MORE JRSE NEWS!!
members.xoom.com join Free!
Jacobson Resonance Enterprises Targeting European CE-Mark
BOCA RATON, Fla.--(BUSINESS WIRE)--Feb. 16, 1999--Jacobson Resonance Enterprises Inc. (OTC BB:JRSE) announced Tuesday that the company is continuing on target towards the goal of obtaining the European CE-Mark in 1999.
Jacobson Resonance of Spain is currently working with the technical homologation of the Jacobson Resonator performed by CETECOM, the Spanish Technical Company certified by the European Commission. At the same time, they are complying with the Direccion General de Productos Sanitarios y Farmaceuticos (Health Ministry of Spain) in fulfilling their requirements and guidelines with respect to clinical studies.
Alfonso Serrato, former senior executive of Medtronic (NYSE:MDT) and a director of Jacobson Resonance Enterprises is leading the European initiative. Serrato said, "To obtain the CE-Marking, we are in full compliance with the European Union's Medical Device Directive (MDD), and we have received the classification class 2-A which references a medical instrument that is non-hazardous and is an active therapeutic and diagnostic device." He added, "There have been approximately 300 treatments performed on patients in Spain having a documented medical diagnosis and suffering from various etiologies in the area of chronic pain. The success rate for alleviation of pain has been greater than 90%."
Dr. Jerry Jacobson, chairman of Jacobson Resonance Enterprises, said, "During the next few months Jacobson Resonance of Spain will be engaged in setting up the manufacturing and distribution system throughout Europe. We want to insure firstly that the CE-Mark is obtained, and secondly to prepare for the initiation of full commercialization of products and services." Data resulting from clinical studies in the United States and submitted to the Food and Drug Administration (FDA) will be provided to our European colleagues as supporting evidence of clinical efficacy of the Jacobson Resonator." Construction of the European Educational and Training Center will begin by the middle of February, and will be located in Marbella, Spain. It is anticipated that the facility will be fully operational by the third quarter of 1999.
Forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties detailed in the company's filings with the Securities and Exchange Commission.
CONTACT:
Jacobson Resonance Enterprises Inc., Boca Raton
Frank A. Chaviano, 561/477-8020
Fax 561/477-6101
Web: www.jrse.com |
