InspireMD Reports Financial Results for the Quarter and Six Month Period Ended December 31, 2013

BOSTON, MA – February 26, 2014 – InspireMD Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems, today announced financial and operating results for the quarter and the six month period ended December 31, 2013.

 

Recent Highlights

  • MASTER II trial on track to complete enrollment in the fourth quarter 2014; international sites now fully activated
  • Successfully implanted new CGuard™ EPS (Embolic Protection System) carotid stent in first patients with positive feedback from physicians
  • Secured $10 million of venture debt in October 2013 in order to advance drug eluting stent (DES) and carotid programs
  • Appointed new sales leadership in Europe to focus on increasing global sales effectiveness
    • 39% revenue growth in Tier 1 countries for three months ended December 31, 2013
    • Fully implemented HPMS (High Performance Management System)

 

“We closed 2013 on a very positive note and created momentum across all four phases of our business strategy,” stated Alan Milinazzo, Chief Executive Officer of InspireMD. “Our MASTER II trial is on track to be fully enrolled by the end of 2014. We made significant progress within our product pipeline over the past few months, including implanting the CGuard Carotid embolic protection system in patients for the first time. We are also advancing our DES program after initial positive testing of the MicroNet™ mesh with a number of CE marked drug eluting stents. Both of these important programs should further enable the fourth element of our strategy which involves partnering to accelerate our business. Finally, revenue growth in our Tier 1 countries continued to improve and we added key sales positions recently to further support our commercial efforts,” Milinazzo concluded.

 

Operational Overview

 

The Master II clinical trial is on track to complete enrollment in the fourth quarter of 2014. In total, the multi-center, randomized trial is set to include up to 70 sites in the U.S. and Europe and as many as 1,114 patients.  The MASTER II trial is evaluating the safety and effectiveness of the MGuard™ Prime EPS in patients suffering from ST Elevation Myocardial Infarction (STEMI). The results are intended to support the Company’s Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA) to market the MGuard™ Prime MicroNet™ covered coronary stent system in the U.S.

 

The Company recently announced that its new CGuard carotid embolic protection system has been successfully implanted in multiple patients. These initial clinical placements are expected to provide physician feedback and information for the Company to better understand the complexities and challenges of treating this patient population and help define further clinical activities for CGuard. The next step for the CGuard will be moving forward with the CARENET (CARotid Embolic protection using MicroNet™) study, which will evaluate the safety and efficacy of the CGuard EPS.

 

InspireMD has initiated bench testing the viability of combining its proprietary MicroNet™ technology with several already CE Marked drug eluting coronary stents. These tests will evaluate the safety and efficacy of the stent when it is combined with the Company’s MicroNet™ technology. This is an important phase in the development of our next generation embolic protection system.

 

From a commercial standpoint, the results of the MASTER trial 12-month follow up have been used to advance the Company’s evolving sales strategy. Directing these sales efforts is a new leadership team appointed during the quarter to focus on Tier 1 regions as well as support partners distributing the MGuard in other regions.  In order to more effectively support sales in Europe, InspireMD entered into an agreement with Healthlink Europe, a medical device support services and distribution company, to provide logistical and customer support for InspireMD’s commercial operations and clinical activities.

 

Quarter Ended December 31 2013 Financial Results

 

Revenue for the quarter ended December 31, 2013 was $1.6 million, an increase of 15.1% compared to $1.4 million for the same period in 2012. This reflects a 39.5% year-over-year increase within Tier 1 regions.

 

Gross profit for the quarter ended December 31, 2013 totaled $0.9 million, an increase of 7.3% compared to $0.8 million for same period in 2012. Gross margin for the three months ended December 31, 2013 was 55.5%, a decrease from 59.5% in the three months ended December 31, 2012. The quarter ended December 31, 2013 included a write off of $0.1 million of inventory.  Excluding this write off, the gross profit would have increased by 20.3% to $1.0 million and gross margin would have been 62.2% for the period.

 

Total operating expenses for the quarter ended December 31, 2013 were $5.8 million, an increase of 12.3% compared to $5.2 million for the same period in 2012. This was primarily due to increased sales and marketing expenses as the Company focuses on building its sales infrastructure for future growth in Tier 1 countries and research and development expenses attributable to the MASTER II trial.

 

The loss from operations for the quarter ended December 31, 2013 was $4.9 million, an increase of 13.2% compared to a loss of $4.4 million for the same period in 2012.

 

Total financial expenses for the quarter ended December 31, 2013 were $0.4 million, compared to financial income of $2.5 million in the same period in 2012. During the quarter ended December 31, 2012, the Company recognized $3.5 million of financial income pertaining to the non-cash revaluation of certain warrants and $0.9 million of amortization expense and related issuance costs pertaining to its previously outstanding senior convertible debentures. The quarter ended December 31, 2013 included a non-cash expense of $0.1 million associated with certain anti-dilution rights.  Excluding these non-cash effects, the financial expenses for the quarter ended December 31, 2013 would have totaled $0.3 million, as compared to $0.2 million for the same period in 2012.

 

The net loss for the quarter ended December 31, 2013 totaled $5.4 million, or $0.16 per basic and diluted share, compared to a net loss of $1.9 million, or $0.11 per basic and diluted share in the same period in 2012.

 

Non-GAAP net loss for the quarter ended December 31, 2013 was $4.5 million, or $0.13 per basic and diluted share, an increase of 45.7% compared to a non-GAAP net loss of $3.1 million, or $0.18 for the same period in 2012.  The non-GAAP net loss for the quarter ended December 31, 2013 primarily excludes $0.7 million of share-based compensation. The non-GAAP net loss for quarter ended December 31, 2012 primarily excludes $2.6 million in non-recurring, non-cash income associated with the Company’s previously retired convertible debt and associated warrants, $0.9 million of MGuard™ royalties buyout expenses and $0.5 million in share-based compensation.

