Picard Medical, Inc.
For the period ended Jun 30, 2026. Filed Aug 19, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 19, 2026
PMI$9.00+14.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001437749-26-017342
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-19.
0001437749-26-028565
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 64 previous paragraphs and 73 current paragraphs.
42 unchanged; 16 reworded; 13 added; 6 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 2 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
During the second quarter of 2026, we continued development of the Emperor TAH program, including the successful completion of a series of acute in vivo implant studies evaluating the latest iteration of the Emperor TAH and the presentation of new in vivo Emperor data at the American Society for Artificial Internal Organs (“ASAIO”) 2026 Annual Conference. We also presented new clinical outcomes research involving patients supported with the SynCardia TAH at ASAIO 2026.
Current report
Subsequent to June 30, 2026, we publicly presented the integrated architecture of the Emperor TAH platform for the first time at the 48th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (“IEEE EMBC 2026”). The presentation provided the biomedical engineering community with a detailed view of the Emperor platform and its electromechanical drive architecture. We believe the presented architecture has the potential to be a platform for a first-of-a-kind fully implantable total artificial heart. We continue to pursue development of the Emperor platform, with our longer-term objective of building the world’s first fully artificial heart.
Current report
The NYSE American’s acceptance allows us to continue to be listed on the NYSE American, subject to PMI achieving the milestones set forth in the Compliance Plan and being subject to quarterly review by the NYSE American. We are subject to a maximum period of 18 months from the original notice of noncompliance to regain compliance, which date is November 8, 2027.
Current report
Comparison of Six Months Ended June 30, 2026 and 2025
Current report
Total revenues increased by $1.4 million, or 50%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. This increase is due to an increase in U.S. product sales of $1.5 million, an increase in rest of world sales of $0.2 million, offset by a $0.4 million decrease in Europe sales.
Current report
Total cost of revenues decreased by $0.02 million, or 0%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.
Current report
The decrease was primarily driven by improved gross margins on product sales, which more than offset the costs associated with rental sales. As a result, total cost of revenue decreased to 78% of total sales for the six months ended June 30, 2026, compared with 118% for the corresponding period in 2025. This is due to improved finished goods inventory management between the periods.
Current report
Selling, general and administrative expenses increased by $2.0 million, or 43%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The increase was primarily attributable to a $1.2 million increase in stock based compensation expenses, a $0.2 million in franchise tax fees, a $0.1 million increase in employee benefits and a $0.5 million increase in professional and legal expenses.
Current report
Total other expenses decreased by $1.4 million, or 25%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease was attributed to the increase of loss on settlement of debt and loss on Warrant Exchange, offset by changes in fair value of the Senior Secured Note and warrant liabilities.
Current report
Research and Development Expenses
Current report
Selling, General and Administrative Expenses
Current report
Total Other Income (Expenses)
Current report
In May 2026, the Company completed the May 2026 Offering, in which it sold an aggregate (i) 333,333 shares of its Common Stock, or in lieu thereof, for certain purchasers, prefunded warrants, (ii) Series A Common Warrants to purchase up to 333,333 shares of common stock, and (iii) Series B Common Warrants to purchase up to 333,333 shares of common stock for a combined offering price of $15.0 per share for gross proceeds of $5.0 million. Net proceeds from the May 2026 Offering were $3.06 million after deduction of $0.94 million of offering costs with $1.0 million in a cashless transaction to settle the principal of the Company’s Senior Secured Note.
Removed paragraphs (6)
Previous report
The Company’s management has begun its analysis regarding submission of the Plan to the NYSE American by the June 7, 2026, deadline. If the NYSE American accepts the Company’s Plan, the Company will have an eighteen month cure period to comply with the Plan and be able to continue its listing during such period and will be subject to continued periodic review by the NYSE American staff. If the Plan is not submitted, or not accepted, or is accepted but the Company does not make progress consistent with the Plan during the Plan period, the PMI will be subject to delisting procedures as set forth in the Company Guide.
Previous report
The NYSE Notice has no immediate impact on the listing of the Company’s shares of Common Stock, which will continue to be listed and traded on the NYSE American during this period, subject to the Company’s compliance with the other listing requirements of the NYSE American. The Common Stock will continue to trade under the symbol “PMI” but will have an added designation of “.BC” to indicate the status of the Common Stock as “below compliance”.
