Ultime notizie per Edap TMS (NASDAQ:EDAP) Azioni

Edap TMS

Edap TMS SA is a holding company operating in three divisions namely, HIFU (High-Intensity Focused Ultrasound), ESWL (Extracorporeal ShockWave Lithotripsy), and Distribution. The HIFU division develops, manufactures, and markets devices for the invasive destruction of certain types of tumors using HIFU technology. It markets three HIFU devices: the Ablatherm, Ablatherm Fusion, and the Focal One. The ESWL division is engaged in the manufacturing, marketing, and servicing of its installed base of Sonolith range of lithotripters. The Distribution division markets products that are complementary to its global activity such as lasers, micro-ultrasound systems, and other medical products from third parties. Its geographical segments are Asia, France, United States, and Others.

EDAP TMS S.A. - American Depositary Shares, each representing One Ordinary Share

Edap TMS SA

EDAP TMS SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>), the global leader in robotic energy-based therapies, today announced that the first patients have been treated in a Phase I/II study evaluating the Company's proprietary Focal One&#xAE; robotic high-intensity focused ultrasound (HIFU) technology for the treatment of benign prostatic hyperplasia (BPH). &nbsp;
"We've been offering targeted HIFU ablation to prostate cancer patients for more than 15 years," said Harry Toledano, MD, Head of the Urology Department of Martigues Hospital in Martigues, France. "Based on this large experience and the follow-up of hundreds of prostate cancer patients with their functional outcomes, we believe that the HIFU energy precisely delivered by Focal One has the potential to improve BPH symptoms with minimal side effects allowing a quick return to normal activities for a significant number of patients. We are enthusiastic to co-lead the first phase of this important clinical trial with our colleagues from Edouard Herriot Hospital – Lyon University and are looking forward to offering a new option to our BPH patients."
"We are excited to initiate this important clinical study evaluating Focal One robotic HIFU for the treatment of BPH, a condition which impacts millions of men each year," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. "While there are other treatment options available for treating BPH, there remains a significant need for much less invasive treatment approaches that can preserve and protect the integrity of the urethra and other critical structures. We believe Focal One is ideally positioned to deliver this type of treatment solution, and this clinical approach in addressing BPH represents a logical next step in expanding our technology beyond the application in prostate cancer. We also believe this study will serve as a foundation for initiating a BPH clinical study in the United States next year."
The Phase I/II study is a company-sponsored, prospective, multicenter clinical trial designed as a two-part study. Part 1 of the Phase I/II study will take place at two leading academic prostate treatment centers in France with a recognized expertise in the treatment of BPH as well as in the use of Focal One HIFU technology. Part 1 is designed to define the optimal treatment parameters to effectively treat BPH and its related symptoms with minimal side effects. Part 2 of the study will expand patient enrollment across a larger number of treatment centers in order to validate the safety and efficacy of the parameters as defined in Part 1 of the study.

News

EDAP

EDAP TMS Begins Phase I/II Trial for Robotic HIFU Treatment of Enlarged Prostate

HC Wainwright &amp; Co. analyst Swayampakula Ramakanth reiterates Edap TMS (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>) with a Buy and maintains $19 price target.

Price Target

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Buy on Edap TMS, Maintains $19 Price Target

WIIM

EDAP TMS shares are trading higher after the company reported better-than-expected Q2 revenue results.

Edap TMS (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>) reported quarterly losses of $(0.18) per share which missed the analyst consensus estimate of $(0.12) by 50 percent. The company reported quarterly sales of $16.970 million which beat the analyst consensus estimate of $15.695 million by 8.12 percent. This is a 9.33 percent increase over sales of $15.522 million the same period last year.

Earnings

Earnings Beats

Earnings Misses

Edap TMS Q2 2024 GAAP EPS $(0.18) Misses $(0.12) Estimate, Sales $16.970M Beat $15.695M Estimate

<ul>
<li>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</li>
<li>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</li>
<li>Significant improvements were observed across primary and secondary outcome measures (endometriosis and digestive symptoms) across the entire study population at three months
<ul>
<li>The Phase 3 study continues as planned per protocol, with patients from the Sham treatment arm electing HIFU therapy</li>
</ul>
</li>
</ul>

Biotech

General

EDAP Reports Interim Results From Phase 3 Study Evaluating Robotic HIFU For Deep Infiltrating Endometriosis

Edap TMS Q1 2024 GAAP EPS €(0.12) Misses €(0.11) Estimate, Sales €14.908M Beat €14.877M Estimate

