S-1/A: Picard Medical Files Amended IPO Prospectus Amidst Mounting Losses and Going Concern Warning

Sentiment:

Initial Public Offering Amendment 23 May 2025 3:53 PM

Picard Medical, Inc., a medical technology company specializing in total artificial hearts, has filed an amended S-1 registration statement for its initial public offering, revealing continued significant operating losses, a substantial working capital deficit, and an auditor's going concern warning, despite ongoing product development and international expansion efforts.

Delay expectedThe company voluntarily withdrew its EU CE mark in July 2022 and is planning to reapply for an MDR CE mark during Q3 2025, indicating a significant delay in European market access.The 180-day PMA supplement for expanded IFU (removing 'imminent death' and adding 'Bridge to Candidacy') was converted to a Panel Track Submission by the FDA in March 2025, which typically implies a longer and more rigorous review process than a standard 180-day supplement, potentially delaying approval beyond the expected Q3 2025 answer.The 2024 Convertible Notes and the aggregated related-party convertible note are currently past due, and the company is working with lenders to extend their maturity dates, indicating financial delays or challenges in meeting obligations.The regulatory approval processes of the FDA are explicitly stated as "lengthy, time-consuming and inherently unpredictable," with no guarantee of receiving approval on expected timelines or at all for new products and upgrades (e.g., next-generation portable driver expected late 2026, Unicorn driver system approval mid-2027, Emperor TAH approval 2028).

Capital raiseThe company is undertaking an Initial Public Offering (IPO) of common stock, with an estimated initial public offering price between $ and $ per share, to obtain additional capital.The net proceeds from the IPO are estimated to be approximately $ million (based on the midpoint of the price range), which will be used to support operations, market expansion (joint venture in China), R&D activities, and sales/marketing capabilities.The company has historically funded operations through Series A-1 Preferred Stock, loans from related parties, and convertible notes issued to related parties and other investors.In March 2025, the company sold 163,934 shares of common stock for $500,000.In April 2025, the company sold 323,024 shares of common stock for $1.0 million.The company has outstanding Series A-1 Preferred Stock (18,406,857 shares) that will automatically convert into common stock upon a public offering resulting in gross proceeds of $25 million.Various convertible notes (2023 and 2024 Convertible Notes, and aggregated related-party convertible note totaling over $15 million) will automatically convert into common stock at a 50% discount to the IPO price upon consummation of the IPO, leading to significant dilution.The company explicitly states that it expects to raise sufficient cash to fund operations into 2025 based on its current business plan, but there is no assurance of success in raising cash from this offering or that additional funding will be available on acceptable terms when needed.

Worse than expectedThe company reported a significant increase in net loss from $15.6 million in 2023 to $21.1 million in 2024, and a further increase to $5.6 million in Q1 2025 from $2.0 million in Q1 2024.Total revenues decreased substantially by 13% in 2024 and by 69% in Q1 2025, indicating a sharp decline in sales performance.The company's auditor has issued a going concern warning, highlighting substantial doubt about the company's ability to meet its obligations within one year.The working capital deficit has significantly worsened, from $(0.451) million in Dec 2023 to $(30.435) million in Mar 2025.Total liabilities have increased from $14.926 million in Dec 2023 to $40.620 million in Mar 2025, driven by increased debt and derivative liabilities.

