Mobius Medical

What Mobius Medical does

Mobius Medical is a privately held, founder-led contract research organization (CRO) founded in 2006 and headquartered in North Sydney, Australia, with additional offices in Auckland, New Zealand and Minneapolis, USA. The company specializes exclusively in clinical trial services for medical devices — covering clinical trial strategy, full-service trial execution, regulatory affairs, quality management, data analysis, and post-market surveillance — and has managed 140+ trials across 27+ therapeutic areas, supporting 100+ devices to regulatory approval. Its differentiated offering is the 'ANZ-to-US bridge model,' which leverages shorter Australian and New Zealand ethics approval timelines (6-12 weeks) to generate FDA- and EMA-acceptable data for US market entry, addressing a niche that larger pharma-focused CROs (IQVIA, Parexel) do not prioritize for MedTech.

The company operates under an ISO 9001-certified quality management system (held 10+ years) with ICH-GCP and ISO 14155 compliance, producing inspection-ready trial outputs. Service tiers include early feasibility studies (AUD $250K-$1M per project), pivotal studies (higher cost, multi-year), and an expanding ecosystem of supplementary services covering pre-clinical testing, design and development support, clinical trial supplies, reimbursement, and commercialization planning. The customer base spans two primary segments: MedTech startups and scale-ups needing investment-grade feasibility data and regulatory pathway support, and global enterprises/CROs requiring local ANZ site activation, regulatory submissions, and ANZ-to-US data bridging. The company is structured as Mobius Medical Pty Ltd (Australia, ABN 70 054 967 646) and Mobius Medical USA, Inc. (Minnesota), with continued founder control under CEO Stefan Czyniewski, COO Suzanne Williams, and CFO Richard Brookes.

Name

Mobius Medical

Legal name

Mobius Medical Pty Ltd

Website

https://mobius-cro.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

51–100 employees

Short description

Mobius Medical is a founder-led, ISO 9001-certified contract research organization specializing in end-to-end clinical trial services for medical devices, serving MedTech startups and global enterprises across Australia, New Zealand, and the USA.

Ownership category

akta.pro rank

Product category

Contract Research Organization (Medical Device Clinical Trials)

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro industry

PRIMARYHLAGAAAA

Clinical CROs (Phase I–IV)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAB

Preclinical CROs (Discovery/Pharmacology/DMPK)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

Keywords

• Clinical trial services
• Medical device CRO
• Regulatory affairs
• Clinical research organization
• Site activation management

Headquarters

HQ city

North Sydney

HQ country

Australia

HQ region

Oceania

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Trial Services: Full-service clinical research organization providing end-to-end clinical trial services for medical devices. Revenue generated through project-based fees for study design, execution, regulatory strategy, site management, monitoring, data management, and reporting.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Mobius Medical is a boutique Contract Research Organization (CRO) providing end-to-end clinical trial services specifically for medical device innovators. Its service platform spans three core pillars—Clinical Trial Strategy, Clinical Trial Execution, and Regulatory & Beyond—covering feasibility analysis, site activation, monitoring, data management, biostatistics, regulatory submissions, and post-market surveillance. The company operates across Australia, New Zealand, and the USA, with an ANZ-to-US Bridge model that uses FDA-accepted Australian and New Zealand trial data for accelerated US market entry.

