TEL AVIV, Israel, March 6, 2012 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) (the "Company" or "InspireMD"), a medical device company focusing on the development and commercialization of its proprietary stent platform technology for use in patients with Acute Myocardial Infarctions, today announced financial results for the year ended December 31, 2011.
Ofir Paz, Co-Founder and CEO of InspireMD, said: "I am encouraged by the progress we made at InspireMD in 2011, as we experienced increased demand for our MGuard stent system from early adopters outside the United States and a related increase in product shipments. We also expanded the international presence of MGuard through distributors in new territories and invested in our sales infrastructure to help drive future growth."
Dr. Asher Holzer, Co-Founder and President of InspireMD, added, "In 2011 we substantially increased our R&D investments in connection with launching a comprehensive clinical trial program for MGuard, including a randomized MASTER trial in patients with acute ST-segment elevation myocardial infarction (the most severe form of a heart attack, referred to as "STEMI"). Patients are being enrolled on schedule in this MASTER trial and we expect to report results in the second half of 2012. We also began preparatory work for our MGuard FDA registration trial."
- Initiated MASTER Trial comparing MGuard with the standard of care in STEMI patients. As of March 2, 2012, 202 patients (out of 432 planned) were enrolled.
- Expanded the international presence of MGuard through distributors in South Africa, India and Russia. MGuard is currently approved and sold via distributors in more than 30 countries.
- Doubled MGuard production levels to meet the ongoing increase in demand in shipments.
- Commenced trading as a public company in the United States on the Over-the-Counter Bulletin Board (OTC BB).
- Concluded a series of financings in which the Company raised an aggregate of approximately $12.1 million of cash.
- Elected Sol J. Barer, Ph.D. as Chairman of the Board of Directors, and elected Paul Stuka and Eyal Weinstein as independent directors.
- On a product delivery basis, shipments increased 78% during 2011 compared to the same period in 2010. Revenues for the year increased 21% to $6.0 million from $4.9 million due to revenue recognition policies related to entries into new regions and compliance with U.S. GAAP standards.
- Gross profit was $3.0 million, or 49.9% gross profit margin, compared to $2.3 million or 45.5% gross margin in 2010.
- Total operating expenses were $16.7 million for 2011 compared to $5.5 million in 2010. This increase was mainly driven by share-based compensation of $7.8 million, increased R&D expenditures relating to the MASTER trial and planned FDA trials of $1.2 million, other sales and marketing expenses of $0.4 million and corporate business expenses related to becoming a public company of $1.8 million.
- The Company reported a loss from operations of $13.7 million in 2011 compared to a loss from operations of $3.2 million 2010.
- The net loss for the year was $14.7 million, or $0.24 per weighted average share, compared to a net loss of $3.4 million in 2010.
- The Company ended 2011 with cash and cash equivalents of approximately $5.1 million, as compared to $636,000 at the end of 2010. The cash balance was supplemented by $10.6 million in net proceeds from equity offerings throughout the year and $1.5 million from the exercise of options.
Recent (Post Period) Developments