Summary

Picard Medical, Inc. is a holding company that owns SynCardia Systems, LLC, which manufactures and sells the only U.S. FDA and Health Canada approved implantable total artificial heart (SynCardia TAH).
The company is pursuing an Initial Public Offering (IPO) to raise capital, create a public market for its common stock, and fund operations, including market expansion in China, R&D for next-generation products, and building sales capabilities.
Picard Medical has a history of significant net losses, reporting $21.1 million in 2024 and $15.6 million in 2023, and a net loss of $5.6 million for the three months ended March 31, 2025.
Revenues decreased by 13% to $4.391 million in 2024 from $5.043 million in 2023, and by 69% to $0.620 million for Q1 2025 compared to $1.980 million in Q1 2024.
The company's auditor has included an explanatory paragraph regarding substantial doubt about Picard Medical's ability to continue as a going concern.
Picard Medical is developing a fully implantable total artificial heart (Emperor) with expected FDA approval in 2028, and is working on upgraded portable (Freedom+) and hospital (Companion 3) drivers, with Freedom+ approval anticipated by H2 2025.
The company voluntarily cancelled its EU CE mark in July 2022 due to post-market surveillance deficiencies under MDD and plans to reapply for an MDR CE mark in Q3 2025.
A field correction was initiated for cannula tears in the SynCardia TAH, with 104 reports but zero serious adverse events as of March 20, 2025; a design change is expected to be submitted to the FDA in Q3 2025.
The company plans to invest $2.85 million from IPO proceeds into SynCardia Medical (Beijing), Inc. for a 60% ownership interest to facilitate market entry into China.
As of March 31, 2025, the company had cash and cash equivalents of $0.688 million and a total stockholders deficit of $48.922 million.
The company has significant related-party loans and convertible notes, some of which are past due and will convert to common stock at a 50% discount to the IPO price upon a successful IPO, leading to significant dilution for new investors.

Sentiment

Score: 2

Explanation: The company faces severe financial distress, evidenced by significant and increasing net losses, a substantial working capital deficit, and an explicit going concern warning from its auditor. While it possesses a unique FDA-approved product and a promising R&D pipeline, the declining revenues, heavy reliance on related-party financing, and significant regulatory hurdles (EU CE mark, FDA panel track submission) indicate a highly precarious financial position and substantial operational risks. The planned IPO and capital raises are critical for survival, but the terms (e.g., 50% discount conversion for debt) suggest desperation and will lead to heavy dilution. The overall outlook is highly negative, with significant uncertainty regarding its ability to achieve profitability or even sustain operations without further substantial capital injections.

Positives

SynCardia TAH is the only U.S. FDA and Health Canada approved implantable total artificial heart, providing a significant competitive advantage in these markets.
The company has extensive clinical experience with over 2,100 SynCardia TAHs implanted in patients across 27 countries since 1985.
Strong R&D pipeline with next-generation products like the fully implantable Emperor TAH and upgraded drivers (Freedom+, Companion 3) aimed at improving patient quality of life and performance.
The SynCardia TAH is reimbursed by Medicare under DRG 001, the highest possible reimbursement, with payments ranging from $193,000 to $469,000, and has success in securing private insurance reimbursement.
Proprietary Segmented Polyurethane Solution (SPUS) used in heart ventricles is FDA approved and has a long clinical history, presenting a barrier to competitors.
Successful completion of the latest MDSAP audit in November 2024, indicating robust quality management systems.
Strategic international expansion plans, including a joint venture in China and efforts to enter markets in India, the Middle East, and Latin America.
Existing patents for pneumatic drivers and newly awarded patents for the next-generation total artificial heart (Emperor) in the U.S. and China provide intellectual property protection.
Established clinical training and education program with over 30 certified centers and a focus on continuous improvement and support for medical teams.