Previous report
Revenues
Previous report
Cost of Revenues
Previous report
Revenues
Previous report
Cost of Revenues
Reworded paragraphs (16)
Previous wording
PMI functions as a holding company and owns 100% of the membership interests of SynCardia. Business operations are carried out by and through SynCardia, and accordingly most of the information set forth in this Quarterly Report on Form 10-Q relates to the business of SynCardia. SynCardia is a medical technology company that manufactures and sells the only U.S. Food and Drug Administration (“FDA”) and Health Canada approved SynCardia TAH, which fully replaces the function of a failing human heart. To date, more than 2,100 SynCardia TAHs have been implanted in patients across 27 countries, and the SynCardia TAH is an established bridge to heart transplantation for patients with biventricular heart failure, also referred to as end-stage heart failure, in the U.S. and around the globe. SynCardia is also pursuing additional research and advancements in medical technology, including the next-generation, fully implantable and driver-less heart, the Emperor TAH. Both the SynCardia and Emperor TAH are subject to additional development and regulatory review.
Current wording
PMI functions as a holding company and owns 100% of the membership interests of SynCardia. Business operations are carried out by and through SynCardia, and accordingly most of the information set forth in this Quarterly Report on Form 10-Q relates to the business of SynCardia. SynCardia is a medical technology company that manufactures and sells the only U.S. Food and Drug Administration (“FDA”) and Health Canada approved SynCardia TAH, which fully replaces the function of a failing human heart. To date, more than 2,100 SynCardia TAHs have been implanted in patients across 27 countries, and the SynCardia TAH is an established bridge to heart transplantation for patients with biventricular heart failure, also referred to as end-stage heart failure, in the U.S. and around the globe. We are also pursuing additional research and advancements in medical technology, including the next-generation Emperor Total Artificial Heart (“Emperor TAH”), which is designed to combine the proven SynCardia TAH ventricles with the Company’s next-generation electromechanical Emperor Drive System. The Emperor TAH is being developed as a platform to a fully implantable total artificial heart and eliminate the need for external drivers. The Emperor TAH is subject to additional development and regulatory review.
Previous wording
Implantation of the SynCardia TAH is covered by the U.S. Centers for Medicare and Medicaid Services under National Coverage Determination 20.9.1 and is generally reimbursed under Diagnosis Related Group 001, the highest reimbursement category for cardiac procedures. Hospital reimbursement varies based on case complexity and institutional adjustments. Because reimbursement is determined primarily by the procedure rather than the specific device used, hospitals evaluate mechanical circulatory support technologies based on clinical suitability and overall cost effectiveness within the applicable reimbursement framework.
Current wording
Implantation of the SynCardia TAH is covered by the U.S. Centers for Medicare and Medicaid Services under National Coverage Determination 20.9.1 and is generally reimbursed under Diagnosis Related Group 001, the highest reimbursement category for cardiac procedures. Hospital reimbursement varies based on case complexity and institutional adjustments. Because reimbursement is determined primarily by the procedure rather than the specific device used, hospitals evaluate mechanical circulatory support technologies based on clinical suitability and overall cost effectiveness within the applicable reimbursement framework. We currently have SynCardia TAH inventory available to support near-term customer requirements.
Previous wording
On May 8, 2026, the Company received a notice of noncompliance from NYSE Regulation (“NYSE Notice”) stating that it is not in compliance with Section 1003(a)(ii) in the NYSE American Company Guide (the “Company Guide”) since the Company reported stockholders’ equity of $3.8 million as of December 31, 2025, and had net losses in three of its four most recent fiscal years then ended (the "Stockholders' Equity Rule"). In order to maintain the Company’s listing on the NYSE American, the NYSE American has requested that the Company submit a plan of compliance (the “Plan”) by June 7, 2026, advising of actions it has taken or will take to regain compliance with Section 1003(a)(ii) of the Company Guide by November 8, 2027.
Current wording
On May 8, 2026, the Company received a notice of noncompliance from NYSE Regulation (“NYSE Notice”) stating that it was not in compliance with Section 1003(a)(ii) in the NYSE American Company Guide (the “Company Guide”) since the PMI reported stockholders’ equity of $3.8 million as of December 31, 2025, and had net losses in three of its four most recent fiscal years then ended (the "Stockholders' Equity Rule"). In order to maintain our listing on the NYSE American, the NYSE American requested that PMI submit a plan of compliance (the “Compliance Plan”) by June 7, 2026, advising of actions it has taken or will take to regain compliance with Section 1003(a)(ii) of the Company Guide by November 8, 2027. Subsequently, PMI timely filed the Plan with NYSE American. On July 22, 2026, we received a letter from the NYSE American stating that PMI's Compliance Plan had been accepted.
