|Over a week ago|
EDAP in exclusive global distribution pact with Exact's for diagnostic devices » 16:3805/1205/12/20
EDAP announced that the…
EDAP announced that the company has signed an exclusive worldwide distribution agreement with Exact Imaging, a developer of high resolution micro-ultrasound imaging technologies. Under the terms of the agreement, EDAP will market Exact Imaging's micro-ultrasound diagnostic devices alongside its Focal One high intensity focused ultrasound (HIFU) treatment solution. The combination of these technologies represents the most complete end-to-end solution, from diagnosis through treatment, available to urologists. Marc Oczachowski, Chairman and Chief Executive Officer of EDAP, commented: "We are very excited to announce this exclusive worldwide partnership with Exact Imaging. Integrating their ExactVu diagnostic device with our range of innovative and state of the art product lines at a global distribution level will allow us to continue to drive growth in our distribution business, which has grown by more than 200% over the past five years. In addition to being a great stand-alone product and a unique ultrasound solution, clinical studies have reported a diagnostic accuracy similar to MRI in identifying prostate cancer. Further, a recently published study observed an improvement in diagnostic accuracy when ExactVu micro-ultrasound was added to MRI. ExactVu has a number of synergies with Focal One, and the combination of both makes EDAP the only company able to offer a complete solution from diagnostic to treatment for the focal management of prostate cancer. We are eager to commence this partnership and look forward to leveraging the combination of these two leading technologies to drive HIFU adoption and growth."
|Over a month ago|
Fly Intel: Top five analyst initiations » 10:2404/1504/15/20
TSLA, GM, F, TWLO, CARR, EDAP, PTON
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Tesla (TSLA) was initiated with a Buy at Goldman Sachs, while Ford (F) and General Motors (GM) were initiated with Neutral ratings. 2. Twilio (TWLO) initiated with a Buy at Mizuho. 3. Carrier Global (CARR) initiated with a Sector Perform at RBC Capital. 4. EDAP TMS (EDAP) initiated with a Buy at B. Riley FBR. 5. Peloton (PTON) initiated with a Buy at Roth Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
EDAP TMS initiated with a Buy at B. Riley FBR » 09:0104/1504/15/20
B. Riley FBR analyst…
B. Riley FBR analyst Andrew D'Silva initiated coverage of EDAP TMS with a Buy rating and $5.50 price target. The analyst believes Focal One HIFU systems could "meaningfully disrupt" the prostate cancer treatment paradigm. While COVID-19 will be a headwind, its impact is already reflected in the current share price, D'Silva tells investors in a research note.
EDAP TMS initiated with a Buy at B. Riley FBR » 04:5204/1504/15/20
B. Riley FBR initiated…
B. Riley FBR initiated coverage of EDAP TMS with a Buy rating and $5.50 price target.
Fly Intel: After-Hours Movers » 19:0503/3003/30/20
ALPN, CTMX, XCUR, AAL, RH, EDAP, CRON, AMRN, RETA, SVRA, DPZ, PLNT, GPS, CROX
Check out this…
EDAP TMS reports Q4 EPS (4c), consensus 3c » 16:3903/3003/30/20
Reports Q4 revenue…
Reports Q4 revenue $13.3M, consensus $13.99M. Marc Oczachowski, EDAP's Chief Executive Officer, said: "We are proud of our team for a very successful year in 2019, which was our first full year of U.S. FDA approval for Focal One(R), our latest generation high Intensity Focused Ultrasound (HIFU) robotic device for the targeted ablation of prostate tissue. During the year, we placed Focal One devices at many highly regarded healthcare institutions, including Mayo Clinic, Houston Methodist Hospital, University of California at Irvine Medical Center and University of Chicago Medicine, among others. We ended the year with a strong sales pipeline and good momentum both in the U.S. and worldwide. "As far as financial results, we grew our company sales by 14.5% year-over-year, which was driven by HIFU sales growth of 28%. We expanded our gross margins to a record 46.8%, which represents an increase of 362 basis points in 2019 as higher margin HIFU sales led to higher profitability. The Company has now been profitable for five consecutive quarters, and we have a strong balance sheet with EUR 20.9 million in cash. We are looking forward to the commencement of U.S. reimbursement for Focal One in 2021, which has the potential to be a significant catalyst for further adoption.
