InspireMD Reports 94% Increase in CGuard™ EPS RevenuesInspireMD Reports 94% Increase in CGuard™ EPS Revenuesfor the Second Quarter of 2018

Tel Aviv, Israel— August 6, 2018 – InspireMD, Inc. (NYSE American:NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced results for the second quarter ending June 30, 2018.

Second Quarter 2018 highlights:

  • Revenues in Q2 of $1.0 million for 2018 versus $640,000 in 2017, an increase of 57%
  • CGuard™ EPS revenues in Q2 of $833,000 for 2018 versus $430,000 in 2017, an increase of 94%
  • $6.4 million of cash at June 30, 2018, not including $6.4 million in net proceeds from capital raised in Q2 but received in early July 2018
  • All the Redeemable Preferred Shares were redeemed in early July with proceeds from the most recent stock offering

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We are pleased to report another strong quarter with 94% year-over-year growth in sales of CGuard™ EPS, with total sales in excess of $1 million for the second quarter of 2018.  We achieved these results while in the midst of transitioning our sales and marketing strategy from KOLs, where we are already generating strong adoption, to mainstream physicians, as previously discussed. In particular, we are more aggressively targeting vascular surgeons, who currently treat the majority of patients with carotid artery disease with open surgery. Vascular surgeons have been slow to adopt carotid arterial stenting (CAS) due to stroke risks associated with conventional stents. The response from these vascular surgeons has been positive and when presented with a safe, minimally invasive option, they have shown a willingness to adopt the CGuardTM EPS over the more invasive surgical procedure (CEA) for their patients. We believe expanding into the vascular surgery market segment would significantly expand the addressable market for our product. Importantly, there are 2.2 million people diagnosed with high grade carotid stenosis each year, but only six hundred thousand, or 30%, receive a surgical or stent procedure. This is due, in large part, to the risks associated with traditional procedures. As a result, we see an untapped market of at least 1.6 million additional patients per year that could be helped with CGuard™ EPS as a safer alternative to traditional procedures. With our recent capital raise completed, we are accelerating our commercial activities. We expect to see the impact of this investment, along with our expanded sales and marketing initiatives as we end this year and head into the new year.”

“Overall, the market has been extremely receptive to CGuardTM EPS.  In addition to rapid revenue growth, we have had featured presentations at top industry conferences in just the past quarter including the SBHCI Congress in Brazil, the 10th International Congress of the Polish Society for Vascular Surgery, a live case transmission to the 2nd DGA Interventional Congress, and EuroPCR 2018 where we presented the expanded 24 month follow-up results from the PARADIGM-Extend Clinical Study utilizing CGuard™ EPS.  Cumulative data in the PARADIGM-Extend Clinical Study showed no major strokes in the peri-procedural or post-procedural period up to 30 days (0%) and there were no stroke or stroke-related deaths between 12 and 24 months. In addition, the duplex ultrasound data confirmed normal vessel healing with CGuard™ EPS with no indication of any long term in-stent restenosis. These results included a significant proportion of challenging patients that would have otherwise been sent to surgery (carotid endarterectomy).  Importantly, these and other clinical data suggest that CGuard™ EPS may offer a safer alternative to the surgical gold standard of carotid endarterectomy (CEA).”

“Finally, as previously disclosed, we have met with the FDA regarding our investigational device exemption (IDE) submission for CGuard™ EPS, and, having completed our recent financing, we are actively working on this submission.  We look forward to providing further updates in the coming months.”

Financial Results

Revenue for the second quarter ended June 30, 2018 was $1,003,000 compared to $640,000 during the same period in 2017. The increase was primarily due to an increase in sales of CGuard™ EPS as a result of our continued focus on expanding existing markets such as Germany, Italy and Russia, our transition from our prior exclusive distribution partner for most of Europe to local distributors and expanding into new geographies such as India. The Company’s gross profit for the quarter ended June 30, 2018 was $277,000 compared to $147,000 for the same period in 2017. Gross margin increased to 27.6% in the three months ended June 30, 2018 from 23.0% in the same period in 2017, driven mainly by higher volume and more efficient utilization of our fixed manufacturing resources.

