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Cutting Edge Technologies, Inc.
Park Valley Corporate Center,
155 Phoenixville Pike, Suite 104
West Chester, PA 19380
Ph: (610) 430-8742
Fax: (610) 430-3954

William R. Knepshield, President & CEO

Product Line or Service — The product consists of a sterile, self-sealing, non-latex elastomer combined with an absorbent ring and a breathable waterproof outer adhesive seal. The patch is flexible to fit the patient and has a see-through center for needle penetration that is both non-coring and resealable. It absorbs various densities and volumes of fluids and provides a barrier to contain and seal post injection bleeding at the injection site, allowing hemostasis to occur under its sterile pad. All FDA requirements are in place, the product in inventory and no additional development is required. The first two versions, the SeraGuard™ Injection Device (SID™) and the SeraGuard™ Vascular Access Device (SVAD™), have recently received FDA authorization to market and recognition from OSHA as valid engineering controls against bloodborne pathogen exposure. Product expansion into dialysis, biopsy, pediatric, and lower cost applications may be considered in the future.

Technology/Proprietary Rights — United States Patents 5,342,319 & 5,409,466 are issued. Additional domestic and international patents have been applied for. Patent insurance is in place to assist in the defense of infringement.

Market Opportunities — The company has two products commercially available at present and a family of allied products in various stages. The patented SeraGuard™ products yield preemptive and continuous protection which begins before the wound is made, and continue during and after the sharp instrument is withdrawn (i.e. hypodermic needle, IV line, blood sampling needle, catheter). SeraGuard™ protects healthcare providers from contacting patient blood or sera, the translucent component of blood, and its potentially infectious pathogens. SeraGuard™ similarly protects the patient, because the wound site is covered before the wound is even made. This isolates the wound from possible secondary viral and/or microbial pathogens that may exist on the healthcare worker, instruments or in the healthcare environment. Sera Guard™ products are packaged as sterile, single use, disposable, medical devices.

Marketing/Sales and Distribution — CETI will implement a two-prong distribution strategy consisting of a network of dealers covering various medical specialities and a focused direct sales force. The direct sales force will be responsible for national accounts (major hospital corporations and large buying groups), the military, government agencies, and other market segments, which are not addressed by dealers. Upon widespread acceptance of the product line, CETI anticipates engaging national full-line distributors and large medical supply houses that excel at servicing accounts with immediately available, attractively priced stock. CETI anticipates early acceptance from providers in the market segments of Anesthesia, Pain Management, Correctional Healthcare, Emergency/Trauma, and Lab/Clinical (Phlebotomy). Based on documented total injections per year and an average price across product lines of $0.50, the company estimates the total potential market size at $5 billion per annum.

Competition — There is no direct competition in the market for all the functionality of Seraguard™. Indirect competition exists through the combined use of commodity products such as gauze, bandages, gloves, and occlusive devices manufactured by companies such as Johnson & Johnson, Baxter, and Kendall. These alternatives do not provide preemptive protection or an adequate level of protection, can be more costly on a direct basis, do not fully address the public and OSHA requirements for increased protection, and bear the in direct cost risks for treatment and lost time on the job for an infected healthcare worker. Broad patent coverage, patent defense insurance, and finished product provide CETI with the basis of a sustainable, competitive advantage.

Manufacturing — CETI maintains contract-manufacturing with two independent companies for the production of the proprietary central membrane material and assembly, packaging and sterilization of finished medical devices. Both operate under Confidentially and/or Non-Disclosure/Non-Compete arrangements. The balance of the components is standard, readily available, and includes medical adhesives, vapor transfer tapes, absorbents, product packaging, and box packages.

Financial — The only sales to date have been experimental sales to define the marketplace, determine product acceptance, and define market strategy. The company is currently seeking an equity injection of $1.5M in financing for initial marketing efforts, fund specific product line expansion efforts, and build the infrastructure to support sales.

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