-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, GEIJ4YCvPtoH9uNbPgK/ijI5h6yEUHLdFlqasu0nkItGF4YEScOBVx41VFYAGcJ/ Zl9E2o0PZfPQH/tVVByrUA== 0000927016-98-003678.txt : 19981023 0000927016-98-003678.hdr.sgml : 19981023 ACCESSION NUMBER: 0000927016-98-003678 CONFORMED SUBMISSION TYPE: 10-K/A PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19980331 FILED AS OF DATE: 19981022 SROS: AMEX FILER: COMPANY DATA: COMPANY CONFORMED NAME: CARDIOTECH INTERNATIONAL INC CENTRAL INDEX KEY: 0001011060 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043186647 STATE OF INCORPORATION: MA FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 10-K/A SEC ACT: SEC FILE NUMBER: 001-11737 FILM NUMBER: 98729382 BUSINESS ADDRESS: STREET 1: 11 STATE ST CITY: WOBURN STATE: MA ZIP: 01801 BUSINESS PHONE: 7819334772 MAIL ADDRESS: STREET 1: 11 STATE ST CITY: WOBURN STATE: MA ZIP: 01801 10-K/A 1 FORM 10-K/A SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K/A AMENDMENT NO. 1 ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 1998 Commission File No. 0-28034 ---------------------------- CARDIOTECH INTERNATIONAL, INC. ------------------------------ (Exact name of registrant as specified in its charter) Massachusetts 04-3186647 State or other jurisdiction of (I.R.S. Employer incorporation or organization Identification No.) 78E Olympia Avenue, Woburn, Massachusetts 01801 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (781) 933-4772 SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: COMMON STOCK, $.01 PAR VALUE PER SHARE (TITLE OF CLASS) SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: NONE Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No ----------- Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K . [ ] As of June 25, 1998, 4,272,916 shares of the registrant's Common Stock were outstanding, and the aggregate market value of the registrant's Common Stock held by nonaffiliates of the registrant(without admitting that any person whose shares are not included are affiliates) was $8,131,112, based on the last sale price as reported on the American Stock Exchange on such date. CARDIOTECH INTERNATIONAL, INC. Part I, Items 1. and 2. to the CardioTech International, Inc. Annual Report on Form 10-K, filed with the Securities and Exchange Commission on June 29, 1998 for the fiscal year ended March 31, 1998, are hereby deleted and replaced with Part I, Items 1. and 2. included in this Amendment No. 1. -1- CARDIOTECH INTERNATIONAL, INC. PART I ITEM 1. BUSINESS GENERAL CardioTech is using its proprietary manufacturing technology to develop and manufacture small bore vascular grafts, or synthetic blood vessels, made of ChronoFlex, a family of polyurethanes that has been demonstrated to be biocompatible and non-toxic. Vascular grafts are used to replace, bypass or provide a new lining or arterial wall for occluded, damaged, dilated or severely diseased arteries and are used to provide access for patients undergoing hemodialysis treatments. The Company is developing three types of layered, microporous small bore vascular grafts: (i) a vascular access graft, called the VascuLink Access Graft; (ii) a peripheral graft, called the MyoLink Peripheral Graft, and (iii) a coronary artery bypass graft, called the CardioPass Coronary Artery Bypass Graft. Blood is pumped from the heart throughout the body via arteries. Blood is returned to the heart at relatively low pressure via veins, which have thinner walls than arteries and have check valves which force blood to move in one direction. Because a specific area of the body is often supplied by a single main artery, rupture, severe narrowing or occlusion of the artery supplying blood to that area is likely to cause an undesirable or catastrophic medical outcome. Vascular grafts are used to replace or bypass occluded, damaged, dilated or severely diseased arteries and are sometimes used to provide access to the bloodstream for patients undergoing hemodialysis treatments. Existing small bore graft technologies suffer from a variety of disadvantages in the treatment of certain medical conditions, depending upon the need for biodurability, compliance (elasticity) and other characteristics necessary for long-term interface with the human body. CardioTech is developing its grafts using specialized ChronoFlex polyurethane materials that it believes will provide significantly improved performance in the treatment of arterial disorders. The grafts have three layers similar to natural arteries designed to replicate the physical characteristics of human blood vessels. Additionally, through its CT Biomaterials division, the Company develops, manufactures and markets polyurethane-based biomaterials for use in both acute and chronically implanted devices such as stents, artificial hearts, and vascular ports. These premium biomaterials are sold under the tradenames: ChronoFlex, ChronoThane, HydroThane and ChronoFilm. CardioTech owns a number of patents relating to its vascular graft manufacturing technology. In addition, PolyMedica Corporation ("PMI") has granted to CardioTech an exclusive, perpetual, worldwide, royalty-free license for the use of one polyurethane patent and related technology in