false
0001716621
0001716621
2025-08-18
2025-08-18
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 18, 2025
Catheter Precision, Inc.
(Exact name of registrant as specified in its charter)
|
Delaware
|
|
001-38677
|
|
38-3661826
|
|
(State or other jurisdiction
of incorporation)
|
|
(Commission
File Number)
|
|
(IRS Employer
Identification No.)
|
1670 Highway 160 West
Suite 205
Fort Mill, SC 29708
(Address of principal executive offices, including zip code)
(973) 691-2000
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|
☐
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
☐
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
☐
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
Common Stock, par value $0.0001 per share
|
VTAK
|
NYSE American
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
This Form 8-K is being filed for the purpose of filing the legal opinion of Arnall Golden Gregory LLP dated August 18, 2025 in connection with the Prospectus Supplement dated August 7, 2025 of Catheter Precision, Inc. (the “Company”), in order that it may be incorporated by reference into the Company’s Registration Statement on Form S-3 (Registration No. 333-284217).
Also, the Company issued a press release on August 18, 2025 regarding approval of its LockeT product in Great Britain. A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated by reference herein.
Forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are contained in the press release include that LockeT enhances patient comfort and recovery and enables earlier patient discharge following cardiac procedures and that LockeT helps clinicians deliver more treatments, more efficiently. Risks that could cause the forward-looking statements in the press release not to occur as expected, and other general business risks impacting our business, include the following: there is no guarantee that future LockeT use will generate all of the benefits seen to date, competition in the wound closure space is intense, and many of our competitors are better capitalized than we are, even if they see the benefits of LockeT, hospitals could choose competing products for economic reasons, we will be required to raise additional funds to finance our operations and continue as a going concern, and we may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us, and we may require additional funds sooner than our current expectations; our business has a history of losses, will incur additional losses, and may never achieve profitability; we have identified material weaknesses in our internal control over financial reporting and these material weaknesses could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner; compliance with Sarbanes-Oxley Act Section 404 could have a material adverse impact on our business; we will not be able to reach profitability unless we are able to achieve our product expansion and growth goals; our VIVO and LockeT launch plans require significant investment in infrastructure and sales representatives; 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 LockeT, the surgical vessel closing pressure 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; 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; the recent coronavirus outbreak (“COVID-19”) adversely affected our financial condition and results of operations and we cannot provide any certainty as to whether there will be future impacts from COVID-19 or another pandemic; a variety of risks associated with marketing our products internationally could materially adversely affect our business; the impact of the military conflicts in Ukraine and Israel, and the actions that have been and could be taken by other countries, including new and stricter sanctions and actions taken in response to such sanctions, have affected, and may continue to affect, our business and results of operations, including our supply chain; if the third parties on which we rely for the conduct of our clinical trials and results do not perform our clinical trial activities in accordance with good clinical practices and related regulatory requirements, we may be unable to obtain regulatory approval for or commercialize our product candidates; we may be adversely affected by product liability claims, unfavorable court decisions or legal settlements; our ability to use our net operating loss carryforwards may be limited; we are subject to pervasive and continuing regulation by the FDA and other regulatory agencies; 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 United States (“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; product clearances and approvals can often be denied or significantly delayed, although we have obtained regulatory clearance for our VIVO and LockeT products in the U.S. and certain non-U.S. jurisdictions, our business plans include expanding uses for our products, which will require additional clearances; even after clearance is obtained, our products remain subject to extensive regulatory scrutiny; if we or our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, or any applicable state equivalent, our operations could be interrupted, and our potential product sales and operating results could suffer; if any of our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions; healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets, and if we are unable to obtain and maintain patent protection for our products, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our existing products and any products we may develop, and our technology may be adversely affected.
These forward-looking statements reflect our beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Report and are subject to risks and uncertainties. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. We qualify all of the forward-looking statements in this Report by these cautionary statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit
|
|
Description
|
|
|
|
|
|
|
|
|
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
|
|
CATHETER PRECISION, INC.
|
| |
|
|
|
|
| |
|
|
|
| |
|
|
|
|
|
Date:
|
|
August 18, 2025
|
By:
|
/s/ Philip Anderson |
| |
|
|
|
Philip Anderson
|
| |
|
|
|
Chief Financial Officer
|
EX-5.1
2
ex_854469.htm
EXHIBIT 5.1
ex_854469.htm
Exhibit 5.1
171 17th Street NW
Suite 2100
Atlanta, GA 30363
Direct Phone: 404.873.8500
Facsimile: 404.873.8501
August 18, 2025
Catheter Precision, Inc.
