0001493152-16-008902.txt : 20160414 0001493152-16-008902.hdr.sgml : 20160414 20160414161538 ACCESSION NUMBER: 0001493152-16-008902 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160414 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160414 DATE AS OF CHANGE: 20160414 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: 161571926 BUSINESS ADDRESS: STREET 1: 41 GRAND AVENUE CITY: RIVER EDGE, STATE: NJ ZIP: 07661 BUSINESS PHONE: 201.343.5202 MAIL ADDRESS: STREET 1: 41 GRAND AVENUE CITY: RIVER EDGE, STATE: NJ ZIP: 07661 8-K 1 form8-k.htm

 

 

 

UNITES 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): April 14, 2016

 

NEPHROS, INC.

(Exact name of Registrant as Specified in its Charter)

 

Delaware   001-32288   13-3971809
 (State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

41 Grand Avenue, River Edge, New Jersey 07661

(Address of principal executive offices, including ZIP code)

 

(201) 343-5202

(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 April 14, 2016, Nephros, Inc. issued a press release announcing that it had received 510(k) clearance to market its S100 Point of Use filter. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits  

 

Exhibit No.   Description
     
99.1   Press Release, dated April 14, 2016.

 

 
 

 

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.

 

  Nephros, Inc.
     
Dated: April 14, 2016 By:  /s/ Daron Evans
    Daron Evans
    President & Chief Executive Officer

 

 
 

 

Index to Exhibits Filed with this Report

 

Exhibit No.   Description
     
99.1   Press Release, dated April 14, 2016.

 

 
 

EX-99.1 2 ex99-1.htm

 

 

 

Nephros Receives FDA 510(k) Clearance of S100 Point of Use Filter

 

RIVER EDGE, NJ, April 14, 2016— Nephros, Inc. (OTCQB:NEPH), (the “Company”) a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration (“HDF”) system for use with a hemodialysis machine for the treatment of patients with end stage renal disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its S100 Point of Use filter designed to filter Environmental Protection Agency (“EPA”) quality drinking water to retain waterborne bacteria to assist in infection control.

 

The S100 ultrafilter is designed to assist hospitals and medical facilities with their efforts to protect patients from water-borne bacteria. Legionella and Pseudomonas are common bacteria that can have a devastating impact on infected patients, particularly those whose immune system is compromised. The S100 Point of Use filter attaches to the end of a sink faucet and is designed to provide up to 3 months of protection.

 

“In response to customer feedback, the S100 adds an end of faucet product to our infection control portfolio to support hospitals in their efforts to protect patients from water-borne pathogens,” said Daron Evans, President and CEO of Nephros. “With the 510(k) process completed, we intend to fill initial orders for S100 filters this quarter.”

 

About Nephros, Inc.

 

Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters, as well as a hemodiafiltration system for the treatment of patients with End Stage Renal Disease. Its filters, which it calls ultrafilters, are used primarily in medical applications. Nephros ultrafilters are used by dialysis centers for the removal of biological contaminants from the water and bicarbonate concentrate feeding hemodialysis devices. Additionally, Nephros ultrafilters are used in hospitals and medical clinics as an aid in infection control by retaining bacteria (i.e. Legionella, Pseudomonas), virus and endotoxin from water used by patients.

 

For more information about Nephros, please visit the company’s website at www.nephros.com.

 

 
 

 

Forward-Looking Statements

 

This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the S100, including the timing of filling initial orders for such product, and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, the availability of capital when needed, our dependence on third party manufacturers, regulatory reforms, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Nephros Inc.’s reports filed with the U.S. Securities and Exchange Commission, including with respect to Nephros, its Annual Report on Form 10-K for the year ended December 31, 2015. Nephros, Inc. does not undertake any responsibility to update the forward-looking statements in this release.

 

Contact:

 

Investor:

PCG Advisory Group

Kirin M. Smith, Chief Operating Officer

Direct: 646-863-6519

www.pcgadvisory.com

 

 
 

 

 

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