"The first quarter of 2008 marked another milestone for Nephros on thepath toward U.S. approval of the Nephros HDF treatment for end-stage renaldisease," commented Norman J. Barta, Chairman and CEO of Nephros. "In thefirst quarter, Nephros completed enrollment in the Company's pivotal U.S.clinical trial for the OLpur(TM) H2H(TM) Hemodiafiltration Module andOLpur(TM) MD 220 Hemodiafilter. More recently, Nephros solidified itsmanagement team with the addition of two new executives as we strive to growand expand our water filter sales and European hemodiafilter sales whilepreparing for the anticipated U.S. launch of the Company's HDF therapysystem."
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Financial Performance for the First Quarter Ended March 31, 2008.
For the quarter ended March 31, 2008, Nephros reported product revenues of$387,000, attributable to sales of its OLpur(TM) MD190 and MD220 products inEurope, compared with $296,000 in the corresponding period of 2007, anincrease of 31%. The Company's net loss was $1,640,000 or $.04 per basic anddiluted common share for the first quarter of 2008 versus a net loss of$1,517,000 or $.13 per basic and diluted common share in the first quarter of2007. The substantial change in the per share loss is primarily due to therebeing 38,165,380 weighted average common shares outstanding basic and dilutedduring the 2008 period as compared to 12,317,992 during the 2007 period.
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As of March 31, 2008, Nephros had cash and cash equivalents in the amountof $2,505,000. In addition, Nephros had $4,286,000 invested in auction ratesecurities, which are classified as non-current investments at March 31, 2008.
ESRD Clinical Trial Update
In the first quarter of 2008, Nephros completed enrollment in theCompany's pivotal U.S. clinical trial for the OLpur(TM) H2H(TM)Hemodiafiltration Module and OLpur(TM) MD 220 Hemodiafilter products for thetreatment of patients with end-stage renal disease (ESRD). Nephrosanticipates that all enrolled patients will have completed the study protocolby June 1, 2008.
"In the second half of 2008, we plan to seek FDA approval to market ourleading-edge products here in the U.S.," said Mr. Barta. Nephros believesthat, if approved in 2008, its mid-dilution HDF technology would be the firstapproved online HDF therapy in the United States.
Water Ultrafiltration Products
Nephros is finalizing improvements to the functionality and ergonomics ofits water ultrafiltration products and has applied for stringent water filterperformance certifications from NSF International, an independent non-profitproduct evaluation laboratory. NSF has completed its initial stage of testing,and Nephros anticipates final completion of required NSF testing during thesecond quarter of 2008.
Nephros expects to continue its military product development with supportfrom its existing cost contract with the Office of Naval Research and othercontracts that may arise out of the U.S. Department of Defense appropriationsthat have been made for such purpose.
About Nephros, Inc.
Nephros, Inc., headquartered in New York, is a medical device companydeveloping and marketing filtration products.
The Nephros HDF system is designed to improve the quality of life for theEnd-Stage Renal Disease (ESRD) patient while addressing the critical financialand clinical needs of the care provider. ESRD is a disease state characterizedby the irreversible loss of kidney function. The Nephros HDF system removes arange of harmful substances more effectively, and with greater capacity, thanexisting ESRD treatment methods, particularly with respect to substances knowncollectively as "middle molecules." These molecules have been found tocontribute to such conditions as dialysis-related
