Cutting Edge
Technologies, Inc.
Park Valley Corporate Center,
155 Phoenixville Pike, Suite 104
West Chester, PA 19380
Ph: (610) 430-8742
Fax: (610) 430-3954William 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is withdrawn (i.e. hypodermic needle, IV line, blood sampling needle, catheter).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. |