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Bionacre®.
From research to development.

A nacre-derived biomaterials platform, a first programme in dental bone regeneration and a strategy connecting preclinical assessments, regulatory development and industrialisation.

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The foundations
of the opportunity.

Value creation depends on advancing Bionacre® Bone Graft and preparing its market access. Orthopaedic and cartilage pathways represent separate research opportunities.

01

A focused first application

Bionacre® Bone Graft targets bone defect filling in dental surgery. Socket preservation is an initial development segment.

02

A manufacturing foundation in France

Nacre transformation, processing and quality control are supported by our activities in Crosne and an ISO 13485-certified quality system.

03

A structured intellectual property portfolio

Five patent families support the platform: the base family expires in 2030, and later families between 2035 and 2040. The scope and status of each family are documented in the investor materials.

Our first application: dentistry

Complementary markets.
Focused indications.

Bone graft substitutes and dental membranes represent two complementary markets. Socket preservation is our first targeted indication.

Serviceable market for the first device

0.2US$B

Socket preservation · company estimate

Approximately 30 % of dental grafting procedures

Source: MEGA BIOPHARMA / MEGA Dental estimate

Dental membranes

0.68US$B

Estimated global market in 2025

+7.3 % per year
Forecast compound annual growth · 2026–2033

Source: Grand View Research

Target market · dental membranes

≈ 0.20US$B

Socket preservation · company assumption

Assumption: 30 % of the global membrane market
US$0.68B × 30% = 204 US$M

Source: MEGA BIOPHARMA / MEGA Dental estimate based on the 2025 market

Bone graft substitutes: rounded figures and assumptions from the September 2026 investor presentation. Membranes: Grand View Research estimate for 2025, rounded to US$0.68B; the 30% targeting assumption by value is that of MEGA BIOPHARMA / MEGA Dental. Reference years differ and scopes must not be added without adjustment. Target markets are not acquired market shares, revenue forecasts or an order book.

BIONACRE® BONE GRAFT / DEVELOPMENT

A staged
regulatory pathway.

TODAY

Late preclinical stage

Material characterisation, biological assessments and preclinical studies support device development.

UNITED STATES

FDA · 510(k)

A pre-submission was completed in 2022. The programme is preparing the assessments and dossier needed for a future submission.

EUROPE

Clinical development

The strategy includes a clinical investigation to support the European pathway. The detailed roadmap is available on request.

Bionacre® Bone Graft is in development. A pre-submission or dossier submission does not constitute market authorisation.

Request the roadmap

MEGA Dental · Distribution

From research
to practitioners.

MEGA BIOPHARMA and MEGA Dental share the same founder, Joël Drai, and roots in the dental sector.

MEGA BIOPHARMA develops biomaterials. MEGA Dental, a distributor of dental products and equipment, contributes its understanding of dental practices and its distribution network in France.

This network will support the future distribution of Bionacre® Bone Graft, subject to the necessary authorisations.

Discover MEGA Dental ↗

Speak with management

Explore
the opportunity.

Request the investor presentation and speak with our team about the development plan, economic assumptions and associated funding requirements.

Detailed roadmap and financial information available on request.

investisseurs@megabiopharma.com

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