Catheter Precision, Inc. Reports Third Quarter Results of Operations and Filing of Third Quarter 10-Q

Rhea-AI Summary

Catheter Precision, Inc. (NYSE American: VTAK) announced third-quarter highlights, including expansion in Europe, progress in clinical trials, cost-saving measures, and financial updates. Total assets were $32.9 million, cash on hand was $5.6 million, and revenues for the nine months ended September 30, 2023, were $314 thousand.

Insights

Financial Analyst

The announcement from Catheter Precision, Inc. regarding their third-quarter corporate highlights presents a mixed picture. The approval for the first purchase in France and the expansion of the VIVO system into six European countries signify progress in market penetration, which could lead to increased revenue streams. However, the total revenues reported for the nine months ending September 30, 2023, amounting to $314 thousand, appear modest relative to the medical device industry standards, where competitors often report revenues in the millions or billions.

The successful completion of enrollment for the Phase I LockeT study and the initiation of the Phase II study are critical milestones in the product development lifecycle. These steps indicate the company's commitment to innovation and could potentially enhance its credibility and market share if the outcomes are positive. The initiation of design changes to LockeT based on early feedback demonstrates adaptability, which is vital in the fast-paced medical device sector.

From an asset management perspective, the company's total assets and cash on hand, $32.9 million and $5.6 million respectively, provide a snapshot of its financial health. These figures, particularly the cash reserves, are essential for sustaining operations and funding ongoing clinical trials. However, investors may scrutinize the burn rate and the potential need for future capital raises.

Medical Research Analyst

The progression of the LockeT study into Phase II is a significant development for stakeholders interested in the company's research and development efforts. Phase II trials are pivotal in establishing the efficacy of new medical devices and are a prerequisite for regulatory approval and commercialization. The one-to-one randomized study design comparing the standard of care to LockeT will provide robust data on the product's effectiveness and safety. If LockeT demonstrates a clear benefit over existing solutions, it could disrupt the current standard of care and provide a competitive advantage.

The finalized new build processes for the VIVO disposable component aimed at reducing manufacturing costs could improve the company's gross margins and profitability in the long run. This operational efficiency may make the product more attractive to hospitals by lowering the total cost of ownership, which is a significant factor in purchasing decisions within the healthcare industry.

Furthermore, the mention of the VIVO System's potential to support the growth of ventricular ablation programs positions the company in a high-growth segment of the cardiology market. The comparison to the atrial fibrillation market, which is well-established and lucrative, suggests optimism about the VIVO System's future performance.

Industry Analyst

The strategic moves by Catheter Precision, Inc., including the expansion into new European markets and the development of the VIVO and LockeT systems, indicate an aggressive approach to capturing market share in the cardiac arrhythmia space. The cardiac device market is known for its high barriers to entry due to stringent regulatory requirements and the need for significant clinical evidence. Thus, the IRB approval for Phase II of the LockeT study is a commendable achievement.

The company's focus on reducing manufacturing costs and initiating design changes based on feedback suggests a lean approach to product development. This strategy could enhance their competitiveness against larger incumbents. However, the relatively low revenue figures may raise concerns about the company's current market impact and its ability to sustain long-term growth without additional capital infusion.

Overall, the company's activities align with industry trends towards cost-effectiveness and personalized medicine. The success of their clinical trials and the adoption of their products will be critical in determining their future position within the industry.

FORT MILL, SC / ACCESSWIRE / December 22, 2023 / Catheter Precision, Inc. (NYSE American:VTAK) an innovative US-based medical device Company dedicated to improving the lives of patients with cardiac arrhythmias, announced corporate highlights of the third quarter of 2023.

Highlights of the third quarter include the following:

		Received approval for first purchase in France. VIVO is now active in six European countries.
		Completed enrollment of Phase I LockeT study in excess of 100 patients.
		Received Institutional Review Board (IRB) approval for Phase II LockeT study and began enrolling patients. This study is a one-to-one randomized study comparing outcomes of standard of care to LockeT.
		Finalized new build processes for VIVO disposable component to reduce manufacturing costs.
		Initiated design changes to LockeT based on early feedback.
		Total assets at September 30, 2023, were $32.9 million.
		Total cash on hand at September 30, 2023 was $5.6 million.
		Total revenues for the nine months ended September 30, 2023 were $314 thousand.

David Jenkins, acting CEO, commented: "We are pleased to have the Q3 financial filings completed and have a lot of momentum as we move into the fourth quarter. Our sales and clinical team have successfully introduced VIVO and LockeT to a number of new hospital centers and the products have been well received. Over the next several months we expect hospital approval to begin additional product evaluations and subsequent purchase orders. Catheter Precision's VIVO System continues to support the electrophysiologist and hospital in growing their ventricular ablation programs, which we believe will rival the atrial fibrillation market in the future. LockeT offers a more affordable and easier to use option for wound closure and the first publication demonstrating these benefits is underway and will be available soon."

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. Reincorporated as Ra Medical Systems, Inc. in Delaware in 2018, the Company changed its name to Catheter Precision, Inc. on August 17, 2023.

