Ivivi Technologies Receives CE Approval for Certain of its Electrotherapy Devices
27 Junio 2007 - 7:30AM
Business Wire
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,� commented Andr� 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. About Ivivi Technologies, Inc. Based in
Northvale, NJ, Ivivi Technologies, Inc. is a medical technology
company focusing on designing, developing and commercializing its
proprietary electrotherapeutic technology platform. Ivivi�s
research and development activities are focused specifically on
pulsed electromagnetic field, or PEMF, technology, which, by
creating a therapeutic electrical current in injured soft tissue,
stimulates biochemical and physiological healing processes to help
repair the injured tissue and reduce related pain and inflammation.
The Company�s Electroceuticals� have been used in non-invasive
treatments for a wide array of conditions, including chronic
wounds, pain and edema following plastic and reconstructive surgery
and chronic inflammatory disorders. Forward-Looking Statements This
release contains "forward-looking statements" made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including the statements related to the preliminary
data discussed above. Forward-looking statements reflect
management's current knowledge, assumptions, judgment and
expectations regarding future performance or events. Although
management believes that the expectations reflected in such
statements are reasonable, they give no assurance that such
expectations will prove to be correct and you should be aware that
actual results could differ materially from those contained in the
forward-looking statements. Forward-looking statements are subject
to a number of risks and uncertainties, including, but not limited
to, the Company�s limited operating history, history of significant
and continued operating losses and substantial accumulated earnings
deficit, difficulties with its financial accounting controls, the
failure of the market for the Company�s products to continue to
develop, the inability for customers to receive third party
reimbursement, the inability to obtain additional capital, the
inability to protect the Company�s intellectual property, the loss
of any executive officers or key personnel or consultants,
competition, changes in the regulatory landscape or the imposition
of regulations that affect the Company�s products and other risks
detailed from time to time in the Company�s filings with the
Securities and Exchange Commission, including the Company�s
registration statement on Form SB-2. The Company assumes no
obligation to update the information contained in this press
release.
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