Tel Aviv, Israel— September 19, 2019 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, today announced the pricing of an underwritten public offering of 2,777,777 units at a price to the public of $1.80 per unit. InspireMD expects to receive aggregate gross proceeds of approximately $5 million from the offering, assuming no exercise of the underwriter’s option to purchase additional securities. Each unit contains one share of common stock (or common stock equivalent) and one Series E warrant to purchase one share of common stock at an exercise price of $1.80 per share. The common stock (or common stock equivalents) and the accompanying Series E warrants included in the units can only be purchased together in this offering, but will be issued separately and will be immediately separable upon issuance.

In connection with the offering, InspireMD has granted the underwriter a 30-day option to purchase up to an additional 416,666 shares of common stock and/or Series E warrants to purchase up to 416,666 shares of common stock. The offering is expected to close on or about September 24, 2019, subject to customary closing conditions.
 
H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.
 
InspireMD intends to use the net proceeds of this offering for research and development, capital expenditures, working capital, sales and marketing and other general corporate purposes.
 
A registration statement on Form S-1 (File No. 333-233432) relating to the public offering of the securities described above was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on September 19, 2019. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus, and when available, electronic copies of the final prospectus may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, 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.
 
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable stroke free long-term outcomes.
 
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 and NSPR.WSB.
     
Forward-Looking Statements
This press release includes statements relating to the offering of InspireMD’s shares of common stock, including as to the closing 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) statements relating to the underwritten public offering, including the potential completion of the offering, the expected closing date and the intended use of proceeds, (ii) market acceptance of our existing and new products, (iii) negative clinical trial results or lengthy product delays in key markets, (iv) an inability to secure regulatory approvals for the sale of our products, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) 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 (xiv) 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:
 
Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com
 
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com
 

Tel Aviv, Israel — September 9, 2019 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, today provided a business update.

Positive CGuard™ EPS Data Presented at the Joint Congress of the World Heart Federation (WHF-2019) and the European Society of Cardiology (ESC-2019)

At the recent joint Congress of World Heart Federation (WHF-2019) and the European Society of Cardiology (ESC-2019) which was held August 31-September 4 in Paris, data was presented for the first time on a patient-level mesh stent metanalysis that included 556 symptomatic and asymptomatic carotid artery disease patients from four trials (Metanalysis from Stabile et al, 30 day results published in JACC, 11;23; 2405-11. Recently submitted one-year results update). Presenters included Alberto Cremonesi (Bergamo, Italy) and Serge Kownator (Thionville, France) as chairpersons, as well as Prof. Piotr Musialek (Krakow, Poland), all highly regarded thought leaders in the field of carotid intervention.

Key highlights from the presentation:

• The results demonstrate superiority of CGuard™ EPS in clinical safety and efficacy as compared to competitor devices, both first generation stents and second-generation double layer or mesh covered devices. At the one-year follow-up, patients who received a competitive double layer stent or another mesh covered stent, experienced an intrastent restenosis/thrombosis rate of 4% compared to CGuard™ EPS with a reduced incidence of 0.7% (p=0.007).
• CGuard™ demonstrated positive trends compared to competitors’ devices with a combined endpoint at 12 months showing a 33% reduction in death and stroke and a greater than 50% reduction in overall mortality.

In an earlier session, entitled, “New Data in Carotid Disease: From Understanding the Pathology to Management,” chaired by Piero Montorsi (Milan, Italy) and Augusto Franco Gallino (Bellinzona, Switzerland), Professor Piotr Musialek presented four-year follow-up data from his ongoing PARADIGM-EXTEND Study. The presentation, “PARADIGM-EXTEND Prospective Academic Trial: Accumulating Long-Term Evidence for MicroNet™^TM Covered Stent Safety and Stroke Prevention Efficacy,” demonstrated encouraging short- and long-term clinical results for the CGuard™ EPS. After 402 patients were treated with 436 stents, no major stroke occurred at 30 days and less than 1% of any death/stroke or myocardial infarction at 30 days.  Additionally, Professor Musialek reported on 61 patients now followed out four years showing no device related or procedure related adverse events.

Receives Two New US Patents Covering Single Fiber Mesh Jacket Stent Technology

InspireMD also announced today that the company has been granted two new U.S. patents (No. 10,406,006 and No. 10,406,008) covering its proprietary single fiber mesh technology. The single fiber mesh, known as MicroNet™^TM, is a key differentiating feature of the company’s C-Guard™ EPS for the prevention of stroke in patients being treated for carotid artery disease (CAD).  

