New York Stock Exchange Accepts InspireMD’s Plan to Regain Compliance

Tel Aviv, Israel – October 24, 2017 – InspireMD, Inc. (NYSE AMER:NSPR) (NYSE AMER:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that the New York Stock Exchange has accepted the Company’s plan to regain compliance with the NYSE American’s stockholder’s equity continued listing standard (Part 10, Section 1003(a)(iii)). As previously disclosed, the NYSE American notified the Company on August 17, 2017, that it had fallen below the NYSE’s continued listing standards.

Based upon a review of the compliance plan and information submitted by the Company, the Exchange determined that the Company made a reasonable demonstration of its ability to make substantial progress toward regaining compliance with Section 1003(a)(iii) of the Company Guide by February 17, 2018.

The Company will be subject to periodic review by the exchange staff during the period covered by the plan. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the plan period could result in the Company’s shares being delisted from the Exchange.

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 Distribution Agreement for MGuard Prime™ in Chile

Tel Aviv, Israel—October 12, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed an agreement with CorpMedical Chile Ltda, a leading medical distributor in Chile, with its headquarters in Santiago de Chile, to distribute the MGuard Prime™ Embolic Protection System (EPS) for the treatment of acute coronary syndromes, namely Acute Myocardial Infarctions (AMI).
Mr. Jaime Kehr, Chief Executive Officer of CorpMedical Chile Ltda, noted, “MGuard Prime™ with its MicroNet™TM technology is a very effective treatment option in STEMI (ST segment elevation in myocardial infarction) patients in the presence of high thrombotic content and in patients with Saphenous Vein Grafts as seen in clinical trials evaluating MGuard. MGuard is the only implant device available in the market we are aware of that offers protection against embolization following stenting in patients with acute myocardial infarction. Given the safety advantages of MGuard™ Prime, supported by positive clinical data demonstrating its ability to significantly reduce the incidence of no-reflow syndrome and its associated risk of increased mortality, we look forward to bringing this technology to market in Chile.”
Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are excited to partner with CorpMedical Chile Ltda., which brings long standing relationships with key opinion leaders in Chile. With a population of more than 17 million people, Chile represents an attractive new growth opportunity and will help further expand our presence in Latin America.”

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 the Start of Patient Enrollment in an Investigator Initiated Trial of CGuard™ EPS in Russia

CGuard™ Embolic Prevention System (EPS) to be Randomized Against
Abbott’s RX ACCULINK® Carotid Stent System

Tel Aviv, Israel—October 9, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in Embolic Prevention Systems (EPS) / thrombus management technologies and neurovascular devices, today announced the start of patient enrollment in an investigator initiated trial in Russia, entitled: Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus CGuard™EPS. The objective of the trial is to assess the neuro protection and clinical superiority of the minimally invasive interventional procedure with the CGuard™ EPS versus Abbott’s RX ACCULINK® Carotid Stent in subjects at high risk for Carotid Endarterectomy (CEA), a surgical procedure.

The trial is a single center randomized trial with two interventional arms comparing CGuard™ EPS to Acculink™. The trial will enroll 100 consecutive eligible patients with 50 patients in each arm. The primary endpoint of the trial will be new ischemic areas in the brain within 24 to 48 hrs post procedure, and new lesion permanence at 30-days as determined by Diffusion-Weighted Magnetic Resonance Imaging (DWMRI). Each patient will receive clinical and ultrasound follow-up at 1 year. The trial will be conducted at the Center of Vascular and Hybrid Surgery within the Scientific Research Institute of Circulation Pathology in Novosibirsk, which is associated with the Novosibirsk State University, one of Russia’s top three universities (QS World University Rankings® 2016). The research will be lead by Professor Andrei Karpenko, the head of the vascular surgery department.

Professor Karpenko commented, “Having been aware of the very impressive data supporting the use of CGuard EPSTM for the treatment of carotid artery stenosis, we are excited to now have the opportunity to evaluate this system versus Abbott’s RX ACCULINK® which is widely used in Russia today.”

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We are honored that Professor Karpenko and his team have elected to study CGuardTM EPS in this Vascular Surgeon led clinical trial at the Center of Vascular and Hybrid Surgery within the Scientific Research Institute of Cardiovascular Pathology in Novosibirsk. We understand the first patients have been enrolled and treated in the trial and we look forward to the results at the conclusion of the trial.  Once again, we believe that this trial will reinforce our current CGuardTM clinical data, and continue to validate the growing interest and support in CGuardTM across all clinical specialties treating carotid artery disease.”