the field consisting of the development, manufacture and sale of implantable medical devices and biodurable polymer material to third parties for the use in medical applications (the "Implantable Device and Materials Field"). PMI also owns, jointly with Thermedics, Inc., certain polyurethane patents relating to the Chronoflex technology (the "Joint Technology"). PMI has granted to CardioTech a non-exclusive, perpetual, worldwide, royalty-free sublicense of the Joint Technology for use in the Implantable Devices and Materials Field. -2- The Company was founded in 1993 as a subsidiary of PMI. In June 1996, PMI distributed (the "Spin Off") all of the shares of CardioTech's Common Stock that PMI owned to PMI stockholders of record as of June 3, 1996. The Company is headquartered in Woburn, Massachusetts and also has production facilities in Brymbo, Wrexham, U.K. ChronoFlex and ChronoFilm are registered trademarks of PMI. ChronoThane, ChronoPrene, HydroThane, PolyBlend and PolyWeld are tradenames of CardioTech. DuraGraft, VascuLink, MyoLink, CardioPass are trademarks of CardioTech. PRODUCTS IN DEVELOPMENT VASCULINK VASCULAR ACCESS GRAFT Patients suffering from end-stage renal disease may be required to undergo hemodialysis. The majority of these patients require long-term vascular access to facilitate treatment. A point of access for dialysis needles may be created by connecting an artery and a vein in the patient's arm. However, because kidney dialysis therapy typically requires patients to undergo hemodialysis treatment three times per week, these natural shunts often become unusable over time. Other methods of vascular access for kidney dialysis, such as transcutaneous catheters, are only designed for temporary use. A synthetic graft is implanted in hemodialysis patients to provide routine vascular access. The vast majority of these synthetic grafts are presently made of polytetafluoroethylene ("ePTFE"). The use of ePTFE grafts is often accompanied by excessive bleeding when the dialysis needle is withdrawn, requiring a nurse to apply pressure to help stop the bleeding and requiring the patient to remain in the treatment area until the bleeding has stopped. In addition, to limit the risk of graft infection following implant, at least a four to six week healing period following implantation is required before initiating dialysis in order to allow for tissue in-growth into the graft. The Company believes that the VascuLink Graft that it is developing may offer advantages over currently used synthetic grafts because of its needle- hole-sealing-capability. The Company believes that this characteristic will be effective in sealing puncture sites in its grafts with minimal compression time and bleeding as compared with ePTFE grafts and, as a result, will reduce dialysis procedure and administrative time per patient and their associated costs. In addition, the Company believes, based on animal studies, that patients who receive the VascuLink Graft will be able to be dialized in a shorter period of time than four to six weeks. The Company believes that approximately 185,000 patients in the United States undergo kidney dialysis each year, of which approximately 140,000 undergo vascular access surgeries using either natural vessel grafts or synthetic access grafts. The Company estimates that of these patients, approximately 55,000 are implanted with synthetic grafts. The Company believes that a comparable market exists overseas. The Company is currently conducting clinical trials of the VascuLink Graft in Holland, France and Sweden with patients undergoing routine hemodialysis treatment. The Company's clinical trials will compare patency and complication rates of the Company's VascuLink Graft with ePTFE grafts. The clinical trial in Holland began in November 1996 at one site, the clinical trial in France began in June 1997 at three sites and the clinical trial in Sweden began during the first three months of 1998 at two -3- sites. The clinical trials in Holland, France and Sweden involve an aggregate of up to 60 patients. There can be no assurance that the Company's clinical trials will be successful. MYOLINK PERIPHERAL GRAFT In the United States, an estimated 16 million people suffer from diabetes, which is often further complicated by atherosclerosis, or the blockage of arteries. Eventually, many atherosclerosis patients require vascular grafts to bypass severely occluded leg arteries, which impede circulation to the lower extremities and can ultimately lead to amputation. Lack of adequate circulation to the lower limbs and toes results in approximately 54,000 yearly amputations in the United States alone. Current techniques of surgical intervention rely on autologous saphenous veins from the leg for use as substitute vessels. However in over 40% of all atherosclerosis patients, the saphenous veins are deemed unsuitable, making it necessary to use a vein constructed from artificial materials. The Company is designing the MyoLink Peripheral Graft that it is developing to be suitable for providing needed circulation from the upper thigh, across the knee and into the mid calf. In order to accommodate the bend at the knee, CardioTech