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ENPATH REVISES GUIDANCE FOR 3RD QTR/REMAINDER 0F 2004.


Enpath Medical Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:NPTH NPTH Non-Plated Through-Hole (PCB (printed circuit board manufacturing) ), Minneapolis has updated its outlook for the third and fourth quarters of 2004 and provided an overview of other business developments.

The company now expects third quarter sales to be 5-7% less than the sales of $7.3 million achieved in the second quarter of 2004. For the full year of 2004, Enpath anticipates sales to approximate a range of $29-30 million compared to $19.6 million in 2003. The company also stated that due to lower sales projections, it now expects total company gross margins to be approximately 40% in the third and fourth quarters of 2004, compared to its previous guidance range of 42-44%.

The revised guidance was lowered due to continued softness in orders of accessories and adaptors from a major customer of Enpath's Lead Technologies Division. The company acquired the Lead Technologies Division from Cleveland- based BIOMEC Inc. in October 2003. Enpath also stated that its July guidance anticipated significant sales of its new delivery tool for epicardial leads, the Fastac Flex(TM), upon its expected market launch late in the third quarter of 2004. Based on more recent discussions with customers it now appears that the Fastac Flex will be launched through the customers' sales forces at the same time the Myopore Rx(TM), Enpath's new steroid eluting epicardial lead, is available for sale in the US, which the company anticipates will be in the first quarter of 2005.

The company also reported that, due to the lower sales estimates at the Leads Division, the company now anticipates the earn-out payment to BIOMEC Inc. related to the company's acquisition of BIOMEC Cardiovascular Inc. would be reduced to approximately $2 million, and if earned would be due March 31, 2005.

"A year ago sales to this major customer represented nearly half of the total sales at our Leads Division," said James D. Hartman, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Based on sales to date plus newly forecasted orders, we anticipate sales to this customer will decline 60% in 2004 compared to 2003 as the customer balances inventory levels. While these sales are important to the company in absorbing overhead and maintaining staffing levels, they are not our strategic proprietary products that represent the future growth opportunities for the company."

"The change in our customers' plans to launch our Fastac Flex delivery device for epicardial lead placement concurrent with the launch of our steroid lead is a logical strategy. However, it is different than our original understanding and delays our anticipated sales of this product for approximately four months," Hartman continued. "These changes to our sales forecast Sales forecast

A key input to a firm's financial planning process. External sales forecasts are based on historical experience, statistical analysis, and consideration of various macroeconomic factors.
 for the second half of 2004 have not diminished our optimism about the sales growth opportunities for each of these products in 2005. We believe that the enhancements offered by the Myopore Rx steroid lead and the Fastac Flex delivery device will make these products the standard of care in the placement of epicardial leads." The primary growth driver for the use of epicardial leads is the rapidly expanding treatment of congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time.  by means of cardiac resynchronization therapy (CRT (1) (C RunTime) See runtime library.

(2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons.
). It is estimated that over 4,000,000 people suffer from congestive heart failure worldwide, with an estimated 86,000 patients expected to receive CRT systems in 2004. Roughly 10-20% of those patients receiving treatment will ultimately receive an epicardial lead similar to those sold by the company.

In other developments, the company announced the following:

-- The Lead Technologies Division has executed supply agreements for its Myopore Rx steroid lead with two of the three major CRM (Customer Relationship Management) An integrated information system that is used to plan, schedule and control the presales and postsales activities in an organization.  companies.

-- The Delivery Systems Division is on budget with a targeted sales increase of 15-20% over 2003.

-- The FlowGuard valved introducer was successfully launched in the dialysis market with very positive reviews and nearly all of the major participants in that market have placed orders for the product.

-- Enpath will begin first shipments of FlowGuard for the pacing market this week to a major customer.

-- The Lead Technologies Division is working with a major medical institution on the development of a next generation deep brain stimulation In neurotechnology, deep brain stimulation (DBS) is a surgical treatment involving the implantation of a medical device called a brain pacemaker, which sends electrical impulses to specific parts of the brain.  lead.

-- The Delivery Systems Division is currently working with a number of companies on different projects to design advanced delivery systems for new therapeutic devices and the company is also preparing to submit its own FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 submission prior to the end of the year to gain marketing clearance on its own family of proprietary articulating introducers.

About Enpath Medical

Enpath Medical, Inc., headquartered in Plymouth, Minnesota Plymouth is a city in Hennepin County, Minnesota, United States. The population was 68,978 at the 2005 census, making it the seventh largest city in the state of Minnesota. Plymouth operates under a council-manager form of government. , is a leader in the design, development, manufacture and marketing of percutaneous delivery systems and stimulation leads technologies. Its products include venous vessel introducers, epicardial epicardial

pertaining to the visceral pericardium (epicardium) or to the epicardia.


epicardial receptors
receptors in the left ventricle adapted to respond to stretch and chemical stimulants.
 and endocardial endocardial /en·do·car·di·al/ (-kahr´de-al)
1. situated or occurring within the heart.

2. pertaining to the endocardium.


endocardial

1. situated or occurring within the heart.

2.
 stimulation leads, safety needles and other products for use in pacemaker, defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a , catheter and infusion port procedures as well as neuromodulation and hearing restoration markets. Its products are sold worldwide through partnering relationships with other medical device companies.

For more information, call 415/896-6820 or visit http://www.enpathmed.com.
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Title Annotation:Enpath Medical Inc.
Publication:Biotech Financial Reports
Geographic Code:1USA
Date:Nov 1, 2004
Words:819
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