InspireMD, Inc. Announces Underwriter Exercise of Over-Allotment Option in Full and Closing of $11.5 Million Follow-On Underwritten Public Offering

Tel Aviv, Israel— June 8, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today the closing, on June 5, 2020, of its $11.5 million follow-on underwritten public offering, which included $1.5 million from the exercise, in full, by the underwriter of its over-allotment option for the offering. Pursuant to the offering, InspireMD issued 25,555,500 shares of common stock or common stock equivalents, along with an equivalent number of Series F warrants to purchase common stock, in units, at a price to the public of $0.45 per unit. Each Series F warrant is exercisable for one share of common stock at an exercise price of $0.495 per share. The common stock (or common stock equivalents) and the accompanying Series F warrants included in the units were issued separately to investors at the closing.

A.G.P. / Alliance Global Partners served as the sole book-running manager for the offering.

InspireMD intends to use the net proceeds of this offering—estimated at $10.7 million— for research and development, sales and marketing, working capital and other general corporate purposes.

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.

A registration statement on Form S-1 (File No. 333-238247) 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 2, 2020. The offering was carried out only by means of a prospectus forming part of the effective registration statement. The final prospectus relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, by calling (212) 624-2060 or emailing investmentbanking@allianceg.com, or at the SEC’s website at http://www.sec.gov.

 

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

 

Forward-Looking Statements

This press release includes statements related to the offering of InspireMD’s units, including as to the use of net proceeds from that offering. 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, potential risks and uncertainties associated with (i) the uses of the proceeds from the underwritten public offering and the adequacy of those proceeds, (ii) market acceptance of the Company’s existing and new products, (iii) negative clinical trial results or lengthy product delays in key markets, (iv) the inability to secure regulatory approvals for the sale of the Company’s products, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) the Company’s limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third-party payers for the Company’s products, (x) the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) the Company’s reliance on single suppliers for certain product components, (xiii) the fact that the Company will need to raise additional capital to meet its business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the 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 website 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, unless required by law.

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

 

 

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

Tel Aviv, Israel— June 3, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, today announced the pricing of an underwritten public offering of 22,222,200 units at a price to the public of $0.45 per unit. InspireMD expects to receive aggregate gross proceeds of approximately $10.0 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 F warrant to purchase one share of common stock at an exercise price of $0.495 per share. The common stock (or common stock equivalents) and the accompanying Series F 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 45-day option to purchase up to an additional 3,333,333 units, consisting of shares of common stock and/or Series F warrants, for additional gross proceeds of up to $1.5 million. The offering is expected to close on or about June 5, 2020, subject to customary closing conditions.

A.G.P. / Alliance Global Partners is acting as the sole book-running manager for the offering.

InspireMD intends to use the net proceeds of this offering for research and development, sales and marketing, working capital and other general corporate purposes.

A registration statement on Form S-1 (File No. 333-238247) 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 2, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus and, when available, electronic copies of the final prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, by calling (212) 624-2060 or emailing investmentbanking@allianceg.com, or at the SEC’s website at http://www.sec.gov.

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

 

About InspireMD, Inc.

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

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

 

Forward-Looking Statements

This press release includes statements related to the offering of InspireMD’s units, including as to the closing of the offering 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) the underwritten public  offering, including the potential non-completion of the offering, the actual proceeds therefrom and the uses thereof, (ii) market acceptance of the Company’s existing and new products, (iii) negative clinical trial results or lengthy product delays in key markets, (iv) an inability to secure regulatory approvals for the sale of the Company’s products, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) the Company’s limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third-party payers for the Company’s products, (x) the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) the Company’s reliance on single suppliers for certain product components, (xiii) the fact that the Company will need to raise additional capital to meet its business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the 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 website 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, unless required by law.

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

 

InspireMD Announces First Quarter 2020 Financial Results

First quarter revenue growth driven by continued strong uptake of the CGuard Embolic Prevention System (EPS) in the company’s major markets

Management to host investor conference call today, May 12, at 8:30am ET

Tel Aviv, Israel— May 12, 2020 – 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 (CAD), today announced financial and operating results for the first quarter ended March 31, 2020.

First Quarter 2020 and recent highlights:

  • Generated CGuard™ EPS revenue of $971,000, an increase of 158.2% compared to $376,000 in the first quarter of 2019, when the company’s previous third-party sterilizer equipment failures caused a significant interruption in sterilized product supply for the majority of the first quarter.
  • For the third consecutive year, company was chosen to demonstrate a successful live clinical case transmission featuring CGuard™ EPS at the Leipzig Interventional Course (LINC) 2020 that showcased CGuard’s ease-of-use and exceptional patient safety features
  • Completed all additional bench testing requested by FDA in support of the company’s pending IDE application, which the company expects to re-file in May 2020
  • Continued to advance plans to broaden the company’s product portfolio with procedural protection devices based on its reverse flow technology as well as develop new indications for the CGuard EPS with MicroNet™.

