ITEM 1. DESCRIPTION OF BUSINESS
DiaSys Corporation (DiaSys, Company) designs, develops, manufactures and distributes propriety workstation-instruments, consumables, reagents and specialized test kits to hospital, clinical and private physician laboratories worldwide. The Companys workstation instruments standardize laboratory analysis of urine sediment, fecal concentrates, cerebral spinal fluid (CSF), fine needle aspirations (FNA), and other cell suspensions compared to traditional laboratory testing methods. The Company believes that by automating the laboratory process, its customers save labor expense in handling the separate steps of the analytic process involved; however, the Company has not conducted independent, objective studies to quantify or support such belief. The Companys consumable products are in most cases combined with the Companys workstation instruments to create practical, affordable system-solutions, while other consumables provide cost-effective alternatives to similar products offered by other companies. The Company is holding for future development a rapid, inexpensive method for screening Multiple Myeloma and other cancers, Monoclonal Gammopathies, Diabetes, Hypertension, and other disease states. Multiple Myeloma is Americas second most prevalent blood cancer. The Multiple Myeloma test is sold in Europe for research purposes only. The Company is also developing a version of its Parasep fecal concentrator for use in the veterinary field in conjunction with the Veterinary Laboratories Agency (VLA), an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) in the United Kingdom.
DiaSys was organized in March 1992 in the State of Connecticut and effected a statutory merger into a Delaware Corporation of the same name in December 1993. The Company completed its initial public offering (Offering) in January 1995. In January 2003 a complete management turnover occurred when the Chief Executive Officer, Mr. Todd DeMatteo, and the entire board of directors resigned. A new Chief Executive Officer and board of directors headed by Mr. Morris Silverman were appointed to fill the vacancies. The Companys shares were traded on the American Stock Exchange under the symbol DYX from December 2000 through January 2006. Since February 2006, the Companys shares have been quoted on the OTC Bulletin Board under the symbol DYXC.OB.
The Companys wholly-owned subsidiary, DiaSys Europe Limited, is located in Wokingham, England. DiaSys Europe markets the Companys urinalysis and parasitology workstations, the full DiaSys line of rapid test kits, consumables, immunology, oncology and virology products and manufactures reagents. DiaSys Europes facility is ISO 9001-2000 certified for the design and manufacture of devices for the scientific, diagnostics, medical & industrial markets. In June 2005, all manufacturing and assembly operations that had been conducted in the Companys Waterbury facility were consolidated into its DiaSys Europe facility. DiaSys Europe products are registered with MHRA (Medicines and Healthcare Products Regulatory Agency) for CE marking under the Directive 98/79 in Vitro Diagnostics Medical Devices, and have FDA approval as well. The operating results of the subsidiary are reflected in the accompanying consolidated financial statements.
The Company sells its products in North America both directly and through strategic distribution relationships with Cardinal Heath (NYSE:CAL), and Fisher Healthcare, a division of Fisher Scientific International Inc (NYSE:FSH). It also markets its products through numerous relationships with group purchasing organizations including Broadlane Inc. and VWR International.
The Company directly sells and services its products in the United Kingdom through DiaSys Europe. Sales and service throughout Europe, Asia and South America is conducted through independent, third party distributors or strategic trading partners. All distributors and strategic partners are managed by the Company through either of its offices in the United States or United Kingdom.
The Company is currently focusing its efforts to: (i) develop, acquire and patent several new proprietary technologies such as its fecal concentrator for use in the veterinary market; (ii) market a version of Parasep that does not require the use of solvents; (iii) have a fecal sample collection device incorporated into its existing fecal concentrator design; (iv) develop urine sediment and parasitology workstations that are closed systems; (v) adapt its fecal concentrator for DNA and ELISA testing; (vi) build the infrastructure needed to support global manufacturing and distribution operations; (vii) establish market and technical acceptance of its products among the medical laboratory community; (viii) attract significant strategic selling partners in major markets; and (ix) implement a plan for long term market penetration.
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Since inception, the Company has: (i) developed, acquired and patented several new proprietary technologies; (ii) erected the infrastructure needed to support global manufacturing and distribution operations; (iii) established market and technical acceptance of its initial products among the medical laboratory community; (iv) attracted significant strategic selling partners in major markets; and (v) implemented a plan for long term market penetration. Since its inception, the Company has operated at a loss.
BUSINESS STRATEGY
Since its inception, the Company has adhered to the following business strategy: (i) identify gaps in its product offerings of leading medical diagnostic manufacturers; (ii) fill the gaps with proprietary, practical and cost-effective solutions; (iii) protect its intellectual property with broad-based patents and trademarks; (iv) turn its technology into affordable products; (v) secure market acceptance of its products; (vi) create strategic sales and distribution alliances with industry and/or territorial leaders (see: STRATEGIC RELATIONSHIPS below); and (vii) proceed to global sales and distribution. The Company currently has products at each stage of its business strategy.
RECENT MANAGEMENT CHANGES
On February 23, 2007, Mr. Gregory Witchels services as Chief Executive Officer of the Company were terminated. Mr. Jeffrey B. Aaronson, President of the Company, assumed the responsibilities of Chief Executive Officer. On March 29, 2007, Mr. Witchel resigned as a Director of the Company. On July 2, 2007, Mr. Aaronson resigned as President, Chief Financial Officer, Chief Executive Officer and as a Director of the Company. The Board of Directors has determined that, despite the many significant contributions of Mr. Witchel and Mr. Aaronson to the long-term strategic planning of the Company, it would be in the best interests of the Company to have management focus on the day to day details necessary to realize the marketing potential of the Companys various product lines.