Final results demonstrate a significantly higher salvage treatment free survival rate&nbsp;(STFS) at 30 months&nbsp;of 89.6%&nbsp;in the HIFU-treated&nbsp;arm&nbsp;versus&nbsp;86.2% in&nbsp;patients who underwent&nbsp;radical&nbsp;prostatectomy&nbsp;(RP)
Functional evaluation criteria show better results with respect to urinary continence and erectile function in patients receiving HIFU therapy versus patients receiving RP
Final study results were presented during a plenary session of the AUA focused on paradigm-shifting and practice-changing clinical trials in urology
HIFI Study is the largest clinical study ever conducted evaluating treatment outcomes with Focal One robotic HIFU, enrolling a total of 3,328 prospective patients, including 1,967 consecutive HIFU patients and 1,361 RP patients across 46 centers
LYON, France, May 6, 2024 - EDAP TMS SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>), the global leader in robotic energy-based therapies, announced a recent presentation highlighting the positive, final results from a large, prospective, multicenter, non-inferiority study, the HIFI Study, comparing Focal One&#xAE; high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 119th American Urological Association Annual Meeting (AUA 2024), which took place from May 3-6, 2024, in San Antonio, Texas, USA. Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the HIFI Study, highlighted the final results from the study during an oral presentation at the AUA plenary session, "Paradigm-shifting, Practice-changing Clinical Trials in Urology".
HIFI is the first prospective, multi-center, investigator-sponsored study comparing robotic HIFU to RP in the management of prostate cancer. The study, which ran from April 2015 through March 2022, compared Focal One HIFU versus RP as a first line treatment for patients with localized prostate cancer (grade groups &lt;3). A total of 3,328 patients from 46 treatment centers were included: 1,967 consecutive patients were treated with EDAP's robotic HIFU technologies, where Focal One was used for 90% of the patients. 1,361 patients underwent radical prostatectomy surgery. All patients were followed for 30 months.
Select data highlights:
<ul>
<li>At 30 months, the STFS was higher in the HIFU arm (89.6%) compared with RP arm (86.2%)</li>
<li>The propensity score-adjusted result is similar to the univariate result (HR=0.75 [0.55-1.03], p=0.076). After adjustment on different variables (Age, BMI, ASA score, Grade Group, prostate volume, PSA) the results are similar to the univariate analysis: the risk of salvage treatment is lower in the HIFU arm compared to RP</li>
<li>International Continence Society (ICS) score, a measure of urinary incontinence, was significantly lower after HIFU for 3 of the 4 questions</li>
<li>Urinary Symptom Profile (USP) showed a significantly lower stress incontinence score for patients after HIFU than RP (0 vs 1, p &lt; 0.001)</li>
<li>International Index of Erectile Function-5 (IIEF-5), a well validated measurement of erectile function, decreased significantly less after HIFU than after RP in patients 69 and older with a score of 15 or higher at baseline (median Δ = -8 vs -13 p &lt; 0.001)</li>
<li>Post-procedural benefits of HIFU on both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older (median age was 74.7 years for HIFU vs 65.1 years for RP, p&lt;0.0001)</li>
</ul>
"The final results from the HIFI Study clearly demonstrate that treatment with robotic HIFU for the management of localized prostate cancer is at least as effective as radical prostatectomy, but with added potential for improved safety outcomes with respect to urinary continence and sexual function," said Professor Pascal Rischmann. "It is increasingly evident that the application of robotic HIFU has growing relevance in the management of localized disease, and these final results from the HIFI Study provide conclusive evidence in support of this technology as a safe, effective, and less invasive approach to remove cancerous tissue from the prostate."
"As the largest and most rigorous clinical study ever conducted to evaluate treatment outcomes with Focal One robotic HIFU, the final results from the HIFI Study provide clear and compelling evidence that supports the use of robotic HIFU as an important and growing treatment option for the management of prostate cancer," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. "We believe the final results from the HIFI study not only represent an important clinical milestone for EDAP, but also serves as a further validation of Focal One as the best focal therapy of choice for the management of men diagnosed with early-stage prostate cancer. EDAP remains well positioned to deliver this technology as we continue to build world-class treatment programs for urologists centered around our leading Focal One robotic HIFU technology platform."&nbsp;&nbsp;

EDAP Announces Final Results From The HIFI Study Comparing Outcomes Of Focal One HIFU Versus Radical Prostatectomy During Plenary Session At The 119th American Urological Association Annual Meeting

Events

EDAP Announces Final Results From HIFI Study Comparing Outcomes Of Focal One HIFU Versus Radical Prostatectomy To Be Presented During Plenary Session At t119th American AUA Annual Meeting

Offerings

EDAP TMS SA Files For Mixed Shelf Of Up To $125M

HC Wainwright &amp; Co. analyst Swayampakula Ramakanth maintains Edap TMS (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>) with a Buy and raises the price target from $16 to $19.

