What Amber Therapeutics does

Amber Therapeutics is a UK-based, venture-backed medical device company founded in 2021 by Aidan Crawley, Tim Denison, Stefan De Wachter, and Charles Knowles to develop adaptive neuromodulation therapies for areas of unmet clinical need. The company's lead program, Amber-UI, is a fully implantable neurostimulation therapy that targets the pudendal nerve to treat women with mixed urinary incontinence (MUI) — a population of roughly 40 million symptomatic women in the US of whom only 16 million receive any therapy. Amber's core technology is the Picostim System running the DyNeuMo firmware platform, which combines integrated sensing with adaptive closed-loop stimulation in a single implantable pulse generator, originally developed for deep brain stimulation and acquired via the September 2023 Bioinduction transaction.

The Picostim DyNeuMo platform is positioned as the first singular therapy capable of addressing both urge and stress components of MUI in a single device, validated in the AURA-2 first-in-human study (13 women at University Hospital Antwerp) which met primary safety/feasibility endpoints and showed pilot efficacy and quality-of-life improvements. A US registration trial is planned for 2026 to support FDA approval, and Amber has extended its pipeline through ongoing studies (SPARKS, CADET, MINDS, EPIONE) and a December 2025 collaboration with MintNeuro on next-generation miniaturized semiconductor chips.

Amber is pre-revenue and pre-commercial; its go-to-market is built around clinical trials with academic medical centers and a planned enterprise field sales motion to urology/pelvic-health specialists and hospital systems once regulatory approval is obtained. Revenue mechanics, once commercial, will be hardware sales of the implantable Picostim device plus procedure-driven service revenue, with pricing not publicly disclosed and distribution expected through direct engagement with hospital procurement. The company has raised $100 million in Series A financing (June 2024, led by NEA) and is backed by F-Prime Capital, Lightstone Ventures, Intuitive Ventures, Oxford Science Enterprises, and 8VC.

Name

Amber Therapeutics

Legal name

Amber Therapeutics Ltd.

Website

https://amber-tx.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Amber Therapeutics is a UK medical device company developing Amber-UI, a fully implantable, closed-loop neuromodulation therapy that targets the pudendal nerve to treat women with mixed urinary incontinence, with a US registration trial planned for 2026.

Ownership category

akta.pro rank

Product category

Implantable Neuromodulation Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK)

Keywords

• Implantable neuromodulation devices
• Bioelectronic medical devices
• Urinary incontinence therapy
• Adaptive neurostimulation
• Pelvic floor neuromodulation

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Implantable Neuromodulation Devices: Amber Therapeutics generates revenue through the sale of its Picostim System and Amber-UI therapy devices - fully implantable neurostimulation devices for treating mixed urinary incontinence. The company also acquired Bioinduction Limited, consolidating itself as an integrated manufacturer and developer of neuromodulation devices.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Amber Therapeutics develops and manufactures fully implantable neuromodulation devices, primarily the Picostim System powered by its DyNeuMo firmware, to deliver adaptive pudendal nerve stimulation. Its lead therapy, Amber-UI, is the first single therapy designed to treat mixed urinary incontinence (both urge and stress incontinence) in women. The company is advancing the therapy through clinical trials (AURA-2) toward FDA approval, and serves as an integrated developer and manufacturer following its 2023 acquisition of Bioinduction Limited.

Product overview

Amber Therapeutics develops a unified product ecosystem centered on its Picostim System with DyNeuMo firmware platform, which serves as the foundation for its Amber-UI therapy. The Picostim is a fully implantable device that combines stimulation and sensing capabilities to deliver adaptive closed-loop neuromodulation for mixed urinary incontinence. The company also maintains the legacy Finetech-Brindley SARS System (no longer for new patients). The portfolio architecture consists of the Picostim hardware platform with integrated sensors, the DyNeuMo adaptive firmware enabling real-time therapy adjustment, and the Amber-UI therapy which represents the configured treatment for urinary incontinence.