On July 13, 2007, the Board of Directors appointed Fredric H. Neikrug as interim President and Chief Executive Officer. On October 1, 2007, Mr. Morris Silverman was appointed Chief Financial Officer.
PRODUCTS
The Companys products can be broadly classified into two categories: (i) workstation-systems which increase the accuracy and reduce the cost to perform routine laboratory analysis of various body fluids; and (ii) consumable diagnostic products, reagents and test kits which facilitate accurate diagnosis of certain medical conditions. Each category can be further described as follows:
Workstation-Systems
The Companys workstation-systems are composed of the R/S and FE series of products.
R/S Series: The R/S series workstations standardize, automate, and reduce the cost to perform routine microscopic analysis of urine sediment. Users of the R/S series workstations include: (i) large scale clinical laboratory chains performing in excess of 20,000 urine tests per night; (ii) major medical centers performing several hundred urine tests per day; and (iii) local hospital laboratories performing approximately 100 tests per week. The URIPREP centrifuge tube with its unique insert enables the system to accurately measure sediment at one milliliter of sediment to five micro liters of examined sample. The urine sediment workstation is also available with a counting grid chamber of one micro liter divided into four grids of .25 micro liters each containing 25 boxes of .01 microliters. This enables the user to standardize each test. The R/S is a fully enclosed semi-automatic system which provides safety to laboratory technicians improves patient morphology and reduces biowaste.
The Company believes that the R/S series workstations are a preferred practice of major laboratory networks, health maintenance organizations (HMOs) and core medical facilities such as Quest and Kaiser Permanente.
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FE Series: The FE series workstation-systems are composed of the FE-5, and Parasep collection tubes and fecal concentrators. These workstation-systems automate and reduce the cost of microscopic analysis of fecal concentrates; a procedure performed by thousands of hospital, public health and private commercial laboratories worldwide in order to detect the presence of ova (eggs), cysts, and parasites in the lower intestinal tract of humans and animals. The presence of such organisms is critical to the proper care of the patient. The test is non-invasive, can be performed on an outpatient basis, and quickly provides confirmatory results. The Parasep filtration tube is used in conjunction with the FE-5 workstation and the result is reduced bio-waste, increased safety to the laboratory technician from a fully enclosed system which avoids exposure to ethylacetate, increased patient morphology, and standardized sample size for examination.
Disposable Consumables, Diagnostic Test Products and Kits
Consumables: The Company manufactures and distributes numerous consumable diagnostic products, reagents and test kits. The markets for these products are hospital and commercial laboratories, biotech and pharmaceutical companies.
Point of Care Test Kits: The Company acquired an inexpensive method for the screening of Multiple Myeloma and other cancers and other disease states at or near the patient through its purchase of Intersep Limited, a privately owed company based in Wokingham, England, in 2000. Multiple Myeloma is America's most prevalent blood cancer behind leukemia, and accounts for 2% of all known cancer deaths. The Company is currently selling the test in Europe for research applications, and has announced its intention to market the product in the United States and other markets if and as regulatory approvals are secured. The regulatory requirement and review process differ widely among countries and can be very expensive to obtain. If the Company does not receive regulatory approvals on a timely basis, it will have to carry development costs for a longer period and will lose market share to its competitors. The Company has filed patent applications with the United States Patent and Trademark Office covering the Bence Jones point of care test which has been expanded to include additional disease states. At the present time it is estimated that the research and development costs necessary to commercialize this application exceed the Companys cash flow capacity, and as such development of these products is not expected to contribute to sales or profitability until fiscal 2009 or later.
Additional Products
The Company is in the continuous process of developing new products for the global healthcare marketplace. The Companys current product development plan extends into 2008. The Company is focusing its research and development on several projects: Parasep SF, a solvent free fecal concentrator, a fecal sample collection device incorporated into its existing fecal concentrator design, a fecal concentrator for use in the veterinary market, urine sediment and parasitology workstations that are closed systems accepting only DiaSys consumables, adaptations of the fecal concentrators for DNA and ELISA testing markets, new proprietary consumable products to be used in conjunction with the workstations, fully automated urine sediment and parasitology workstations, and a proprietary series of in-vitro immunoassays. New applications for the Companys technology are also being pursued in the industrial market. During the 4
th
quarter of fiscal year 2005, the Company completed its project to develop a more powerful, lightweight, smaller and more efficient workstation for both the urinalysis and parasitology markets. The Company is also in the process of evaluating the purchase, license or distribution of compatible product lines.
MARKET FOR THE COMPANYS PROCUCTS
The Company believes that there is a substantial market for its current product lines and related applications and for the underlying proprietary technology; however, because it has lacked adequate capital and management resources, the Company has not been able to take full advantage of opportunities to develop, market and sell its products and technology.
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SALES, MARKETING AND DISTRIBUTION
North America
The Company sells and services its workstation-systems and consumable products through its office headquarters in Waterbury, Connecticut. North American sales efforts are supported by the President and a Customer Service specialist, located at the Companys headquarter office. Sales in North America are facilitated through marketing and distribution with Cardinal Health, Fisher Healthcare, Broadlane and VWR in the United States and VWR in Canada (see: Strategic Relationships below).
South and Central America
The Company has distribution operations in parts of South, Latin and Central America. Distribution is conducted by independent, third party distributors and monitored by the Companys President and Regional Sales Manager for Latin/South America, Marketing and Service, Rest of World (ROW) based in Waterbury, Connecticut. Distributors are exclusive to their assigned territory and are required to meet certain minimum revenue commitments within the terms of the Companys distribution plan and agreement.
