World Heart second quarter results
World Heart Corp WHT Shares issued 14,078,743 Jul 21 close $15.00 Thu 22 Jul 99 News Release Dr. Tofy Mussivand reports The second quarter saw significant advances by World Heart Corporation in bringing Heartsavervad to initial clinical use and in developing the strength and capabilities of the corporation. With six months remaining in this millennium, the objective of implanting the first Heartsavervad in a human during 1999 continued to be achievable. However, on July 16, during internal performance testing, a reliability issue arose respecting the battery currently intended for use with the device. Full assessment of this issue is being undertaken by World Heart and the battery supplier. In light of the time required to complete this assessment and fully test any changes in the battery, it is likely that preclinical trials will not be completed in time for clinical use of Heartsavervad this year. Operating financial results for the quarter were again better than forecast, with no revenues reported and expenses below budget by approximately $396,000. The net loss for the quarter was $2,199,016, or 16 cents per share, compared with $922,671, or nine cents per share for the second quarter of 1998. As budgeted, research and development expenses for the quarter, reflecting the costs of prototype production and preclinical trials, were $1,296,910 compared with $211,664 for the second quarter last year. The financial condition of the corporation was strengthened with net proceeds of $26.5-million from the sale of 1,780,548 shares from treasury at $16.50 per share. At end of the quarter cash and securities held by the corporation totalled $36,381,913. Total cash usage for the first six months of the year was approximately $5.5-million, and is projected to be approximately $10-million for the second half. The projected cash balance of approximately $26-million entering 2000 is expected to finance the corporation well into 2001. Dr. Tofy Mussivand, president of World Heart, said: "Overall, activities in the quarter added to our confidence in the success of Heartsavervad. Although first human use will not likely occur this year, we do not anticipate delays, which would be material in the timing of completion of clinical trials or commercial introduction of the product." The program to complete preparations for clinical trials progressed well during the quarter. Seven in vivo performance tests of the final preclinical system were conducted bringing the total of such tests to 12 for more than 70 hours of run time. The decision was made to group long-term formal trials in the third and fourth quarters, resulting in the two long-term trials that had been forecast for the quarter not being performed. The absence of these trials during the second quarter does not affect the timing of completion of the preclinical trials. These trials will be completed 90 days following the final in vivo preclinical implant. To provide added flexibility in managing the timing of these trials, additional preclinical trial centres were added, bringing the total to nine. With timely availability of systems during the third quarter, and subject to the battery review now under way, the preclinical trial program can be completed in the fourth quarter. An additional 12 preclinical systems were manufactured bringing total preclinical systems to 23. These were subjected to a range of in vitro tests including more than 32 weeks of cumulative run time. Six of these systems were implanted for in vivo performance tests. A further 20 systems were in various stages of manufacturing at the end of the quarter. These systems, together with the systems built during the second quarter, are expected to be available for use in the preclinical trials program. The in vivo performance tests provided satisfactory results respecting evidence of the efficacy of the Heartsavervad system. The system is designed to support the patient's natural heart by replacing part or all of the pumping capacity of the left ventricle. In vivo tests indicated blood flow rates of more than 10.5 litres per minute from the device. This comfortably exceeds the maximum capacity of eight litres per minute, currently accepted as a guideline. A key factor in the success of Heartsavervad is minimization of any thrombogenic effect of the device, potentially permitting operation with little or no continuing use of anticoagulant. In vivo tests during the quarter demonstrated the best results yet achieved in this regard. Earlier prototypes had performed satisfactorily, however, a number of technical improvements in the manufactured product appear to have further reduced risks of thrombosis. Operation of transcutaneous energy and information transfer (TEIT) system was tested in the in vivo performance tests. Initial tests in this series indicated a need for increased strength of the communication signal between the internal electronics of the device and the external controller. Technical adjustments were made followed by a series of in vivo tests, which produced satisfactory results from the TEIT. The corporation believes that this is the only VAD, which is powered, monitored and controlled remotely without perforation in the skin and tissue. During the quarter the corporation agreed to supply, subject to the appropriate propriety rights and confidentiality agreement, a TEIT system to Baylor College of Medicine for use in the college's research and development activities. The second quarter test program identified eight items affecting operational reliability or convenience of implantation requiring further improvement. Action on each of these items was in process at the end of the second quarter. Technical adjustments are being made to existing devices and those in process. Preparation of preclinical and clinical protocols proceeded according to plan. Manufacturing staff increased by eight people, engineering by three and regulatory affairs by one person. WARNING: The company relies upon litigation protection for "forward-looking" statements. (c) Copyright 1999 Canjex Publishing Ltd. canada-stockwatch.com
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