Total operating expenses for the quarter ended June 30, 2018 were $1,750,000, a decrease of 28.3% compared to $2,441,000 for the same period in 2017. This decrease was primarily due to a decrease in salary expenses, primarily due to a salary related accrual in 2017 and a decrease in share-based compensation expenses. Financial income for the quarter ended June 30, 2018 was $846,000 compared to $0 for the same period in 2017, largely due to non-cash income associated with our preferred stock. Net loss for the quarter ended June 30, 2018 totaled $627,000, or $0.15 per basic and diluted share, compared to a net loss of $2,294,000, or $7.30 per basic and diluted share, in the same period in 2017.

Revenue for the six months ended June 30, 2018 was $2,010,000 compared to $1,209,000 during the same period in 2017. The increase was primarily due to an increase in sales of CGuard™ EPS as a result of our transition from our prior exclusive distribution partner for most of Europe to local distributors, continued focus on expanding existing markets such as Germany and Italy and expanding into new geographies such as India. The Company’s gross profit for the six months ended June 30, 2018 was $570,000 compared to $221,000 for the same period in 2017. Gross margin increased to 28.4% in the six months ended June 30, 2018 from 18.3% in the same period in 2017, driven mainly by higher volume and more efficient utilization of our fixed manufacturing resources.

Total operating expenses for the six months ended June 30, 2018 were $3,996,000, a decrease of 18.8% compared to $4,919,000 for the same period in 2017. This decrease was primarily due to a decrease in salary expenses, primarily due to a salary related accrual in 2017 and a decrease in share-based compensation expenses, partially offset by an increase in legal expenses. Financial income for the six months ended June 30, 2018 was $410,000 compared to $154,000 of financial expenses for the same period in 2017, largely due to non-cash income associated with our preferred stock. Net loss for the six months ended June 30, 2018 totaled $3,016,000, or $0.76 per basic and diluted share, compared to a net loss of $4,853,000, or $25.64 per basic and diluted share, in the same period in 2017.

As of June 30, 2018, cash and cash equivalents were $6,442,000, compared to $3,710,000 as of December 31, 2017.  The June 30, 2018 cash balance does not include $6.4 million in net proceeds from capital raised in Q2 2018 but received in early July 2018.

 

About InspireMD, Inc.

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

InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

Forward-looking Statements

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

 

Investor Contacts:

 

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com  

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

(tables follow)

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)

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

     

Six months ended

   
 

Three months ended

 

June 30,

 

June 30,

 

2018

 

2017

 

2018

 

2017

               
               

Revenues

$1,003

 

$640

 

$2,010

 

$1,209

Cost of revenues

726

 

493

 

1,440

 

988

               

Gross Profit

277

 

147

 

570

 

221

               

Operating Expenses:

             

Research and development

230

 

403

 

482

 

753

Selling and marketing

580

 

632

 

1,072

 

1,164

General and administrative

940

 

1,406

 

2,442

 

3,002

               

Total operating expenses

1,750

 

2,441

 

3,996

 

4,919

               

Loss from operations

(1,473)

 

(2,294)

 

(3,426)

 

(4,698)

               

Financial expenses (income)

(846)

 

 

(410)

 

154

               

Loss before tax expenses

(627)

 

(2,294)

 

(3,016)

 

(4,852)

               

Tax expenses (Income)

 

 

 

1

               

Net Loss

$(627)

 

$(2,294)

 

$(3,016)

 

$(4,853)

               

Net loss per share – basic and diluted

$(0.15)

 

$(7.30)

 

$(0.76)

 

$(25.64)

               

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

6,745,360

 

313,812

 

4,511,681

 

213,840

 

CONSOLIDATED BALANCE SHEETS (1)

(U.S. dollars in thousands)

ASSETS

June 30,

 

December 31,

2018

 

2017

       

Current Assets:

     

Cash and cash equivalents

$6,442

 

$3,710

Accounts receivable:

     

    Trade, net

916

 

643

    Other

175

 

207

Prepaid expenses

71

 

