Welcome!

Microsoft Cloud Authors: Janakiram MSV, Yeshim Deniz, David H Deans, Andreas Grabner, Stackify Blog

News Feed Item

InspireMD Reports Results For Period Ending Sept. 30, 2012

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 24th 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

--The MASTER trial of MGuard EPS, presented on Oct. 24 at TCT, met its primary endpoint (proportion of patients with ST segment resolution of ≥ 70%, measured at 60 to 90 minutes post procedure), showing the MGuard EPS was significantly superior to the control arm of bare metal and drug eluting stents in the treatment of heart attack patients.

--During the past month, the Company instituted changes which it believes will strengthen relationships with its best distribution partners, and it is in the process of appointing new distributors in certain territories.

--Direct sales channels are being established in key European countries where end user average selling prices and the lack of strong distributors are limiting factors.

--Five experienced sales and marketing executives joined the Company last month to help bolster sales of MGuard EPS following the MASTER trial through third party distribution and direct sales channels.

About Stenting and MGuard EPS

Standard stents weren't engineered for heart attack patients.  They were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.

In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.

The MGuard EPS is integrated with a precisely engineered micro net mesh that prevents the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off.

While offering superior performance relative to standard stents in STEMI patients, the MGuard EPS requires no change in current physician practice - an important factor in promoting acceptance and general use in time-critical emergency settings.

About InspireMD, Inc.

InspireMD is a 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 quoted on the OTC under the ticker symbol NSPR.

About MGuard™ Embolic Protection Coronary Stent

MGuard™ EPS combines 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 is integrated with the stent. The MGuard EPS is designedto provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard EPS is CE Mark approved. MGuard™ is not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

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 payers 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 (xii) 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 (SEC), including the Company's Transition Report on From 10-K/T and its Quarterly Reports on Form 10-Q.  Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

                   CONSOLIDATED STATEMENTS OF OPERATIONS [(1)]
 
                (U.S. dollars in thousands, except per share data)
 
                                                   Three months ended
                                                      September 30,
                                                 2012              2011
 
    Revenues                                            $509            $1,986
    Cost of Revenues                                     230               801
 
    Gross Profit                                         279             1,185
 
    Operating Expenses:
    Research and development                             946               547
    Selling and marketing                                402               302
    General and administrative                         2,212             2,486
 
    Total operating expenses                           3,560             3,335
 
    Loss from Operations                              -3,281            -2,150
    Financial (income),expenses net                    4,218               108
 
    Loss before tax expenses                          -7,499            -2,258
    Tax Expenses                                           7                25
 
    Net Loss                                        ($7,506)          ($2,283)
 
    Net loss per share - basic and diluted           ($0.11)           ($0.04)
 
    Weighted average number of shares of
    common stock used in computing net
    loss per share - basic and diluted            68,296,940        64,300,685


                      CONSOLIDATED BALANCE SHEETS [(2)]
                         (U.S. dollars in thousands)
                                                    June 30,    June 30,
    ASSETS                                            2012        2012
 
    Current Assets:
    Cash and cash equivalents                           $8,297     $10,284
    Restricted cash                                         37          37
    Accounts receivable:
    Trade                                                1,078       1,824
    Other                                                  408         264
    Prepaid expenses                                        56          93
    Inventory:
    On hand                                              2,076       1,744
    On consignment                                          22          63
 
    Total current assets                                11,974      14,309
 
    Property, plant and equipment, net of
    accumulated depreciation and amortization              463         462
    Other non-current assets:
    Funds in respect of employees rights upon
    retirement                                             304         282
    Deferred debt issuance costs                           874         961
 
    Total other non-current assets                       1,178       1,243
 
    Total assets                                       $13,615     $16,014


                                              September 30,                 June 30,
    LIABILITIES AND EQUITY                           2012                       2012
    Current liabilities:
    Accounts payable and
    accruals:
    Trade                                            $556                       $441
    Other                                           2,628                      2,925
    Advanced payment from
    customers                                         169                        174
    Deferred revenues                                  10                         10
 
    Total current liabilities                       3,363                      3,550
 
    Long-term liabilities:
    Liability for employees
    rights upon retirement                            394                        354
    Convertible loans                               5,635                      5,018
    Contingently redeemable
    warrants                                        4,979                      1,706
 
    Total long-term
    liabilities                                    11,008                      7,078
 
    Total liabilities                              14,371                     10,628
 
    Equity:
    Common stock, par value
    $0.0001 per share;
    125,000,000 shares
    authorized; 68,596,903 and
    68,160,161 shares issued
    and outstanding at
    September 30, 2012 and
    June 30, 2012.                                      7                          7
    Additional paid-in capital                     50,464                     49,101
    Accumulated deficit                           -51,227                    -43,722
 
    Total equity (capital
    deficiency)                                      -756                      5,386
 
    Total liabilities and
    equity (capital
    deficiency)                                   $13,615                    $16,014
 
    (1) All 2012 financial information is derived from the Company's 2012
    unaudited financial statements and all 2011 financial information is derived
    from the Company's 2011 unaudited financial statements, as disclosed in the
    Company's Quarterly Report on Form 10-Q, filed with the Securities and
    Exchange Commission.
 
    (2) All September 30, 2012 financial information is derived from the Company's
    2012 unaudited financial statements and all June 30, 2012 financial
    information is derived from the Company's 2012 audited financial statements,
    as disclosed in the Company's Transition Report on Form 10-KT, filed with the
    Securities and Exchange Commission.
 