Negatives

The company has a history of significant operating losses, with net losses of $21.1 million in 2024 and $5.6 million in Q1 2025.
Auditor's report includes an explanatory paragraph raising substantial doubt about the company's ability to continue as a going concern due to recurring losses and a net capital deficiency.
Total revenues decreased by 13% in 2024 and by 69% in Q1 2025, indicating a significant decline in sales.
High customer concentration, with Customer A accounting for 41% of revenue in 2024 and 49% in Q1 2025, and no long-term exclusive agreements with customers.
Voluntary cancellation of the EU CE mark in July 2022 due to post-market surveillance deficiencies, limiting market access in Europe until MDR re-certification is obtained (expected Q3 2025).
Reliance on single-source suppliers (Bimba, Heitek Automation) for crucial driver components, with no formal supply agreements or access to all necessary drawings, posing a significant supply chain risk.
Outstanding royalty payments of approximately $492,000 owed to Medtronic for the Med-Hall Valves, with Medtronic holding a security interest that could be foreclosed upon.
Significant increase in total other expenses, primarily due to interest expense and non-cash derivative losses related to convertible notes.
The company's current products are not protected by original patents, relying on trade secrets and know-how, which are vulnerable to misappropriation or independent development by competitors.
The company expects to continue incurring significant expenses and operating losses for the foreseeable future due to R&D investments and public company operating costs.
The 2024 Convertible Notes and the aggregated related-party convertible note are currently past due, and the company is working with lenders to extend maturity dates.

Risks

Inability to achieve and sustain profitability, leading to continued adverse effects on financial condition and working capital.
Dependence on a limited number of products (SynCardia TAH) for substantially all revenue, making the business vulnerable to declines in sales or failure to gain market acceptance.
Challenges in manufacturing the SynCardia TAH due to highly specialized knowledge and operator skills, risking production delays or quality issues.
Reliance on specialized single-source suppliers for critical components (e.g., Bimba for PCA, SynHall Valves), with potential for supply interruptions or quality problems.
Unproven future demand for current and new products, and potential reluctance of physicians/hospitals to adopt SynCardia TAH over existing alternatives like LVADs.
Lengthy, time-consuming, and unpredictable FDA and other regulatory approval processes for new products, enhancements, or expanded indications, with no guarantee of timely approval or at all.
Failure to reinstate the CE certificate under CE MDR could materially adversely affect the business and ability to market products in European markets.
Prior weaknesses in compliance with post-market surveillance requirements under CE MDD may limit future market access or product introductions in Europe.
Risk of product liability claims, recalls, or field actions due to inherent risks of implantable medical devices, misuse, or product deficiencies (e.g., cannula tears).
Exposure to risks associated with international operations, including political/economic instability, trade policy changes (especially with China), currency fluctuations, and difficulties in enforcing intellectual property.
Many aspects of the SynCardia TAH are no longer patent-protected, increasing reliance on trade secrets and know-how, which are vulnerable to disclosure or independent development.
Potential for costly and distracting intellectual property litigation, including claims of infringement or misappropriation of trade secrets.
Volatility in share price due to various factors, including clinical study results, regulatory developments, competition, and general market conditions.
Significant dilution for existing and new stockholders upon conversion of Series A-1 Preferred Shares and convertible notes, especially those converting at a 50% discount to the IPO price.
Increased costs and demands on management due to compliance with public company laws and regulations, potentially diverting resources from core business operations.
Risk of securities class action or derivative litigation, which could result in substantial costs and diversion of management attention.
Inability to implement and maintain effective internal control over financial reporting, potentially leading to loss of investor confidence.
Uncertainty regarding the development or sustainability of an active trading market for common stock after the offering.
Reliance on controlled company corporate governance exemptions, which may afford stockholders fewer protections compared to companies subject to full NYSE American requirements.
Exclusive forum provisions in the company's charter could limit stockholders' ability to bring claims in preferred judicial forums.
Potential for medical advances to provide better, less costly, or less invasive alternatives to total artificial hearts, reducing demand for SynCardia TAHs.
Challenges in attracting and retaining highly qualified personnel in a competitive medical device industry.

Future Outlook

Picard Medical aims to develop the world's first fully implantable SynCardia TAH as an alternative to heart transplantation, with expected FDA approval for the Emperor system in 2028. Near-term product developments include innovating current driver technology to expand the SynCardia TAH's indication for use from Bridge to Transplantation (BTT) to Bridge to Candidacy (BTC) and for long-term use (two years or more), with an FDA answer on the PMA supplement expected in Q3 2025. The company also anticipates FDA approval for the upgraded Freedom+ Driver by H2 2025 and next-generation Freedom and C2 Drivers by H2 2026 and H2 2027, respectively. International market expansion, particularly in China, India, the Middle East, and Latin America, is a key strategic driver. The company expects to continue incurring significant expenses and operating losses for the foreseeable future due to heavy investment in R&D and public company operating costs.