62

Inventory

637

 

533

       

Total current assets

8,241

 

5,155

       
       

Non-current assets:

 

Property, plant and equipment, net

431

 

476

Deferred Issuance Costs

310

 

Funds in respect of employee rights upon retirement

489

 

476

       

Total non-current assets

1,230

 

952

       

Total assets

$9,471

 

$6,107

 

 

LIABILITIES AND EQUITY

June 30,

 

December 31,

2018

 

2017

       

Current liabilities:

     

Accounts payable and accruals:

     

    Trade

$476

 

$328

    Other

1,978

 

2,134

Contract liability

26

 

20

       

Total current liabilities

2,480

 

2,482

       

Long-term liabilities:

     

Liability for employees rights upon retirement

629

 

624

       

Total long-term liabilities

629

 

624

       

Total liabilities

3,109

 

3,106

       

Redeemable preferred shares

2,264

 

274

       

Equity:

     

Common stock, par value $0.0001 per share; 150,000,000 shares authorized at June 30, 2018 and December 31, 2017; 6,453,428 and 1,483,556 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively

 

Preferred B shares, par value $0.0001 per share;

500,000 shares authorized at June 30, 2018 and December 31, 2017; 17,303 and 27,075 shares issued and outstanding at June 30, 2018 and  December 31, 2017, respectively

 

Preferred C shares, par value $0.0001 per share;

1,172,000 shares authorized at June 30, 2018 and December 31, 2017; 378,840(3) and 741,651 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively

 

Preferred D shares, par value $0.0001 per share; 750 shares authorized at June 30, 2018 and December 31, 2017; 300(4) and 750 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively

 

Additional paid-in capital

147,466

 

143,079

Accumulated deficit

(143,368)

 

(140,352)

       

Total equity

4,098

 

2,727

       

Total liabilities, redeemable preferred shares and equity

$9,471

 

$6,107

     

 

 

 

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

(2) Including 306,917 shares that are classified in Redeemable Preferred Shares and were redeemed in  full on July 3, 2018.

(3) The 300 shares are classified in Redeemable Preferred Shares and were redeemed in full on July 3, 2018.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

InspireMD Schedules Second Quarter 2018 Earnings Conference Call

Tel Aviv – July 31, 2018 – InspireMD, Inc. (NYSE: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that it will host a conference call on Tuesday, August 7th at 8:00 a.m. Eastern Time to discuss the company’s financial results for the second quarter ended June 30, 2018, as well as the Company’s corporate progress and other meaningful developments.

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 August 21, 2018 until 8:00 am ET, 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: 36394.

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. Additional information about the Company is available at: www.inspiremd.com.

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 Opening of First Two CGuard™ EPS Centers of Excellence

Tel Aviv, Israel— July 23, 2018 – InspireMD, Inc. (NYSE AMER: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that it has established its first two Centers of Excellence (COE) at leading hospitals in Europe.

The first COE is at the Augusta Hospital Clinic for Vascular Surgery in Düsseldorf, Germany and is led by Prof. Ralf Kolvenbach, Head of the Cardiovascular Diseases Department and Medical Director of the Catholic Hospitals. Prof. Kolvenbach is one of the leading vascular surgeons in Germany and treats a significant number of patients suffering form carotid artery disease.  The second COE is at the Maria Cecilia Hospital, in Cotignola, Italy and is led by Dr. Alberto Cremonesi, Chief of the Cardiovascular Department and a leading interventional cardiologist in Italy, also treating a large number of patients suffering from carotid artery disease.

The Augusta Hospital Clinic for Vascular Surgery and Maria Cecilia Hospital recently held their first workshop, which covered the indications and strategies for the use of CGuard™ EPS.  This included lectures and proctoring of live cases to illustrate the advantages of the minimally invasive carotid artery revascularization procedures using CGuard™ EPS versus endarterectomy, which is the more commonly utilized surgical approach.  

