Biopsafe
BiopSafe (BiopSafe ApS), founded in 2014 in Vedbæk, Denmark, sells a CE-marked closed-system biopsy container with formalin encapsulated in the lid, protecting healthcare workers from formaldehyde exposure during biopsy handling. It distributes via a global partner network to hospitals and pathology labs.
- Company typePrivate
- Founded2014
- HeadquartersVedbæk, Denmark
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Biopsafe does
BiopSafe ApS is a Danish medical device company, founded in 2014 and headquartered in Vedbæk, Denmark, that develops and sells a single-product line: a closed-system biopsy container with formalin encapsulated in the lid, released into the vial by a single thumb press to create a hermetically sealed environment. The product is offered in two sizes — 20ml for individual biopsies and 60ml for handling multiple biopsies in cassettes — and is designed to eliminate occupational exposure of healthcare workers to formaldehyde, a Class 1B carcinogen, during biopsy fixation and transport to the laboratory.
The underlying technology is mechanical rather than digital: a proprietary lid-encapsulated formalin reservoir that ruptures on actuation, ensuring no liquid spillage or vapor escape. The device is CE marked under EU IVD 2017/746, complies with Regulation (EC) No 1272/2008 on substance classification, holds an EU Declaration of Conformity (Rev02), a manufacturing-site Quality System Certificate (October 2024), and a Free Sales Certificate valid 2025-2027. BiopSafe operates as a branded sub-line of Axlab, a pathology-focused parent company that provides manufacturing, QA/RA, and commercial infrastructure.
Commercially, BiopSafe generates revenue through hardware sales of its two vial SKUs via a global distributor network covering approximately 35 countries across Europe, the Middle East, Oceania, and the Americas. The end customers are hospitals, surgical centers, and pathology laboratories. Go-to-market emphasizes occupational-health-driven demand creation through co-marketing with the European Biosafety Network, multilingual website content (six languages), webinars, white papers, and trade press. Pricing is not publicly disclosed and requires direct inquiry or online demo registration.
Biopsafe firmographics
Firmographics- Name
- Biopsafe
- Legal name
- BiopSafe ApS
- Website
- https://biopsafe.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- BiopSafe (BiopSafe ApS), founded in 2014 in Vedbæk, Denmark, sells a CE-marked closed-system biopsy container with formalin encapsulated in the lid, protecting healthcare workers from formaldehyde exposure during biopsy handling. It distributes via a global partner network to hospitals and pathology labs.
- Ownership category
- akta.pro rank
Biopsafe industry classification
Industry- Product category
- Medical Devices - Biopsy Containers
- NAICS
- Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)
- akta.pro secondary industry
- Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)
Keywords
Where Biopsafe is headquartered
LocationHeadquarters
- HQ city
- Vedbæk
- HQ country
- Denmark
- HQ region
- Europe
Offices1 record
Markets served
Biopsafe business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Operations, Personnel, Marketing or Sales, Technology or R&D
Revenue model
- Medical device sales: BiopSafe generates revenue through the sale of its biopsy vials with encapsulated formalin. The vials are sold in two sizes (20ml and 60ml) through a global distributor network to hospitals, clinics, and pathology departments.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
Biopsafe product offering
Product offeringCore offering
BiopSafe develops and sells a closed-system biopsy container that encapsulates formalin in the lid; a light thumb press releases the formalin inside a hermetically sealed vial to safely cover biopsy samples. The product is offered in 20ml and 60ml sizes and is sold to hospitals, clinics, and pathology laboratories through a global distributor network to eliminate healthcare worker exposure to formaldehyde during biopsy handling and transport.
Product overview
BiopSafe is a single-product medical device company offering a closed-system biopsy container that encapsulates formalin in the lid. The product portfolio consists of two sizes (20ml and 60ml) that provide the same core functionality—a thumb-press mechanism that releases formalin in a hermetically sealed system, protecting healthcare workers from formaldehyde exposure during biopsy procedures. The product is CE marked and compliant with EU IVD 2017/746 Regulation. BiopSafe is part of Axlab, a company specializing in pathology solutions, and was invented in 2014.
Differentiator
Problem solved
Functional benefit
Products and services
- BiopSafe Biopsy Container (20ml) A closed-system biopsy container with formalin encapsulated in the lid that releases the formalin via a thumb press to safely cover biopsy samples, preventing healthcare worker exposure to liquid or vapor formaldehyde. The 20ml size is designed for individual biopsy handling.