1670 Highway 160 West, Suite 205
Fort Mill, South Carolina
Ladies and Gentlemen:
We have acted as counsel to Catheter Precision, Inc., a Delaware corporation (the “Company”), in connection with the registration of the offer and sale of up to an additional $1,071,718 of shares (the “Shares”) of the Company’s common stock, $0.0001 par value per share, pursuant to the Company’s shelf Registration Statement on Form S-3 (File No. 333-284217), filed on January 10, 2025 and declared effective by the Securities and Exchange Commission (the “Commission”) on January 22, 2025 (the “Registration Statement”).
The offering and sale of the Shares are being made pursuant to the At Market Offering Agreement (the “Sales Agreement”) dated as of May 19, 2025 by and between the Company and Ladenburg Thalmann & Co. Inc.
We have examined copies of the Sales Agreement, the Registration Statement, the base prospectus that forms a part thereof and the prospectus supplements thereto related to the offering of the Shares, including the prospectus supplement dated May 19, 2025 and the prospectus supplement dated as of August 7, 2024 and filed by the Company in accordance with Rule 424(b) promulgated under the Securities Act of 1933, as amended. We have also examined instruments, documents and records which we deemed relevant and necessary for the basis of our opinion hereinafter expressed.
In such examination, we have assumed (i) the authenticity of original documents and the genuineness of all signatures, (ii) the conformity to the originals of all documents submitted to us as copies, and (iii) the truth, accuracy, and completeness of the information, representations and warranties contained in the records, documents, instruments and certificates we have reviewed.
Based on and subject to the foregoing, we are of the opinion that the Shares have been duly authorized by the Company and, when issued and delivered by the Company against payment therefor in accordance with the terms of the Sales Agreement, the applicable prospectus and prospectus supplements, and the Board’s authorizing resolutions, will be validly issued, fully paid and nonassessable.
We express no opinion as to the laws of any other jurisdiction other than the federal laws of the United States of America and the General Corporation Law of the State of Delaware.
We hereby consent to the filing of this opinion as an exhibit to the Company’s Current Report on Form 8-K filed on or about August 18, 2025 for incorporation by reference into the Registration Statement.
We consent to the reference to our firm under the caption “Legal Matters” in the base prospectus dated January 22, 2025 and prospectus supplement dated May 19, 2025. In giving such consent, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission thereunder.
| |
Very truly yours,
ARNALL GOLDEN GREGORY LLP
|
EX-99.1
3
ex_854595.htm
EXHIBIT 99.1
ex_854595.htm
Exhibit 99.1
Catheter Precision Receives Approval for LockeT in the United Kingdom
Fort Mill, SC, August 18, 2025 – Catheter Precision, Inc. (VTAK - NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced registration and approval in the United Kingdom for its LockeT product.
LockeT is a suture retention device that recently received CE Mark for European approval and distribution in May 2025 and now has approval to commercialize in the UK.
Catheter Precision has partnered with a distributor, HC21, for several years with another product line and has entered into an agreement with HC21 for LockeT. With an annual revenue of €180 million and more than 500+ employees across the UK and Ireland, HC21 works with many of the world’s leading medical device companies and help them drive growth and achieve quicker, more efficient routes to market though existing and new channels.
Fatih Ayoglu, Sales Manager EMEA & APAC, said "We are proud to announce the approval of LockeT for use in the United Kingdom, marking a significant milestone in our mission to support healthcare systems with innovative, patient-centric solutions. LockeT’s intuitive design and ease of deployment not only enhance patient comfort and recovery but also enable earlier discharge following cardiac procedures. This directly supports NHS efforts to reduce waiting lists by freeing up hospital capacity and accelerating patient throughput. With the NHS recently achieving its first reduction in waiting lists in 17 years, LockeT is poised to contribute meaningfully to this momentum by helping clinicians deliver more treatments, more efficiently. We look forward to working closely with UK healthcare providers to bring LockeT’s benefits to patients nationwide."
About LockeT
Catheter Precision’s LockeT is a suture retention device intended to assist in wound closure after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA and has received CE Mark approval.
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
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, statements regarding product evaluations at the hospital, and that the purchase order indicates that the hospital and its staff see the value and benefits that LockeT can bring and expectations regarding LockeT evaluations in the coming weeks. 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 filed with the SEC and available at www.sec.gov.
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:
Investor Relations
973-691-2000
IR@catheterprecision.com
# # #
エドガーで原本を確認する
