Healthcare Industry News: Ablatherm
News Release - February 22, 2008
EDAP TMS Launches Ablatherm-HIFU ENLIGHT Patient Awareness ProgramWeb Site and Call Center to Aid in Patient Awareness of Phase II/III Clinical Trial for Prostate Cancer
LYON, France, Feb. 22, 2008 (Healthcare Sales & Marketing Network) -- EDAP TMS SA (NasdaqGM:EDAP ), the global leader in therapeutic ultrasound, announced today that the patient awareness program to facilitate enrollment in the ENLIGHT trial has launched. The ENLIGHT study is a multi-center Phase II/III clinical trial testing EDAP's Ablatherm-HIFU (high-intensity focused ultrasound) for the treatment of localized prostate cancer. The program, led by Fleishman-Hillard's Clinical Trials Division, consists of a patient Web site, a centralized call center, and site recruitment tool kits that provide detailed information for both patients and physicians.
Marc Oczachowski, CEO of EDAP TMS, stated, ``The launch of the patient awareness program is a major milestone for EDAP as we execute the next step of our strategy to conduct the U.S. clinical trials for Ablatherm-HIFU. The trials are fully funded following our October capital raise and we are on track to ramp up patient enrollment following the recent launch of the Web site and centralized call center. We are committed to a clear path of PMA approval in the U.S. and are now well positioned to recruit patients at high quality sites in the U.S. and Canada.''
The Web site, http://www.PCaResearch.com, provides a patient prescreener that is closely based on the trial's inclusion and exclusion criteria. Prospective patients interested in learning if they may prequalify for the study may call the toll-free number at 1-866-650-4466. Prospective patients who meet the enrollment criteria will have the option to submit their contact and prescreening information to the nearest site participating in the ENLIGHT study.
John D. McAnulty, Fleishman-Hillard senior vice president and partner and head of the Clinical Trials Division, said, ``We are excited to launch this recruitment program to accelerate awareness and enrollment for EDAP's prostate cancer study. We will implement a variety of customized communications strategies to recruit men aged 60 and older with early-stage, localized prostate cancer. These include grassroots marketing and Internet-based outreach, as well as informing local media and national patient organizations about the study.''
About the ENLIGHT Patient Awareness Program
The ENLIGHT patient awareness program is designed to facilitate enrollment by providing prescreened patient pools from which to recruit eligible patients for the study.
Information for Patients
All sites with IRB approval of the patient recruitment materials will receive a recruitment tool kit containing patient brochures and posters. In addition to the recruitment materials provided to each site, patients may also receive information on their nearest participating site.
Patients can visit http://www.PCaResearch.com or call the call center to prescreen for the study using a questionnaire that is closely based on the inclusion and exclusion criteria. Patients who meet the enrollment criteria will be asked to submit contact and prescreening information for distribution to the nearest ENLIGHT site. If the patient agrees, the site will receive a fax or e-mail or both (based on preference) that informs the site about the patient and provides the clinical information collected during the prescreening questionnaire along with the patient's contact information so follow-up to schedule a screening appointment can occur.
A call center with a toll-free number (1-866-650-4466) has been set up that will connect prospective patients with a call center whose team will be able to answer basic questions about the trial and also prescreen patients based on the inclusion and exclusion criteria. If patients prequalify and agree to be referred, they will then be referred to the nearest ENLIGHT site.
Information for Physicians
For select sites participating in the cryotherapy arm of the study, a pilot grassroots campaign will also be conducted. The goal of this program is to raise awareness among patients by reaching them directly through patient support groups and also indirectly via their contacts within their respective communities. Community organizers will be identified in pilot markets and will work directly with patient support groups, community leaders, and women's support groups. The latter is to address that it is often the women in a man's life who drive the direction of care. These groups will be informed about the ENLIGHT trial and how a patient can learn more about it.
For select sites participating in the HIFU arm of the study, a pilot media outreach program in which local media in the pilot markets will be contacted with information about the ENLIGHT trial will be implemented. This program will focus on the exciting aspects of this novel non-invasive method of treating prostate cancer.
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States. The company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the company, please visit http://www.edap-tms.com, http://www.hifu-planet.com, http://www.PCaResearch.com, or http://www.urotoday.com/HIFU.
In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
Source: EDAP TMS
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