InspireMD Provides Year End Business Update and Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2016

Transition from Exclusive Distribution Partner to Local Distributors and Internal Sales Strategy Validated by Strong Revenue Growth in Select Markets

 

BOSTON, MA—February 16, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today provided a year-end business update including an update on its new commercialization strategy.  The Company also reported financial and operating results for the fourth quarter and year ended December 31, 2016.

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “Over the past six months we have rebuilt the InspireMD management team, bringing greater focus to our sales and marketing efforts. However, revenue has yet to mirror the clinical success and physician interest we have witnessed. In 2015, we announced an exclusive distribution agreement with Penumbra, Inc., covering 18 European countries. Through Penumbra, our CGuard was largely sold to interventional neuroradiologists. In an effort to broaden our sales efforts to vascular surgeons, interventional cardiologists and interventional radiologists as well, we have decided to shift our commercial strategy to focus sales on these specialties through local distribution partners and our own internal sales initiatives. As such, we and Penumbra have agreed to transition our European efforts to an InspireMD managed direct distribution model, which focuses on regional distributors that have access to all of the aforementioned clinical specialties.  Given the positive growth we saw in 2016, with an annual increase in sales of 67% in select markets where this model has been in place and managed by InspireMD, we are very optimistic about this approach.”

“As an example of our recent success, in Italy, one of the largest markets, we experienced 59% year-over-year growth in 2016 and were able to access all four clinical specialties.  The next market we are targeting is Germany, the largest market in Europe for carotid artery stenting.  We plan to launch CGuard™ EPS in several leading German medical centers in the first half of 2017.  Once we have firmly established our presence in Germany, we believe the other European markets will rapidly follow.  We are now in advanced discussions with distributors in multiple markets including Germany, Poland, Belgium, Netherlands and Portugal. As a result, we are excited about the outlook of the business as we transition to a regional model, which we will now manage directly and expect to see similar results to our own direct distribution efforts over the last year.”

 

“Looking ahead, we are engaging new distribution partners in countries with current or near-term regulatory approval.  We recently received approval in Russia where we plan to commence sales in the first half of this year.  We also anticipate regulatory approvals in India and Mexico where we plan to launch our sales initiatives in the second half of this year. We are also pursuing partnership strategies in the Asia Pacific region.”

“As these initiatives begin to take hold, we continue to maintain strict financial discipline.  We believe InspireMD is well positioned for growth in the coming years. We appreciate the continued support of all our stakeholders and remain laser focused on driving value for shareholders.” 

 

Financial Results

Revenue for the fourth quarter ended December 31, 2016 was $322,000 compared to $516,000 during the same period in 2015. The decrease was primarily the result of a decline in sales of MGuard™ Prime EPS associated with the trend of doctors increasingly using drug eluting stents rather than bare metal stents in STEMI patients. This decrease was partially offset by a slight increase in sales of CGuard™ EPS.  Total operating expenses for the quarter ended December 31, 2016 were $2,038,000, a decrease of 17.7% compared to $2,475,000 for the same period in 2015. This decrease was primarily due to a reduction of compensation related expenses, clinical and development expenses and other savings associated with our ongoing cost reduction plan.  Net loss for the quarter ended December 31, 2016 totaled $2,268,000, or $0.88 per basic and diluted share, compared to a net loss of $2,854,000, or $9.34 per basic and diluted share, in the same period in 2015.

Revenue for the twelve months ended December 31, 2016 was $1,894,000, compared to $2,310,000 during the same period in 2015. The decrease was predominantly driven by the aforementioned decline in sales of MGuard™ Prime EPS. This decrease was partially offset by an increase in sales of $444,000 of CGuard™ EPS. Total operating expenses for the twelve months ended December 31, 2016 were $7,750,000, a decrease of 45.4% compared to $14,189,000 for the same period in 2015. This decrease was primarily due to a reduction of compensation related expenses, clinical and development expenses, restructuring and impairment costs, consulting fees and other savings associated with our ongoing cost reduction plan. Net loss for the twelve months ended December 31, 2016 totaled $8,461,000, or $5.93 per basic and diluted share, compared to a net loss of $15,585,000, or $55.85 per basic and diluted share, in the same period in 2015.