 

Six Months Ended December 31 2013 Financial Results

 

Revenue for the six month period ended December 31, 2013 was $3.1 million, an increase of 67.0% compared to $1.9 million for the same period in 2012. This reflects a 120.6% year-over-year increase within Tier 1 regions.

 

Gross profit for the six month period December 31, 2013 totaled $1.7 million, an increase of 53.7% compared to $1.1 million for same period in 2012. The increase in gross profit is attributable to an increase in revenue, partially offset by $0.3 million in inventory write off and non-recurring effects of the consolidation of our manufacturing facilities.

 

Gross margin for the six month period ended December 31, 2013 was 53.6%, a decrease from 58.2% in the six month period ended December 31, 2012. Excluding the non-recurring effects of the consolidation of our manufacturing facilities and inventory write off in the six month period ended December 31, 2013, gross margin for the six month period ended December 31, 2013 would have been 63.2%.

 

Total operating expenses for the six month period ended December 31, 2013 were $10.5 million, an increase of 20.2% compared to $8.7 million for the same period in 2012. This was primarily due to increased research and development expenses attributable to the MASTER II trial and sales and marketing expenses as the Company focuses on building its sales infrastructure for future growth in Tier 1 countries.

 

The loss from operations for the six month period ended December 31, 2013 was $8.8 million, an increase of 15.4% compared to a loss of $7.6 million for the same period in 2012.

 

Total financial expenses for the six month period ended December 31, 2013 were $0.5 million, a decrease of 71.2% compared to $1.7 million in the same period in 2012. During the six month period ended December 31, 2012, the Company recognized $0.3 million of financial income pertaining to the non-cash revaluation of certain warrants and $1.6 million of amortization expense and related issuance costs pertaining to its previously outstanding senior convertible debentures. Excluding these non-cash effects, as well as the non-cash effects of the anti-dilution rights in the 2013 period, financial expenses would have totaled $0.3 million and $0.4 million for the six month periods ended December 31, 2013 and December 31, 2012, respectively.

 

The net loss for the six month period ended December 31, 2013 decreased 1.0% to $9.3 million, or $0.27 per basic and diluted share, compared to a net loss of $9.4 million, or $0.54 per basic and diluted share in the same period in 2012.

 

Non-GAAP net loss for the six month period ended December 31, 2013 was $7.6 million, or $0.22 per basic and diluted share, compared to a non-GAAP net loss of $5.7 million or $0.33 for the same period in 2012.  The non-GAAP net loss for the six month period ended December 31, 2013 primarily excludes $1.5 million of share-based compensation. The non-GAAP net loss for six month period ended December 31, 2012 primarily excludes $1.4 million in share-based compensation, $1.3 million in non-recurring, non-cash cost associated with the Company’s previously retired convertible debt and associated warrants and $0.9 million of MGuard™ royalties buyout expenses.

 

 

Cash and Cash Equivalents

 

As of December 31, 2013, cash and cash equivalents were $17.5 million, compared to $14.8 million as of June 30 2013.  The principal source of this increase was the $10 million in venture debt secured by the Company on October 24, 2013.

 

Change to Fiscal Year

 

As announced on September 17, 2013, the Company changed its fiscal reporting year end from June 30th to December 31st.  The six months ending December 31st constitutes the abridged fiscal year from July 1, 2013 to December 31, 2013.  Management believes that this change will allow the Company to better align its financial periods and annual budget planning with its business cycle, as well as assist the investment community in following the Company’s progress moving forward.

 

Investor Conference Call

 

The Company will host a conference call at 4:30 p.m. ET on Wednesday, February 26th to review the Company’s financial results and business outlook.  Participants should call (877) 407-0784 (United States) or (201) 689-8560 (International) and request the InspireMD call or provide confirmation code 13576207. A live webcast of the call will also be available on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors.   Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

 

An archive of the webcast will be available approximately one hour after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors for a limited time.  A dial-in replay of the call will also be available to those interested until March 12, 2014.  To access the replay, dial (877) 870-5176 (United States) or (858) 384-5517 (International) and enter code 13576207.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™) and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

 

Use of Non-GAAP Financial Measures

 

To supplement the Company’s consolidated financial statements presented on a GAAP basis, the Company discloses a non-GAAP measure as non-GAAP net loss because management uses this supplemental non-GAAP financial measure to evaluate performance period over period, to analyze the underlying trends in its business, and to establish operational goals and forecasts that are used in allocating resources. In addition, many investors use this non-GAAP measure to monitor the Company’s performance. This non-GAAP measure should not be considered as an alternative to GAAP measures as an indicator of the Company’s operating performance.

 

Non-GAAP net loss is defined by the Company as net loss excluding non-cash financial expenses, share-based compensation expenses and royalties buyout amortization. Non-cash financial expenses are items that are related to the amortization of discount on convertible debt and related issuance costs, the revaluation of warrants and expenses related to the anti-dilution rights of our March 2011 investors.

 

Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position or cash flow that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The non-GAAP measures discussed above, however, should be considered in addition to, and not as a substitute for or superior to operating loss, cash flows, or other measures of financial performance prepared in accordance with GAAP.  A reconciliation of non-GAAP to GAAP financial measure is set forth in the table below.

 

The Company believes that presenting a non-GAAP net loss, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for financial and operational decision-making and allows investors to see the Company’s results “through the eyes” of management. The Company further believes that providing this information assists investors in understanding the Company’s operating performance and the methodology used by management to evaluate and measure such performance.

