InspireMD Schedules Conference Call to Discuss Recent Developments, Preliminary Sales Results and Proposals for Upcoming Shareholder Meeting

Tel Aviv—January 3, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it will host a conference call on Wednesday, January 10th at 10:00 a.m. Eastern Time to discuss recent developments, preliminary unaudited fourth quarter 2017 sales results, and proposals under consideration for the upcoming shareholder meeting. A link to the Company’s definitive proxy statement is available at: https://www.sec.gov/Archives/edgar/data/1433607/000149315217015034/def14a.htm.

The conference call will be available via telephone by dialing toll free 877-407-0782 for U.S. callers or +1 201-689-8567 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 January 24, 2018, 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: 23561.

About InspireMD, Inc.

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

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

 

Investor Contacts:

 

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com   

 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

InspireMD Announces Regulatory Approval of CGuard™ EPS in India; Signs Agreement with Leading Indian Medical Device Distributor

Tel Aviv, Israel— January 3, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it has received regulatory approval for the CGuard™ Embolic Prevention System (EPS) in India. The approval was granted by India’s Central Drugs Standard Control Organisation within the Ministry of Health & Family Welfare. The Company also announced it signed Hester Diagnostics Pvt. Ltd. as its exclusive distributor in India. This partnership follows similar distribution agreements across Asia, including Hong Kong, Taiwan, Australia, New Zealand and Vietnam

 

Hester Diagnostics brings over 25 years of distribution and marketing experience in India, including medical devices, diagnostic kits and a wide range of additional products for the healthcare industry. Hester works with many of the leading medical device companies in the United States, Europe and Japan covering clinical specialties that include interventional cardiology, interventional neuroradiology, and interventional radiology.

 

Sanjiv Gandhi, Managing Director of Hester Diagnostics, commented, “We are excited to partner with InspireMD, given the extensive clinical data illustrating the safety advantages of CGuard™ EPS. We are now gearing up and look forward to commencing the formal commercial launch of the product.” 

 

“The approval of CGuard™ EPS in India marks another commercial milestone as we continue to expand our global footprint,” said Agustin Gago, EVP and Chief Commercial Officer of InspireMD.  “We are excited to partner with Hester Diagnostics, which brings an impressive track record launching medical devices in India and to the key clinical specialties that treat 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’s CGuard™ Embolic Prevention System Once Again Featured in a Successful Live Clinical Case at Leading Industry Conference

Professor Pierfrancesco Veroux treated a patient
with carotid artery disease using CGuard™ EPS

Tel Aviv, Israel— December 18, 2017 – InspireMD, Inc.  (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that CGuardTM EPS was once again prominently featured in a live clinical case at an industry conference. Professor Pierfrancesco Veroux, Head of Vascular Surgery and Transplant Center, Policlinico Vittorio Emanuele di Catania, performed the live procedure featuring the CGuard™ EPS at ENDOGRAFT. ENDOGRAFT is the Endovascular Global Roman Arterial Featured Therapies conference, which was held from December 14th-16th, 2017 in Rome. The case was transmitted real time to the entire congress on December 15, 2017. Professor Veroux is also a President of the conference.
The ENDOGRAFT conference is an international and multidisciplinary conference dedicated to the treatment of complex vascular diseases. The conference brings together endovascular specialists including vascular surgeons, interventional cardiologists, radiologists and neurologists from around the world.
Professor Veroux commented, “The CGuard™ EPS performed extremely well during the live procedure, and I believe this technology should become standard-of-care given the strong supporting clinical data which demonstrates the MicroNet™ technology’s ability to reduce the risk of post-procedural embolism and stroke.”
“We were honored to have Professor Veroux feature CGuard™ and the MicroNet™ technology in a live case transmission at the ENDOGRAFT conference,” said James Barry, PhD, Chief Executive Officer of InspireMD. “We continue to see that key opinion leaders across all clinical specialties not only want to use CGuard™ EPS to treat their patients suffering from carotid artery disease, but are also demonstrating its benefits to other physicians. We are especially gratified to have our technology featured so prominently at this leading industry conference by a surgeon of Professor Veroux’s caliber and reputation. While most of these conferences have a limited amount of live transmissions, CGuard™ is being chosen by these thought leaders once again.”