“The ongoing COVID-19 pandemic has placed unprecedented pressure on healthcare systems around the world, and we are seeing this impact on elective procedure volumes, including carotid artery disease treatments,” stated Marvin Slosman, Chief Executive Officer of InspireMD. “However, these procedures must ultimately occur to save lives, and we stand ready with our support and supply infrastructure to quickly fulfill the needs of physicians and their patients as a more normalized healthcare environment reemerges.”

“I am more enthusiastic than ever about the potential of CGuard EPS – and its novel MicroNet™® technology – to fundamentally disrupt the current standard of care in carotid stenosis. During the quarter, we continued to see consistent growth across all our current markets while we simultaneously worked to open new opportunities in Brazil, France, the Asia/Pacific region and, of course, the United States. Longer-term, I believe we can establish another pillar of growth by further exploiting our reverse flow technology in a procedural protection device and to expand our product pipeline with CGuard with MicroNet™ into new high-value indications.

“During these highly challenging and uncertain times, I am buoyed by our team’s ability to maintain these essential growth drivers in light of the changes we have made in order to operate safely and effectively. This is a reflection of our team’s ongoing quest for high achievement, high accountability and laser focus,” concluded Mr. Slosman.

Financial Results

For the three months ended March 31, 2020, revenue increased by $619,000, or 149.2%, to $1,034,000, from $415,000 during the three months ended March 31, 2019. This increase was predominantly driven by a 158.2% increase in sales volume of CGuard EPS from $376,000 during the three months ended March 31, 2019, to $971,000 during the three months ended March 31, 2020, mainly due to the company’s previous third-party sterilizer equipment failures which caused a significant interruption in sterilized product supply for the majority of the first quarter 2019 as well as the company’s continued focus in expanding revenue base in the company’s major markets. In addition, MGuard Prime EPS sales increased from $39,000 during the three months ended March 31, 2019, to $63,000 during the three months ended March 31, 2020, due to the delayed shipments of sterilized products during the three months ended March 31, 2019, as mentioned above. The company’s gross profit for the quarter ended March 31, 2020 was $295,000, compared to a gross loss of $73,000 for the same period in 2019. This increase in gross profit was primarily driven by a higher volume of sales of CGuard EPS less the related material and labor costs and a decrease in write-offs of inventory during the three months ended March 31, 2020 due to the same sterilization issue mentioned above. Gross margin increased to 28.5% in the first quarter of 2020 from (17.6%) for the same period in 2019.

Total operating expenses for the quarter ended March 31, 2020 were $2,316,000, a decrease of 24.2% compared to $3,057,000 for the same period in 2019. This decrease was primarily due to a reduction of $328,000 in clinical expenses associated with CGuard EPS, mainly related to the IDE approval process, a decrease of $354,000 due to settlement expenses made to a former service provider pursuant to a settlement agreement during the three months ended March 31, 2019, which did not occur during the three months ended on March 31, 2020 as well as $59,000 of miscellaneous expense reductions.

Financial income for the quarter ended March 31, 2020 was $43,000 compared to financial expenses of $77,000 for the same period in 2019. This increase in income of $120,000 was predominately due to changes in exchange rates.  Net loss for the fourth quarter of 2020 totaled $1,978,000, or $0.43 per basic and diluted share, compared to a net loss of $3,207,000, or $3.82 per basic and diluted share, for the same period in 2019.

As of March 31, 2020, cash and cash equivalents were $3,141,000, compared to $5,514,000 at December 31, 2019.

Conference Call and Webcast Details

The conference call will be available via telephone by dialing toll free 877-451-6152 for U.S. callers, or +1 201-389-0879 for international callers, and referencing conference ID 13703268. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=139696. The webcast will be archived on the Company’s website.

About InspireMD, Inc.