 

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 the Company’s 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 the Company’s products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) the Company’s limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement by governmental and other third party payers for the Company’s products, (viii) the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful, (ix) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (x) the Company’s reliance on single suppliers for certain product components, (xi) the fact that the Company will need to raise additional capital to meet its business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xii) the fact that the Company conducts business in multiple foreign jurisdictions, exposing the Company 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 Form 10-KT 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.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com

 

######

 

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)

(U.S. dollars in thousands, except per share data)

                  Three months ended

            Six months ended

                    December 31,

             December 31,

                    2013

        2012

             2013

         2012

Revenues

$1,554

$1,350

$3,105

$1,859

Cost of revenues

692

547

1,442

777

Gross Profit

862

803

1,663

1,082

Operating Expenses:
Royalties buyout expenses

918

918

Other research and development expenses

1,771

1,256

3,315

2,202

Selling and marketing

1,817

1,206

2,647

1,608

General and administrative

2,215

1,789

4,528

4,001

Total operating expenses

5,803

5,169

10,490

8,729

Loss from operations

(4,941)

(4,366)

(8,827)

(7,647)

Financial expenses (income)

442

(2,488)

499

1,730

Loss before tax expenses

(5,383)

(1,878)

(9,326)

(9,377)

Tax expenses

7

42

10

49

Net Loss

($5,390)

($1,920)

($9,336)

($9,426)

Net loss per share – basic and diluted

($0.16)

($0.11)

($0.27)

($0.54)

Weighted average number of shares of common stock used in computing net loss per share – basic and diluted

33,968,030

17,727,815

33,963,901

17,401,025

 

 

                RECONCILIATION OF NON-GAAP NET LOSS (2)

(U.S. dollars in thousands, except per share data)

Three months ended

Six months ended

December 31,

December 31,

2013

2012

2013

2012

GAAP Net Loss

($5,390)

($1,920)

($9,336)

($9,426)

Non-GAAP Adjustments:

Non-cash financial expenses (income)(3)

123

(2,645)

200

1,332

Share-based compensation expenses

698

500

1,549

1,431

Royalties buyout expenses and amortization

21

943

32

943

Total Non-GAAP Adjustments

842

(1,202)

1,781

3,706

Non-GAAP Net Loss

($4,548)

($3,122)

($7,555)

($5,720)

Non-GAAP net loss per share – basic and diluted

($0.13)

($0.18)

($0.22)

($0.33)

Weighted average number of shares of common stock used in computing net loss per share – basic and diluted

33,968,030

17,727,815

33,963,901

17,401,025

 

 

 

CONSOLIDATED BALANCE SHEETS (4)

(U.S. dollars in thousands)

ASSETS

December 31,

June 30,

2013

2013

Current Assets:
Cash and cash equivalents

$17,535

$14,820

Restricted cash

93

93

Accounts receivable:
Trade

1,855

1,739

Other

387

388

Prepaid expenses

141

272

Inventory:
On hand

1,593

1,593

Total current assets

21,604

18,905

Property, plant and equipment, net

652

550

Non-current assets:
Deferred issuance costs

310

Funds in respect of employee rights upon retirement

434

406

Long term prepaid expenses

114

Royalties buyout

852

884

Total non-current assets

1,710

1,290

Total assets

$23,966

$20,745

LIABILITIES AND EQUITY

December 31,

June 30,

2013

2013

Current liabilities:
Accounts payable and accruals:
Trade

$1,623

$831

Other

3,141

3,028

Advanced payment from customers

179

174

Current maturity of loan

1,181

Deferred revenues

10

Total current liabilities

6,124

4,043

Long-term liabilities:
Liability for employees rights upon retirement

610

600

Long term loan

8,593

Total long-term liabilities

9,203

600

Total liabilities

15,327

4,643

Equity:
Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 33,983,346 and 33,888,845 shares issued and outstanding at December 31, 2013 and June 30, 2013, respectively

3

3

Additional paid-in capital

90,952

89,079

Accumulated deficit

(82,316)

(72,980)

Total equity

8,639

16,102

Total liabilities and equity

$23,966

$20,745

 

(1)        All  financial information for the six months ended December 31, 2013 is derived from the Company’s 2013 audited financial statements, as disclosed in the Company’s Transition Report on Form 10-KT for the six months ended December 31, 2013, filed with the Securities and Exchange Commission. All financial information for the three months ended December 31, 2013 is derived from the Company’s unaudited, internal financial statements. All 2012 financial information is derived from the Company’s 2012 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2012, filed with the Securities and Exchange Commission.

(2)        Our non-GAAP net loss is presented as management uses this supplemental non-GAAP financial measure to evaluate performance period over period, analyze the underlying trends in our business, and establish operational goals and forecasts that are used in allocating resources. We believe by presenting this additional measurement, we our providing investors with greater transparency to the information used by our management for our financial and operational decision-making, as well as allowing investors to see our results “through the eyes” of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.

 

(3)        Non-cash financial expenses (income) are items related to the amortization of the discount on the convertible loan and its related issuance costs, the issuance of shares as a result of the anti-dilution rights of our March 2011 investors and the revaluation of warrants.

 

(4)        All December 31, 2013 financial information is derived from the Company’s 2013 audited financial statements and all June 30, 2013 financial information is derived from the Company’s 2013 audited financial statements, as disclosed in the Company’s Transition Report on Form 10-KT for the six months ended December 31, 2013, filed with the Securities and Exchange Commission.

InspireMD to Report Financial Results for Six Month Period Ended December 31, 2013 on Wednesday, February 26, 2014

BOSTON, MA – February 18, 2014 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection stents, announced today that it will release its financial results for the six month period ended December 31, 2013 on February 26, 2014.

 

The Company will host a conference call at 4:30 p.m. ET on Wednesday, February 26th to review the Company’s financial results and business outlook.  Participants should call (877) 407-0784 (United States) or (201) 689-8560 (International) and request the InspireMD call or provide confirmation code 13576207. A live webcast of the call will also be available on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors.   Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

 

An archive of the webcast will be available approximately one hour after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors for a limited time.  A dial-in replay of the call will also be available to those interested until March 12, 2014.  To access the replay, dial (877) 870-5176 (United States) or (858) 384-5517 (International) and enter code 13576207.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™) and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com

InspireMD Reports Successful Implantation of the New CGuardTM Carotid Embolic System with MicroNet™TM Technology

Acclaimed Embolic Protection System Expands to Treat Carotid Artery Disease

 

BOSTON, MA – February 5, 2014 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection systems, today announced that its new CGuardTM carotid embolic protection system has been successfully implanted in  recent procedures, including a patient treated during the 17th Annual Symposium on Interventional Cardiology & Angiology held in Hamburg, Germany on February 1, 2014.

