Welcome to our dedicated page for Edap Tms SEC filings (Ticker: EDAP), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
EDAP TMS SA filings document a France-based medical-device issuer with Nasdaq-listed American depositary shares, each representing one ordinary share. Its current reports cover operating results for the HIFU business, Focal One robotic HIFU system sales and procedure trends, ESWL and Distribution revenue, investor presentation materials, and product regulatory updates such as FDA 510(k) clearances for Focal One enhancements.
The company’s SEC disclosures also record capital-structure and financing matters, including a European Investment Bank credit facility and related warrants to purchase ordinary shares. Governance filings address board composition, committee assignments, and shareholder-vote matters, while foreign-issuer reports provide formal disclosure around EDAP’s therapeutic ultrasound strategy, risk statements, and public-company reporting obligations.
EDAP TMS, operating as FocalTherics, used its 2026 Investor Day to lay out a pure‑play HIFU strategy and updated financial framework. The company is moving its ESWL and Distribution businesses to discontinued operations from Q2 2026 and focusing on its Focal One robotic focal therapy platform.
HIFU revenue grew from $16M in 2022 to $37M in 2025, and guidance for calendar 2026 is $50–$54M, implying about 40% year‑over‑year growth and a 32% three‑year CAGR. Management targets HIFU gross margin of roughly 60% and a pathway to breakeven operating income and positive EBITDA in 2028, driven by installed‑base expansion and procedure growth.
The presentation highlights accelerating adoption of Focal One in prostate cancer, with 91 systems in the U.S. and 41 in Europe, reimbursement support including a Cat. 1 CPT code and 2026 Medicare outpatient payment of $9,671 for HIFU, and indication expansion opportunities in benign prostatic hyperplasia and deep infiltrating endometriosis that together contribute to a stated total addressable opportunity of more than four million annual procedures and over $10B in potential revenue.
EDAP TMS S.A. announced it will begin operating under the new corporate name FocalTherics to highlight its exclusive focus on high-growth robotic focal therapy. Its American Depositary Shares will start trading on the Nasdaq Global Market under the new ticker symbol FOCL at the market open on June 1, 2026, while the legal name remains EDAP TMS S.A. and a formal legal name change will be submitted for shareholder approval at a future general meeting.
The company also plans to report and classify its Extracorporeal Shock Wave Lithotripsy and Distribution operating segments as discontinued operations beginning with its second quarter 2026 financial results. Management will discuss the new corporate identity, growth strategy, and business outlook at an Investor Day on June 1, 2026, with a live webcast and replay available through its investor relations website.
EDAP TMS S.A. is asking shareholders to vote on 32 resolutions at its Annual Combined General Meeting on June 26, 2026 in Vaulx-en-Velin, France. Proposals include renewing all five directors, ratifying David Horn’s appointment, and approving 2025 statutory and consolidated financial statements.
Shareholders will cast a non-binding say-on-pay vote for named executive officer compensation and choose the frequency of future say-on-pay votes, with the board favoring an annual vote and opposing two- and three-year cycles. Extensive capital-authorization items would delegate to the board the ability to issue shares and other securities, with and without preferential subscription rights, and in connection with potential mergers or financings.
Additional proposals cover free share grants to employees and officers, amendments to share-capital and governance bylaws, and reappointment of the statutory auditor. As of April 29, 2026, 37,484,069 Ordinary Shares were outstanding and eligible for instruction through Ordinary Shares or ADSs.
EDAP TMS SA reported that SVP, Marketing & Product Management, Steven Annen received equity-based compensation consisting of restricted stock units and stock options. He was granted 90,000 RSUs, each representing one share of EDAP common stock upon settlement.
The RSUs were granted under the issuer's 2025-2 Restricted Stock Unit (Free Share) Plan and will vest over four years, with one-half vesting on the second anniversary of the grant date and the remaining half vesting in equal installments every six months through the fourth anniversary. Following this grant, Annen directly holds 131,490 shares of common stock.
He was also granted 100,000 stock options exercisable for EDAP common stock at an exercise price of $4.17 per share, converted from 3.54 euros. These options vest over three years, becoming exercisable as to one-sixth after six months from the grant date and the remainder monthly thereafter, and expire on May 12, 2036. These awards are compensation-related acquisitions rather than open-market purchases or sales.
EDAP TMS SA granted equity awards to its General Counsel and Corporate Secretary, Sanket Shah. He received 67,500 restricted stock units of common stock at no purchase price, taking his direct common share holdings reported in this filing to 67,500 shares.
The RSUs were granted under the 2025-2 Restricted Stock Unit (Free Share) Plan and will vest over four years: half on the second anniversary of the grant date of May 12, 2026, and the rest in equal installments every six months through the fourth anniversary. Shah was also granted stock options for 75,000 shares of common stock at an exercise price of $4.17 per share, expiring on May 12, 2036.
These options become exercisable over three years, with one-sixth vesting six months after the grant date and the remaining five-sixths vesting monthly thereafter. After this grant, Shah directly holds 75,000 stock options linked to EDAP common stock in addition to the RSUs.
EDAP TMS SA reported that Chief Executive Officer Ryan Rhodes received new equity compensation. On May 12, 2026, he was granted 304,500 restricted stock units (RSUs), which will vest over four years starting on the second anniversary of the grant date.
On the same date, he was also granted 390,000 stock options exercisable for EDAP common stock at an exercise price of $4.17 per share, with vesting beginning six months after the grant date and continuing monthly through the third anniversary. Following these grants, his direct holdings of EDAP common stock totaled 605,649 shares.
EDAP TMS SA director Lance Willsey received a grant of stock options covering 114,285 shares of common stock. The options have an exercise price of $4.17 per share, converted from 3.54 euros, and expire on May 12, 2036. This is a compensation-related award, not an open-market purchase or sale.
According to the vesting terms, one-sixth of the options will become exercisable six months after the grant date of May 12, 2026, and the remaining five-sixths will vest monthly through the third anniversary of the grant.
EDAP TMS SA’s Chief Financial Officer, Kenneth S. Mobeck, received new equity awards as part of his compensation. He was granted 120,000 restricted stock units (RSUs), each representing one share of EDAP common stock, bringing his direct common stock holdings to 176,610 shares.
Under the 2025-2 Restricted Stock Unit (Free Share) Plan, one-half of the RSUs will vest on the second anniversary of the May 12, 2026 grant date, with the remaining half vesting in equal installments every six months through the fourth anniversary. He was also granted stock options on 144,141 shares at an exercise price of $4.17 per share, expiring on May 12, 2036. One-sixth of these options become exercisable six months after grant, with the remaining five-sixths vesting monthly through the third anniversary.
EDAP TMS SA director Joshua Levine reported an open-market purchase of Common Stock. On May 11, 2026, he bought 10,000 shares at $4.22 per share. After this transaction, he directly owns 35,000 shares of the company’s Common Stock.