Organization, Description of Business, Going Concern and Significant Risks and Uncertainties |
9 Months Ended |
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Sep. 30, 2026 | |
| Organization, Description of Business, Going Concern and Significant Risks and Uncertainties [Abstract] | |
| Organization, Description of Business, Going Concern and Significant Risks and Uncertainties | Note 1 — Organization, Description of Business, Going Concern and Significant Risks and Uncertainties
Description of Business
Profusa, Inc. (the “Company”), originally incorporated in California on May 11, 2009, develops biointegrated sensors designed to provide continuous, clinical-grade monitoring of body chemistry for personal and medical use.
The Company’s Lumee™ Oxygen Platform, monitors tissue oxygen levels and is intended for applications such as peripheral artery disease, chronic wounds (including diabetic ulcers and pressure sores), and reconstructive surgery. The Company’s research and development efforts are primarily focused on the Lumee™ Glucose Platform, a continuous glucose monitor (“CGM”) consisting of a biocompatible gel injected under the skin that monitors interstitial glucose levels for several months from a single injection, offering an alternative to traditional finger-stick glucometers and short-term needle-type CGMs.
On July 11, 2025 (the “Closing Date”), NorthView Acquisition Corporation (“Northview”) consummated its business combination (the “Business Combination”) with Profusa, Inc., a California corporation (“Legacy Profusa”), pursuant to the Merger Agreement and Plan of Reorganization, dated November 7, 2022 (as amended, the “Merger Agreement”), among Northview, Legacy Profusa, and NV Profusa Merger Sub Inc., a wholly-owned Delaware subsidiary of Northview (“Merger Sub”). At closing, Merger Sub merged with and into Legacy Profusa (the “Merger”), with Legacy Profusa surviving as a wholly-owned subsidiary of Northview. In connection with the closing, Northview changed its name to “Profusa, Inc.”
Change in Directors and Executive Officers
Effective July 21, 2026, Jack Stover was appointed Executive Chairman and Chief Executive Officer (“CEO”) and Ben Hwang was appointed President. On July 26, 2026, Mr. Hwang resigned from the Board while continuing to serve as President, and Liviu Goldenberg was appointed as an independent director.
Going Concern
The Company has incurred significant net operating losses from operations. As of September 30, 2026, the Company had a working capital deficit of approximately $20.7 million. For the nine months ended September 30, 2026, the Company incurred a net loss of $17.2 million and used $6.9 million of cash in operating activities. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of research and development activities. The Company has been able to finance its operations primarily with the proceeds from the issuance of equity and debt instruments. Additional funds may be necessary to maintain current operations and will be required for successful product commercialization efforts.
On February 11, 2025, Northview executed a Securities Purchase Agreement (the “PIPE Subscription Agreement”) with Ascent Partners Fund LLC (“Ascent” or together with any party who may become party to the PIPE Subscription Agreement, the “PIPE Investors”). During the nine months ended September 30, 2026, the Company drew an aggregate of $3.1 million in principal from Ascent under the PIPE Subscription Agreement. Subsequent to September 30, 2026, the Company issued an additional convertible note to Ascent with an aggregate principal amount of approximately $0.8 million. As of the issuance date of these condensed consolidated financial statements, the Company has $8.4 million of principal available for draw down under the PIPE Subscription Agreement, subject to certain conditions and at the investor’s discretion.
On July 28, 2025 (the “effective date”), the Company entered into the Equity Line of Credit (“ELOC”) Securities Purchase Agreement (the “ELOC Purchase Agreement”) and the ELOC Registration Rights Agreement (the “ELOC Registration Rights Agreement”) with Ascent (the “Committed Equity Facility”). Upon the terms and subject to the satisfaction of the conditions contained in the ELOC Purchase Agreement, from and after the effective date, the Company will have the right, in its sole discretion, to sell to Ascent up to $100.0 million of shares of the Company’s common stock, subject to certain limitations set forth in the ELOC Purchase Agreement, from time to time during the term of the ELOC Purchase Agreement. Sales of common stock under the ELOC Purchase Agreement, and the timing of any such sales, are solely at the Company’s option, and the Company is under no obligation to sell any securities to Ascent under the ELOC Purchase Agreement. During the nine months ended September 30, 2026, approximately $2.9 million representing 93,020 shares of the Company’s common stock were sold pursuant to the ELOC Purchase Agreement. The Company did not have any sales of common stock pursuant to the ELOC Purchase Agreement during the three months ended September 30, 2026. The Company has entered into this strategic Committed Equity Facility in order to continue to fund its operating cash flows. As of the issuance date of these condensed consolidated financial statements, the Company has $86.9 million of common stock available for issuance to Ascent under the Committed Equity Facility.
