873198--3/29/2007--GUARDIAN_TECHNOLOGIES_INTERNATIONAL_INC

related topics
{stock, price, share}
{product, liability, claim}
{regulation, government, change}
{control, financial, internal}
{product, candidate, development}
{product, market, service}
{interest, director, officer}
{operation, international, foreign}
{property, intellectual, protect}
{stock, price, operating}
{personnel, key, retain}
{customer, product, revenue}
{acquisition, growth, future}
{debt, indebtedness, cash}
{provision, law, control}
{financial, litigation, operation}
{competitive, industry, competition}
Risks Related to Our Company and Our Operations Our business plan and technologies are unproven. We have generated minimal revenues from our operation, and incurred substantial operating losses since our inception. We have very limited cash resources. We have a severe working capital deficit and, in addition to proceeds from financings, we have relied upon loans from our chief executive officer and deferrals of salaries by our executive officers and a consultant to fund operations. Dilutive effect of conversion of Series A 10% Senior Convertible Debentures and exercise of Series D Warrants and Midtown placement agent s warrants. Current shareholdings may be diluted if we make future equity issuances or if outstanding debentures, warrants, and options are exercised for or converted into shares of common stock. We have incurred substantial debt which could affect our ability to obtain additional financing and may increase our vulnerability to business downturns. We may face competition from other developers or sellers of imaging and radiology technology and baggage screening technology. We may undertake acquisitions which pose risks to our business. Our independent registered public accounting firm has expressed uncertainty regarding our ability to continue as a going concern. Investor confidence in the price of our stock may be adversely affected if we are unable to comply with Section 404 of the Sarbanes-Oxley Act of 2002. We recently restated certain of our audited and unaudited consolidated financial statements. Our certifying officers evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2005, as of March 31, 2006, June 30, 2006, September 30, 2006, and December 31, 2006, and concluded that our disclosure controls were not effective and that we had certain weaknesses in our internal controls over timely financial reporting. In order to comply with public reporting requirements, we must continue to strengthen our financial systems and controls, and failure to do so could adversely affect our ability to provide timely and accurate financial statements. Investors could lose confidence in our financial reports, and our stock price may be adversely affected, if our internal controls over financial reporting are found not to be effective by management or by an independent registered public accounting firm or if we make disclosure of existing or potential significant deficiencies or material weaknesses in those controls. Our stock price is volatile. There is a limited market for our common stock. Because we became public because of a reverse acquisition, we may not be able to attract the attention of major brokerage firms or institutional investors. Our common stock is subject to the SEC s Penny Stock Regulations. Certain provisions of our charter and bylaws may discourage mergers and other transactions. Our board of directors may issue additional shares of preferred stock without stockholder approval. We depend on key personnel. Our directors and named executive officers own a substantial percentage of our common stock. Our ability to attract and retain additional skilled personnel may impact our ability to develop our technology and attract customers in growing our business. We have never paid a cash dividend Risks Related to Our Industries Changes may take place in funding for healthcare. Virtually all of our prospective customers in the healthcare industry are subject to governmental regulation, including Medicare and Medicaid regulation. Competition for healthcare information systems is intense. Product liability claims may occur. Product malfunction liability claims may occur. Specific government regulations relating to Medicare and Medicaid may impinge on us. Medical device regulation may require us to obtain approval for our products. System errors and warranties may subject us to liability. We may infringe the proprietary rights of others. Unforeseeable disruption in the economy may take place consequent to terrorism or other international events. A number of factors that affect our revenues make our future results difficult to predict, and therefore we may not meet expectations for a particular period. We expect to depend on a small number of customers for a substantial portion of our future revenues. Governmental agencies, the primary customers for our PinPoint products, are subject to budget processes which could limit the demand for these products. Legislative actions could lead to fluctuations in demand for transportation security scanning products and services. Governmental agencies have special contracting requirements, which create additional risks. Our growth depends on our introduction of new products and services, which may be costly to develop and may not achieve market acceptance. Our PinPoint product may fail to obtain certification by the TSA. Our existing PinPoint product may fail to obtain re-certification by the TSA for changes in the PinPoint system. Our major potential customer, the TSA, is a part of the Department of Homeland Security, a newly created agency that has experienced, and may continue to experience, delays in its operations, which may cause delays in our receiving orders for our products from the TSA. Future sales of our PinPoint products will depend on the ability of airports to secure funding to build baggage handling systems and to integrate our PinPoint product into such systems, which they may not be able to do. If our PinPoint product fails to detect explosives, we could be exposed to product liability and related claims for which we may not have adequate insurance coverage, and we may lose current and potential customers. We expect to substantially depend on large orders from a limited number of customers. As a result, order cancellations from any of our customers or the failure of these customers to continue to purchase PinPoint products could have a material negative impact on our business and financial results. The sales cycle for our PinPoint products is lengthy and we may expend a significant amount of effort in obtaining sales orders and not receive them. Our future international sales subject us to risks that could materially harm our business. Exchange rate fluctuations could cause a decline in our financial condition and results of operations. Our inability to adapt to rapid technological change could impair our ability to remain competitive. The transportation security scanning industry is highly competitive. Given the anticipated continuing demand for airport security products, competition may increase. Litigation may be necessary to enforce or defend against claims of intellectual property infringement, which could be expensive and, if we lose, could prevent us from selling our products.

Full 10-K form ▸

related documents
873198--4/16/2008--GUARDIAN_TECHNOLOGIES_INTERNATIONAL_INC
873198--5/16/2006--GUARDIAN_TECHNOLOGIES_INTERNATIONAL_INC
1018354--4/14/2008--NEW_YORK_HEALTH_CARE_INC
1424768--3/31/2010--VYCOR_MEDICAL_INC
725460--4/2/2007--LANGER_INC
859737--11/24/2010--HOLOGIC_INC
1057377--4/14/2008--SAMARITAN_PHARMACEUTICALS_INC
1383183--3/18/2010--CombiMatrix_Corp
1383183--3/19/2008--CombiMatrix_Corp
1059784--10/15/2007--GENEREX_BIOTECHNOLOGY_CORP
1159036--3/9/2007--HALOZYME_THERAPEUTICS_INC
727510--2/29/2008--ENZON_PHARMACEUTICALS_INC
930553--3/16/2007--ISTA_PHARMACEUTICALS_INC
357097--4/15/2009--ISOLAGEN_INC
1383183--3/27/2009--CombiMatrix_Corp
1159036--3/13/2009--HALOZYME_THERAPEUTICS_INC
749647--3/28/2008--Celsion_CORP
1396335--2/19/2008--Powersafe_Technology_Corp
1479426--9/30/2010--DynaVox_Inc.
1318310--2/25/2010--ev3_Inc.
1427222--3/31/2010--WELLQUEST_MEDICAL_&_WELLNESS_CORP
883697--3/28/2007--REGEN_BIOLOGICS_INC
1364326--1/5/2010--Pure_Pharmaceuticals_CORP
1200528--12/15/2008--EN2GO_INTERNATIONAL_INC
704328--2/8/2007--SOMANETICS_CORP
1030839--2/5/2009--Synovics_Pharmaceuticals
702131--3/1/2007--MGI_PHARMA_INC
1082324--3/31/2008--VirnetX_Holding_Corp
789132--3/15/2010--SPECTRANETICS_CORP
784199--2/19/2009--CRYOLIFE_INC