 

The proprietary CGuard carotid embolic protection system uses the same MicroNet™TM technology featured on its MGuardTM and MGuard PrimeTM coronary systems. The MicroNet™ technology is a single fiber knitted mesh wrapped on an open cell stent design in order to trap the debris that can travel downstream after a patient is treated with traditional stenting methods. This protects patients from plaque debris and blood clots breaking off and traveling distally in the arteries which can lead to life threatening strokes. The size, or aperture, of the MicroNet™ ‘pore’ is only 150-180 microns in order to maximize protection against plaque and thrombus.

 

“For the past several years, improvements in technology for treating carotid artery disease have been extremely limited,” stated Alan Milinazzo, President and Chief Executive Officer of InspireMD. “Due to large cell openings, traditional carotid artery stents have certain limitations and challenges when used for this indication.  Our multi-year experience with our MicroNet™ technology in the coronary space has been critical in the development of our new CGuard carotid embolic protection technology. We will continue to develop and refine this system, in order to better understand the life-saving implications it can have for those suffering from cardiac and carotid issues. Our goal is to offer patients clear benefits with this technology and we are pleased with our initial experiences with CGuard.”

 

The CGuard is CE-Marked and is currently being evaluated clinically in Europe. The initial clinical placements are expected to provide physician feedback and information for the Company to better understand the complexities and challenges of this disease state within the patient population and help define further clinical activities for CGuard.

 

“As a clinician who has successfully implanted the CGuard carotid embolic protection in multiple patients, I have experienced first-hand the life-saving applications it can have,” stated Professor Joachim Schofer, MD, from the Hamburg University Cardiovascular Center, in Hamburg, Germany. “The small pore size of the MicroNet™ technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. The CGuard technology provides an elegantly simple solution for embolic protection for my carotid patients.”

 

For more information about InspireMD and its offerings, visit www.inspiremd.com.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuardTM) and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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, multinational 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 Annual Report on Form 10-K 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.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Samantha Wolf / Taylor McGrann

KCSA Strategic Communications

212-896-1220 / 212-896-1253

swolf@kcsa.com / tmcgrann@kcsa.com

InspireMD to Present at the 24th Annual Oppenheimer & Co. Healthcare Conference in New York City on December 11th

BOSTON, MA – December 3, 2013 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), today announced that its CEO, Alan Milinazzo will be presenting at the 24th Annual Oppenheimer & Co. Healthcare Conference at the Crowne Plaza Hotel in New York City. The Company will present at 2:45 p.m. ET on Wednesday, December 11, 2013.

 

Investors unable to attend the Oppenheimer & Co. conference may listen in to the webcast, which can be found on the Investors section of the Company’s website at www.inspiremd.com/site_en/for-investors/.  The webcast will be available for 90 days following the presentation.

 

About Stenting and MGuard™ EPS

 

Standard stents were not 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 with regard to ST segment resolution, the MGuard EPS requires no change in current physician practice – an important factor in promoting acceptance and general use in time-critical emergency settings.

 

MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA at this time. This release is for the sole purpose of informing the investing community and is no way intended to market or promote MGuard EPS or any other InspireMD product to consumers or prospective patients in the U.S.

 

 

About InspireMD 

 

InspireMD seeks to utilize its proprietary MGuard technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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, multinational 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 Annual Report on Form 10-K 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.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com  / grussell@kcsa.com

 

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com

InspireMD Appoints Rick Olson as Vice President of Global Sales Operations

Company Strengthens Leadership Team with Addition of Experienced Global Sales Executive

 

BOSTON, MA – December 2, 2013 – InspireMD Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems, today announced the appointment of Rick Olson as Vice President of Global Sales Operations based in the United Kingdom.

 

Mr. Olson, 52, will be responsible for fully implementing the global sales strategy the Company has developed over the past several months. Also, his extensive experience in coronary, vascular and peripheral product sales will enable the Company to begin to advance commercial efforts across all three therapeutic areas.

 

Mr. Olson is a 25-year global sales, marketing and management executive with expertise in developing and executing strategies to achieve scalable growth for an array of novel medical device technology companies, including Boston Scientific and Covidien.  Prior to joining InspireMD, Mr. Olson served as the Director of International Strategy and HPMS (High Performance Management System) at Covidien. Before it was acquired by Covidien, Mr. Olson was Director of International Neurovascular Marketing & Sales Force Development at ev3, Inc., where he initiated market development and sales execution strategies for all OUS markets. During his tenure with ev3, revenues increased from less than $5 million to over $400 million in sales leading up to the acquisition of ev3 by Covidien in 2008.  Prior to that, Mr. Olson spent nine years at Boston Scientific where he served in various sales and marketing leadership positions both in Europe and the United States. Mr. Olson holds a Bachelor’s Degree in Psychology from Oregon State University.

“We are delighted to have Rick join the team at this important time in the Company’s commercialization efforts” commented Alan Milinazzo, Chief Executive Officer of InspireMD. “Rick has a strong track record of building successful sales organizations in the coronary, vascular and peripheral therapeutic markets. His ability to positively lead our organization in all three therapeutic areas is a tremendous benefit to our commercial efforts as we enter the next phase of our selling activities. Further, Rick’s success in implementing highly efficient and successful sales strategies has spanned virtually all geographies. This allows us to advance our current market strategies but to evaluate new markets across all therapeutic areas.”