In November 2004 the Company entered into an agreement with Repreclin Lab providing for exclusive distribution rights to the Companys products in Venezuela for a period of one year
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Although such agreement has expired in accordance with its terms, the Company continues to do business with Repreclin under the terms of the original agreement.
In December 2005, the Company entered into an agreement with DICIPA, a Mexican distributor providing for exclusive distribution rights to the Companys parasitology system in Mexico for a period of three years. The agreement calls for minimum purchases by DICIPA of approximately $1,870,000 in the first year, $3,360,000 in the second year, and $7,420,000 in the third and final year. The Companys products were issued registration in August of 2006, and systems have subsequently been delivered by DICIPA to both the private and public sector labs in Mexico. System testing has been ongoing, and full-scale distribution of systems and consumables is occurring on a daily basis; however, the minimum purchase obligations were not met and in November of 2006 DICIPA revised their estimates for scheduled deliveries of private and public sector labs. The total forecast remains similar to that previously reported, however the timing of delivery and testing of systems has been delayed due to the registration process, budget delays, and the like. Through June 30, 2007, total sales under this contract have been approximately $161,250. Because the registrations have been delayed, the Company is not in a position to enforce the original minimum purchase requirements in accordance with their terms.
In January 2006, the Company entered into agreements with Rochem Biocare Colombia S.A., Rochem Biocare del Peru S.A., Sistemas de Salud Rocarsystem S.A., and Rochem de Panama S.A. providing for exclusive distribution rights to the Companys parasitology and urine sediment systems in Colombia, Peru, Ecuador and Panama. The agreements call for aggregate minimum purchases by Rochem Biocare Colombia of approximately $408,800 in the first year, $542,000 in the second year, and $697,200 in the third and final year. Product shipments to these countries have been nominal to date pending product registration with their respective governments. Product registrations were completed in Columbia, Peru, Ecuador and Panama in August 2006. Aggregate sales under these contracts for the fiscal year ended June 30, 2007 were approximately $30,421. The delay in product sales is attributable to the distributors waiting for product registration before commencing any marketing activities. Because the registrations have been delayed, the Company is not in a position to enforce the original minimum purchase requirements in accordance with their terms.
In March 2006 the Company entered into an agreement with Galenica providing for exclusive distribution rights to the Companys parasitology and urine sediment systems in Chili. The agreement calls for aggregate minimum purchases by Galencia of approximately $149,000 in the first year, $314,000 in the second year, and $547,000 in the third and final year. Product shipments to Chile have been nominal to date under the contract, pending product registration with the government of Chile. The Companys products were issued registration in August of 2006.
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The Companys products were registered in all of the above-mentioned territories as of August 2006; however product orders have not yet materialized in the amounts anticipated. Current management is scheduled to meet with all of these distributors at the Medicus Conference to be held in Germany in October 2007, and will better be able to gauge the status of these relationships at that time.
In April 2006, the Company entered into an agreement with Labymed to distribute its parasitology and urine sediment systems in Guatemala. There have been no sales to Labymed under this contract. The Company is in the process of registering its products in Guatemala.
Europe and the Middle East
The Company sells and services its workstation-systems and consumable products in Europe, the Middle East, India, and Africa through its subsidiary based in the United Kingdom. DiaSys Europe sells and services the Companys products directly in the United Kingdom and through independent third party distributors in the balance of the territory. Distributors are generally exclusive to their assigned territory and are required to meet certain minimum revenue commitments within the terms of the Companys distribution plan and agreement.
China and Pacific Asia
Sales and service of the Companys products in China and Hong Kong is conducted by the Companys strategic trading partner, Hua Sin Science Company, under the direction and guidance of the Companys CEO. The agreement with Hua Sin expired on December 31, 2006. The Company is evaluating contract renewal or termination and is reviewing other possible distributors for this territory. In the interim, sales to Hua Sin are ongoing. (See: Strategic Relationships below).
In August 2005, the Company entered into an agreement with BioQuest Diagnostics to distribute the Companys urine sediment system in the Philippines. This agreement terminated in August 2006. The Company is evaluating distributors for this and other Pacific Asian territories.
Australia and New Zealand
The Company entered into exclusive distribution agreements with Laboratory Diagnostics in Australia and Diagnostic Bioserve, LTD in New Zealand to promote, sell and service the Companys product line. The contracts for both distributors have expired. The Company expects to renew its distribution agreement with Laboratory Diagnostics to include the territories of Australia, New Zealand and Papua New Guinea, and the Solomon Islands.
STRATEGIC RELATIONSHIPS
Veterinary Laboratories Agency
:
The Company has entered into a contractual agreement with the Secretary of State for Environment, Food and Rural Affairs (UK) through the Veterinary Laboratories Agency (VLA) to develop, test and commercially market the Veterinary Parasep, a new helminth egg counting method. The initial test results by VLA have concluded that the Veterinary Parasep for counting eggs in ovine feces is superior to existing methods. Once all testing is concluded Diasys will commercially market the test kits throughout Europe, the U.S., and Australia to end users that currently use the VLAs formerly-endorsed method.
Broadlane Inc:
In 2002, the Company was awarded a five-year supply contract expiring on March 31, 2007 by Broadlane Inc., one of the nations foremost group purchasing organizations (GPO). The Company has decided not to renew its relationship with Broadlane.
