PMI 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• 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 medica…

• The currently approved SynCardia TAH System consists of an implant including: (i) left and right artificial ventricles; (ii) external pneumatic drivers that power the implant; and (iii) drivelines that connect the external driver to the implant. The implantation procedure follows routine surgical te…

• 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 bas…

• Following the May 2026 Offering, Hunniwell Picard I LLC no longer controls a majority of the voting power of the outstanding common stock of PMI, causing the Company to cease being a "controlled company" within the meaning of applicable rules of NYSE American. The Company is now subject to complianc…

• 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…

相对上期删除的文字 · 来源:10-Q · 2025-11-14

• We are a holding company that is the sole owner of SynCardia. The business of our company is carried out by SynCardia, and thus most of the information set forth in this Quarterly Report on Form 10-Q relates to the business of SynCardia.

• Our long-term mission is to build a portfolio of medical technology companies active in the cardiovascular space. We intend to achieve this goal by acquiring, developing, or by in-licensing of promising technologies or assets with a focus on approved devices, or devices close to being approved. We m…

• The SynCardia TAH is the only total artificial heart that is approved and commercially available in the United States as a bridge to heart transplant, and it is also available in a number of other countries around the world under special exemptions or compassionate use. The system is comprised of an…

• We generate revenue from the sale of our total artificial heart for patients, rental of Freedom drivers, and from training and certification services, which are required before the first time a transplant center may deploy a SynCardia TAH. Revenue includes sales and services to appropriate patient a…

• In August 2025, the United States Patent and Trademark Office issued U.S. Patent No. 12,383,722 B2, covering core technology for our next-generation total artificial heart system. Together with U.S. Patents Nos. 11,918,798 and 12,121,711 B2, these three patents encompass a total of 34 claims and col…

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives of ensuring that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Ex…

• There were no changes in the Company’s internal control over financial reporting during the quarter ended March 31, 2026, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

相对上期删除的文字 · 来源:10-Q · 2025-11-14

• Lack of written policies and procedures over it business processes.

• Continue to develop formal policies and procedures on accounting and internal control over financial reporting and monitor the effectiveness of existing controls and procedures.

• Improve communication and monitoring of related party transactions throughout the Company.

• There were no changes in the Company’s internal control over financial reporting during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.