As of December 31, 2016, cash and cash equivalents were $7,516,000, compared to $3,257,000 as of December 31, 2015. The Company also disclosed in its Annual Report on Form 10-K for the year ended December 31, 2016, which was filed on February 16, 2017 with the Securities and Exchange Commission, the audited financial statements contained a going concern qualification paragraph in the audit opinion from its independent registered public accounting firm.  See further discussion in Note 1 to the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K.  This announcement is made pursuant to NYSE MKT Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company’s consolidated financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2016.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

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) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) 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 (xiii) 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.

 

  

Feb 2017 A

 

 

Feb 2017 B

 

 

Feb 2017 C

 

 

(1) All financial information for the twelve months ended December 31, 2016 is derived from the Company’s 2016 audited financial statements and all financial information for the twelve months ended December 31, 2015 is derived from the Company’s 2015 audited financial statements, as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2016 filed with the Securities and Exchange Commission. All financial information for the three months ended December 31, 2016 and 2015 is derived from the Company’s unaudited, internal financial statements.
(2) All December 31, 2016 financial information is derived from the Company’s 2016 audited financial statements and all December 31, 2015 financial information is derived from the Company’s 2015 audited financial statements, as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2016 filed with the Securities and Exchange Commission.
 

InspireMD’s CGuard™ Carotid Embolic Prevention System to be Featured at LINC 2017

PD Dr. Andrej Schmidt to perform live case transmission
of carotid stent surgery utilizing CGuard™

BOSTON, MA– January 24, 2016 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced that its CGuard™ Carotid Embolic Prevention System will be featured in three tracks at the Leipzig Interventional Course (LINC) 2017 to be held January 24th to 27th at the Trade Fair Leipzig, Hall 2 in Leipzig Germany. 

On January 24, from 4:30 – 6:00 PM Central European Time, PD Dr. Andrej Schmidt and Dr. Sven Bräunlich from the Department of Angiology, University Hospital Leipzig, Division of Interventional Angiology, Leipzig, Germany will perform a live stent endovascular interventional procedure featuring the CGuard™ EPS Carotid Stent that will be transmitted real time to the congress. PD Dr. Andrej Schmidt is also a member of the LINC Scientific Committee.

The CGuard™ Carotid Embolic Prevention System will be featured at Penumbra, Inc.’s booth (15c).

LINC is a leading global forum for new methods in the field of vascular medicine. LINC brings together medical professionals from different specialties around the world who perform endovascular interventions.

Sessions featuring CGuard™ will include:

 

What:               Clinical results and mechanical properties of a novel double-layered carotid stent
                          (C. Wissgott)

When:              January 24: 3:35 – 3:40 PM Central European Time

Where:            Speakers’ Corner

 

What:               Early results of a prospective registry of carotid stenting with the new CGuard™
                          mesh covered stent in real world: The IRON-GUARD registry (L. Capoccia)

When:              January 24: 3:45 – 3:50 PM Central European Time

Where:            Speakers’ Corner

 

What:               CGuard™ embolic prevention system (EPS) – routine use in carotid revascularisation for

                          stroke prevention: Accumulating clinical evidence (P. Musialek)

When:              January 26: 12:35 – 1:20 PM Central European Time

Where:            Room 3 – Technical Forum

 

“We are excited to have CGuard™ featured so prominently at LINC 2017,” said James Barry, PhD, Chief Executive Officer of InspireMD.  “It is an even greater honor to have a professor of Dr. Schmidt’s stature perform a live broadcast of a carotid stent procedure featuring our technology.”

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

Investor Contacts:

InspireMD, Inc.

Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com   

 

Crescendo Communications, LLC

David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com

InspireMD Announces Change in Presentation Time at LD Micro Main Event Conference to Tuesday, December 6 at 4:30PM PT

BOSTON, Mass. – December 5, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced a change in the Company’s presentation time at the LD Micro 9th Annual Main Event on Tuesday, December 6 in Los Angeles, California. Chief Financial Officer, Craig Shore, will now present at 4:30pm PT. Mr. Shore will provide a corporate overview and discuss the Company’s proprietary MicroNet™ technology, which has been developed to address key issues found with current stenting options.