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Hua Sin Science Co. LTD:
In 1999, the Company entered into a three year sales and service agreement with Hua Sin Science Co. LTD, located in Guangzhou China. Hua Sin manufactures and distributes instruments and reagents to Chinas 67,000 hospital and medical laboratories. Hua Sin is also the exclusive distributor of Bayers CLINITEK series urine chemistry analyzers in China (see Bayer above). The Company officially commenced a distribution agreement with Hua Sin in April, 1999, and on May 4, 2000, announced that Chinas Health Ministry, the equivalent of the United States Food and Drug Administration (FDA), certified the Companys urinalysis and fecal concentrate workstations for use by all of Chinas 67,000 medical laboratories. In 2002, the Company and Hua Sin expanded their relationship to include sales and service operations in Hong Kong. On September 22, 2003, the Company announced that Hua-Sin renewed its exclusive distribution agreement with DiaSys for a period of three years. Sales to Hua Sin during the 2006 fiscal year were minimal and subsequent to the end of its fiscal year the Company terminated its relationship with Hua Sin. The Company is reviewing other possible distributors for this territory; however in September of 2007 the Company agreed to resume shipping product to Hua-Sin on an interim trial basis.
COMPETITION
The R/S Series:
The R/S series urine sediment workstations automate and standardize routine urine sediment testing, utilizing a patented optic glass flow cell that reduces handling while providing superior image clarity. The R/S series workstations are designed to make urine sediment testing faster, safer, more standardized and less expensive than conventional methodologies. These workstations can literally pay for themselves through elimination of disposables normally associated with urine sediment testing and substantially reducing the waste disposable costs of these disposables. There are, five competing technologies for the R/S series: (i) traditional use of a microscope to examine a glass slide of urine sediment; (ii) traditional use of a microscope to examine urine sediments introduced into a pre-formed plastic slide assembly; (iii) imaging system which automatically recognizes and counts pre-stored images of common shapes found in urine sediment; (iv) a flow cytometry based system which detects abnormal urines thereby reducing the number which must be manually analyzed; and, (v) pre-screening using chemically treated reagents or dip strips.
The oldest technology is the use of a microscope to examine a glass slide of urine sediment. However, the use of microscope slides and cover slips is time consuming, prone to inconsistencies, and expensive. Pre-formed plastic slides are easier to handle than glass and provide more standardization. However, the optical quality seen through plastic slides tends to be significantly inferior to that of glass and the cost is generally higher due to the shorter product life of plastic slides. The video imaging system currently available on the market provides a standard procedure for urinalysis, dispenses with the need for costly consumable items such as glass or plastic slides, and, sharply reduces exposure to potentially infectious materials carried in urine. However, the video imaging systems require expensive proprietary reagents to operate and cost between $55,000 and $110,000 to acquire. The Company believes because the systems are costly, only the largest laboratories can justify the purchase and/or use of such a system. The flow cytometry -based system screens-out normal urines thereby reducing the number of abnormal urines requiring manual analysis. However, in addition to still requiring manual analysis of some samples, the flow cytometry -based systems cost approximately $110,000 and require comparatively expensive proprietary reagents to operate, making the system somewhat expensive for normal laboratory implementation. Lastly, reagent strips are very efficient for determining chemical compositions, but they do not detect the existence of many types of particulate matter otherwise having clinical significance.
The FE Series:
The Company knows of no other workstation-system for direct microscopic analysis, which standardizes, automates and reduces the cost to collect, process, and analyze fecal concentrates from parasites, eggs and cysts. The system integrates the FE workstation with the Parasep fecal concentrator. The centrifuged sample is aspirated simultaneously into a dual stained and unstained chamber on the microscope stage, without incidence of clogging or sample cross contamination. The Company competes with (i) traditional direct method, (ii) ELISA testing that is target specific, (iii) DNA testing that is target specific (iv) rapid test strips that are target specific and IFA testing that is target specific.
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The Company, however, expects to encounter competition in the laboratory equipment industry. While the Company believes that its R/S and FE series workstations are currently the only products of their type in the market, many of the Companys competitors and potential competitors have substantially greater resources, including capital, research and development, personnel and manufacturing and marketing capabilities, and also may offer well established, broad product lines and ancillary services. The Companys products are not fully automated walk away systems. They do not have an image recognition system, data storage, or on-screen monitor display. Some of the Companys competitors have long-term or preferential supply arrangements with hospitals. These arrangements may act as a barrier to market entry to the Companys products. Competing companies may succeed in developing products that are more efficacious or less costly and these companies may also be more successful than the Company in production and marketing. Rapid technological development by others may result in the Companys products becoming obsolete before the Company recovers a significant portion of the research, development and commercialization expenses incurred by it with respect to those products. There can be no assurance that the Company will be able to compete successfully against any newly developed or improved products.
Disposable Diagnostic Products and Test Kits:
The disposable diagnostic product and test kit market is a multi-billion dollar industry made up of a number of companies, many of whom have more financial resources, research and development, marketing, and distribution capabilities than the Company. The Company therefore believes that the commercial success of these products will depend upon their continued high quality, competitive advantages (including price, quality, service and the ability to transport product cost efficiently) and the distribution efforts of the Companys strategic trading partners.
The Company believes that some of the disadvantages of its products are that they are not fully automated in that there is no image recognition system, no data storage, and no on-screen monitor display. These systems are not fully-automated, walk-away systems. The Company is not aware of any competitor which offers solutions to all of these problems.
MANUFACTURING AND WARRANTY OBLIGATIONS
The Company designs its workstations in Waterbury, Connecticut. The Company develops its consumable products in its United Kingdom office, but manufactures them through a network of molders, machine shops and other third party subcontractors. All sub-assemblies, parts, consumables and kits manufactured by sub-contractors are made according to Company specifications. All final assemblies and final tests are conducted by the Company in its UK facility. The Company has developed alternate qualified vendors for supply of its critical raw material and supplies that could fulfill its requirements if needed. Implementation of this manufacturing plan has resulted in higher manufacturing quality, reduced lead-time-to-delivery and reduced costs in manufacturing.
