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Thoratec Laboratories Reports Record Fourth Quarter; Revenues Increase 43 Percent.


Business Editors

PLEASANTON, Calif.--(BW HealthWire)--Jan. 24, 2000

Thoratec Laboratories Corporation (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
: THOR), a medical device company, today reported unaudited results for the fourth quarter and all of fiscal 1999.

For the quarter ended January 1, 2000, Thoratec reported total revenues of $7.3 million, a 43 percent increase over revenues of $5.1 million in the fourth quarter of 1998. Thoratec reported a loss of $498,000, or $0.02 per diluted share, in the fourth quarter of 1999 versus a loss of $458,000, or $0.02 per diluted share, in the fourth quarter of 1998.

&uot;Thoratec's VAD (Value Added Dealer) Same as VAR.  (Ventricular Assist Device ventricular assist device: see under heart, artificial. ) system had a very strong quarter. Revenues from VAD sales increased by more than 40 percent versus both last quarter and the fourth quarter of 1998. We saw growth not only domestically but also internationally, where sales more than doubled over last quarter,&uot; said D. Keith Grossman, president and chief executive officer. &uot;Demand remained very strong as we added 36 new centers during the year bringing the total to 130.&uot;

Grossman said the company is also on track to submit documentation for the validation of a new component for its TLC-II(TM) Portable VAD Driver. He said the company plans to complete testing and data analysis by the end of February and, based on satisfactory results, resume shipping to Europe and submit an amendment to the 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.
 for the IDE in the U.S.

&uot;Thoratec also realized several key milestones with its graft devices during the quarter,&uot; noted Grossman. &uot;With our Aria(TM) CABG CABG coronary artery bypass graft.

CABG
abbr.
coronary artery bypass graft


CABG Coronary artery bypass graft, see there
 (Coronary Artery Bypass Graft coronary artery bypass graft
n. Abbr. CABG
A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery.
) device, we have now implanted four patients in the AEGIS/Canada (AlternativE Graft Investigational Study) clinical trial for the device. The perfusion scan perfusion scan Perfusion scintigraphy Cardiology A radionuclide technique for assessing myocardial or pulmonary blood flow, measured by IV injection of 99mTc microaggregated albumin, or thallium, TC-MIBI. See Myocardial infarction. Cf Ventilation scan.  for the first patient was completed at two months with normal results. We also filed our Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  (IDE) with the Food and Drug Administration for the Aria CABG AEGIS/U.S. trial,&uot; he continued. &uot;We received informal notice from the FDA that there would be additional questions to answer on this filing and we intend to respond as rapidly as possible to those questions.&uot;

The Aria graft, which incorporates the company's proprietary biomaterial Thoralon(TM), will be tested in patients undergoing coronary artery bypass surgery Coronary artery bypass surgery, also coronary artery bypass graft surgery, and colloquially heart bypass or bypass surgery is a surgical procedure performed to relieve angina and reduce the risk of death from coronary artery disease.  with few or no suitable native vessels. It is estimated that up to 20 percent of the more than 750,000 CABG procedures done per year worldwide involve patients having few or no suitable native vessels. The AEGIS/Canada and AEGIS/U.S. studies are designed to compare the patency pa·ten·cy
n.
The state or quality of being open, expanded, or unblocked.



patency

the condition of being open.
 of the Aria graft to poor quality autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
 veins at one year after implant.

Donald Middlebrook, Thoratec's vice president for regulatory affairs and quality assurance, said, &uot;It is not unusual for the FDA to respond to an IDE with questions and they typically concern animal data, clinical protocol and the like. While we do not fully know the nature of these questions, we hope we will be able to address them quickly and that it will not greatly impact the timing of our U.S. clinical program.&uot;

Key elements of the proposed AEGIS/U.S. protocol include less than 150 patients enrolled, one year follow up and randomizing against poor quality saphenous veins as the control group. We hope we will be able to pool data from this trial with our Canadian program, potentially reducing the number of patients and time required to complete both trials,&uot; he continued.