A live webcast of the presentation will be available in the investor section of the Company’s website or by clicking here. A replay will be available on the Company’s website or by clicking here following the presentation.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

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) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) 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 (xiii) 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:

InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone:   1-888-776-6804 FREE
Email: craigs@inspiremd.com

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
Email: dcarey@lazarpartners.com

InspireMD to Present at LD Micro Main Event on December 6

BOSTON, Mass. – November 28, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced that Chief Financial Officer Craig Shore will present at the LD Micro 9th Annual Main Event on Tuesday, December 6, 2016 at 7:30 a.m. PT in Los Angeles, California. Mr. Shore will provide a corporate overview and discuss the Company’s proprietary MicroNet™ technology, which has been developed to address key issues found with current stenting options.

A live webcast of the presentation will be available in the investor section of the Company’s website or by clicking here. A replay will be available on the Company’s website or by clicking here following the presentation.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

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) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) 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 (xiii) 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:

 InspireMD, Inc.

Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
dcarey@lazarpartners.com

InspireMD Reports Financial Results for the Third Quarter Ended September 30, 2016

– Company to Host Conference Call Today at 4:30pm ET –

BOSTON, MA – November 14, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced financial and operating results for the third quarter and nine months ended September 30, 2016, and provided a business update.

“We have been very active these last few months building a foundation for commercial, corporate, and regulatory success, and executing our strategy for realizing the value of our lead product, the CGuard™ Embolic Prevention System. There continues to be a growing body of data on CGuard, including recent data published in the Journal of Endovascular Therapy and long term follow-up data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium. These clinical data continue to showcase the benefits of this innovative device, including long-term reduction of post-procedural embolization, resulting in less complications for patients,” said James Barry, PhD, Chief Executive Officer of InspireMD. “These important data will help to support our marketing efforts as we look to expand our sales into new geographies and to grow sales in existing areas. Reinforced by the key addition of Agustin Gago as the Company’s new Chief Commercial Officer and plans for an IDE submission in the United States in 2017, InspireMD is poised for growth on several fronts in the coming quarters.”

 

Recent Highlights:

FINANCIAL

  • Closing of a $14.6 million public offering of approximately 442,424 shares of Series B Convertible preferred stock and warrants to purchase up to 1,769,696 shares of common stock (post reverse split)
  • Regained compliance with the NYSE MKT listing standards
  • Completed 1-to-25 reverse stock split

 

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

  • Received regulatory approval to commercialize the CGuard™ Embolic Prevention System for the treatment of carotid artery disease in Russia.
  • 12-month follow up data from PARADIGM-101, an investigator-initiated clinical trail of CGuard™, were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium in Washington, D.C. The study found device and procedure success were each 99.1%, with vessel narrowing reduced from 83±9% to only 6.7±5%, and 0% peri-procedural death/major stroke/myocardial infarction (MI), along with a normal healing profile at 12 months.
  • An independent study titled “Clinical Results and Mechanical Properties of the Carotid CGUARD™ Double-Layered Embolic Prevention Stent,” was published in the Journal of Endovascular Therapy. The study found 100% success in implanting the CGuard™ EPS, no peri- or post-procedural complications, no deaths or major adverse events, and all vessels treated with the CGuard system remained patent (open) at six months.

 

INTELLECTUAL PROPERTY

  • Received Notice of Allowance from the U.S. Patent & Trademark Office for a continuation of a patent titled “Optimized Drug-eluting Stent Assembly.” The parent patent, U.S. Patent No. 9,132,003, was originally issued in September 2015. The previously issued and currently allowed patents cover a stent assembly with the Company’s proprietary MicroNet™ technology that elutes a drug.

 

EXECUTIVE APPOINTMENTS

  • In September, InspireMD appointed Thomas Kester to its Board of Directors and as Chairman of the Company’s Audit Committee. Mr. Kester has 40 years of public accounting experience as well as board member experience of publicly traded companies.
  • In October, Agustin Gago was appointed as Executive Vice President and Chief Commercial Officer of InspireMD. Mr. Gago brings over 25 years of industry experience, including senior management positions leading international commercial sales and marketing organizations.


 

UPCOMING Commercial AND REGULATORY MILESTONES

  • Commercial launch of CGuard™ EPS in Brazil in the first half of 2017.
  • Commercial launch of CGuard™ EPS in India in the second half of 2017.
  • 2017 Investigational Device Exemption (IDE) submission to the FDA.

