What Bioretec does

Bioretec Ltd is a Finland-headquartered, publicly listed (Nasdaq First North Growth Market Finland) medical device company that designs, manufactures, and commercializes bioabsorbable orthopedic implants for fracture fixation and bone repair, with a primary focus on pediatric and adult orthopedic surgery and current commercial emphasis on foot and ankle procedures. Founded in 2003 in Tampere by Professor Pertti Törmälä and operating with approximately 60 employees, Bioretec runs two proprietary product platforms: the RemeOs line based on a magnesium-calcium-zinc absorbable metal alloy (notably free of rare earth elements), and the Activa line based on self-reinforced PLGA 85/15 biopolymer with patented Auto-Compression and Self-Locking SL functionality. The company's clinical positioning rests on implants that degrade in approximately two years, eliminating the need for secondary removal surgery — a particularly relevant benefit in pediatric patients whose ongoing bone growth otherwise typically requires metal implant extraction.

The company has built a defensible regulatory footprint: FDA De Novo market authorization for RemeOs Screw LAG Solid in March 2023 (first absorbable metal orthopedic implant in the U.S.), CE Mark under EU MDR for RemeOs Trauma Screw in January 2025, three FDA Breakthrough Device Designations (RemeOs portfolio), and CMS Transitional Pass-Through Payment status with HCPCS code C1741 effective October 1, 2025. The product portfolio spans RemeOs screws (LAG, LAG Solid, COM, FT), RemeOs DrillPin and a Spinal Interbody Cage in development, and Activa products including interference screws, cannulated screws, nails, pins, and IM-Nails, collectively used in over 400,000 procedures historically with zero reported adverse events.

Bioretec operates a hybrid go-to-market: a direct U.S. sales force led by VP of Sales USA Frank Sarcone targeting hospitals and surgery centers, combined with an OUS organization under VP Jordy Winters and an extensive distributor network covering approximately 40 countries across Europe, Asia, Africa, Latin America, and the Middle East. Revenue is generated from one-time hardware sales of implants per surgical procedure, with FY2025 net sales of EUR 3.522 million (down 22.5% YoY) and a reset financial target of exceeding EUR 10 million in net sales by 2028. The company has undergone multiple capital raises — including EUR 9.2 million via rights issue in June 2025 and EUR 12.9 million in April 2026 — and a CEO transition (Sarah van Hellenberg Hubar-Fisher succeeding Alan Donze in 2025) amid production-side restructuring.

Name

Bioretec

Legal name

Bioretec Ltd

Website

https://bioretec.com

Company type

Public

Founded year

2003

Operating status

Operating

Headcount range

51–100 employees

Short description

Bioretec Ltd is a Finnish publicly listed medical device company that designs and commercializes bioabsorbable orthopedic implants (RemeOs magnesium alloy and Activa PLGA polymer platforms) for fracture fixation in pediatric and adult orthopedic surgery, distributed via direct sales in the U.S. and approximately 40-country distributor network globally.

Ownership category

akta.pro rank

Product category

Orthopedic Implants / Bioabsorbable Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Orthopedic Trauma & Extremities Fixation (Plates/Screws/Nails/External Fixation) (HLAHAEAB)

Keywords

• Bioabsorbable orthopedic implants
• Magnesium alloy implants
• Polymer bone fixation
• Absorbable fracture fixation
• Orthopedic medical devices

Headquarters

HQ city

Tampere

HQ country

Finland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Orthopedic Implant Sales: Bioretec generates revenue primarily from the sale of bioabsorbable orthopedic implants including RemeOs (magnesium alloy screws) and Activa (PLGA polymer implants). Products are sold through direct sales force and distributor network in approximately 40 countries. Revenue model is traditional medical device hardware sales - one-time purchase per procedure.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

Bioretec designs, develops, and manufactures bioabsorbable orthopedic implants for fracture fixation and bone repair. Its two product lines—RemeOs (proprietary magnesium-calcium-zinc alloy) and Activa (self-reinforced PLGA 85/15 biopolymer)—are sold to hospitals, ambulatory surgery centers, and orthopedic surgeons for both pediatric and adult procedures, with implants engineered to degrade naturally in the body in approximately two years and eliminate the need for removal surgery.