 

Inducement Award

 

In connection with his appointment, InspireMD made an inducement grant to Mr. Olson pursuant to a stand-alone award agreement outside of InspireMD’s 2011 Umbrella Option Plan as an inducement material to Mr. Olson entering into employment with InspireMD in accordance with Section 711(a) of the NYSE MKT Company Guide. The inducement grant was approved by the compensation committee of InspireMD’s board of directors, which is comprised solely of independent directors. Mr. Olson’s inducement grant consists of a stock option to purchase up to 150,000 shares of InspireMD’s common stock, with a per share exercise price equal to the closing price of the Company’s common stock on December 2, 2013, the first trading day following the effective date of Mr. Olson’s employment with InspireMD. Mr. Olson’s option vests and becomes exercisable in three equal annual installments beginning on the one-year anniversary of the date of grant, subject to his continuous service through each vesting date. The option has a term of 10 years from the date of grant.

 

About Stenting and MGuard™ EPS

 

Standard stents were not 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 with regard to ST segment resolution, the MGuard EPS requires no change in current physician practice – an important factor in promoting acceptance and general use in time-critical emergency settings.

 

The MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA at this time. This release is for the sole purpose of informing the investing community and is no way intended to market or promote the MGuard EPS or any other InspireMD product to consumers or prospective patients in the U.S

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

 

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, multinational 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 Annual Report on Form 10-K 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.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Samantha Wolf / Taylor McGrann

KCSA Strategic Communications

212-896-1220 / 212-896-1253

swolf@kcsa.com / tmcgrann@kcsa.com

InspireMD Announces Upcoming Investor Event in Israel

Company to Host Investor Event on December 2, 2013 at 5:00 p.m. IST  

BOSTON, MA – November 19, 2013 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection stents, today announced that it will host an investor event at the Dan Tel Aviv Hotel in Tel Aviv, Israel on December 2, 2013 at 5:00 p.m. local time.

At the event, the senior management team of InspireMD will review the recently announced 12-month follow up data from its MASTER trial, discuss its recent clinical and operational efforts, and answer questions from the audience. 

Investors wishing to attend the event should RSVP to Bars@inspiremd.com with “Investor Event” in the subject line.

 

About Stenting and MGuard™ EPS

 

Standard stents were not 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 with regard to ST segment resolution, 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 seeks to utilize its proprietary MGuard™ technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

MGuard™ EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA 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, multinational 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 Annual Report on Form 10-K 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.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com  

InspireMD Reports Financial Results for Quarter Ended September 30, 2013

BOSTON, MA – November 11, 2013 – InspireMD Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection stents, today announced financial results for the quarter ended September 30, 2013.

 

Key Highlights of Recent Events

  • MGuard™ outperformed bare metal and drug eluting stents in all-cause mortality in STEMI patients for the 12-month follow-up data from the MASTER Trial
  • Secured $10 million in venture debt financing to support product development and clinical expansion
  • Initiated direct selling activities in Germany

 

Upcoming Near-term Milestones

  • Expanding direct selling organization and activities in other key European countries
  • Accelerating product development and clinical programs to expand the MicroNet™ therapeutic platform to a drug eluting stent, as well as for carotid and peripheral artery
  • CGuard™ first in man carotid stent trial initiation planned for Q1 2014

 

“The positive mortality data from the MASTER trial 12-month follow-up is being well received by physicians since the results were announced at the TCT conference just two weeks ago.  We believe this data will be an important factor in our efforts to increase adoption rates for the MGuard and for recruitment in the MASTER II trial,” stated Alan Milinazzo, President and Chief Executive Officer of InspireMD.  “The acute benefits reported with the MGuard in ST segment resolution, improved TIMI flow and reduced infarct size, gives us the confidence that these improved clinical results are achieved due to the embolic protection benefits of our MicroNet™ technology.”

 

“Encouraged by the MASTER trial 12-month data, we believe there is significant potential for our platform technology, MicroNet™, to support a broader pipeline of devices in the coronary and vascular setting. We recently put into place a financing strategy that offers us greater flexibility to accelerate these programs,” concluded Mr. Milinazzo.

 

Operational Overview

 

On October 29, 2013, the Company announced the 12-month follow up results from the MASTER trial for its MGuard Embolic Protection Stent (EPS). The findings showed that the novel MGuard EPS provides a significant acute advantage in reducing ST segment elevation versus traditional bare metal and drug eluting stents. As a result, MGuard may hold the potential to prolong the survival of heart attack victims, as evidenced by the 12-month data.  The 12-month follow up results are an important data point for physicians evaluating the MGuard, as the first year is an important period for evaluating a patient who has received a stent during a heart attack.  As the Company now has this data in hand, it intends to ramp commercial activity for the remainder of 2013 and 2014.

 

The Company continues enrollment in its MASTER II clinical trial to evaluate the safety and effectiveness of the MGuard™ Prime EPS in patients suffering from ST Elevation Myocardial Infarction (STEMI). In total, the multi-center, randomized trial is expected to include up to 70 sites in the U.S. and Europe and as many as 1,114 patients. The results are intended to support the Company’s Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA) to market the MGuard™ Prime MicroNet™ covered coronary stent system in the U.S.

 

While the MASTER II trial is fully funded, the Company took additional steps to secure strategic financing and protect shareholder value.  On October 24th, the Company announced it had secured $10 million in venture debt to support expanding its emerging clinical research and product development efforts.  The Company also put into place a one year stockholder rights plan which the Board believed was prudent in order to protect shareholders’ interests.

 

Quarter Ended September 30, 2013 Financial Results

 

Revenue for the quarter ended September 30, 2013 was $1.6 million, an increase of 205% compared to $0.5 million for the same period in 2012.  The increase year over year reflects the positive impact of recent steps taken to stabilize the global distribution strategy and the early success of targeted selling activities in Brazil as well as select European countries.