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

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

Forward-looking Statements

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

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

 

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS(1)

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

 

 

 

 

Three months ended

March 31,

 

2020

 

2019

 

 

 

 

 

 

 

 

Revenues

$1,034

 

$415

Cost of revenues

739

 

488

 

 

 

 

Gross Profit (Loss)

295

 

(73)

 

 

 

 

Operating Expenses:

 

 

 

Research and development

523

 

1,125

Selling and marketing

624

 

634

General and administrative

1,169

 

1,298

 

 

 

 

Total operating expenses

2,316

 

3,057

 

 

 

 

Loss from operations

(2,021)

 

(3,130)

 

 

 

 

Financial expenses (Income)

(43)

 

77

 

 

 

 

Net Loss

$(1,978)

 

$(3,207)

 

 

 

 

Net loss per share – basic and diluted

$(0.43)

 

$(3.82)

 

 

 

 

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

4,623,034

 

839,533

 

 

CONSOLIDATED BALANCE SHEETS(2)

(U.S. dollars in thousands)

ASSETS

March 31,

 

December 31,

2020

 

2019

 

 

 

 

Current Assets:

 

 

 

Cash and cash equivalents

$3,141

 

$5,514

Accounts receivable:

 

 

 

     Trade, net

856

 

823

     Other

174

 

150

Prepaid expenses

63

 

87

Inventory

1,202

 

1,236

 

 

 

 

Total current assets

5,436

 

7,810

 

 

 

 

 

 

 

 

Non-current assets:

 

Property, plant and equipment, net

496

 

547

Operating lease right of use assets

864

 

937

Funds in respect of employee rights upon retirement

589

 

586

 

 

 

 

Total non-current assets

1,949

 

2,070

 

 

 

 

Total assets

$7,385

 

$9,880

 

 

LIABILITIES AND EQUITY

March 31,

 

December 31,

2020

 

2019

Current liabilities:

 

 

 

Accounts payable and accruals:

 

 

 

     Trade

$562

 

$646

     Other

2,024

 

2,449

Contract liability

17

 

20

Total current liabilities

2,603

 

3,115

 

 

 

 

Long-term liabilities:

 

 

 

Operating lease liabilities

544

 

653

Liability for employees rights upon retirement

761

 

729

Total long-term liabilities

1,305

 

1,382

 

 

 

 

Total liabilities

3,908

 

4,497

 

 

 

 

 

 

 

 

Equity:

 

 

 

Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2020 and December 31, 2019; 4,338,910 and 3,916,134 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively

 

Preferred B shares, par value $0.0001 per share;
500,000 shares authorized at March 31, 2020 and December 31, 2019; 17,303 shares issued and outstanding at March 31, 2020 and December 31, 2019.

 

Preferred C shares, par value $0.0001 per share;
1,172,000 shares authorized at March 31, 2020 and December 31, 2019; 26,558 and 34,370 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively

 

Additional paid-in capital

163,087

 

163,015

Accumulated deficit

(159,610)

 

(157,632)

 

 

 

 

Total equity

3,477

 

5,383

 

 

 

 

Total liabilities and equity

$7,385

 

$9,880

 

 

(1) All 2020 financial information is derived from the Company’s 2020 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2019 financial information is derived from the Company’s 2019 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

 

(2) All March 31, 2020 financial information is derived from the Company’s 2020 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, 2019 financial information is derived from the Company’s 2019 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2019 filed with the Securities and Exchange Commission.

 

 

 

 

InspireMD to Report First Quarter 2020 Financial Results and Provide Business Update on Tuesday, May 12

InspireMD to Report First Quarter 2020 Financial Results and Provide Business Update on Tuesday, May 12

Tel Aviv, Israel— May 5, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today that management will host a conference call and webcast on Tuesday, May 12, 2020, to discuss financial results for the first quarter ended March 31, 2020, and provide a corporate update.

 

Conference Call & Webcast:

Tuesday, May 12th @ 8:30am EDT

Within the US:                               877-451-6152

Outside the US:                             201-389-0879

Conference ID:                              13703268

Webcast:                                        http://public.viavid.com/index.php?id=139696

 

About InspireMD, Inc.

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

 

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

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

 

InspireMD Announces Fourth Quarter and Year-End 2019 Financial Results

Robust CGuard™ EPS year-over-year revenue growth of 31%

Management to host investor conference call today, March 10, at 8:30am ET

Tel Aviv, Israel— March 10, 2010 – 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 (CAD), today announced financial and operating results for the fourth quarter and year ended December 31, 2019.

