Profusa's High-Stakes Bet on an Implantable PAD Sensor

BERKELEY, CA – November 24, 2025 – Digital health company Profusa, Inc. is preparing for a pivotal moment. The company announced it will present a late-breaking clinical trial update for its Lumee™ Oxygen platform at the prestigious Paris Vascular Insights conference in December. The presentation, delivered by renowned vascular surgeon Dr. Peter Schneider, promises a new look at data from a U.S. study of its novel implantable sensor in patients with Peripheral Artery Disease (PAD).

For a company navigating the treacherous path from innovation to revenue, this is more than just a scientific update. It’s a high-stakes bid for validation in front of a global audience of clinicians, partners, and investors. While the press release highlights a “disruptive biochemistry monitoring platform,” a deeper look reveals a company at a critical commercialization crossroads, where promising technology is clashing with harsh financial realities.

A New Front in the War on Amputation

Peripheral Artery Disease is a silent and widespread circulatory problem affecting an estimated 8.5 million Americans and over 200 million people globally. Caused by the buildup of plaque in arteries, it restricts blood flow, most commonly to the legs. While some patients experience the classic symptom of leg pain during exertion, known as claudication, up to 40% have no pain at all, allowing the disease to progress undetected.

This progression can be devastating. As oxygen-starved tissue begins to fail, it can lead to chronic pain, non-healing wounds, gangrene, and ultimately, amputation. The key to preventing these severe outcomes is effective monitoring of tissue oxygenation, but current methods have significant limitations. The standard of care often involves periodic, non-invasive tests like the ankle-brachial index (ABI) or transcutaneous partial pressure of oxygen (tcpO₂) measurements. These provide only a snapshot in time, typically taken within a clinical setting, and fail to capture the dynamic, real-time changes happening within the tissue.

Profusa aims to fundamentally change this paradigm. Its Lumee™ Oxygen platform is built around a tiny, injectable hydrogel sensor, no bigger than a grain of rice, designed to reside just under the skin for long-term use. This sensor fluoresces in response to local oxygen levels. A non-invasive, wearable electronic patch is placed over the sensor site, powering it and reading the fluorescent signal. The data is then transmitted wirelessly to a smartphone app, providing a continuous, real-time stream of tissue oxygen data. The vision is to move monitoring out of the clinic and into the patient's daily life, offering an unprecedented view of their underlying physiology.

“Our Lumee oxygen tissue monitoring technology enables continuous, real-time measurement of tissue oxygen directly within the body, a first-of-its-kind, disruptive biochemistry monitoring platform designed for use both in the clinic and at home,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO, in the company's announcement.

The Weight of Commercialization

While the technology holds immense promise, Profusa’s journey illustrates the immense pressure of translating innovation into a viable business. Despite identifying as a “commercial stage” company, its recent financial filings paint a precarious picture. The company reported zero revenue for the third quarter of 2025 and saw its net loss swell to over $22 million. With only $3 million in cash against a working capital deficit of $19.3 million as of September 30, management has been forced to acknowledge “substantial doubt about the company’s ability to continue as a going concern.”

Compounding these financial headwinds are compliance challenges with the Nasdaq stock exchange. Profusa has received multiple notices for failing to meet minimum requirements for its stock price and market value, putting it at risk of delisting if it cannot regain compliance by spring 2026. The company recently delayed filing its quarterly report, citing a need for more time to finalize disclosures.

This context transforms the Paris presentation from a routine scientific discourse into a critical catalyst for the company's survival. Positive, compelling data that demonstrates the Lumee sensor's accuracy and clinical utility compared to the tcpO₂ standard could be a powerful lifeline. It could reassure anxious investors, attract new capital, and validate the company's long-term strategy, potentially boosting its stock price back into compliance. A lackluster presentation, however, could have the opposite effect, deepening concerns about its ability to execute on its commercial goals.

The Long Road to Market

Despite the financial strain, Profusa has been making tangible progress on its commercialization pathway. The data being presented in Paris comes from its ongoing U.S. clinical trial (NCT04514861), which began in late 2020 and is not expected to be completed until 2027. This long-term study is designed to formally correlate the Lumee platform's readings with the established tcpO₂ measurement, a crucial step for gaining FDA approval and wider clinical adoption in the United States.

In parallel, the company has pursued a European strategy. The Lumee Oxygen platform received its CE Mark approval in January 2020, clearing it for sale in Europe. Profusa has laid the groundwork for a European launch in the first quarter of 2026, establishing distribution partnerships with AngioPro and Dismeval, S.L. to cover key markets and securing collaborations with influential clinicians like Dr. Marianne Brodmann at the Medical University of Graz in Austria. These efforts suggest a methodical approach to building a market presence, even if revenue generation, projected to begin in 2026, has yet to materialize.

The competitive landscape for PAD diagnostics is growing, with the global market projected to exceed $5.9 billion by 2035. While companies like Edwards Lifesciences and Spectros Medical Devices offer non-invasive tissue oximetry systems, Profusa’s key differentiator is its implantable, long-term sensor for continuous home and ambulatory monitoring. If the clinical data proves its value, this unique capability could carve out a significant niche, offering clinicians a tool to proactively manage PAD and potentially prevent the catastrophic limb-threatening events that plague so many patients. For Profusa, the path from prototype to profit is reaching a critical inflection point, and the spotlight in Paris will be incredibly bright.