Management Comments

"Our future vision is to develop the worlds first fully implantable SynCardia TAH as an alternative to heart transplantation for patients with biventricular heart failure in the U.S. and around the world."
"For near term new product developments, we are committed to innovating our current driver technology, to expand the current indication for use of the SynCardia TAH from Bridge to Transplantation (BTT), to Bridge to Candidacy (BTC), and for long-term use of two years or more."
"We believe that, based on our technology, intellectual property, know-how, and extensive human clinical experience, we have significant advantages over other companies developing other TAH products."
"We expect to raise sufficient cash to fund our operations into 2025 based on our current business plan, and expectations and assumptions considering current macroeconomic conditions. However, these plans have not been finalized and there can be no assurance that we will be successful in raising any cash in connection with this offering."
"We consider our relationship with our employees to be good."

Industry Context

Picard Medical operates in the highly competitive medical device industry, specifically targeting advanced heart failure patients requiring mechanical circulatory support or heart replacement. The global burden of cardiovascular disease is significant, with 6.8 million people suffering from heart failure in the U.S. and 56.2 million globally. Heart transplantation remains the treatment of choice, but donor heart supply is limited (over 7,500 patients on U.S. waitlist). The market for heart implants is substantial, with millions of heart failure patients in regions like the EU, India, China, and the Middle East. Picard's SynCardia TAH competes with Left Ventricular Assist Devices (LVADs) like Abbott's HeartMate 3, which are more commonly used and produced by larger companies. Direct TAH competitors include Carmat SA (Aeson device, CE marked in EU but facing software issues and re-certification challenges) and BiVACOR, Inc. (early-stage human clinical testing). Picard emphasizes its unique FDA/Health Canada approval, extensive clinical experience (over 2,100 implants), and proprietary technology (SPUS) as competitive strengths against these emerging alternatives.

Comparison to Industry Standards

**SynCardia TAH vs. LVADs (e.g., Abbott HeartMate 3):** The SynCardia TAH replaces both ventricles and all four heart valves, allowing patient discharge, while LVADs typically support only the left ventricle and may be for in-hospital use or limited long-term support. Both are reimbursed under DRG 001, with similar payment ranges ($193,000-$469,000). The average selling price of Abbott HeartMate 3 is around $120,000, while SynCardia TAH is not explicitly priced but is reimbursed at a high DRG.
**SynCardia TAH vs. Carmat (Aeson):** SynCardia TAH is the only TAH approved in the US (2004) and Canada (2005) for BTT. Carmat's Aeson is approved in the EU (2020) but is undergoing re-certification under MDR and has faced quality and software issues, leading to recommendations for early natural heart transplantation. SynCardia TAH has over 2,100 implants, while Aeson has 100 as of February 2025. Aeson's implant size (750ml) and weight (900g) are significantly larger and heavier than SynCardia's 50cc/70cc implants (250-400ml, 200-240g), potentially limiting fit for smaller patients.
**SynCardia TAH vs. BiVACOR:** BiVACOR's system is in early-stage human clinical testing (5 of 20 patients in EFS as of March 2025) and has no market approvals to date. SynCardia TAH has a substantial lead in clinical experience and regulatory approvals.
**Clinical Outcomes:** The PMA FDA Study for SynCardia TAH showed 79% survival to transplantation compared to 46% for controls (p<0.001) and 1-year survival of 70% vs. 31% for controls. Post-transplant 1-year and 5-year survival rates were 86% and 64% respectively. Real-world data shows 1-year survival rates ranging from 75% to 86.6%, depending on center experience and patient profile. Neurological event incidence in RWD (5% of total adverse events) compares favorably to the PMA FDA study (27% for all implanted patients, 5% for per-protocol patients).