For additional information:

InspireMD Desk

Redington, Inc.

+1-212-926-1733
+1-203-222-7399
[email protected]



SOURCE InspireMD, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
SYS-CON Events announced today that NetApp has been named “Bronze Sponsor” of SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. NetApp is the data authority for hybrid cloud. NetApp provides a full range of hybrid cloud data services that simplify management of applications and data across cloud and on-premises environments to accelerate digital transformation. Together with their partners, NetApp em...
What is the best strategy for selecting the right offshore company for your business? In his session at 21st Cloud Expo, Alan Winters, U.S. Head of Business Development at MobiDev, will discuss the things to look for - positive and negative - in evaluating your options. He will also discuss how to maximize productivity with your offshore developers. Before you start your search, clearly understand your business needs and how that impacts software choices.
SYS-CON Events announced today that Interface Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Interface Corporation is a company developing, manufacturing and marketing high quality and wide variety of industrial computers and interface modules such as PCIs and PCI express. For more information, visit http://www.i...
SYS-CON Events announced today that Keisoku Research Consultant Co. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Keisoku Research Consultant, Co. offers research and consulting in a wide range of civil engineering-related fields from information construction to preservation of cultural properties. For more information, vi...
SYS-CON Events announced today that MIRAI Inc. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MIRAI Inc. are IT consultants from the public sector whose mission is to solve social issues by technology and innovation and to create a meaningful future for people.
SYS-CON Events announced today that Fusic will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Fusic Co. provides mocks as virtual IoT devices. You can customize mocks, and get any amount of data at any time in your test. For more information, visit https://fusic.co.jp/english/.
SYS-CON Events announced today that N3N will exhibit at SYS-CON's @ThingsExpo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. N3N’s solutions increase the effectiveness of operations and control centers, increase the value of IoT investments, and facilitate real-time operational decision making. N3N enables operations teams with a four dimensional digital “big board” that consolidates real-time live video feeds alongside IoT sensor data a...
Mobile device usage has increased exponentially during the past several years, as consumers rely on handhelds for everything from news and weather to banking and purchases. What can we expect in the next few years? The way in which we interact with our devices will fundamentally change, as businesses leverage Artificial Intelligence. We already see this taking shape as businesses leverage AI for cost savings and customer responsiveness. This trend will continue, as AI is used for more sophistica...
Real IoT production deployments running at scale are collecting sensor data from hundreds / thousands / millions of devices. The goal is to take business-critical actions on the real-time data and find insights from stored datasets. In his session at @ThingsExpo, John Walicki, Watson IoT Developer Advocate at IBM Cloud, will provide a fast-paced developer journey that follows the IoT sensor data from generation, to edge gateway, to edge analytics, to encryption, to the IBM Bluemix cloud, to Wa...
SYS-CON Events announced today that Massive Networks, that helps your business operate seamlessly with fast, reliable, and secure internet and network solutions, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. As a premier telecommunications provider, Massive Networks is headquartered out of Louisville, Colorado. With years of experience under their belt, their team of...
SYS-CON Events announced today that Enroute Lab will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enroute Lab is an industrial design, research and development company of unmanned robotic vehicle system. For more information, please visit http://elab.co.jp/.
SYS-CON Events announced today that Mobile Create USA will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Mobile Create USA Inc. is an MVNO-based business model that uses portable communication devices and cellular-based infrastructure in the development, sales, operation and mobile communications systems incorporating GPS capabi...
There is huge complexity in implementing a successful digital business that requires efficient on-premise and cloud back-end infrastructure, IT and Internet of Things (IoT) data, analytics, Machine Learning, Artificial Intelligence (AI) and Digital Applications. In the data center alone, there are physical and virtual infrastructures, multiple operating systems, multiple applications and new and emerging business and technological paradigms such as cloud computing and XaaS. And then there are pe...
SYS-CON Events announced today that SIGMA Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. uLaser flow inspection device from the Japanese top share to Global Standard! Then, make the best use of data to flip to next page. For more information, visit http://www.sigma-k.co.jp/en/.
SYS-CON Events announced today that B2Cloud will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. B2Cloud specializes in IoT devices for preventive and predictive maintenance in any kind of equipment retrieving data like Energy consumption, working time, temperature, humidity, pressure, etc.
Agile has finally jumped the technology shark, expanding outside the software world. Enterprises are now increasingly adopting Agile practices across their organizations in order to successfully navigate the disruptive waters that threaten to drown them. In our quest for establishing change as a core competency in our organizations, this business-centric notion of Agile is an essential component of Agile Digital Transformation. In the years since the publication of the Agile Manifesto, the conn...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, will discuss how data centers of the future will be managed, how th...
SYS-CON Events announced today that Nihon Micron will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Nihon Micron Co., Ltd. strives for technological innovation to establish high-density, high-precision processing technology for providing printed circuit board and metal mount RFID tags used for communication devices. For more inf...
SYS-CON Events announced today that Suzuki Inc. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Suzuki Inc. is a semiconductor-related business, including sales of consuming parts, parts repair, and maintenance for semiconductor manufacturing machines, etc. It is also a health care business providing experimental research for...
SYS-CON Events announced today that Ryobi Systems will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Ryobi Systems Co., Ltd., as an information service company, specialized in business support for local governments and medical industry. We are challenging to achive the precision farming with AI. For more information, visit http:...