Also during the quarter, Thoratec announced the first commercial European implant of its Vectra VAG VAG Vagina
Vag Vaginal
VAG Freiburger Verkehrs Ag (German transportation company)
VAG Versicherungsaufsichtsgesetz (German: supervision of insurance companies act)
VAG Vancouver Art Gallery
 (Vascular Access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing  Graft), which took place at Albert Schweitzer Hospital The Medical Research Unit of the Albert Schweitzer Hospital was established in order to study major causes of disease burden in the local population. Since its foundation 25 years ago, it has become a leading African research centre, specialising in pathophysiology and treatment of  in Dordrecht in the Netherlands. The device, which incorporates Thoralon, is designed to provide access to the blood stream in renal failure renal failure
n.
Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema,
 patients undergoing hemodialysis. The patient was a 71-year-old man with polycystic polycystic /poly·cys·tic/ (-sis´tik) containing many cysts.

pol·y·cys·tic
adj.
Having or containing many cysts.



polycystic

containing many cysts.
 renal disease Renal disease
Kidney disease.

Mentioned in: Glycogen Storage Diseases

hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg
 who had been undergoing hemodialysis through a jugular jugular /jug·u·lar/ (jug´u-lar)
1. cervical.

2. pertaining to a jugular vein.

3. a jugular vein.


jug·u·lar
adj.
 dialysis catheter that was performing poorly. The implant represents the first step preceding a European rollout scheduled to begin in the next several weeks for Thoratec's distribution program for the device with Guidant Corporation (NYSE/PCX:GDT GDT Global Descriptor Table
GDT Geographic Data Technology Inc.
GDT Gas Discharge Tube (energy, electrotechinical and electronics)
GDT Getting Things Done
GDT Geometric Dimensioning & Tolerancing
GDT Ground Data Terminal
). The Guidant agreement covers worldwide marketing and distribution rights to the device, except in Japan.

&uot;In addition, we continued to make excellent progress with our U.S. clinical trials for the device,&uot; Grossman noted. &uot;We have now enrolled all 140 patients and will have six-month data for at least 91 of them next month. Based on our analysis of the data, we could submit our results to the FDA via a 510(k) to gain FDA clearance to begin marketing as early as the middle of this year.&uot;

For all of 1999, the company reported revenues of $23.2 million, a 37 percent increase over revenues of $17.0 million in 1998. Thoratec reported a loss of $1.8 million, or $0.09 per diluted share, versus a loss of $2.3 million, or $0.11 per diluted share, in 1998.

Thoratec Laboratories Corporation is engaged in the research, development, manufacture and marketing of medical devices for circulatory support and vascular graft applications, all of which incorporate its proprietary biomaterial, Thoralon. For additional information about Thoratec, visit the company's Web site at http://www.thoratec.com.

The portions of this news release that relate to future plans, events or performance, are forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including the results of clinical trials, announcements by the company's competitors, risks related to the government regulatory approval process, rapidly changing technology, an intensely competitive market and market acceptance of new products. These factors, and others, are discussed more fully in the company's annual report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the fiscal year ended January 2, 1999, and the company's other filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. These forward-looking statements speak only as of the date hereof. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

                   Thoratec Laboratories Corporation
            Highlights of Financial Information (Unaudited)
            (numbers in thousands, except per share data)

                       Consolidated Operations

                          Fourth Quarter Ended    Fiscal Year Ended
                           Jan. 1,    Jan. 2,     Jan. 1,    Jan. 2,
                            2000       1999        2000       1999

Product sales and
 rental income           $7,165       $4,990      $22,508     $16,320

Interest and other income   163          137          692         660

Total revenue             7,328        5,127       23,200      16,980

Costs of products sold    3,406        2,046        9,739       6,504

Research and development  1,910        1,404        5,793       5,096

Selling, general and
 administrative           2,510        2,135        9,457       7,701

Total costs and expenses  7,826        5,585       24,989      19,301

Net loss                  $(498)       $(458)     $(1,789)    $(2,321)

Basic and diluted
 loss per share           $(.02)      $(0.02)      $(0.09)     $(0.11)

Shares used to compute
 basic and diluted
 loss per share          20,465       20,396       20,446      20,340


                   Consolidated Balance Sheet Items

                                                 Jan. 1,     Jan. 2,
                                                  2000        1999

Cash, Cash Equivalents
 and Short-term investments
 available for sale                               $1,973        $4,745

Current Assets                                    14,463        14,582

Total Assets                                      25,060        25,208

Current Liabilities                                3,930         3,331

Long-term deferred
 distributor revenue                                 854             0

Shareholders' equity                              20,276        21,877
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Geographic Code:1USA
Date:Jan 24, 2000
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