Catheter Precision, Inc. Announces Publication of LockeT Data in the Journal of Cardiovascular Electrophysiology

Rhea-AI Summary

Catheter Precision, Inc. (NYSE American:VTAK) has announced the publication of its first LockeT study in the Journal of Cardiovascular Electrophysiology. The study, involving 102 patients and 182 LockeT devices, demonstrates the effectiveness and safety of LockeT, a novel external compression vascular closure device. Key findings include:

• Immediate hemostasis achievement
• 98% hemostasis retention at 2 hours
• No major complications observed
• Majority of patients discharged same day
• Average time to ambulation under 4 hours

The study suggests LockeT offers benefits similar to manual compression without prolonged bed rest or monitoring, facilitating early mobilization and same-day discharge. Further studies are ongoing, with the next one expected to conclude this year.

Positive

• Successful clinical study of LockeT device published in a reputable journal
• Demonstrated effectiveness in achieving immediate hemostasis in 98% of patients
• No major complications observed in the study
• Facilitated same-day discharge for majority of patients
• Average time to ambulation under 4 hours, indicating quick recovery

Negative

• None.

Medical Device Expert

The publication of LockeT data in a peer-reviewed journal is a significant milestone for Catheter Precision. This study provides crucial clinical evidence supporting the safety and efficacy of their vascular closure device. The results are promising, showing immediate hemostasis achievement and maintenance in 98% of patients after 2 hours, with no major complications.

The key advantage of LockeT appears to be enabling early mobilization and same-day discharge, which could lead to improved patient outcomes and reduced healthcare costs. The average time to ambulation of under 4 hours is particularly noteworthy, as it could significantly enhance patient comfort and hospital efficiency.

However, investors should note that while these results are encouraging, further studies are needed to solidify LockeT's position in the market. The planned conclusion of an additional study this year will be important in providing more comprehensive data.

Healthcare Market Analyst

This publication positions Catheter Precision favorably in the competitive vascular closure device market. The positive clinical outcomes could translate into increased adoption by healthcare providers, potentially driving revenue growth. The device's ability to facilitate same-day discharge aligns with the healthcare industry's push towards cost-effective, outpatient procedures.

Investors should consider the market potential: with an aging population and increasing prevalence of cardiovascular procedures, demand for efficient vascular closure devices is likely to grow. However, it's important to monitor how LockeT compares to existing solutions in terms of cost-effectiveness and ease of use.

The company's commitment to ongoing studies indicates a strong R&D focus, which could lead to further product improvements and market expansion. This proactive approach to clinical validation could be a key differentiator in securing market share and potential partnerships with healthcare systems.

FORT MILL, SC / ACCESSWIRE / August 6, 2024 / Catheter Precision, Inc. (NYSE American:VTAK), a US based innovative medical device company, announced today the publication of its first LockeT study in the Journal of Cardiovascular Electrophysiology. The study titled, Feasibility, safety and efficacy of a novel external compression vascular closure device: The LockeT Study, was made available online on August 5, 2024.

The study demonstrates the first clinical use of LockeT in 102 patients utilizing 182 LockeT devices and suggests that LockeT is effective for hemostasis, and early ambulation can be achieved with no major complications. The use of LockeT appears to generate the same benefits as standard of care (manual compression) without needing prolonged bed rest or monitoring, facilitating early mobilization and same-day discharge. Highlights of the study include:

• Hemostasis was immediately achieved

• Hemostasis remained at 2 hours in 98% of patients

• No major complications were observed

• The majority of patients were discharged same day

• Average Time to ambulation was under 4 hours

Further studies with LockeT are underway and the next study is planned to be concluded this year with additional data.

About LockeT
Catheter Precision's LockeT is a suture retention device intended to assist in hemostasis after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA.

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.

Forward-Looking Statements
Statements in this press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to substantial risk and uncertainties. Forward-looking statements can be identified by words such as "believe," "anticipate," "may," "might," "can," "could," "continue," "depends," "expect," "expand," "forecast," "intend," "ongoing," "predict," "plan," "rely," "should," "will," "may," "seek," "would," "forward," or the negative and alternative word forms of these terms and other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, statements that LockeT appears to generate the same benefits as standard of care (manual compression) without needing prolonged bed rest or monitoring, facilitating early mobilization and same-day discharge, and that the next study is planned to be concluded this year with additional data. 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 the risk that Phases II and III LockeT studies will not achieve the outcomes that we expect; that members of the EP community and other doctors and hospitals will fail to recognize LockeT's value or for other reasons will prefer other methodologies and/or products, including the products of our current competitors as well as possible new and emerging competing products of which we are not yet aware; the risk that hospitals undergoing initial evaluations may not choose to continue using LockeT following such evaluation; risks that we will be unable to obtain the necessary financing to carry out our business goals, including to continue ongoing efforts to gather and publish clinical data and to build out LockeT as well as VIVO; risk that peer-reviewed journals or other journals may choose not to publish data submitted in connection with our products; risks that our business relationships with distribution partners and customers could be disrupted by armed conflicts and unrest in Israel and the Gaza strip and elsewhere, and/or changes in U.S. international relations and/or related geopolitical changes; and other, or disruptions to local and global economies; and the other risks and uncertainties attendant to our business included under the caption "Risk Factors" in the Company's Form 10-K and other SEC filings available at www.sec.gov. These additional risks and uncertainties include, but aren't limited to, risks that our cash needs will continue to exceed our liquidity, we 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 entered into joint marketing agreements with respect to our products, and may enter into additional joint marketing agreements, that will reduce our revenues from product sales, royalty agreements with respect to our LockeT device will reduce any future profits from this product, 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 December 31, 2023 and March 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 and finished product 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 finished product, or we may be unable to manage these components or product procurement effectively or obtain these components or products 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 potential product liability risks as well as 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, could place pressure on our average selling prices as our customers seek to offset the impact of increased tariffs on their own products, increased tariffs 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, disruptions to our ability to conduct business overseas, including to our supply chain, from the Ukraine war, the Israeli-Hamas armed conflict and other ongoing hostilities and instabilities in the Middle East and elsewhere, and ongoing volatility in the stock markets and the U.S. economy in general. In addition, market conditions that are outside our control could significantly how our stock is viewed by potential investors.

CONTACTS:
At the Company
David Jenkins
973-691-2000
IR@catheterprecision.com

# # #

Contact Information
Missiaen Huck
COO
mhuck@catheterprecision.com
9736912000

SOURCE: Catheter Precision

View the original press release on accesswire.com

FAQ

What are the key findings of Catheter Precision's LockeT study published in August 2024?

The LockeT study, involving 102 patients and 182 devices, showed immediate hemostasis achievement, 98% hemostasis retention at 2 hours, no major complications, same-day discharge for most patients, and average time to ambulation under 4 hours.

How many patients were involved in Catheter Precision's (VTAK) LockeT study?

The LockeT study involved 102 patients utilizing 182 LockeT devices.

What are the potential benefits of Catheter Precision's (VTAK) LockeT device compared to standard care?

LockeT appears to offer the same benefits as manual compression (standard care) without requiring prolonged bed rest or monitoring, facilitating early mobilization and same-day discharge.

When is the next study for Catheter Precision's (VTAK) LockeT device expected to conclude?

The next study for the LockeT device is planned to be concluded later in 2024, with additional data expected.