BEI Medical Systems Reports Fiscal 2002 First Quarter Results; Sales Show Momentum for the Hydro ThermAblator.Business Editors & Health/Medical Writers TETERBORO, N.J.--(BW HealthWire)--Feb. 12, 2002 BEI Bei (pā, bā), river, c.200 mi (320 km) long, formed by the union of two headstreams in the Nanling Mts., N Guangdong prov., S China. It flows S into the Xi River, E of Guangzhou, to form the Pearl River delta. Medical Systems Company, Inc. (Nasdaq:BMED BMED British Mediterranean Airways BMed Bachelor of Medicine BMEd Bachelor of Mathematics Education ) today reported that total revenues for the first quarter of fiscal 2002 ended December 29, 2001 were $521,000, versus $31,000 in the comparable period of fiscal 2001, and were up 62% from $321,000 in the fourth quarter of fiscal 2001. The net loss for the fiscal 2002 first quarter was $2,319,000, or $0.24 per share, compared with a net loss of $1,053,000, or $0.14 per share, in the first quarter of fiscal 2001. The company ended the first quarter of fiscal 2002 with $7.7 million in cash and cash equivalents. "We are very pleased with the progress we have made as we continue to introduce the Hydro ThermAblator(R) (HTA HTA Health Technology Assessment HTA Hipertension Arterial (Spanish: Hypertension) HTA HTML Application HTA Help the Aged HTA Human Tissue Authority (UK) HTA Hochschule für Technik und Architektur ) in key markets throughout the U.S.," stated Richard W. Turner, president and chief executive officer. "Of particular note, we had a presence at the prestigious AAGL AAGL American Association of Gynecologic Laparoscopists Global Congress of Gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology. Endoscopy endoscopy Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the in San Francisco San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden , where we sponsored various seminars featuring the HTA. In addition, we worked throughout the country, supporting introductory first surgeries at hospitals, surgery centers and doctors' offices as well as sponsoring HTA workshops. In anticipation of expected demand, we expanded our internal sales management Sales Management Role and Goal Importance of sales management is critical for any commercial organization. Expanding business in not possible without increasing sales volumes, and effective sales management goal is to organize sales team work in such a manner that ensures a team by adding a fourth zone sales manager sales manager n → gerente m/f de ventas sales manager n → directeur commercial sales manager sale n → to cover the southeastern United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , and we continued the recruitment and training of our new and growing team of sales and marketing specialty organizations," Mr. Turner continued. The company noted that it has been developing as well as refining a wide variety of sales and marketing materials to support its sales and distribution efforts. These marketing materials range from HTA introductory and training videos to user manuals, direct mail, journal advertising and other HTA promotional programs. In addition, the company has developed a supplementary reimbursement information workbook work·book n. 1. A booklet containing problems and exercises that a student may work directly on the pages. 2. A manual containing operating instructions, as for an appliance or machine. 3. for physicians and payors, which favorably compares the economics of HTA with other ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. methods and with hysterectomy hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries . The company received Premarket Approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. of a supplement which permits modifications to the assembly of the sheath used in the HTA procedure set in December 2001. Commenting on this approval, Mr. Turner said, "This approval allows BEI to incorporate streamlined, cost-effective manufacturing practices in the production of the HTA procedure set. We anticipate that the adaptations to the sheath assembly will be implemented during the second half of fiscal year 2002, once sterilization sterilization Any surgical procedure intended to end fertility permanently (see contraception). Such operations remove or interrupt the anatomical pathways through which the cells involved in fertilization travel (see reproductive system). validation and the transition to manufacturing of the modified design are completed. We anticipate an eventual savings of approximately 50% in the cost of the procedure set as production volumes accelerate." About the Hydro ThermAblator(R) (HTA) and Menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea. men·or·rha·gia n. See hypermenorrhea. Menorrhagia, or excessive menstrual bleeding, often occurs in the absence of uterine fibroids Uterine Fibroids Definition Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer. or tumors, and hormonal treatment is often unsatisfactory. The condition is responsible for approximately 150,000 of the 600,000 hysterectomies performed annually in the United States, but many women who do not seek hysterectomy for relief may suffer in silence until the occurrence of menopause. In April 2001, the U.S. Food and Drug Administration (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. ) approved the HTA system, which uses circulating heated saline to ablate ab·late v. To remove or destroy the function of. ablate to remove, especially by cutting. ablate verb To remove; excise the endometrium endometrium /en·do·me·tri·um/ (-me´tre-um) pl. endome´tria the mucous membrane lining the uterus. en·do·me·tri·um n. pl. , or the lining of the uterus, to decrease or eliminate abnormal uterine bleeding uterine bleeding Abnormal bleeding from the uterus not related to menstruation. Most common in the first few years after menarche and as menopause approaches, it is thought to occur when malfunctioning ovaries reduce blood estrogen levels. . The portable HTA control unit features a control panel with step-by-step prompts, while gravity flow safely limits the maximum fluid pressure to the patient. HTA therapy includes direct visual control of transcervical access and visualization throughout the duration of the procedure. In the