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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 24, 1997
REGISTRATION NO. 333-39621
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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POST-EFFECTIVE AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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PERCLOSE, INC.
(Exact name of Registrant as specified in its charter)
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<S> <C>
DELAWARE 94-3154669
(State of incorporation) (I.R.S. Employer
Identification
Number)
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199 JEFFERSON DRIVE
MENLO PARK, CALIFORNIA 94025
(Address, including zip code, and telephone number, including area code, of
Registrant's principal executive offices)
HENRY A. PLAIN, JR.
PRESIDENT AND CHIEF EXECUTIVE OFFICER
PERCLOSE, INC.
199 JEFFERSON DRIVE
MENLO PARK, CALIFORNIA 94025
(650) 473-3100
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
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COPIES TO:
J. CASEY MCGLYNN, ESQ. MICHAEL W. HALL, ESQ.
CHRISTOPHER D. MITCHELL, ESQ. ROBERT V. W. ZIPP, ESQ.
ROGER E. GEORGE, ESQ. TAMARA L. THOMPSON, ESQ.
Wilson Sonsini Goodrich & Rosati Venture Law Group
Professional Corporation A Professional Corporation
650 Page Mill Road 2800 Sand Hill Road
Palo Alto, California 94304 Menlo Park, California 94025
(650) 493-9300 (650) 854-4488
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APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after the effective date of this Registration Statement
and the Underwriting Agreement is executed.
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If only the securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. / /
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered in connection with dividend or interest
reinvestment plans, check the following box. / /
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. / /
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. / /
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. / /
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CALCULATION OF REGISTRATION FEE
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PROPOSED MAXIMUM
AGGREGATE PROPOSED MAXIMUM
TITLE OF EACH CLASS OF NUMBER OF SHARES OFFERING PRICE AGGREGATE AMOUNT OF
SECURITIES TO BE REGISTERED TO BE REGISTERED PER SHARE OFFERING PRICE(1) REGISTRATION FEE
<S> <C> <C> <C> <C>
Common Stock, $.001 par value...... 1,150,000 $23.50 $27,025,000 $8,189(2)
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(1) Estimated solely for the purpose of computing the amount of the registration
fee. The estimate is made pursuant to Rule 457(c) of the Securities Act of
1933, as amended.
(2) Entire amount previously paid.
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THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SUCH SECTION 8(a),
MAY DETERMINE.
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EXPLANATORY NOTE
This post-effective amendment is being filed for the purpose of
incorporating the attached Prospectus Supplement dated November 24, 1997 into
the Registration Statement and the Prospectus constituting a part thereof.
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PERCLOSE, INC.
PROSPECTUS SUPPLEMENT DATED NOVEMBER 24, 1997 TO
PROSPECTUS DATED NOVEMBER 20, 1997
On November 24, 1997, Perclose, Inc. ("Perclose" or "the Company") announced
that it has commenced a voluntary manufacturer's recall of specific lots of
Techstar XL 6 french percutaneous vascular surgery ("PVS") products. These
products include approximately 1,000 units that have been shipped
internationally since September 1997 as well as approximately 1,000 units that
were shipped domestically following receipt of FDA PMA supplement approval for
the Techstar XL 6 french and Techstar 6 french PVS products in November 1997.
The Company has traced the problem resulting in the recall to a defective
mold which resulted in one part of the product being out of specification in
particular production runs. The problem is not attributable to a design defect.
The Company is not aware of any increase in adverse patient consequences as a
result of these product performance issues. In addition, the Company believes,
based on reports received from the field to date, that overall product
performance and the rate of product malfunction have been consistent with
performance observed in clinical trials and that suggested by the labeling of
the product. The Company will voluntarily notify the FDA regional office of the
recall, but will be able to resume production of Techstar XL 6 products
following replacement of the defective mold on the production line, which has
already occurred.
The Company plans to replace the recalled Techstar XL 6 units with Techstar
6 units currently in inventory. The Company believes it has a sufficient
inventory of Techstar 6 units in inventory to meet customer requirements until
Techstar XL 6 shipments resume in early December 1997. The Company intends to
replace the parts out of specification on the recalled units and on the
approximately 3,500 Techstar XL 6 units in inventory and to resterilize and ship
those units.
The Company anticipates that the costs of the recall, replacement and rework
of the Techstar XL 6 products will have only a limited effect on its results of
operations in the current quarter. As previously reported, the Techstar 6 and
Techstar XL 6 received FDA approval for marketing at the same time and the
Company had intended to scrap the Techstar 6 units currently held in inventory
in favor of the more advanced Techstar XL 6 units. The Techstar XL 6 design
enables the operator to achieve proper placement of the device, known as
"marking," in an average of approximately 30 seconds, versus an average of
approximately 80 seconds for the Techstar 6. In all other material respects, the
devices function identically.
There can be no assurance that customers will not react adversely to the
recall and reduce or discontinue their use of the Company's PVS products. Any
such adverse reaction could adversely affect the Company's ability to achieve
its anticipated results of operations for current or future periods. In
addition, any such adverse reaction could be protracted and could adversely
affect long-term market acceptance of the Techstar XL product line and the
Company's other PVS products, which would have a material adverse effect on the
Company's business, financial condition and results of operations. See "Risk
Factors-- Dependence Upon Prostar and Techstar Products," "--Uncertainty of
Market Acceptance," "--Government Regulation," "--Limited Manufacturing
Experience and Scale-up Risk," "--Product Liability and Recall Risk; Limited
Insurance Coverage," "Business--Products and Technology," "--Manufacturing," and
"--Government Regulation."
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SIGNATURES
Pursuant to the requirements of the Securities Act, the Registrant has duly
caused this Post-effective amendment to Registration Statement to be signed on
its behalf by the undersigned, thereunto duly authorized, in the City of Menlo
Park, State of California, on the 24th day of November, 1997.
PERCLOSE, INC.
By: /s/ HENRY A. PLAIN, JR.*
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Henry A. Plain, Jr.,
PRESIDENT AND CHIEF EXECUTIVE
Pursuant to the requirements of the Securities Act of 1933, as amended, this
Post-effective amendment to Registration Statement has been signed by the
following persons in the capacities and on the dates indicated:
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SIGNATURE TITLE DATE
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<C> <S> <C>
/s/ HENRY A. PLAIN, JR.* President, Chief Executive Officer and
-------------------------------------- Director (Principal Executive November 24, 1997
Henry A. Plain, Jr. Officer)
/s/ KENNETH E. LUDLUM Vice President and Chief Financial
-------------------------------------- Officer (Principal Financial and November 24, 1997
Kenneth E. Ludlum Accounting Officer)
/s/ VAUGHN D. BRYSON*
-------------------------------------- Director November 24, 1997
Vaughn D. Bryson
/s/ MICHAEL L. EAGLE*
-------------------------------------- Director November 24, 1997
Michael L. Eagle
/s/ SERGE LASHUTKA*
-------------------------------------- Director November 24, 1997
Serge Lashutka
/s/ JOHN B. SIMPSON, PH.D., M.D.*
-------------------------------------- Director November 24, 1997
John B. Simpson, Ph.D., M.D.
/s/ JAMES W. VETTER, M.D.*
-------------------------------------- Director November 24, 1997
James W. Vetter, M.D.
/s/ MARK A. WAN*
-------------------------------------- Director November 24, 1997
Mark A. Wan
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*By: /s/ KENNETH E. LUDLUM
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Attorney-in-fact