EDAP TMS requires majority of employees to work remotely amid COVID-19 » 08:4003/1703/17/20
EDAP TMS issued the…
EDAP TMS issued the following letter to shareholders: "The COVID-19 virus represents a new challenge for us all, and I want to formally update you on the situation as it pertains to EDAP TMS. We are taking this global threat very seriously and are closely monitoring developments. To this end, we have implemented numerous precautions and protective measures to safeguard our employees and to ensure an uninterrupted supply of our devices and disposables. Among the steps we have taken are requiring the majority of our employees to work remotely, maintaining minimum supply chain activity, curtailing all business travel following local regulations and guidelines, and adjusting to the reality of delayed and cancelled sales and marketing events. We remain fully supportive of all of our hospital, medical center, and clinic customers in the management of this pandemic. With most operating rooms having been re-dedicated to the management of emergencies, all non-urgent procedures - including ESWL and HIFU treatments - may be postponed to free up resources for clinical teams to handle the most urgent cases. In the near term, we expect this situation to cause decreased activity in our recurring usual activity with some cancellation of ESWL and HIFU treatments, which may have some impact on our recurring business. We also anticipate that device sales projects may be postponed on a near-term basis as hospital purchase and investment decisions are put on hold. However, we want to be clear that our sales cycles are long, and we expect that sale projects currently in process to merely expect some delays and to eventually be completed. This short-term impact might not affect the pipeline of projects nor the long-term momentum of market adoption of HIFU and its numerous added value for patient including quality of life preservation. We have in inventory several devices and accessories that are ready to be shipped, so the Company would be well positioned to resume delivery activities at any time. More importantly in this unique and unknown crisis situation is EDAP's strong and solid cash position, which enables us to manage quietly and safely through this global crisis with as little disruption as possible. Our cash position, the nature of our business and our constant focus give us confidence in keeping our company stable, our employees and their expertise safe and preserved as well as our full capability of supporting our valued customers, users and prospects. In closing, I reiterate that EDAP will employ all necessary measures to contribute to fight the COVID-19 pandemic, and we will continue to fully support our employees and global customer clinical teams who are valiantly devoting their efforts to the care of patients."
|Over a quarter ago|
EDAP TMS announces sale of Robotic Focal One HIFU to University of Miami » 08:4201/2901/29/20
EDAP TMS announced that…
EDAP TMS announced that the University of Miami Sylvester Comprehensive Cancer Center is the latest highly-regarded health care institution to acquire Focal One, the most advanced technology available for delivering high intensity focused ultrasound to target and ablate diseased prostate tissue. The Sylvester Cancer Center was one of the first hospitals in the U.S. to offer HIFU using EDAP's Ablatherm system, with more than 100 patients successfully treated to date, and the medical center has already performed multiple treatments using Focal One. The evolution from Ablatherm to Focal One allows Sylvester Cancer Center to continue to offer the latest generation HIFU to men with localized prostate cancer.
