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MW Medical receives FDA clearance for new microwave applicator
Scottsdale, Arizona (ots-PRNewswire) - MW Medical (OTC Bulletin
Board: MWMD) received FDA clearance for its new, large aperture hair
removal applicator. This accessory for the MW 2000 hair removal
system provides a significantly larger treatment footprint to improve
operator efficiency and increase treatment efficacy.
The clinical trial was performed in December, 2000 by Dr. David
Duffy of Torrance, CA., under an IRB approved protocol with
monitoring by MW Medical clinical personnel. After following patients
for the prescribed period of the trial, the data was submitted to the
FDA to support the 510(k) filing to begin marketing this new
accessory. "We are indebted to Dr. Duffy and his staff for their
interest in the project and quality of this study. Their dedication
and diligence throughout the process was outstanding," states Tyler
Brown, MW Medical COO.
Due to the nature of the accessory and the company's earlier
approval, MW Medical requested and was granted a special 510(k)
clearance. The trial was completed with one hundred percent
compliance and zero adverse events. "This was truly an outstanding
effort on all fronts -- the development team, Dr. Duffy and the
clinical staff and our regulatory advisors -- all worked closely to
make this project run flawlessly," stated Jan Wallace, MW Medical
CEO. Regulatory Specialists of Irvine, CA. served as consultants to
the company on the project and continue to support on-going
The new applicator's design also incorporates an improved energy
distribution profile, increased efficiency and a new handle design.
These features will provide more effective and efficient energy
delivery to the hair follicles and a more comfortable design. This
improves target heating while enhancing tissue cooling and reducing
potential tissue damage at higher energy settings.
MW is particularly pleased with achieving this regulatory
clearance, as it demonstrates the company's continuing objective to
advance the use and safety of microwave technology in the medical
Statement Under the Private Securities litigation Reform Act
With the exception of the historical information contained in this
release, the matters described herein contains forward-looking
statements that involve risk and uncertainties that may individually
or mutually impact the matters herein described, including but not
limited to product acceptance, economic, competitive, governmental,
results of litigation, technological and/or other factors, which are
outside the control of the Company.
ots Original Text Service: MW Medical
Contact: Dean Drummond of MW Medical, Phone: +1 480-315-8600
Company News On-Call: http://www.prnewswire.com/comp/133884.html or fax +1 800 758-5804, ext. 133884