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 Postpones Special Meeting of Stockholders to October 27, 2017

Tel Aviv, Israel—October 4, 2017 – InspireMD, Inc. (NYSE AMER:NSPR) (NYSE AMER:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it has postponed its Special Meeting of Stockholders that was to have taken place originally on October 3, 2017. The new date for the Special Meeting is October 27, 2017 at 11:30 a.m. Eastern time and it will take place at the offices of Haynes and Boone, LLP, located at 30 Rockefeller Plaza, 26th Floor, New York, New York 10112. The record date of August 28, 2017 remains unchanged.
The Company also announced it has withdrawn its proposal to amend the Company’s 2013 Long-Term Incentive Plan. The two remaining proposals are for (i) an authorization of the board of directors, in its discretion but prior to the annual meeting of stockholders in 2018, to amend the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split of the Company’s common stock at a ratio in the range of 1-for-10 to 1-for-25, such ratio to be determined by the board of directors (the “Reverse Stock Split Proposal”) and (ii) to approve any adjournment of the Special Meeting of Stockholders, if necessary, to solicit additional proxies if there are not sufficient votes in favor of any of the foregoing proposal (the “Adjournment Proposal”). The board of directors recommends a vote FOR the two Proposals.
James Barry, PhD, Chief Executive Officer of InspireMD, commented, “While the board of directors does not have a present intention to effect a reverse stock split, stockholder approval would provide us flexibility to pursue strategic transactions and other opportunities that may arise as a result of the progress we have made the past three quarters. As shareholders ourselves, we believe the removal of the employee stock option plan demonstrates our commitment to shareholders. Similarly, the request for authorization for a reverse split could provide us an additional tool that we would only consider if we deem it to be in the best interests of the shareholders.”
InspireMD will, as promptly as practicable, distribute to its stockholders of record a supplement to the proxy statement for the Special Meeting of Stockholders. Valid proxies that have already been submitted will continue to be valid for purposes of the rescheduled Special Meeting on Friday, October 27, 2017 and at any and all adjournments or postponements thereof. Stockholders who have not yet voted are encouraged to do so. Stockholders that own their shares in “street name” through a stock brokerage account or through a bank or nominee should consult the broker, bank or nominee about its procedures to vote the shares.

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 Distribution Agreement for CGuardTM EPS in Portugal

Tel Aviv, Israel—September 21, 2017 – InspireMD, Inc. (NYSE AMER:NSPR) (NYSE AMER:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed an agreement with Medicinália Cormédica MC Medical Lda, a leading medical distributor in Portugal, to distribute CGuard™ EPS (Embolic Prevention System). Medicinália Cormédica MC Medical Lda is a subsidiary of WerfenLife Company, one of Europe’s largest distributors of medical products.
Mr. António Cabral, Managing Director of Medicinália Cormédica, noted, “CGuard™ continues to demonstrate its superiority over conventional stents in repeated clinical trials and we look forward to bringing this technology to market in Portugal. Moreover, the clinical data supports the safety and efficacy of carotid artery stenting with CGuard as a minimally invasive alternative to carotid endarterectomy, which further expands the addressable market.”
Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “The addition of Medicinália Cormédica provides us a strong foothold in Portugal, which represents a new market for CGuard™ EPS. We continue to gain traction and grow sales both in Europe and globally, as we add leading distributors in each of the respective markets.”

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 to Present at the 19th Annual Rodman & Renshaw Global Investment Conference in New York City

 Tel Aviv, Israel—September 6, 2017 – InspireMD, Inc. (NYSE AMER:NSPR) (NYSE AMER:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it will present at the 19th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC.  The conference is being held on September 10-12, 2017 at Lotte New York Palace Hotel in New York City.

James Barry, PhD, Chief Executive Officer of InspireMD will provide an overview of the Company’s business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference. 

If you are an institutional investor, and would like to attend the Company’s presentation, please click on the following link (www.rodmanevents.com) to register for the Rodman & Renshaw conference.  Once your registration is confirmed, you will be prompted to log into the conference website to request a one-on-one meeting with the Company.