U.S. patent No. 10,406,006 covers a method of stenting and a method of providing a stent assembly, with an expandable mesh jacket, that includes a therapeutically effective amount of active pharmaceutical agent eluted to advantageously treat a disorder in a carotid or coronary artery or a cerebral aneurysm.

U.S. patent No. 10,406,008 covers a method of stenting and a stent assembly, where the stent (expandable stent and expandable mesh jacket) is adapted to treat an aneurysm generally, which should help the company expand into both the peripheral vascular and neuro vascular fields.

With these two patents, InspireMD now holds 15 issued or allowed patents in the U.S. and 47 issued or allowed patents outside of the U.S., with an additional 6 patent applications pending in the U.S. and 19 patent applications pending outside of the U.S. 

US Regulatory Update

InspireMD also announced today that it has been working closely with the FDA on providing further bench testing information to secure approval for an Investigational Device Exemption (IDE). As the company noted in its August 6^th quarterly conference call with investors, seeking additional information in connection with an IDE application is not unusual. To this point, the company has interacted with the agency during the formal review period to resolve a few items and the company intends to continue to work closely with the FDA to resolve these additional requests. The FDA has concurred with the clinical study design which provides specificity on the clinical data requirements to support the market approval of the device.  Following additional discussions with the FDA, the company expects to have a better sense of the timing of a formal response to the agency.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable stroke free long-term outcomes.

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 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:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

Tel Aviv, Israel — September 9, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the  CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, today announced that James Barry, PhD, Chief Executive Officer and Craig Shore, Chief Financial Officer, will present a company update at the HC Wainwright 21^st Annual Global Investment Conference, which is being held September 8-10 at the Lotte New York Palace Hotel. Management’s presentation is scheduled for Tuesday, September 10 from 3:50 to 4:15pm ET.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable stroke free long-term outcomes.

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 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:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

Tel Aviv, Israel — August 9, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that it has received a letter from the NYSE American on August 7, 2019, indicating that InspireMD does not meet a certain NYSE American LLC (the “NYSE American”) continued listing standard as set forth in Part 10, Section 1003(a)(iii) of the Company Guide of the NYSE American, due to the fact the Company had reported stockholders’ equity of less than $6 million as of June 30, 2019, and had net losses in its five most recent fiscal years ended December 31, 2018. The Exchange’s notice has no immediate effect on the listing of the Company’s common stock on the Exchange. The Company’s management is reviewing its options to address the deficiency and expects to submit a compliance plan to the NYSE American on or before September 6, 2019, the deadline set by the Exchange, addressing how it intends to regain compliance with Sections 1003(a)(iii) of the Company Guide by August 7, 2020.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable stroke free long-term outcomes.

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 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:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

U.S. Investigational Device Exemption (IDE) application submitted to FDA

Company to host investor conference call today, August 6, at 8:00am ET

Tel Aviv, Israel— August 6, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced results for the second quarter ended June 30, 2019.

Second Quarter 2019 and recent highlights:

• Submitted U.S. IDE application which, if approved, will allow the company to commence U.S. clinical trials of CGuard™
• Successfully transitioned to a new sterilization partner and cleared all of the $592,000 sales backlog that existed entering the second quarter
• Cash and equivalents expected to fund operations until the end of 2019

“Despite the headwinds that we faced in the first quarter of the year with the company’s prior sterilization partner that limited us to selling products that were predominantly in stock in our warehouse from 2018, we were pleased to see the entire $592,000 of product backlog shipped in the second quarter, as key accounts were once again able to obtain the products, and we returned to normalizing product availability in all of our markets,” said James Barry, PhD, Chief Executive Officer of InspireMD. “Importantly, we submitted our IDE application as planned, and if approved, we would have the ability to begin U.S. clinical trials. We believe CGuard™ represents a true paradigm shift in the treatment of carotid artery disease, and we continue to execute on our multi-faceted growth plan with the goal of making this cutting-edge device technology platform available to patients worldwide.”