“We are privileged to have established these first two CGuard™ EPS Centers of Excellence at two of the leading hospitals in Germany and Italy, which are key markets for CGuard,” commented James Barry, PhD, Chief Executive Officer of InspireMD.  “COEs are a key element in our broader strategy to educate and convert vascular surgeons and interventionalist away from the more invasive surgical carotid endarterectomy procedure and towards CGuardTM EPS in the treatment of patients with carotid artery disease given the sustained safety and embolic and stroke prevention benefits clinically seen with the CGuard™ EPS.  Converting physicians away from treating carotid artery disease with surgery will result in a significant increase in the addressable market for our product, which we believe is a billion-dollar product category in carotid artery procedures alone. The goal of these COEs is to train, educate and share experiences among both surgeons and interventionalists to incorporate CGuard™ EPS into their daily practice as the system of choice for carotid revascularization and stroke prevention.  We look forward to announcing additional COEs as we continue to execute on our strategy.”

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, noted, “The initial workshops held at both the Augusta Hospital Clinic for Vascular Surgery and at the Maria Cecilia Hospital were well attended and illustrate the growing interest among vascular surgeons as well as interventionalists in CGuard™ EPS, which utilizes our patented MicroNet™® technology.”

About InspireMD, Inc.

InspireMD has developed the CGuardTM Embolic Protection System to aid vascular surgeons and other medical specialists to guard against the debilitating effects of stroke caused by carotid artery disease, one of the highest risk factors of this condition. CGuardTM EPS, with its patented MicroNet™® and SMARTFITTM technologies, provides a minimally invasive, safe and effective alternative to surgery and other interventions with their associated risk factors. InspireMD intends to pursue further applications of its platform MicroNet™® technology in neurovascular, coronary and peripheral artery procedures.

Forward-looking Statements

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

Investor Contacts:

 

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com  

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

InspireMD, Inc. Announces Pricing of $10 Million Underwritten Public Offering

Tel Aviv, Israel— June 29, 2018 – InspireMD, Inc. (NYSE American: NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the pricing of an underwritten public offering of 33,333,333 units at a price to the public of $0.30 per unit. InspireMD expects to receive aggregate gross proceeds of approximately $10 million from the offering, assuming no exercise of the underwriter’s option to purchase additional securities. Each unit contains one share of common stock (or common stock equivalent) and one Series D warrant to purchase one share of common stock. The common stock (or common stock equivalents) and the accompanying Series D warrants included in the units can only be purchased together in this offering, but will be issued separately and will be immediately separable upon issuance.  

In connection with the offering, InspireMD has granted the underwriter a 30-day option to purchase up to additional 4,999,999 shares of common stock and/or Series D warrants to purchase up to 4,999,999 shares of common stock. The offering is expected to close on or about July 3, 2018, subject to customary closing conditions.

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

 InspireMD intends to use $2,264,269 of the proceeds of this offering to redeem the outstanding shares of its Series C Convertible Preferred Stock held by the holder of its Series D Convertible Preferred Stock and all outstanding shares of its Series D Convertible Preferred Stock and the remainder of the net proceeds of this offering for research and development, capital expenditures, working capital and other general corporate purposes, as well as potential acquisition.

 A registration statement on Form S-1 relating to the public offering of the securities described above was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on June 29, 2018. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and a final prospectus relating to the offering will be filed with the SEC, and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus, when available, may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing placements@hcwco.com.

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

 

About InspireMD, Inc.

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

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

 

 

Forward-Looking Statements

This press release includes statements relating to the offering of InspireMD’s securities, including as to the closing of this offering described above and the use of net proceeds therefrom. These statements and other statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) 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 (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 and (xiv) market conditions. 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 Featured at the SBHCI Congress in Brazil

Tel Aviv, Israel— June 20, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that CGuard™ EPS was featured at the SBHCI Congress, sponsored by the Brazilian Society of Hemodynamics and Interventional Cardiology, which took place in Curitiba, Brazil from June 13-15, 2018.  The Congress hosted approximately 1,200 participants including doctors from across Brazil and Central and South America.