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Board Composition	Upon IPO completion, the company will be a 'controlled company' with Hunniwell Picard I, LLC controlling a majority of voting power. Hunniwell's three managers (Dr. Richard Fang, Sin Yew Daniel Teo, Chris Hsieh) will serve as directors, effectively controlling shareholder approval matters, mergers, acquisitions, and dividends.	Upon completion of the Initial Public Offering	This structure allows the controlling shareholder to elect and remove directors and influence key corporate decisions, potentially limiting the influence of other shareholders and raising concerns about independent oversight, as the company intends to rely on controlled company exemptions from certain NYSE American corporate governance requirements (e.g., majority independent board, independent nominating/compensation committees) while searching for independent directors.
Stockholder Action	Stockholders may not take action by written consent but only at annual or special meetings. Special meetings can only be called by the Board, Chairperson, CEO, or President.	Upon completion of the Initial Public Offering	This provision restricts the ability of stockholders, even those with a majority, to take immediate action or force consideration of proposals, potentially delaying changes in management or corporate policy.
Advance Notice Requirements	Stockholders must provide timely notice (90-120 days prior to annual meeting anniversary, or specific windows for special meetings) for proposals or director nominations.	Upon completion of the Initial Public Offering	This may preclude stockholders from bringing matters or nominations before meetings if not planned well in advance, reinforcing existing management's control.
Supermajority Requirements	Bylaws can be amended or repealed by the Board or by a two-thirds (66 2/3%) vote of outstanding voting stock. Certain Charter provisions require a two-thirds (66 2/3%) vote of voting stock.	Upon completion of the Initial Public Offering	These supermajority requirements make it more difficult for minority shareholders to amend governing documents or effect significant corporate changes, further entrenching the current control structure.
Board Vacancies	Any vacancy on the Board may be filled by a majority vote of directors then in office, not by stockholders. The number of directors is fixed exclusively by Board resolution.	Upon completion of the Initial Public Offering	This provision prevents stockholders from increasing board size or filling vacancies with their own nominees, making it harder to change board composition and promoting management continuity.
Exclusive Forum Selection	The Charter designates Delaware Court of Chancery as the exclusive forum for most stockholder litigation (derivative actions, fiduciary duty claims, DGCL claims, internal affairs doctrine). Federal district courts are the exclusive forum for Securities Act claims.	Upon completion of the Initial Public Offering	This provision aims to centralize litigation in specific courts, potentially limiting stockholders' ability to choose a favorable forum and increasing costs, which may discourage lawsuits against the company or its management. Enforceability of the Securities Act provision is uncertain.
Related Person Transaction Policy	Will adopt a written policy for review and approval/ratification of related person transactions exceeding $120,000 or 1% of average total assets, with the audit committee responsible for review.	Upon completion of the Initial Public Offering	Aims to minimize potential conflicts of interest from dealings with affiliates and ensure proper disclosure, which is a standard governance practice for public companies.

Legal Proceedings

As of the date of the prospectus, Picard Medical is not a party to any material legal matters or claims.
The company may become party to legal matters and claims in the ordinary course of business in the future, but does not anticipate them having a material adverse impact on financial position, results of operations, or cash flows.

