Profusa, Inc. Common Stock

Profusa Receives ISO 13485:2016 Certificate from GMED

Profusa received its ISO 13485:2016 certificate from GMED, an EU MDR notified body, covering the design, development and manufacture of the Lumee Oxygen Platform at its Berkeley, California facility. The certification supports ongoing MDR conformity assessment toward a potential MDR certificate and CE marking, and enables Profusa to begin manufacturing the Lumee Oxygen Sensor Platform. No assurance was given on timing or outcome of the remaining MDR activities or CE marking; the release also references a pending option to acquire G3 Vision Labs and a prior withdrawal of a registration statement.

•20d ago

Profusa Announces Significant Progress Towards Lumee® Oxygen Platform CE Mark with ISO 13485 Certification Expected in Early October

Profusa received a positive decision from notified body GMED on ISO 13485 certification of its quality management system, a key step toward European CE marking of the Lumee Oxygen Platform. Certification is expected in early October, after which the company must still complete remaining MDR conformity assessment activities before the CE mark can be issued. The company cautions there is no assurance on the timing or outcome of the remaining assessments, so the milestone advances but does not guarantee the European launch path.

•1mo ago

Profusa, Inc. Receives Nasdaq Compliance Determination

Profusa, Inc. (Nasdaq: PFSA) announced it received a Nasdaq Compliance Determination Letter dated September 9, 2026, confirming the company has demonstrated compliance with both the minimum bid price rule (5550(a)(2)) and the equity rule (5550(b)(1)). The relief is conditional: Profusa remains subject to a one-year Mandatory Panel Monitor, and if it fails the equity rule during that period Nasdaq will issue a delist determination without offering a compliance plan, though an appeal hearing would stay further action. Profusa is a Berkeley, CA-based digital health company developing biosensor technologies, and it holds an option to acquire G3 Vision Labs, with the combined company expected to operate as a public diagnostics company.

•1mo ago

Profusa Announces Signing of Option Agreement for the Acquisition of a Commercial Stage Diagnostics Company, G3 Vision Labs

Profusa signed an option agreement to acquire G3 Vision Labs and its subsidiaries, a commercial-stage diagnostics business with estimated 2025 net revenues of approximately $111 million. The transaction is contingent on Profusa securing at least $30 million in financing, refinancing G3's existing debt, and obtaining shareholder and Nasdaq approvals. As consideration for the option, Profusa issued 201,120 common shares and approximately 52,904 preferred shares, with the potential for significant dilution if the option is exercised given the 1:1000 conversion ratio on preferred stock.

•3mo ago

Profusa Announces Key Management Changes and Signing of Non-Binding Term Sheet for the Acquisition of a Commercial Stage Diagnostics Company

Profusa signed a non-binding term sheet to acquire a private, commercial-stage diagnostics and toxicology testing company with estimated 2025 net revenues of $111 million. The transaction is expected to transform the combined entity into a public diagnostics company with recurring revenues from national CLIA-certified laboratories. Simultaneously, the company announced key management changes, appointing Jack Stover as Executive Chairman and CEO while former CEO Ben Hwang transitions to President. Liviu Goldenberg has also been appointed to the board as an independent director. To support the closing of the transaction, Profusa anticipates securing approximately $7 million in financing through a convertible note with a 12-month term, 9% original issue discount, and 7% annual interest rate.

•3mo ago

Profusa Initiates Board-Led Process to Evaluate Strategic Alternatives and Maximize Shareholder Value

Profusa's Board has initiated a process to evaluate strategic alternatives, including potential business combinations and asset sales, to maximize shareholder value with Tungsten Advisors as its exclusive financial advisor. Operationally, the company completed the required on-site audits by GMED for the Lumee Oxygen platform and anticipates CE Mark certification in Q3 or early Q4. Separately, Profusa signed an Asset Purchase Agreement on April 21 to acquire the PanOmics Assay assets from Bio Insights, subject to stockholder approval.

•6mo ago