Event:  19th Annual Rodman & Renshaw Global Investment Conference

Date:  Tuesday, September 12, 2017

Time:  3:50-4:15 PM (Eastern Time)

Location:  Kennedy I; Lotte New York Palace Hotel in New York City

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 Distribution Agreement for CGuardTM EPS in Switzerland

Tel Aviv, Israel—August 25, 2017 – InspireMD, Inc. (NYSE AMER:NSPR) (NYSE AMER:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed an agreement with 1a medical ag, a leading medical distributor in Switzerland, to distribute CGuard™ EPS (Embolic Prevention System).
Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are delighted to partner with 1a medical ag, which brings long standing relationships with the top key opinion leaders and physicians across all relevant clinical specialites in Switzerland. The agreement contains guaranteed minimum sales, further illustrating their confidence in CGuard EPS.”
Mr. Albert Kaiser, CEO of 1a medical ag, noted, “We look forward to launching CGuard™ in Switzerland, which is in line with our mission to bring best-in-class technologies to medical practices across Switzerland. Based on the strong supporting clinical data, we believe CGuard™ EPS has the potential to rapidly become standard of care in Switzerland due to its distinct safety advantages.”

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 Shares CGuardTM EPS Video Testimonials from European Key Opinion Leaders

Tel Aviv—August 22, 2017 – InspireMD, Inc. (NYSE AMER:NSPR) (NYSE AMER:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has posted video testimonials about its CGuardTM Embolic Prevention System from several European key opinion leaders on its website: https://www.inspiremd.com/en/kol-testimonials/

Featured testimonials include:

  • Dr. Alberto Cremonesi, Chief of the Cardiovascular Department at Maria Cecilia Hospital, Cotignola, Italy
  • Dr. Antonio Moreno, Chief Medical Officer of Endovascular Intervention World MEDICA, Madrid, Spain
  • Dr. Bernhard Reimers, Clinical and Invasive Cardiology Unit Director at Humanitas Research Hospital, Milan, Italy
  • Prof. Ralf Kolvenbach, Head of the Cardiovascular Diseases Department, Medical Director of the Catholic Hospitals, Duesseldorf, Germany
  • Prof. Piotr Musialek, Jagiellonian University Department of Cardiac & Vascular Diseases, Krakow, Poland

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We are honored that such respected clinicians from the fields of vascular surgery, interventional cardiology and interventional neuroradiology across Europe are willing to publicly endorse our very promising technology.  These testimonials provide detailed and diverse clinical views on the advantages of the CGuard Embolic Prevention System, as described by those who use it routinely in their daily practices to improve patient outcomes.”

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 Notification of NYSE AMERICAN Listing Deficiency and Expectation to Regain Compliance

Tel AvivAugust 22, 2017InspireMD, Inc. (NYSE AMER: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it received a letter from the NYSE American on August 17, 2017 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, 2017 and had net losses in its five most recent fiscal years ended December 31, 2016. 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 17, 2017, the deadline set by the Exchange, addressing how it intends to regain compliance with Sections 1003(a)(iii) of the Company Guide by February 17, 2019.

.

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 Reports Double Digit Sequential and Year-Over-Year Revenue Growth for the Second Quarter of 2017

Completes Transition to Local Distribution Network Across Europe

 CGuard Sales in European Countries Transitioned Back from Former Distributor Increase 122% Versus Q1 2017

Tel Aviv—August 8, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today provided a business update, including the successful transition of all territories previously covered by the Company’s former European distributor to a local network of regional distributors.  The Company also reported financial and operating results for the second quarter ended June 30, 2017.

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “I am pleased to report we successfully completed our transition from a single distributor covering 18 European countries, to now having a direct distribution model with local distributors that have much greater reach into all the relevant clinical specialties and each of their respective markets. Our new distributors share our belief that CGuard™ can achieve market leadership in all countries where it is available.  Moreover, we completed the rollout on schedule and there has been tremendous support from the top key opinion leaders (KOL) in each of these markets.  In fact, CGuard sales in these specific European countries increased 122% sequentially versus the first quarter of 2017.”