As part of the scientific sessions, Dr. Antonio Micari, MD, PhD of Maria Cecilia Hospital, in Cotignola, Italy, presented “How to Minimize Complications, the Safe Carotid Artery Stenting (CAS), Step by Step.”  Dr. Micari discussed the importance of selecting the right type of stent to minimize the risks of complications in CAS procedures.  He presented CGuard™ EPS as the carotid embolic protection stent system of choice.  In addition to his presentation he also showed a challenging and successful case that utilized the CGuard™ EPS which employs the company’s patented MicroNet™ PET fiber and SmartFitTM Technology.

“We are pleased to have had CGuard™ EPS featured so prominently at the SBHCI Congress in Brazil, which included over a thousand attendees from across Central and South America,” commented James Barry, PhD, Chief Executive Officer of InspireMD. “We particularly appreciate the continued support from Dr. Micari from Maria Cecilia hospital, one of the leading endovascular surgery facilities in Italy and one of the leaders in the world doing more than 40,000 endovascular procedures per year.  Regional congresses such as SBHCI are central to our strategy as we expand our footprint and generate awareness among both key opinion leaders and leading physicians in Latin America.”

About InspireMD, Inc.

InspireMD seeks to utilize its patented 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 and NSPR.WSB.

Forward-looking Statements

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

Investor Contacts:

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com  

 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

InspireMD’s CGuard™ EPS Prominently Featured at the 10th International Congress of the Polish Society for Vascular Surgery

Study results presented from 46 patients treated over two years with zero complications

President of the Polish Society for Vascular Surgery presented clinical cases illustrating the advantages of CGuard EPS

Tel Aviv, Israel— June 18, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that study results on its CGuard™ EPS were presented at the 10th International Congress of the Polish Society for Vascular Surgery by Dr. Jan Jakub Kęsik. Dr Kecik, from Lublin Medical University Hospital, presented an overview study of his experience with CGuard™ EPS, which included 46 patients with 100% procedural success, 0% clinical complications, 0% MACNE, and 0% instent restenosis. The presentation featured the advantages of the CGuard™ EPS covered with the company’s proprietary MicroNet™TM PET fiber versus the metallic dual layer Roadsaver® and other conventional carotid stents.

Additionally, Prof. Piotr Szopiński, President of the Polish Society for Vascular Surgery also spoke about his positive experiences with CGuard™ EPS and presented pre-recorded illustrative carotid procedures performed with the product. The Company’s local distributor in Poland, Arteriae Sp., also hosted a booth that featured CGuardTM EPS at the conference that was well attended.

“We are pleased with the continued and growing favorable response to CGuard™ EPS by vascular surgeons as was seen at the 10th International Congress of the Polish Society for Vascular Surgery,” commented James Barry, PhD, Chief Executive Officer of InspireMD. “We appreciate the support from Dr. Kecik and Professor Szopiński who are both vascular surgeons and highlighted the advantages of CGuard™ EPS in their respective presentations.  Dr. Kecik’s study, which included 46 patients with zero complications, adds to the growing body of evidence supporting the advantages of CGuard™ EPS  versus conventional and alternative stents.  This is just another example of how CGuardTM EPS is becoming a primary solution for surgeons who might otherwise be considering surgery for their patients with carotid artery disease.”

The 10th International Congress of the Polish Society for Vascular Surgery is one of the premier European medical conferences covering the field of vascular surgery with over 400 attendees.  The event was hosted by the Polish Society of Vascular Surgery, an organization aimed at advancements in the field of vascular surgery, dissemination of knowledge and the exchange of experiences among individuals and organizations in the field.

About InspireMD, Inc.