Related Party Transactions

Picard Medical, Inc. is a holding company that owns 100% of SynCardia Systems, LLC. Most information in the prospectus relates to SynCardia's business.
Hunniwell Picard I, LLC (Hunniwell), through Picard Medical, Inc., purchased 85% of SynCardia Systems, LLC in September 2021.
Picard Medical, Inc. agreed to purchase a majority ownership (60%) of SynCardia Medical (Beijing) Inc. for $2.85 million, contingent on becoming publicly traded. Chinese investors (Binzhou Taige Shibei Venture Capital LLC, CICH (Beijing) Investment Fund Management Co., and Jinhu Zhu) will invest $2.85 million for 40%.
As of March 31, 2025, the company has related party or affiliated loans totaling $6.500 million, including from Hunniwell and Fang Family Funds (entities affiliated with executive director Richard Fang).
A $0.112 million unsecured promissory note from Versa Capital Management, LLC (shares common ownership with Sindex SSI Financing, LLC, former owner of SynCardia) remains uncollected as of March 31, 2025.
Various short-term, interest-free, and 6% interest-bearing loans from Fang Family Fund, LLC and Fang Family Fund II, LLC were provided between June 2023 and March 2025, totaling over $9 million in principal, with some repaid and others outstanding.
Effective July 2, 2024, approximately $7.0 million in related party loans from Richard Fang and Fang Family Funds were consolidated into one convertible note, accruing 6% interest and automatically converting into common stock at a 50% discount to the IPO price upon an IPO.
On November 12, 2024, Richard Fang donated the $7.0 million aggregated convertible note to unrelated not-for-profit organizations, Nexus Science Foundation Inc. and Another Dimension Foundation, who will each receive 50% of the converted value in registered shares.
The Nexus and Another Dimension notes are currently past due, and the company is working with the lenders to extend their maturity dates.
The company issued 623,792 shares at a fair value of $1.72 per share to US Unicorn Foundation, Inc. (Unicorn) on August 25, 2024, for advisory services related to the IPO, with an additional 3% equity contingent on a follow-on financing within 12 months of the listing.
The Series A-1 Preferred Stock, all owned by Hunniwell Picard I, will automatically convert into 18,406,857 shares of common stock upon a public offering resulting in gross proceeds of $25 million.

Stakeholder Impact

**Shareholders:** Existing shareholders face significant dilution from the conversion of preferred stock and convertible notes (some at a 50% discount to IPO price) into common stock. New investors will experience immediate dilution. The company's going concern warning and history of losses pose a high risk to investment value. The controlled company structure limits the influence of non-controlling shareholders.
**Employees:** The company has increased sales specialists and is actively increasing social media presence. Stock-based compensation is part of executive compensation, aligning interests with company performance. However, the going concern risk could impact job security and future compensation.
**Customers (Hospitals/Medical Centers):** Continued availability of SynCardia TAH is crucial for patients with end-stage heart failure. The company's financial instability and regulatory challenges (EU CE mark, cannula tears) could impact product supply, support, and confidence in the device. The company's training and education programs are vital for successful implantations.
**Suppliers:** Reliance on single-source suppliers for critical components (e.g., Bimba, Heitek Automation) means any disruption could impact the company's ability to manufacture and deliver products, potentially affecting supplier relationships and payments.
**Creditors:** The company has substantial debt, including related-party loans and convertible notes, some of which are past due. The going concern warning indicates a high risk for creditors regarding repayment of obligations.

Next Steps

Complete the Initial Public Offering (IPO) to raise capital and list shares on the NYSE American under the symbol PMI.
Fund SynCardia Medical (Beijing), Inc. with $2.85 million from IPO proceeds to support market expansion in China.
Continue research and development activities for the fully implantable Emperor TAH, including acute animal studies in H1 2025, aiming for FDA approval in 2028.
Pursue FDA approval for the upgraded portable Freedom+ Driver, anticipated by H2 2025.
Continue development of next-generation Freedom and C2 Drivers, aiming for FDA approvals in H2 2026 and H2 2027, respectively.
Await FDA's answer in Q3 2025 regarding the PMA supplement to expand SynCardia TAH's Indications for Use (removing 'imminent death' and adding 'Bridge to Candidacy').
Submit a design change to the FDA for cannula tears via a 180-day PMA Supplement in Q3 2025 after validation activities are completed.
Reapply for an MDR CE mark in Q3 2025 to regain market access in the European Union.
Continue efforts to enter and expand into international markets, including India, the Middle East, and Latin America, by seeking local distribution partners and regulatory approvals.
Work with lenders to extend the maturity dates of currently past-due convertible notes.
Implement and maintain effective internal controls over financial reporting as a public company.