The Company provides its customers with a one year limited warranty against defects in parts or workmanship on all new or refurbished workstations from the date of delivery. In the event a unit fails due to a defect in parts and/or workmanship during the warranty period, the Company will at its option repair or replace the unit at no charge to the customer. For service after the initial year of warranty, the Company provides repair and service at an hourly rate plus parts. The Company experiences minimal additional costs associated with its warranty obligations.
PATENTS AND TRADEMARKS
The Companys success rests in part on the uniqueness of its intellectual property. The Company, therefore, continues to build and maintain a worldwide network of patents and trademarks.
Patents:
The Company has been granted 20 patents on its R/S, FE, and Parasep technologies. Four patents have been issued both on the concept and specific architecture of the Companys workstation-systems. The Company has also been granted similar patent protection in Australia, Brazil, Canada, China, Switzerland, Germany, Spain, France, Great Britain, Greece, Italy, Japan, Portugal, and Singapore. The patents were granted between 1992 and 2002 and will expire as follows:
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The Parasep Fecal Parasite Concentrator is protected by patents through 2018;
The optical slide assembly and workstation for urine sediment analysis patents expire in 2013;
The optical slide assembly and workstation for fecal sediment analysis patents expire in 2018.
Patent applications are pending for a DiaSys device for testing for Bence Jones Protein in urine.
The Company has additional applications for patents pending, both domestic and abroad.
Trade Names
:
The Company has been granted trade name protection for DiaSys and the following product names (both domestically and abroad): Urizyme, DiaSys, Uriprep, Parasep, and Urisep.
There can be no assurance that any future applications by the Company for patent protection will result in patents being issued, or, if issued, that such patents will provide a competitive advantage or will afford protection against competitors, with similar technology, or that competitors of the Company will not circumvent, or challenge the validity of any patents issued or licensed by the Company. Moreover, there can be no assurance that the Companys non-disclosure agreements and other safeguards will adequately protect its proprietary information and trade secrets or provide adequate remedies for the Company in the event of unauthorized use or disclosure of such information, or that others will not be able to independently develop such information. Additionally, the Company may not be aware of any infringements on its patents or other protected intellectual property rights. There can be no assurance that if the Company becomes aware of any such infringement that it will have adequate resources to defend its patents or other rights or that it would be successful in such defense.
GOVERNMENT REGULATIONS
The Company has obtained all necessary safety certifications for its products. DiaSys Europes facility is ISO 9001-2000 certified for the design and manufacture of devices for the scientific, diagnostics, medical & industrial markets. All DiaSys Europe Ltd products are registered with MHRA (Medicines and Healthcare Products Regulatory Agency) for CE marking under the Directive 98/79 in Vitro Diagnostics Medical Devices.
On May 23, 1995, the Company received clearance from the Food and Drug Administration (FDA) to release the R/S 2003 and related products to market. In the same letter, the FDA stated that any of the Companys future products, which are substantially equivalent to the new workstations, might be marketed directly without first submitting pre-market notification.
Although the R/S and FE series workstations are exempt from FDA 510(k) pre-market notification requirements, the development, testing, manufacturing and marketing of the Companys products in the United States are regulated by the FDA, which generally requires clearance of such products before marketing. Moreover, regulatory approval, if granted, may include significant limitations on the indicated uses for which a product may be marketed. Failure to comply with applicable regulatory requirements can result in, among other things, fines, suspensions of approvals, product seizures, injunctions, recalls of products, operating restrictions and criminal prosecutions. There can be no assurance that the Company will be able to obtain the necessary regulatory clearance for the manufacturing and marketing of other products, which are currently in the development stage, either in the United States, or in foreign markets on a timely basis or at all. Certain of the Companys future diagnostic products may require submission to the FDA of an application for Pre-market Approval. Delays in receipt of or failure to receive clearances to commence clinical studies or to market products, or loss of previously received clearances, would adversely affect the marketing of the Companys proposed products and, as a result, the Companys future operations.
None of the Companys rapid tests, including the one for multiple myeloma, have been FDA approved.
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The Companys Leishmania Rapid Test product for visceral leishmania, also known as kalaazar, received FDA 510(k) clearance in the United States in 2003. Visceral leishmania is the most severe form of leishmania which, if untreated, has a mortality rate of almost 100 percent. The Company is currently selling this product in the United States.
Commercial distribution in most foreign countries is also subject to varying government regulations. In addition, federal, state and international government regulations regarding the manufacture and sale of diagnostic devices are subject to future change, and additional regulations may be adopted which may prevent the Company from obtaining, or affect the timing of, future regulatory clearances and may adversely affect the Company.
The Companys manufacturing process is guided by its ISO 9001:2000 certification governing the use, generation, manufacture, storage, handling and disposal of certain materials and wastes, and regarding the manufacture, testing, labeling, record keeping, and storage of diagnostic devices, including current Good Manufacturing Practices regulations and similar foreign regulations. All products are manufactured in accordance to the IVD 98/97/EC 7.12.99 directive with the instruments also meeting the requirement of the EMC 89/336/EEC directive and the low voltage directive 72/23 EEC.
Although the Company believes that it and its subcontractors have complied in all material respects with such laws and regulations, there can be no assurance that the Company will not be required to incur significant costs in the future in complying with manufacturing and environmental regulations.
Product registration in Central and South America is a process that is used by various governmental agencies to control the importation of products into their country. The registration processes in each of the various countries in which our products are sold are unique to that country. The Company has relied on its local sales representatives and distributors to shepherd the applications through each process. Management has been advised by its sales representatives that such registrations in South American countries are typically ministerial and do not involve substantive review of the underlying merits, effectiveness or safety of the products themselves. The Company has now obtained registration for all products discussed. Management has determined that any future registration applications will be monitored closely for both compliance and planning purposes.
