-----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, G+PeQrj4t55BckRWxpwqCPmizI5r5jkDc6IqfP4ofqY+KTGqeLXHHqBbvHgUkXno 5tOeyBOMDTHotNDof94XRQ== 0000922423-05-001013.txt : 20050617 0000922423-05-001013.hdr.sgml : 20050616 20050617101623 ACCESSION NUMBER: 0000922423-05-001013 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050617 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050617 DATE AS OF CHANGE: 20050617 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: 05901652 BUSINESS ADDRESS: STREET 1: 3960 BROADWAY CITY: NEW YORK STATE: NY ZIP: 10032 BUSINESS PHONE: 2127815113 8-K 1 kl00644_8k.txt FORM 8K 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) June 17, 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 June 17, 2005, Nephros, Inc. issued a press release announcing the 510(k) approval of its OLpur(TM) HD190 dialyzer from the United States Food and Drug Administration. The full text of this press release 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 June 17, 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: June 17, 2005 NEPHROS, INC. By: /s/ Marc L. Panoff --------------------------------- Marc L. Panoff Chief Financial Officer (Principal Financial and Accounting Officer) EX-99 2 kl00644_ex99-1.txt EXHIBIT 99.1 PRESS RELEASE Exhibit 99.1 Contact: Marc Panoff, CFO Garth Russell / Todd Fromer Nephros, Inc. KCSA Worldwide Tel: 212-781-5113 212-896-1250 / 212-896-1215 grussell@kcsa.com / tfromer@kcsa.com ------------------------------------ Nephros Receives FDA Approval For its OLpur(TM) HD190 High Flux Filter NEW YORK, June 17, 2005 -- Nephros, Inc. (AMEX: NEP), announced today that it received 510(k) clearance for its OLpur(TM) HD190 high flux filter from the United States Food and Drug Administration (FDA). This 510(k) clearance allows Nephros to market its OLpur(TM) HD190 filter in the United States. Norman Barta, CEO of Nephros, stated, "We're excited that this filing with the FDA was approved this quickly. The OLpur(TM) HD190 shares a number of components and characteristics with our core OLpur(TM) MD190 filter. This approval marks the beginning of our move into the U.S, and we believe this approval should also simplify and accelerate the 510(k) approval process for our MD190 and H2H(TM) products." Nephros's OLpur(TM) HD190 is designed for use in a variety of End Stage Renal Disease (ESRD) therapies, including hemodialysis (HD) and hemodiafiltration (HDF), and is labeled accordingly. On-line HDF is not currently approved in the United States. While the OLpur(TM) HD190 is not expected to offer a substantial sales opportunity in the foreseeable future, Nephros believes the approval of the OLpur(TM) HD190 is an important step in the regulatory process to gain approval for its more advanced ESRD therapies in the U.S. Nephros'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, The Netherlands and Sweden. 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, as amended. Such statements may include statements regarding the efficacy and intended use of Nephros's technologies under development, the timelines for bringing such products to market and the availability of funding sources for continued development of such products and other statements that are not historical facts, including statements which may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown 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 risks that: (i) potential products that appeared promising in early research or clinical trials to Nephros may not demonstrate efficacy or safety in subsequent pre-clinical or clinical trials; (ii) Nephros may not obtain appropriate or necessary governmental approvals; (iii) product orders may be cancelled, patients currently using Nephros's products may cease to do so and patients expected to begin using Nephros's products may not; (iv) Nephros may not be able to obtain funding if and when needed; (v) Nephros may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures; (vi) HDF therapy may not be accepted in the United States and/or Nephros's technology and products may not be accepted in target markets; (vii) Nephros may not be able to sell its products at competitive prices or profitably; and (viii) Nephros may not be able to secure or enforce adequate legal protection, including patent protection, for its products. More detailed information about Nephros and the risk factors that may affect the realization of forward-looking statements is set forth in Nephros's filings with the Securities and Exchange Commission, including Nephros's Annual Report on Form 10-KSB filed with the SEC for the fiscal year ended December 31, 2004 and its Quarterly Report on Form 10-QSB filed with the SEC for the fiscal quarter ended March 31, 2005. Investors and security holders are urged to read those documents free of charge on the SEC's web site at www.sec.gov. Nephros does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. # # # -----END PRIVACY-ENHANCED MESSAGE-----