“With our European distribution network in place, we are now focusing our efforts on expansion into other markets around the world.  Most recently, we signed an agreement with a leading distributor in Taiwan.  This follows a similar agreement in Hong Kong earlier this year, and we are in talks with a number of distributors across Asia to further expand our footprint. We expect to make additional announcements on this subject in the coming months.  We also announced recent agreements in Peru and Ecuador, and our plan is to continue to expand our presence in Central and South America. CGuard™ is a platform technology that can be transferred to a number of other products, and building this global distributor network should allow us to launch new products quickly and efficiently as our pipeline develops over the coming years.”

“We also continue to report new data and are gaining significant attention from top KOLs around the world. In May, we reported publication of the investigator initiated IRON-GUARD Italian clinical registry in the peer reviewed journal EuroIntervention.  IRON-GUARD was an independent, multicenter, multi-disciplinary clinical study treating patients with carotid artery disease using the CGuard™ EPS in 12 Italian centers. The IRON-GUARD registry enrolled 200 patients, and showed results of 100% technical success placing the device, and zero incidence of major adverse cardiovascular events (MACE), comprised of death, major stroke or myocardial infarction, in all patients at 30 days.  Also in May, we were honored to have the team of Professor Alberto Cremonesi, Chief of the Cardiovascular Department and Director of the Interventional Cardiovascular Unit of Maria Cecilia Hospital – GVM Care & Research, Cotignola (Italy), perform a live endovascular interventional procedure featuring the CGuard™ EPS Carotid Stent at EuroPCR 2017.  The case was transmitted real time to the entire congress. EuroPCR is the world’s leading course in interventional cardiovascular medicine bringing together over 12,000 clinicians and industry executives each year.”

Dr. Barry concluded, “We remain extremely encouraged by the favorable response from leading medical practitioners around the world. Now that we have a robust distribution network in place across Europe, we believe we have a highly scalable and cost-effective platform to grow sales.  We plan to replicate this model around the world.  Overall, we achieved solid double-digit year-over-year and sequential revenue growth, which we expect to continue in the second half of the year.  We also remain focused on carefully managing expenses and driving shareholder value.  We appreciate the patience and support of our shareholders, and look forward to announcing additional significant milestones in the months ahead.”

Financial Results

Revenue for the second quarter ended June 30, 2017 was $640,000 compared to $540,000 during the same period in 2016. The increase was primarily due to an increase in sales of CGuard™ EPS as we entered new regional markets during the transition from our prior exclusive distribution partner for most of Europe.  The transition to local distributors reflects an effort to broaden our sales efforts from only interventional neuroradiologists to include vascular surgeons, interventional cardiologists and interventional radiologists, as well. In addition to the increase in sales of CGuard™ EPS, sales of MGuard™ Prime EPS slightly increased, as well.  Total operating expenses for the quarter ended June 30, 2017 were $2,441,000, an increase of 33.5% compared to $1,828,000 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), as well as an increase in salary expenses primarily due to a non-cash accrual adjustment. Net loss for the quarter ended June 30, 2017 totaled $2,294,000, or $0.21 per basic and diluted share, compared to a net loss of $1,946,000, or $4.56 per basic and diluted share, in the same period in 2016.

Revenue for the six months ended June 30, 2017 was $1,209,000 compared to $1,103,000 during the same period in 2016. The increase was predominantly driven by the increase in sales of CGuard™ EPS offset by a decrease in sales of MGuard™ Prime EPS associated with the trend of doctors increasingly using drug eluting stents (DES) rather than bare metal stents in STEMI patients.  Total operating expenses for the six months ended June 30, 2017 were $4,919,000, an increase of 25.4% compared to $3,924,000 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), as well as an increase in salary expenses primarily due to a non-cash accrual. Net loss for the six months ended June 30, 2017 totaled $4,853,000, or $0.73 per basic and diluted share, compared to a net loss of $4,198,000, or $11.21 per basic and diluted share, in the same period in 2016.

As of June 30, 2017, cash and cash equivalents were $6,879,000, compared to $7,516,000 as of December 31, 2016.

Conference Call

The Company will host a conference call on Wednesday, August 9 at 8:00 a.m. Eastern Time. The conference call will be available via telephone by dialing toll free 866-682-6100 for U.S. callers or +1 862-255-5401 for international callers, or on the Company’s Investor Relations section of the website: https://www.inspiremd.com/en/investors/investor-relations/.

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, through midnight August 23, 2017, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 15963.

About InspireMD, Inc.

