InspireMD’s CGuard™ Carotid Embolic Prevention System to be Featured at ICCA Stroke 2017 in Moscow, Russia

BOSTON, MA—March 23, 2017 – 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 at the ICCA Stroke 2017 to be held March 24th-25th at the Vishnevskiy Institute of Surgery of the Ministry of Public Health in Moscow, Russia.

ICCA Stroke is an interdisciplinary and interactive course with leading experts in the field, recorded cases, step by step presentations, debates and hands-on workshops on catheter-based treatment of acute stroke.

Sessions featuring CGuard™ will include:

 

When: March 24th, 10:45 – 11:45

Where: Main Area

Symposium: CGuard Embolic Prevention Stent System – A new paradigm in carotid stenting 

Moderator: Horst Sievert, MD / Panagiotis Papanagiotou, MD
Panelist: Piotr Musialek, MD /  Ivo Petrov, MD / Bernhard Reimers, MD/ Sergey V. Volkov MD / Christian Wissgott, MD

CGuard Embolic Prevention System (EPS) – Routine use in carotid revascularization for stroke prevention: accumulating clinical evidence
Speaker: Piotr Musialek, MD, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases in Krakow, Poland

Clinical results and mechanical properties of a Novel Dual Layer Carotid Stent
Speaker: Christian Wissgott, MD, Assistant Director at Westkustenklinikum, Heide, Germany

CGuard challenging cases 

Case 1
Speaker: Ivo Petrov, MD

Case 2
Speaker: Sergey V. Volkov, MD

Case 3
Speaker: Bernhard Reimers, MD

When: March 24th, 14:45 – 15:45

Where: Main Area

 

Session 5: Case examples of carotid stenting and acute stroke interventions

Moderator: Klaus Mathias, MD/ Bagrat Alekyan, MD
Panelist: Iris Grunwald, MD / Kenneth Snyder, MD / Alexander Drofa, MD

Complex Carotid Stent Case

Speaker: Piotr Musialek, MD

  

The CGuard™ Carotid Embolic Prevention System will also be featured at InspireMD’s Booth throughout the event.


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.

 

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 Repays Term Note Ahead of Schedule

Tel Aviv—March 22, 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 announced that it has repaid the remaining balance of $1.2 million on its term loan facility with Hercules Technology Growth Capital, Inc.  All liens and security interests granted to Hercules by the Company and its subsidiaries in connection with the term loan facility have been released.   

Craig Shore, Chief Financial Officer of InspireMD, commented, “We are pleased to have repaid the balance of our term loan ahead of schedule.  As a result, we have no remaining debt.  We continue to carefully manage expenses while pursuing a cost-effective, yet aggressive sales and marketing strategy for CGuard™ EPS through distibution partners across Europe and around the world.”

 

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 payors 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   

 

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

InspireMD Announces Distribution Agreement for CGuard™ EPS in Hong Kong

BOSTON, MA—March 21, 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 announced it has signed a distribution agreement for CGuard™ EPS with a distributor partner in Hong Kong.

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are pleased to announce this latest agreement with a leading medical device distribution partner for Hong Kong, which represents an important step in our planned expansion into the Asian market.  Hong Kong, a Special Administrative Region of the People’s Republic of China, has a population of approximately 7.2 million. Our partner has a strong physician network across all the relevant clinical specialties that treat carotid artery disease. Moreover, this agreement includes minimum required purchases for CGuard™ EPS, which reinforces their confidence in the market potential. We look forward to announcing additional distributor agreements across Asia throughout this year.”

 

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.

 

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 CGuardTM Distribution Agreement for the Russian Federation

Tel Aviv—March 20, 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 announced it has signed an agreement with Nerin Assets OU (“Nerin”), a leading regional distributor, covering the Russian Federation to distribute CGuardTM EPS (Embolic Prevention System).

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “In addition to refocusing our distribution strategy across Europe, we are also aggressively entering new global markets.  At the end of last year, we received regulatory approval for CGuardTM EPS in Russia.  We have since moved swiftly to sign an agreement with one of the leading distributors in the country and are in the midst of preparation for launch during this quarter. Nerin has relationships with the top physicians from all the clinical specialties treating carotid artery disease, enabling us to penetrate all market segments in the Russian Federation. The agreement includes minimum required purchases and Nerin plans to expand its sales force and clinical specialists to focus on CGuardTM EPS.”

Mr. Daniel Golubtsov, Managing Director of Nerin Assets OU, stated, “We are very pleased to be working with InspireMD and see the CGuardTM as a game changing medical device for treating carotid artery disease with potentially dramatic safety advantages over both conventional carotid stents as well as surgical options. We see significant potential for CGuardTM in Russia as this is a sizeable market with the highest per capita prevalence of carotid artery disease and stroke in Europe, where carotid artery stenting is increasingly becoming the preferred intervention versus surgery.”