has designed the MyoLink graft to be "non-kinking." Further, CardioTech believes that it has the expertise and capability to manufacture a graft that tapers from an inside diameter of approximately 6mm for the portion above the knee to an inside diameter of approximately 4mm for the portion below the knee, roughly the same dimensions as the natural artery. The Company is currently conducting pre-clinical development studies of the MyoLink Graft at its Brymbo, Wrexham, UK facility. On April 1, 1998, the Company, through its wholly owned subsidiary , CardioTech International, Ltd. ("CTI Ltd."), entered into a two year research collaborative with The Royal Free Hospital School of Medicine (University of London) ("Royal"), which relates to the investigation and clinical trials of the MyoLink graft and the clinical evaluation of endothelial cell-seeding of peripheral vascular grafts. This research, if successfully commercialized may result in the payment of royalties to the Royal Free Hospital. The research is being funded by a loan of (Pounds)252,942 (or $429,875 as of September 30, 1998) (the "Loan") from Freemedic PLC, a subsidiary of Royal (together with Royal, "Freemedic"), to CTI, Ltd. The Loan, plus accrued interest, is convertible under certain conditions, at either the Company's or Freemedic's option, into Common Stock of the Company at a conversion price of $3.70 per share. Freemedic may terminate the collaboration at any time upon a material breach by the Company of any obligation under the collaboration agreement or upon any event of default under the Loan agreement. CARDIOPASS CORONARY ARTERY BYPASS GRAFT Coronary artery bypass graft ("CABG") surgery is performed to treat the impairment of blood flow to portions of the heart. CABG surgery involves the addition of one or more new vessels to the heart to re-route blood around blocked coronary arteries. Autogenous grafts (using the patient's own saphenous vein or mammary artery) have been successfully used in CABG procedures for a number of years and have shown a relatively high patency rate (80% to 90% for saphenous veins and over 90% for mammary arteries one year after surgery) with no risk of tissue rejection. However, the surgical harvesting of vessels for autogenous grafts involves significant trauma and expense. In addition, not all patients requiring CABG surgery have sufficient native vessels as a result of previous bypass surgeries, or their vessels may be of inferior quality due to trauma or disease. Cryopreserved saphenous veins are available, but these veins often deteriorate due to attack by the body's immune system. -4- The Company is developing the CardioPass Coronary Artery Bypass Graft to be a synthetic graft of 3mm in diameter specifically designed for use in CABG surgery. If successfully developed, the Company believes that the CardioPass Graft may be used initially to provide an alternative to patients with insufficient or inadequate native vessels for use in bypass surgery as a result of repeat procedures, trauma, disease or other factors. The Company believes, however, that the CardioPass Graft may ultimately be used as a substitute for native saphenous veins, thus avoiding the trauma and expense associated with the surgical harvesting of the vein. The Company believes that in 1995, approximately 700,000 CABG procedures were performed worldwide, of which nearly 500,000 were performed in the United States. The Company believes that approximately 20% of these CABG procedures were performed on patients who had previously undergone bypass surgery, and that the number of repeat procedures will continue to increase as a percentage of procedures performed. Currently, approximately 70% of CABG procedures are performed utilizing the saphenous vein. The Company estimates that approximately 100,000 patients are diagnosed by their physicians as having native vessels that are inadequate for use in bypass surgery. The CardioPass Coronary Artery Bypass Graft is currently in pre- clinical development. If the CardioPass Graft is successfully developed, the Company believes that the graft may initially be used for these patients. The Company also believes that if long-term clinical results are acceptable to clinicians (generally, greater than 50% patency five years after implant), the graft may ultimately be used as a direct substitute for autogenous saphenous veins. BIOMATERIALS CardioTech also develops, manufactures and sells a range of polymer-based materials customized for use in the manufacture of certain medical devices to other medical device manufacturers. CardioTech sells these custom polymers under the tradenames ChronoFilm, ChronoFlex, ChronoThane, ChronoPrene, HydroThane, PolyBlend and PolyWeld. The Company also provides development services relating to biomaterials to medical device customers. In 1992, PMI entered into a long term development and materials supply agreement with Bard Access Systems, Inc. pursuant to which Bard purchases several formulations of ChronoFlex for use in the manufacture of a line of catheters and implantable vascular access ports that are used to deliver doses of pharmaceuticals over an extended period of time or to deliver