Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.
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We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.
We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.
We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.
Axon assisted a Dutch IVD company in securing a EUR 24M equity financing round, advising on the transaction structure, investment documentation and related matters.
Axon acted on behalf of an investor in connection with their investment in a clinical-stage biotech company developing first-in-class therapeutics and diagnostics for fibrosis. We conducted legal due diligence on the target company and reviewed the transaction documentation on behalf of the investors.