InspireMD seeks to utilize its patented 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

InspireMD’s CGuard™ MicroNet™ EPS Featured in a Live Case Transmission to the 2nd DGA Interventional Congress

Tel Aviv, Israel— June 11, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that its CGuard™ MicroNet™ covered Embolic Prevention System (EPS) was successfully featured in a live case transmission on June 8th to the 2nd DGA Interventional Congress of the DGA-Akademie GmbH, the academy for vascular medicine in Hamburg, Germany.
The focus of this angiology congress is presentation and objective discussion of new diagnostic and therapeutic strategies in arterial and venous disease among leading endovascular physicians, interventional cardiologists, interventional radiologists and interventional neuroradiologists from across Europe.
Dr. Ralf Langhoff, Medical Director of Angiology/Vascular Medicine, St. Gertrauden-Krankenhaus in Berlin, performed a challenging live endovascular procedure on a 77 year-old male patient with 80% restenosis of the right internal carotid artery following surgical endarterectomy in 2017, which is considered the current gold standard. The procedure featured CGuard™ EPS and was transmitted real time to the congress.
Dr. Langhoff commented, “CGuard™ EPS is becoming an important tool for the treatment of patients with carotid artery disease. The patented MicroNet™ technology offers plaque protection, while the product exhibits no foreshortening and delivers excellent conformability. The live case we performed went extremely well and clearly highlights the advantages of CGuard™ EPS in the treatment of carotid artery disease.  CGuard™ EPS is making carotid artery stenting an increasingly viable alternative to the surgical carotid endarterectomy procedure.”
“It is an honor to have our technology featured at this leading industry conference by Dr. Ralf Langhoff, one of the premier vascular interventionalists in Europe,” commented James Barry, PhD, Chief Executive Officer of InspireMD. “The DGA Interventional Congress is one of the most prominent conferences in the field of vascular surgery and interventional medicine featuring new developments in therapeutic strategies and technologies, and brings together top key opinion leaders from around the world.”

About InspireMD, Inc.
InspireMD seeks to utilize its patented 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 on Expanded 2 Year Follow-up Results from the PARADIGM Clinical Study Using CGuard™ EPS

Results Presented at EuroPCR 2018

Confirm Sustained Safety and Cerebral Embolic Prevention out to 24 months

Tel Aviv, Israel— May 30, 2018 –  InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS),  thrombus management technologies and neurovascular devices, today announced that Professor Piotr Musiałek, from the Department of Cardiac and Vascular Diseases, John Paul II Hospital, Kraków, Poland, presented the expanded 24 month follow-up results from the PARADIGM-Extend Clinical Study utilizing CGuard™ EPS at EuroPCR 2018, in Paris on May 24, 2018. 

PARADIGM-Extend is the continuation of PARADIGM, an investigator-led clinical study evaluating the use of CGuard™ EPS in patients with symptomatic or asymptomatic carotid artery stenosis with increased stroke risk. The latest results include 251 patients, which is more than double the patient population of 101, which was previously reported in December 2017. Overall cumulative data showed no major strokes in the peri-procedural or post-procedural period up to 30 days (0%).  There was one minor peri-procedural stroke (0.4%), and only one death (non-device related) at 30 days (0.4%).  These results are consistent with earlier reported data in the first patient cohort. Importantly, there were no stroke or stroke-related deaths between 12 and 24 months.

Professor Musialek, commented, “The 24-month clinical and duplex ultrasound evidence is consistent with the unprecedented, sustained safety and cerebral embolism prevention efficacy of CGuard™ EPS in both symptomatic and asymptomatic patients with carotid stenosis.”

“We feel privileged to have had Professor Musialek, one of the leading interventional cardiologists in Europe, present his expanded results of the PARADIGM study at EuroPCR 2018,” said James Barry, PhD, Chief Executive Officer of InspireMD. “Professor Musialek’s PARADIGM-Extend trial continues to demonstrate consistent and strong clinical evidence of durable protection against potential stroke that can result from post procedural embolization. In addition, the duplex ultrasound data confirms normal vessel healing with the CGuardTM EPS device and with no indication of any long term in-stent restenosis. These results include a significant proportion of challenging patients that would have otherwise been sent to surgery (carotid endarterectomy).  Furthermore, these results are consistent with other CGuard™ EPS clinical trials including: CARENET, IRON-GUARD, WISSGOTT Study and CASANA Study.  This excellent data continues to build on the extensive body of evidence supporting the clinical advantages of CGuard™ EPS in preventing stroke that can result from high grade carotid stenosis.”