 

Third Quarter 2016 Financial Results

Revenue for the third quarter ended September 30, 2016 was $469,000 compared to $632,000 during the same period in 2015. The decrease was primarily the result of an expected decline in sales of MGuard™ Prime EPS associated with the trend of doctors increasingly using drug eluting stents rather than bare metal stents in STEMI patients. There was no material change in the sales of CGuard™ EPS, the Company’s carotid product.

The Company’s gross profit for the quarter ended September 30, 2016 was $31,000 compared to $89,000 for the same period in 2015. The decrease in gross profit was largely attributable to a decrease in product revenues and an increase in expenses related to the underutilization of our manufacturing resources, offset by a decrease in labor and material costs attributable to lower revenues.

Total operating expenses for the quarter ended September 30, 2016 were $1,801,000, a decrease of 48.5% compared to $3,500,000 for the same period in 2015. This decrease was primarily due to a reduction of compensation related expenses, consultant fees and other savings associated with our ongoing cost reduction plan.

The loss from operations for the quarter ended September 30, 2016 was $1,770,000, a decrease of 48.1% compared to a loss of $3,411,000 for the same period in 2015.

For the quarter ended September 30, 2016, there was no material change in financial expenses compared to the same period in 2015.

The net loss for the quarter ended September 30, 2016 totaled $2.0 million, or $0.86 per basic and diluted share, compared to a net loss of $3.6 million, or $11.93 per basic and diluted share, in the same period in 2015.

 

Nine Months Ended September 30, 2016 Financial Results

Revenue for the nine months ended September 30, 2016 was $1,572,000 compared to $1,794,000 during the same period in 2015. The decrease was predominantly driven by an expected decline in sales of MGuard™ Prime EPS associated with the trend of doctors increasingly using drug eluting stents rather than bare metal stents in STEMI patients. This decrease was partially offset by an increase in sales of $415,000 of CGuard™ EPS.

The Company’s gross profit for the nine months ended September 30, 2016 was $158,000 compared to a gross loss of $160,000 for the same period in 2015. This increase in gross profit was largely attributable to a decrease of write-offs of MGuard™ Prime EPS inventory and a decrease in labor and material costs attributable to lower revenues, offset by expenses related to the underutilization of our manufacturing resources and a decrease in product revenues.

Total operating expenses for the nine months ended September 30, 2016 were $6,116,000, a decrease of 47.8% compared to $11,714,000 million for the same period in 2015. This decrease was primarily due to a reduction of compensation related expenses, restructuring and impairment costs, clinical and development expenses and other savings associated with our ongoing cost reduction plan.

The loss from operations for the nine months ended September 30, 2016 was $5,958,000, a decrease of 49.8% compared to a loss of $11,874,000 for the same period in 2015.

Financial expenses for the nine months ended September 30, 2016 were $638,000, a decrease of 25.5% compared to the same period in 2015. This decrease was primarily due to a reduction in interest expense of our outstanding loan.

The net loss for the nine months ended September 30, 2016 totaled $6,597,000, or $6.37 per basic and diluted share, compared to a net loss of $12,731,000, or $47.13 per basic and diluted share, in the same period in 2015.

 

Cash and Cash Equivalents

As of September 30, 2016, cash and cash equivalents were $10,468,000, compared to $3,257,000 as of December 31, 2015.

 

Conference Call

The company has scheduled a conference call to discuss third quarter 2016 financial results for today at 4:30 pm Eastern Time. To participate in the conference call, please dial 866-652-5200 (United States) or 412-317-6060 (International) and request the InspireMD call. A live webcast will be available in the Investor Relations section of the Company’s website or by clicking here. 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 two hours following the call and will be accessible in the Investor Relations section of the Company’s website or by clicking here. A dial-in replay of the call will also be available to those interested until November 28, 2016. To access the replay, dial 877-344-7529 (United States) or 412-317-0088 (International) and enter code 10095759.

 

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

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) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) 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 (xiii) 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:

InspireMD, Inc.

Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com

 

Lazar Partners

David Carey
Investor Relations
(212) 867-1768
Email: dcarey@lazarpartners.com

 

 

 

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(1) All 2016 financial information is derived from the Company’s 2016 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission, all 2015 financial information is derived from the Company’s 2015 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

 

2) All September 30, 2016 financial information is derived from the Company’s 2016 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2015 financial information is derived from the Company’s 2015 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2015 filed with the Securities and Exchange Commission. 