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’s CGuard™ EPS Demonstrates Improved Outcomes over Carotid Endarterectomy in 50 Patient Comparative Study; Preliminary Results Featured at the 7th Munich Vascular Conference 2017

Tel Aviv, Israel— December 7, 2017 – InspireMD, Inc.  (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that Professor Ralf Kolvenbach, head of the Vascular Surgery and Endovascular Therapy Department, and Medical Director of the Catholic Hospital, Düsseldorf, Germany, presented the preliminary results of a 50 patient study at the 7th Munich Vascular Conference, which demonstrated improved outcomes using CGuard™ EPS versus carotid endarterectomy (CEA).
Key highlights of this preliminary study include:
⦁ The gold standard more invasive CEA surgical procedure did not show show any clinical benefit versus CGuard™ EPS
⦁ Cranial nerve injury was significantly lower in patients with CGuard™ EPS versus patients undergoing CEA
⦁ Hospital discharge was faster in the CGuard™ EPS group compared to CEA

In contrast to conventional stents, CGuard™ EPS has been designed to deliver post-procedural long term protection for treatment of carotid lesions. The transcervical carotid stenting (T-CAR ) method was used in the CGuard™ EPS group, and is a less invasive method than CEA. TCAR is a method used by many vascular surgeons to facilitate direct stent implanation into the carotid artery.
Professor Kolvenbach commented, “I am very pleased with the preliminary results in this study. Our goal is to demonstrate with long term data that the CGuard™ EPS when implanted with the TCAR method will continue to perform as it did in this preliminary cohort of patients and ultimately show better results to CEA.”
50 consecutive symptomatic patients were evaluated. In one study group, 31 patients were treated with CGuard™ EPS using the TCAR method, and in the other group 19 patients were treated with CEA. The study did not find advantages for CEA in clinical endpoints or in DW-MRI postprocedural images, while cranial nerve injury was significantly more frequent in the CEA group compared to the CGuard™ EPS group. Hospital discharge in the CGuard™ EPS group was an average of 1.5 days earlier compared to CEA.
James Barry, PhD, Chief Executive Officer of InspireMD, commented, “The results of this trial further demonstrate the effectiveness of our technology. These results continue to support the protective role of CGuard™ EPS in the treatment of carotid artery disease.”
The 7th Munich Vascular Conference (MAC), held on December 7-9, 2017, is a platform for mutual exchange between vascular clinicians from all vascular medical specialties and colleagues from translational and basic research. The 7th MAC addresses aortic, carotid, venous and peripheral arterial diseases, featuring the latest advances in clinical and translational vascular research, including the newest open and endovascular technologies, biological mechanisms of atherosclerosis and the latest imaging modalities.

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 Preliminary 2 Year Follow-up Results from the PARADIGM Clinical Study Using CGuard™ EPS

No procedure or device related adverse events at 24 months

Results presented at the 2017 VEITHsymposium in New York
and ICI Meeting 2017 in Tel Aviv

Tel Aviv, Israel— December 5, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the preliminary 24 month follow-up results in the PARADIGM 101 Clinical Study utilizing CGuard™ EPS. Dr. Piotr Musiałek, Department of Cardiac and Vascular Diseases, John Paul II Hospital, Kraków, Poland, presented the long-term follow-up at the 2017 VEITH Symposium in New York on November 16th, 2017 and the ICI Meeting 2017 in Tel Aviv on December 4, 2017.

PARADIGM-101 is an investigator-led clinical study evaluating the use of CGuard™ EPS in 101 consecutive all-comer patients with symptomatic or high-risk asymptomatic carotid artery stenosis. The data presented illustrate that no periprocedural or postprocedural intervention related death, major stroke, or myocardial infarction had occurred in the study patients at 24-month follow-up.

These excellent results in PARADIGM-101 are consistent with the other CGuard™ EPS Trials, including CARENET, IRON-GUARD, WISSGOTT Study and CASANA Study. The PARADIGM study long-term preliminary results further confirm the sustained benefits of CGuard™ out to two years and make it a potential permanent therapeutic protection option for all-comer patients with carotid artery disease.

