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Simulated Environment Concepts to Seek FDA Registration Approval

^{Published on 2010-11-09 09:05:24 - Market Wire}
 

MIAMI--([ 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 companya™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"

aWe can easily continue to operate within the commercial markets without registration with the FDA,a stated Dr. Ilya Spivak, Marketing Director of Simulated Environment Concepts (SE Concepts) and co-inventor of the SpaCapsule. aHowever, 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,a Dr. Spivak concluded.

Currently, SE Concepts possesses several significant international distribution contracts a" spanning the next four years a" 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 companya™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 SpaCapsulea™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®, PTjetCapsulea" and Celude Laboratoriesa" 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.