Non-invasive neuromodulation · designed for the EU MDR Class IIa pathway

A breakthrough wearable
for depression & anxiety.

BioVie Beam delivers clinically studied transcranial direct current stimulation (tDCS) in a lightweight, app-free headband — built for health systems to scale, not the shelf.

Discover the device Talk to the team
9,000+peer-reviewed studies
FDA-validatedat-home tDCS category (2025)
B2B-onlyclinician-led care
581M

people worldwide live with depression or anxiety — treatable conditions where access and capacity, not the science, are the binding constraints.

$1T lost to productivity each year
12B working days lost annually
4× return per $1 invested in scaling care

The problem

Depression and anxiety are outpacing the systems meant to treat them.

Hundreds of millions of people are affected, with major knock-on effects on health systems and economies. Demand keeps rising — but access and clinician capacity are the binding constraints.

280M

People living with depression worldwide (2019).

301M

People living with anxiety disorders worldwide (2019).

$1T

Estimated annual global productivity loss from depression & anxiety.

12B

Working days lost to depression & anxiety every year.

The device

Meet BioVie Beam.

A next-generation wearable that treats depression and anxiety with transcranial direct current stimulation — a gentle, non-invasive current to the brain regions that regulate mood, delivered through providers and engineered for public-health deployment.

  • Clinically aligned — designed for the EU MDR Class IIa pathway and NHS reimbursement
  • Headband fit, app-free operation; suitable across tech-ability levels
  • Provider-first: B2B only, with optional clinician connectivity for oversight
  • Cost-effective & reusable — one device supports multiple episodes
See the evidence

How it works

Home-based care that fits real-world pathways.

Clear protocols, delivered via providers — not direct-to-consumer.

  1. 01

    Prescribe & onboard

    Patients receive the device through a provider pathway — for example NHS Talking Therapies or primary care.

  2. 02

    Guided sessions

    Short sessions at home with a simple interface and optional clinician connectivity for monitoring.

  3. 03

    Measure outcomes

    Standard scales and real-world evidence support reimbursement, safety and continuous iteration.

Why Beam

Built for outcomes, access, and the bottom line.

Clinically aligned

Designed for the EU MDR Class IIa pathway and NHS reimbursement requirements.

Simple patient experience

Headband fit and app-free operation — suitable for patients across every level of tech ability.

Provider-first model

B2B only (no direct-to-consumer), with optional clinician connectivity for oversight.

Cost-effective & reusable

A single device supports multiple episodes and reduces per-patient delivery cost.

Payer-grade evidence

Built to generate the outcomes and health-economic data that reimbursement requires.

4× return

For every $1 invested in scaling evidence-based treatment for depression & anxiety.

The evidence

Not a gadget. A clinically-backed therapy.

9,000+

peer-reviewed publications on tDCS

FDA 2025

first at-home tDCS device approved — category validation

Class IIa

EU MDR pathway the device is designed for

$11.7bn

neurostimulation devices market by 2032

The difference

Where other tDCS devices stalled, Beam was built to scale.

Strong evidence has never been the problem. Reaching health systems has. Beam is engineered around reimbursement and clinical integration from day one.

Consumer tDCS devices

  • Sold direct-to-consumer, bypassing medical oversight
  • Low clinical confidence, no reimbursement route
  • No structured protocols or remote monitoring
  • Poorly suited to psychiatry or primary care

BioVie Beam

  • B2B-only — delivered through health providers
  • Reimbursement-ready clinical & health-economic evidence
  • Optional clinician connectivity & remote monitoring
  • Designed for EU MDR Class IIa and NHS pathways

Go-to-market

From an NHS wedge to EU and US scale.

Win a high-need public-health wedge — UK Talking Therapies — then scale into EU payers and beyond, with a single payer and clear pathways providing strong reference value.

🇺🇸

United States

FDA's Dec 2025 approval of the first at-home tDCS device de-risks the category. ~21M US adults have a major depressive episode each year.

🇩🇪

Germany

Europe's most advanced market for prescribable digital therapies through the DiGA pathway.

🇫🇷

France

Expanded funding for psychological and telemedicine services suits non-drug, home-based care.

🇫🇮

Nordics

High digital-health adoption; Finland has already piloted tDCS in national health settings.

£72m

saved each year at 5% of IAPT referrals (~90,156 patients) — £801 per referral switched. Every +1% ≈ £14.4m.

Implementation

A regulatory-aligned route to market.

  1. 2024

    Foundation & feasibility

    BioVie Ltd formed. IP due diligence confirmed freedom to operate; KOL interviews shaped product design.

  2. 2025

    Prototype & regulatory engagement

    Specifications finalised and working prototype built. Early dialogue with NICE and the MHRA; CE-marking preparations begin.

  3. 2026

    Clinical validation & reimbursement

    Primary-care NHS study assessing outcomes, usability and cost-effectiveness — targeting reimbursement and Drug Tariff listing.

  4. 2027

    Commercial launch & scale

    Full UK launch via selected Integrated Care Systems, with expansion into Germany and FDA preparation for the US.

News

Latest from BioVie.

Product

BioVie launches a live NHS business-case tool for commissioners

Our new commissioner tool runs on live NHS Talking Therapies data — refreshed monthly from official statistics — and localises the BioVie Beam case to every Integrated Care Board in England: burden, eligible cohorts, adoption, outcomes, released capacity and net budget impact.

Explore the free live ICB map · Open the full tool (access password required — request access)

Intellectual property

BioVie files patent for the Beam neuromodulation device

BioVie has filed a patent in 2026 covering the BioVie Beam wearable and its approach to delivering transcranial direct current stimulation for depression and anxiety. The filing protects the core technology as the company moves through clinical validation and toward NHS reimbursement.

Team

Lois Willey joins as Project Implementation Manager

BioVie welcomes Lois Willey as a dedicated project manager to see the BioVie Beam programme through its regulatory processes — coordinating clinical validation, CE marking and NHS pathway requirements through to launch.

The team

Neuroscience, market access, and execution.

TG

Toby Gunner

Chief Executive Officer

Pharma launch and market-access strategist with a track record of global product positioning across top-tier pharmaceutical launches.

LinkedIn
SR

Sandra Rafferty

Chief Growth Officer

20 years across pharma, medtech and digital health, with CNS-focused commercial leadership — driving go-to-market strategy and payer engagement.

LinkedIn
JS

Jamie Sale

Non-Executive Director

Currently a senior leader in Europe for a global pharma company and a UK/EU market-access specialist in HTA and reimbursement strategy. Named in analyst top-5 launches of 2026.

LinkedIn
LW

Lois Willey

Project Implementation Manager

Dedicated project manager steering BioVie's regulatory processes — coordinating clinical validation, CE marking and NHS pathway requirements through to launch.

LinkedIn

Help bring Beam to the patients who need it most.

BioVie is engaging NHS stakeholders and partners across the EU and US, and is raising EIS / seed capital to complete development, clinical validation, and payer readiness.

Or email hello@biovie.co.uk