Ivivi Technologies receives EU approval for electrotherapy devices
11 July 2007 Northvale. USA. Ivivi Technologies, Inc. (AMEX:II), a
leader in non-invasive, electrotherapeutic technologies, today announced
that it has received CE Mark certification for the commercial distribution
of certain of its patented electrotherapy devices, in the member countries
of the European Union, for use in the promotion of wound healing, reduction
of pain and post operative edema. “Obtaining the CE approval is a
significant milestone for our company in our efforts to commercialize our
non-invasive electrotherapeutic technology throughout Europe,” said André
DiMino, Co-CEO, Ivivi Technologies. “It supports our strategy of
establishing channel partnerships with global medical device and healthcare
companies.” Ivivi’s electrotherapy devices consist of a signal generator
and applicator and are programmed to provide therapy at optimal intervals
throughout the course of therapy. As previously announced, a recent study
conducted at Akademikliniken Hospital in Stockholm, Sweden by Dr. Per Heden,
an internationally-recognized plastic surgeon and researcher, reinforced
clinical data that shows the ability of Ivivi’s technology to enhance
post-surgical pain management.
Preliminary data from a randomized double-blind, placebo-controlled
clinical study entitled “Effect of Pulsed Electromagnetic Fields (“PEMF”) on
Post-Surgical Pain Reduction for Breast Augmentation” showed an 80%
acceleration in pain relief in patients treated with the active technology
as compared to patients treated with placebo units. To top
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