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Trimedyne Issued U.S. Patent on New Device to Treat Widespread Heart Valve Disorder 10:00 a.m. 06/09/2004 Provided by
IRVINE, Calif., Jun 9, 2004 (BUSINESS WIRE) -- Trimedyne, Inc. (TMED) today announced the issuance of U.S. Patent No. 6,740,107, which covers new, minimally invasive laser devices designed to treat mitral valve regurgitation. An estimated 4 million Americans suffer from this condition. Each year in the United States, approximately 50,000 people undergo open-heart surgery to repair or replace a mitral valve. In addition, an estimated 75,000 mitral valve repairs or replacements are performed during bypass surgery. In many people who have both mitral valve regurgitation and heart failure, the condition is not treated, as they are too ill to undergo surgery.
Mitral valve regurgitation or "prolapse" occurs when the valve does not fully close and blood leaks backward into the left atrium with each heartbeat, causing the heart to work harder, and possibly leading to heart failure. Traditional open-heart surgery requires the patient's chest to be opened, the heart stopped, a heart-lung machine to be used, a 5 to 7 day hospital stay and a long recuperation period.
Trimedyne's patent covers designs for two new laser devices to treat this condition; one for use by surgeons during bypass surgery, and one for use by cardiologists in the cath lab through a puncture in an artery in the groin. The device for use by surgeons will consist of a patented, side-firing optical fiber encased in a balloon. The balloon is designed to be inflated in the annulus or "collar" of the valve. Laser energy is then emitted from the device as it is rotated, like the beacon of a lighthouse. The laser energy shrinks the annulus and the leaflets of the valve, just as laser energy is used to shrink facial tissues to treat wrinkles. The device may also be positioned in the left ventricle to shrink the tendons that close the valve, but which may become stretched over time. The device is designed to significantly reduce the surgical trauma of conventional valve repair or replacement.
The device for use by cardiologists will consist of a catheter designed to be inserted into the patient's femoral artery and positioned in the annulus of the mitral valve or the left ventricle. In this device, the balloon is intentionally made lop-sided, with the side from which laser energy will be emitted significantly larger in diameter than the opposite side. When the balloon is inflated with a fluid opaque to x-rays or ultrasound energy, the cardiologist can see the shape of the balloon and determine the direction in which laser energy will be emitted.
Trimedyne earlier acquired U.S. Patent No. 5,989,284, which covers the use of laser, radiofrequency, electrical or microwave energy to shrink the mitral valve. The new patent covers specific devices designed for use with these and other forms of thermal energy to treat mitral valve regurgitation, expanding Trimedyne's patent position in this field.
Clinical trials at substantial cost and FDA approval will be required before any of the above devices can be marketed in the United States. However, with modest sized clinical trials, such devices may be marketed in Europe, when CE Marked, and most countries in Asia, the Middle East and South America.
Trimedyne manufactures lasers and proprietary fiber optic devices for a variety of minimally invasive surgical procedures, many of which are performed on an outpatient basis at substantially less cost than conventional surgery. For product, financial and other information, visit Trimedyne's website, http://www.trimedyne.com .
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act:
Statements in this news release may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1993 and Section 21E of the Securities and Exchange Act of 1934. Such statements may involve various risks and uncertainties, some of which may be discussed in the Company's most recent report on Form 10-KSB and subsequently filed SEC reports. There is no assurance such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements.
Trimedyne, Inc. Craig Smith, 949-951-3800, Ext. 288 csmith@trimedyne.com
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Trimedyne Reports Revenue and Profit for the Quarter Ended March 31, 2004 10:00 a.m. 05/21/2004 Provided By PrimeZone
IRVINE, Calif., May 21, 2004 (PRIMEZONE via COMTEX) -- Trimedyne, Inc. (TMED) today reported a net profit of $149,000 or $0.01 per share, fully diluted, on net revenues from sales and other income received of $1,451,000 for the quarter ended March 31, 2004, compared to a net profit of $207,000 or $0.02 per share, fully diluted, on net revenues from sales and other income received of $1,676,000 for the same quarter of the prior year.
This represents the Company's sixth, consecutive, profitable quarter. However, the Company had a loss from operations of $24,000 in the current quarter, compared to an operating profit of $210,000 in the prior year quarter. Proceeds from royalties and the settlement of litigation were $181,000 in the current quarter.
Revenues in the current quarter were 23% less than in the same period of the prior year, primarily due to a decline in laser sales. However, sales of lasers are expected to increase in the coming quarter, as we intend to expand our laser product offering. With lasers selling for $40,000 to $100,000, an increase or decrease in the number of lasers sold in a quarter can have a significant impact on revenues and profits. Sales of disposable and reusable fiber optic devices remained relatively stable in the quarter ended March 31, 2004, compared to the prior year quarter.
As a percentage of sales, the Company's cost of goods was comparable in both quarters, SG&A increased from 35% to 42%, R&D expenses rose to 7% from 2% and gross profit declined to 48% in the current quarter from 50% in the same period of the prior year. A $4,000 provision for income tax was required in the current quarter, while $26,000 in income tax was incurred in the prior year quarter.
About Trimedyne, Inc.
Trimedyne manufactures lasers and proprietary fiber optic devices for a variety of minimally invasive surgical procedures, many of which are performed on an outpatient basis at substantially less cost than conventional surgery. For product, financial and other information, visit Trimedyne's website: ( http://www.trimedyne.com ).
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act:
Statements in this news release may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1993 and Section 21E of the Securities and Exchange Act of 1934. Such statements may involve various risks and uncertainties, some of which may be discussed in the Company's most recent report on Form 10-KSB and subsequently filed SEC reports. There is no assurance such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements.
Trimedyne, Inc. Craig Smith (949) 951-3800 ext. 288 csmith@trimedyne.com
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