Fourth Quarter 2019 and recent highlights:

  • Announced the appointment of leading medical devices executive Marvin Slosman as Chief Executive Officer
  • Generated revenue of $1,013,000, representing growth of 23% over the fourth quarter 2018, driven by continued strong growth in sales of CGuard™ EPS
  • Generated CGuard™ EPS revenue of $921,000, up 31% over the fourth quarter 2018
  • Chosen for the third consecutive year to demonstrate a successful live clinical case transmission featuring CGuard™ EPS at the Leipzig Interventional Course (LINC) 2020 that showcased CGuard’s ease-of-use and exceptional patient safety features
  • Presented updated data at the 2019 VEITH Symposium and LINC 2020 from the IRONGUARD 2 study, a physician initiated prospective multi-center and multi-specialty registry that enrolled more than 700 patients, which suggested that the use of the CGuard EPS in routine clinical practice is associated with no major periprocedural and 30-day neurologic complications
  • Began exploring the potential broadening of the company’s product portfolio with procedural protection devices based on its reverse flow technology
  • Beginning to engage with French health authorities to gain reimbursement in France
  • Advanced productive discussions with FDA and addressed requests related to the company’s pending IDE application

“I assumed the role of Chief Executive Officer of InspireMD because I believe the combination of the substantial amount of published data confirming the safety and efficacy of CGuard, along with real world performance demonstrating the unique patient safety features of the device and a growing appreciation of CAS, or carotid artery stenting, as a first line treatment for CAD, position CGuard EPS and MicroNet™ to change the standard of care in this disease,” said Marvin Slosman, Chief Executive Officer. “The strong revenue growth that we reported in the fourth quarter was again driven by growing demand for CGuard in our key European markets, and my  discussions with our physician and distribution partners in the field confirm that we are realizing this success by educating practitioners and creating awareness for the value of our platform.”

“We are also executing on another of the pillars of our commercial focus which is compilation of multiple clinical registries designed to capture relevant data to support additional indications for the CGuard EPS platform, which we believe are numerous and significant.”

“Presentations at key industry conferences such as VEITH and LINC, along with our strong relationships with key opinion leaders in the field, are absolutely crucial to our long-term growth, and we are pleased to continue to play a significant role at these events, which attract leading vascular surgeons and interventionalists from around the world. We believe these presentations serve as the foundation of a multifaceted commercial growth strategy that we continue to drive in CE mark territories and Asia.”  

“In parallel with these efforts, we continue to work vigorously to address FDA’s information and testing requests in support of our pending IDE application, and the initiation of clinical testing in the all-important US market which is among our highest corporate priorities.”

Financial Results

For the three months ended December 31, 2019, revenue increased by 23.2%, to $1,013,000, from $822,000 during the three months ended December 31, 2018. This increase was predominantly driven by a 31.4% increase in sales volume of CGuard EPS from $701,000 during the three months ended December 31, 2018, to $921,000 during the three months ended December 31, 2019, mainly due to our continued focus on expanding existing markets. This increase in sales of CGuard EPS was partially offset by a 24.0% decrease in sales of MGuard Prime EPS, largely driven by the general shift in preference to drug-eluting stents rather than bare metal stents, such as MGuard Prime EPS, in ST-Elevation Myocardial Infarction (“STEMI”) patients. The company’s gross profit for the quarter ended December 31, 2019 was $259,000, compared to a gross profit of $227,000 for the same period in 2018. This increase in gross profit was primarily driven by a higher volume of sales of CGuard EPS less the related material and labor costs, offset by an increase in write-offs predominantly driven by a non-recurring component supply issue of CGuard EPS. Gross margin decreased to 25.6% in the fourth quarter of 2019 from 27.6% for the same period in 2018.

Total operating expenses for the quarter ended December 31, 2019 were $2,765,000, an increase of 13.6% compared to $2,433,000 for the same period in 2018. This increase was primarily due to payments related to the separation agreement of $684,000 the company entered into with its former chief executive officer, offset by a reduction of miscellaneous expenses of approximately $352,000 throughout the organization.

Financial expenses for the quarter ended December 31, 2019 were $27,000 compared to financial expenses of $7,000 for the same period in 2018. This increase in financial expenses of $20,000 was predominately due to changes in exchange rates.  Net loss for the fourth quarter of 2019 totaled $2,557,000, or $0.57 per basic and diluted share, compared to a net loss of $2,213,000, or $2.64 per basic and diluted share, for the same period in 2018.

For the twelve months ended December 31, 2019, revenue increased by $120,000, or 3.3%, to $3,721,000, from $3,601,000 during the twelve months ended December 31, 2018. This increase was predominantly driven by a 10.0% increase in sales volume of CGuard EPS from $2,970,000 during the twelve months ended December 31, 2018, to $3,265,000 during the twelve months ended December 31, 2019, as a result of our continued focus on expanding existing markets such as Poland, Switzerland, Italy, and Spain and expansion into new geographies such as Australia and South Africa. This increase was offset by a 27.7% decrease in sales volume of MGuard Prime EPS from $631,000 during the twelve months ended December 31, 2018, to $456,000 during the twelve months ended December 31, 2019. In addition, the overall increase mentioned above was offset across the board by shipment delays in the three months ended March 31, 2019 associated with the company’s decision to switch its third-party sterilizer. The transition to the new sterilization company was completed in early April 2019, and the company does not currently anticipate any future disruptions in fulfilling new orders.

