Simulated Environment Concepts to Seek FDA Registration Approval
November 09 2010 - 8:30AM
Business Wire
Simulated Environment Concepts (Pink Sheets:SMEV), the
manufacturer and developer of medical, aesthetic and wellness
equipment, announced today that they will file a 510(k) Medical
Device registration application with the U.S. Food and Drug
Administration to further enhance the company’s flagship product,
SpaCapsule, and its PT (Physical Therapy) model, PTJetCapsule.
“We can easily continue to operate within the commercial markets
without registration with the FDA,” stated Dr. Ilya Spivak,
Marketing Director of Simulated Environment Concepts (SE Concepts)
and co-inventor of the SpaCapsule. “However, as a proper gesture, a
company manufacturing medical grade and aesthetic devices for
health, medical and wellness communities, we should seek an
appropriate acknowledgment from the FDA. It will be another plus to
our PT model,” Dr. Spivak concluded.
Currently, SE Concepts possesses several significant
international distribution contracts – spanning the next four years
– securing over 500 potential bulk unit sales, or roughly $3
Million per year. However, sales within the global medical
community are expected to increase substantially. Companies such as
Zen & O (French distributor), which this past October supported
SE Concepts by displaying and selling the H2O Body System at an
international physiotherapist tradeshow, have increased the
company’s penetration into the medical markets abroad. Significant
interest is also building rapidly among domestic distributors
specializing in the Physical Therapy markets. Obtaining an FDA
registration will assist SE Concepts in solidifying the increasing
demand for SpaCapsule’s PT model by the health, medical and the
wellness communities.
About Simulated Environment Concepts, Inc.
Simulated Environment Concepts, Inc. (SE Concepts) (SYMBOL:
SMEV) is an industry leading manufacturer and developer of cutting
edge medical, health and wellness equipment.
SE Concepts was established in 2000 by doctors dedicated to
advancements in medical technology and aesthetics. Its flagship
product, SpaCapsule®, which is currently distributed in over 37
countries, is a robotic massage therapy system used for medical
rehabilitation, relaxation, weight loss, cellulite management and
general wellness.
For more information on SE Concepts, SpaCapsule®, PTjetCapsule™
and Celude Laboratories™ products you can visit the company's
product website at www.spacapsule.com, the corporate website
at www.seccorporation.com, the corporate blog at
http://www.spacapsule.wordpress.com, facebook at
http://www.facebook.com/SpaCapsule or request more information via
email at ir@spacapsule.com, or call at (888) 757-0797 or (305)
651-9200.
Safe Harbor
Statements in this news release that are not historical facts,
including statements about plans and expectations regarding
products and opportunities, demand and acceptance of new or
existing products, capital resources and future financial results
are forward-looking. Forward-looking statements involve risks and
uncertainties which may cause the Company's actual results in
future periods to differ materially from those expressed. These
uncertainties and risks include changing consumer preferences, lack
of success of new products, loss of the Company's customers,
competition and other factors discussed from time to time in the
Company's filings with the Securities and Exchange Commission.
SpaCapsule is registered trademark of Simulated Environment
Concepts, Inc.
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