Catheter Precision, Inc. Completes Acquisition of Cardionomic Heart Failure Assets
- Acquisition expands product portfolio into the large ADHF market with over 1 million annual hospitalizations in the US
- Initial studies of the CPNS System show positive results
- Technology addresses a significant unmet medical need with high mortality rates
- Innovative solution targeting the root cause of heart failure through electrical stimulation
- Financial terms of the acquisition not disclosed
- Product still in development phase, requiring further clinical validation
- Integration and development costs could impact near-term financials
FORT MILL, S.C., May 06, 2025 (GLOBE NEWSWIRE) -- Catheter Precision, Inc. (VTAK - NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that its
As previously announced, Catheter Precision entered into a definitive agreement with an assignor of Cardionomic, Inc. in April. For several years Cardionomic had been developing a new therapy based upon novel technology for the treatment of acute decompensated heart failure, or ADHF, for which over 1 million Americans are hospitalized annually. Patients admitted for ADHF have high in-hospital morbidity, frequent rehospitalization and subsequent death. The CPNS System consists of electrical stimulation via a temporary catheter inserted in the pulmonary artery targeting the root cause of heart failure by stimulating the autonomic cardiac nerves to restore autonomic balance. The initial studies show positive results.
David Jenkins, CEO of Catheter Precision, said, “Completing this acquisition is a significant milestone in the expansion of our product offering. Cardionomic’s unique solution to ADHF represents an exciting opportunity for Catheter Precision and the chance to bring advanced treatment options to millions of patients in the future.”
About Catheter Precision
Catheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.
Cautionary Note Regarding Forward-Looking Statements
This communication contains forward-looking statements. Forward-looking statements can be identified by words such as "believe," "anticipate," "may," "might," "can," "could," "continue," "depends," "expect," "expand," "forecast," "intend," "predict," "plan," "rely," "should," "will," "may," "seek," "promising," "potential," or the negative of these terms and other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, but are not limited to, express and implied statements regarding the following: our expectations regarding the assets acquired. The Company's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks and changes in circumstances, including but not limited to risks and uncertainties included under the caption "Risk Factors" in the Company's 2024 Form 10-K filed with the SEC and available at www.sec.gov. These risks and uncertainties include, but aren't limited to: that our ability to develop and commercialize the CPNS System 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 the new 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 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. FDA review of the CPNS System is likely to be costly and lengthy, and there is no guarantee that clearance and approval will ever occur or occur on a timetable that is beneficial to the Company. 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. There is no guarantee that the success of the pilot studies will be repeated in future trials or ultimately lead to a successful commercialization of the CPNS System. The medical device industry in general is highly competitive, and some of our competitors have longer, more established operating histories, with significantly greater financial, technical, marketing, sales, distribution, and other resources. The CPNS System is not the only device-based neuromodulation therapy currently in development for the treatment of heart failure and further must also compete against potential new drug therapies. In general, results of anticipated trials may not turn out as we currently expect, and future trials may not occur on the timetables we expect or may be more costly than anticipated.
In addition, our forward looking statements are subject to the following additional uncertainties and risks: 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 few 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. The risks and uncertainties described above may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty, or other pandemics, supply chain disruptions from the Ukraine war or Israeli-Hamas conflict and otherwise, and ongoing volatility in the stock markets and the U.S. economy in general.
The forward-looking statements included in this communication are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
CONTACTS:
At the Company
David Jenkins
973-691-2000
info@catheterprecision.com
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FAQ
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