The Company’s gross profit for the twelve months ended December 31, 2019 was $756,000 compared to a gross profit of $995,000 for the same period in 2018. This decrease in gross profit resulted from a $142,000 increase in write-offs predominantly driven by a non-recurring component supply issue of CGuard EPS and slow moving MGuard Prime EPS, $69,000 of expenses related to upgrades made to our production facilities and $48,000 of expenses pertaining to annual and new employee training of production workers, and offset by a reduction of $20,000 in miscellaneous expenses. Gross margin decreased to 20.3% in the twelve months ended December 31, 2019 from 27.6% in the same period in 2018.

Total operating expenses for the twelve months ended December 31, 2019 were $10,572,000, an increase of 22.8% compared to $8,606,000 for the same period in 2018. This increase was primarily due to an increase of $804,000 in clinical expenses associated with CGuard™ EPS, mainly related to IDE efforts in 2019, payments related to the separation agreement of $684,000 the company entered into with its former chief executive officer and a settlement payment of $354,000 made to a former service provider.

Financial expenses for the twelve months ended December 31, 2019, were $200,000 as compared to financial income of $371,000 for the twelve months ended December 31, 2018. The increase in financial expenses primarily resulted from the $438,000 of financial income related to the revaluation of the embedded derivative of the Series C Convertible Preferred Stock recorded during the twelve months ended December 31, 2018, which did not occur during the twelve months ended in December 31, 2019, and an increase of $144,000 in financial expenses related to changes in exchange rates. These increases in financial expenses were partially offset by a decrease of $11,000 in miscellaneous expenses during the twelve months ended December 31, 2019. Net loss for the twelve months ended December 31, 2019 totaled $10,040,000, or $4.80 per basic and diluted share, compared to a net loss of $7,240,000, or $16.67 per basic and diluted share, for the same period in 2018.

As of December 31, 2019, cash and cash equivalents were $5,514,000, compared to $9,384,000 at December 31, 2018. Based on the Company’s current business plan, the Company believes its cash and cash equivalents as of December 31, 2019, will be sufficient to meet its operating requirements until the end of May 2020. As disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, which was filed on March 9, 2020, with the Securities and Exchange Commission, the audited financial statements contained a going concern qualification paragraph in the audit opinion from its independent registered public accounting firm. See further discussion in Note 1b to the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K. This announcement is made pursuant to NYSE American Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph.

Conference Call and Webcast Details

The conference call will be available via telephone by dialing toll free 877-451-6152 for U.S. callers, or +1 201-389-0879 for international callers, and referencing conference ID 13699019. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=138070. The webcast will be archived on the Company’s website.

About InspireMD, Inc.

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

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

Forward-looking Statements

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

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

 

 

 

 

 

 

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS

 

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

 

 

 

 

Twelve months ended

 

 

 

Three months ended

 

 

December 31,

 

December 31,

 

 

2019

 

2018

 

2019

 

2018

 

Revenues

$1,013

 

$822

 

$3,721

 

$3,601

 

Cost of revenues

754

 

595

 

2,965

 

2,606

 

 

 

 

 

 

 

 

 

 

Gross Profit

259

 

227

 

756

 

995

 

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

Research and development

522

 

637

 

2,954

 

1,535

 

Selling and marketing

605

 

564

 

2,396

 

2,241

 

General and administrative

1,638

 

1,232

 

5,222

 

4,830

 

 

 

 

 

 

 

 

 

 

Total operating expenses

2,765

 

2,433

 

10,572

 

8,606

 

 

 

 

 

 

 

 

 

 

Loss from operations

(2,506)

 

(2,206)

 

(9,816)

 

(7,611)

 

 

 

 

 

 

 

 

 

 

Financial expenses (income)

27

 

7

 

200

 

(371)

 

 

 

 

 

 

 

 

 

 

Loss before tax expenses

(2,533)

 

(2,213)

 

(10,016)

 

(7,240)

 

 

 

 

 

 

 

 

 

 

Tax expenses

24

 

 

24

 

 

 

 

 

 

 

 

 

 

 

Net Loss

$(2,557)

 

$(2,213)

 

