8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): July 21, 2005

Enpath Medical, Inc.

(Exact name of registrant as specified in its charter)

Minnesota
(State or Other Jurisdiction of Incorporation)
0-19467	41-1533300
(Commission File Number)	(IRS Employer Identification No.)
15301 Highway 55 West
Plymouth, Minnesota	55447
(Address of Principal Executive Offices)	(Zip Code)

(763) 559-2613

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Section 2 – Financial Information

Item 2.02   Results of Operations and Financial Disclosure

On July 21, 2005, Enpath Medical, Inc. (the “Company”) issued a press release reporting the results of its operations for the quarter ended June 30, 2005.  A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The Company also furnishes as Exhibit 99.2 to this Form 8-K the statement of James D. Hartman, the Company’s Chief Executive Officer, and other officers of the Company, that will be issued in connection with the July 21, 2005, Enpath Medical, Inc. conference call reporting the results of operations for the quarter ended June 30, 2005.

Section 7– Regulation FD

Item 7.01  Regulation FD Disclosure

On July 21, 2005, the Company issued a second press release announcing that it had received FDA marketing clearance for its steerable sheath and announcing that it has entered into an exclusive license and supply agreement for that product in the electrophysiology market.  A copy of that press release is furnished as Exhibit 99.3 to this Form 8-K.

The information provided pursuant to Items 2.02 and 7.01 of this Form 8-K is being furnished and is not “filed” for purposes of Section 18 of the Securities Act of 1934, and may not be deemed incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in that filing.

Section 9. - Financial Statements and Exhibits.

Item 9.01   Financial Statements and Exhibits

(c)           Exhibits

The following are filed or furnished as Exhibits to this Report:

Exhibit No.	Description of Exhibit
99.1	Press release dated July 21, 2005, reporting results for the quarter ended June 30, 2005.
99.2	Statement of James D. Hartman, Chief Executive Officer of Enpath Medical, Inc., and other officers of the Company, in connection with the July 21, 2005, Enpath Medical, Inc. conference call.
99.3	Press release dated July 21, 2005, announcing FDA 510(k) clearance and execution of new supply and license agreement.

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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 hereunto duly authorized.

	ENPATH MEDICAL, INC.
Dated: July 21, 2005	By:	/s/ James D. Hartman
		James D. Hartman
		Chief Executive Officer

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EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE	Contact:	Jim Hartman
		Enpath Medical, Inc.
		(763) 577-2212
		Investors: EVC Group, Inc. Doug Sherk (415) 896-6820 Jennifer Beugelmans (415) 896-6817

July 21, 2005

Enpath Medical Reports Second Quarter Results

Sales Meet Company Guidance

Conference Call Scheduled for 1:30 PM CDT Today

MINNEAPOLIS—Enpath Medical, Inc. (Nasdaq: NPTH) today reported second quarter sales of $7.2 million compared with $7.3 million in the second quarter of 2004.  For the six months ended June 30, 2005, the Company reported sales of $13.8 million, compared with $14.6 million in the same period of 2004.  For the second quarter of 2005, the Company reported a net loss of $225,000, or $.04 per diluted share, compared with a net loss of $1.8 million, or $.31 per diluted share, in the second quarter of 2004.  Second quarter 2004 results included a one-time, non-cash impairment adjustment of $2.8 million ($1.9 million after tax) related to the Company’s safety needle investment.  For the six months ended June 30, 2005, the Company reported a net loss of $575,000, or $.10 per diluted share, compared with a loss of $1.5 million, or $.27 per diluted share for the first half of 2004, including the $1.9 million after tax safety needle impairment adjustment.