 

 

InspireMD Announces CGuardTM Embolic Prevention System Commercialization Approval in Russia

BOSTON, MA – November 14, 2016 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced that it has received regulatory approval to commercialize the CGuardTM Embolic Prevention System for the treatment of carotid artery disease in Russia. The approval was granted by Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor). According to a presentation titled “Carotid Stenting and Surgery in 2016 in Russia” at Novosibirsk Research Institute of Circulation Pathology, the Management Board Report of Russian Society of Angiology and Vascular Surgeons reported that Russia, among all European countries, has the highest rate of mortality from cerebrovascular disease. The presentation[i] concluded that carotid stenting in Russia has been increased among carotid reconstructions

 

“The approval of CGuardTM in Russia is another important commercial milestone for the Company’s continued growth,” said James Barry, PhD, Chief Executive Officer of InspireMD, “With this approval coming on the heels of our positive 12-month follow up data from PARADIGM-101, we are pleased to bring this technology to another important market in the global marketplace.”

As previously announced, Prof. Piotr Musialek, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases, in Krakow, Poland, reported 12-month follow up data from PARADIGM-101 at the Transcatheter Cardiovascular Therapeutics 2016 scientific symposium. PARADIGM-101 is an investigator-led clinical study evaluating the use of CGuard™ EPS in 101 consecutive patients with carotid artery stenosis. A link to the data results and presentation can be accessed: https://www.inspiremd.com/en/wp-content/uploads/TCT_16.-PARADIGM-12M_-Piotr-Musialek.pdf

 

About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous

cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system. Dr. Musialek previously presented data from the first cohort in the PARADIGM study, which comprised 71 CGuard™ EPS procedures in unselected all-comer patients, at EuroPCR 2015. The early outcome data in the target cohort of 101 patients were presented as a Late-Breaking Clinical Trial at EuroPCR 2016 and were simultaneously published in EuroIntervention. These data showed a 100% success rate for the CGuard Embolic Prevention System during the placement procedure. Importantly, there were no procedure-related complications during CGuardTM EPS placement and at 30 days post procedure. Similarly, there were no major adverse cardiac or neurological events, as determined by operator-independent neurologist and non-invasive cardiologist evaluation. The new data presented at TCT are important because they confirm safety and durability of the CGuardTM EPS innovative treatment over 12 months.

 

About CGuard™ EPS

The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate (PET).

CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

Carotid stenosis is a narrowing of the carotid arteries, the major arteries that supply blood and oxygen to the brain. This narrowing results from a buildup of plaque inside the blood vessel and reduces blood flow to the brain. The presence of plaque in the blood vessel can also cause the development of blood clots, which may also reduce blood flow to the brain. In some cases, plaque may rupture or dislodge from the vessel wall and block smaller downstream arteries. Patients with carotid stenosis have an increased risk of stroke as a result of cerebral embolism and decreased blood flow to the brain.

Patients with symptomatic carotid stenosis are typically treated by placement of a stent inside the blood vessel in order to re-open the carotid artery and improve blood flow to the brain. InspireMD’s CGuardTM EPS uses the company’s patented MicroNet™ technology to provide the revascularization benefits of a stent with a mesh “safety net” that secures the plaque against the blood vessel’s arterial wall and thereby prevents plaque and other debris from flowing through the stent’s scaffold. 

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

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) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) 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 (xiii) 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:

InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com

 

Lazar Partners
David Carey
Investor Relations
Phone: (212) 867-1768
Email: dcarey@lazarpartners.com


 

 

[i] Starodubtsev V, Karpenko A, Ignatenko P. Carotid stenting and surgery in 2016 in Russia. Novosibirsk Research Institute of Circulation Pathology. 2016. http://acst-2.org/onewebmedia/10.Starodubtsev.pdf. Accessed November, 13, 2016.

 

InspireMD to Report Third Quarter Financial Results on Monday, November 14, 2016

BOSTON, MA – November 7, 2016 – InspireMD, Inc. (NYSE MKT: NSPR.WS), a leader in embolic protection systems, announced today that it will release its financial results for the third quarter ended September 30, 2016 on Monday, November 14 after the market close, followed by a conference call at 4:30 p.m. ET to review results and provide a company update.