 

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.

 


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 Reports Continued Progress in the Transition of European Sales and Distribution

Announces Agreements with Leading Distributors in the Baltic States

 

BOSTON, MA—March 15, 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 announced it has signed agreements with distributors in Estonia, Lithuania and Latvia as part of its strategy to transition from a single distributor in a number of European markets for its CGuard™ EPS.

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “As recently announced, with the objective to broaden our sales effort and reach all the clinical specialties that treat carotid disease, we are transitioning away from our single distributor that covered 18 European countries, in favor of local distribution partners that have a greater footprint in their respective territories. Our experience shows that in countries where we have followed this model we can achieve meaningful growth.  Our new partners in the Baltics are among the top distributors in the region. We continue to experience significant interest in CGuard™ EPS from additional distributors across Europe and look forward to announcing further agreements in the near future.”


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.

 

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 Closing of Public Offering of Approximately $6.8 Million

BOSTON, MA – March 14, 2017 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the closing of a “best efforts” public offering of 1,069,822 shares of Series C Convertible Preferred Stock, Series B warrants to purchase 4,279,288 shares of common stock and Series C warrants to purchase 4,279,288 shares of common stock. Each share of Series C Convertible Preferred Stock is initially convertible into 4 shares of common stock at a conversion price equal to $1.60 per share.  The Series B warrants shall be exercisable immediately and have a term of exercise of five years from the date of issuance and have an exercise price of $2.00 per share of common stock.  The Series C warrants shall be exercisable immediately and have a term of exercise of six months from the date of issuance and have an exercise price of $1.60 per share of common stock. The Company received gross proceeds of approximately $6.8 million from the offering, before deducting placement agent fees and offering expenses payable by the Company.

The Company intends to use the net proceeds from the offering to further fund the expansion of its sales and marketing activities for CGuard ™ EPS and MGuard ™ Prime EPS. If the Company receives sufficient proceeds from the exercise of the Series C warrants, the Company plans to continue the development of and manufacturing enhancements for CGuard EPS and further its efforts to obtain an Investigational Device Exemption approval for CGuard EPS.

Dawson James Securities, Inc. acted as the sole placement agent. 

The securities sold in the offering described above were offered pursuant to a registration statement on Form S-1 which was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on March 8, 2017. A final prospectus supplement relating to the offering was filed with the SEC on March 10, 2017. Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from Dawson James Securities, Inc., Attention: Prospectus Department, 1 North Federal Highway, 5th Floor, Boca Raton, FL 33432, mmaclaren@dawsonjames.com or toll free at 866.928.0928.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.


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.

 

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 Pricing of Public Offering of up to $7.5 Million

BOSTON, MA – March 9, 2017 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the pricing of a “best efforts” public offering of up to 1,171,875 shares of Series C Convertible Preferred Stock, Series B warrants to purchase up to 4,687,500 shares of common stock and Series C warrants to purchase up to 4,687,500 shares of common stock. Each share of Series C Convertible Preferred Stock is convertible into 4 shares of common stock at a conversion price equal to $1.60 per share.  The Series B warrants shall be exercisable immediately and have a term of exercise of five years from the date of issuance and have an exercise price of $2.00 per share of common stock.  The Series C warrants shall be exercisable immediately and have a term of exercise of six months from the date of issuance and have an exercise price of $1.60 per share of common stock. The Company expects to receive gross proceeds of up to $7.5 million from the offering, before deducting placement agent fees and estimated offering expenses payable by the Company, assuming completion of the maximum offering.

 

The offering is expected to close on or about March 14, 2017, subject to customary closing conditions.

The Company intends to use the net proceeds from the offering to further fund the expansion of its sales and marketing activities for CGuard ™ EPS and MGuard ™ Prime EPS. If the Company receives sufficient proceeds from the exercise of the Series C warrants, the Company plans to continue the development of and manufacturing enhancements for CGuard EPS and further its efforts to obtain an Investigational Device Exemption approval for CGuard EPS.

Dawson James Securities, Inc. is acting as the sole placement agent. 

The securities intended to be sold in the offering described above are being offered pursuant to a registration statement on Form S-1 which was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on March 8, 2017. A final prospectus supplement relating to the offering will be filed with the SEC by March 10, 2017. Copies of the prospectus relating to the offering may be obtained from Dawson James Securities, Inc., Attention: Prospectus Department, 1 North Federal Highway, 5th Floor, Boca Raton, FL 33432, mmaclaren@dawsonjames.com or toll free at 866.928.0928.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.


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.

 

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 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