-----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, AhXwUdQWVR7kG5IP1CRse4A3ic4G9laqnzjDdtDQJ2/062WdKKtb99x2PIMMwZVC dsH4XIvCx/iSfB/JvRAEAQ== 0000922423-05-000489.txt : 20050315 0000922423-05-000489.hdr.sgml : 20050315 20050314173118 ACCESSION NUMBER: 0000922423-05-000489 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050314 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050315 DATE AS OF CHANGE: 20050314 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEPHROS INC CENTRAL INDEX KEY: 0001196298 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 133971809 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32288 FILM NUMBER: 05679430 BUSINESS ADDRESS: STREET 1: 3960 BROADWAY CITY: NEW YORK STATE: NY ZIP: 10032 BUSINESS PHONE: 2127815113 8-K 1 kl00339_8k.txt FORM 8-K CURRENT REPORT UNITED STATES 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) March 14, 2005 -------------- Nephros, Inc. ------------- (Exact Name of Registrant as Specified in Charter) Commission File Number: 001-32288 Delaware 13-3971809 -------- ---------- (State or other Jurisdiction of (I.R.S. Employer Incorporation) Identification No.) 3960 Broadway, New York, New York 10032 --------------------------------------- (Address of Principal Executive Offices) (Zip Code) (212) 781-5113 -------------- (Registrant's telephone number, including area code) Not Applicable -------------- (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 8.01. Other Events. On March 14, 2005, Nephros, Inc. issued a press release, a copy of which is attached hereto as Exhibit 99.1. The information in this report shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liability of that Section. Item 9.01. Financial Statements and Exhibits. (c) Exhibits 99.1 Press Release issued by Nephros, Inc. dated March 14, 2005. 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 hereunto duly authorized. Date: March 14, 2005 NEPHROS, INC. By: /s/ Marc L. Panoff --------------------------------- Marc L. Panoff Chief Financial Officer (Principal Financial and Accounting Officer) EX-99 2 kl00339_ex99-1.txt EXHIBIT 99.1 PRESS RELEASE Exhibit 99.1 [GRAPHIC OMITTED][GRAPHIC OMITTED] Press Release Nephros Announces 510(k) Filing with FDA For its OLpur(TM) HD190 High Flux Filter NEW YORK, March 14, 2005 -- Nephros, Inc. (AMEX: NEP), announced today that it has provided a 510(k) submission for its OLpur(TM) HD190 to the United States Food and Drug Administration (FDA). The Company's OLpur(TM) HD190 is a high flux filter designed for use in a variety of End Stage Renal Disease (ESRD) therapies, including dialysis and hemodiafiltration (HDF). Submission of form 510(k) is the first step for Nephros in the regulatory process to gain approval for its ESRD therapies in the U.S. Norman Barta, chief executive officer of Nephros, stated, "Our initial filing for approval in the U.S. is an important step in working with the FDA. While we do not anticipate OLpur HD190 to provide a significant sales opportunity in the foreseeable future, this filing will help streamline the process as we submit other existing products for U.S. approval. The OLpur(TM) HD190 high flux filter for example shares similar components with our core OLpur(TM) MD190 filter, and we believe this 510(k) filing will serve to lay the groundwork and help accelerate approval for the OLpur(TM) MD190 in the U.S." The Company's OLpur(TM) MD190 hemodiafilter is an advanced proprietary cartridge designed specifically for use in HDF therapy, which is currently not available in the U.S. The OLpur(TM) MD190 hemodiafilter received CE Mark regulatory approval in 2003 and is currently in use in Europe, including the U.K., France, Germany, Italy and the Netherlands. Nephros plans to seek FDA approval of its OLpur(TM) MD190 and its OLpur(TM) H2H(TM) - an add-on module that converts the most common types of hemodialysis machines into HDF-capable machines - and to introduce both products in the U.S. simultaneously. About Nephros, Inc. Nephros, Inc., headquartered in New York, is a medical device company developing and marketing products designed to improve the quality of life for the End Stage Renal Disease (ESRD) patient, while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. Nephros believes that its products remove a range of harmful substances more effectively, and more cost-effectively, than existing treatment methods; particularly with respect to substances known collectively as "middle molecules", due to their molecular weight, that have been found to contribute to such conditions as carpal tunnel syndrome, dialysis related amyloidosis, degenerative bone disease, and ultimately, to mortality in the ESRD patient. Forward Looking Statements This news release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding the efficacy and intended utilization of Nephros's technologies under development, are not guarantees of future performance, are based on certain assumptions and are subject to risks and uncertainties, many of which are beyond the control of Nephros. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risk that potential products that appeared promising in early research or clinical trials to Nephros do not demonstrate efficacy or safety in subsequent pre-clinical or clinical trials, and the risk that Nephros will not obtain appropriate or necessary governmental approvals to market products. More detailed information about Nephros and the risk factors discussed above is set forth in Nephros' filings with the Securities and Exchange Commission, including Nephros's Quarterly Report on Form 10-QSB filed with the SEC on November 15, 2004. Investors and security holders are urged to read such document free of charge at the Commission's web site at www.sec.gov. Nephros does not undertake an obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Contact: Marc Panoff, CFO Nephros, Inc. Tel.: 212-781-5113 -----END PRIVACY-ENHANCED MESSAGE-----