Previous wording
Total revenues increased by $0.5 million, or 85%, for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. This increase is due to an increase in U.S. sales of $0.6 million, offset by a $0.1 million decrease in sales in Europe.
Current wording
Total revenues increased by $0.8 million, or 39%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. This increase is due to an increase in U.S. sales of $0.8 million.
Previous wording
Total cost of revenues decreased by $0.1 million, or 11%, for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The decrease was primarily due to $0.3 million decrease in outside service costs, offset by a $0.2 million increase in labor cost. Rental revenue and rental cost are not directly correlated. Rental revenue is earned when a patient is discharged from a hospital with a Freedom Driver. The rental costs are primarily related to machine maintenance to maintain reliability and are incurred on a time schedule that is dependent on the amount of time the Freedom Driver is actually used. The Freedom Driver may be used for multiple patients before maintenance service is required. Rental revenue is earned when a patient is discharged from a hospital with a Freedom Driver. Rental Revenue is recognized when it becomes likely that we will receive payment. The timing differences between usage and payment receipt generally do not correlate to the cost of service maintenance. Our total cost of revenue as a percentage of total sales for the three months ended March 31, 2026 and 2025, was 76% and 158%, respectively.
Current wording
Total cost of revenues increased by $0.08 million, or 4%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase in cost of revenues for the three months ended June 30, 2026, was mainly due to $0.17 million increase in product manufacturing costs, offset by a $0.09 million decrease in rental costs. Rental revenue and rental cost are not directly correlated. Rental costs are mainly related to machine maintenance to maintain reliability and are incurred on a time schedule that is dependent on the amount of time the Freedom Driver is actually used. The Freedom Driver may be used for multiple patients before maintenance service is required. Rental revenue is earned when a patient is discharged from a hospital with a Freedom Driver. Rental Revenue is recognized when it becomes likely that we will receive payment. The timing differences between usage and payment receipt generally do not correlate to the cost of service maintenance, resulting in negative gross margins. Our total cost of revenue as a percentage of total sales for the three months ended June 30, 2026 and 2025, was 79% and 106%, respectively.
Previous wording
Research and development expenses increased by $1.1 million, or 135%, for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The increase was primarily attributable to increased activity and phase scheduling in the new product research. We do not track expenses by product candidate. While research and development supply expense are isolated by product, personnel are not. Research and Development personnel do not work on current product production, therefore labor expense is not isolated by product.
Current wording
Research and development expenses increased by $0.6 million, or 85%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase was primarily attributable to increased activity and phase scheduling in the new product research. We do not track expenses by product candidate. While research and development supply expense are isolated by product, personnel are not. Research and Development personnel do not work on current product production, therefore labor expense is not isolated by product.
Previous wording
Selling, general and administrative expenses increased by $0.8 million, or 39%, for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The increase was primarily attributable to a $0.8 million increase in professional and legal expenses.
Current wording
Selling, general and administrative expenses increased by $1.2 million, or 46%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase was primarily attributable to a $1.2 million increase in stock based compensation expense.
Previous wording
Total other income (expense) increased by $0.8 million, or 36%, for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The increase was attributed to the increase of loss on settlement of debt, offset by changes in fair value of Senior Secured Note and warrant liabilities.
Current wording
Total other expenses decreased by $2.2 million, or 68%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The decrease was attributed to the increase of loss on settlement of debt, offset by changes in fair value of Senior Secured Note and warrant liabilities.
Previous wording
We have incurred operating losses since inception, including net losses of $7.6 million and $5.6 million for the three months ended March 31, 2026 and 2025, respectively. While we already have FDA-approved products that are generating commercial revenue, the business needs to scale up in order to offset a large, fixed overhead cost from our site in Tucson, Arizona. Moreover, we are also investing heavily in the development of updates and next generation devices; therefore, we expect to continue to incur significant expenses and operating losses for the foreseeable future. Furthermore, we expect to incur additional expenses with transitioning to, and operating as, a public company.
Current wording
We have incurred operating losses since inception, including net losses of $13.3 million and $12.3 million for the six months ended June 30, 2026 and 2025, respectively. While we already have FDA-approved products that are generating commercial revenue, the business needs to scale up in order to offset a large, fixed overhead cost from our site in Tucson, Arizona. Moreover, we are also investing heavily in the development of updates and next generation devices; therefore, we expect to continue to incur significant expenses and operating losses for the foreseeable future. Furthermore, we expect to incur additional expenses with transitioning to, and operating as, a public company.