 

Gross profit for the quarter ended September 30, 2013 totaled $0.8 million, an increase of 187% compared to $0.3 million for same period in 2012. The increase in gross profit is attributable to an increase in revenue of approximately $1.1 million, as described above, partially offset by an increase in cost of revenues of approximately $0.5 million. Gross margin for the three months ended September 30, 2013 was 51.7%, a decrease from 54.8% in the three months ended September 30, 2012. If the non-recurring effects of the consolidation of our manufacturing facilities in the three months ended September 30, 2013 are removed, gross margin for the three months ended September 30, 2013 would have been 63.1%.

 

Total operating expenses for the quarter ended September 30, 2013 were $4.7 million, an increase of 31.7% compared to $3.6 million for the same period in 2012. The increase was primarily due to an increase in startup costs associated with initiating the MASTER II trial, as well as increased sales and marketing expenses, as the Company begins to build the appropriate sales infrastructure for future growth.

 

The loss from operations for the quarter ended September 30, 2013 was $3.9 million, an increase of 18.4% compared to a loss of $3.3 million for the same period in 2012.

 

Total financial expenses for the quarter ended September 30, 2013 were $0.1 million, a decrease of 98.6% compared to $4.2 million in the same period in 2012. The decrease in financial expenses resulted primarily from the absence of any non-cash revaluations of our warrants or amortization expenses during the three months ended September 30, 2013. In contrast, during the three months ended September 30, 2012, we recognized approximately $4.0 million in non-recurring, non-cash cost associated with the Company’s previously retired convertible debt and associated warrants. If the non-cash effects in the three months ended September 30, 2012, as well as the non-cash effects in the three months ended September 30, 2013 are removed, financial expenses for the three months ended September 30, 2012 would have totaled approximately $0.2 million, as compared to approximately $20,000 of financial income for the three months ended September 30, 2013.

 

The net loss for the quarter ended September 30, 2013 totaled $3.9 million, or $0.12 per basic and diluted share, a decrease of 47.4% compared to a net loss of $7.5 million, or $0.44 per basic and diluted share in the same period in 2012.

 

Non-GAAP net loss for the quarter ended September 20, 2013 was $3.0 million, or $0.09 per basic and diluted share, an increase of 15.7% compared to a non-GAAP net loss of $2.6 million or $0.15 for the same period in 2012.  The non-GAAP net loss for the quarter ended September 30, 2013 primarily excludes $0.9 million of share-based compensation. The non-GAAP net loss for quarter ended September 30, 2012 primarily excludes $4.0 million in non-recurring, non-cash cost associated with the Company’s previously retired convertible debt and associated warrants and $1.0 million in share-based compensation.

 

Cash and Cash Equivalents

 

At September 30, 2013, cash and cash equivalents were $11.4 million, a decrease of 22.8% compared to $14.8 million at June 30, 2013. The Company’s cash decreased in line with its anticipated burn rate.

 

On October 24, 2013, the Company secured $10 million in venture debt financing to support product development and clinical expansion.

 

Change to Fiscal Year

 

As announced on September 17th, the Company will be changing its fiscal reporting year end from June 30th to December 31st.  The three month period ending September 30th was the first half of the transitional six-month fiscal year from July 1st to December 31st, 2013.  Management believes that this change will allow the Company to better align its financial periods and annual budget planning with its business cycle, as well as assist the investment community in following the Company’s progress moving forward.

 

Investor Conference Call

 

The Company will host a conference call today at 4:30 p.m. ET to review the Company’s financial results and business outlook.  Participants should call (877) 407-4018 (United States) or (201) 689-8471 (International) and request the InspireMD call or provide confirmation code 13572723. A live webcast of the call will also be available on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors/.  Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

 

An archive of the webcast will be available approximately one hour after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors/.   A dial-in replay of the call will also be available to those interested.  To access the replay, dial (877) 870-5176 (United States) or (858) 384-5517 (International) and enter code 13572723.

 

About Stenting and MGuard™ EPS

 

Standard stents were not 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 with regard to ST segment resolution, 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 seeks to utilize its proprietary MGuard technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA at this time.

 

Use of Non-GAAP Financial Measures

 

To supplement the Company’s consolidated financial statements presented on a GAAP basis, the Company discloses a non-GAAP measure as non-GAAP net loss because management uses this supplemental non-GAAP financial measure to evaluate performance period over period, to analyze the underlying trends in its business, and to establish operational goals and forecasts that are used in allocating resources. In addition, many investors use this non-GAAP measure to monitor the Company’s performance. This non-GAAP measure should not be considered as an alternative to GAAP measures as an indicator of the Company’s operating performance.

 

Non-GAAP net loss is defined by the Company as net loss excluding non-cash financial expenses, share-based compensation expenses and royalties buyout amortization. Non-cash financial expenses are items that are related to the amortization of discount on convertible debt and related issuance costs, the revaluation of warrants and expenses related to the anti-dilution rights of our March 2011 investors.

 

Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position or cash flow that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The non-GAAP measures discussed above, however, should be considered in addition to, and not as a substitute for or superior to operating loss, cash flows, or other measures of financial performance prepared in accordance with GAAP.  A reconciliation of non-GAAP to GAAP financial measure is set forth in the table below.

 

The Company believes that presenting a non-GAAP net loss, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for financial and operational decision-making and allows investors to see the Company’s results “through the eyes” of management. The Company further believes that providing this information assists investors in understanding the Company’s operating performance and the methodology used by management to evaluate and measure such performance.

