Osborne Clarke advises CoaguSense on acquisition of DOASENSE DOAC testing business

Osborne Clarke has advised CoaguSense, Inc., a leading developer of point-of-care coagulation monitoring systems and a subsidiary of i-SENS, Inc., on the acquisition of the DOAC testing business of DOASENSE GmbH, Heidelberg. With this transaction, CoaguSense strengthens its position in the global anticoagulation diagnostics market and expands its portfolio beyond traditional Vitamin K Antagonist (VKA) monitoring to include tests for the dynamically growing market of Direct Oral Anticoagulants (DOACs).

For this purpose, CoaguSense has entered into a binding asset purchase agreement to acquire the DOASENSE DOAC testing business. Completion of the transaction is subject to customary closing conditions and is expected to occur within the next twelve months.

Expansion of point-of-care portfolio to include DOAC diagnostics

The scope of the transaction includes in particular the DOASENSE product family centred around the DOAC Dipstick, the first point-of-care test for the detection of direct oral factor Xa and thrombin inhibitors. Unlike traditional blood-based assays, the DOAC Dipstick uses urine samples and enables qualitative test results within around ten minutes – an important component for clinical practice in emergency departments, the perioperative environment and other time-critical care situations.

The product portfolio includes, in addition to the DOAC Dipstick, the DOASENSE Reader as well as supplementary control solutions. The products are IVDR CE-marked and registered with various regulatory authorities, including the European Union (EU), the MHRA (United Kingdom), the TGA (Australia) and ANVISA (Brazil).

The acquisition of the DOASENSE DOAC testing business supplements the recent European IVDR approval of the Coag-Sense® PT/INR Monitoring System for patient self-testing. In combination, this creates a broad, practice-oriented range of solutions for monitoring both traditional warfarin therapies and modern DOAC treatments, and consolidates CoaguSense’s role as a versatile provider in the global anticoagulation diagnostics market.

“With this transaction, we are further expanding our excellent life sciences and healthcare transactions practice in the area of innovative diagnostic solutions,” said Robin Eyben, M&A Partner at Osborne Clarke. “Advising CoaguSense on the acquisition of the DOASENSE DOAC testing business illustrates how international medtech companies strategically broaden their product portfolios to meet the clinical need for fast, reliable coagulation diagnostics in point-of-care settings – and the important role that carefully designed transaction and regulatory structures play in this.”

Comprehensive legal support in a regulated medtech environment

Osborne Clarke provided CoaguSense with comprehensive advice on the corporate, transactional, contractual, regulatory and competition law aspects of the transaction. The advice covered, among other matters, structuring of the asset deal, negotiation of the transaction documentation, IP and IT law issues, regulatory requirements in the medical devices and diagnostics sector, as well as competition law issues in connection with the international orientation of the business.

The Osborne Clarke team that advised CoaguSense comprised Robin Eyben (lead), Maximilian Vocke, Dr Paul Rhode, Natalie Merkle, Dana Alpar (all Corporate / M&A), Dr Florian Reiling, Dr Jonas Völkel, Anton Salmhofer (all IP), Julia Kaufmann, Dr Florian Eisenmenger (both IT), Marco Aatz, Susanne Schricker (both Competition), Alexander Schlicht, Anna Lehner (both Employment) and Sarah Grigo (Commercial).