“Our second quarter sales results were in line with our previously provided guidance and we achieved gross margins of 38.7%, which was slightly better than the 37.6% reported in the second quarter of last year,” said James D. Hartman, chairman and CEO. “Sales of our core introducer product line were consistent with the second quarter of 2004,” Hartman continued.  “However, sales of advanced delivery products, safety needles and contract manufacturing all declined modestly, resulting in a decline in delivery system sales of approximately $250,000 compared with the same period of 2004.  Within our lead technologies product line, we are beginning to see the positive impact of our involvement with a variety of neuro-stimulation lead projects that we have undertaken on behalf of our partner companies.  As a result, year over year sales in this product line increased 6%.

“As we stated in our July 14, 2005 news release, we are obviously very disappointed with the conclusion by the FDA that it will require human clinical trials in order to grant marketing clearance for the Myopore Rx,” Hartman continued.  “Notwithstanding the original determination agreement with the FDA that human trials were not necessary to grant clearance for our device, it is not feasible for us, due to cost and time considerations, to conduct human clinical trials at this late date in the development cycle, unless those trials are very modest in nature.  We are meeting with our marketing partners to determine other potential courses of action as well as evaluating options related to a further appeal of this most recent FDA decision to the next level within the FDA. Despite this latest decision regarding Myopore Rx, we continue to feel encouraged by our opportunities in Europe.  We are shipping the Myopore Rx steroid lead to one partner in Europe and this partner has indicated to us that both sales and positive customer feedback have exceeded its expectations.

“Our profitability was again affected by higher than anticipated research and development expenditures related to our FDA appeal,” Hartman stated. “It has been an intense, costly and highly sophisticated process that has involved a number of expert consultants.  In addition, our profitability was also affected by development expenditures directed towards our steerable sheath catheter projects, primarily to meet the requirements necessary to complete certain milestone work and to finalize our license and supply agreement with Bard EP, a division of C. R. Bard, Inc., which we announced today in a separate news release.  These products are far more complex than anything we have developed in the past, and we have incurred more significant costs than anticipated related to the testing and manufacturing process development activities

that are associated with these projects.  Research and development expenses for the second quarter were $1.6 million or 22% of sales, an increase of 40% over the same quarter in 2004.

“Selling, general and administrative expenses were $1.47 million for the second quarter, or 20.4% of sales, compared to $1.42 million, or 19.5% in the second quarter of 2004.  We continue to monitor our general and administrative expenses and were pleased that those costs actually declined slightly from the second quarter of 2004.  Selling expenses increased about 10% from 2004’s second quarter primarily related to additional physician-based show activity.

 “Our product development pipeline is full at the present time with seven very active advanced delivery introducer projects, including five with companies that are now, or soon to be, in human clinical trials,” continued Hartman. “In addition, we are involved with four neuro-stimulation development projects, a next generation epicardial lead and delivery system as well as a number of enhancements to our core introducer product line.  We continue to stay actively involved in the entities developing the new IS-4 connector configuration, the pacing lead connector technology, and believe the new specifications will be finalized by the European Union in 2005,” Hartman concluded.

2005 Outlook and Guidance

The Company stated that it expects sales for the upcoming two quarters of 2005 to approximate sales achieved in the second quarter, while it achieves modest profitability in those same quarters assuming no significant additional expenditures are made in an effort to gain FDA marketing clearance for the Myopore Rx lead.

Conference Call Today

The management team of Enpath Medical will host a conference call to discuss the results beginning at 1:30 P.M. Central Time, today, July 21, 2005.  To participate, domestic participants should dial 800-257-1927 and international participants should dial 303-262-2138.  A recording of the conference call will be available approximately one hour after the conclusion of the call and can be accessed for seven days.  To access the replay, please dial 1-800-405-2236 for domestic callers and 303-590-3000 for international callers; please reference the pass code 11035104#.

The conference call will also be webcast live on the company’s web site, www.enpathmed.com, and may be accessed by clicking on the 2^nd Quarter 2005 Earnings Call icon.  An audio replay will be archived on the Enpath website for one year.

About Enpath Medical

Enpath Medical, Inc., headquartered in Plymouth, Minnesota, 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 and endocardial stimulation leads, safety needles and other products for use in pacemaker, defibrillator, 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.

