What NORAKER does

NORAKER is a French medical device company founded in 2005 as a spin-off from INSA Lyon's MATEIS research group (led by Professor Jérôme Chevallier). The company designs, manufactures, and markets Class III implantable devices for bone regeneration and osteosynthesis based on synthetic, resorbable bioactive glass 45S5 — a calcium/sodium/phosphorus/silicon biomaterial licensed exclusively from MATEIS, which forms a hydroxyapatite carbonatée (HCA) layer chemically similar to natural bone mineral and is gradually assimilated and replaced by the patient's own tissue. The product portfolio is organized in four lines by surgical indication — GlassBone™ (spine), AktiBone™ (orthopedics and traumatology), BiologicGlass™ (craniomaxillofacial and ENT), and ActivIoss™ (dental) — each offered in granules and ready-to-use injectable putty formats, plus GRAFTYS® QUICKSET, an FDA-cleared calcium-phosphate injectable bone graft for the US market.

NORAKER's technology stack is anchored by the patented 45S5 synthesis process and is supported by a stringent regulatory and quality apparatus: NF EN ISO 13485 certification since 2008, CE marking under MDR (EU) 2017/745 as a Class III device (CE-MDR 5-year certificate granted May 2022 through notified body GMED 0459), FDA clearance for QUICKSET, and CNEDIMTS LPP registration for GlassBone Injectable Putty (March 2020). Manufacturing runs from a 1,500+ sqm dedicated Bioglass facility at the headquarters in Lyon (60 Avenue Rockefeller, 69008 Lyon), expanded fivefold in capacity via the Bioserra 2 site (completed 2020-2021).

The business model is direct enterprise sales of medical device implants to healthcare institutions, with surgeons as primary users across orthopedic, spine, craniofacial, ENT, and dental specialties. Revenue derives from hardware sales of implants through a field sales organization led by Marc Dumas (Director of Sales and Operational Marketing) covering both France and Export markets, supplemented by distributor and congress-driven international outreach (MEDICA, Arab Health, EUROSPINE, SFCR, SOFCOT). Marketing and GTM emphasize surgeon KOL engagement via webinars, congress presence, and professional publications. The company holds an active international footprint (France, US, and named export markets including Italy) and has secured approximately €7.94 million in cumulative non-dilutive grants from BPI France, the European Commission (Horizon 2020 / REBOOT), regional agencies, and the Plan France 2030 V.I.P research consortium — funding oriented to industrial scaling and product diversification rather than venture equity. Reference users include Hôpital Saint Joseph Saint Luc, Hospices Civils de Lyon, and Maria Cecilia Hospital (Italy). Leadership comprises CEO Céline Saint Olive (since 2015, ex-Philips and L'Oréal), Catherine Flacard (Compliance & Innovation), and Mickaël Pulici (Operations, since 2006).

Name

NORAKER

Legal name

NORAKER

Website

https://noraker.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

NORAKER is a French medical device company that designs, manufactures, and markets implantable bioactive glass-based bone substitutes for orthopedic, spine, craniofacial, ENT, and dental surgeries, serving surgeons and healthcare institutions globally.

Ownership category

akta.pro rank

Product category

Orthopedic Bone Graft Substitutes

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Dental Equipment and Supplies Manufacturing (339114)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Bone Graft Substitutes & Orthobiologics (Synthetic/Allograft/DBM) (HLAHAEAG)

Keywords

• Bone graft substitutes
• Bioactive glass implants
• Synthetic bone regeneration
• Orthobiologic medical devices
• Resorbable biomaterials

Headquarters

HQ city

Villeurbanne

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Devices Sales: NORAKER designs, manufactures, and markets implantable medical devices based on synthetic and resorbable biomaterials for bone regeneration and osteosynthesis. Products are sold directly to healthcare professionals (surgeons) in orthopedic, spine, craniofacial, ENT, and dental specialties. Revenue is generated from product sales across multiple surgical applications.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

NORAKER designs, manufactures, and markets Class III implantable medical devices based on synthetic and resorbable bioactive glass 45S5 biomaterials for bone regeneration and osteosynthesis. Its portfolio covers spine, orthopedic/trauma, craniomaxillofacial/ENT, and dental surgical applications, with products delivered as ready-to-use granules or injectable putties that are gradually assimilated by the body and replaced by the patient's own bone. The products are sold directly to surgeons and healthcare institutions in France, the US (FDA-cleared QUICKSET), and international export markets.