EDAP TMS expects acceleration of global growth in 2020 » 09:2601/0901/09/20
EDAP TMS issued a letter…
EDAP TMS issued a letter to shareholders, which read in part, "As we turn the page on 2019, I thought this would be a good opportunity to recap our recent progress as well as to preview what we expect to be a very exciting 2020 and beyond. Recall that our latest generation high Intensity Focused Ultrasound robotic device, Focal One, was cleared by FDA in 2018 for the targeted ablation of cancerous prostate tissue. Focal One addresses the significant unmet medical need that exists between the two extremes in prostate cancer treatment: active surveillance and radical prostatectomy surgery. The latter is highly invasive and can often result in devastating side effects, including incontinence and impotence. With Focal One, the prostate is preserved. The development of Focal One extends our long-standing position as a leading innovator in the field of therapeutic ultrasound, and this is reflected in the growing sales traction that we are seeing in the U.S. and other key markets around the world. We have conducted extensive research on the global addressable market for HIFU, and specifically Focal One, and have concluded that the opportunity in front of us is substantial. Around the world, it is estimated that there are roughly 680,000 newly diagnosed cases of localized prostate cancer annually, of which approximately 180,000 occur in the United States. Even if we employ modest assumptions regarding HIFU and Focal One market share and procedure volumes per device, we believe we are poised to embark on a significant growth trajectory that at its peak, could take a significant share in of a multi-billion dollar PCa treatment market. A significant percentage of this would be recurring, driven by procedure-related disposable kits and device service contracts. Needless to say, this analysis easily justifies our growing optimism. In the United States, despite being in the early stages of our physician outreach and educational programs, and while the number of sales is of course an important metric, it is the quality of the institution - a hospital's ability to act as a reference center to help drive awareness - where initial sales are clearly having an impact. Our Focal One customers include such highly-regarded institutions as Mayo Clinic, Houston Methodist Hospital, University of California at Irvine Medical Center and University of Chicago Medicine, among others. These Focal One sales, combined with our presence at important medical meetings such as the American Urology Association Annual Meeting, are driving accelerating growth in our pipeline of potential U.S. customers. Leading urology centers around the country are realizing that this technology is a key differentiator that helps drive increased patient throughput. A significant catalyst to further adoption of Focal One in the U.S. occurred in June of last year, when we learned that the American Medical Association's CPT Editorial Panel accepted our application to establish a new Category 1 CPT code that will facilitate reimbursement for the ablation of malignant prostate tissue with HIFU technology. Having a definitive path to reimbursement for the Focal One procedure in the U.S. removes significant financial uncertainty on the part of the hospital, as Focal One represents a meaningful capital investment. The AMA's decision will go a long way toward helping close additional sales ahead of January 2021, when reimbursement commences. In parallel with these activities, outside of the United States, we continue to further penetrate existing markets such as Brazil, where we now have five installed Focal One devices. At the same time, we opened substantial new markets with sales to Moscow State University of Medicine, a top urology center in Russia and our first in the region, and Farrer Park Hospital in Singapore, our first in Southeast Asia. We are successfully executing on our multi-faceted growth plan, and as a result, we have now recorded four consecutive quarters of profitability as of September 30, 2019. onger term, we see opportunity to leverage our state-of-the-art ablation technology into new indications as well. One example is using robotic Focal One HIFU to treat deep rectal endometriosis. We are in ongoing discussions with French regulators to initiate a Phase 2 clinical trial designed to show the safety and efficacy of our technology. We also successfully expanded our product portfolio with the recent introduction of our brand-new Endo-UP Endourology Platform at the 2019 World Congress of Endourology and Lithotripsy. Endo-UP is designed for the complete management of urinary stones by combining a fully dedicated endourology table with X-ray and ultrasound imaging systems, an integrated shockwave generator and holmium laser source. We believe combining all the tools available to surgeons provides them with the ability to select the best approach or combination of approaches depending on the patient and the stone. This represents a true breakthrough in urinary stone management and again reflects our robust research and development capabilities. As a result of the solid foundation that we built over the past several years, we enter 2020 with significant momentum and an opportunity to offer our disruptive breakthrough technologies to patients and physicians around the world."
EDAP TMS announces publication of Focal One endometriosis study » 08:3912/1912/19/19
EDAP TMS announced that…
EDAP TMS announced that Focal One data has been accepted for publication in the journal of Ultrasound in Obstetrics & Gynecology. Data from the Phase 1 study confirm the feasibility of using EDAP's Focal One high intensity focused ultrasound technology for the treatment of deep invasive endometriosis. Endometriosis affects nearly 10% of women of childbearing age, which is approximately 176 million women worldwide. Digestive endometriosis affects 20% of these women. It is one of the most symptomatic forms of the disease, mostly when the rectum is involved, and is responsible for a significant decline in quality of life. The symptoms of endometriosis include pain during menstrual cycles and ovulation, defecation during or after sexual intercourse, infertility, and can impact general physical, mental, and social wellbeing. When medical treatments are ineffective, surgical resection remains the standard despite significant adverse events. Focal One HIFU, as a minimally invasive ablative procedure, may prove to be a real benefit for these women who have no effective therapeutic options today.