Safe Harbor

This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Certain important factors could cause results to differ materially from those anticipated by some statements made herein.  All forward-looking statements involve risks and uncertainties.  A number of factors that could cause results to differ materially are discussed in our Annual Report on Form 10-K for the year ended December 31, 2004, as well as in our quarterly reports on Form 10-Q and Current Reports on Form 8-K.  Among the factors that could cause results to differ materially are the following: Enpath’s ability to complete development of its Myopore Rx steroid epicardial lead and FasTac Flex delivery tool and obtain regulatory approval to market these devices in a number of countries without significant delay or expenditure of resources; the ability of Enpath and its distribution partners to successfully introduce the Myopore Rx and FasTac Flex;  Enpath’s dependence upon a limited number of key customers for its revenue; the ability of Enpath’s customers to successfully develop and market therapies that utilize the Company’s advanced delivery systems; Enpath’s dependence upon licensing agreements with third parties for the technology underlying some of its products; Enpath’s ability to effectively manufacture its products, including the new Myopore Rx steroid lead and the FasTac Flex delivery device, in anticipated required quantities; Enpath’s ability to develop or acquire new products to

increase its revenues; Enpath’s ability to attract and retain key personnel; introduction of competitive products; Enpath’s ability to successfully protect its intellectual property against misappropriation or claims of infringement by third parties; government regulatory matters; economic conditions; and Enpath’s ability to raise capital.  All forward-looking statements of Enpath, whether written or oral, and whether made by or on behalf of Enpath, are expressly qualified by these cautionary statements.  In addition, Enpath disclaims any obligation to update forward-looking statements to reflect events or circumstances after the date hereof.

Condensed Balance Sheets

	Unaudited		Audited
	06/30/05		12/31/04
Assets
Cash and cash equivalents	$	—	$	362,625
Inventory, receivables and prepaids	8,466,430		8,514,675
Other current assets	796,200		504,683
Property, plant and equipment, net	5,066,521		5,176,086
Goodwill	9,607,975		9,593,662
Intangible assets with finite lives, other	6,736,557		7,016,009
Total Assets	$	30,673,683	$	31,167,740
Liabilities & Shareholders’ Equity
Current liabilities	$	4,708,547	$	4,162,001
Long-term liabilities	2,333,320		3,230,882
Shareholders’ equity	23,631,816		23,774,857
Total Liabilities & Shareholders’ Equity	$	30,673,683	$	31,167,740

Income Statements (Unaudited)

	Three Months Ended						Six Months Ended
	June 30, 2005			June 30, 2004			June 30, 2005			June 30, 2004
Sales	$	7,193,659		$	7,295,113		$	13,810,411		$	14,592,167
Cost of sales	4,413,522			4,549,519			8,663,749			9,078,339
Gross profit	2,780,137			2,745,594			5,146,662			5,513,828
Operating expenses:
Research and development	1,592,166			1,135,608			2,970,139			2,182,311
Selling, general and administrative	1,466,142			1,420,817			2,922,711			2,696,897
Safety needle asset impairment	0			2,809,199			0			2,809,199
Total operating expenses	3,058,308			5,365,624			5,892,850			7,688,407
Operating loss	(278,171		)	(2,620,030		)	(746,188		)	(2,174,579		)
Other income (expense):
Interest expense	(61,151		)	(46,486		)	(124,153		)	(94,151		)
Interest income	0			213			0			1,608
Other	(6,392		)	(4,315		)	(13,953		)	(1,032		)
Total other income (expense)	(67,543		)	(50,588		)	(138,106		)	(93,575		)
Loss before income taxes	(345,714		)	(2,670,618		)	(884,294		)	(2,268,154		)
Income tax benefit	121,000			854,644			309,503			725,313
Net Loss	$	(224,714	)	$	(1,815,974	)	$	(574,791	)	$	(1,542,841	)
Loss per share
Basic	$	(0.04	)	$	(0.31	)	$	(0.10	)	$	(0.27	)
Diluted	$	(0.04	)	$	(0.31	)	$	(0.10	)	$	(0.27	)
Weighted average shares
Basic	5,948,430			5,880,308			5,924,135			5,799,922
Diluted	5,948,430			5,880,308			5,924,135			5,799,922

EX-99.2

Exhibit 99.2

Second Quarter 2005 Conference Call

Statement of Jim Hartman, Mark Kraus and Jim Mellor

Enpath Medical, Inc.

