Welcome!

Microsoft Cloud Authors: Pat Romanski, Lori MacVittie, Andreas Grabner, Jim Kaskade, John Basso

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
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2017 New York. The 20th Cloud Expo and 7th @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Internet to enable us all to im...
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
"At ROHA we develop an app called Catcha. It was developed after we spent a year meeting with, talking to, interacting with senior citizens watching them use their smartphones and talking to them about how they use their smartphones so we could get to know their smartphone behavior," explained Dave Woods, Chief Innovation Officer at ROHA, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry’s single source for the cloud. Fusion’s advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including cloud...
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, discussed how VPaaS enables you to move fast, creating scalable video experiences that reach your aud...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.