EuroPCR is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the world-leading course in interventional cardiovascular medicine.  Bringing together over 12,000 clinicians and industry executives each year, EuroPCR is the global forum for sharing within and between all interventional communities. EuroPCR 2018 took place in Paris from May 22-25, 2018.

 

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 Receives Regulatory Approval for both CGuard™ EPS and MGuard Prime™ in Ecuador

Tel Aviv, Israel— May 16, 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) and MGuard Prime™ from the Ministry of Health in Ecuador. Both of these devices utilize the company’s patented MicroNet™ technology.

In May of 2017 the company announced it had entered into an exclusive distribution agreement with CARDIOBENE S.A., a leading medical device distributor in Ecuador. The two companies have worked diligently to successfully secure these regulatory approvals. Sales for both products, CGuard™ EPS and MGuard Prime™, will commence immediately in Ecuador.
Patricio Arboleda Erazo, CARDIOBENE S.A., commented, “We have been working with key opinion leaders as well as the top hospitals in the country in anticipation of these approvals in order to start selling the products. The clinical advantages for both of these products is compelling and we expect our physicians to start using the products very quickly.”
“This approval enhances our footprint across Latin America,” said Agustin Gago, EVP and Chief Commercial Officer of InspireMD. “We are very excited to work with CARDIOBENE, one of the most successful distributors of endovascular products in Ecuador.”
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 132% Increase in CGuard™ EPS Sales for the First Quarter of 2018

Tel Aviv, Israel— May 7, 2018 – InspireMD, Inc. (NYSE American:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced results for the first quarter ending March 31, 2018.

First Quarter 2018 highlights:

  • Achieves revenue of $1.0 million for Q1 2018 versus $569,000 in Q1 2017, an increase of 77%
  • Total CGuard™ EPS sales increase 132% to $831,000 for Q1 2018
  • 5th consecutive quarter of sequential double-digit growth
  • Continues global expansion setting up distribution in South Korea, Greece and the Carribean.
  • Achieves regulatory approvals and launches CGuardTM in India and Peru
  • Ends Q1 with $4.6 million of cash plus an additional $4.1 million in net proceeds from capital raise that closed in Q2

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We are pleased to report sales in excess of $1 million for the first quarter of 2018.  This marks a major milestone since full implementation of our new commercial strategy in Q3 of 2017.  Achieving this level of sales in such a short time is a tribute to our operational and commercial teams, as well as the growing physician enthusiasm and appreciation for CGuard™ EPS.  Specifically, sales of CGuardTM EPS increased by 132% versus the same period last year. We believe this sets the foundation for continued growth in 2018.  At the same time, we are building strong support among key opinion leaders, illustrated by the featured presentations at top industry conferences and publication of clinical results in leading journals.”

“Given the enthusiasm by leading physicians, including their conducting investigator initiated clinical trials, we remain confident in the potential for CGuard™ EPS to become the preferred option for patients that are candidates for carotid artery stenting (CAS).  In addition, clinical data suggests that CGuard™ EPS may offer a safer alternative to the surgical gold standard carotid endarterectomy (CEA).  This could significantly expand the addressable market for CGuardTM given the safety advantages of our device, as we believe more physicians, including surgeons, would choose a minimally invasive procedure over surgery for their patients.”

“Having met previously with the FDA regarding our investigational device exemption (IDE) submission for CGuard™ EPS, we are now evaluating plans to restart the regulatory approval process in the United States. Concurrently, we are exploring other synergistic opportunities and product extensions that may allow us to leverage our distribution network and growing sales channels in Europe, Asia and Latin America.” 

Financial Results

Revenue for the first quarter ended March 31, 2018 was $1,007,000 compared to $569,000 during the same period in 2017. The increase was primarily due to an increase in sales of CGuard™ EPS as we transitioned from our prior exclusive distribution partner for most of Europe to local distributors, continued focus on expanding existing markets such as Germany and Italy and expanding into new geographies such as India. Total operating expenses for the quarter ended March 31, 2018 were $2,246,000, a decrease of 9.4% compared to $2,478,000 for the same period in 2017. This decrease was primarily due to a decrease in share-based compensation expenses and a decrease in salary expenses, primarily due to a salary related accrual in 2017, partially offset by an increase in legal expenses. Financial expenses for the quarter ended March 31, 2018 were $436,000 compared to $154,000 for the same period in 2017, largely due to a non-cash expense associated with our preferred stock.

