-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, J2qAKePBASQGz+5dWghppBo1NtkZW74oNndiM7Raiy7MZigZSYnVeTz+IDDLE/J7 zCfWcWz0weH7BWBMbJFsDg== 0001047469-97-005892.txt : 19971125 0001047469-97-005892.hdr.sgml : 19971125 ACCESSION NUMBER: 0001047469-97-005892 CONFORMED SUBMISSION TYPE: POS AM PUBLIC DOCUMENT COUNT: 1 FILED AS OF DATE: 19971124 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: PERCLOSE INC CENTRAL INDEX KEY: 0000934438 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 943154669 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: POS AM SEC ACT: SEC FILE NUMBER: 333-39621 FILM NUMBER: 97726966 BUSINESS ADDRESS: STREET 1: 199 JEFFERSON DR CITY: MENLO PARK STATE: CA ZIP: 94025 BUSINESS PHONE: 4154733100 POS AM 1 POS AM AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 24, 1997 REGISTRATION NO. 333-39621 - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 -------------------------- POST-EFFECTIVE AMENDMENT NO. 1 TO FORM S-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 -------------------------- PERCLOSE, INC. (Exact name of Registrant as specified in its charter) DELAWARE 94-3154669 (State of incorporation) (I.R.S. Employer Identification Number)
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) -------------------------- 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 -------------------------- 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. -------------------------- 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. / / -------------------------- CALCULATION OF REGISTRATION FEE
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 Common Stock, $.001 par value...... 1,150,000 $23.50 $27,025,000 $8,189(2)
(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. ------------------------ 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. - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- 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. 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." 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.* ----------------------------------- 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:
SIGNATURE TITLE DATE - ------------------------------------------------ --------------------------------------- ---------------------- /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
*By: /s/ KENNETH E. LUDLUM - -------------------------------------- Attorney-in-fact -----END PRIVACY-ENHANCED MESSAGE-----