Needle Concept

What Needle Concept does

Needle Concept is a French medical device company founded in 2008 and headquartered in Biarritz, specializing in proprietary injection technologies for aesthetic, regenerative, and gynecological medicine. The company designs, hand-assembles, and distributes a portfolio of CE0459-certified Class IIa devices manufactured under ISO 13485:2016, including the U225® electropneumatic intradermal injector, the U225® EVO specialized for gynecological applications, the Magic Needle® flexible micro-cannula co-developed with Dr. Bernard Hertzog, and the Mesbio® Needle range spanning gauges up to 34G. Each U225 unit requires 7 hours of hand-assembly by qualified technicians at the Biarritz facility, with the underlying needle-syringe separation technology engineered to eliminate vibrational phenomena and ensure linear, precise injection movement with adjustable depth from 1–10mm.

The company's revenue model is multi-stream: hardware sales of its own-brand injectors, micro-cannulas, and needles through a global network of 40+ authorized distributors; CDMO (Contract Development and Manufacturing Organization) services covering design, prototyping, clean-room assembly, packaging, and sterilization for pharma and medical device partners; and custom private-label manufacturing such as the Unither Pharmaceuticals Euroject partnership. Customers include aesthetic medicine practitioners (dermatologists, plastic surgeons, aesthetic physicians performing mesotherapy, dermal filler injections, botulinum toxin treatments, and skin/scalp rejuvenation), gynecologists performing intimate-zone treatments, and pharmaceutical companies requiring specialized needle manufacturing.

A 2025 strategic pivot positions Needle Concept for significant scaling: the company entered a strategic partnership with Unither Pharmaceuticals (Feb 2025) to develop Euroject-compatible needles and broke ground on a new Landes-region factory targeting 500M+ needles/year across three production lines. Both companies are recognized laureates of the French government's AMI Capacity Building program, underscoring industrial sovereignty support. The company maintains active presence at major international aesthetic medicine congresses (IMCAS, AMWC, SBME, FACE, CCR) as its primary demand-generation channel, with multilingual distribution across EMEA, APAC, LATAM, and North America.

Name

Needle Concept

Legal name

NEEDLE CONCEPT

Website

https://needleconcept.fr

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Needle Concept is a French medical device manufacturer specializing in proprietary injection technologies—including the U225® electropneumatic injector, Magic Needle® micro-cannula, and Mesbio® needles—for aesthetic medicine practitioners, gynecologists, and pharmaceutical partners worldwide.

Ownership category

akta.pro rank

Product category

Medical Injection Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Needle-Free Injection Systems (Jet Injectors/Microneedle Patches) (HLAHAIAD)

Keywords

• Medical injection devices
• Aesthetic medicine equipment
• Intradermal injectors
• Micro-cannula manufacturing
• Medical device CDMO

Headquarters

HQ city

Biarritz

HQ country

France

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of proprietary intradermal injectors (U225, U225 EVO), micro-cannulas (Magic Needle), and hypodermic needles (Mesbio Needle) to healthcare professionals through official distributors worldwide.
2. CDMO Services: Contract Development and Manufacturing Organization services offering design, prototyping, production, assembly, and packaging of medical devices for pharmaceutical and medical device companies. Services include design/development, machining, plastic injection, clean room assembly, packaging/labeling, and sterilization.
3. Private Label / Custom Manufacturing: Custom needle production for pharmaceutical partners, as demonstrated by the Unither Pharmaceuticals partnership for Euroject system-compatible needles.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Needle Concept designs, hand-assembles and sells proprietary medical injection devices for healthcare professionals, including the U225® electropneumatic intradermal injector, the U225® EVO gynecological variant, the Magic Needle® flexible micro-cannula, and the Mesbio® Needle range. The company also provides CDMO services covering design, prototyping, machining, plastic injection, clean-room assembly, packaging and sterilization for pharmaceutical and medical-device partners.

Product overview

Needle Concept offers a portfolio of injection technologies for aesthetic and regenerative medicine. The core offerings include the U225® electropneumatic intradermal injector (mesogun) and its specialized variant U225® EVO for gynecological applications, along with the Magic Needle® flexible micro-cannula and Mesbio® Needle hypodermic needles. These products work together as a system: the U225 injectors deliver injectable treatments while Magic Needle and Mesbio Needle provide the cannulas and needles for different injection techniques. The company also provides CDMO services for custom medical device development and manufacturing.

Differentiator

Problem solved

Functional benefit

Brands

• U225®: Reference intradermal injector / mesogun for multiple treatments including mesotherapy, designed and hand-assembled in France. Class IIa medical device, CE certified 0459 and ISO 13485.
• U225® EVO
• Magic Needle®
• Mesbio® Needle

Products and services

• U225® Electropneumatic intradermal injector (mesogun) for mesotherapy, dermal fillers, botulinum toxin, skin rejuvenation, hair restoration and body treatments; adjustable injection depth 1-10mm, ergonomic for both right and left-handed users, near-painless high-frequency application. Hand-assembled in France over 7 hours. CE0459 and ISO 13485:2016 Class IIa certified medical device for healthcare professionals in aesthetic medicine.
• U225® EVO Specialized intradermal injector for gynecological indications, designed for external and internal treatments of the female genital area (vulvo-perineal zone, vaginal vestibule, introitus, and intra-vaginal). Adjustable penetration depth 1-10mm. CE0459 and ISO 13485 Class IIa certified medical device for gynecologists.
• Magic Needle® Flexible micro-cannula for less invasive injections; flexible design with original injection orifice does not cut skin or underlying tissues, allowing use with fillers of various viscosities over larger areas with limited injection points. Available in multiple gauges (14G90, 16G70, 16G90, 18G70, 18G90, 20G70, 20G90, 22G57, 22G70, 22G90, 25G40, 25G50, 25G60, 27G37, 30G27). Developed in partnership with Dr. Bernard Hertzog. Exported worldwide as a reference product in aesthetic medicine.
• Mesbio® Needle Intradermal and hypodermic needles for micro-injections, available in gauges up to 34G and various lengths for mesotherapy, botulinum toxin, and other injection applications. Sterile, single-use with color-coded Luer-lock hubs compliant with ISO standards. CE0459 and ISO 13485:2016 Class IIa certified medical device.
• CDMO Services Contract Development and Manufacturing Organization services for medical devices, covering design and development, prototyping, quality assurance and regulatory affairs, machining, plastic injection, production and assembly in clean rooms, packaging and labeling, and sterilization. Serves pharmaceutical companies and medical-device manufacturers in aesthetic medicine, general medicine, and other fields (exemplified by the Unither Pharmaceuticals Euroject® system partnership).

Quantifiable outcome

• 7 hours of hand-assembly per U225 unit ensures highest quality craftsmanship
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Unither PharmaceuticalscoreStrategic or Co-development Partner · 25 February 2025Strategic partnership to develop a new generation of needles compatible with Unither's Euroject system. Euroject is a single-dose Blow-Fill-Seal (BFS) delivery system for injectable drugs. Needle Concept brings fluid delivery expertise and high-precision needle manufacturing capability to design needles specifically adapted to the Euroject system. Needle Concept is constructing a new factory in Landes region near Biarritz with capacity of over 500 million needles per year to support this partnership. Both companies are AMI Capacity Building program laureates, supported by the French government for healthcare industrial sovereignty initiatives.

Scale indicators4 records

Recent moves7 records

Expansion highlights4 records

Market position

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/needle-concept

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds1 record

Investors1 record

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 Needle Concept