FocalTherics™ Announces Proposed Public Offering of American Depositary Shares

FocalTherics™ Announces Proposed Public Offering of American Depositary Shares

AUSTIN, Texas and LYON, France, Aug. 11, 2026 (GLOBE NEWSWIRE) — FocalTherics™ (NASDAQ: FOCL) (the “Company”), a global leader in robotic energy-based therapies, announced today that it has commenced an underwritten public offering of American Depositary Shares (“ADSs”), each representing one ordinary share of the Company, €0.13 nominal value per share (the “Offering”). All of the ADSs in the proposed Offering will be sold by the Company. The Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the ADSs sold in the Offering on the same terms and conditions. The terms of the ADSs to be issued in the Offering are to be determined upon pricing of the Offering. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed or as to the actual size or terms of the Offering. 

TD Cowen and Mizuho will act as joint book-running managers for the Offering. H.C. Wainwright & Co. and Lucid Capital Markets and will act as co-managers for the Offering.        

The Company intends to use the net proceeds from the Offering for operating costs, capital expenditures and for general corporate purposes, including working capital.

The Offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-294597), previously filed with the Securities and Exchange Commission (the “SEC”) on March 25, 2026, amended on March 27, 2026, and declared effective on March 31, 2026. The Offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed Offering will be filed with, and will be available on, the SEC’s website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement (and accompanying prospectus) relating to the Offering may be obtained, once available, from: TD Securities (USA) LLC,  c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at TDManualrequest@broadridge.com; Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by telephone (212) 205-7600, or by email: US-ECM@mizuhogroup.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

About FocalTherics
A recognized global leader in Robotic Focal Therapy, FocalTherics develops, manufactures, and markets minimally invasive medical devices worldwide to treat various conditions using proprietary focused ultrasound technology. The Company’s flagship platform, Focal One Robotic HIFU, combines advanced imaging, real-time treatment planning, robotic precision, and HIFU technology to deliver personalized focal therapy designed to optimize clinical outcomes while preserving quality of life.

Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, as amended, including statements about the Company’s expectations regarding the proposed Offering, including the expected timing, terms, size and use of proceeds of the Offering and the Company’s expectation that it will complete the proposed Offering, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect the Company’s views about future events and financial performance. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties, including matters not yet known to the Company or not currently considered material by the Company, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, but are not limited to, uncertainties related to market conditions, those risks relating to the Offering and others described in the preliminary prospectus supplement and in particular in the sections “Cautionary Statement on Forward-Looking Statements” and “Risk Factors” and those risks relating to the Company’s business, which are described in the Company’s filings with the SEC and in particular in the section “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.

Forward-looking statements speak only as of the date they are made. Other than required by law, the Company does not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to the Company as of the date of this press release, and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete.

Investor Contact
Louisa Smith
Gilmartin Group
investor.relations@focalone.com