Product overview

Mobius Medical is a full-service Contract Research Organization (CRO) offering an integrated platform of clinical trial services for MedTech innovators. The core offerings comprise three interconnected service pillars: Clinical Trial Strategy (design and planning), Clinical Trial Execution (end-to-end management), and Regulatory & Beyond (compliance and market access). Supporting these core services are supplementary modules including Site Activation & Support, Physician Interface, Regulatory Affairs & Planning, Quality & Safety, Data Analysis & Reporting, and Commercialisation & Market Access. The company also offers specialized pathways including the ANZ-to-US Bridge model for efficient regulatory navigation. Additional ecosystem services encompass Pre-Clinical Services, Design & Development Support, Clinical Trial Supplies, Reimbursement Support, and Post-Market Surveillance, enabling clients to progress from concept through commercialization within a single partner ecosystem.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trial Strategy A MedTech-focused clinical trial strategy service that performs concept and feasibility analysis, clinical planning, synopsis development, regulatory package creation, IEC/IRB approvals, and Key Opinion Leader collaboration. It is designed for medical device innovators and startups seeking investor-grade trial design and regulator-ready submissions.
• Clinical Trial Execution An end-to-end clinical trial management service covering site selection, qualification, approvals, IP handling, activation, enrollment, monitoring, safety reporting, biostatistics, and clinical investigation reports. It is used by medical device companies and global CROs running trials across Australia, New Zealand, and the USA.
• Regulatory & Beyond A regulatory pathway and compliance service offering pathway assessments, submissions support, TGA CTN Local Sponsor services, ISO 9001-certified QMS, compliance/CAPA systems, and independent Quality Assurance oversight. It is intended for medical device clients submitting to the FDA, EMA, TGA, and other regulators.
• Pre-Clinical Services Pre-clinical evidence generation services including bench and lab testing, small and large animal testing, and cadaver wet lab testing. These services support medical device clients needing preliminary evidence before first-in-human clinical studies.
• Design & Development Support Product design and development support including product development, prototype and small batch manufacturing, technical file development, clean room and equipment hire, MVP/design lock, scale-up, and clinical engineer support. It is aimed at medical device startups progressing innovations from concept to clinical trial.
• Clinical Trial Supplies Clinical trial supply services including pathology kits, core labs, imaging, logistics, investigational product storage and distribution, and IP compounding. These support medical device and combination product trial execution.
• Reimbursement Support Reimbursement and market access support covering medical policy and coverage research, payer research and gap analysis, coding and billing, and health economics. It serves medical device companies preparing for commercialization following regulatory approval.
• Post-Market Surveillance Post-market clinical follow-up (PMCF) studies, safety reporting, and ongoing clinical evaluation services to maintain regulatory compliance after product launch. Used by medical device manufacturers as required by FDA, EMA, and TGA.
• ANZ-to-US Bridge Program A regulatory pathway program that uses early feasibility or safety studies in Australia and New Zealand to generate high-quality clinical data accepted by the FDA and EMA for IDE, 510(k), De Novo, or CE Mark submissions. It targets medical device innovators seeking accelerated entry into the US market, leveraging Australian ethics approvals typically obtained in 6–12 weeks.

Quantifiable outcome

• 140+ clinical trial projects managed successfully
• +3 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Monash IVFcoreStrategic or Co-development PartnerCollaborative partner in conducting the pivotal multicentre clinical trial for Memphasys electrophoretic sperm selection system. Mobius managed the trial while Monash IVF provided clinical expertise and site facilities for the comparative study against standard laboratory methods.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• NAMSA: Specialized MedTech-focused CRO providing preclinical, clinical, and regulatory services for medical devices; closest direct peer to Mobius given its end-to-end MedTech focus and combined clinical/regulatory service lines.
• Premier Research: CRO with a dedicated Medical Device and Diagnostics practice offering clinical and regulatory services; comparable to Mobius in serving MedTech innovators across feasibility through pivotal stages.
• Clinipace Worldwide: Mid-sized full-service CRO with experience across therapeutic areas and medical device clinical research; comparable boutique-to-mid tier CRO pursuing similar MedTech and emerging biotech sponsors.

Broad incumbents

• ICON plc: Large global CRO operating a Medical Device and Diagnostics unit alongside broader pharma services; comparable to Mobius in clinical trial execution for devices but vastly larger in scale and footprint.
• Medpace: Mid-sized global CRO with a dedicated Medical Device and Diagnostics division; directly comparable to Mobius for medical device trial execution, with significantly larger scale across global geographies.
• CPR Pharma Services / Bioclinica CRO: CRO and clinical research services provider with medical device and diagnostics experience; partially overlaps with Mobius's clinical trial execution and data management offerings at a larger scale.
• Worldwide Clinical Trials: Global CRO with medical device clinical research capability among its broader service lines; comparable to Mobius in device clinical trial management but operates at a larger enterprise scale.
• IQVIA: Largest global CRO with broad MedTech clinical research offerings; overlaps with Mobius on device trial design, site management, and data services, though IQVIA's portfolio extends across pharma and life sciences more broadly.

Regional players

• George Clinical: Asia-Pacific based CRO with strong ANZ presence providing clinical research across multiple therapeutic areas; directly comparable to Mobius's ANZ regional footprint and ANZ-to-US bridging positioning.

Emerging players

• Device Clinical Trials (DeviceCROs): Boutique medical device CRO focused specifically on device clinical trial management and regulatory strategy; closely comparable specialist positioning to Mobius in the niche MedTech trial services market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/mobius-medical-pty-ltd
• Xx.com/MobiusMedicalAu
• Facebookfacebook.com/mobiusmedical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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 Mobius Medical