Differentiator

Problem solved

Functional benefit

Brands

• Amber-UI: Adaptive neuromodulation therapy for treating women suffering with mixed urinary incontinence (both urge and stress incontinence), targeting the pudendal nerve with a fully implantable device.
• Picostim DyNeuMo
• AURA-2

Products and services

• Amber-UI Amber-UI is an adaptive neuromodulation therapy for treating women with mixed urinary incontinence (both urge and stress incontinence). It uses a fully implantable Picostim System that targets the pudendal nerve, combining stimulation and sensing of physiological responses through adaptive algorithms configurable to individual patient needs. It is intended for healthcare providers and urology/pelvic health specialists treating refractory patients.
• Picostim System Picostim is a fully implantable neurostimulation device with integrated sensors capable of both stimulating and sensing physiological responses. It is configured to deliver adaptive closed-loop neuromodulation targeting the pudendal nerve for the Amber-UI therapy and is sold to clinical and hospital customers.
• Finetech-Brindley SARS System The Finetech-Brindley SARS System is a legacy implantable bladder control system for patients with urinary incontinence. It is no longer available for new patients and is maintained only for servicing and repair of existing implants, serving healthcare providers with patients already implanted.

Quantifiable outcome

• Primary aim of demonstrating safety and feasibility of surgical procedure fulfilled in AURA-2 study
• +3 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature5 records

Partnerships

Three partnerships are on record, tiered major and core.

• MintNeuromajorTechnology or Integration · 24 December 2025Collaboration with MintNeuro (Imperial College London spinout) to develop next-generation version of the Picostim device using specialized semiconductor chips that could make devices up to 1,000 times smaller than current technologies.
• Bioinduction LimitedcoreStrategic or Co-development Partner · 5 September 2023Amber Therapeutics acquired Bioinduction Limited and its Picostim DyNeuMo neuromodulation platform in September 2023. The acquisition consolidated Amber as an integrated manufacturer and developer of neuromodulation devices and supports the advancement of its Amber-UI therapy through clinical trials and commercialisation.
• University of OxfordcoreStrategic or Co-development Partner · 29 November 2022Academic collaboration led by University of Oxford for the Picostim DyNeuMo research platform. Amber supplies devices for multiple first-in-human trials sponsored by academic collaborators. Co-founders Tim Denison (joint appointment in Engineering Science and Clinical Neurosciences) and company origins tie to Oxford.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Axonics: Axonics is a direct competitor with an FDA-approved rechargeable sacral neuromodulation system (r-SNM) for urge incontinence and overactive bladder. Most directly comparable commercial neuromodulation peer targeting the same urology call point and patient population.
• BlueWind Medical: BlueWind Medical develops the Revi miniature tibial neuromodulation system for urge incontinence — a direct emerging competitor pursuing a different implant site (tibial vs. pudendal) but addressing the same unmet need Amber targets.
• Valencia Technologies: Valencia Technologies developed the eCoin leadless, nickel-sized, battery-free tibial nerve stimulator for urge urinary incontinence — a minimally invasive direct competitor in the incontinence neuromodulation space.
• Laborie (Pelvalon / Cogentix): Laborie acquired Pelvalon (Eclipse vaginal insert for fecal incontinence) and Cogentix (Urgent PC percutaneous tibial neuromodulation) — directly competing in the pelvic floor and incontinence neuromodulation/treatment space.

Broad incumbents

• Medtronic: Medtronic's InterStim sacral neuromodulation system is the established market leader in implantable neuromodulation for urinary incontinence. Co-founder Tim Denison's prior technical leadership at Medtronic makes it a closely watched incumbent competitor and benchmark.
• Boston Scientific: Boston Scientific operates a broad neuromodulation portfolio (Vercise DBS, Spectra WaveWriter SCS, Vertiflex) and is a potential strategic acquirer or competitor as Amber expands beyond UI into adjacent indications.
• Abbott: Abbott's neuromodulation franchise (Proclaim DRG, Infinity DBS, Eterna SCS) makes it a relevant broad incumbent and potential strategic acquirer as Amber commercializes its closed-loop platform.

Emerging players

• Saluda Medical: Saluda Medical commercializes the Evoke closed-loop spinal cord stimulation system, making it the closest technological analogue to Amber's closed-loop DyNeuMo platform — relevant for IP/competitive positioning and exit comparables.
• Nalu Medical: Nalu Medical developed a miniaturized, battery-free peripheral nerve stimulation system — a relevant emerging peer in the miniaturized implantable neuromodulation category Amber is targeting via MintNeuro.
• Nuroflux (formerly Elidah): Elidah/Nuroflux develops wearable neuromodulation devices for stress urinary incontinence in women — an adjacent emerging peer pursuing a non-invasive alternative in the same MUI/UI market segment Amber addresses.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds4 records

Investors8 records

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

M&A1 record

Investments

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

Frequently asked questions about Amber Therapeutics