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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) NOVEMBER 4, 1996.
GYNECARE, INC.
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(Exact name of registrant as specified in its charter)
Delaware 94-3197941
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
235 Constitution Drive, Menlo Park, California 94025
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (415) 614-2500
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(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS
On November 4, 1996, Gynecare, Inc. (the "Company") issued a press release
with respect to the approval by the U.S. Food and Drug Administration of the
Company's application for 510(k) approval of its VersaPoint product, a copy of
which is attached hereto as Exhibit 99.1.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) EXHIBITS.
99.1 Press Release dated November 4, 1996.
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SIGNATURE
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.
GYNECARE, INC.
/s/ MALCOLM M. FARNSWORTH, JR.
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Malcolm M. Farnsworth, Jr.
Vice President, Finance and
Chief Financial Officer (Principal
Financial Officer), Secretary
Date: November 11, 1996
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GYNECARE, INC.
CURRENT REPORT ON FORM 8-K
INDEX TO EXHIBITS
Exhibit No. Description
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99.1 Press Release dated November 4, 1996.
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EXHIBIT 99.1
FOR INVESTOR INQUIRIES CONTACT: FOR MEDIA INQUIRIES CONTACT:
Gynecare, Inc. Schwartz Communications, Inc.
Malcolm M. Farnsworth, Jr. Shirley Macbeth or Hallie Loring
Chief Financial Officer (415) 512-0770
(415) 614-2530 Lloyd Benson or Deirdre O'Connell
http://www.gynecare.com (617) 431-0770
GYNECARE RECEIVES FDA CLEARANCE
TO MARKET VERSAPOINT SYSTEM FOR FIBROID REMOVAL
NEW, MINIMALLY INVASIVE THERAPY OFFERS VIABLE ALTERNATIVE TO HYSTERECTOMY;
ENABLES DIAGNOSIS AND TREATMENT IN SINGLE INTERVENTION UNDER LOCAL ANESTHESIA
MENLO PARK, CALIF.--NOVEMBER 4, 1996--Gynecare-TM-, Inc. (NASDAQ:GYNE), today
announced that the U.S. Food and Drug Administration (FDA) has given the company
clearance to market its VersaPoint-TM- system for hysteroscopic fibroid removal,
a minimally invasive alternative to hysterectomy. Uterine fibroids are the
leading cause of hysterectomy (surgical removal of the uterus) in the United
States, accounting for approximately 30% of the more than 600,000 hysterectomies
performed annually. It is estimated that more than 1.5 million hysterectomies
are performed each year, worldwide.
"We're delighted with today's decision by the FDA," said Lad Burgin, president
and CEO of Gynecare. "This approval is a major step toward the elimination of
hysterectomy as the primary treatment for uterine disorders. We look forward to
providing women across the country with a safe, cost-effective alternative that
has the potential to be performed under local anesthesia."
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GYNECARE RECEIVES FDA CLEARANCE TO MARKET VERSAPOINT
NOVEMBER 4, 1996
PAGE 2 OF 4
The VersaPoint system is designed to reduce the risks of traditional surgical
fibroid removal procedures, including hysterectomy, through the use of
proprietary bipolar electro-vaporization technology. The VersaPoint system is a
minimally invasive, cost-effective electrosurgical tool that enables the
gynecologist to vaporize, cut or desiccate tissue. In the vaporizing mode, the
device instantaneously vaporizes tissue upon contact.
DIAGNOSIS AND TREATMENT IN A SINGLE INTERVENTION
When evaluating excessive uterine bleeding, a debilitating symptom which affects
30% of women who suffer from uterine fibroids, the patient is commonly scheduled
for diagnostic hysteroscopy in an outpatient clinic or hospital. If pathology
such as a fibroid is found, the patient is often rescheduled for an operative
procedure. As the VersaPoint system is sized to fit down the working channel of
a micro-hysteroscope, the physician can first diagnose and then treat fibroids
and other benign pathology in a single intervention, saving both the patient and
the healthcare system the time and cost of multiple visits.
