These risks and uncertainties include, but aren't limited to: that we may be unable to successfully build a profitable collaboration with QHSLab and that our sales force may not be able to successfully sell into that product/service space, that the notes acquired from QHSLab are currently in default and have been for some time, and therefore QHSLab may be unable to pay any or all of the amounts owing under them, that although the notes are convertible into QHSLab common stock, that common stock is thinly traded and could be difficult to liquidate, and the conversion is subject to a 4.99% beneficial ownership blocker, that QHSLab has not agreed to our calculation of the total amounts outstanding under that notes, that our ability to develop and commercialize the CPNS System acquired from Cardionomic could be adversely impacted if we are unable to maintain protection of the patents and trade names related thereto, which we are acquiring on an as is basis without recourse; that we may not be able to obtain the financing for our Cardionomix subsidiary that we anticipate and/or such financing even if obtained may not be adequate for the development of the CPNS System; and that we may not adequately address the lessons learned from the Cardionomic pilot studies which included fatigue to nerves if stimulation is delivered for too long; high amplitude stimulation can lead to unstable hemodynamics, rhythm disturbances, and patient sensation; optimal stimulation response is dependent on more than just contractility; stimulation beyond 48 hours did not show additional benefit; stimulator modifications required to reduce procedure time, complexity, and improve user experience; and minor catheter modifications needed to accommodate larger anatomy in heart failure patients. Additionally, the new subsidiary has other, minority investors aside from the Company, and future financings are expected to involve the issuance of securities by the subsidiary, which will reduce the Company's share in the profits, if any, from the CPNS System and the new subsidiary, and is likely to involve the grant of special corporate governance rights to other subsidiary investors so that the Company will not have unfettered control of the new subsidiary. In addition, our forward looking statements are subject to the following additional uncertainties and risks: even with this recent financing, we do not have sufficient liquidity to fund our business unless we are able to obtain additional financing or enter into a strategic transaction that would provide additional liquidity during the next three to six months will not be able to reach profitability unless we are able to achieve our product expansion and growth goals, our research and development and commercialization efforts may depend on entering into agreements with corporate collaborators, we have in the past entered into joint marketing agreements with respect to our products, and may again enter into additional joint marketing agreements in the future that could reduce our revenues from product sales, if we experience significant disruptions in our information technology systems, our business may be adversely affected, litigation and other legal proceedings may adversely affect our business, if we make acquisitions or divestitures, we could encounter difficulties that harm our business, failure to attract and retain sufficient qualified personnel could also impede our growth, failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock, we have determined that our internal controls and disclosure controls were not effective as of March 31, 2024, June 30, 2024, September 30, 2024, and December 31, 2024, and as a result, without effective remediation of the material weaknesses that we have identified, we may not be able to accurately report our financial results or prevent fraud, our revenues may depend on our customers' receipt of adequate reimbursement from private insurers and government sponsored healthcare programs, we may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do, our future operating results depend upon our ability to obtain components in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components, or we may be unable to manage these components effectively or obtain these components on such terms, if hospitals, physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any, our medical device operations are subject to pervasive and continuing FDA regulatory requirements, our products may be subject to additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business, changes in trade policies among the U.S. and other countries, in particular the imposition of new or higher tariffs by the U.S. and/or its trading partners could increase our expenses, require us to increase prices, potentially lowering demand for our products, and/or reduce our revenues and operating results, and such increase , or the imposition of other barriers to international trade, could have a material adverse effect on our revenues and operating results.
Author: Catheter Precision, Inc.
Published at: 2025-05-12 22:41:00
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