LABORATORY REGULATIONS
Regulations issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) became effective September 1, 1992. CLIA is intended to increase the quality of laboratory services and extends these requirements to physician office laboratories. CLIA requires laboratory licensing and written operational and quality control procedures for tests that are carried out in the laboratory. It establishes personnel standards regarding qualification and training of individuals who carry out the tests. It also mandates periodic inspection and proficiency evaluation of the performance of these procedures and individuals. CLIA requires the more complex procedures such as clinical microscopy to be performed by more skilled medical technologists. The CLIA requirements have caused more physicians offices to transfer their laboratory testing to local hospital or reference laboratories and have also resulted in consolidation of many smaller reference laboratories.
The Company believes that its workstation-systems and consumables improve the accuracy and reproducibility of laboratory procedures, and therefore believes that CLIA regulations are likely to help rather than hinder its sales efforts in the longer term.
BIOHAZARD CONTAINMENT
OSHA mandates that all necessary precautions be taken to ensure the safety of clinical laboratory personnel handling biohazardous materials including body fluids that may contain life-threatening, blood-borne infectious pathogens such as tuberculosis, hepatitis B and human immunologic viruses.
The Company believes OSHA regulations are likely to help rather than hinder sales of the Companys products since the Companys workstation-systems and consumables diminish or eliminate the inherent risks of handling body fluids by providing a sealed and/or quick method of analysis.
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THE INDUSTRY
The health care industry has experienced fundamental changes over the past several years. Specifically, laboratories were generally considered to be cost-centers (i.e. operating profitably is not a priority). Through global health care reform, however, the cost-center mentality has substantially fallen out of favor in most major markets throughout the world, and laboratory managers are increasingly concerned about ways to conserve resources and increase cost-efficiency without reducing test accuracy or quality of medicine. Moreover, the quest for greater laboratory efficiency has put immense pressure on leading manufacturers to develop or find new, appropriate technologies for the market.
Laboratories world-wide have become significantly more cost-conscious, many imposing more intense reviews of capital acquisitions, particularly for new systems like the Companys workstation-systems, which address areas traditionally not requiring significant capital investments.
However, laboratories must contend with the aforementioned OSHA and CLIA regulations. Since the Companys products are designed to reduce the amount of labor required to perform laboratory tests and the specimen biohazard exposure, as well as to standardize and improve the analytical quality of the test procedure, the Company believes these factors could enhance its competitive position in the market.
PRODUCT LIABILITY
The Company faces potential liability in connection with the use of its products. The Company has purchased product liability insurance in the amount of $2,000,000. The Company believes that its present insurance is sufficient for its current level of business operations. There can be no assurance however that such insurance will be sufficient to cover potential claims or that the present level of coverage will be available in the future at a reasonable cost.
RESEARCH AND DEVELOPMENT
The Company conducts research and development as part of its ongoing efforts to improve existing product and development of new products. The Company is focusing its research and development on several projects: new proprietary consumable products to be used in conjunction with the workstations, Parasep fecal concentrator that does not require the use of solvents, workstations that are closed systems preventing the use of competitors consumables, a collection device incorporated into the existing Parasep design, DNA and ELISA applications for fecal concentrators,, a proprietary series of in-vitro immunoassays and a paracep fecal concentrator for use in the veterinary market. New applications for the Companys technology are also being pursued in the industrial market. The Company primarily conducts research and development internally and typically does not utilize the services of third parties for such purposes; however, on September 15, 2005 the Company announced that it had engaged BioCheck, Inc. and its principal scientist to complete development of its proprietary Bence Jones protein technology.
BACKLOG
The Company had unshipped orders totaling $216,580 as of June 30, 2007.
EMPLOYEES
As of June 30, 2007 the Company had 10 full-time employees, 3 of whom were engaged in sales and marketing, 1 in research and development, 3 in manufacturing, and 4 in administrative, finance and other clerical support activities.
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ITEM 1A. RISK FACTORS
RISKS RELATED TO THE COMPANY
The Company has a history of losses.
The Company has experienced losses during each fiscal year since its initial public offering in 1995. In order to achieve profitability, the Company must increase its revenues. Although the Company believes that such increases are attainable, there can be no assurances that the Company will achieve sufficient revenues to become profitable in the current fiscal year.
The Company does have a need for additional financing, which may not be available to it on acceptable terms
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The Company will need to seek additional financing from the sale of equity or debt, from private and public sources and/or from collaborative licensing and/or marketing arrangements with third parties. However, the Company has not made arrangements for any such additional external funding and additional financing may not be available to the Company on acceptable terms, if at all. If the Companys cannot obtain such additional financing or partnering arrangements, the Company will need to modify the Companys business objectives and reduce or even cease certain or all of the Companys product development programs and other operations.
The laboratory equipment industry is highly competitive and many of the Companys potential competitors have greater financial and technological resources then the Companys have. The Company is engaged in a highly competitive industry.
The Company expects to encounter competition in the laboratory equipment industry from numerous existing companies, including large international enterprises and others entering the industry. Although the Company believes that the "R/S" and "FE" series workstations are currently the only products of their type in the market, competing technologies exist such as: (i) traditional use of a microscope to examine a glass slide of human body fluids; (ii) traditional use of a microscope to examine human body fluids introduced into a pre-formed plastic slide assembly; (iii) a video imaging system which automatically "recognizes" and "counts" pre-stored images of "common shapes" found in human body fluids; (iv) a slow cypomtry based system which detects "abnormal" urines thereby reducing the number which must be manually analyzed; and, (v) pre-screening using chemically treated reagent or "dip" strips.