Financial Results

For the three months ended June 30, 2019, revenue was $1,354,000, representing an increase of 35.0% from the comparable period in 2018. This increase was predominantly driven by a 34.0% increase in sales of CGuard EPS from $833,000 in the three months ended June 30, 2018, to $1,116,000 in the three months ended June 30, 2019, and a 39.9% increase in sales of MGuard EPS from $170,000 in the three months ended June 30, 2018, to $238,000 in the three months ended June 30, 2019. Both increases were due to the shipments during the three months ended June 30, 2019 of approximately $592,000 of backlog that accumulated in the three months ended March 31, 2019 that we were unable to previously ship. These increases, however, were partially offset by sales decreases in certain markets during the three months ended June 30, 2019, resulting from new orders being delayed while the product backlog was being cleared.

The Company’s gross profit for the quarter ended June 30, 2019 was $442,000 compared to a gross profit of $277,000 for the same period in 2018. Gross margin increased to 32.6% in the three months ended June 30, 2019 from 27.6% in the same period in 2018. This increase in gross profit resulted from a $180,000 increase in revenues, less the related material and labor costs, as discussed above, and a receipt of $135,000 compensation from the company’s former third-party sterilizer for the delays related to the product sterilization interruption during the first quarter of 2019. These increases were offset by $69,000 of expenses related to upgrades made to the company’s production facilities, $40,000 of expenses pertaining to annual and new employee training of the production workers and an increase of $41,000 in miscellaneous expenses.

Total operating expenses for the quarter ended June 30, 2019 were $2,625,000, an increase of 50.0% compared to $1,750,000 for the same period in 2018. This increase was primarily due to an increase in clinical expenses associated with CGuard™ EPS, mainly related to IDE efforts in 2019 and due to a salary related accrual reversal in the second quarter of 2018 that did not repeat itself in the same period this year.

Financial expenses for the quarter ended June 30, 2019 were $23,000 compared to financial income of $846,000 for the same period in 2018. This decrease in financial income of $869,000 was predominately due to a non-cash income associated with the company’s preferred stock in the quarter ended June 30, 2018, which did not occur during this quarter.  Net loss for the quarter ended June 30, 2019 totaled $2,206,000, or $1.59 per basic and diluted share, compared to a net loss of $627,000, or $7.66 per basic and diluted share, for the same period in 2018.

For the six months ended June 30, 2019, revenue was $1,769,000, representing a decrease of 12.0% from the comparable period in 2018. This decrease was predominantly driven by a 10.3% decrease in sales of CGuard EPS from $1,664,000 in the six months ended June 30, 2018, to $1,492,000 in the six months ended June 30, 2019, and a 19.9% decrease in sales of MGuard EPS from $346,000 in the six months ended June 30, 2018, to $277,000 in the six months ended June 30, 2019. Both decreases were primarily due to shipment delays in the three months ended March 31, 2019 associated with us changing sterilization companies and sales decreases in certain of the company’s markets. The transition to the company’s new sterilization is now complete and we do not currently anticipate any future disruptions in fulfilling new orders.

The Company’s gross profit for the six months ended June 30, 2019 was $369,000 compared to a gross profit of $570,000 for the same period in 2018. Gross margin decreased to 20.9 % in the six months ended June 30, 2019 from 28.4% in the same period in 2018. This decrease in gross profit resulted from a $69,000 decrease in revenues (as mentioned above), less the related material and labor costs, $69,000 of expenses related to upgrades made to the company’s production facilities, $38,000 of expenses pertaining to annual and new employee training of the production workers, and an increase of $25,000 in miscellaneous expenses.

Total operating expenses for the six months ended June 30, 2019 were $5,682,000, an increase of 42.2% compared to $3,996,000 for the same period in 2018. This increase was primarily due to an increase in clinical expenses associated with CGuard™ EPS, mainly related to IDE efforts in 2019 and due to a settlement payment made to a former service provider pursuant to a settlement agreement.

Financial expenses for the six months ended June 30, 2019 were $100,000 compared to financial income of 410,000 for the same period in 2018. This decrease in financial income of $510,000 was predominately due to a non-cash income associated with the company’s preferred stock in the six months ended June 30, 2018, which did not occur during the six months ended June 30, 2019.  Net loss for the six months ended June 30, 2019 totaled $5,413,000, or $4.86 per basic and diluted share, compared to a net loss of $3,016,000, or $38.48 per basic and diluted share, for the same period in 2018.

As of June 30, 2019, cash and cash equivalents were $4,823,000, compared to $9,384,000 at December 31, 2018.

Conference Call and Webcast Details

The conference call will be available via telephone by dialing toll free 877-451-6152 for U.S. callers, or +1 201-389-0879 for international callers, and referencing conference ID 13683949. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=135364. The webcast will be archived on the Company’s website.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for Carotid Stenting by providing outstanding acute results and durable stroke free long-term outcomes.

