What Uneedle does

Uneedle (legal entity: U-Needle B.V.) is a Dutch medical device company founded in 2008 and headquartered in Enschede, Netherlands, specializing in the design and manufacture of proprietary silicon microneedle drug delivery devices. The company leverages semiconductor MEMS manufacturing processes — specifically crystal plane etching — to produce atom-sharp hollow needle cannulas with ultra-short bevels that are difficult to replicate using conventional steel needle grinding techniques. Uneedle operates two product platforms: the Bella-mu intradermal delivery system (lead product Bella-mu 1.4mm, CE marked and FDA 510(k) cleared) for cancer vaccines, prophylactic vaccines, and aesthetic applications, and the Bella-Vue suprachoroidal ophthalmic system (lead product Bella-Vue 1.0mm) for retinal disease therapeutics. Both product lines are manufactured in-house at GMP-compliant cleanroom facilities on the University of Twente campus, supported by a full-scope ISO 13485 quality management system.

The company serves enterprise pharmaceutical and biotechnology customers through a B2B model combining hardware sales of CE/FDA-cleared needle products, licensing of proprietary technology, and custom product development services. Its go-to-market is consultative enterprise sales ([email protected]) targeting partners developing intradermal and suprachoroidal therapies, with disclosed engagements including BriaCell Therapeutics (Phase 3 metastatic breast cancer candidate Bria-IMT, NCT06072612), Aston Sci (Korean cancer vaccine trial NCT05163223), and UMC Leiden (vaccine dose-sparing research). Notable customers in the data include BriaCell Therapeutics, Aston Sci, and UMC Leiden, reflecting an enterprise pharmaceutical and academic customer profile.

Uneedle's business model centers on a small-dedicated-team structure (11-50 employees) generating revenue through a mix of regulated medical device product sales, technology licensing royalties, and bespoke design/development services. The company positions itself as a co-development partner rather than a pure component supplier, with the 2026 MoU with BriaCell establishing a commercial supply framework contingent on Phase 3 success. Distribution is direct B2B with no intermediary channels, and the regulatory footprint spans the EU and US markets via CE and FDA clearances, with global reach subject to regional approvals.

Name

Uneedle

Legal name

U-Needle B.V.

Website

https://uneedle.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Uneedle (U-Needle B.V.) is a Dutch medical device company that designs and manufactures proprietary silicon microneedle drug delivery devices for pharmaceutical partners, serving ophthalmic, cancer vaccine, and immunotherapy applications through its Bella-Vue and Bella-mu platforms.

Ownership category

akta.pro rank

Product category

Medical Devices - Microneedle Drug Delivery

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Single-Use Surgical Devices & Procedure Packs (Disposable instruments, drapes, kits) (HLAHADAM)

Keywords

• Silicon microneedles
• Intradermal drug delivery
• Suprachoroidal injection devices
• Medical device manufacturing
• Ophthalmic drug delivery

Headquarters

HQ city

Enschede

HQ country

Netherlands

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Silicon Microneedle Product Sales: Sale of proprietary silicon microneedles and microneedle-based drug delivery devices including Bella-Vue (suprachoroidal) and Bella-mu (intradermal) product families. Products are CE marked and FDA 510(k) cleared medical devices.
2. Licensing: Licensing of proprietary technology and existing products to pharmaceutical companies for use in their therapies. Companies can license Uneedle's designs for custom development built on proprietary microneedle technology.
3. Custom Product Development: Design and development services to translate customer requirements into custom microneedle designs. Full scope Quality Management System yielding needle designs that fulfill customer and regulatory requirements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Uneedle designs, develops, and manufactures proprietary silicon microneedle-based drug delivery devices for pharmaceutical partners, organized into two product platforms: Bella-Vue for suprachoroidal ophthalmic injections (targeting retinal diseases such as wet/dry AMD, diabetic retinopathy, and macular edema) and Bella-mu for intradermal injections (used in cancer vaccines, viral infection vaccines, and aesthetic treatments). Lead commercial products include the Bella-Vue 1.0 and Bella-mu 1.4 mm needles, both manufactured in-house at GMP-compliant cleanroom facilities in the Netherlands. The company also provides custom product development services and licenses its proprietary microneedle technology to pharmaceutical companies.

Product overview

Uneedle offers a proprietary silicon microneedle technology platform for drug delivery, organized into two product families: the Bella-Vue platform for suprachoroidal ophthalmic injections targeting retinal diseases, and the Bella-mu platform for intradermal injections used in cancer vaccines, viral infections, and aesthetics. The company provides both off-the-shelf needle products (Bella-Vue 1.0, Bella-mu 1.4 mm) and custom development/manufacturing services. All products are manufactured in-house at GMP-compliant facilities in the Netherlands using semiconductor processes, and are CE certified and FDA 510(k) cleared.