chemotherapy agents to specific organs. PMI assigned this agreement to CardioTech prior to the Spin Off. CardioTech also manufactures and sells its proprietary HydroThane biomaterials to medical device manufacturers that are evaluating HydroThane for use in their products. HydroThane is a thermoplastic, water-absorbing, polyurethane elastomer, that possesses properties that CardioTech believes make it well suited for the complex requirements of a variety of catheters. In addition to its physical properties, CardioTech believes HydroThane exhibits an inherent degree of bacterial resistance, clot resistance and biocompatibility. When hydrated, HydroThane has elastic properties similar to living tissue. During the fiscal year ended March 31, 1998, the Company was the recipient of two Small Business Innovation Research grants awarded by National Institutes of Health ("NIH") to support the Company's research and development programs. -5- Research revenues related to biomaterials were approximately $278,343, $872,521 and $570,676 for the three months ended June 30, 1998 and the years ended March 31, 1998 and 1997, respectively. For the year ended March 31, 1998, 26% and 56% of research revenues were generated from Bard Access Systems, Inc. and the NIH, respectively. For the three months ended June 30, 1998, 22.5% and 48.9% of research revenues were generated from Bard Access Systems, Inc. and the NIH, respectively. MANUFACTURING CardioTech currently manufactures limited quantities of ChronoFlex and HydroThane for sale to medical device manufacturers. To date, CardioTech's manufacturing activities with respect to the specialized ChronoFlex materials used in vascular grafts have consisted primarily of manufacturing small quantities of such products for use in clinical trials. CardioTech currently has the ability to produce quantities of vascular grafts sufficient to support its current testing needs. CardioTech also has the ability to produce quantities of vascular grafts sufficient to support its needs for early-stage clinical trials. However, CardioTech may need to acquire manufacturing facilities and improve its manufacturing technology in order to meet the volume and cost requirements for later clinical trials and will require additional manufacturing facilities in order to undertake commercial production of vascular grafts, if it elects to do so. To achieve profitability, CardioTech's products must be manufactured in commercial quantities in compliance with regulatory requirements and at acceptable costs. Production in commercial quantities will require CardioTech to expand its manufacturing capabilities significantly and to hire and train additional personnel. CardioTech has no experience in large- scale manufacturing, and there can be no assurance that CardioTech will be able to make the transition to commercial production successfully. The Company's manufacturing operations in the United Kingdom currently hold an ISO 9001 Certificate of Registration from National Quality Assurance, Ltd. This internationally recognized endorsement of ongoing quality management represents the highest level of certification available. The development and manufacture of CardioTech's products are subject to good laboratory practice ("GLP") and good manufacturing practice ("GMP") requirements prescribed by the Food and Drug Administration ("FDA") and other standards prescribed by the appropriate regulatory agency in the country of use. There can be no assurance that CardioTech will be able to obtain or manufacture products in a timely fashion at acceptable quality and prices, that it or any suppliers can comply with GLP or GMP, as applicable, or that it or such suppliers will be able to manufacture an adequate supply of product. MARKETING CardioTech plans to market its vascular graft products for which it obtains regulatory approvals either through a small targeted direct sales group or through licensing arrangements with large medical device companies. Implementation of this strategy will depend on many factors, including the market potential for CardioTech's products and financial resources. There can be no assurance that CardioTech will be able to successfully market its products. -6- COMPETITION Competition in the medical device industry in general is intense and based primarily on scientific and technological factors, the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain governmental approval for testing, manufacturing and marketing products. CardioTech will compete with products offered by W.L. Gore and Associates ("W.L. Gore"), Impra, Inc. ("Impra"), Corvita Corporation ("Corvita") and Thoratec Corporation ("Thoratec"). CardioTech believes that W.L. Gore and Impra, whose synthetic graft products have been sold in the United States and worldwide for many years, sell approximately 90% of the intermediate diameter peripheral synthetic vascular grafts and vascular access grafts used throughout the world. While CardioTech believes that the attributes of its vascular grafts will allow it to compete effectively, both W.L. Gore and Impra can be expected to defend their market positions vigorously, and both have substantially greater