Product overview

NORAKER specializes in bioactive glass 45S5-based medical devices for bone regeneration and osteosynthesis. The product portfolio comprises multiple product lines organized by surgical application: GlassBone™ (spine surgery), AktiBone™ (orthopedics and traumatology), BiologicGlass™ (craniomaxillofacial and ENT), and ActivIoss™ (dental applications). Each product line is available in two formulations - Injectable Putty and Granules. GRAFTYS® QUICKSET represents a calcium phosphate-based alternative for US market applications. All products utilize proprietary bioactive glass technology licensed from INSA Lyon research, providing synthetic, resorbable bone substitutes that are gradually assimilated by the body and replaced with natural bone.

Differentiator

Problem solved

Functional benefit

Brands

• GlassBone™: Bioactive glass bone substitute product line for spine surgery, available in granules and injectable putty forms.
• AktiBone™
• BiologicGlass™
• ActivIoss™
• GRAFTYS® QUICKSET

Products and services

• GlassBone™ Injectable Putty Synthetic, bioactive, and absorbable bone substitute composed of 45S5 bioactive glass and a polymer, designed for spine surgery applications. Sold directly in syringe, ready to use, providing a fully synthetic alternative to autograft and allograft in spinal fusion and vertebral reconstruction.
• GlassBone™ Granules Synthetic bioactive bone substitute in granule form for spine surgery applications, composed of bioactive glass 45S5 ceramic containing silicon, sodium, phosphorous, and calcium oxides. Indicated for spinal fusion and bone void filling in vertebral reconstruction.
• AktiBone™ Injectable Putty Injectable putty composed of bioactive glass 45S5 and a polymer for orthopedic surgeries. 100% synthetic and completely assimilable by the body, providing a ready-to-use Class III medical device for bone void filling in orthopedic trauma and reconstruction.
• AktiBone™ Granules Synthetic bioactive bone substitute in granule form indicated for orthopedic surgery. Based on bioactive glass 45S5 ceramic, providing excellent biocompatibility and osteogenesis support for trauma, tumor resection, prosthetic revision, and degenerative pathology cases.
• BiologicGlass™ Injectable Putty Bioactive glass-based injectable putty for craniomaxillofacial and ENT surgeries, providing bone regeneration capabilities through bioactive glass technology for craniofacial reconstruction and otolaryngological procedures.
• BiologicGlass™ Granules Granular form of bioactive glass for craniomaxillofacial and ENT surgical applications, supporting natural bone regeneration in craniofacial reconstruction and mastoid filling procedures.
• ActivIoss™ Injectable Putty Dental-specific injectable putty bone substitute for periodontology and implantology applications, utilizing bioactive glass technology for dental bone regeneration procedures.
• ActivIoss™ Granules Dental bone substitute in granular form for periodontology and implantology procedures, based on bioactive glass technology for dental bone regeneration.
• GRAFTYS® QUICKSET FDA-cleared calcium-phosphate injectable bone graft with injectability, self-hardening, macroporous structure, and easy preparation features. Designed as a bone void filler for trauma, arthroplasty revision, and benign bone tumor surgery, marketed primarily in the United States.

Quantifiable outcome

• Used clinically for 7+ years with excellent results in complex orthopedic cases including bone tumors and infected indications
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Nine partnerships are on record, tiered core, supporting, exploratory and foundational.

