InspireMD Announces First Patient Treated with CGuardTM EPS in India

Patient with severe stenosis, calcification and thrombosis successfully treated with CGuardTM EPS

 

Tel Aviv, Israel— March 5, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced successful treatment of the first patient in India with CGuard™ EPS. The case was performed at Shri B. D Mehta Mahavir Hospital in the city of Surat, Gujarat state, by Dr. Hiral Shah, a leading interventional neuro-radiologist.

This first case in India follows the recently announced exclusive distribution agreement for CGuard™ EPS with Hester Diagnostics Pvt. Ltd., as well as recent regulatory and marketing clearance granted by India’s Central Drugs Standard Control Organisation within the Ministry of Health & Family Welfare.

Sanjiv Gandhi, Managing Director of Hester Diagnostics, commented, “The patient in this case had severe stenosis with the carotid artery occluded by more than 80 percent, including blockage of blood flow through the left common carotid artery, and the patient was experiencing transient ischemic attacks.  Following the procedure, Dr. Shah reported complete procedural success using CGuard™ EPS.  We are very happy with the product performance, as anticipated, and look forward to rolling out CGuard™ EPS broadly across India.”

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are extremely pleased by how quickly the first procedure was performed in India following regulatory and marketing clearance and announcing our distribution partnership with Hester Diagnostics. The speed in which this was done not only underscores our distributor capabilities but having CGuardTM EPS used in India also represents a milestone in our expansion efforts across Asia.”

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American 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 Expansion of its Distribution Network

Tel Aviv, Israel— March 1, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed an exclusive distribution agreement with T-Vascular IKE Medical Supplies, in Greece, and Endo-Serv, SRL in the Caribbean, both of whom are premier suppliers of high-tech medical devices used in minimally invasive procedures. Endo-Serv markets products in the Dominican Republic, Jamaica, Aruba, Curacao, as well as Trinidad and Tobago.

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We continue to expand our commercial footprint across Europe through this latest partnership with T-Vascular IKE Medical Supplies in Greece. Our agreement with Endo-Serv also provides us with an ideal foothold across the Caribbean region. Importantly, both of these distributors have established relationships with KOLs at the leading hospitals in each of their respective markets. We believe our ability to attract the top distributors from around the world further illustrates the growing market demand for 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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American 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, Inc. Announces Pricing of Public Offering of Common Stock

Tel Aviv, Israel— February 27, 2018 – InspireMD, Inc. (NYSE American: NSPR),  a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the pricing of an underwritten public offering of 1,000,000 shares of its common stock at a price to the public of $3.00 per share. InspireMD also granted the underwriter a 30-day option to purchase up to an additional 150,000 shares of its common stock at the public offering price of $3.00 per share, less underwriting discounts and commissions. InspireMD expects to receive aggregate gross proceeds of $3 million from the offering, assuming no exercise of the underwriter’s option to purchase additional shares. The offering is expected to close on or about March 1, 2018, subject to customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

InspireMD intends to use 15% of the gross proceeds of this offering to redeem the outstanding shares of its Series D Convertible Preferred Stock, and the remainder of the net proceeds of this offering for research and development, capital expenditures, working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on February 23, 2018. A preliminary prospectus supplement describing the terms of the offering was filed with the SEC on February 26, 2018, and is available on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing placements@hcwco.com or at the SEC’s website at http://www.sec.gov.

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. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

 

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

 

Forward-Looking Statements

This press release includes statements relating to the proposed offering of InspireMD’s shares of common stock, including as to the consummation of this offering described above and the use of net proceeds therefrom. These statements and other statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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, Inc. Announces Proposed Public Offering of Common Stock

Tel Aviv, Israel— February 26, 2018 – InspireMD, Inc. (NYSE American: NSPR),  a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. InspireMD also expects to grant the underwriter a 30-day option to purchase additional shares of its common stock to cover over-allotments, if any.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

InspireMD intends to use 15% of the gross proceeds of this offering to redeem the outstanding shares of its Series D Convertible Preferred Stock, and the remainder of the net proceeds of this offering for research and development, capital expenditures, working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on February 23, 2018. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC and will form a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing placements@hcwco.com or at the SEC’s website at http://www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

 

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

 

Forward-Looking Statements

This press release includes statements relating to the proposed offering of InspireMD’s shares of common stock, including as to the consummation of this offering described above and the use of net proceeds therefrom. These statements and other statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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 Exclusive Distribution, Sales and Marketing Agreement for CGuard™ EPS in South Korea

Solvit Medical to fund all regulatory, registration and reimbursement submissions

Tel Aviv, Israel— February 22, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed an exclusive distribution, sales and marketing agreement with Solvit Medical Inc. (“Solvit”), a leading distributor of medical devices and pharmaceuticals in South Korea. The agreement grants Solvit the exclusive right to market and sell InspireMD’s CGuardTM Embolic Protection System (EPS) for the treatment of carotid disease upon the Korean Ministry of Food and Drug Safety’s (MFDS) approval. 