 

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 the Company’s 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 the Company’s products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) the Company’s limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement by governmental and other third party payers for the Company’s products, (viii) the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful, (ix) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (x) the Company’s reliance on single suppliers for certain product components, (xi) the fact that the Company will need to raise additional capital to meet its business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xii) the fact that the Company conducts business in multiple foreign jurisdictions, exposing the Company 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 Annual Report on Form 10-K 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.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com

 

 

 

######

 

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)

(U.S. dollars in thousands, except per share data)

Three months ended

September 30,

2013

2012

Revenues

$1,552

$509

Cost of Revenues

750

230

Gross Profit

802

279

Operating Expenses:
Research and development expenses

1,544

946

Selling and marketing

830

402

General and administrative

2,313

2,212

Total operating expenses

4,687

3,560

Loss from Operations

(3,885)

(3,281)

Financial expenses

57

4,218

Loss before income taxes

(3,942)

(7,499)

Tax expenses

3

7

Net Loss

($3,945)

($7,506)

Net loss per share – basic and diluted

($0.12)

($0.44)

Weighted average number of shares of common stock used in computing net loss per share – basic and diluted

33,959,773

17,074,235

 

 

RECONCILIATION OF NON-GAAP NET LOSS (2)

(U.S. dollars in thousands, except per share data)

Three months ended

September 30,

2013

2012

GAAP Net Loss

($3,945)

($7,506)

Non-GAAP Adjustments:
Non-cash financial expenses(4)

77

3,977

Share-based compensation expenses

851

931

Royalties buyout expenses and amortization

11

0

Total Non-GAAP Adjustments

939

4,908

Non-GAAP Net Loss

($3,006)

($2,598)

Non-GAAP net loss per share – basic and diluted

($0.09)

($0.15)

Weighted average number of shares of common stock used in computing net loss per share – basic and diluted

33,959,773

17,074,235

 

 

CONSOLIDATED BALANCE SHEETS (3)

(U.S. dollars in thousands)

ASSETS

September 30,

June 30,

2013

2013

Current Assets:
Cash and cash equivalents

$11,440

$14,820

Restricted cash

93

93

Accounts receivable:
Trade

2,128

1,739

Other

447

388

Prepaid expenses

144

272

Inventory

1,392

1,593

Total current assets

15,644

18,905

Property, plant and equipment, net

591

550

Non-current assets:
Funds in respect of employee rights upon retirement

436

406

Long term prepaid expenses

143

Royalties buyout

873

884

Total non-current assets

1,452

1,290

Total assets

$17,687

$20,745

 

 

CONSOLIDATED BALANCE SHEETS (Cont.)(3)

(U.S. dollars in thousands)

 

LIABILITIES AND EQUITY

September 30,

June 30,

2013

2013

Current liabilities:
Accounts payable and accruals:
Trade

$850

$831

Other

3,016

3,028

Advanced payment from customers

176

174

Deferred revenues

10

Total current liabilities

4,042

4,043

Long-term liabilities –
Liability for employees rights upon retirement

637

600

Total long-term liabilities

637

600

Total liabilities

4,679

4,643

Equity:
Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 33,965,950 and 33,888,845 shares issued and outstanding at September 30, 2013 and June 30, 2013, respectively.

3

3

Additional paid-in capital

89,930

89,079

Accumulated deficit

(76,925)

(72,980)

Total equity

13,008

16,102

Total liabilities and equity

$17,687

$20,745

 

 

(1)               All 2013 financial information is derived from the Company’s 2013 unaudited financial statements and all 2012 financial information is derived from the Company’s 2012 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

 

(2)               Our non-GAAP net loss is presented as management uses this supplemental non-GAAP financial measure to evaluate performance period over period, analyze the underlying trends in our business, and establish operational goals and forecasts that are used in allocating resources. We believe by presenting this additional measurement, we our providing investors with greater transparency to the information used by our management for our financial and operational decision-making, as well as allowing investors to see our results “through the eyes” of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.

 

(3)               All September 30, 2013 financial information is derived from the Company’s 2013 unaudited financial statements and all June 30, 2013 financial information is derived from the Company’s 2013 audited financial statements, as disclosed in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission.

 

(4)               Non-cash financial expenses are items related to the amortization of the discount on the convertible loan and its related issuance costs, the revaluation of warrants and the issuance of shares as a result of the anti-dilution rights of the Company’s March 2011 investors.

InspireMD’s MGuard Stent Shows Lower Mortality Rate in STEMI Patients at Twelve Months Compared to Control Group

Company to Host Conference Call Tomorrow at 5:30 a.m. PT / 8:30 a.m. ET

BOSTON, MA – October 29, 2013 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection stents, today announced new 12-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrating that the MGuard outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.  Results from the trial were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco earlier today.

Additionally, the Company will be holding an evening symposium tomorrow, October 30th, starting at 6:30 pm PT. Dr. Gregg Stone, Dr. Ori Ben-Yehuda and Dr. Jose Henriques will lead the symposium and will be joined by a panel of medical experts.

The MGuard utilizes the Company’s proprietary MicroNet™ technology, which is a circular knitted mesh that wraps around the stent to protect patients from plaque debris flowing downstream upon deployment.  This advanced technology allows the MGuard to specifically address the unmet need for STEMI patients, and save the life of those who suffer from heart attacks.

The MASTER trial achieved its primary endpoint (p value = 0.008), in complete ST-segment resolution at 60-90 minutes post-procedure. ST-segment resolution is historically known to be a strong predictor of mortality. Secondary endpoint clinical outcomes continued to show a lower mortality rate with the MGuard EPS compared to the control (1.0% vs. 3.3%, p=0.092) at 12 months.  These findings are in line with the previously announced 6 month follow-up results showing that all-cause mortality with MGuard EPS was lower than bare metal and drug eluting stents used as a control (0.5% vs. 2.8%, p=0.056).  Additional 12-month results are available at www.inspiremd.com.

“The positive follow-up data presented at TCT suggests that our MGuard EPS offers STEMI patients a higher likelihood of survival at 12 months than standard bare metal and drug eluting stents,” stated Alan Milinazzo, President and Chief Executive Officer of InspireMD. “This data further supports the evidence that positive acute results at the time the patient is treated are associated with improved outcomes at 12 months.  Additionally and importantly, the subset data we released on treatment time from symptom onset to reperfusion revealed that MGuard may increase the therapeutic window for physicians treating STEMI patients. This could be a very important factor when physicians assess clinical treatment options for their patients.”