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We are excited to see Prof. Musialek’s report out on the long-term follow-up data from the PARADIGM study, which represents the longest known clinical follow-up with any such carotid devices to date. This is just antoher piece of data that continues to reinforce the potential benefits of CGuard EPS. The 24 month follow-up data from this trial simply confirms the sustained long term benefit CGuard could provide to pateints with carotid artery disease.”
The VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features rapid-fire presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques.
The ICI Meeting 2017 is the premier international conference for innovations in cardiovascular systems (heart, brain and peripheral vessels) and high-tech life science companies.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

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

Investor Contacts:

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

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

InspireMD Announces Expansion of its Distribution Network for CGuard™ EPS in Australia, New Zealand and Vietnam

Tel Aviv, Israel— December 4, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed Diverse Devices Pty Ltd as its exclusive distributor for Australia and New Zealand, and has signed Do Gia Production and Trading JSC as its exclusive distributor in Vietnam.

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are pleased to announce these two additional distributors in the Asia Pacific Rim, which represents the continuation of our planned expansion into the Asian market and further expand our global distribution footprint. Our partners have strong physician networks across all the relevant clinical specialties that treat carotid artery disease in their respective regions. These agreements follow similar announcements in Hong Kong and Taiwan. The Asia-Pacific region represents a sizable and important market given the prevalence of carotid stenting as a preferred alternative to vascular surgery. We look forward to announcing additional partnerships for the region in the coming months.”

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 Planned Recapitalization

Tel Aviv, Israel— November 29, 2017 – InspireMD, Inc. (NYSE MKT:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it entered into a securities purchase agreement with an institutional investor for the issuance and sale of 750 shares of InspireMD’s Series D Preferred Stock for aggregate gross proceeds of $750,000 as part of a planned recapitalization of the Company.

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “At the time of our last capital raise, we were in the early stages of a turnaround, which limited our funding options and resulted in a complicated capital structure.  We have since executed against our operational plan as illustrated by the strong sequential and year-over-year growth in sales of CGuard™ EPS.  Despite this growth, our current capital structure has proven an impediment to driving shareholder value.  As such, we decided to undertake a proposed recapitalization.  We believe these steps were necessary and will ultimately prove beneficial for shareholders given the operational success we are now experiencing.”

The Series D Preferred are convertible into shares of common stock at the lesser of $0.50 or 60% of the closing bid price immediately prior to the closing date under the securities purchase agreement, which shall be the earlier of December 11, 2017, and the date immediately following the date that the closing bid price of the common stock is $0.33 per share or less, subject to a $0.20 floor (“Series D Conversion Price”).  To the extent that the Series D Conversion Price is greater than $0.33, it will be reset to $0.20 per share if the price of the common stock is less than $0.33 per share at any time subsequent to the closing date. The Series D preferred stock does not contain any substantive features that differ materially from the Company’s common stock other than a mechanism that would prevent a holder of such preferred stock from converting the preferred stock into common stock or voting such preferred stock to the extent it would cause such holder to beneficially own more than 19.99% of the Company’s common stock until shareholder approval of the conversion of the Series D Preferred into in excess of 19.99% of our outstanding common stock.  The closing is subject to the satisfaction of customary closing conditions. 

As a result of the issuance and sale of the Series D Preferred Stock, the conversion price of the outstanding shares of Series B Stock will be reduced to the Series D Conversion Price pursuant to the anti-dilution adjustment provisions of the Series B Preferred Stock.  There will, however, be no change to the conversion price of the outstanding Series C Preferred Stock as a result of holders of a majority of the outstanding Series C Preferred Stock consenting to an amendment to the terms of the Series C Preferred exempting the issuance of the Series D Preferred from the anti-dilution adjustment provisions of the Series C Preferred Stock.

Among other things, in connection with the securities purchase agreement, the Company has agreed (1) to refrain from issuing shares of common stock until 90 days after the closing date of the securities purchase agreement, except that the Company may commence an offering of its common stock or common stock equivalents for gross proceeds of at least $8 million (a “Qualified Offering”) at any time after February 26, 2018, and make certain other exempt issuances, (2) to use 12.5% of the proceeds from any subsequent offering of the Company’s securities to redeem the outstanding shares of Series B Preferred Stock owned by the purchasers executing the securities purchase until the Company has redeemed an aggregate of up to $1.5 million of stated value of Series B Preferred Stock, and (3) to refrain from entering into certain variable rate transactions until the date that is six months after the closing date.