 

Under terms of the agreement, Solvit will fund and manage the registration and reimbursement submissions for CGuardTM EPS in South Korea.  All regulatory filings will be in the name of InspireMD, Ltd. In addition, Solvit will be contractually committed to purchase a minimum number of CGuardTM EPS systems annually during the term of the agreement, starting when commercial sales begin in South Korea, which is expected to be in the second quarter of next year. The term of the agreement extends for five years following regulatory approval in South Korea.

 

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “This agreement is an important step in bringing CGuardTM EPS to South Korea which represents one of the larger Asian market opportunities, where carotid disease is a major health issue. We believe this Agreement, which includes a significant upfront investment on Solvit Medical’s part, is a significant validation of the growing interest in CGuardTM EPS and our MicroNet™TM technology, both in Asia and globally.  We continue to pursue additional strategic partnerships to address other key Asian markets, given the meaningful opportunity in this part of the world.” 
 
Mr. K.S. Kim, president and CEO of Solvit, stated, “Becoming the exclusive distributor of CGuardTM EPS in South Korea is aligned with our business goals, including bringing a best-in-class solution to our physician customers who treat carotid artery disease. This partnership allows us to bring meaningful, innovative carotid technology to the South Korean medical community, as well as expand our current product offerings to key customers in the interventional, neurovascular and vascular surgery segments, which span all the major clinical specialties that treat carotid artery disease in South Korea. We further view this as the first step in building a strong partnership with InspireMD, as their platform technology is adapted to treat other important vascular disease indications.” 

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American 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 Commercial Launch and First Sales of CGuard™ EPS in India

Tel Aviv, Israel— February 20, 2018 – InspireMD, Inc. (NYSE American:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the commercial launch and first sales of its CGuard™ Embolic Prevention System (EPS) in India. As previously announced, CGuard™ EPS was recently granted marketing clearance by India’s Central Drugs Standard Control Organisation within the Ministry of Health & Family Welfare. The Company also recently announced it had signed Hester Diagnostics Pvt. Ltd. as its exclusive distributor in India.

 

“We are pleased with our launch of CGuard™ EPS in India, immediately following receipt of regulatory marketing clearance. This illustrates our ability to enter new markets and it further validates our capabilities to develop and support a global footprint and distribution model,” said Agustin Gago, EVP and Chief Commercial Officer of InspireMD.  “We believe India represents an attractive and growing market for CGuard™ EPS, and constitutes another milestone in our expansion strategy across Asia.”

 

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American 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 Fourth Quarter and Year-End 2017 Results; CGuard™ EPS Fourth Quarter Sales Increase 211% Versus Same Period Last year

Tel Aviv, Israel— February 14, 2018 – InspireMD, Inc. (NYSE American:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced results for the fourth quarter and year-ending December 31, 2017.

Fourth Quarter 2017 financial highlights:

  • Sales increase 159% versus the same period last year
  • CGuard™ EPS sales increase 211% versus Q4 2016

Recent operating highlights:

  • CGuard™ EPS prominently featured in two successful live case transmissions at LINC 2018 in Germany, a live case transmission at ENDOGRAFT 2017 in Italy, and a live case transmission at Cracow Vascular Summit 2017 in Poland
  • New distributors announced for CGuard™ EPS in India, Australia, New Zealand and Vietnam
  • Regulatory approval of CGuard™ EPS granted in India
  • Independent imaging study published highlighting the advantages of CGuard™ EPS in reducing stent plaque prolapse compared to another next generation carotid stent
  • CGuard™ EPS demonstrated improved outcomes over carotid endarterectomy in a 50-patient comparative study; preliminary results featured at the 7th Munich Vascular Conference 2017
  • Follow-up results from the PARADIGM clinical study presented at the 2017 VEITH Symposium in New York and ICI Meeting 2017 in Tel Aviv demonstrating the sustained benefits of CGuard™ out to two years
  • Patient enrollment commenced in a randomized investigator-initiated trial of CGuard™ EPS vs the market leading Acculink™ carotid stent in Russia