Key Dates

Date	Description
1981	Commercial development of the SynCardia TAH started by Symbion Inc.
1985	FDA withdrew Investigational Device Exemption (IDE) for Jarvik-7 clinical trial due to non-compliance.
1991	CardioWest, Inc. founded; Symbion transferred technology, renamed CardioWest Total Artificial Heart.
1993	CardioWest and University Medical Center in Tucson, Arizona started new IDE study of 70cc CardioWest Total Artificial Heart.
1999	SynCardia TAH 70cc implant first obtained CE mark in Europe under MDD.
2001	Company rebranded and incorporated as SynCardia Systems, Inc. in Delaware.
October 15, 2004	FDA Pre-Market Authorization (PMA) for 70cc SynCardia TAH.
2005	Health Canada approval for 70cc SynCardia TAH.
October 26, 2005	Post-market Surveillance Plan approved by FDA.
May 2008	United States Centers for Medicare and Medicaid Services (CMS) approved SynCardia TAH implant procedures for DRG 001 reimbursement.
2008	Began development of the Freedom Driver.
2010	Freedom Driver received CE mark and Freedom Driver System IDE Study began.
July 2011	SynCardia Systems, Inc. organized German subsidiary, SynCardia Systems Europe GmbH.
May 16, 2012	C2 Driver System PMA Supplement approved by FDA.
2012	C2 Driver obtained FDA approval.
July 2013	Entered into a 10-year License Agreement with Medtronic for Med-Hall Valves.
2014	50cc SynCardia TAH received CE Mark.
June 26, 2014	Freedom Driver PMA Supplement approved by FDA.
2014	Freedom Driver approved by FDA.
2015	Began clinical trials on smaller SynCardia TAH 50cc implant.
July 2016	Assets of SynCardia Systems, Inc. acquired by SynCardia Systems, LLC.
September 2021	Hunniwell Picard I, through Picard Medical, Inc., purchased 85% of SynCardia Systems, LLC.
November 1, 2021	Employment offer letter with Dr. Tinker as Chief Technology Officer.
December 2021	BSI suspended SynCardia's CE mark pending completion of a post-market surveillance study.
February 15, 2022	Granted stock option awards to NEOs, including Dr. Tinker.
June 7, 2022	Entered into a purchase order with Heitek Automation for C2 Driver pneumatic manifold drawings.
June 2022	Asked BSI to cancel MDD CE mark for SynCardia TAH to focus on MDR approval.
July 20, 2022	SynCardia Medical (Beijing), Inc. established in Beijing, China.
July 2022	BSI cancelled CE mark; EU distributors notified of cancellation.
2022	Initiated development of a next-generation portable driver (lighter, more compact Freedom Driver).
2022	Initiated informal discussions with CDSCO in India regarding market clearance pathways.
October 2022	Completed first-ever SynCardia TAH sale into Saudi Arabia.
February 17, 2023	Issued urgent field safety notice regarding potential cannula tears (FDA Class 2 recall).
May 2023	Application for Import and Distribution License for SynCardia TAH with Saudi Food and Drug Authority (SFDA) submitted.
July 2, 2023	Picard Medical, Inc. agreed to purchase majority ownership of SynCardia Medical (Beijing) Inc., contingent on becoming publicly traded.
July 2, 2023	SynCardia Systems, LLC and SynCardia Medical (Beijing), Inc. entered an exclusive Distribution Agreement and a Regulatory Affairs Service Agreement.
July 2023	License Agreement with Medtronic expired.
2023	Began development of next generation pneumatic driver system codenamed Unicorn.
2023	Began development of fully implantable total artificial heart codenamed Emperor.
November 2023	Bernard Skaggs appointed Chief Financial Officer; Matt Schuster appointed Chief Operating Officer.
January 2, 2024	SynCardia Systems Australia Pty Ltd. formed as a wholly owned Australian subsidiary.