Many of the Companys competitors and potential competitors have substantially greater resources, including capital, research and development, personnel and manufacturing and marketing capabilities, and also may offer well-established, broad product lines and ancillary services. Some of the Companys competitors have long-term or preferential supply arrangements with hospitals. Such arrangements may act as a barrier to market entry to the Companys products. Competing companies may succeed in developing products that are more efficacious or less costly, and such companies may also be more successful than us in production and marketing.
The Companys operating results have fluctuated in the past and are likely to continue to fluctuate in the future on an annual and quarterly basis, due to numerous factors, many of which are outside of the Companys control
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Some of the factors that may cause these fluctuations include:
- changing market demand for, and declines in the average selling prices of, the Companys products;
- the timing of and delays or cancellations of significant orders from major customers;
- the loss of one or more of the Companys major customers;
- the cost, availability and quality of components from the Companys suppliers;
- the cost, availability, and quality of assemblies from contract and subcontract manufacturers;
- delays in the introduction of new products;
- competitive product announcements and introductions;
- development of new technologies by the Companys competitors;
- changes in customer preferences;
- changes in the regulatory environment, product health and safety concerns
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- general economic conditions; and
- loss of key personnel.
The laboratory equipment market is subject to frequent and rapid changes in technology and customer preferences
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The Companys competitors may develop new products that are more useful or less costly than the Companys products. Rapid technological development by others may result in the Companys products becoming obsolete before it recovers a significant portion of the research, development and commercialization expenses incurred with respect to those products. If the Company cannot develop new products in response to changes in technology or customer preferences, the Company will lose market share to the Companys competitors. Patents and intellectual property rights are important to the Company but could be challenged.
Proprietary protection for the Companys products is of material importance to the Companys business in the U.S. and most other countries
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The Company has numerous patents and trademarks throughout the world, and many additional applications pending. The Company has sought and will continue to seek proprietary protection for the Companys products to attempt to prevent others from commercializing equivalent products in substantially less time and at substantially lower expense. The Companys success may depend on its ability to (1) obtain effective patent protection within the United States and internationally for its proprietary technologies and products, (2) defend patents the Company owns, (3) preserve its trade secrets, and (4) operate without infringing upon the proprietary rights of others.
While the Company has obtained numerous patents and has additional patent applications pending, the extent of effective patent protection in the United States and other countries is highly uncertain and involves complex legal and factual questions. No consistent policy addresses the breadth of claims allowed in or the degree of protection afforded under patents of medical and pharmaceutical companies. Patents the Company currently owns or may obtain might not be sufficiently broad to protect the Company against competitors with similar technology. Any of the Companys patents could be invalidated or circumvented.
The patent application and issuance process takes years, and may be expensive. The Company might not obtain all of the United States patents the Company has applied for related to the "R/S" and "FE" series or other technology or products that the Company may develop. In addition, the Company does not have and may never obtain foreign patents equivalent to the claims in its U.S. patents.
Because a United States pending patent application is confidential, the Company cannot know the inventions claimed in pending patent applications filed by third parties. The Company may need to defend or enforce its patent and license rights or determine the scope and validity of the proprietary rights of others through litigation. Defense and enforcement of patent claims may be expensive and time-consuming, even when the outcome is in its favor. Defense and enforcement actions may use substantial resources originally allocated to other activities such as studies and continuing development of the Companys products and technologies. While the Company believes that its patents will prevail in any potential litigation, it is possible that the holders of these competing patents will commence a lawsuit against us and that the Company will not prevail in any such lawsuit. Litigation could result in substantial cost to and diversion of effort by the Company, which may harm its business. In addition, the Companys efforts to protect or defend its proprietary rights may not be successful or, even if successful, may result in substantial cost to the Company. In the event of an unfavorable outcome in any patent infringement suit, the Company may be required to:
- assume significant liabilities to third parties,
- obtain licenses from third parties,
- alter the Companys products or processes, or
- cease altogether any of the Companys related research and development activities or product sales.
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The Company depends on agreements with third parties to protect its rights to certain technology
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The Company may encounter disputes regarding the proprietary rights to technological information that employees, consultants, advisors or other third parties independently develop and apply to any of its proposed products. These disputes might not be resolved in the Companys favor. The Company may also rely on trade secrets and proprietary know-how that may become known to others despite its efforts to keep them confidential. Although the Company seeks to protect the Companys trade secrets and proprietary know-how in part by its confidentiality agreements with employees, consultants, advisors or others, these parties may breach their agreements, and the Company might not obtain adequate remedies. Similarly, competitors may discover or independently develop the Companys trade secrets or proprietary know-how in such a manner that the Company has no legal recourse.
The Company is dependent on third party subcontractors for the production of certain components of its products.
The Company relies on subcontractors to manufacture certain components of its products, based on its specifications. The risks associated with reliance on subcontractors include:
- subcontractors may fail to meet the Companys requirements for quality, quantity, timeliness, or pricing; and
- although the Company has developed alternate qualified vendors for its critical raw materials and supplies, it
may not be able to find or obtain additional substitute vendors, if required.
The Company depends upon third parties for the sale, marketing and distribution of its products.
The Company depends on third parties for the sale, marketing and distribution of its products. Such dependence requires it to spend significant funds to inform these third-party distributors of the distinctive characteristics and benefits of the Companys products. The Companys operating results and long term success will depend on its ability to establish and maintain successful arrangements with these third parties.
The Company expects to incur substantial marketing costs.
