TEL AVIV, Israel, Aug. 16, 2011 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) (“Inspire” or the “Company”), the developer of the MGuard mesh protective stent system, today announced that it has filed its Form 10-Q for the three months ended June 30, 2011 with the U.S. Securities and Exchange Commission. The Company provided an update on progress year-to-date:
Year-to-Date Highlights
- Year-to-date shipment volumes increased 93% compared to the first six months of last year, reflecting increased demand and an expanding distribution network.
- The Company expanded its board of directors with the addition of three highly prominent independent directors:
- Biotechnology industry veteran Sol J. Barer, the founder and former Chairman, President, CEO and COO of Celgene, joined the Company’s Board, bringing over 30 years of experience with publicly traded biotechnology companies. Dr. Barer spent 18 years leading Celgene as president, COO and CEO, culminating with a tenure as Celgene’s Executive Chairman before retiring in June of 2011. Celgene’s market capitalization at his retirement was approximately $27 billion.
- Paul S. Stuka, Managing Member of Osiris Partners and a 30-year investment industry veteran, also joined InspireMD’s Board. Mr. Stuka’s career includes senior roles at Longwood Partners, State Street Research and Management, and Fidelity Management and Research.
- Eyal Weinstein, C.P.A, a proven executive and consultant in Israel, also joined the board. Mr. Weinstein served as an auditor for Kost-Lev-Ari, the Israeli branch of Ernst & Young. Mr. Weinstein has also served as a senior executive of three firms, where he helped lead their sale to third parties, and currently sits on the board of several publicly traded companies, including B.O.S. Better Online Solutions Ltd., a Nasdaq-listed company.
- On July 26, 2011, InspireMD announced that the first patient had been enrolled in the MASTER (MGuard for Acute ST Elevation Reperfusion) Randomized Trial, a multinational randomized controlled trial designed to demonstrate MGuard Coronary Stent’s superiority over standard care for STEMI (heart attack) patients. The patient was enrolled in the Department of Haemodynamics and Angiocardiography, headed by Dr. Krystrof Zmudka, at the Krakow Specialist Hospital - John Paul II in Krakow, Poland. The MASTER Randomized Trial will enroll 432 patients in a two-arm, parallel design, with the objective to demonstrate superiority of the MGuard stent over commercially-approved bare-metal stents (BMS) or drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI). The primary endpoint is complete ST segment resolution.
- InspireMD announced that in a preliminary evaluation by Drs. Dmitry Dratva, Yaron Almagor, Jonathan Balkin, David Rosenmann, Mark Klutstein, Dan Tzivoni and David Meerkin from the Department of Cardiology at Shaare Zedek Medical Center, Jerusalem, Israel, the MGuard stent demonstrated excellent performance in a highly complex lesion subset with limited angiographic and procedural complications, suggesting its effectiveness in minimizing the possible embolic shower during stenting procedure, potentially replacing thrombus aspiration and distal protection devices in selected cases. The results of the analysis were presented at the EuroPCR 2011, the official congress of the European Association of Percutaneous Cardiovascular Interventions, in May in Paris, France.
- InspireMD announced a distribution agreement with Indian distributor Kirloskar Technologies (KTPL), making MGuard available in India. KTPL has already received and shipped the initial order for the MGuard stent to India.
- During March and April 2011, InspireMD completed financing transactions totaling $11.1 million, comprised of $10.4 million in cash and $0.7 million worth of loans that were converted into common stock and warrants.
Dr. Asher Holzer, Co-Founder of InspireMD and the Company’s President, commented, “InspireMD continues to make significant progress in developing, clinically validating and ultimately commercializing our patent-pending mesh net technology. Our presence at the EuroPCR conference in Paris in May was well-received, and the cocktail reception we hosted to celebrate the commencement of the MASTER randomized trial was attended by many industry leaders, demonstrating the significant and growing interest in our technology. We expect data from our MASTER trial, chaired by Dr. Gregg Stone, Director of Cardiovascular Research and Education from Columbia University in New York, in mid-2012, and are confident this study will drive additional adoption of our technology. In addition, we have begun the process of securing approval to sell our stents in the United States, pending approval from the United States Food and Drug Administration (FDA), which is targeted during 2014. We continue to collaborate with the Harvard Clinical Research Institute (HCRI), an international leader in design and conduct of coronary device trials, in order to obtain FDA approval.”
Mr. Ofir Paz, Co-Founder and CEO of InspireMD, commented, “In addition to our focus on the clinical data necessary to advance our efforts, we are simultaneously expanding our sales and marketing efforts in anticipation of the completion of the MASTER trial. This effort includes the recruiting of proven sales and marketing leadership to further grow our global distribution and the expansion of the sales and marketing team with the addition of proven personnel in key regions. In addition, we remain focused on innovation, with plans to introduce additional products based on our mesh net technology. Additional products will expand our total market opportunity, creating additional value for our shareholders. We are excited about our progress, and increasingly confident that we are on the right path.”
Dr. Holzer concluded, “During the quarter, we also expanded our board of directors, adding three experienced executives. We expect that these additions will prove to be invaluable, as our board is better able to provide management with greater guidance on driving value for patients, doctors, and shareholders.”
On a product delivery basis, shipments increased 74% during the second quarter of 2011 compared to the same period in 2010, and have increased 93% year-to-date compared to the first six months last year. For the quarter, total revenue was $1,040,000, an increase of 15% compared to $908,000 during the same period in 2010. The increase was primarily attributed to initial sales to its distributor in the Netherlands, as well as an increase in sales to distributors in Germany, Argentina and Israel. Year-to-date revenues decreased 10% to $2.7 million from $3.0 million due to revenue recognition policies related to entries into new regions and compliance with U.S. GAAP standards.
The Company completed the quarter with cash and cash equivalents of approximately $8.1 million, as compared to $636,000 as of December 31, 2010. The Company’s cash utilization rate, year-to-date, was approximately $900,000 per quarter, inclusive of cash inflows from operations. Additional financial details, including financial statements, are contained in the Form 10-Q.
About MGuard Coronary
MGuard presents a combination of a coronary stent merged with an embolic protection specifically designed for Acute MI patients. The embolic protection is comprised of an ultra-thin polymer micron net that wraps the stent. The MGuard stent is intended to provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard is CE Mark approved. Mesh-based protection is now recommended for use in the recent Guidelines of the Task force of Myocardial Revascularization of the European Society of Cardiology (ESC).
About InspireMD Inc.
InspireMD is an innovative medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard. InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures. InspireMD’s common stock is listed on the OTC BB under the ticker symbol “NSPR”. For more information, visit www.inspiremd.com.
Forward-looking Statements:
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multi-national companies, (v) product liability claims, (vi) our limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement by governmental and other third party payors for our products, (viii) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (ix) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (x) our reliance on single suppliers for certain product components, (xi) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xi) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission, including the Company’s Registration Statement on Form S-1 filed with the SEC on June 16, 2011. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. The Company assumed no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Company Contact:
www.inspire-md.com
Jonina Ohayon
Marketing Director
jonina@inspire-md.com
OTC BB: NSPR
Investor Contact:
Jeffrey Stanlis
Partner, Hayden IR
jeff@haydenir.com
(602) 476-1821
SOURCE InspireMD, Inc.
