Ekos Corporation

Starting point, 1999

Ekos Corporation had developed an ultrasound-based technology for localized thrombolysis — an innovation with substantial market potential in the treatment of deep vein thrombosis and pulmonary embolism. The FDA data set in the US was robust, but for the German and European market there was no comparative clinical data from a German treatment pathway.

Without study data generated in Germany, a hospital listing in cardiology or interventional radiology was out of reach. German department heads do not ask for US studies — they ask for data from German comparison cohorts.

Mandate

Ekos became one of the first mandates in the year MEX was founded. The task: set up a multi-center clinical study, win KOLs at German university hospitals in cardiology and interventional radiology, adapt the study protocol to German reimbursement and treatment practice, and coordinate the pipeline from study start through to publication.

Delivery

MEX set up the multi-center trial at five German university hospitals, in the following steps:

• KOL identification and acquisition in cardiology and interventional radiology at leading university hospitals.
• Study protocol translated into German treatment standards in coordination with the study centers (dosing, comparator procedures, outcome definitions).
• Ethics committee coordination across the five participating sites.
• Operational study coordination during patient recruitment, data management and quality monitoring.
• Pipeline translation of the FDA data sets into an EU and German publication and listing format.

In parallel, MEX prepared the regulatory market entry track — at the time still under the Medical Devices Directive 93/42/EEC, the predecessor of today’s MDR 2017/745.

What it meant for the MEX model

The Ekos mandate was the first practical demonstration that a German launch is not primarily a sales question but a question of clinical evidence. That experience fed directly into the roadmap for the Zassi mandate, which began shortly afterwards, and shaped what later became the MEX module Board of Experts (Module 6).

In today’s language: Ekos showed that a KOL test plus a clinical study at a leading German hospital is the entry ticket — and that neither a distributor nor a marketing agency can provide it.

Where this transfers

For foreign MedTech manufacturers whose product is clinically explanation-intensive and who bring robust study data from their home market, a comparable arc is still the fastest route to clinical listings — structured through Module 6 (Board of Experts) and Module 2 (MDR compliance) of the MEX plug-and-play solution.

We are happy to discuss it in a 30-minute discovery call.