July 21, 2005

Welcome to the Enpath Medical second quarter, 2005 conference call.  Thank you for joining us today.  I am Jim Hartman, Chairman and Chief Executive Officer of Enpath Medical.  My comments today will contain forward-looking statements that involve risks and uncertainties.  Any number of factors could cause our results to vary from those that may be anticipated by some statements made today.  You should read our press release issued this morning and our SEC filings, specifically our 2004 Annual Report on Form 10-K filed in March 2005, for a listing of some of the factors that could cause results to differ materially.

Joining me on the call today is Mark Kraus, Senior Vice President and Chief Technology Officer and Jim Mellor, Senior Vice President of Sales and Marketing.

During my remarks today I will highlight certain aspects of our second quarter financial results that were not covered in our press release issued this morning.  I will outline our options related to the Myopore Rx in light of the denial of our appeal by the FDA last week.  Jim and Mark will discuss new opportunities the company is pursuing.  I will then provide our outlook and guidance for the upcoming quarter and remainder of the year.   At the conclusion of my remarks, Mark, Jim and I will be available to answer questions.

Second quarter revenues were $7.2 million, compared to $7.3 million in the second quarter of 2004, a 1% decrease.  For the six months, sales declined 5% to $13.8 million compared to $14.6 million in 2004.  Sales of delivery systems products decreased 5% to $4.7 million in the second quarter when compared to the previous year.  Sales of our core introducer product line were basically the same as in 2004 at $4.1 million, when we had experienced a 21% increase over

2003, as a result of the launch of the FlowGuard introducer.  Year to date introducer sales have actually increased $300,000 compared to the first six months of 2004.

Sales of our lead technologies product line increased during the quarter from $2.4 million last year to $2.5 million.  For the six months, sales were $4.2 million compared to $4.8 million in the first six months of last year.  Sales of proprietary leads and adaptors increased $220,000 compared to the first quarter of this year as we made our first shipment of Myopore Rx steroid leads to one of our two partners for a European launch.  Sales of leads and adaptors still declined $130,000 compared to the second quarter of 2004 as we go through what we believe to be the final stages of the inventory overstock situation that started a year ago with our largest leads customer.

The largest sales gain from our lead technologies activities came from engineering services related to the numerous contracts the company is currently working on in the neuro stimulation and modulation area.  We billed $349,000 during the quarter and $469,000 for the six months developing lead designs in several different markets for our customers.  We have one of the top group of neuro lead engineering teams in the country and currently have as much work as we can handle.

Second quarter gross margins on a consolidated basis were 38.7% compared to 37.6% a year ago. Gross margins on the delivery systems product line declined slightly primarily due to the lower sales volume as well as the costs related to establishing our manufacturing capabilities for steerable catheters in advance of any real production.  Margins on the lead technologies product line increased five percentage points to 33.4% compared to 28.2% in the second quarter of 2004, primarily due to discontinuing several low margin contract manufacturing jobs in 2004, as well as increased sales volume.

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Our research and development expenditures increased 40% during the quarter to $1.6 million compared to $1.1 million in the second quarter last year.  As a percentage of sales, R & D was 22.1%, compared to 15.6% in 2004.  For the year, research and development expenditures were just slightly less than $3 million or 21.5% of sales compared to $2.2 million or 15% of sales last year in the first six months.  Gaining approval from the FDA to begin marketing our epicardial steroid lead has been a costly and so far unsuccessful effort.  The appeal process that we undertook over the last six months entailed substantial use of consultants and attorneys.  It was intense, arduous and expensive.  Mark and Jim will comment further regarding the FDA situation in a moment.

