IBS by licensing exclusive worldwide rights to a functional dyspepsia GDH protocol developed by Drs. Sarah Kinsinger (Loyola Medicine) and Olafur Palsson (UNC-Chapel Hill, originator of the gold-standard North Carolina GDH protocol). Additional pipeline indications include heartburn and ulcerative colitis, all leveraging the same hypnotherapy delivery architecture. The company holds the registered Regulora trademark and was named to the CB Insights Digital Health 150 list in 2022.

Commercially, metaMe operates a prescription-only model in which physicians prescribe Regulora and patients access the treatment via mobile apps, generating revenue through PDT sales and potential future licensing royalties. Pricing is not publicly disclosed, though the company has signaled openness to outcomes-based pricing models through its 2024 Indegene partnership. International expansion is executed via channel partners, with Launchit Ventures licensed for Canadian commercialization. metaMe has raised approximately $6.4 million across five funding rounds from 2019-2024, including a $3.8 million round led by LionBird (2019) and a $2.2 million round led by HPA / Hyde Park Angels (2022), with later smaller exempt offerings in 2023 and 2024.

Name

metaMe Health

Legal name

metaMe Health, Inc.

Website

https://metamehealth.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

metaMe Health is a Chicago-based prescription digital therapeutics company whose FDA-authorized product Regulora delivers self-administered gut-directed hypnotherapy via iOS and Android apps for adults with IBS-related abdominal pain. The pipeline extends the same platform to functional dyspepsia, heartburn, and ulcerative colitis.

Ownership category

akta.pro rank

Product category

Prescription Digital Therapeutics

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Non-prescription / OTC Digital Therapeutics (HLACANAC)

akta.pro secondary industry

General Gastroenterology (HLAKAEAA)

Keywords

• Prescription digital therapeutics
• Gut-directed hypnotherapy
• Irritable bowel syndrome treatment
• Digestive health software
• FDA-cleared mobile therapy

Headquarters

HQ city

Chicago

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2C

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Prescription Digital Therapeutics: Revenue generated from FDA-authorized prescription digital therapeutic products, primarily Regulora for IBS treatment. Products are prescribed by physicians and delivered via mobile applications.
2. Licensing Royalties: Potential licensing revenue from worldwide licensing rights to GDH protocols for functional dyspepsia and other conditions being developed.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

metaMe Health develops and sells prescription digital therapeutics—software applications that deliver evidence-based therapeutic interventions for chronic gastrointestinal conditions. Its flagship and currently commercialized product, Regulora, is the first FDA-authorized PDT for abdominal pain associated with irritable bowel syndrome (IBS) in adults, providing self-administered gut-directed hypnotherapy via iOS and Android mobile apps under physician prescription. A pipeline of similar PDTs for functional dyspepsia, heartburn, and ulcerative colitis is in development.

Product overview

metaMe Health is a prescription digital therapeutics (PDT) company developing software-based treatments that deliver evidence-based therapeutic interventions through high-quality applications. The company's core product is Regulora, the first FDA-authorized PDT specifically for abdominal pain associated with IBS in adults, which provides self-administered gut-directed hypnotherapy via iOS and Android apps. The pipeline includes PDTs for heartburn and ulcerative colitis, plus a functional dyspepsia treatment licensed from Loyola Medicine and UNC researchers. All products operate on a single platform architecture delivering hypnotherapy sessions through smartphone/tablet applications.

Differentiator

Problem solved

Functional benefit

Brands

• Regulora: FDA-authorized Prescription Digital Therapeutic for abdominal pain associated with irritable bowel syndrome (IBS) in adults, delivering gut-directed hypnotherapy through a mobile app.

Products and services

• Regulora FDA-authorized prescription digital therapeutic providing self-administered gut-directed hypnotherapy through an iOS and Android mobile application for the treatment of abdominal pain associated with irritable bowel syndrome (IBS) in adults; physician-prescription required.

Quantifiable outcome

• 96% treatment completion rate in functional dyspepsia pilot trial
• +2 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered minor and core.

• IndegeneminorStrategic or Co-development Partner · 14 March 2024Partner firm for go-to-market strategy for Regulora. Senior Vice President Marut Setia discussed plans for FDA-authorized digital therapeutic including openness to outcomes-based pricing and wider commercialization strategy.
• Dr. Sarah KinsingercoreTechnology or Integration · 4 January 2023Licensed exclusive worldwide rights to use and distribute newly developed gut-directed hypnotherapy protocol for functional dyspepsia treatment. Dr. Kinsinger, associate professor and director of behavioral medicine for digestive health at Loyola Medicine in Chicago, developed the protocol with Dr. Palsson and will work with metaMe Health to conduct pivotal trials.
• Dr. Olafur PalssoncoreTechnology or Integration · 4 January 2023Licensed exclusive worldwide rights to standardized GDH protocol for functional dyspepsia. Dr. Palsson, professor of medicine at University of North Carolina at Chapel Hill and originator of gold-standard North Carolina treatment protocol, partnered with metaMe Health to develop FDA submission for the first fully automated hypnosis treatment for functional dyspepsia.
• Launchit VenturescoreChannel Partner/ Reseller/ Distributor · 29 September 2022Global partnership to bring Regulora to the Canadian market. Launchit Ventures licensed commercialization rights and will work to obtain regulatory authorization in Canada and develop commercialization strategy. Tim Rudolphi, CEO at metaMe Health, stated confidence in Launchit Ventures to manage Canadian regulatory and commercialization processes.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Click Therapeutics: Click Therapeutics develops prescription digital therapeutics across multiple indications and has pursued FDA clearance pathways analogous to metaMe's, representing a broader PDT platform competitor.
• Akili Interactive: Akili Interactive commercializes FDA-authorized prescription digital therapeutics and shares metaMe's prescription PDT business model, regulatory pathway, and commercialization challenges across different therapeutic areas.
• Pear Therapeutics: Pear Therapeutics was the pioneer commercial-stage prescription digital therapeutics company with FDA-authorized PDTs, and while now restructuring, set the regulatory and commercial precedent that metaMe's Regulora model follows.

Emerging players

• Oshi Health: Oshi Health delivers virtual-first gastroenterology care including dietary and behavioral interventions for IBS, serving the same patient demographic as metaMe through telehealth rather than a standalone PDT.
• Salvo Health: Salvo Health launched a remote patient monitoring program for GI conditions including IBS, GERD, and celiac disease in 2024, offering an adjacent digital-first GI care model that competes for the same gastroenterology prescribing audience as metaMe.
• Vivante Health: Vivante Health provides digital GI care programs combining nutrition, microbiome testing, and personalized coaching, addressing the same IBS patient population as metaMe via a different delivery modality.
• Big Health: Big Health provides digital therapeutic solutions for mental health and insomnia that share metaMe's evidence-based, prescription or payor-reimbursed digital therapeutic distribution model.

Direct peers

• Better Therapeutics: Better Therapeutics developed prescription digital therapeutics for cardiometabolic conditions using behavioral therapy, sharing metaMe's PDT regulatory and commercial model with analogous pipeline and FDA-authorization risks.
• Mahana Therapeutics: Mahana Therapeutics develops prescription digital therapeutics for gastrointestinal conditions, including IBS, making it a direct competitor to metaMe's Regulora in the gut-directed hypnotherapy/DTx category.
• Bold Health: Bold Health offers digital therapeutics for IBS and other GI conditions using cognitive behavioral therapy and gut-directed hypnotherapy, directly competing with metaMe in the digital GI therapeutics category.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/metame-health
• Xx.com/metamehealth

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds5 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about metaMe Health