“It is very reassuring to see that the 12-month follow up data is consistent with the acute results presented at TCT last year, especially the data that shows the mortality benefit trend of using this unique technology,” stated Prof. Dariusz Dudek, Physician-in-Chief, 2nd Department of Clinical Cardiology and Cardiovascular Interventions at the University Hospital in Krakow.  “These positive results should give clinicians the confidence to use MGuard technology as a first line of defense against distal embolization for their STEMI patients.”

The MASTER trial enrolled a total of 433 patients with STEMI presenting within 12 hours of symptom onset undergoing percutaneous coronary intervention were randomized at 50 sites in 9 countries to the MGuard EPS (n = 217) or commercially available bare metal or drug-eluting stents (n = 216).

 

Conference Call and Webcast Details

 

InspireMD will host a conference call and webcast to review 12-month MASTER trial follow-up data on Wednesday, October 30, 2013 at 8:30 a.m. ET / 5:30 a.m. PT.  To access the call, participants should call (877) 842-0788 (United States/Canada) or (317) 468-2947 (International) and request the InspireMD call or provide confirmation code 90920442. A live webcast of the call will be available on the Investor Relations section of the Company’s website at http://www.inspiremd.com/site_en/for-investors/. Please allow 10 minutes prior to the call to visit the site and download any necessary audio software.

 

A replay of the conference call will be available approximately two hours after completion of the live conference call and will be accessible until 11:59 p.m. ET on November 13, 2013. To listen to the replay, dial (855) 859-2056 (United States/Canada) or (404) 537-3406 (International) and enter code 90920442. The webcast of the event will also be archived for a limited time on the Investor Relations section of the Company’s website at http://www.inspiremd.com/site_en/for-investors/.

 

About Stenting and MGuard™ EPS

 

Standard stents were not 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 with regard to ST segment resolution, 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 seeks to utilize its proprietary MGuard™ technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

MGuard™ EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA 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, multinational 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 Annual Report on Form 10-K 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.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com  

 

InspireMD Schedules Conference Call to Discuss MASTER Trial 12-month Follow-Up Data

BOSTON, MA – October 28, 2013 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection stents, announced today that it will host a conference call to discuss its MASTER trial 12-month follow up data on October 30, 2013 at 8:30 a.m. ET / 5:30 a.m. PT.

 

Joining the call will be Alan Milinazzo, President and Chief Executive Officer, Craig Chore, Chief Financial Officer, and Dr. Campbell Rogers, a member of InspireMD’s Board of Directors.

 

Participants should call (877) 842-0788 (United States/Canada) or (317) 468-2947 (International) and request the InspireMD call or provide confirmation code 90920442. A live webcast of the call will be available on the Investor Relations section of the Company’s website at http://www.inspiremd.com/site_en/for-investors/. Please allow 10 minutes prior to the call to visit the site and download any necessary audio software.

 

A replay of the conference call will be available approximately two hours after completion of the live conference call and will be accessible until 11:59 p.m. ET on November 13, 2013. To listen to the replay, dial (855) 859-2056 (United States/Canada) or (404) 537-3406 (International) and enter code 90920442. The webcast of the event will also be archived for a limited time on the Investor Relations section of the Company’s website at http://www.inspiremd.com/site_en/for-investors/.

 

About Stenting and MGuard™ EPS

 

Standard stents were not 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 with regard to ST segment resolution, 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 seeks to utilize its proprietary MGuard™ technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

MGuard™ EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA at this time.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com

InspireMD Files At-the-Market Offering and Shelf Registration Statement

BOSTON, MA – October 24, 2013 – InspireMD Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection stents, announced today that it has filed a $75 million shelf registration statement on Form S-3 with the Securities and Exchange Commission (the “SEC”).  Once declared effective by the SEC, the shelf registration statement would permit the Company to sell, from time to time over the next three years, up to $75 million in aggregate value of its common stock, preferred stock and/or warrants, either individually or in units. The shelf registration statement is intended to provide the Company with flexibility to access additional capital when market conditions are appropriate.

 

The registration statement has been filed with the SEC, but has not yet become effective. Any offers, solicitations of offers to buy, or sales of the securities will only be made once the shelf registration statement has been declared effective by the SEC, including any prospectuses and prospectus supplements. These securities may not be sold, nor may offers to buy be accepted prior to the time that the registration statement becomes effective.

 

In addition, the Company announced today that it has filed a prospectus as part of the shelf registration statement to sell, of the $75 million of securities being registered, up to an aggregate of $40 million of its common stock (the “Shares”) through an “at-the-market” (“ATM”) offering.  If utilized, the Shares would be offered through MLV & Co. LLC (“MLV”) as sales agent. MLV, at the Company’s discretion and instruction, will use its commercially reasonable efforts to sell the Shares at market prices from time to time, including sales made directly on the NYSE MKT.  The Company currently intends to use the proceeds from any sales related to the ATM offering to support general corporate purposes, including the development of new stent technologies using its MicroNet™ technology for use in carotid and peripheral artery procedures, as well as combining MicroNet™ with other stent technologies, including drug-eluting coatings.  The Company’s agreement with MLV automatically terminates upon the earlier to occur of the three-year anniversary of the date hereof, or the issuance and sale of all of the Shares (unless earlier terminated pursuant to the terms thereof).

 

Sales in the ATM offering, if any, would be made pursuant to the prospectus filed with the shelf registration statement filed today, which has not yet become effective. The Shares may not be sold, nor may offers to buy be accepted prior to the time that the shelf registration statement becomes effective.

 

This press release is not an offer to sell the securities covered by the shelf registration statement or the Shares and it is not soliciting an offer to buy those securities in any state where the offer or sale is not permitted. For more complete information about the Company, the shelf registration statement and the ATM offering, you are encouraged to read the shelf registration statement, the ATM prospectus and other documents the Company has filed with the SEC.  You may obtain these documents on the SEC’s website at www.sec.gov.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

 

InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

MGuard™ EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA 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, multinational 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 Form 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.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com