Additional financing is available through the ELOC Purchase Agreement and executing remaining tranches of the PIPE Subscription Agreement which would provide an aggregate of up to an additional $8.4 million in cash for operating expenses to further the product research and development as of the issuance date of these condensed consolidated financial statements. The actual cash proceeds from any additional issuances may be less than the aggregate principal amount due to original issue discounts. Additional financing may also be obtained through the ELOC Purchase Agreement, subject to applicable conditions and limitations. There can be no assurance that the Company will obtain additional financing under either agreement or that sufficient funds will be available to support its ongoing operations, product research and development, and commercialization activities.
Lumee Oxygen previously received regulatory approval in Europe through the attainment of a CE Mark, which subsequently lapsed in 2020. The Company is currently pursuing renewed CE Mark certification under the European Union Medical Device Regulation (“MDR”) to support commercialization in Europe in order to generate revenues. The Company continues to work with GMED to complete the remaining applicable MDR conformity assessment activities necessary to obtain renewed CE Mark certification. On October 15, 2026, the Company announced that it had received ISO 13485:2016 certification from GMED, a European Union notified body, for its quality management system covering the design, development and manufacture of the Lumee Oxygen Platform. The certification represents a milestone in the Company’s ongoing European Medical Device Regulation conformity assessment process. The Company continues to work toward completion of the remaining conformity assessment activities required to obtain CE marking for the Lumee Oxygen Platform. There can be no assurance regarding the timing or successful completion of the remaining regulatory requirements or the issuance of the CE Mark.
On September 11, 2025, Nasdaq notified the Company that it was not in compliance with the Minimum Bid Price Requirement and the Market Value of Listed Securities (“MVLS”) Requirement, and on October 27, 2025, that it was not in compliance with the Market Value of Publicly Held Shares (“MVPHS”) Requirement. The Company did not regain compliance by the applicable deadlines (March 10, 2026 for bid price and MVLS; April 27, 2026 for MVPHS), and Nasdaq determined the Company’s securities were subject to delisting. The Company appealed and appeared before the Nasdaq Hearings Panel (the “Panel”) on April 21, 2026.
On May 6, 2026, the Panel granted the Company continued listing subject to conditions, including (i) transferring to The Nasdaq Capital Market, which became effective May 15, 2026, (ii) obtaining stockholder approval for a reverse stock split by June 23, 2026, and (iii) demonstrating compliance with the minimum bid price and stockholders’ equity requirements by July 20, 2026, which Nasdaq later extended to July 31, 2026.
The Company regained compliance with the MVPHS Requirement as of August 21, 2026. On September 9, 2026, Nasdaq confirmed compliance with the minimum bid price and stockholders’ equity requirements under Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), respectively, and placed the Company under a one-year Mandatory Panel Monitor pursuant to Listing Rule 5815(d)(4)(B). During the monitoring period, a further failure to comply with the stockholders’ equity requirement would result in a prompt Staff Delisting Determination, without an opportunity to submit a compliance plan or receive a cure period, although the Company may appeal. There can be no assurance that the Company will maintain compliance with Nasdaq’s continued listing standards. Delisting could adversely affect the liquidity and market price of the Company’s securities and its ability to raise capital.
The Company’s condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has reviewed the relevant conditions and events surrounding its ability to continue as a going concern including among others: historical losses, projected future results, increased tariffs, cash requirements for the upcoming year, funding capacity, net working capital deficit, and future access to capital.
As of September 30, 2026, there continue to be factors which raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date the condensed consolidated financial statements are issued. The condensed consolidated financial statements do not contain any adjustments that might result from the outcome of this uncertainty. |