$(10,040)

 

$(7,240)

 

 

 

 

 

 

 

 

 

 

Basic and Diluted Loss Per Share:

 

 

 

 

 

 

 

 

Extinguishment and accretion of preferred shares

 

 

 

(456)

 

 

 

 

 

 

 

 

 

 

Net Loss Applicable to Ordinary Shares

$(2,557)

 

$(2,213)

 

$(10,040)

 

$(7,696)

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

$(0.57)

 

$(2.64)

 

$(4.80)

 

$(16.67)

 

 

 

 

 

 

 

 

 

 

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

4,449,020

 

838,268

 

2,089,964

 

461,539

 

                       

 

 

 

CONSOLIDATED BALANCE SHEETS

(U.S. dollars in thousands)

ASSETS

December 31,

 

December 31,

2019

 

2018

Current Assets:

 

 

 

Cash and cash equivalents

$5,514

 

$9,384

Accounts receivable:

 

 

 

     Trade, net

823

 

716

     Other

150

 

104

Prepaid expenses

87

 

81

Inventory

1,236

 

1,134

 

 

 

 

Total current assets

7,810

 

11,419

 

 

 

 

 

 

 

 

Non-current assets:

 

Property, plant and equipment, net

547

 

421

Operating lease right of use assets

937

 

Funds in respect of employee rights upon retirement

586

 

448

 

 

 

 

Total non-current assets

2,070

 

869

 

 

 

 

Total assets

$9,880

 

$12,288

 

 

 

LIABILITIES AND EQUITY

December 31,

 

December 31,

2019

 

2018

Current liabilities:

 

 

 

Accounts payable and accruals:

 

 

 

     Trade

$646

 

$929

     Other

2,449

 

1,966

Contract liability

20

 

25

Total current liabilities

3,115

 

2,920

 

 

 

 

Long-term liabilities:

 

 

 

Operating lease liabilities

653

 

Liability for employees rights upon retirement

729

 

605

Total long-term liabilities

1,382

 

605

 

 

 

 

Total liabilities

4,497

 

3,525

 

 

 

 

Redeemable preferred shares

 

 

 

 

 

Equity:

 

 

 

Common stock, par value $0.0001 per share; 150,000,000 shares authorized at December 31, 2019 and 2018; 3,916,134 and 768,615 shares issued and outstanding at December 31, 2019 and 2018, respectively

 

Preferred B shares, par value $0.0001 per share;
500,000 shares authorized at December 31, 2019 and 2018; 17,303 shares issued and outstanding at December 31, 2019 and 2018, respectively

 

Preferred C shares, par value $0.0001 per share;
1,172,000 shares authorized at December 31, 2019 and 2018; 34,370 and 61,423 shares issued and outstanding at December 31, 2019 and 2018, respectively

 

Additional paid-in capital

163,015

 

156,355

Accumulated deficit

(157,632)

 

(147,592)

 

 

 

 

Total equity

5,383

 

8,763

 

 

 

 

Total liabilities and equity

$9,880

 

$12,288

 

 

(1) All financial information for the twelve months ended December 31, 2019 is derived from the Company’s 2019 audited financial statements and all financial information for the twelve months ended December 31, 2018 is derived from the Company’s 2018 audited financial statements, included in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2019 filed with the Securities and Exchange Commission.  All financial information for the three months ended December 31, 2019 and 2018 is derived from the Company’s unaudited, financial statements.

 

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

 

 

 

 

InspireMD to Report Fourth Quarter 2019 Financial Results and Provide Business Update on Tuesday, March 10

Management to host conference call and webcast at 8:30am ET

Tel Aviv, Israel— March 3, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today that it will host a conference call and webcast on Tuesday, March 10, 2020, to discuss financial results for the fourth quarter and year ended December 31, 2019, and provide a corporate update.

 

Conference Call & Webcast:

Tuesday, March 10th @ 8:30am Eastern Time

Within the US:                                   877-451-6152

Outside the US:                                 201-389-0879

Conference ID:                                  13699019

Webcast:                                             http://public.viavid.com/index.php?id=138070

 

About InspireMD, Inc.

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

 

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

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

 

InspireMD Announces Successful Live Clinical Case Transmissions Featuring CGuard™ EPS at the Leipzig Interventional Course (LINC) 2020

Case demonstrates ease-of-use and exceptional patient safety features of CGuard™ EPS

Tel Aviv, Israel — January 29, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, today announced that a successful live case featuring CGuard™ EPS was presented at the international LINC conference 2020, which is being held January 28 – 31 in Leipzig, Germany.

