Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that the U.S. Food and Drug Administration has issued a formal response to the company's 510(k) application.
On June 30, Nephros received a final decision letter from the FDA for the company's 510(k) submission which stated that the FDA could not reach a substantial equivalence determination for the company's hemodiafiltration (HDF) system.
"We are disappointed both by the FDA's decision to reject our application and by the fact that the company was not provided an opportunity to address the current comments prior to a final decision being rendered," said Paul A. Mieyal, acting CEO of Nephros. "After more than 15 months without a substantive communication, the company expected either an approval or further dialogue as the next step in the process. We feel that the issues raised in the current letter are addressable and have requested an in-person meeting with the review team to discuss options for moving forward."
"Outside of the United States, hemodiafiltration is widely regarded by nephrologists as the gold standard therapy for dialysis patients. We are disappointed that the availability of HDF therapy in the U.S. has been further delayed," commented Lawrence J. Centella, a member of Nephros's Board of Directors and former Chief Operating Officer of Gambro Healthcare, Inc.
Nephros has requested an in-person meeting to discuss the issues raised in the current FDA letter as well as the process for moving forward.
Based upon the in-person meeting with the FDA reviewers, the company will determine the appropriate course of action, which could include filing a new 510(k) application or filing an appeal related to the current application.
Nephros has engaged King & Spalding LLP as regulatory counsel to advise the company in its next interactions with the FDA. The company also intends to utilize the FDA's Ombudsman process.
Impact on Operations
The current decision by the U.S. FDA with regard to Nephros's HDF system does not impact the ability of the company to market and sell its mid-dilution (MD) filters for hemodiafiltration procedures outside of the U.S.
The Nephros dual stage ultrafilter (DSU) received 510(k) marketing clearance from the FDA in 2009 to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. The 510(k) approval for the DSU filters is unrelated to the 510(k) application for the company's HDF system.
Nephros continues to work with STERIS Corporation under the development agreement executed in March 2010.
Nephros is continuing the development of its dual stage ultra reliable personal water filtration system under support from its U.S. Department of Defense appropriation.