Net loss for the quarter ended March 31, 2018 totaled $2,389,000, or $1.08 per basic and diluted share, compared to a net loss of $2,559,000, or $28.31 per basic and diluted share, in the same period in 2017.

As of March 31, 2018, cash and cash equivalents were $4,637,000, compared to $3,710,000 as of December 31, 2017.  Based on the Company’s current business plan, the Company believes its cash and cash equivalents as of March 31, 2018, will be sufficient to meet its operating requirements for approximately 12 months from the date of the balance sheet.

About InspireMD, Inc.

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

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

Forward-looking Statements

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

 

Investor Contacts:

 

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com  

 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

(tables follow)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   
 

Three months ended

March 31,

 

2018

 

2017

       
       

Revenues

$1,007

 

$569

Cost of revenues

714

 

495

       

Gross Profit (Loss)

293

 

74

       

Operating Expenses:

     

Research and development

252

 

350

Selling and marketing

492

 

532

General and administrative

1,502

 

1,596

       

Total operating expenses

2,246

 

2,478

       

Loss from operations

(1,953)

 

(2,404)

       

Financial expenses

436

 

154

       

Loss before tax expenses

(2,389)

 

(2,558)

       

Tax expenses (Income)

 

1

       

Net Loss

$(2,389)

 

$(2,559)

       

Net loss per share – basic and diluted

$(1.08)

 

$(28.31)

       

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

2,253,945

 

112,756

 

 

 

CONSOLIDATED BALANCE SHEETS

(U.S. dollars in thousands)

ASSETS

March 31,

 

December 31,

2018

 

2017

       

Current Assets:

     

Cash and cash equivalents

$4,637

 

$3,710

Accounts receivable:

     

     Trade, net

754

 

643

     Other

238

 

207

Prepaid expenses

53

 

62

Inventory

517

 

533

       

Total current assets

6,199

 

5,155

       
       

Non-current assets:

 

Property, plant and equipment, net

444

 

476

 

155

 

Funds in respect of employee rights upon retirement

487

 

476

       

Total non-current assets

1,086

 

952

       

Total assets

$7,285

 

$6,107

 

 

 

LIABILITIES AND EQUITY

March 31,

 

December 31,

2018

 

2017

       

Current liabilities:

     

Accounts payable and accruals:

     

     Trade

$512

 

$328

     Other

2,417

 

2,134

Contract liability

26

 

20

       

Total current liabilities

2,955

 

2,482

       

Long-term liabilities:

     

Liability for employees rights upon retirement

635

 

624

Derivative liability

872

 

       

Total long-term liabilities

1,507

 

624

       

Total liabilities

4,462

 

3,106

       

Redeemable preferred shares

1,779

 

274

       

Equity:

     

Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2018 and December 31, 2017, respectively; 3,501,331 and 1,483,556 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively

 

Preferred B shares, par value $0.0001 per share;
500,000 shares authorized at March 31, 2018 and December 31, 2017, respectively; 17,303 and 27,075 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively

 

Preferred C shares, par value $0.0001 per share;
1,172,000 shares authorized at March 31, 2018 and December 31, 2017, respectively; 451,695 and 741,651 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively

 

Preferred D shares, par value $0.0001 per share; 750 shares authorized at March 31, 2018 and December 31, 2017, respectively; 300 and 750 issued and outstanding at March 31, 2018 and December 31, 2017, respectively

 

Additional paid-in capital

143,785

 

143,079

Accumulated deficit

(142,741)

 

(140,352)

       

Total equity

1,044

 

2,727

       

Total liabilities, redeemable preferred shares and equity

$7,285

 

$6,107

       

 

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

 

(2) All March 31, 2018 financial information is derived from the Company’s 2018 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2017 financial information is derived from the Company’s 2017 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2017 filed with the Securities and Exchange Commission.