“For the third year in a row, we were chosen to showcase CGuard™ EPS in a live case procedure. This again confirms both clinical utility and ease of use of the device relative to alternative stent options and carotid endarterectomy,” said Marvin Slosman, chief executive officer of InspireMD. “Together with the panel discussions and presentations featuring CGuard™ EPS at this year’s LINC conference, the totality of evidence demonstrating CGuard’s safety and efficacy continues to reiterate the value of CGuard as a standard of care treatment for carotid artery disease. We would like to express our thanks to Drs. Micari and Castriota, two world-renowned interventionalists, for again demonstrating superior results of CGuard™ EPS in a real-time clinical setting.”

Live case #17: Symptomatic high-risk carotid artery disease

The live case was conducted by Dr. Antonio Micari and Dr. Fausto Castriota, interventional cardiologists at Humanitas Gavazzeni Hospital, Bergamo, Italy. The 82-year old male patient presented with symptomatic high-risk carotid artery disease and experienced a transient ischemic attack (TIA) with left-sided hemiparesis approximately one month ago. Risk factors included hypertension and hypercholesterolemia. The procedure was successfully performed with CGuard™ EPS, lasted approximately 20 minutes and had an excellent angiographic result.

Following the procedure, Drs. Micari and Castriota commented, “We believe CGuard™ EPS is a game changer in the plaque–stent interaction paradigm.”

 

About LINC

LINC is a leading global forum for new methods in the field of vascular medicine. LINC brings together medical professionals from different specialties around the world who perform endovascular interventions.

 

About InspireMD, Inc.

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

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

Forward-looking Statements

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

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

InspireMD’s CGuard™ Embolic Prevention System to be Prominently Featured in Live Case Transmission at LINC, 28th to the 31st January 2020, in Leipzig, Germany

Several Clinical Presentations, Updates, and Panel Discussions on CGuard EPS to also be presented 

Tel Aviv, Israel— January 27, 2020 – InspireMD, Inc.  (NYSE American: NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that its CGuard™ Carotid Embolic Prevention System (EPS) will be featured in a live case transmission at the Leipzig Interventional Course (LINC) 2020 to be held from January 28th to the 31st at the Trade Fair Leipzig, Hall 2 in Leipzig, Germany.  CGuard™ EPS will also be featured in three panel discussions and two scientific posters at the conference.

Live case:

Tuesday, 10:18 – 10:48 Live from Bergamo Technical Forum · Room 3

Case 17 – BG 03: male, 82 years (P-R)

Symptomatic high-risk coronary artery disease

Operators: F. Castriota, A. Micari

 

Additional presentations featuring CGuard™ EPS will include:

  What:              Immediate and one-month results from a prospective real-world multicentre clinical practice of CAS using the CGuard embolic prevention system: The IRONGUARD 2 study P. Sirignano

When:              January 28, 12:45 – 12:50 PM Central European Time

Where:            Room 6 – Speaker’s Corner

 

What:              Accumulating long-term evidence for the MicroNet™-covered stent safety, efficacy and durability in primary and secondary stroke prevention: 5-year data from the PARADIGM-Extend prospective academic trial P. Musialek

When:              January 28, 12:50 – 12:55 PM Central European Time

Where:            Room 6 – Speaker’s Corner

 

What:              OPTIMAI endovascular sequestration of high-risk carotid plaque using the CGuard™ MicroNet™-covered embolic prevention stent system in consecutive patients with symptoms or signs of carotid stenosis-related brain injury: An intravascular ultrasound – controlled investigator-initiated multicentric multi-specialty study (CGuard OPTIMA) P. Musialek

When:              January 28, 12:55 – 13:00 PM Central European Time

Where:            Room 6 – Speaker’s Corner

 

What:              Reconstruction of left subclavian artery using carotid technology B. Huasen

When:              January 28, 14:30 – 14:35 PM Central European Time

Where:            Main Arena 1

 

What:              The use of CGuard stents; U.K. experience B. Huasen

When:              January 28, 16:35 – 16:40 PM Central European Time

Where:            Main Arena 1

 

The CGuard™ Carotid Embolic Prevention System will also be featured at the Company’s booth (16d2). InspireMD will be represented by its management, sales and clinical staff and welcomes all enquiries from clinicians and other interested parties.

 

About LINC

LINC is a leading global forum for new methods in the field of vascular medicine. LINC brings together medical professionals from different specialties around the world who perform endovascular interventions.