 

Participants should call 866-652-5200 (United States) or 412-317-6060 (International) and request the InspireMD call. A live webcast will be available in the Investor Relations section of the Company’s website or by clicking here

 

An archive of the webcast will be available approximately two hours following the call and will be accessible in the Investor Relations section of the Company’s website or by clicking here.  A dial-in replay of the call will also be available to those interested until November 28, 2016.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

Investor Contacts:

InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
Email: dcarey@lazarpartners.com

InspireMD CGuard™ Embolic Prevention System 12-Month Clinical Trial Data Further Validate Potential of CGuard™ to Improve Management of Carotid Artery Disease and Prevent Stroke

BOSTON, MA – November 1, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced 12-month follow up data from PARADIGM-101 of the CGuard™ Embolic Prevention System (EPS) which were presented in two presentations at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium, taking place October 29 – November 2 in Washington, D.C. at the Walter E. Washington Convention Center.

In an oral presentation today in the Featured Clinical Research Session titled “Twelve-month Safety and Efficacy of CGuard™ MicroNet™-Covered Embolic Prevention Stent System: Routine Use to Perform Carotid Revascularization in Symptomatic and Increased Stroke Risk Asymptomatic Patients: The PARADIGM All-Comer Prospective Academic Study,” Prof. Piotr Musialek, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases, in Krakow, Poland, reported 12-month follow up data from PARADIGM-101. PARADIGM-101 is an investigator-led clinical study evaluating the use of CGuard™ EPS in 101 consecutive patients with carotid artery stenosis. Key findings from the presentation included:

  • Zero device-related adverse events at 12 months
  • CGuardTM EPS device and procedure success were each 99.1%. The device showed excellent placement precision, and there was no foreshortening or elongation
  • Vessel narrowing was reduced from 83±9% to only 6.7±5% (p<0.001) by independent core lab analysis
  • Peri-procedural death/major stroke/myocardial infarction (MI) was 0%.
  • One peri-procedural event was adjudicated by the Clinical Events Committee as a minor stroke (0.9%), with no change in NIH Stroke Scale or modified Ranking scale and no clinical sequel
  • At 12 months the device showed a normal healing profile, and the patency of the external carotid artery was normal

“These data further reinforce the strong safety and efficacy profiles reported in previous trials of the CGuardTM EPS, and validate the system as an important option for endovascular management of patients with carotid artery disease,” said Prof. Musialek. “Importantly, the very low incidence of peri- or post-procedural complications and stroke create a positive risk-benefit profile for CGuardTM EPS in patients with asymptomatic carotid artery disease. These patients are frequently denied intervention due to fear of the complications associated with conventional intervention, and are left with a substantial risk of stroke when treated only with medication. Our study found that CGuardTM EPS is applicable in up to 90% of all-comer patients with carotid stenosis. These data indicate that CGuardTM EPS may fundamentally alter the paradigm for managing patients with carotid artery disease, whether they have symptoms or not.”

 

In addition, a poster titled “Highly Calcific Carotid Lesions Endovascular Revascularizaton Using a Novel Dual-layer Carotid Stent System CGuard™: Analysis from the PARADIGM Study,” was presented by Adam Mazurek, MD, also from the Jagiellonian University Department of Cardiac & Vascular Diseases. Dr. Mazurek’s study described the use of CGuardTM EPS to treat highly calcific carotid stenosis. Because patients with highly calcified carotid lesions are typically contraindicated for endovascular intervention due to suboptimal procedural outcomes with conventional stents, CGuard provides an important new treatment solution.

 

Key findings from Dr. Mazurek’s presentation included:

  • 16 of the 101 patients in PARADIGM-101 had hepatocellular carcinoma (HCC) lesions
  • No difference in procedural success rates with CGuardTM EPS between highly calcified lesions and other lesions treated in this trial
  • Use of CGuardTM EPS in management of highly calcified lesions was safe, with no neurologic or cardiac events during the procedure and during the stent healing period
  • Highly calcified lesions treated with CGuardTM EPS showed no restenosis at 12 months

“Highly calcified lesions are particularly difficult to manage with conventional endovascular intervention due to the difficulty in achieving optimal procedure results on one hand, and the risk of carotid artery rupture or perforation on the other. Patients with these lesions remain at risk of stroke, and they require a safe treatment,” said Dr. Mazurek. “The results of this study show that the design and mechanical properties of CGuardTM EPS enable safe and effective endovascular management and revascularization of highly calcified lesions. I believe CGuardTM EPS has significant potential as a new approach to managing these difficult lesions and reducing the risk of stroke in patients with highly calcified lesions. Additional studies of CGuard EPSTM in this patient population should further validate common use of this innovative embolic prevention stent system to improve the treatment and outcomes of carotid artery disease.”