Previous wording
To date, we have funded our operations primarily with the proceeds from Series A-1 Preferred Stock, loans from related parties, convertible notes and cash received from, in exchange for common shares, or loans payable from other investors. In September 2025, the Company consummated our Initial Public Offering. See also Note 1 to the condensed consolidated financial statements.
Current wording
To date, we have funded our operations primarily with the proceeds from Series A-1 Preferred Stock, loans from related parties, convertible notes and cash received from, in exchange for shares of common stock, or loans payable from other investors. In September 2025, the Company consummated our Initial Public Offering.
Previous wording
In December 2025, the Company entered into a Securities Purchase Agreement pursuant to which the Company issued $15.0 million aggregate principal amount of Senior Secured Notes due 2028, with the right to issue up to an additional $35.0 million in subsequent closings.
Current wording
In December 2025, the Company entered into a Securities Purchase Agreement pursuant to which the Company issued $15.0 million aggregate principal amount of Senior Secured Note due 2028, with the right to issue up to an additional $35.0 million in subsequent closings.
Previous wording
Net cash used in operating activities of $3.8 million for the three months ended March 31, 2026, was primarily attributable to $7.6 million net loss and non-cash expenses related to net changes in fair value of the Senior Secured Note and warrant liability of $3.0 million, offset by $0.7 million in accounts payable and accrued expenses and loss on settlement of notes payable of $6.1 million.
Current wording
Net cash used in operating activities of $5.2 million for the six months ended June 30, 2026, was primarily attributable to $ 13.3 million net loss, and $5.7 million net changes in fair value of the Senior Secured Note and warrant liability, offset by $9.3 million non-cash loss on settlement of debt, $0.9 million increase in accounts payable and accrued expenses, $1.5 million in stock based compensation, a $0.5 million increase in the loss on warrant exchange, $0.6 million in provision for excess and obsolete inventory, $0.7 million in inventory, $0.2 million in prepaid and other current asset.
Previous wording
Net cash used in operating activities of $2.2 million for the three months ended March 31, 2025, was primarily attributable to $5.6 million net loss, offset by $0.5 million increase in accounts receivable and $0.5 million increase in accounts payable and accrued expenses.
Current wording
Net cash used in operating activities of $4.8 million for the six months ended June 30, 2025, was primarily attributable to $12.3 million net loss, offset by $2.5million in embedded derivative loss, $0.6 million in increased inventory, $2.4 million amortization of discount on debt issued, $0.2 million amortization of ROU asset, and $1.8 million increase in accounts payable and accrued expenses.
Previous wording
Net cash used in investing activities was $0.03 million and $0 for the three months ended March 31, 2026 and 2025, respectively.
Current wording
Net cash used in investing activities was $0.03 million and $0 million for the six months ended June 30, 2026 and 2025, respectively.
Previous wording
Net cash used in financing activities was $7.5 million for the three months ended March 31, 2026, primarily consisting of repayment of $7.4 million of notes payable, $0.9 million of repayments of loans from related parties, and $0.02 million repayments of finance lease obligations, offset by $0.7 million of proceeds from related party loans, and $0.04 million of stock option exercise.
Current wording
Net cash used in financing activities was $6.3 million for the six months ended June 30, 2026, primarily consisting of repayment of $9.5 million of notes payable, $0.9 million of repayments of loans from related parties, and $0.03 million repayments of finance lease obligations, offset by $0.7 million of proceeds from related party loans, and $0.06 million of stock option exercise, $3.1 million of proceeds from issuance of Common stock and warrants.
Previous wording
Net cash provided by financing activities was $2.8 million for the three months ended March 31, 2025, primarily consisting of net proceeds of $1.0 million from the issuance of convertible notes and $1.4 million related party loans, and $0.5 million from the issuance of common stock.
Current wording
Net cash provided by financing activities was $5.1 million for the six months ended June 30, 2025, which primarily consisted of net proceeds of $2.0 million from the issuance of convertible notes, $1.5 million from the issuance of common stock, and $1.6 million net of related party loans.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Research and development expenses increased by $1.7 million, or 111%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The increase was primarily attributable to increased activity and phase scheduling in the new product research. We do not track expenses by product candidate. While research and development supply expense are isolated by product, personnel are not. Research and Development personnel do not work on current product production, therefore labor expense is not isolated by product.
Current report — wording carried from elsewhere
The following table summarizes Picard’s results of operations (in thousands, except percentages) (unaudited):