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 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:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

(1) All 2019 financial information is derived from the Company’s 2019 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2018 financial information is derived from the Company’s 2018 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All June 30, 2019 financial information is derived from the Company’s 2019 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2018 financial information is derived from the Company’s 2018 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2018 filed with the Securities and Exchange Commission.

Management to host conference call and webcast at 8am ET

Tel Aviv, Israel— July 30, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, announced today that it will host a conference call and webcast on Tuesday, August 6, 2019, to discuss financial results for the second quarter and six months ended June 30, 2019, and provide a corporate update.

Conference Call & Webcast:

Tuesday, August 6^th @ 8am Eastern Time

Within the US:                                   877-451-6152

Outside the US:                                 201-389-0879

Conference ID:                                  13692587

Webcast:                                             http://public.viavid.com/index.php?id=135364

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for treatment of carotid artery disease by providing outstanding acute results and durable stroke free long-term outcomes.

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:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

On-Track to Submit U.S. IDE expected in Mid-2019

Company to Host Investor Conference Call at 8:00am ET

Tel Aviv, Israel— May 14, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced results for the first quarter ending March 31, 2019.

First Quarter 2019 and recent highlights:

• Pre-clinical testing remains on track for U.S. IDE submission expected in mid 2019
• $5.8 million of cash as of March 31, 2019
• Subsequent to the end of the quarter, completed a follow-on offering of common stock that raised gross proceeds of approximately $2.5 million
• Pro-forma cash and equivalents expected to be sufficient to achieve key milestones through year-end

Other developments:

• During the first quarter 2019, the Company’s third party sterilizer experienced equipment failures that resulted in significant interruption in product processing for the majority of the quarter. As a result, InspireMD primarily sold CGuard™ units already in inventory. The Company estimates that this issue negatively impacted the reported first quarter revenue by approximately $600,000 and created a $600,000 backlog. The Company immediately validated an alternate sterilization partner, conducted all required testing, submitted all materials and received approval from the European Notified Body for the new supplier on April 1^st.  As such, the issue has been completely resolved and InspireMD has cleared the majority of the back orders as of the date of this press release.

“Notwithstanding the issue that we encountered with our primary sterilization partner during the first quarter which led to a shortfall of product available to ship to our distributors, we continued to execute on our multi-faceted growth plan,” said James Barry, PhD, Chief Executive Officer of InspireMD. “In addition to our more focused sales strategy opening more hospital centers in our key European territories, our Centers of Excellence that we have established continue to yield very positive results by providing interventional cardiologists and vascular surgeons with hands-on, real-world experience with the CGuard™ device and continues to help us expand our user base across clinical specialities. We believe these efforts are creating a solid foundation from which to drive future growth. Finally, our IDE submission remains on-track for submission expected in the coming months.  The continuing and growing body of evidence confirming the superiority of the CGuard™ procedure versus conventional open strut stents and carotid endarterectomy surgery, continued through the first quarter as we reported earlier in the year from the data presented at the LINCC meeting in January.  We continue to believe CGuard™ is well positioned to become the new standard of care in the treatment of carotid artery disease.”

Financial Results

For the three months ended March 31, 2019, revenue was $415,000, representing a decrease of 59% from the comparable period in 2018. This decrease was predominantly driven by a 55% decrease in sales of CGuard EPS from $831,000 in the three months ended March 31, 2018, to $376,000 in the three months ended March 31, 2019, and a 78% decrease in sales of MGuard EPS from $176,000 in the three months ended March 31, 2018, to $39,000 in the three months ended March 31, 2019. Both decreases were due to the Company’s third-party sterilizer’s equipment failures that resulted in significant interruption in sterilized product supply for the majority of the quarter. As a result, the Company was unable to fulfill a significant portion of the orders received during the quarter resulting in a backlog of approximately $600,000. As of today, the third-party sterilizer issue has been resolved and the majority of the $600,000 of the backlog recorded has been shipped.

The Company’s gross loss for the quarter ended March 31, 2019 was $73,000 compared to a gross profit of $293,000 for the same period in 2018. Gross margin decreased to (17.6) % in the three months ended March 31, 2019 from 29.1% in the same period in 2018. This decrease in gross margin resulted from a $249,000 decrease in revenues, less the related material and labor costs, resulting from delays related to product sterilization interruption as discussed above and an increase of $118,000 in write-offs of inventory due to the same issue.