The data presented at TCT add to a growing body of clinical evidence validating the use of the CGuard as a proven treatment for both symptomatic and asymptomatic patients with carotid artery disease.

 

About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous

cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system. Dr. Musialek previously presented data from the first cohort in the PARADIGM study, which comprised 71 CGuard™ EPS procedures in unselected all-comer patients, at EuroPCR 2015. The early outcome data in the target cohort of 101 patients were presented as a Late-Breaking Clinical Trial at EuroPCR 2016 and were simultaneously published in EuroIntervention. These data showed a 100% success rate for the CGuard Embolic Prevention System during the placement procedure. Importantly, there were no procedure-related complications during CGuardTM EPS placement and at 30 days post procedure. Similarly, there were no major adverse cardiac or neurological events, as determined by operator-independent neurologist and non-invasive cardiologist evaluation. The new data presented at TCT are important because they confirm safety and durability of the CGuardTM EPS innovative treatment over 12 months.

 

About CGuard™ EPS

The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate (PET).

CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

Carotid stenosis is a narrowing of the carotid arteries, the major arteries that supply blood and oxygen to the brain. This narrowing results from a buildup of plaque inside the blood vessel and reduces blood flow to the brain. The presence of plaque in the blood vessel can also cause the development of blood clots, which may also reduce blood flow to the brain. In some cases, plaque may rupture or dislodge from the vessel wall and block smaller downstream arteries. Patients with carotid stenosis have an increased risk of stroke as a result of cerebral embolism and decreased blood flow to the brain.

Patients with symptomatic carotid stenosis are typically treated by placement of a stent inside the blood vessel in order to re-open the carotid artery and improve blood flow to the brain. InspireMD’s CGuardTM EPS uses the company’s patented MicroNet™ technology to provide the revascularization benefits of a stent with a mesh “safety net” that secures the plaque against the blood vessel’s arterial wall and thereby prevents plaque and other debris from flowing through the stent’s scaffold.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

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) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) 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 (xiii) 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:

InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com

 

Lazar Partners
David Carey
Investor Relations
Phone: (212) 867-1768
Email: dcarey@lazarpartners.com

 

Long-term Clinical Data on InspireMD’s CGuard™ Embolic Prevention System to be Presented at Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium

Presentations Highlight Potential for CGuard™ to Improve
Management of Carotid Artery Disease and Prevent Stroke

BOSTON, MA – October 27, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced that 12-month follow up data from PARADIGM-101, an investigator led clinical trial evaluating the Company’s CGuard™ Embolic Prevention System (EPS), will be discussed in two presentations at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium, taking place October 29 – November 2 in Washington, D.C. at the Walter E. Washington Convention Center.

PARADIGM-101 is a clinical study evaluating the use of CGuard™ EPS in 101 consecutive patients with carotid artery stenosis (CAS). The study included patients with symptoms of CAS as well as asymptomatic patients who had an increased risk of stroke.

Prof. Piotr Musialek, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases in Krakow, Poland, will deliver an oral presentation titled “Twelve-month Safety and Efficacy of CGuard™ MicroNet™-Covered Embolic Prevention Stent System Routine Use to Perform Carotid Revascularization in Symptomatic and Increased-Stroke-Risk Asymptomatic Patients: The Carotid Revascularization PARADIGM All-Comer Prospective Academic Study”. 