HC Wainwright & Co. Maintains Buy on Edap TMS, Raises Price Target to $19

Edap TMS (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>) reported quarterly losses of $(0.15) per share which missed the analyst consensus estimate of $(0.05) by 200 percent. This is a 7.14 percent decrease over losses of $(0.14) per share from the same period last year. The company reported quarterly sales of $21.30 million which beat the analyst consensus estimate of $19.66 million by 8.34 percent. This is a 31.55 percent increase over sales of $16.19 million the same period last year.

Edap TMS Q4 EPS $(0.15) Misses $(0.05) Estimate, Sales $21.30M Beat $19.66M Estimate

<h3>Companies Reporting Before The Bell</h3>
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&bull; Edap TMS (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>) is expected to report quarterly loss at $0.05 per share on revenue of $19.66 million.
&bull; Vanguard Extended Duration Treasury ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EDV#NYSE">EDV</a>) is expected to report earnings for its fourth quarter.
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&bull; Altimmune (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALT#NASDAQ">ALT</a>) is projected to report earnings for its fourth quarter.
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&bull; Lands&#39; End (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LE#NASDAQ">LE</a>) is expected to report quarterly earnings at $0.21 per share on revenue of $502.71 million.
&bull; Cintas (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CTAS#NASDAQ">CTAS</a>) is projected to report quarterly earnings at $3.58 per share on revenue of $2.39 billion.
&bull; GlycoMimetics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GLYC#NASDAQ">GLYC</a>) is projected to report earnings for its fourth quarter.
&bull; Sonida Senior Living (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SNDA#NYSE">SNDA</a>) is projected to report earnings for its fourth quarter.
&bull; UniFirst (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNF#NYSE">UNF</a>) is projected to report quarterly earnings at $1.42 per share on revenue of $587.84 million.
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&bull; Draganfly (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DPRO#NASDAQ">DPRO</a>) is likely to report earnings for its fourth quarter.
&bull; VNET Gr (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNET#NASDAQ">VNET</a>) is projected to report quarterly loss at $0.18 per share on revenue of $279.03 million.
&bull; RH (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RH#NYSE">RH</a>) is estimated to report quarterly earnings at $1.67 per share on revenue of $777.48 million.
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&bull; Celcuity (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CELC#NASDAQ">CELC</a>) is expected to report earnings for its fourth quarter.
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&bull; Rumble (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RUM#NASDAQ">RUM</a>) is likely to report quarterly loss at $0.22 per share on revenue of $28.13 million.
This article was generated by Benzinga&#39;s automated content engine and reviewed by an editor.

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Earnings Scheduled For March 27, 2024

Edap TMS (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>) is set to give its latest quarterly earnings report on Wednesday, 2024-03-27. Here's what investors need to know before the announcement.
Analysts estimate that Edap TMS will report an earnings per share (EPS) of $-0.05. 
Edap TMS bulls will hope to hear the company announce they've not only beaten that estimate, but also to provide positive guidance, or forecasted growth, for the next quarter.
New investors should note that it is sometimes not an earnings beat or miss that most affects the price of a stock, but the guidance (or forecast).
<h3>Past Earnings Performance</h3>
Last quarter the company missed EPS by $0.00, which was followed by a 4.56% drop in the share price the next day.
Here's a look at Edap TMS's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q3 2023</th>
<th>Q2 2023</th>
<th>Q1 2023</th>
<th>Q4 2022</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-0.11</td>
<td>-0.05</td>
<td>-0.03</td>
<td>-0.01</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-0.11</td>
<td>-0.14</td>
<td>-0.22</td>
<td>-0.14</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-5.0%</td>
<td>1.0%</td>
<td>-5.0%</td>
<td>2.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1711465272_0.png" alt="eps graph" />
<h3>Stock Performance</h3>
Shares of Edap TMS were trading at $7.4 as of March 25. Over the last 52-week period, shares are down 34.23%. Given that these returns are generally negative, long-term shareholders are likely bearish going into this earnings release. 
<a href="https://www.benzinga.com/quote/EDAP/earnings">To track all earnings releases for Edap TMS visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Earnings Outlook For Edap TMS

EDAP TMS SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). In June 2018, the FDA cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue.