Cautionary Note Regarding 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," "predict," "plan," "rely," "should," "will," "may," "seek," or the negative 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, our expectations that hospital approval will begin additional product evaluations and subsequent purchase orders, that ventricular ablation programs will rival the atrial fibrillation market in the future, and the timing of the first publication demonstrating the benefits of LockeT. 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 Form 10-K for the year ended December 31, 2022 and Forms 10-Q for the quarters ended March 31, 2023, June 30, 2023, and September 30, 2023 filed with the U.S. Securities and Exchange Commission and available at www.sec.gov. These risks and uncertainties include, but aren't limited to, that 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 join 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, if our internal controls are not effective, 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, 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 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
mhuck@catheterprecision.com

# # #

CATHETER PRECISION, INC. (formerly known as RA MEDICAL SYSTEMS, INC.)
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2023			2022			2023			2022
Revenues
Product sales	$	133		$	-		$	314		$	14
Cost of revenues
Product sales		6			-			23			42
Service and other		-			-			-			119
Total cost of revenues		6			-			23			161
Gross profit (loss)		127			-			291			(147)
Operating expenses
Selling, general and administrative		2,745			3,514			14,393			8,292
Research and development		112			727			486			6,238
Restructuring and impairment		-			542			-			4,069
Loss on impairment of goodwill		-			-			60,934			-
Total operating expenses		2,857			4,783			75,813			18,599
Operating loss		(2,730)			(4,783)			(75,522)			(18,746)
Other income, net
Change in fair value of royalty payable		716			-			5,333			-
Interest income		87			24			275			41
Other (expense) income, net		-			(4)			11			(1)
Total other income, net		803			20			5,619			40
Loss from operations before income taxes		(1,927)			(4,763)			(69,903)			(18,706)
Income taxes		-			-			-			-
Net loss	$	(1,927)		$	(4,763)		$	(69,903)		$	(18,706)
Deemed dividends from the warrant inducement offer		-			-			(800)			-
Net loss attributable to common stockholders	$	(1,927)		$	(4,763)		$	(70,703)		$	(18,706)
Net Loss per share attributable to common stockholders, basic and diluted	$	(0.28)		$	(4.36)		$	(14.20)		$	(28.00)
Weighted average common shares used in computing net loss per share, basic and diluted		6,805,958			1,091,623			4,980,538			668,494

CATHETER PRECISION, INC. (formerly known as RA MEDICAL SYSTEMS, INC.)
Condensed Consolidated Balance Sheets
(in thousands, except share data)

		September 30,2023				December 31,2022
ASSETS		(Unaudited)
Current Assets
Cash and cash equivalents		$	5,579			$	15,859
Accounts receivable, net			46				-
Inventories			64				-
Prepaid expenses and other current assets			87				977
Total current assets			5,776				16,836
Property and equipment, net			59				-
Operating lease right-of-use assets			200				-
Intangible assets, net			26,828				-
Other non-current assets			8				-
TOTAL ASSETS		$	32,871			$	16,836
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable		$	165			$	92
Accrued expenses			1,781				7,484
Current portion of operating lease liabilities			89				-
Total current liabilities			2,035				7,576
Royalties payable			8,848				-
Operating lease liabilities			121				-
Total liabilities			11,004				7,576
Commitments and contingencies (see Note 16)
Stockholders' Equity
Series A Convertible Preferred Stock, $0.0001 par value, 10,000,000 shares authorized; 4,578 and 0 shares issued and outstanding as September 30, 2023 and December 31, 2022, respectively			-				-
Series X Convertible Preferred Stock, $0.0001 par value, 15,404 shares authorized; 12,675 and 0 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively			-				-
Common stock, $0.0001 par value, 300,000,000 shares authorized; 7,008,002 and 2,161,950 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively			1				-
Additional paid-in capital			296,906				214,397
Accumulated deficit			(275,040)				(205,137)
Total stockholders' equity			21,867				9,260
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$	32,871			$	16,836

SOURCE: Catheter Precision, Inc

View the original press release on accesswire.com

FAQ

What is the ticker symbol for Catheter Precision, Inc.?

The ticker symbol for Catheter Precision, Inc. is VTAK on the NYSE American.

What were the highlights of Catheter Precision, Inc.'s third quarter of 2023?

The highlights include expansion into six European countries, completion of enrollment for Phase I LockeT study, IRB approval for Phase II LockeT study, new build processes for VIVO disposable component, and design changes to LockeT.

What were the total assets and cash on hand for Catheter Precision, Inc. on September 30, 2023?

The total assets were $32.9 million, and the total cash on hand was $5.6 million on September 30, 2023.

What were the total revenues for Catheter Precision, Inc. for the nine months ended September 30, 2023?

The total revenues for the nine months ended September 30, 2023, were $314 thousand for Catheter Precision, Inc.

Who is the acting CEO of Catheter Precision, Inc.?

David Jenkins is the acting CEO of Catheter Precision, Inc.