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “2017 was a transformative year for InspireMD, culminating in a 211% increase in sales of CGuard™ EPS for the fourth quarter of 2017.  We are rapidly building a global distribution network, but most importantly, we are growing our market share in countries where we have existing business.  In addition, we continue to build strong support among key opinion leaders around the world. CGuard™ EPS has been featured at six major conferences, including live case transmissions at three of these conferences, since the fourth quarter of 2017 alone. CGuard™ EPS continues to be featured in a number of independent studies and third-party publications that further illustrate the enthusiasm for, and clinical benefits of, our technology. As a result, not only do we believe CGuard™ EPS has the potential to become a leading option for patients that undergo carotid artery stenting (CAS), but we also believe CGuard™ EPS may represent a safer alternative to the current gold standard, carotid endarterectomy (CEA), for patients with carotid artery disease, which, we believe, could significantly expand the addressable market for CGuardTM. Overall, we are extremely excited about the outlook for the business and are off to a very strong start to the first quarter of 2018.”

Financial Results

Revenue for the fourth quarter ended December 31, 2017 was $833,000 compared to $322,000 during the same period in 2016. The increase was primarily due to an increase in sales of CGuard™ EPS as we transitioned from our prior exclusive distribution partner for most of Europe to local distributors, expanded into new geographies such as Russia, and continued focus on expanding existing markets such as Italy. In addition to the increase in sales of CGuard™ EPS, sales of MGuard Prime EPS™ also increased primarily from increased geographical coverage in Latin America. Total operating expenses for the quarter ended December 31, 2017 were $1,660,000, a decrease of 18.4% compared to $2,035,000 for the same period in 2016. This decrease was primarily due to a decrease in salary expenses primarily due to a salary related accrual as well as a decrease in clinical and development costs related to CGuard™ EPS. Net loss for the quarter ended December 31, 2017 totaled $1,500,000, or $7.38 per basic and diluted share, compared to a net loss of $2,265,000, or $30.59 per basic and diluted share, in the same period in 2016.

Revenue for the twelve months ended December 31, 2017 was $2,761,000, representing an increase of 31.4% compared to $1,894,000 during the same period in 2016. The increase was primarily due to an increase in sales of CGuard™ EPS as we transitioned from our prior exclusive distribution partner for most of Europe to local distributors, expanded into new geographies such as Russia, and continued focus on expanding existing markets such as Italy.  Total operating expenses for the twelve months ended December 31, 2017 were $8,817,000, an increase of 13.8% compared to $7,750,000 for the same period in 2016. This increase was primarily due to an increase in sales and marketing expenses (primarily to support the commercialization of CGuard™ EPS). Net loss for the twelve months ended December 31, 2017 totaled $8,438,000, or $34.98 per basic and diluted share, compared to a net loss of $8,461,000, or $207.72 per basic and diluted share, in the same period in 2016.

As of December 31, 2017, cash and cash equivalents were $3,710,000, compared to $7,516,000 as of December 31, 2016.  Based on the Company’s current business plan, the Company believes its cash and cash equivalents as of December 31, 2017, will be sufficient to meet its operating requirements up to 4 months from the date of issuing these consolidated financial statements. As disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, which was filed on February 13, 2018, 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 American Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph.

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American 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

 

(tables follow)




InspireMD Announces 1-for-35 Reverse Stock Split

Tel Aviv, Israel— February 7, 2018 – InspireMD, Inc. (NYSE American: NSPR, NSPR.WS, NSPR.WSB), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced a 1-for-35 reverse split of its common stock, effective as of February 7, 2018.  Beginning on February 8, 2018, the Company’s common stock will trade on the NYSE American on a split adjusted basis.

At InspireMD’s special meeting of stockholders on February 7, 2018, the Company’s stockholders authorized the Board of Directors to amend the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split at a ratio in the range of 1-for-25 to 1-for-50.

Upon effectiveness, the reverse stock split will cause a reduction in the number of shares of common stock outstanding and issuable upon the conversion of the Company’s outstanding shares of preferred stock and the exercise of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and will cause a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants. The number of shares of common stock issuable upon exercise or vesting of outstanding stock options and warrants will be rounded up to the nearest whole share. Accordingly, upon effectiveness of the reverse stock split, each outstanding warrant currently trading on the NYSE American under the symbol “NSPR.WS” shall become a warrant to purchase one thirty-fifth (1/35) of one share of common stock at an exercise price of $175.00 per full share of common stock, and each outstanding warrant currently trading on the NYSE American under the symbol “NSPR.WSB” shall become a warrant to purchase one thirty-fifth (1/35) of one share of common stock at an exercise price of $70.00 per full share of common stock, pursuant to the terms of such warrants. Warrants may only be exercisable for a whole number of shares of common stock. Warrants exercised on or prior to February 7, 2018, will be on a pre-adjusted basis.