• V.I.P Research Consortium (NORAKER, NOVOTEC, LBTI/CNRS, INMG/INSERM)coreStrategic or Co-development Partner · 1 January 2024Consortium awarded €4 million funding under Plan France 2030 for V.I.P research project on innovative bone regeneration approaches.
• French Healthcare AssociationsupportingGTM or Marketing Partner · 1 January 2021NORAKER joined French Healthcare Association to promote its Bioglass technology and continue international development, particularly in orthopedics.
• EIT HealthsupportingGTM or Marketing Partner · 1 January 2020Selected for EIT Health Bridgehead program providing individualized support for international expansion of activities.
• EvonikexploratoryTechnology or Integration · 1 January 2019NORAKER was selected to present its innovations to Evonik managers in Essen, Germany. Exploring new approaches to bone regeneration.
• NOVOTECcoreStrategic or Co-development PartnerResearch consortium partner in V.I.P project for bone regeneration research.
• LBTI (CNRS)coreStrategic or Co-development PartnerResearch consortium partner (Laboratoire de Biologie Tissulaire et Ingénierie Cellulaire) in V.I.P project.
• INMG (INSERM)coreStrategic or Co-development PartnerResearch consortium partner (Institut Necker-Enfants Malades) in V.I.P project.
• INSA Lyon / MATEIS GroupfoundationalStrategic or Co-development PartnerNORAKER is spin-off from INSA Lyon MATEIS group led by Professor Jérôme Chevallier. Holds exclusive license to patented bioactive glass manufacturing process.
• GMEDcoreOthersFrench notified body (0459) conducting conformity assessment for NORAKER medical devices. Ensures CE marking compliance with European medical device regulations.

Scale indicators8 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• NovaBone Products: NovaBone is a US-based pioneer in bioactive glass bone graft substitutes, the same 45S5-based chemistry NORAKER builds on. It is the closest direct competitor in synthetic, resorbable bone regeneration across dental, orthopedic, and spine indications.
• Geistlich Pharma: Swiss leader in dental bone regeneration with Bio-Oss and Bio-Gide. Geistlich directly competes with NORAKER's ActivIoss dental bone substitute line in periodontology and implantology worldwide.
• Biomatlante: French synthetic bone substitute manufacturer (MBCP technology) serving spine, orthopedic, and dental indications. Direct competitor to NORAKER in the French market with overlapping indications and similar synthetic biomaterial positioning.
• Curasan: German manufacturer of bone regeneration materials (Cerasorb) and dental implants. Directly comparable portfolio in synthetic bone substitutes for dental, CMF, and orthopedic applications.
• BoneSupport (BONESUPPORT HOLDING): Swedish-listed orthopedic-focused company marketing CERAMENT bone graft substitute (ceramic-based, injectable). Direct competitor to NORAKER's AktiBone putty in trauma, revision, and infection indications.

Emerging players

• Graftys: French bone graft substitute company whose injectable calcium phosphate technology forms the basis of NORAKER's GRAFTYS QUICKSET product. Strategic commercialization partner and adjacent direct competitor in the same chemistry class.
• Septodont: French dental pharmaceutical and regenerative company. Septodont competes with NORAKER in dental bone regeneration and broader dental surgical biomaterials globally.

Broad incumbents

• Medtronic (Orthobiologics): Broad incumbent with the Infuse bone graft (rhBMP-2) franchise dominating spine and orthopedics. Medtronic competes with NORAKER in spine fusion and trauma via much larger sales infrastructure and clinical data.
• Stryker (Orthobiologics): Stryker markets Vitoss and other bone graft substitutes across orthopedic and spine. As a broad incumbent with a far larger salesforce, it competes with NORAKER for hospital formulary and trauma/spine business.
• Bioventus: Public orthobiologics company with bone graft substitute products (Exponent) and an active bone healing franchise. Directly competes with NORAKER in orthopedic bone void filling and bone healing markets.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInfr.linkedin.com/company/noraker

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds1 record

Investors2 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 NORAKER