The Company currently markets its products through regional sales management in the United Kingdom and through independent distributors in several foreign countries. The Company expects to incur substantial costs in connection with marketing and sales efforts.
Recent Management Changes
. On February 23, 2007, Mr. Gregory Witchels services as Chief Executive Officer of the Company were terminated. Mr. Jeffrey B. Aaronson, President of the Company, assumed the responsibilities of Chief Executive Officer. On July 2, 2007, Mr. Jeffrey B. Aaronson resigned as President, Chief Financial Officer, Chief Executive Officer and Director of the Company. The Board of Directors has determined that, despite the many significant contributions of Mr. Witchel and Mr. Aaronson to the long-term strategic planning of the Company, it would be in the best interests of the Company to have management focus on the day to day details necessary to realize the marketing potential of the Companys various product lines. On July 13, 2007, the Board of Directors appointed Fredric H. Neikrug as interim President and Chief Executive Officer. On October 1, 2007, Mr. Morris Silverman was appointed Chief Financial Officer. The Company is unable to predict what adverse effects, if any, may follow such changes in senior management.
The Company may be subject to potential product liability claims, creating risk and expense.
The Company is exposed to product liability risks inherent in the development, testing, manufacturing, marketing and sale of its products. Product liability insurance for the diagnostic industry is extremely expensive, difficult to obtain and may not be available on acceptable terms, if at all. The Company currently has product liability insurance to cover claims related to its products with coverage of $2 million for any one claim and coverage of $2 million in total. A successful claim against the Company if the Company is uninsured, or which is in excess of the Companys insurance coverage, if any, could have a material adverse effect upon the Company and on its financial condition.
Revenue growth may be delayed by lengthy sales and implementation cycles
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The period between initial contact with a potential customer and the customer's purchase of the Companys products is often long and may have delays associated with the lengthy budgeting and approval process of such potential customers. To successfully sell the Companys products, it must educate potential customers regarding the use and benefit of such products, which can require significant time and resources.
The Company must effectively manage its growth
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To date, the Companys growth has caused a significant strain on its management, operational, financial and other resources. The Companys ability to effectively manage growth will require it to improve its management, operational and financial processes and controls. The failure to effectively manage growth could materially and adversely affect the Companys business and operating results.
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Industry Risks
The Companys failure to receive governmental approvals for its proposed products on a timely basis, or ever, could damage its business, financial condition and results of operations
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Some of the Companys new products may require the Company to obtain governmental clearance before marketing such products in the United States. The process of obtaining the required regulatory approvals is lengthy, expensive and uncertain. Moreover, regulatory approval, if granted, may include limitations on the approved uses of a product. If the Company fails to comply with applicable regulatory requirements it may incur fines, suspensions of approvals, product seizures, injunctions, recalls of products, operating restrictions and criminal prosecutions. If the Company fails to receive clearances to commence clinical studies or to market products, it would adversely affect the results of the Companys future operations.
Variations in the regulatory requirements of foreign authorities could delay the Companys introduction of products into countries outside the United States and limit its marketing scope
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Because the Company intends to sell and market its products outside the United States, the Company will be subject to foreign regulatory requirements governing the conduct of clinical trials, product licensing, pricing and reimbursements. These requirements vary widely from country to country. The Companys failure to meet each foreign country's requirements could delay the introduction of its proposed products in the respective foreign country and limit its revenues from sales of the Companys proposed products in foreign markets.
The Companys failure to comply with regulatory requirements could subject the Company to regulatory or enforcement actions.
Even if the Company obtains regulatory approvals, the FDA and comparable foreign agencies continually review and regulate marketed products. A later discovery of previously unknown problems or the Companys failure to comply with the applicable regulatory requirements could subject the Company to regulatory or judicial enforcement actions. These actions could result in the following:
- recalls or seizures of the Companys proposed products,
- restrictions on marketing of the Companys proposed products,
- regulatory authorities' refusal to approve new products or withdrawal of existing approvals,
- enhanced product liability exposure,
- injunctions,
- civil penalties, or
- criminal prosecution.
The Company will face intense competition from companies that are substantially larger, have more substantial histories, backgrounds, experience and records of successful operations, greater financial, technical, marketing and other resources, more employees and more extensive facilities than the Company now has, or will have in the foreseeable future.
The Company will compete directly with manufacturers of other proprietary test kits. The Company will also compete indirectly, and may in the future compete directly, with providers of related or alternative technologies. Almost all of the companies with which the Company competes are substantially larger, have more substantial histories, backgrounds, experience and records of successful operations, greater financial, technical, marketing and other resources, more employees and more extensive facilities than the Company now has, or will have in the foreseeable future. Further, the Company believes that certain of its key competitors have invested, and will continue to invest, substantially greater funds in developing new products and technologies. Accordingly, there can be no assurance that the Companys competitors do not have, or will not develop or introduce, new products and technologies that could render the Companys products less competitive or obsolete. Any failure by the Company to compete effectively with regard to new product offerings, product innovations and technological changes and to offer products that provide performance that is at least comparable to competing products would have a material adverse effect on the Companys business, operating results and financial condition.
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The Companys success will be dependent upon its ability to increase the production volume on a timely and cost-effective basis, while maintaining product quality.
The Company has only limited production facilities, located in Wokingham, England. Such production facilities will not be adequate to service projected demand for the Companys products. The Company is currently negotiating with independent manufacturers to arrange production on a contract basis. There can be no assurances that such arrangements will be satisfactorily concluded or that, if so concluded, the manufacturers will be able to produce products at the quantity and quality adequate to meet demand. If the Company is unable to ship product in a timely basis, or if shipped products do not meet quality standards, the Company may lose important customer contracts.