Differentiator

Problem solved

Functional benefit

Brands

• Bella-Vue: Ophthalmic microneedle platform designed for suprachoroidal injections to facilitate precise delivery of small molecules or biologics to the back of the eye. Clinical lead product is Bella-Vue 1.0 with an effective needle length of 1.0 mm.
• Bella-mu

Products and services

• Bella-Vue Platform
• Bella-Vue 1.0
• Bella-mu Platform
• Bella-mu 1.4 mm
• GMP Compliant Manufacturing Services
• Product Development Services

Named customers3 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Four partnerships are on record, tiered core.

• BriaCell TherapeuticscoreStrategic or Co-development Partner · 25 June 2026BriaCell Therapeutics has entered into a Memorandum of Understanding with Uneedle to support commercial readiness of Bria-IMT (Phase 3 clinical candidate for metastatic breast cancer) using Uneedle's proprietary intradermal microneedle technology. The technology is currently being used in BriaCell's pivotal Phase 3 study (ClinicalTrials.gov identifier: NCT06072612). The non-binding MoU establishes a plan for scaling Uneedle's microneedle devices for commercial quantities, contingent upon successful regulatory approval of Bria-IMT.
• BriaCell TherapeuticscoreStrategic or Co-development Partner · 25 June 2026Partnership with BriaCell for intradermal administration of lead Phase 3 clinical candidate Bria-IMT for metastatic breast cancer treatment. Supporting commercial readiness of Uneedle's proprietary microneedle technology.
• Aston ScicoreStrategic or Co-development PartnerKorean company using Bella-mu silicon microneedles in a clinical trial (NCT05163223) to deliver cancer vaccination therapy targeting breast cancer. Demonstrates application in therapeutic cancer vaccination.
• UMC LeidencoreStrategic or Co-development PartnerPartnership with UMC Leiden demonstrated 5x dose-sparing potential of Bella-mu compared to standard intramuscular injection for Spikevax (Moderna), validating dose-sparing capabilities for viral infection vaccines.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Vaxxas: Vaxxas develops high-density microneedle patches (Nanopatch) for vaccine and therapeutic intradermal delivery. Direct peer: both companies target the same pharmaceutical-decision-maker with microneedle-based intradermal drug delivery, overlapping in cancer vaccine, viral vaccine, and dose-sparing use cases.
• PharmaJet: PharmaJet provides needle-free jet injection systems (Stratis and Tropis) for intradermal and intramuscular vaccine administration. Direct peer in vaccine delivery: targets the same pharmaceutical partners for dose-sparing intradermal administration, with an alternative (jet) mechanism.
• Micron Biomedical: Micron Biomedical develops dissolvable microneedle patches for vaccines (measles, flu, polio) and is backed by program grants including from the Gates Foundation. Direct peer: same end customer (vaccine developers), same delivery route (intradermal), competing mechanism of action.
• Nanopass Technologies: Nanopass is an Israeli microneedle company with silicon-based micron-scale needle technologies used for intradermal delivery in vaccines and therapeutics. Closest technology peer: both use semiconductor-process silicon microneedles and target identical intradermal pharmaceutical application areas.
• Clearside Biomedical: Clearside has the approved suprachoroidal injection platform SCS Microinjector used in Xipere for macular edema and is partnering with retinal therapy developers. Direct Bella-Vue competitor: same suprachoroidal drug delivery procedure, same ophthalmology pharmaceutical customer, same retinal disease indications.

Broad incumbents

• 3M Drug Delivery Systems: 3M Drug Delivery Systems is a leading manufacturer of transdermal patches and microneedle technologies (via the 3M Microstructured Transdermal System) used by pharmaceutical partners. Broad incumbent: large device manufacturer with adjacent microneedle drug delivery offering, with greater resources and broader commercial reach than Uneedle.
• Kindeva Drug Delivery: Kindeva Drug Delivery (formerly 3M Drug Delivery) is a contract drug delivery manufacturer offering transdermal, microneedle, and inhalation delivery solutions to pharma partners. Broad incumbent: serves the same pharmaceutical co-development customer set with comparable microneedle and transdermal capabilities at much larger scale.
• Corium (LTS Lurb): Corium, now part of LTS Lurb, develops transdermal drug delivery systems including microneedle-based platforms. Broad incumbent: established transdermal delivery company with overlapping customer base in pharmaceutical drug delivery, but operating at much greater scale and with broader product portfolio.
• BD Medical (Becton Dickinson): Becton Dickinson is a global medical device company making injection and drug delivery devices including prefillable syringes, auto-injectors, and intradermal needles. Broad incumbent: dominant incumbent in injection drug delivery with established pharma distribution; potentially positioned as an acquirer or competitor in the microneedle niche.

Others

• West Pharmaceutical Services: West Pharmaceutical Services is a leading provider of primary packaging, delivery systems, and contract development services for injectable pharmaceutical products. Enabler/ecosystem peer: not a direct microneedle competitor, but the supplier-of-record and contract manufacturer of injection/packaging components used in combination products.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/uneedle

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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 Uneedle