Company's Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the , treatment using the HTA completely eliminated uterine bleeding in 40% of the patients whose condition was reviewed 12 months following treatment, while an additional 42% exhibited a decrease in uterine bleeding to normal levels or less, as defined by the FDA. HTA treatment resulted in an overall average reduction in uterine bleeding of 84.8%. For those women who were available for follow-up and whose condition was reviewed 24 months following treatment, 47.0% had complete cessation of uterine bleeding and an additional 45.1% had a reduction in uterine bleeding to normal levels or less. In addition, at 24 months following treatment, 94.0% of patients were satisfied with the results of their HTA treatment and 92.5% of patients reported alleviation of menstrual discomfort. About BEI Medical Systems In April 2001 BEI Medical Systems Company, Inc. received FDA approval to market its sole product, the Hydro ThermAblator, a proprietary system that is intended to treat menorrhagia (abnormal uterine bleeding). BEI Medical Systems, Hydro ThermAblator and HTA are registered trademarks of BEI Medical Systems Company, Inc. in the United States and certain foreign countries. This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements may be deemed to include information that is not historical, including without limitation, statements based on our current expectations, assumptions, estimates and projections about our Company and our industry, including statements with respect to the timely acceptance, commercialization and pricing of our Hydro ThermAblator or HTA, the establishment of a qualified sales representative network, the impact of our cost reduction programs or approval of the modifications to the sheath assembly on the cost of the HTA procedure set, the impact of competitive products and pricing, the efficacy of the HTA on future patients, the ability of the Company to satisfy the conditions of the FDA approval and on-going regulatory requirements and general economic conditions as they affect our customers. Readers are cautioned that the forward-looking statements reflect management's analysis only as of the date hereof, and we assume no obligation to update these statements. Actual events or results may differ materially from the results discussed in or implied by the forward-looking statements. In addition to the factors set forth elsewhere in this press release, factors that might cause such a difference include, but are not limited to, risks related to the Company's ability to raise additional capital, and those risks and uncertainties discussed from time to time in the Company's filings with the Securities and Exchange Commission, including 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 period ended September 29, 2001 and the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the period ended December 29, 2001.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
BEI Medical Systems Company, Inc. and Subsidiaries
(Unaudited)
(amounts in thousands except per share amounts)
Three Months Ended
----------------------------------
December 29, December 30,
2001 2000
----------------------------------------------------------------------
Revenues $521 $31
Cost of revenues 448 133
----------------------------------------------------------------------
Gross profit (loss) 73 (102)
Selling, general and
administrative expenses 2,146 713
Research, development
and related expenses 290 294
----------------------------------------------------------------------
2,436 1,007
----------------------------------------------------------------------
Loss from operations (2,363) (1,109)
Interest income 48 57
Interest expense (4) (1)
----------------------------------------------------------------------
Loss before income taxes (2,319) (1,053)
Income taxes -- --
----------------------------------------------------------------------
Net loss ($2,319) ($1,053)
======================================================================
Loss per Common Share
Net loss per common share ($0.24) ($0.14)
======================================================================
Weighted average
shares outstanding 9,742 7,636
======================================================================
CONDENSED CONSOLIDATED BALANCE SHEETS
BEI Medical Systems Company, Inc. and Subsidiaries
(dollars in thousands)
December 29, September 29,
2001 2001
(Unaudited) (See note below)
----------------------------------------------------------------------
ASSETS
Current assets
Cash and cash equivalents $7,703 $9,846
Restricted cash 159 159
Marketable securities 474 452
Trade receivables, net 314 284
Inventories 829 720
Income taxes -- 284
Other current assets 268 158
----------------------------------------------------------------------
Total current assets 9,747 11,903
Plant and equipment, net 546 446
Patents, net 160 164
Other assets 68 68
----------------------------------------------------------------------
Total assets $10,521 $12,581
======================================================================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Trade accounts payable $902 $626
Accrued expenses and
other liabilities 1,288 1,313
Current portion of
lease obligation 27 26
----------------------------------------------------------------------
Total current liabilities 2,217 1,965
Long term lease obligation,
less current portion 116 123
Stockholders' equity 8,188 10,493
----------------------------------------------------------------------
Total liabilities and
stockholders' equity $10,521 $12,581
======================================================================
Note: The balance sheet at September 29, 2001 has been derived from the audited consolidated balance sheet consolidated balance sheet A balance sheet in which assets and liabilities of a parent company and its controlled subsidiaries are combined, thereby presenting balance sheet items for the parent and its subsidiaries as if they were a single firm. at that date but does not include all the information and footnotes required by generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting for complete financial statements. |
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