We are also conducting significant R & D work on steerable introducers for our own family of steerable devices for which we did recently receive FDA marketing clearance.  Our announced agreement with Bard EP for an exclusive arrangement to market our steerable device into the electrophysiology field is the initial validation for this investment.  During this past couple of years, we have begun the transition from relatively simple medical devices to far more sophisticated products such as the Myopore Rx lead, FasTac Flex delivery tool and steerable catheters.  We have experienced greater than estimated costs due to the complexity of these products, but believe we are bringing more efficiency to our development effort.  Coupling the increased development costs with the fact that we have no material amount of revenue yet from these efforts, has compounded our challenge to achieving profitability during this time period.

Selling, general and administrative expenses were 20.4% of sales for the quarter, compared to 19.5% in the second quarter of 2004.  In real dollars, general and administration expenses actually declined from 2004 by a modest amount, while sales and marketing increased $50,000 or 10%.  This increase is primarily attributable to more participation at trade shows

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targeted towards physicians in an effort to gain recognition for our steerable catheters and FasTac Flex delivery tool.

I’ll now turn the presentation over to Mark and Jim to discuss the product development activities and update you on the FDA situation with our Myopore Rx steroid lead.

(Mark) We have been diligently continuing our efforts to complete the significant number of new products in our development pipeline.  As we have communicated in the past we have been focusing our attention on the development of our proprietary steerable introducers and stimulation leads to serve the rapidly growing cardiac rhythm management, neuromodulation and vascular interventional markets.  To date the demand for these new products and development services has exceeded our capacity to complete such projects.  Nonetheless, we have remained vigilant to our need to rapidly grow the company through the launch of new products over the next couple years.

The most immediate of these opportunities is the launch of our steerable introducers for the electrophysiology market.  We have been extremely busy completing the first two sizes of this product line in support of our Bard EP agreement which we announced today.  These steerable introducers are based on our proprietary technology and will be, along with two additional sizes, used to enable more precise access to areas of the heart for the completion of certain ablation procedures.  The first shipment of one of these sizes happened earlier this week, and the second size, which will be used in conjunction with Bard’s Atrial Fibrillation ablation technology clinical study, is expected to ship within the next week.  We will be launching the remaining two Bard sizes, along with a new ergonomically designed handle, before the end of the year.

As indicated earlier, we have been developing our proprietary advanced delivery technologies to support other emerging interventional procedures such as mitral valve repair, septal defect repair,

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and cardiac resynchronization therapy.  To date, four of these applications have entered their human clinical study phase, with our products receiving high praise from the study physicians.  We have also begun the development of a steerable sheath to enable more efficient Carotid Artery stent placements, although at this point we have no partner for this application.  Our steerable introducer technology will provide the physician the needed flexibility to access the arteries of those patients who have anatomies which could not be easily accessed otherwise.  The FDA 510(k) marketing clearance we received for this product back in early June will cover all of these clinical applications in addition to the Bard EP products.

We have defined a new valve configuration for our venous introducers and will be entering the heaviest part of the product development cycle in the second half of the year.  The product has been designed as an addition to our FlowGuard introducer, but primarily targeted for the placement of pacing leads.  We fully expect to have this product on the market sometime in the first quarter of 2006.

In the area of leads, our efforts have been focused primarily on the development of a number of neuromodulation and CRM leads on a contract basis, and the early development of concepts for a proprietary next generation Epicardial lead and spinal cord stimulation lead.  We believe that we have one of the most experienced lead development groups in the world, so we have made a conscience effort to sell those development services in conjunction with securing long term manufacturing rights to those contract developed products.  Currently we are working on, or are about to begin development of, leads that will be used in pain management, cardiac defibrillation, and pelvic floor stimulation for incontinence.