In addition, upon the consummation of a Qualified Offering, the purchaers have agreed to exchange shares of Series B Preferred Stock and Series C Preferred Stock owned by them into the securities sold by the Company in the Qualified Offering upon the terms set forth in the securities purchase agreement.  The purchasers shall also have the option to exchange their Series D Preferred Stock into the seucrities issued in a Qualfied Offering. 

Additional details of the transaction will be available in the Company’s Form 8-K filed with the Securities & Exchange Commission on or prior to November 29, 2017, and is available at www.sec.gov.  

The Company also announced that on November 22, 2017 it recevieved an additional letter from the New York Stock Exchange that it is not in compliance with Section 1003(a)(ii) of the Company Guide relating to the stockholders’ equity and net income continued listing standards.  This follows the Company’s announcement on October 24, 2017 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)). The Company has until February 17, 2019 to regain compliance with the continued listing requirements and believes that the proposed recapitalization will help further address the requirements of the New York Stock 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 MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

Forward-looking Statements

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

 

Investor Contacts:

 

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com  

 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

InspireMD Announces Third Quarter 2017 Results; CGuard™ Revenue Increases 90% Versus Same Period Last year

Tel Aviv, Israel—November 7, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in Embolic Prevention Systems (EPS) / thrombus management technologies and neurovascular devices, today announced preliminary results for the third quarter ending September 30, 2017.
James Barry, PhD, Chief Executive Officer of InspireMD, commented, “Not only did we achieve a 90% year-over-year increase in sales of CGuard™ EPS for the third quarter of 2017, but we also achieved a 22% sequential increase versus the second quarter of 2017. We achieved these strong results, even though the third quarter tends to be seasonally weak. We believe this growth is evidence that our new distribution and key opinion leader strategy is working. We are hopeful that this growth will continue as the broader community of mainstream vascular surgeons, interventional cardiologists, interventional neuroradiologists, and interventional radiologists begin to adopt our technology. Given the safety advantages of the CGuard™ EPS, we believe that CGuard™ has the potential to become the standard of care and to be regarded by physicians as a safer alternative to vascular surgery for patients with carotid artery disease, thereby expanding the addressable market opportunity.”
Dr. Barry continued, “We had several other notable accomplishments during the quarter. Most recently a live endovascular interventional procedure featuring the CGuard™ EPS was transmitted real time at the Cracow Vascular Summit (CVS) 2017. The case was extremely challenging, and CGuard™ EPS Carotid System performance was excellent. Additionally, patient enrollment began in an investigator initiated trial in Russia, to assess the neuro protection and clinical superiority of the CGuard™ EPS versus Abbott’s RX ACCULINK® Carotid Stent in subjects at high risk for Carotid Endarterectomy (CEA), a surgical procedure. Earlier in the second quarter, we announced publication of an independent clinical review, authored by leading U.S. and European physicians supporting the safety advantages of treating carotid artery disease with next generation carotid devices, specifically highlighting the CGuardTM EPS clinical data compared to its competitors. We also announced that an endovascular interventional procedure featuring the CGuard™ EPS was performed by two of the top key opinion leaders in Latin America and was broadcast at the SOLACI CACI Congress of Cardiology 2017 in Buenos Aires. We believe these premier presentations, publications, and live clinical cases at major clinical meetings further illustrate the growing interest and support for CGuard™ across Europe and around the world.”
Dr. Barry concluded, “Operationally, we believe that the business looks very good as we continue to implement the strategy we set out at the end of last year. We continue to grow our sales with our European distributors and are expanding our distribution network globally. Several top key opinion leaders in Europe are embracing and advocating the CGuard™ EPS to their colleagues. This is evident not only through their use of the product, but further illustrated by the testimonials we recently posted on our website featuring leading clinicians from the fields of vascular surgery, interventional cardiology and interventional neuroradiology. As a result, we remain hopeful CGuard™ EPS will in time become standard-of-care.”
Financial Results
Revenue for the third quarter ended September 30, 2017 was $718,000 compared to $469,000 during the same period in 2016. The increase was primarily due to an increase in sales of CGuard™ EPS as we continued focus on expanding existing markets such as Italy, expansion into new geographies such as Russia as well as the transition from our prior exclusive distribution partner for most of Europe to local distributors. Total operating expenses for the quarter ended September 30, 2017 were $2,238,000, an increase of 25.2% compared to $1,788,000 for the same period in 2016. This increase was primarily due to an increase in sales and marketing expenses to support the commercialization of CGuard™ EPS. Net loss for the quarter ended September 30, 2017 totaled $2,086,000, or $0.19 per basic and diluted share, compared to a net loss of $1,995,000, or $0.85 per basic and diluted share, in the same period in 2016.
Revenue for the nine months ended September 30, 2017 was $1,927,000 compared to $1,572,000 during the same period in 2016. The increase was primarily due to an increase in sales of CGuard™ EPS as we expanded into new geographies such as Russia, continued focus on expanding existing markets such as Italy as well as the transition from our prior exclusive distribution partner for most of Europe to local distributors. Total operating expenses for the nine months ended September 30, 2017 were $7,157,000, an increase of 25.3% compared to $5,712,000 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 salary related accrual. Net loss for the nine months ended September 30, 2017 totaled $6,939,000, or $0.87 per basic and diluted share, compared to a net loss of $6,193,000, or $5.98 per basic and diluted share, in the same period in 2016.
As of September 30, 2017, cash and cash equivalents were $4,765,000, compared to $7,516,000 as of December 31, 2016. Based on the Company’s current business plan, the Company believes its cash and cash equivalents as of September 30, 2017, will be sufficient to meet its operating requirements up to 4 months from the date of issuing these interim consolidated financial statements.