Government

Regulations

EDAP Announces FDA Breakthrough Device Designation for Focal One in the Treatment of Deep Infiltrating Rectal Endometriosis

Guidance

Health Care

EDAP TMS Reports Preliminary FY2023 Revenues Of €60.4M (Around $65.4M) Versus Consensus Of €58.151M And Q4 FY2023 Revenues Of €19.6M (Around $21.3M) Versus Consensus Of €17.232M

<ul>
<li>60 Patients Completed Enrollment in Under 9 Months</li>
<li>Study Results Expected in the Second Half of 2024</li>
</ul>

EDAP Announces Completion Of Enrollment In Phase 3 Study Evaluating Focal One HIFU Therapy For Deep Infiltrating Rectal Endometriosis

Company reports preliminary placement results of twelve Focal One Systems, inclusive of ten capital sales
LYON, France, January 8, 2024 - EDAP TMS SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDAP#NASDAQ">EDAP</a>), ("EDAP"), the global leader in robotic energy-based therapies, announced today preliminary Focal One placement results for the fourth quarter of calendar year 2023. The Company experienced robust demand for its Focal One robotic HIFU technology, placing twelve Focal One systems, inclusive of ten capital sales. Additionally, it was a record quarter for sales of ExactVu&#x2122; Micro-Ultrasound systems used for prostate biopsy. The breadth of these new Focal One and ExactVu placements continues to be strong, with growing interest amongst both academic medical centers and community hospitals.&nbsp;&nbsp;
"Our Focal One commercial team continues to gain significant momentum as reflected by our record-setting number of capital sales as well as overall system placements in the fourth quarter of 2023," said Ryan Rhodes, Chief Executive Officer of EDAP. "Utilizing our state-of-the-art robotic technology platform, a growing number of urologists can now offer their patients a non-invasive, tissue-sparing treatment option that provides excellent oncologic outcomes with the opportunity for preserving patient quality of life. Looking ahead, we believe Focal One is quickly becoming a necessary solution in the management of prostate cancer, and our team is leading the effort to help urology practices establish world-class treatment programs with our Focal One platform."
The above information is preliminary and subject to completion of quarter-end financial reporting processes and reviews. EDAP expects to release final fourth quarter financial results in March.

EDAP Announces Preliminary Q4 Record Focal One System Sales And Placements; Company Reports Preliminary Placement Results Of Twelve Focal One Systems, Inclusive Of Ten Capital Sales

Management

EDAP Appoints Ken Mobeck As Global Chief Financial Officer

EDAP TMS (EDAP) has released an update. EDAP TMS SA, a leader in robotic energy-based therapies, has welcomed seasoned healthcare executive Fran Sc...

EDAP TMS Strengthens Board with Healthcare Expert

EDAP TMS (EDAP) has released an update. EDAP TMS SA, a leading company in robotic energy-based therapies, has announced interim results from a Phas...

EDAP Reports Promising HIFU Therapy Study Results

Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on Apellis Pharmaceuticals (APLS – Research Report) a...

Analysts' Opinions Are Mixed on These Healthcare Stocks: Apellis Pharmaceuticals (APLS) and EDAP TMS (EDAP)

Lake Street analyst Frank Takkinen reiterated a Buy rating on EDAP TMS (EDAP – Research Report) today and set a price target of $10.00. The company...

Lake Street Keeps Their Buy Rating on EDAP TMS (EDAP)

EDAP TMS S.A. Q2 2024 Earnings Preview

Here's the major earnings before the open tomorrow

EDAP TMS S.A. GAAP EPS of -$0.18 misses by $0.05, revenue of $16.97M misses by $0.16M

EDAP TMS (EDAP) has released an update. EDAP TMS S.A., a leader in robotic energy-based therapies, has reported a 10.6% increase in Q2 2024 total w...

EDAP TMS Reports Strong Growth and Clinical Advances

EDAP TMS S.A. (EDAP) Q2 2024 Earnings Call Transcript

H.C. Wainwright analyst Swayampakula Ramakanth maintained a Buy rating on EDAP TMS (EDAP – Research Report) today and set a price target of $19.00....

EDAP TMS: Strategic Growth and Diverse Revenue Streams Support Buy Rating

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Press Releases

EDAP to Present at the Jefferies Global Healthcare Conference

EDAP Appoints New Executive Leaders to Strengthen Europe and Middle East Commercial Operations

EDAP Appoints Fran Schulz to Board of Directors

EDAP Announces Interim Results from Phase 3 Study Evaluating Robotic HIFU for the Treatment of Deep Infiltrating Endometriosis

EDAP's Focal One Robotic HIFU Platform to be Featured at 41st World Congress of Endourology and Uro-Technology Meeting (WCET 2024)

EDAP to Announce Second Quarter 2024 Financial Results on August 28, 2024

EDAP Reports Second Quarter 2024 Financial Results

EDAP to Participate in the H.C. Wainwright 26th Annual Global Investment Conference

EDAP and Avenda Health Launch World's First AI-Assisted Focal One® Robotic HIFU Procedures

EDAP Announces First Patients Treated in Phase I/II Study Evaluating Focal One Robotic HIFU for the Treatment of Benign Prostatic Hyperplasia (BPH)

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