The Company’s common stock will continue to trade on the NYSE American under the symbol “NSPR.” The new CUSIP number for the common stock following the reverse stock split is 45779A 861.

The number of authorized shares of the Company’s common stock will remain at 150,000,000, while the number of outstanding shares will be reduced from approximately 58.6 million to 1.7 million. No fractional shares will be issued following the reverse stock split.

Registered stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form do not need to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Action Stock Transfer Corp, will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. Action Stock Transfer Corp can be reached at (801) 274-1088.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on December 26, 2017, a copy of which is also available at www.sec.gov or at www.inspiremd.com under the SEC Filings tab located on the Investors page.

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbols NSPR.WS and NSPR.WSB.

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’s CGuard™ Embolic Prevention System Featured in a Second Live Case Transmission at LINC 2018 by Leading Interventional Cardiologists

Tel Aviv, Israel— January 31, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that its CGuard™ Embolic Prevention System (EPS) was successfully featured once again on a live case transmission at the Leipzig Interventional Course (LINC) 2018 on January 30th.

Dr. Andrej Schmidt and Dr. Matthias Ulrich from the Department of Angiology, University Hospital Leipzig, Division of Interventional Angiology, Leipzig, Germany, performed a challenging live endovascular procedure entitled, “Restenosis after CEA [surgery] left internal carotid artery,” featuring CGuard™ EPS that was transmitted real time to the congress.

The case treated was a carotid restenosis after a previous surgical endarterectomy. The angiogram confirmed a short and severe stenosis complicated with large post-surgical dilatations, affecting the common carotid.

Dr. Andrej Schmidt commented, “CGuard™ EPS is becoming an important tool for the treatment of patients with carotid artery disease. The MicroNet™ technology offers plaque protection and the product has no foreshortening and excellent conformability. The live case we performed today at LINC 2018 went extremely well and clearly highlights the advantages of CGuard™ EPS’ SmartFit™ technology”

“Our technology was featured prominently in not just one, but two live case transmissions at LINC 2018, one of the leading global forums in the field of vascular medicine,” commented James Barry, PhD, Chief Executive Officer of InspireMD. “Our previous live case yesterday at LINC 2018, was performed by vascular surgeons, whereas Dr. Andrej Schmidt and Dr. Matthias Ulrich are leaders in the field of interventional cardiology.  Participation in such conferences is not only validation of our technology, but indicates that world renowned physicians from different clinical specialties that treat carotid artery disease are embracing CGuard™ EPS and recognizing its advantages.  This example of multiple specialties conducting live transmissions using CGuard™ EPS, further supports our market expansion strategy to penetrate mainstream users within all the relevant clinical specialties through partnership with key opinion leaders in each of these specialties.”

 

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American 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’s CGuard™ Embolic Prevention System Featured in Successful Live Case Transmissions at LINC 2018 by Leading Vascular Surgeons

Tel Aviv, Israel— January 30, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that its CGuard™ Embolic Prevention System (EPS) was successfully featured in a live case transmission at the Leipzig Interventional Course (LINC) 2018 on January 30th.

Dr. Antonio Micari and Dr. Fausto Castriota, vascular surgeons with Maria Cecilia Hospital, Cotignola, Italy, performed a live endovascular procedure entitled, “Symptomatic left internal carotid disease in a 79-year old woman,” featuring CGuard™ EPS that was transmitted real time to the congress.

Dr. Fausto Castriota commented, “We have now been using CGuard™ EPS in our routine practice since we were first introduced to it in May 2017 and felt it would be the right system for treating this patient and demonstrating CGuard™ EPS’ advantages.  In this case, CGuard™ EPS performed perfectly, as expected.  It will continue to be an important tool in the treatment paradigm for carotid artery disease as carotid artery stenting becomes an increasingly viable alternative to the surgical carotid artery endarderectomy procedure in Europe.”

“It is an honor to have our technology featured so prominently at this leading industry conference, especially by these two leading vascular surgeons,” commented James Barry, PhD, Chief Executive Officer of InspireMD. “LINC is one of the leading global forums on new products and methods in the field of vascular medicine, and brings together leading medical professionals from around the world. The fact that CGuard™ EPS was, once again, selected for live case transmission at this leading global conference is strong validation of the uptake we are experiencing with key opinion leaders.”

 

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 American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American 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