Corporate Profile Facial Concepts, Inc. (FCI) d.b.a. Facial-Flex Corporation   Physical Address:  1055 W. Germantown Pike  Norristown, PA  19403   USA Mailing Address: P.O. Box 99  Blue Bell, PA  19422   USA Phone:  (800) 469-FLEX  (610) 539-5869 Fax:  (610) 539-9430 Email: info@facialconcepts.con URL Address: www.facialconcepts.com Facial Concepts, Inc. (FCI) was formed in 1989 to develop the commercial market for a patented, facial rehabilitation device that increases oral-motor muscle strength.  More than 600,000 product units have been sold under the product line name Facial-Flex®.  The Facial-Flex® facial exercise device was developed originally as a treatment method for a condition called microstomia, which is a severe constricture of the orbicularus oris muscle (the muscle surrounding the mouth) secondary to deep facial burns.   However, the potential of the device for broader, multiple rehabilitation applications was recognized both for speech-language pathology and esthetics medicine.  FCI has taken the device from prototype, through United States Food & Drug Administration (FDA) registration, clinical testing, manufacturing, packaging, marketing, sales and distribution over the period from 1990 through the present.  During that time FCI has used the esthetics market as a development laboratory in which the Facial-Flex® device was functionally tested by a broad cross section of people experiencing facial muscle laxity, but without oral-motor impairment. The device was found to be safe and effective.  FCI has used this market to build brand name recognition. FCI has established the Facial-Flex® product line in the market as a medical product for facial care and rehabilitation. Completed and ongoing pilot studies show significant, positive results, and suggest multiple applications for mechanically aided resistance exercise devices in a range of craneo-facial rehabilitation applications, such as Temporomandibular Joint Disease, speech disorder, and other facial muscle weaknesses. Consequently, FCI is now moving to address the need for a dynamic resistance exercise device in craneo-facial physical therapy and  speech-language pathology.   Within these healthcare market segments, initial experience has confirmed that the completed and published clinical studies are sufficient to gain a preliminary level of acceptance.  In rehabilitative healthcare applications, such as speech-language pathology, restoration of oral-motor muscle strength is typically a major objective in the treatment regimen.  There is currently no device offered by other manufacturers that speech-language pathologists (SLPs) could provide, prescribe or recommend to their patients, to systematically improve oral-motor strength, range and coordination.  Presently, SLPs must improvise to create oral motor exercises offering resistance, adapting other items such as tongue depressors to enhance these exercises.  Presently, there is no competing device in speech-language pathology or craneo-facial physical therapy that offers dynamic resistance to movement of the oral facial muscles.  There is no competing device or method that can be applied in a systematic, measurable way to improve oral motor abilities, as well as quantify the outcomes of treatment.  Results and measurable outcomes are a central focus in managed healthcare today. The FCI business strategy addresses the market for a medical technology that has multiple applications in both clinical healthcare and over-the-counter settings.  New applications and product line extensions for craneo-facial rehabilitation and treatment of TMJ will be pursued through cooperative research with major universities and expert healthcare practitioners.  A current example is a successful pilot study on treatment of TMJ completed in February 1999 by Temple University in Philadelphia.  The results of this study were presented in May 1999 at the annual conference of the American Association of Orthodontists. Another study was recently completed at the University of Toronto in Speech Pathology which indicated positive impact on speech-motor physiology.  The body of clinical evidence supporting the efficacy of the Facial-Flex® device, coupled with being first to market in both over-the-counter and clinical healthcare applications, contributes significantly to building brand name recognition and represents a distinctive advantage over competitors.  Simultaneous with clinical initiatives, FCI will continue targeting over-the-counter healthcare in the esthetics market.