Total operating expenses for the quarter ended March 31, 2019 were $3,057,000, an increase of 36 % compared to $2,246,000 for the same period in 2018. This increase was primarily due to an increase in clinical expenses associated with CGuard™ EPS, mainly related to IDE efforts in 2019 and due to a settlement payment made to a former service provider pursuant to a settlement agreement.

Financial expenses for the quarter ended March 31, 2019 were $77,000 compared to $436,000 for the same period in 2018. This decrease of $359,000 was predominately due to a non-cash expense associated with our preferred stock in the quarter ended March 31, 2018 that we did not incur this quarter.  Net loss for the quarter ended March 31, 2019 totaled $3,207,000, or $3.82 per basic and diluted share, compared to a net loss of $2,389,000, or $54.00 per basic and diluted share, for the same period in 2018.

As of March 31, 2019, cash and cash equivalents were $5,807,000, compared to $9,384,000 at December 31, 2018. Subsequent to the end of the first quarter, the Company completed an offering of common stock that yielded gross proceeds of approximately $2.5 million.

Conference Call and Webcast Details

The conference call will be available via telephone by dialing toll free 877-451-6152 for U.S. callers, or +1 201-389-0879 for international callers, and referencing conference ID 13683949. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=133118

A webcast will also be archived on the Company’s website and a telephone replay of the call will be available approximately one hour following the call for approximately two weeks and can be accessed by dialing 844-512-2921 for U.S. callers or +1 412-317-6671 for international callers and entering conference ID: 13687159.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for Carotid Stenting by providing outstanding acute results and durable stroke free long-term outcomes.

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 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:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

(1) All 2019 financial information is derived from the Company’s 2019 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2018 financial information is derived from the Company’s 2018 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All March 31, 2019 financial information is derived from the Company’s 2019 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2018 financial information is derived from the Company’s 2018 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2018 filed with the Securities and Exchange Commission.

Management to host conference call and webcast at 8am ET

 Tel Aviv, Israel— May 7, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, announced today that it will host a conference call and webcast on Tuesday, May 14, 2019, to discuss financial results for the first quarter ended March 31, 2019, and provide a corporate update.

Conference Call & Webcast:

Tuesday, May 14th @ 8am Eastern Time

Within the US:                                   877-451-6152

Outside the US:                                 201-389-0879

Conference ID:                                  13689927

Webcast:                                             http://public.viavid.com/index.php?id=134146

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for treatment of carotid artery disease by providing outstanding acute results and durable stroke free long-term outcomes.

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:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

Tel Aviv, Israel — April 4, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced the pricing of its previously announced underwritten public offering of 486,957 shares of its common stock at a price to the public of $5.00 per share. InspireMD expects to receive aggregate gross proceeds of approximately $2.4 million from the offering. The offering is expected to close on or about April 8, 2019, subject to customary closing conditions.  InspireMD also granted the underwriter a 30-day option to purchase an additional 73,043 shares of its common stock.

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

  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 and accompanying prospectus relating to the offering was filed with the SEC on April 3, 2019 and is available on the SEC’s website located at http://www.sec.gov.   A final prospectus supplement and accompanying prospectus will be filed with the SEC.  Electronic 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, 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.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for treatment of carotid artery disease by providing outstanding acute results and durable stroke free long-term outcomes.

Forward-Looking Statements

This press release includes statements relating to the offering of InspireMD’s shares of common stock, including as to the closing of this offering described above. 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 InspireMD’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 InspireMD and the risk factors that may affect the realization of forward looking statements is set forth in InspireMD’s filings with the SEC, including InspireMD’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. InspireMD assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.

Tel Aviv, Israel — April 3, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that it intends to offer and sell 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. 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.

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

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. The offering of the shares of common stock will be made only by means of a prospectus supplement and accompanying prospectus that forms a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Before you invest, you should read the registration statement (including the preliminary prospectus supplement for the offering and accompanying prospectus) for more complete information about InspireMD and the offering. 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, 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.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for treatment of carotid artery disease by providing outstanding acute results and durable stroke free long-term outcomes.

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, which is subject to market and other conditions. 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 InspireMD’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 InspireMD and the risk factors that may affect the realization of forward looking statements is set forth in InspireMD’s filings with the SEC, including InspireMD’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. InspireMD assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com