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

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

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com   

 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)

 

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

 

 

 

 

Six months ended

 

 

 

Three months ended

 

 

June 30,

 

June 30,

 

 

2017

 

2016

 

2017

 

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

$640

 

$540

 

$1,209

 

$1,103

 

Cost of revenues

493

 

478

 

988

 

975

 

 

 

 

 

 

 

 

 

 

Gross Profit

147

 

62

 

221

 

128

 

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

Research and development

403

 

278

 

753

 

657

 

Selling and marketing

632

 

403

 

1,164

 

768

 

General and administrative

1,406

 

1,147

 

3,002

 

2,499

 

 

 

 

 

 

 

 

 

 

Total operating expenses

2,441

 

1,828

 

4,919

 

3,924

 

 

 

 

 

 

 

 

 

 

Loss from operations

(2,294)

 

(1,766)

 

(4,698)

 

(3,796)

 

 

 

 

 

 

 

 

 

 

Financial expenses

 

180

 

154

 

401

 

 

 

 

 

 

 

 

 

 

Loss before tax expenses

(2,294)

 

(1,946)

 

(4,852)

 

(4,197)

 

 

 

 

 

 

 

 

 

 

Tax expenses (Income)

 

 

1

 

1

 

 

 

 

 

 

 

 

 

 

Net Loss

$(2,294)

 

$(1,946)

 

$(4,853)

 

$(4,198)

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

$(0.21)

 

$(4.56)

 

$(0.73)

 

$(11.21)

 

 

 

 

 

 

 

 

 

 

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

10,983,402

 

426,976

 

7,484,399

 

374,330

 

                       

 

 

 

 

CONSOLIDATED BALANCE SHEETS (2)

(U.S. dollars in thousands)

ASSETS

June 30,

 

December 31,

2017

 

2016

 

 

 

 

Current Assets:

 

 

 

Cash and cash equivalents

$6,879

 

$7,516

Accounts receivable:

 

 

 

     Trade, net

451

 

356

     Other

161

 

157

Prepaid expenses

73

 

65

Inventory

429

 

500

 

 

 

 

Total current assets

7,993

 

8,594

 

 

 

 

 

 

 

 

Non-current assets:

 

Property, plant and equipment, net

459

 

379

Funds in respect of employee rights upon retirement

430

 

399

Royalties buyout

25

 

38

 

 

 

 

Total non-current assets

914

 

816

 

 

 

 

Total assets

$8,907

 

$9,410

 

 

 

LIABILITIES AND EQUITY

June 30,

 

December 31,

2017

 

2016

 

 

 

 

Current liabilities:

 

 

 

Current maturity of long-term loan

$-

 

$2,680

Accounts payable and accruals:

 

 

 

     Trade

473

 

618

     Other

2,066

 

1,447

Advanced payment from customers

54

 

33

 

 

 

 

Total current liabilities

2,593

 

4,778

 

 

 

 

 

 

 

 

Long-term liabilities

 

 

 

Liability for employees rights upon retirement

572

 

587

 

 

 

 

Total long-term liabilities

572

 

587

 

 

 

 

 

 

 

 

Total liabilities

3,165

 

5,365

 

 

 

 

Equity:

 

 

 

Common stock, par value $0.0001 per share; 150,000,000 shares authorized at June 30, 2017 and December 31, 2016; 7,467,646 and 1,475,318 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively

1

 

Preferred B shares, par value $0.0001 per share;

500,000 shares authorized at June 30, 2017 and December 31, 2016; 181,295 and 311,521 shares issued and outstanding at June 30, 2017 and  December 31, 2016, respectively

 

Preferred C shares, par value $0.0001 per share;

1,172,000 shares authorized at June 30, 2017 ; 745,775 shares issued and outstanding at June 30, 2017

 

Additional paid-in capital

142,508

 

135,959

Accumulated deficit

(136,767)

 

(131,914)

 

 

 

 

Total equity

5,742

 

4,045

 

 

 

 

Total liabilities and equity

$8,907

 

$9,410

 

 

 

 

 

 

 

(1) All 2017 financial information is derived from the Company’s 2017 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission, all 2016 financial information is derived from the Company’s 2016 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

 

(2) All June 30, 2017 financial information is derived from the Company’s 2017 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, 2016 financial information is derived from the Company’s 2016 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2016 filed with the Securities and Exchange Commission.