Product overview

Bioretec offers two distinct absorbable orthopedic implant product lines: RemeOs™ (based on bioactive magnesium alloy technology) and Activa™ (based on self-reinforced PLGA biopolymer). RemeOs™ products include multiple screw configurations (LAG, LAG Solid, COM, FT), the DrillPin, and the Spinal Cage (in development), all utilizing proprietary absorbable metal alloy that provides mechanical strength while supporting natural bone healing. Activa™ products comprise interference screws, cannulated screws, nails, pins, and surgical screws using PLGA 85/15 polymer with patented self-reinforcement technology. Both product lines eliminate the need for removal surgeries as implants degrade naturally and are replaced by bone. Products are CE marked and/or FDA cleared/authorized, marketed in approximately 40 countries worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• RemeOs: Premium absorbable orthopedic implant line using state-of-the-art absorbable metal alloy technology. Products are designed to promote natural bone healing without requiring removal surgery. Includes Screw LAG, Screw COM, Screw FT, and Screw LAG Solid variants.
• Activa

Products and services

• RemeOs™ Screw LAG Partially threaded and cannulated screw using high-performance magnesium alloy and hybrid composite technology. Provides strong and stable fixation during healing and gradually degrades as it is replaced by bone; intended for orthopedic surgeons and hospitals performing fracture fixation.
• RemeOs™ Screw LAG Solid Partially threaded and non-cannulated screw made from proprietary magnesium alloy; first-and-only osteopromotive absorbable metal implant for orthopedic use in the United States. Sold to hospitals, ambulatory surgery centers, and orthopedic surgeons for fracture fixation procedures.
• RemeOs™ Screw COM Headless, partially threaded compression screw designed for specific orthopedic fixation applications using absorbable metal alloy technology; targeted at orthopedic surgeons performing foot and ankle, trauma, and reconstructive procedures.
• RemeOs™ Screw FT Headless, fully-threaded compression screw with enhanced fixation properties using magnesium alloy and hybrid composite materials; intended for orthopedic fracture fixation procedures where additional thread engagement is required.
• RemeOs™ DrillPin Biodegradable magnesium alloy implant for fracture fixation in pediatric and adult patients, designed for use in hospitals and surgery centers performing orthopedic procedures.
• RemeOs™ Spinal Cage Next-generation interbody cage using hybrid composite material engineered to regulate degradation speed; in proof-of-concept phase targeting spinal interbody fusion procedures for spine surgeons and hospitals.
• ActivaScrew™ Interference Advanced absorbable interference screw implant made from proprietary self-reinforced PLGA polymer; used in fracture treatment with natural degradation within approximately two years, sold to orthopedic surgeons and hospitals.
• ActivaScrew™ Interference TCP Advanced absorbable biocomposite interference screw with enhanced material properties for secure fixation in orthopedic procedures; targeted at sports medicine and ligament reconstruction surgeries.
• ActivaScrew™ Cannulated Advanced absorbable cannulated screw implant used in various orthopedic surgical procedures for bone fixation; intended for hospitals and surgeons requiring guide-wire-assisted placement.
• ActivaNail™ Advanced absorbable nail implant used in fixation procedures, providing secure stabilization during bone healing with natural degradation; intended for orthopedic surgeons and hospitals performing fracture fixation and osteotomy procedures.
• Activa IM-Nail™ World's first fully absorbable elastic intramedullary nail for orthopedic fixation, enabling less invasive surgical techniques with natural material absorption; intended for pediatric and adult fracture treatment.
• ActivaPin™ Advanced absorbable pin implant used for fixation of bone fractures and soft tissue injuries when appropriate immobilization is applied; targeted at orthopedic and trauma surgeons.
• Activa Screw™ Absorbable surgical screw for fracture treatment, made from self-reinforced PLGA polymer with over 20 years of clinical use and hundreds of thousands of successful applications; sold to hospitals and orthopedic surgeons worldwide.