financial, technical and other resources than CardioTech. Corvita is developing a broad range of polyurethane based synthetic vascular grafts, including vascular access grafts and has commenced clinical trials of certain of its synthetic vascular graft products in both the United States and Europe. Thoratec has developed a small bore polyurethane vascular access graft and has begun limited clinical trials in the United States and foreign countries. In addition, Thoratec has begun to sell its product in Japan and has affixed a CE Mark on its product which enables it to sell the product throughout Europe. Furthermore, the Joint Technology may be licensed or otherwise made available to competitors of CardioTech. Competition among these products will be based, among other things, on product efficacy, safety, reliability, availability, price and patent position. An important factor will be the timing of the market introduction of CardioTech's or competitive products. Accordingly, the relative speed with which CardioTech can develop products, complete the clinical trials and approval processes and supply commercial quantities of the products to the market is expected to be an important competitive factor. CardioTech's competitive position will also depend upon its availability to attract and retain qualified personnel, to obtain patent protection or otherwise develop proprietary products or processes, and to secure sufficient capital resources for the often substantial period between technological conception and commercial sales. RESEARCH AND DEVELOPMENT CardioTech's research and development efforts are focused on developing its synthetic vascular graft technologies. CardioTech's development decisions are based on (i) development costs, (ii) product need, (iii) third-party interest and funding availability and (iv) regulatory considerations. CardioTech believes it will need substantial additional financing to conduct human clinical trials, and produce vascular access graft and other planned products. No assurance can be given, however, that such financing, or other financing, will be available on terms attractive to CardioTech, if at all. Research and Development expenditures for the three months ended June 30, 1998 and for the years ended March 31, 1998, 1997 and 1996 were $485,412, $1,638,381, $1,031,605 and $910,676, respectively. -7- GOVERNMENT REGULATION The sale of medical products throughout Europe is extensively regulated by European Community Law. The Company believes that the sale of its products in European nations will be subject to the requirements of the newly adopted European Medical Device Directive ("EMDD") which provides that medical devices may not be sold in any European country unless the medical device displays a CE Mark. The CE Mark denotes conformity with European standards for safety and allows certified medical devices to be placed on the market in all European countries. In order to obtain a CE Mark, a manufacturer of medical devices must meet (i) the essential safety requirements of the EMDD, (ii) maintain a technical file consisting of all research data and information about the medical device, (iii) adopt a conformity route for its product and (iv) choose a Notified Body, an independent third party, who will be responsible for reviewing the manufacturer's technical file to verify that the manufacturer has addressed the requirements of the EMDD and has satisfied certain clinical trial requirements. In addition, a manufacturer must obtain ISO 9001 certification, a certification that a manufacturer's procedures and manufacturing facilities comply with standards for quality assurance and manufacturing process control. Once a Notified Body has concluded (i) that it has reviewed the manufacturer's technical file and that the manufacturer has addressed the essential requirements of the EMDD and (ii) that the manufacturer is ISO 9001 compliant, the manufacturer may declare that its products are in conformity with the EMDD and affix a CE Mark to its medical device. The Company is currently conducting clinical trials of the VascuLink Graft in the Holland, France and Sweden with patients undergoing routine hemodialysis treatment. The results of these clinical trials will be placed in the Company's technical file that is reviewed by a Notified Body. The Company has selected Lloyd's Register Quality Assurance, Ltd. ("Lloyds") to serve as the Company's Notified Body. In December 1997, Lloyd's reviewed the Company's operations and awarded the Company with an ISO 9001 Certification. This Certification applies to all of the Company's products that are in development. In August 1998, Lloyd's conducted an ongoing review of the Company's operations and again concluded that the Company's operations were in compliance with ISO 9001. The Company anticipates that in mid-November 1998 Lloyds will review the Company's technical file for the Company's vascular graft to assess if the file meets the essential requirements of the EMDD. Upon completion of this review, if Lloyds concludes that the technical file complies with the essential requirements of the EMDD, CardioTech will make a declaration of conformity and affix a CE Mark