- BiopSafe Biopsy Container (60ml) A closed-system biopsy container with formalin encapsulated in the lid that releases formalin via a thumb press to safely cover biopsy samples. The 60ml size facilitates handling multiple biopsies at once, with samples placed in cassettes arranged in the container before lid sealing and formalin release.
Quantifiable outcome
- Complete elimination of formaldehyde exposure risk during biopsy handling
- +1 more outcomes
Companies that use Biopsafe
Customer profileNamed customers1 record
Segments1 record
Ideal customer profiles1 record
Biopsafe technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Biopsafe partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- AxlabcoreBiopSafe is part of Axlab, which is specialized in solutions for pathology. Axlab provides the infrastructure, expertise, and brand association for BiopSafe's product development and global distribution.
- European Biosafety Network (EBN)coreEuropean Biosafety Network collaborates with BiopSafe on educational content including webinars, white papers, and press releases about formaldehyde exposure risks in healthcare settings. EBN provides credibility and regulatory expertise in occupational health.
Scale indicators3 records
Recent moves6 records
Expansion highlights5 records
Biopsafe competitors and assessment
Company assessmentDirect peers
- StatLab Medical Products: Independent manufacturer and distributor of histology and pathology supplies, including biopsy cassettes, containers, and fixatives serving the same hospital and reference lab customer base as BiopSafe.
- Epredia: Global anatomical pathology supplies vendor (formerly Thermo Fisher Anatomical Pathology), offering specimen containers, fixatives, and histology consumables directly comparable to BiopSafe's biopsy-handling portfolio.
- Leica Biosystems: Major pathology and histology solutions provider (Danaher) offering specimen handling, processing, and staining consumables that overlap with BiopSafe's biopsy container use case.
- Simport Scientific: Manufacturer of histology and laboratory consumables, including specimen containers and cassettes, serving the same pathology and clinical laboratory channels as BiopSafe.
- Sakura Finetek: Specialist in histology and pathology processing equipment, including tissue processors and consumables that interface with biopsy fixation workflows similar to BiopSafe's closed-vial system.
- Azer Scientific: US-based supplier of histology and cytology consumables, including specimen containers and reagents that compete for the same pathology procurement budgets.
- Ted Pella: Supplier of microscopy, histology, and specimen preparation products, including biopsy handling accessories that overlap with BiopSafe's offering in research and clinical pathology labs.
- Milestone Medical: Specialist in histopathology and tissue processing equipment, with product lines in specimen handling and fixation that intersect with BiopSafe's biopsy workflow.
Broad incumbents
- Thermo Fisher Scientific: Global life sciences conglomerate with extensive anatomic pathology and lab consumables offerings that overlap with BiopSafe's addressable market, serving as both a competitor and a potential acquirer.
- Cardinal Health: Large diversified medical products distributor with a broad portfolio that includes pathology and lab supplies, giving it incumbent leverage in hospital procurement channels where BiopSafe also competes.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks6 records
Key highlights7 records
Customer concentration
Biopsafe social profiles
Digital presenceBiopsafe compliance and trust
Trust signalCompliance5 records
Biopsafe financial estimates
Financial estimateRevenue estimate
Valuation estimate
Biopsafe leadership team
Management profileNumber of profiles
Profiles7 records
Biopsafe funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Biopsafe M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Biopsafe
What does Biopsafe do?
BiopSafe develops and sells a closed-system biopsy container that encapsulates formalin in the lid; a light thumb press releases the formalin inside a hermetically sealed vial to safely cover biopsy samples. The product is offered in 20ml and 60ml sizes and is sold to hospitals, clinics, and pathology laboratories through a global distributor network to eliminate healthcare worker exposure to formaldehyde during biopsy handling and transport.
Is Biopsafe a public or private company?
Biopsafe is a private company. It is classified as corporate owned and is currently operating.
When was Biopsafe founded?
Biopsafe was founded in 2014. It employs 1 to 10 people.
Where is Biopsafe based?
Biopsafe is headquartered in Vedbæk, Denmark, in the Europe region.
How does Biopsafe make money?
One revenue line is on record: medical device sales.
Who are Biopsafe's main competitors?
Direct peers on record are StatLab Medical Products, Epredia, Leica Biosystems, Simport Scientific, Sakura Finetek, Azer Scientific, Ted Pella and Milestone Medical. Broad incumbents are Thermo Fisher Scientific and Cardinal Health.
Does Biopsafe have an API?
No public API is recorded for Biopsafe.
What industry is Biopsafe in?
Biopsafe's product category is Medical Devices - Biopsy Containers. Its primary akta.pro industry code is HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy), with a secondary code of HLAGAEAB, Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry). Its NAICS code is 3391 and its SIC code is 3841.