الموضوع في 'السوق الأمريكي للأوراق الماليه' بواسطة saad2004, بتاريخ 9 ديسمبر 2003.
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Lifeline BioTechnologies Receives CE Mark Certification of Its Duct Scope Product
Tuesday December 9, 9:56 am ET
Initial Sales to Commence First Quarter 2004
RENO, Nev.--(BUSINESS WIRE)--Dec. 9, 2003--Jim Holmes, CEO of Lifeline BioTechnologies Inc. (NQB:LBTT - News) announced that the company has received CE Mark Certification for its Nipple Endoscope(TM) (nipple microendoscope) in Europe. CE Mark Certification is the equivalent of America's FDA approval. Holmes commented that this is the first in a series of the company's products designed to assist in the early detection of certain types of women's cancers.
Jonathan Reeves, vice president of operations who has led this project, attended an international breast cancer symposium in San Antonio, Texas last week. At this symposium, Reeves met with the company's principal investigator in Europe for the Nipple Endoscope(TM), Dr. Kefah Mokbel, and discussed and planned for the introduction of the product in Europe.
Mokbel stated that this technology is welcomed as an important step forward in the management of nipple discharge. The CE Mark Certification means the technology can be widely marketed and used in Europe. The Nipple Endoscope(TM) has great potential in the outpatient setting due to its ease of use for the physician and the patient. This technology should lead to a reduction in the number of unnecessary ductal incision procedures.
Holmes further commented that efforts were underway to establish a distribution network in Europe for the introduction of the Nipple Endoscope(TM). "The obtaining of this CE Mark will allow the company to sell this technology in every country worldwide that requires CE Mark Certification. It is anticipated that sales of this technology will commence in the first quarter of 2004."
At press time, company management was also exploring the possibility of selling the Nipple Endoscope(TM) in the Chinese market, based on its new CE Mark Certification.
Dr. William Reeves, president and founder of Lifeline BioTechnologies, commented, "Now that the CE Mark certificate has been achieved for the Nipple Endoscope(TM), the company will prepare the appropriate information needed for FDA 510K notification for the technology required for the U.S. market."