Conference Call
The Company will host a conference call on Wednesday, November 8 at 8:00 a.m. Eastern Time. The conference call will be available via telephone by dialing toll free 888-567-1602 for U.S. callers or +1 404-267-0373 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 November 22, 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: 22280.

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 

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)

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

 

 

Three months ended

 

 

September 30,

 

September 30,

 

2017

 

2016

 

2017

 

2016

               
               

Revenues

$718

 

$469

 

$1,927

 

$1,572

Cost of revenues

565

 

439

 

1,553

 

1,414

               

Gross Profit

153

 

30

 

374

 

158

               

Operating Expenses:

             

Research and development

288

 

289

 

1,041

 

946

Selling and marketing

671

 

309

 

1,835

 

1,077

General and administrative

1,279

 

1,190

 

4,281

 

3,689

               

Total operating expenses

2,238

 

1,788

 

7,157

 

5,712

               

Loss from operations

(2,085)

 

(1,758)

 

(6,783)

 

(5,554)

               

Financial expenses

1

 

237

 

155

 

638

               

Loss before tax expenses

(2,086)

 

(1,995)

 

(6,938)

 

(6,192)

               

Tax expenses (Income)

 

 

1

 

1

               

Net Loss

$(2,086)

 

$(1,995)

 

$(6,939)

 

$(6,193)

               

Net loss per share – basic and diluted

$(0.19)

 

$(0.85)

 

$(0.87)

 

$(5.98)

               

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

11,126,366

 

2,341,807

 

8,711,755

 

1,034,943

                   

 

 

 

 

CONSOLIDATED BALANCE SHEETS (2)

(U.S. dollars in thousands)

ASSETS

September 30,

 

December 31,

2017

 

2016

       

Current Assets:

     

Cash and cash equivalents

$4,765

 

$7,516

Accounts receivable:

     

     Trade, net

538

 

356

     Other

167

 

157

Prepaid expenses

109

 

65

Inventory

576

 

500

       

Total current assets

6,155

 

8,594

       
       

Non-current assets:

 

Property, plant and equipment, net

495

 

379

Funds in respect of employee rights upon retirement

444

 

399

Royalties buyout

19

 

38

       

Total non-current assets

958

 

816

       

Total assets

$7,113

 

$9,410

 