on the VascuLink Graft, enabling the Company to begin to sell the VascuLink Graft throughout Europe. There can be no assurance that the Company will be able to obtain or maintain regulatory approval or clearance for its products in Europe. Failure to obtain or maintain such approval could have a material adverse effect on the Company's business, financial condition and results of operations. CardioTech's research and development activities are also subject to regulation for safety, efficacy and quality by numerous governmental authorities in the United States. In the United States, the development, manufacturing and marketing of synthetic vascular grafts are subject to regulation for safety and efficacy by the FDA in accordance with the Food, Drug and Cosmetic Act. Synthetic vascular grafts are subject to rigorous FDA regulation, including pre- clinical and clinical testing. The process of completing clinical trials and obtaining FDA approvals for a medical device is likely to take a number of years, requires the expenditure of substantial resources and is often subject to unanticipated delays. There can be no assurance that any product will receive such approval on a timely basis, if at all. -8- There can be no assurance that the FDA will approve any of CardioTech's products currently under research for marketing, or if they are approved, that they will be approved on a timely basis. Furthermore, CardioTech or the FDA may suspend clinical trials at any time upon a determination that the subjects or patients are being exposed to an unacceptable adverse health risk ascribable to CardioTech's products. If clinical studies are suspended, CardioTech may be unable to continue the development of the investigational products affected. EXCHANGE LISTING The Company's outstanding stock is currently listed on the AMEX under the symbol "CTE." However, there can be no assurance that these shares will not be delisted by the AMEX. The determination by AMEX to delist a company is not based on a precise mathematical formula, but rather on a review of all relevant facts and circumstances in light of the AMEX's policies. The AMEX will normally consider delisting securities of a company which (i) has stockholders' equity of less than $2,000,000 if such company has sustained losses from continuing operations and/or net losses in two of its three most recent fiscal years; or (ii) has sustained losses which are so substantial to its overall operations or its existing financial resources, or if its financial condition has become so impaired that it appears questionable, in the opinion of the AMEX, as to whether such company will be able to continue operations and/or meet its obligations as they mature. As of June 30, 1998 the Company had stockholders' equity of $314,686, and had losses in all three of its most recent fiscal years. If the Company is unable to increase its stockholders' equity and its net losses continue, the Company must be delisted. Failure of the Company to maintain the listing of its Common Stock on AMEX will constitute an event of default under the $1,718,608 senior notes issued by the Company to Dresdner Kleinwort Benson Private Equity Partners, LP ("DKB") and entitle DKB to demand immediate payment of the senior notes. Upon such a default, actions taken by DKB may result in a default under the Freemedic Loan. At this time, the Company is unable to repay such indebtedness. Furthermore, delisted securities would probably trade in the over-the- counter markets. The liquidity of securities traded in the over-the-counter markets may be impaired, not only in the number of shares that could be bought or sold, but also through delays in the timing of transactions, reductions in securities analysts' and media coverage and lower prices. EMPLOYEES As of September 1998, the Company has 12 full-time employees. Of these full-time employees, 5 are in research and development, 3 are in manufacturing and production, and 4 are in management, administrative, or marketing positions. None of the Company's employees is covered by a collective bargaining agreement, and management considers its relations with its employees to be good. YEAR 2000 ISSUES The Company uses computer software programs for its financial business systems and administrative functions. The Company believes that its programs are "Year 2000" compliant, and will be able to appropriately interpret the upcoming calendar year "2000." However, there can be no assurance that potential "Year 2000" compliance failures will not have a material adverse affect on the Company's business, results of operations or financial condition. ITEM 2. PROPERTIES CardioTech leases a total of approximately 22,000 square feet in Woburn, Massachusetts and Brymbo, Wrexham, United Kingdom. CardioTech believes that its current facilities are adequate for the next 5 years, after which the leases relating to these facilities will expire. -9- SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. CardioTech International, Inc. /s/ John E. Mattern ------------------- John E. Mattern Chief Operating Officer, Chief Financial Officer and Clerk Dated: October 22, 1998 -10- -----END PRIVACY-ENHANCED MESSAGE-----