Profusa, Inc.

What they do

Profusa has spent over twelve years and more than $100 million (including roughly $30 million from DARPA and NIH) developing a biosensor platform injected subcutaneously with a hypodermic needle, with the sensor using luminescence to signal a reader placed over the injection site. Its lead product, Lumee Oxygen, monitors perfusion in Critical Limb Ischemia patients and holds a CE mark in Europe; Lumee Glucose, for continuous glucose monitoring, is in clinical trials. The company sold its oxygen sensor for research use only in 2024 and had 2024 annual revenue of $100,000.

Revenue drivers

• Lumee Oxygen — CE-marked in Europe, launched there in 2023 for wound care and CLI perfusion monitoring, and used by key opinion leaders on a trial basis in Germany, Austria and France; U.S. launch is planned for 2026 only if FDA clears or approves it.
• Lumee Glucose — Pre-commercial continuous glucose monitoring product for diabetics and pre-diabetics, expected to launch in Europe in 2026 subject to regulatory approval, with a planned dual strategy of direct-to-hospital professional and personal use plus direct-to-pharmacy personal use.
• Research-use sensor sales — In 2024 the company sold its oxygen sensor for research-use-only applications such as animal models and in vitro testing; this was the source of the $100,000 in 2024 annual revenue.
• G3 Vision Labs (proposed) — No revenue contributed yet; G3's CLIA-certified and CAP/CLIA-accredited national laboratories provide molecular diagnostic infectious disease and urine and blood clinical toxicology testing to providers in addiction treatment, pain management and behavioral health, which the company says would bring recurring revenues.

Recent performance

Cash on hand at June 30, 2026 was $719,000, total assets were $1.0 million, and total liabilities were $28.2 million, producing a total stockholders' deficit of $(27.1) million. Net loss was $(8.8) million for the three months ended June 30, 2026 versus $(2.3) million a year earlier, and $(12.2) million for the six months ended June 30, 2026 versus $(5.1) million a year earlier. Annual net loss widened from $9.2 million in 2024 to $35.8 million in 2025, and operating cash flow went from $(2.1) million in 2024 to $(16.2) million in 2025.

Strategy

Profusa's stated plan is to win FDA clearance or approval for Lumee Oxygen in the U.S. by early 2026 and for Lumee Glucose in late 2026 or early 2027, with Europe serving as the earlier launch market for both. It also describes a joint venture effort with Asian investors (3E Bioventures, Tasly Pharma, VMS Capital, who have collectively invested over $50 million in preferred stock and convertible notes) for Asia Pacific market access. On August 20, 2026 the company reported progress on conditions to exercise its Option Agreement to acquire G3 Vision Labs, a commercial-stage diagnostics company; the option is exercisable but not obligatory. A 4:1 reverse stock split became effective August 18, 2026, and debt and liability holders have executed $10.7 million of Series A Convertible Exchange Agreements, of which $4,570,298 was exchanged into 4,271.298 shares of Series A Convertible Preferred Stock. Profusa also borrowed $650,000 under its current note agreement for near-term working capital.

Risks

• Going concern — The 10-K risk factors state there is substantial doubt about the company's ability to continue as a going concern and that this may hinder its ability to obtain further financing.
• Nasdaq listing compliance — An 8-K filed August 31, 2026 reports a delisting notice or listing-rule failure, and the 10-K already disclosed notification of failure to comply with certain Nasdaq Global Market continued listing requirements.
• No U.S. product approval — Lumee Glucose is not authorized for commercial sale in any jurisdiction and Profusa has no regulatory approval to sell any product in the U.S., leaving commercialization dependent on timely regulatory approval that cannot be assured.
• Internal control weaknesses — Management concluded that internal controls over financial reporting were not effective as of June 30, 2026, citing segregation of duties, lack of review controls and expertise for financial instrument valuations, and lack of technical accounting expertise for complex debt and equity instruments; these material weaknesses were not remediated as of that date.

Outlook

The company says it has obtained sufficient working capital to fund operations for the near term, supported by the $650,000 note borrowing and the executed exchange agreements. It expects stockholders' equity of $28.4 million as of July 31, 2026 as a result of executing the Option Agreement and says the reverse split and option execution have been supportive of meeting Nasdaq's minimum listing requirements. Closing the G3 acquisition is conditioned on, among other things, G3's PCAOB audits of 2024 and 2025, which G3 auditors expect to complete for most business entities by end of August and for the entire business by mid-September. Management's stated product timeline remains FDA approval of Lumee Oxygen in the U.S. by early 2026 and Lumee Glucose in late 2026 or early 2027.