Under the licensing agreement with Bellco, S.r.l., Nephros began 2012 with receipt of the second installment payment of euro 750,000 in January. The third and final installment payment of euro 600,000 is payable to Nephros on January 15, 2013. Beginning on January 1, 2015, Nephros will receive royalty payments from Bellco as part of the license agreement.
On August 11, 2011, Nephros filed a new 510(k) application with the FDA for clearance of the Company's hemodiafiltration (HDF) system for end-stage renal disease. On November 8, 2011 the Company received the initial FDA review of its new 510(k) application (K112314), which included a request for additional information. The Company provided answers to the FDA's request in early February 2012. The Company's response is subject to the FDA's standard review period of 90 days; however, the Company has no assurance that a response will be received within this time period. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.
For 2011, Nephros recorded approximately $618,000 of sales related to its ultrafiltration products, a 23% increase over the prior year. With the recent additions of Shane Sullivan as Director of U.S. Sales and Dr. Joseph Cervia as our strategic consultant, Nephros is working to formalize its marketing approach to the hospital infection control
|SOURCE Nephros, Inc.|
Copyright©2010 PR Newswire.
All rights reserved