 

 

LIABILITIES AND EQUITY

September 30,

 

December 31,

2017

 

2016

       

Current liabilities:

     

Current maturity of long-term loan

$-

 

$2,680

Accounts payable and accruals:

     

     Trade

402

 

618

     Other

2,293

 

1,447

Advanced payment from customers

28

 

33

       

Total current liabilities

2,723

 

4,778

       
       

Long-term liabilities:

     

Liability for employees rights upon retirement

610

 

587

       

Total long-term liabilities

610

 

587

       
       

Total liabilities

3,333

 

5,365

       

Equity:

     

Common stock, par value $0.0001 per share; 150,000,000 shares authorized at September 30, 2017 and December 31, 2016; 7,465,889 and 1,475,318 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively

1

 

Preferred B shares, par value $0.0001 per share;

500,000 shares authorized at September 30, 2017 and December 31, 2016; 180,992 and 311,521 shares issued and outstanding at September 30, 2017 and  December 31, 2016, respectively

 

Preferred C shares, par value $0.0001 per share;

1,172,000 shares authorized at September 30, 2017; 743,213 shares issued and outstanding at September 30, 2017

 

Additional paid-in capital

142,632

 

135,959

Accumulated deficit

(138,853)

 

(131,914)

       

Total equity

3,780

 

4,045

       

Total liabilities and equity

$7,113

 

$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 September 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.

 

 

 

InspireMD Schedules Third Quarter 2017 Earnings Conference Call

Tel Aviv—November 1, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it will host a conference call on Wednesday, November 8th at 8:00 a.m. Eastern Time to discuss the company’s financial results for the third quarter ended September 30, 2017, as well as the Company’s corporate progress and other meaningful developments.

The conference call will be available via telephone by dialing toll free 888-567-1602 for U.S. callers or +1 404-267-0373 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 November 22, 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: 22280.

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’s CGuard™ Carotid Embolic Prevention System Featured in Live Case at Cracow Vascular Summit 2017 in Poland

Prof. Waclaw Kuczmik performed successful case treating a patient with carotid artery disease with CGuard™ EPS in Katowice Clinical Hospital

Tel Aviv, Israel – October 25, 2017 – InspireMD, Inc. (NYSE AMER:NSPR) (NYSE AMER:NSPR.WS), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that Prof. Waclaw Kuczmik, Head of the Vascular Surgery Department of Katowice Clinical Hospital N 7 and his team, performed a live endovascular interventional procedure featuring the CGuard™ EPS at the 4th Edition of the Cracow Vascular Summit (CVS). The case was transmitted real time to the entire congress. Professor Kuczmik is one of the Course Directors of the Cracow Vascular Summit.  

The Cracow Vascular Summit and 2nd Meeting of Polish Foreign Vascular Specialists is an international and multidisciplinary conference dedicated to the treatment of complex vascular diseases that took place from October 19-21, 2017. Bringing together endovascular specialists including vascular surgeons, interventional cardiologists, radiologists and neurologists from Western and Eastern Europe and North America, CVS is a global forum for sharing within and between interventional communities on several topics including limb ischemia, carotid interventions, stroke, clinical trials in endovascular interventions, venous, aortic and endovascular practice building and live satellite transmissions from catheterization labs and hybrid rooms (procedure rooms that are equipped to perform catheter interventions and surgery at the same time) where complex peripheral and aortic interventions are performed live.

Professor Kuczmik commented, “The CGuard™ EPS Carotid System performance was excellent in an extremely challenging case in which we treated a patient with bilateral carotid occlusions. The procedure showcased by us at CVS 2017 shows CGuard™ to have superior flexibility and apposition qualities. This, in conjunction with its ability to prevent embolization with its MicroNet™ technology allowed me to undertake this procedure which I would not have done with any other stent.”

“We are truly honored and grateful to have Professor Kuczmik, as one of the leading vascular surgeons in Europe, broadcast a live case treating a patient with carotid artery disease using CGuardTM. We believe the selection of a clinical case conducted with CGuardTM by the CVS 2017 organizers further illustrates the growing interest and support for our technology,” said James Barry, PhD, Chief Executive Officer of InspireMD.

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