Strategic Investment Opportunity: Anchoring market leadership with disruptive Bone Regeneration

GreenBone SpA – Strategic Pitch

1. Business & Product Overview: b.Bone®

Mission: GreenBone advances post-trauma bone reconstruction using bioactive, biomimetic synthetic substitutes from natural plant sources.

• Patented Transformation: A sinter-free process transforms rattan wood into a bone-like nanocrystalline structure (hydroxyapatite and beta-tricalcium phosphate with strontium and magnesium ions).

• Key Properties:

o Bioactive: High osteoconductive and osteoinductive capabilities.

o Biomimetic: Replicates osteonic canals; fully resorbs within 6–24 months.

o Customizable: Intraoperatively drillable, shapeable, and screwable without brittle failure.

2. Clinical Validation & Results

b.Bone® has transitioned from R&D to a market-proven solution with high efficacy:

• Global Footprint: Adopted across 40+ Clinical Centers for active data collection.

• Track Record: 750+ successful real-world cases with zero adverse device events.

• Scientific Backing: Validated by 22 peer-reviewed publications.

Product Portfolio & Indications

• Wedges & Blocks: Standardized shapes for extremities and pelvis.

• Cylinders: Designed for severe trauma and extensive long-bone defects.

• Granules: Versatile filling for irregular voids and bone cavities.

• Performance: Hierarchical porosity stimulates vascularization and remodeling while enabling structural intraoperative fixation (drilling/screwing).

3. Regulatory Milestones & Intellectual Property

• MDR Certification: EU MDR 2017/745 achieved in 2024 for Extremities, Long Bones, and Pelvis; Spine indication targeted for Summer 2026.

• US Market (FDA): 510(k) pre-submission underway; clearance targeted for Q4 2027 / Q1 2028.

• Intellectual Property: 3 core patent families (licensed from ISTEC-CNR) covering rattan transformation into nanostructured hydroxyapatite in EU, USA, China, and Japan.

• Manufacturing: Dedicated Brescia plant (formerly Medtronic) with scalable capacity up to 50,000 units/year.

4. Executive Leadership

• Saverio Gellini (CEO): 35+ years of global corporate turnaround leadership.

• Dr. Anna Tampieri (Scientific Lead / Inventor): Bioceramics pioneer at ISTEC-CNR; technology inventor.

• Andrea Cha (COO): 22 years of medical device leadership (ex-Medtronic).

• Paolo Sala (CFO): Expert in financial management and exit strategy execution.

5. Financing Strategy: Series C Opportunity

• Round Structure: Target Ask of €200,000,000 (€12,700,000 already committed).

• Investors: Backed by CDP Venture Capital, Origine, 3B Future Health, and Meta Ventures.

• Use of Funds: Advanced clinical trials, FDA 510(k) clearances (Extremities & Spine), and EU commercial expansion.

• Strategic Exit: Target liquidity event planned by 2029.