Microorganopits · NAM system
Patent family & copyright · acquired 2026- PublicationWO 2024/208464 A1 · EP 4 565 678 A1
- NationalUS 19/472,236 · CA 3287463 · CN 202480024583.3
- InventorsS. Munker, S. Zahler, M. Silva
- OriginLMU München
MM4I is the technology provider and laboratory for the medical technologies of the future. Reaching them takes a jump. We build for the landing.
Medicine & Machines 4 Innovation. We enter through oncology, where entering can be justified.
The systems
MM4I acquires and holds intellectual property arising from publicly funded research, carries the regulatory strategy, and takes each system to market on its own before any of them are joined. The work is concentrated today on AI-accelerated drug discovery.
01
Oncera · current focus
AI-accelerated discovery of novel drug candidates, building towards a drug library and the platform that generates it.
02
New approach methodologies, the term regulators use for evidence generated without animal testing. Patient-derived, in place of extensive preclinical testing. Protected by the Microorganopits patent family and copyright, acquired from LMU Munich.
03
A continuous, imaging-derived measure of treatment response for early-phase oncology. Concept validation under way and IP filing in progress. We are working towards letters of intent from FDA and EMA and registration as a medical device.
04
At concept stage. Diagnosis read at the level of the tissue itself, joining the stack once the layers beneath it carry weight.
VITE
Each system runs its own course and merges when it is ready. Discovery moves in silico, preclinical testing gives way to organoids, and those two combine first. CT efficacy joins once there is a response to measure. Tissue-level diagnostics join last.
The four together are VITE, a vertically integrated treatment engine. Held in one place they compound, and an end-to-end individualised medicine, with individualised oncology inside it, becomes a goal we believe is reachable within our lifetime.
Regulation will follow the data points that make that case, and it is already moving. The FDA is spearheading. Its Modernization Acts lifted the statutory requirement to test in animals and put human-relevant methods on an equal footing, and its February 2026 draft guidance on the plausible mechanism framework opens a route for individualised therapies where a randomised trial is not practical. Ethical decision-making is being treated as a priority. The EMA opens a second angle. With its Innovation Task Force it brings new approach methodologies into the nonclinical framework, and its Qualification of Novel Methodologies procedure lets a method be qualified on its own evidence, ahead of any single product and independent of it. Guidance from June 2026 extends that across the full product lifecycle, and organoids sit among the methods the Agency already names. For four systems held in one place, that is the natural door.
Four technologies, four businesses. Discovery and organoids converge first, CT efficacy joins once there is a response to measure, tissue-level diagnostics join last, and from there a single path runs to the endpoint.
The entry point
Individualised medicine asks a patient to accept an approach that, by construction, has not been tested on people like them. We believe advanced solid tumours are where that question can be approached most carefully, and where the variation between patients is a large part of the clinical problem in the first place.
The counterfactual is often weak
In advanced solid cancers, once the standard lines are exhausted, the remaining options can be limited. The case for examining something new is easier to make where the established option has least left to offer.
The framework already exists
Molecular tumour boards, early-phase units and established ethics review already govern individual treatment decisions in oncology. We work inside that framework.
The initial context of use stays deliberately narrow, the clinical and ethical frame is built together with a university-hospital partner, and the path runs through regulatory-science dialogue. None of this is settled, and we would rather work slowly through those questions than around them.
Portfolio
Assets are listed with their identifiers.
Software, model weights, training and evaluation pipelines, datasets and documentation.
Method, validation framework and regulatory strategy. A non-confidential concept summary is available on request.
Takes the discovery system to market under its own name.
Contact
MM4I works with university hospitals, research institutes, funding bodies and industry partners. If your work touches any layer of the stack, we would like to hear from you.
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