Profusa Enters CRO Market with Game-Changing Biosensor Technology

BERKELEY, CA – January 16, 2026 – Digital health pioneer Profusa, Inc. today announced a significant strategic pivot, launching its Lumee™ tissue oxygen monitoring system into the lucrative contract research organization (CRO) market. This move makes the company's advanced biosensor technology commercially available for research-use-only (RUO) applications, a decision poised to generate immediate revenue and reshape how new drugs are developed and tested.

By offering its validated, tissue-integrated sensors to organizations that manage outsourced research for pharmaceutical giants, the Berkeley-based company is tapping into a rapidly expanding sector. More importantly, it introduces a powerful new tool capable of providing continuous, real-time biological data—a dataset that has been largely inaccessible to researchers until now.

A Strategic Play in a Booming Market

Profusa's entry into the CRO space is a calculated move targeting a market characterized by explosive growth. The global pharmaceutical CRO market is estimated to be worth approximately $47.9 billion in 2025 and is projected to more than double in the next decade. Industry analyses, while varying slightly in exact figures, consistently point to a compound annual growth rate (CAGR) exceeding 7%, with some estimates projecting the market could reach over $91.2 billion by 2034. This expansion is fueled by several powerful trends.

Pharmaceutical and biotech companies are facing immense pressure to reduce the staggering costs and lengthy timelines of drug development. Consequently, R&D outsourcing has become standard practice. The increasing complexity of clinical trials, particularly in specialized fields like oncology and gene therapy, demands sophisticated expertise and advanced methodologies that CROs are well-equipped to provide. Furthermore, regulatory bodies are encouraging the use of New Approach Methodologies (NAMs) that can provide more predictive data, reduce reliance on traditional models, and mitigate the risk of costly late-stage trial failures.

By positioning the Lumee system as a ready-to-deploy platform for this market, Profusa aims to provide CROs with a distinct competitive advantage. The ability to offer clients continuous, high-fidelity biological data allows them to deliver deeper insights and potentially more predictive study outcomes, differentiating their services in a crowded field.

Redefining Research with Continuous Data

The core innovation behind Profusa's new offering is the Lumee system itself. Unlike traditional methods that rely on intermittent snapshots or endpoint assays, Lumee utilizes a tiny, injectable hydrogel biosensor that integrates with tissue to stream data continuously. An external optical reader captures the sensor's signals, providing a real-time, minute-by-minute measurement of local tissue oxygen levels.

This capability is a paradigm shift for preclinical research. Tissue oxygenation is a critical parameter in a vast range of biological processes and disease states. In oncology, for example, the oxygen level within a tumor microenvironment can dramatically influence tumor growth, metastasis, and a patient's response to radiation or chemotherapy. With Lumee, researchers can now observe these dynamics unfold in real time, offering unprecedented insights into how a potential cancer therapeutic is performing.

Beyond oncology, the applications are broad. The system can provide invaluable data for studies on wound healing, where oxygen is essential for tissue repair. It can also enhance the physiological relevance of advanced research models like organ-on-a-chip platforms, which aim to better mimic human biology. By providing a continuous stream of data, Lumee allows researchers to move beyond simple before-and-after measurements and understand the complex, dynamic biological processes that occur in response to a new drug candidate.

Navigating the Path to Market

Profusa's ability to enter this market so quickly is facilitated by the 'Research-Use-Only' (RUO) regulatory pathway. RUO products, which must be clearly labeled "For Research Use Only. Not for use in diagnostic procedures," are not intended for making clinical decisions about patient care. This classification allows innovators to get advanced tools into the hands of scientists and researchers without undergoing the lengthy and expensive regulatory approval process required for clinical diagnostic devices. This accelerates the pace of scientific discovery and allows for the rapid integration of new technologies into the drug development pipeline.

To spearhead this commercial effort, Profusa has appointed Sean Givens as the Head of Government and Healthcare Research Business. Givens' background appears tailor-made for the role, with over two decades of experience spanning government contracting, medical devices, and drug development. His previous role as co-founder and COO of MIODx, a company focused on predicting patient response to immunotherapy, demonstrates direct experience in bringing novel research technologies to market. This is complemented by his success in securing major government contracts during his time at Cellerant Therapeutics, making him uniquely qualified to navigate both commercial and government research sectors.

"This is a natural and timely extension of Profusa’s platform building off of previous successes of this market,” said Mr. Givens in the company's press release. “Our sensors are validated, ready to ship, and already generating strong interest across the industry. By partnering with CROs, we can help accelerate better drug development decisions while creating a meaningful, near-term revenue stream for Profusa.”

The Future of Drug Development

The introduction of technologies like the Lumee system signals a broader shift in pharmaceutical research. The industry is moving away from a one-size-fits-all approach and toward a future of precision medicine, where treatments are tailored based on an individual's unique biological makeup. Achieving this vision requires vast amounts of high-quality, personalized data.

Continuous biosensors provide a foundational piece of that puzzle. By offering a direct window into the body's biochemistry, they can help researchers identify biomarkers, understand drug mechanisms of action more deeply, and ultimately predict which patients are most likely to benefit from a particular therapy. This data-driven approach holds the potential to make drug development not only more efficient and cost-effective but also more successful, leading to safer and more effective therapies for patients worldwide. Profusa's strategic launch places its technology at the very heart of this transformation, equipping the research community with a tool to build the future of medicine.