We also recognize that a significant amount of our future lead revenue needs to come from proprietary technologies.  To that end we have been diligently working to define the requirements

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and early designs of a next generation Epicardial lead and delivery system, and a spinal cord stimulation lead.  Because we believe that there will be an increased demand for Epicardial leads, we have identified a number of enhancements to our current lead and delivery system that will make it significantly easier to implant the lead to a precise location on the heart using minimally invasive surgical techniques.  In the case of the spinal cord stimulation lead, we will be implementing technologies that will reduce the likelihood of lead migration after implant and to minimize the overall size of the lead without compromising lead integrity.  The use of spinal cord stimulation leads to manage pain is one of the few FDA approved procedures for neurostimulation.

In conclusion, you can see the opportunities in 2006 and beyond remain extremely positive.  Now I’d like to turn the call over to Jim Mellor.

(Jim M.)

The decision by the FDA to deny our appeal on its non-approvable letter for our PMA submission on the Myopore Rx steroid epicardial lead was both unexpected and disappointing.  Its rationale for non-approval was based on its belief that “the animal study results failed to demonstrate that the Myopore Rx steroid-eluting lead affords a consistent incremental benefit over the non-steroid-eluting lead”, even though the original goal of the animal studies approved by the FDA was equivalence or better which we achieved.  It also advised us “that the least burdensome approach at this time would be for us to conduct an appropriately-sized clinical study.”

The Director of the Office of Device Evaluation, who heard our appeal has committed to work with Enpath and her staff to develop a least burdensome clinical study.  Enpath has scheduled a meeting with the Director to better understand the least burdensome requirement of such a study in order to determine the time and cost feasibility for both Enpath and our OEM partners.  If a

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feasible study solution is not found, then we will take our appeal to the next level with the Director for the Center of Devices and Radiological Health.

We have communicated the FDA’s appeal decision to our two OEM partners and have arranged meetings with them to discuss options moving forward.  We intend to propose a number of commercial options involving other Enpath products at those meetings which we expect will occur during the first two weeks in August.

Meanwhile the sales of our steroid eluting epicardial lead in Europe continue to surpass original expectations.  St. Jude Medical is currently the only company selling these leads in Europe and due to faster than anticipated sales, it has doubled its original first year forecast.  We are still awaiting steroid information from our other OEM partner in order to complete its CE submission.

The FasTac Flex epicardial lead implant tool should receive CE approval this month, enabling distribution in Europe together with the steroid lead.  In recognition of the pending approval, a number of distribution companies have approached us to sell this tool in Europe with the current non-steroid Myopore lead.  The U.S. release of the new implant tool is awaiting additional evaluation from physician customers of our OEM partners.

Our steerable sheath for transseptal access in cardiac ablation started its customer requirements validation study this week with Bard EP, the last step prior to its commercial launch in the U.S. in September.  In addition, we submitted the CE design dossier for our steerable sheath with final approval for this product anticipated in the fall.

The IS-4 connector standard to simplify connections for certain pacemakers and defibrillators continues to make technical progress with ISO approval projected for mid-2006.  Enpath is

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involved in developing and manufacturing adapters to facilitate connections between new and old connectors.  Enpath has also designed an IS-4 clip that enables easier and safer connection of pacing system analyzer cables to IS-4 leads.  Lastly, Enpath has worked with another major OEM partner to develop an extendable/retractable tool that can be used with certain lead designs that have both the current IS-1 and the new IS-4 connectors.  These IS-4 products represent a multi-million dollar revenue opportunity for Enpath in 2006.

Thanks, Jim.  For the remainder of the year we have no significant product introductions scheduled although we will start to supply steerable catheters to Bard EP to commence its product launch as well as begin supplying introducers to several new customers.  Even though the quantities specified in the Bard EP contract are significant, the initial launch orders will be modest. Therefore, we now expect sales in the third and fourth quarter to approximate the level of sales achieved in quarter two.  With reduced spending related to the FDA appeal, and other expense reduction activities undertaken in the second quarter we expect to be modestly profitable for the remainder of the year, although expenses may increase if we agree with the FDA and our partners to undertake a least burdensome clinical trial.