July 2, 2024	Related Party loans from Richard Fang and Fang Family Funds consolidated into one $7.046 million loan.
June 28, 2024	Granted stock option awards to NEOs, including Patrick Schnegelsberg, Bernard Skaggs, and Matt Schuster.
August 19, 2024	Entered into an agreement with US Unicorn Foundation, Inc. for advisory services related to IPO listing.
August 25, 2024	Issued 623,792 shares to US Unicorn Foundation, Inc. for advisory services.
November 12, 2024	Richard Fang donated the $7.0 million aggregated convertible note to Nexus Science Foundation Inc. and Another Dimension Foundation.
November 25, 2024	FDA approved removal of 'temporary' and '-t' from SynCardia TAH Indications for Use (IFU) and product name.
November 2024	Successfully completed the latest MDSAP audit.
January 2025	Submitted a 180-day PMA supplement to remove 'imminent death' and add 'Bridge to Candidacy' (BTC) to SynCardia TAH IFU.
March 20, 2025	As of this date, 104 reports of cannula tears received with zero serious adverse events.
March 2025	FDA notified conversion of 180-day PMA supplement to a Panel Track Submission.
March 2025	Entered into subscription agreements for sale of 163,934 shares of common stock for $500,000.
March 31, 2025	End of the most recent financial reporting period for unaudited condensed consolidated financial statements.
April 2025	Amended $3.835 million of 2023 Convertible Notes to extend maturity and change conversion rate to 50% IPO discount.
April 2025	Entered into subscription agreements for sale of 323,024 shares of common stock for $1.0 million.
First half of 2025	Plan to conduct acute animal studies using selected Emperor design prototypes.
Second half of 2025	Anticipated FDA approval for upgraded portable driver system (Freedom+).
Third quarter of 2025	Expected answer from FDA regarding PMA supplement for expanded IFU (removing imminent death, adding BTC).
Third quarter of 2025	Expected filing of design change submission to FDA for cannula tears.
Third quarter of 2025	Planning to reapply for an MDR CE mark.
Late 2026	Expected FDA approval of next-generation portable driver (lighter, more compact Freedom Driver).
Second half of 2026	Expected completion of regulatory testing for Unicorn driver system.
Middle of 2027	Approximate FDA approval date for Unicorn driver system (if 180-day PMA supplement).
Second half of 2027	Expected FDA approval for next-generation C2 Driver (Companion 3 Driver).
2027	Lease for Tucson facility expires.
2028	May be able to seek FDA approval for Emperor TAH.
December 31, 2029	Earliest date the company ceases to be an emerging growth company.
December 31, 2030	Latest date the company ceases to be an emerging growth company.
2042	Expiration date of U.S. Patent No. 11,918,798 (Next Generation Total Artificial Heart).
February 5, 2044	Expiration date of U.S. Patent No. 12,121,711 B2 (Next Generation Total Artificial Heart).
December 4, 2044	Expiration date of China Patent Application No. 202080094390.7 (Next Generation Total Artificial Heart).

Recommendation

strong sell

Keywords

Total Artificial Heart, TAH, SynCardia, Medical Device, Heart Failure, Cardiovascular, IPO, SEC Filing, FDA Approval, CE Mark, Bridge to Transplant, Bridge to Candidacy, Emperor TAH, Freedom Driver, Unicorn Driver, Biomedical Engineering, Healthcare Technology, Public Offering, Going Concern, Dilution, Related Party Transactions, Intellectual Property, Clinical Trials, Regulatory Compliance, Manufacturing, SPUS

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