UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
July 19, 2024
Commission File Number: 0-29374
EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
Indicate by check mark whether the registrant files or will file annual reports under cover
of Form 20-F or Form 40-F.
Form 20-F [ x] Form 40-F [ ]
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: July 19, 2024
EDAP TMS S.A.
/s/ KEN MOBECK
KEN MOBECK
CHIEF FINANCIAL OFFICER
EDAP Announces Interim Results from Phase 3 Study Evaluating Robotic HIFU
for the Treatment of Deep Infiltrating Endometriosis
| - | Robotic HIFU therapy continues to maintain
an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies
in patients with deep infiltrating endometriosis |
| - | At three months post procedure, the study’s
primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham
treatment arm was not met |
| - | Significant improvements were observed
across primary and secondary outcome measures (endometriosis and digestive symptoms) across
the entire study population at three months |
| - | The Phase 3 study continues as planned per protocol, with patients
from the Sham treatment arm electing HIFU therapy |
LYON, France, July
19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced interim results from its
Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating endometriosis.
The Phase 3 study is a 60-patient comparative, randomized, double blind trial, with the
primary objective of evaluating acute pelvic pain levels. All patients were initially followed for three months after either the HIFU
treatment or the Sham treatment.
Interim results:
| · | Robotic
HIFU therapy continues to maintain an excellent safety profile in patients with deep infiltrating
endometriosis, confirming results from earlier Phase 1 and Phase 2 studies |
| · | While
both arms of the study showed significant reduction in pelvic pain scores at three months
from baseline as measured by Visual Analog Scale (VAS), the primary endpoint of reduced acute
pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met; the
Company and the Principal Investigator of the study believe the three-month post-procedure
follow-up period was likely too short of a time period to show clinically meaningful differences
in pain scores between the two arms of the study |
| · | As measured by MRI,
patients receiving robotic HIFU therapy experienced higher volume reductions in the endometriosis
nodule as compared to patients in the Sham treatment arm |
| · | The
Phase 3 study continues per protocol, with several patients initially in the Sham treatment
arm having elected and already received HIFU therapy after their pelvic pain returned to
baseline levels |
“The interim results from the ongoing Phase
3 study demonstrate that robotic HIFU therapy continues to maintain an excellent safety profile in patients with deep infiltrating endometriosis.
Additionally, the reduction in the volume of the nodules observed in the HIFU arm confirms the therapeutic effect of the HIFU treatment,”
said Professor Gil Dubernard, Head of Gynecology Department at Croix-Rousse Academic Hospital, Lyon, France, and Principal Investigator
of the Study. “This data is consistent with the prior results from the Phase 2 study that was recently published in the Journal
of Human Reproduction1 on the safety and the potential benefit of HIFU treatment for well-selected patients with deep infiltrating
endometriosis.”
“Although this initial data shows similar
levels of improvement in pelvic pain scores between the two arms, we believe that a therapeutic benefit favoring robotic HIFU is more
likely to be confirmed over a longer period of time post-procedure, as suggested by the stabilization of pain scores at six and twelve
months observed in the Phase 2 study,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “Moreover, the cumulative safety
and efficacy data from the Phase 1, 2 and 3 studies, suggests that robotic HIFU is a safe, non-invasive treatment and has significant
potential to reduce pain for women suffering from this debilitating condition. We are encouraged to see additional patients from the
Sham treatment arm elect to be treated with HIFU therapy in accordance with the study protocol, and we look forward to providing another
update on the program later this year.”
About Endometriosis
Endometriosis is a chronic, progressive disease
affecting nearly 10-12% of women of reproductive age. The disease is characterized by tissue resembling the lining of the uterus growing
outside the uterine cavity. This extraneous endometrial tissue may commonly occur in the peritoneum or in pelvic and extra-pelvic organs
such as the bowels, appendix, bladder, diaphragm muscle and thoracic cavity. The space between the uterus and the rectum, known as the
Douglas pouch, is one of the most frequent and symptomatic sites of endometriosis leading to (deep infiltrating) rectal endometriosis.2
1
G Dubernard, E Maissiat, G Legendre, T Dennis, P Capmas, S Warembourg, P Descamps, F Chavrier, H Roman, H Fernandez, E Nguyen-Ba, B Merlot,
P Rousset, C Lafon, Charles-André Philip, Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis:
results from a French prospective multicentre study including 60 patients, Human Reproduction, 2024;, deae127, https://doi.org/10.1093/humrep/deae127
2 Source: https://drseckin.com/rectal-endometriosis/
About EDAP TMS SA
A recognized leader
in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical
devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities
in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in Europe and in the U.S.
as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device,
EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces
and distributes other medical equipment including the Sonolith® i-move lithotripter
and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the
Company, please visit http://www.edap-tms.com, us.hifu-prostate.com and www.focalone.com.
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, 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 our 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 us or not currently considered material by
us, 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,
among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and
distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic,
political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public
health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices
and services.
Other factors that may cause such a difference
may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in
particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's
Annual Report on Form 20-F.
Forward-looking statements speak only as of the
date they are made. Other than required by law, we do 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 us as of the date of
this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited
or incomplete.
Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com
Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com
EDAP TMS (NASDAQ:EDAP)
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