  • Presentation Date/Location/Time: Tuesday, November 1, in Room 209, Level 2 of the convention center at 9:32am EDT
  • Track: Interventional Innovation III: Early Feasibility and First in-Human Studies
  • Session III: Peripheral Vascular Disease Technologies II

 

Adam Mazurek, MD, also from the Jagiellonian University Department of Cardiac & Vascular Diseases John Paul II Hospital will present additional analysis of PARADIGM-101 data in a poster titled “Highly Calcific Carotid Lesions Endovascular Revascularizaton Using a Novel Dual-layer Carotid Stent System CGuard™: Analysis from the PARADIGM Study” (Abstract #796)

  • Presentation Date/Location/Time: Saturday, October 29, in Hall B, Lower Level of the convention center from 6:00-8:00pm ET

 

About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous

cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system. Dr. Musialek previously presented data from the PARADIGM study, which comprised 71 CGuard™ EPS procedures in unselected all-comer patients, at EuroPCR 2015. These data showed a 100% success rate for the CGuard System and the placement procedure. Additionally, there were no procedure-related complications during CGuard placement or at 30 days post procedure. Similarly, there were or major adverse cardiac or neurological events, as determined by operator-independent neurologist and non-invasive cardiologist evaluation, during CGuard placement or at the 30-day time point.

 

About CGuard™ EPS

The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate (PET).

CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

Carotid stenosis is a narrowing of the carotid arteries, the major arteries that supply blood and oxygen to the brain. This narrowing results from a buildup of plaque inside the blood vessel and reduces blood flow to the brain. The presence of plaque in the blood vessel can also cause the development of blood clots, which may also reduce blood flow to the brain. In some cases, plaque may rupture or dislodge from the vessel wall and block smaller downstream arteries. Patients with carotid stenosis have an increased risk of stroke as a result of cerebral embolism and decreased blood flow to the brain.

Patients with symptomatic carotid stenosis are typically treated by placement of a stent inside the blood vessel in order to re-open the carotid artery and improve blood flow to the brain. InspireMD’s CGuardTM EPS uses the company’s patented MicroNet™ technology to provide the revascularization benefits of a stent with a mesh “safety net” that secures the plaque against the blood vessel’s arterial wall and thereby prevents plaque and other debris from flowing through the stent’s scaffold.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

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) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) 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 (xiii) 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:

InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com

 

Lazar Partners

David Carey
Investor Relations
Phone: (212) 867-1768
Email: dcarey@lazarpartners.com

 

InspireMD Announces Appointment of Medical Device Industry Veteran Agustin Gago as Chief Commercial Officer

BOSTON, MA – October 26, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced the appointment of Agustin Gago as the Company’s Executive Vice President and Chief Commercial Officer. In this role, Mr. Gago will be responsible for  developing and implementing InspireMD’s global sales, distribution and marketing strategy for the Company’s CGuard™ EPS, MGuard Prime EPS™, as well as all future pipeline products.

“I am excited to welcome Agustin to the InspireMD team”, said James Barry, PhD, Chief Executive Officer of InspireMD. “Agustin brings a wealth of experience in building and leading global commercial organizations. He will be an invaluable asset to InspireMD as we focus on expanding company sales in the global market place. His successful track record and comprehensive expertise in cardiology, oncology and diagnostic imaging will strengthen our sales and marketing organization. Agustin will be a key addition to our management team as we focus on revenue growth and broadening our product pipeline.”

Mr. Gago has over 25 years of experience in building profitable international commercial, sales and marketing organizations. Before joining InspireMD, he served as a Principal at Dash International, LLC, a consulting firm he founded in 2013, advising CEOs and Boards of Directors of major medical device companies on business strategy. Prior to this, he served as Chief Commercial Officer at Delcath Systems, Inc., an interventional oncology company, creating its direct and contract sales forces as well as a distributor infrastructure serving Europe, Asia and South America. Before his time at Delcath Systems, Mr. Gago was Vice President of International Oncology Surgery Sales at AngioDynamics, Inc., a provider of minimally invasive medical devices for cardiology vascular disease and oncology. There, he was also responsible for the launch of their interventional cardiology product line.  Mr. Gago also worked for 10 years in various leadership roles at E-Z-EM, Inc., a global manufacturer of medical devices and contrast agents for gastrointestinal imaging, eventually being appointed Vice President of Global GI Business and Vice President of International Operations. Mr. Gago is fluent in several foreign languages including Spanish and Portuguese.

“I am pleased to be joining InspireMD, a company whose cutting-edge technology and products have the potential to truly be a game changer for patients with carotid artery, neurovascular and coronary artery disease,” said Mr. Gago. “I look forward to working with my new team to advance InspireMD’s position and products within the Global market place.”

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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 (CGuardTM), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

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) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) 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 (xiii) 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:

InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
Email: dcarey@lazarpartners.com