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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): September 8, 1997
CONCEPTUS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware 0-27596 94-3170244
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification No.)
1021 Howard Avenue
San Carlos, CA 94070
(Address of Principal Executive Offices and Zip Code)
(415) 802-7240
(Registrant's Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
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ITEM 5. OTHER EVENTS
On September 8, 1997, Conceptus, Inc., a Delaware corporation (the
"Company"), announced that it had received United States Food and Drug
Administration (FDA) clearance to market its ERA (Endometrial Resection and
Ablation) Resectoscope Sheath for gynecological procedures. Further details
regarding this announcement are contained in the Company's press release dated
September 8, 1997 attached as an exhibit hereto and incorporated by reference
herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) EXHIBITS.
Exhibit 21.3 Conceptus, Inc. Press Release dated September 8, 1997.
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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 thereunto duly authorized.
CONCEPTUS, INC.
Date: September 10, 1997 By: /s/ Sanford Fitch
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Sanford Fitch
Senior Vice President and Chief
Financial Officer
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CONCEPTUS, INC.
INDEX TO EXHIBITS
EXHIBIT
NUMBER
- -------
21.3 Press Release dated September 8, 1997
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EXHIBIT 21.3
Contacts:
Conceptus, Inc.
Kathryn Tunstall, President & CEO
Sanford Fitch,
VP, Finance and Operations & CFO
(415) 802-7240
FOR IMMEDIATE RELEASE
CONCEPTUS RECEIVES 510(K) CLEARANCE FOR
ERA-TM- RESECTOSCOPE SHEATH
SAN CARLOS, CA SEPTEMBER 8, 1997--Conceptus, Inc. (NASDAQ: CPTS) announced
today that it has received United States Food and Drug Administration (FDA)
clearance to market its ERA Resectoscope Sheath for gynecological procedures,
such as endometrial resection and ablation, myomectomy (fibroid removal) and
polypectomy. The ERA Resectoscope Sheath is a single-use device used in
combination with existing electrosurgical capital equipment to enhance the
safety of therapeutic hysteroscopy procedures.
"We believe that the ERA Resectoscope Sheath is a big advance in women's
health," stated Kathryn Tunstall, President and Chief Executive Officer of
Conceptus, Inc. "By enhancing the safety of therapeutic hysteroscopy
procedures, and making the procedures less costly and less burdensome for the
OR staff, we believe that ERA will encourage the adoption of therapeutic
hysteroscopy as a viable, minimally invasive alternative to the over 700,000
hysterectomy procedures performed in the US annually."
Unlike surgical hysterectomy, therapeutic hysteroscopy involves the
transcervical, selective removal of abnormal or unwanted uterine tissue under
endoscopic guidance, and enables the avoidance of an open surgical procedure
while preserving the uterus. Therapeutic hysteroscopy procedures may be
performed to treat a broad range of uterine abnormalities, such as
dysfunctional uterine bleeding, fibroids and polyps, several of the most
common indications for hysterectomy.
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Although growing in acceptance, the risk of significant intraoperative
complications has constrained the rate of adoption of therapeutic
hysteroscopy. One of the most serious complications may occur as a result of
the absorption of high levels of hypotonic, or low salt, fluids required to
be used in the procedure. This complication, dilutional hyponatremia, can
lead to serious heart, lung and brain disorders, including coma and death.
The ERA Resectoscope Sheath enables the use of isotonic, or physiologic,
fluids in therapeutic hysteroscopy, eliminating the risk of hyponatremia.
Conceptus plans to market the ERA Resectoscope Sheath in the United States
through a combination of a direct sales force and select, specialty
distributors. Both the ERA Resectoscope Sheath and the FUTURA-TM-
Resectoscope Sheath for urology applications such as transuretheral resection
of the prostate (TURP) were acquired by Conceptus in November, 1996. The
Company announced earlier in the year that it had received FDA 510(k)
clearance of the FUTURA device for urology applications.
Conceptus Inc. designs, develops and markets innovative interventional
medical devices for use in reproductive medicine. The Company's initial
focus is on the development of systems to improve the diagnosis and treatment
of fallopian tube diseases and disorders, a primary cause of infertility.
The Company is introducing a novel technology designed to improve the safety
and ease-of-use of therapeutic hysteroscopy, a growing, less invasive
alternative to hysterectomy. Conceptus is also developing a non-surgical
approach to fallopian tube sterilization, the most commonly performed
contraceptive procedure worldwide.
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Except for the historical information contained herein, the matters discussed
in this press release are forward-looking statements, the accuracy of which
is necessarily subject to risks and uncertainties. The receipt of regulatory
approvals, clinical efficacy of and market demand for products, among other
matters discussed in this release, may differ significantly from the
discussion of such matters in the forward-looking statements. Such
differences may be based upon factors within Conceptus's control, such as
strategic planning decisions by management and re-allocation of internal
resources, or on factors outside of Conceptus's control, such as delays by
regulatory authorities, scientific advances by Conceptus or third parties and
introductions of competitive products, as well as those factors set forth in
the Company's Annual Report on Form 10K for the year ended December 31, 1996,
and other filings with the Securities and Exchange Commission.