Quantifiable outcome

• 90% of patients achieved fracture consolidation by 6 weeks with complete healing observed by 12 weeks
• +4 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered minor and core.

• Cure International Clinic (Kenya)minorStrategic or Co-development Partner · 19 June 2025Medical mission partnership in Kiabe, Kenya where Bioretec donated Activa implants for 50 pediatric orthopedic surgeries. Partnership included training local surgeons on less invasive techniques. Demonstrates product benefits in developing world context where removal surgeries are impractical.
• Global Distributor NetworkcoreChannel Partner/ Reseller/ DistributorApproximately 40 distributors globally including: Alpha Trading (Bangladesh), ABL Alpstein (Peru), LH SAS (Colombia), Columbus Medical (Netherlands), Medeco-ch (Switzerland), Acuna y Fombona (Spain), Novastep (France), Kir-Fix Oy (Finland), Fischer Medical (Denmark), and others. Distributors cover Europe, Asia, Africa, Latin America, and Middle East.

Scale indicators9 records

Recent moves6 records

Expansion highlights7 records

Broad incumbents

• Stryker: One of the world's largest orthopedic medical device companies with a broad portfolio of trauma, foot & ankle, and sports medicine implants. Stryker is a primary incumbent Bioretec must displace in the hospital and ASC channels, but does not focus on bioabsorbable technology.
• Johnson & Johnson (DePuy Synthes): Global orthopedic leader within J&J MedTech, with the deepest trauma and extremities fixation portfolio and surgeon relationships. Represents the dominant metal-implant incumbent that Bioretec's absorbable screws must displace in shared hospital accounts.
• Smith & Nephew: Global medical device company with strong trauma, extremities, and sports medicine franchises. Bioretec's incoming Head of R&D Conan Cavanagh previously served as Engineering Director at Smith & Nephew, evidencing direct competitive overlap and the talent pool that flows between the two.
• Zimmer Biomet: Major orthopedic and trauma implant manufacturer with a global direct sales force and broad hospital contracts. Provides the standard-of-care metal screw, plate, and nail alternatives that Bioretec's absorbable RemeOs and Activa lines compete against procedurally.

Direct peers

• Arthrex: Privately held leader in sports medicine and orthopedic soft-tissue-to-bone fixation, with strong surgeon relationships in foot & ankle. Arthrex competes most directly with Bioretec's RemeOs interference screws and ActivaScrew Interference product family in the ASC and sports medicine channels.
• Integra LifeSciences: Specialty surgical and orthopedic implant company with a meaningful extremities and sports medicine portfolio. Operates in many of the same hospital and ASC accounts as Bioretec and offers overlapping screw and fixation product categories for foot & ankle and hand surgeons.
• Orthofix Medical: Focused orthopedic trauma and biologics company with bone growth stimulation and fracture fixation products. Closely comparable to Bioretec in scale, strategic focus, and reliance on novel regenerative/orthobiologic mechanisms of action in fracture healing.
• CONMED: Mid-cap medical device company with a substantial orthopedic and sports medicine portfolio including interference screws and fixation devices. Competes with Bioretec's ActivaScrew Interference line in arthroscopy and sports medicine channels.

Emerging players

• MedShape: Smaller U.S. orthopedic device company focused on shape-memory nickel-titanium (NiTiNOL) and other novel implant materials for foot & ankle and trauma. Comparable to Bioretec in scale and in pursuing material-science-driven differentiation in a market dominated by stainless steel and titanium screws.
• Acuitive Technologies: Early-stage orthopedic biomaterials company developing bioresorbable and bio-integrative implant technologies. Highly comparable to Bioretec in its focus on enabling bone healing without permanent hardware, though still in pre-commercial development.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds6 records

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 Bioretec