Thank you for listening today.  Mark, Jim and I will answer any questions you may have.

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EX-99.3

Exhibit 99.3

FOR IMMEDIATE RELEASE	Approved By:	Jim Hartman (763) 577-2212 Enpath Medical, Inc.
	Contacts:	Investors EVC Group Doug Sherk (415) 896-6820 Jennifer Beugelmans (415) 896-6820

July 21, 2005

Enpath Medical Receives FDA Marketing Clearance for Steerable Sheath Announces Exclusive License & Supply Agreement

Electrophysiology Market Targeted

MINNEAPOLIS—Enpath Medical Inc. (Nasdaq: NPTH) announced today that it has received FDA marketing clearance for the Company’s steerable sheath and has signed an exclusive license and supply agreement with Bard Electrophysiology, a division of C. R. Bard, Inc. (“Bard”)  for distribution of this product in the electrophysiology (“EP”) market.  Although terms of the agreement were not disclosed, the Company stated the agreement was subject to the completion of intellectual property due diligence and Enpath attaining CE mark approval for the device.

“We are enthusiastic about this new opportunity because we believe Bard is well positioned in the EP market, in part through its long-term focus on the therapeutic treatment of cardiac arrhythmias,” said James D. Hartman, Chairman and CEO of Enpath.  “Enpath’s steerable sheath technology will enhance the delivery of diagnostic and therapeutic devices in the heart.  Therapeutic EP is a large and rapidly growing market and it fits directly with Enpath’s mission to develop innovative delivery systems that improve the quality of patient care.”

The Food and Drug Administration 510(k) marketing clearance is for Enpath’s steerable sheath as a stand-alone device for a number of procedural indications including interventional coronary, peripheral vascular and carotid artery access.  The Company is in early discussions with other potential partners regarding distribution of iterations of the product for other attractive market segments.

About Enpath Medical

Enpath Medical, Inc., headquartered in Plymouth, Minnesota, 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 and endocardial stimulation leads, safety needles and other products for use in pacemaker, defibrillator, 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.

Safe Harbor

This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Certain important factors could cause results to differ materially from those anticipated by some statements made herein.  All forward-looking statements involve risks and uncertainties.  A number of factors that could cause results to differ materially are discussed in our Annual Report on Form 10-K for the year ended December 31, 2004, as well as in our quarterly reports on Form 10-Q and Current Reports on Form 8-K.  Among the factors that could cause results to differ materially are the following: the ability of Enpath and Bard to successfully negotiate and execute a definitive license and supply agreement; the ability of Enpath to obtain FDA marketing approval or clearance for its steerable sheath, the ability of Enpath to complete the integration

of the BCI operations; Enpath’s dependence upon a limited number of key customers for its revenue; Enpath’s ability to complete development of its Myopore Rx steroid epicardial lead and FasTac Flex delivery tool and obtain FDA and European approval to market these devices; the ability of Enpath and its distribution partners to successfully introduce the Myopore Rx and FasTac Flex; the ability of Enpath’s customers to successfully develop and market therapies that utilize the Company’s advanced delivery systems; Enpath’s dependence upon licensing agreements with third parties for the technology underlying some of its products; Enpath’s ability to effectively manufacture its products, including the new Myopore Rx steroid lead and the FasTac Flex delivery device, in anticipated required quantities; Enpath’s ability to develop or acquire new products to increase its revenues; Enpath’s ability to attract and retain key personnel; introduction of competitive products; Enpath’s ability to successfully protect its intellectual property against misappropriation or claims of infringement by third parties; government regulatory matters; economic conditions; and Enpath’s ability to raise capital.  All forward-looking statements of Enpath, whether written or oral, and whether made by or on behalf of Enpath, are expressly qualified by these cautionary statements.  In addition, Enpath disclaims any obligation to update forward-looking statements to reflect events or circumstances after the date hereof.