TEL AVIV, Israel, November 2, 2012 /PRNewswire/ --
InspireMD, Inc. ("InspireMD" or the "Company") (OTC: NSPR) announced financial results for the period ended September 30, 2012, the first quarter of its 2013 fiscal year.
As previously indicated, revenue declined from the same period in 2011 due mainly to stocking and selling disruptions caused by a realignment of the Company's distributors in advance of the presentation of the MASTER trial of its MGuard™ Embolic Protective Stent (EPS) at the 24 th Annual Transcathter Therapeutics (TCT) scientific meeting in Miami on October 24.
The positive results, presented at the TCT's Late Breaking Clinical Trials Session by Study Chairman Gregg W. Stone, MD, showed that the novel MGuard EPS provided a statistically and clinically significant acute advantage and, as a result, may hold the potential to lower the incidence of adverse sequela and prolong survival of heart attack victims.MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the Food and Drug Administration (FDA) at this time. The Company plans to initiate a FDA approval study on or before March 31, 2013. Key financial highlights 1Q ended September 30, 2012 include: --Revenue for the period ended September 30, 2012 totaled $509,000, compared to $1,986,000 in the same period in 2011, a decrease of $1,477,000, or 74.4 percent, due largely to anticipated disruptions in stocking and sales activities in the periods leading up to the TCT. --Gross profit for the Sept. 30 2012 period was $279,000, compared to $1,185,000 for the Sept. 30, 2011 period, a decline of 76.5 percent. --Total operating expenses for the Sept. 30, 2012 period were $3,560,000, compared to $3,335,000 in the Sept. 30, 2011 period. A $274,000 decrease in G&A in the Sept. 30, 2012 period was offset by a $399,000 increase in R&D (mainly to support the MASTER trial), and a slight increase in sales and marketing expense. --The loss from operations for the Sept. 30, 2012 period was ($3,281,000), compared to ($2,150,000) for the Sept. 30, 2011 period. -- $4,225,000 in financial and tax expenses for the Sept. 30, 2012 period brought the final net loss to ($7,506,000), or ($0.11) per basic and diluted share. Financial and tax expenses for the Sept. 30, 2011 period were $133,000, bringing final net loss for the period to ($2,283,000), or ($0.04) per basic and diluted share. --At September 30, 2012, cash and cash equivalents stood at approximately $8.3 million, compared to $10.3 million at June 30, 2012. Subsequent Achievements/Activities