A VIABLE ALTERNATIVE UNDER LOCAL ANESTHESIA
The VersaPoint system can be used in hysteroscopes as small as 5 mm in diameter,
which typically do not require cervical dilation. As a result, the VersaPoint
system can be used with local anesthesia in an outpatient setting and has the
potential to be performed in a doctor's office, substantially reducing the cost
of treating fibroids. Recent studies presented at the American Association of
Gynecologic Laparoscopists (AAGL) Conference in September described the
successful use of the VersaPoint system under local anesthesia in patients with
fibroids.
"Gynecare's VersaPoint system not only offers an effective therapy for women
suffering from the debilitating symptoms caused by fibroids, it also preserves
the uterus and the patient's ability to bear children," said David Grainger, MD,
associate professor, Department of Obstetrics and Gynecology, University of
Kansas-Wichita. "By reducing the risks associated with conventional
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GYNECARE RECEIVES FDA CLEARANCE TO MARKET VERSAPOINT
NOVEMBER 4, 1996
PAGE 3 OF 4
fibroid removal procedures--including the risks inherent in the use of general
anesthesia--the VersaPoint system may provide a safer and less costly
alternative for women and their doctors."
VERSAPOINT SYSTEM MINIMIZES RISKS AND OPTIMIZES PHYSICIAN ADOPTION
Current endometrial resection techniques for fibroid removal (myomectomy) have
not gained mainstream acceptance among gynecologists because of the complexity
of the procedures, additional training required and perceived safety issues.
According to Gynecare's market research, approximately 10% of OB/GYN physicians
actually perform endometrial resection; an estimated additional 20% are
currently trained, but do not perform the procedure because they lack the
necessary surgical expertise. The VersaPoint system minimizes surgical risks
associated with current techniques, including the need for:
- - cervical dilation in most patients
- - use under general anesthesia
- - repeated withdrawal of the hysteroscope to remove resected tissue, which
results in increased procedure time
- - use of hypotonic distention fluids with associated risks of hyponatremia
(abnormally low concentrations of sodium ions in the blood).
Conventional monopolar myomectomy requires the use of a distention solution,
such as sorbitol, which may be absorbed into the patient's bloodstream and, if
allowed to build up beyond certain levels, can cause hyponatremia--inducing
seizures, brain swelling, fluid overload or even death. In contrast, the bipolar
technology used in Gynecare's VersaPoint system allows the use of saline, which
is considered the optimal medium for hysteroscopic procedures because it does
not affect normal blood chemistry. Gynecare believes that VersaPoint will give
experienced hysteroscopists a superior tool to facilitate myomectomy.
Additionally, it will provide gynecologists who are trained in endometrial
resection--but not performing the procedure--with the opportunity to offer
patients a new treatment alternative.
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GYNECARE RECEIVES FDA CLEARANCE TO MARKET VERSAPOINT
NOVEMBER 4, 1996
PAGE 4 OF 4
GYNECARE, INC.
Gynecare, Inc. (NASDAQ:GYNE), headquartered in Menlo Park, Calif., designs,
develops and markets innovative, minimally invasive and cost-effective medical
devices for the treatment of women's health disorders. The company's initial
product, the Uterine Balloon Therapy-TM- system, is used to treat women who
experience excessive menstrual bleeding. Uterine Balloon Therapy is currently
investigational in the United States, and is approved for marketing in Canada
and more than 30 other countries. In September 1996, Gynecare announced the
earlier-than-anticipated completion of the patient treatment phase of its U.S.
clinical trials of the Uterine Balloon Therapy system. In April 1996, Gynecare
extended its license and OEM supply agreement with Gyrus Medical, Inc., of
Cardiff, Wales, for innovative electro-vaporization technology for the
VersaPoint system to include the field of laparoscopy.
# # #
This press release contains language that may constitute forward-looking
statements for purposes of the Securities Act of 1933 and the Securities
Exchange Act of 1934. These forward-looking statements reflect the company's
current beliefs and expectations and are subject to a number of risks that may
cause actual events and results to differ materially from the forward-looking
statements. These risks include the uncertainty of the market's acceptance of
the VersaPoint system, the company's limited manufacturing experience and the
uncertainty of whether reimbursement from third-party payors will be available
for use of the system. Investors are encouraged to review the company's annual
and quarterly reports on Form 10K and Form 10Q for a fuller discussion of the
risks and uncertainties regarding the company's business and products.
Gynecare, Uterine Balloon Therapy and VersaPoint are trademarks of Gynecare,
Inc.