 

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
888-776-6804
Email: craigs@inspiremd.com  

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

Email: jeremy@lifesciadvisors.com

 

InspireMD Announces Strong Preliminary Fourth Quarter 2019 Revenue and Reports Inducement Award Under NYSE American Company Guide §711(a)

Tel Aviv, Israel — January 6, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced strong preliminary unaudited revenue for the fourth quarter and reported an inducement grant to the company’s new Chief Executive Officer, Marvin Slosman, who assumed the role effective January 1, 2020.

InspireMD anticipates that preliminary unaudited revenue for the fourth quarter ended December 31, 2019, will be within a range of $1,000,000 to $1,025,000, representing estimated growth of 22%-25% over the comparable period in 2018. The company’s revenue growth during the quarter was driven largely by growing demand for CGuard™ EPS, which increased sales more than 30% over the comparable period in 2018. Actual results may differ materially from the foregoing estimates due to developments or other information that may arise between now and the time the financial results for the fourth quarter of 2019 are finalized. These preliminary results should not be viewed as a substitute for the company’s fourth quarter reviewed consolidated financial statements prepared in accordance with GAAP.

“I assumed the role of Chief Executive Officer because, upon reviewing the significant body of evidence demonstrating the superiority of CGuard™ as compared to other interventional and surgical CAD treatment options, I believe we have a significant opportunity to transform patient care while creating long-term value for our shareholders,” said Marvin Slosman, Chief Executive Officer. “We believe our continued strong revenue growth reflects the increasing awareness of CGuard™ by treating physicians, including vascular surgeons, in our key territories. At the same time, we continue to work to introduce CGuard™ into new markets and anticipate that we will be able to sustain this momentum through 2020.”    

InspireMD also today announced that the Company has granted Marvin Slosman, the new Chief Executive Officer of the company, stock options to purchase up to an aggregate of 60,794[1] shares of common stock of the company and 182,381[2] restricted stock units as inducement awards outside the company’s 2013 Long-Term Incentive Plan. The grant was approved by the Compensation Committee and was made as an inducement material to the employee entering into employment. The grant was made in reliance on the employment inducement exception to shareholder approval provided under the NYSE American Company Guide, Section 711(a), which requires public announcement of inducement awards.

The option award has an exercise price of $1.10 per share, the closing price of the company’s common stock on January 2, 2020 and has a ten-year term. Both the option and restricted stock unit awards will vest in three equal installments on the first, second, and third anniversaries of the date of grant, provided Mr. Slosman remains employed by the company through the applicable vesting dates. These inducement awards also provide for accelerated vesting in connection with a change in control of the company or certain involuntary terminations of Mr. Slosman’s employment. The restricted stock units that vest will be converted into whole shares of the company’s common stock on the first to occur: 1) a change in control of the company, or 2) the date of Mr. Slosman’s termination of employment for any reason other than by the company for cause.

[1] 1.25% of its total issued and outstanding shares of common stock, determined on a fully diluted basis as of the date of grant. Estimated based on 4,863,476 shares of Common Stock outstanding, as calculated on a fully diluted basis, as of December 31, 2019.

[2] 3.75% of its total issued and outstanding shares of common stock, determined on a fully diluted basis as of the date of grant. Estimated based on 4,863,476 shares of Common Stock outstanding, as calculated on a fully diluted basis, as of December 31, 2019.

 

About InspireMD, Inc.

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

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

 

Forward-looking Statements

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

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

InspireMD Announces Planned Leadership Transition

Life sciences industry veteran Marvin Slosman appointed Chief Executive Officer  

 Appointment adds significant medical technology commercialization experience to the InspireMD team

 

Tel Aviv, Israel — December 10, 2019 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced that James Barry, Ph.D. is stepping down as President and Chief Executive Officer to pursue other opportunities. The company’s Board of Directors has appointed life sciences industry veteran Marvin Slosman as new Chief Executive Officer, effective January 1, 2020. Mr. Slosman will also replace Dr. Barry on the company’s Board of Directors.

“Together with my fellow Board members, I would like to welcome Marvin to the InspireMD team and look forward to his leadership and guidance as the company enters it’s next phase of growth,” said Paul Stuka, InspireMD’s Chairman of the Board of Directors. “We believe Marvin is a proven leader with significant medical technology experience and is the perfect fit to further advance development of CGuard™ EPS through development in the U.S. while continuing to expand our commercial presence abroad.”

“We made many important advancements in the business as well as the ongoing development and commercialization of CGuard™ during Jim’s tenure. I would like to thank him for his tireless work and many contributions to get us to this point and wish him the best as he begins the next chapter in his professional career,” Mr. Stuka concluded.

“Throughout my career in medical technology I have had the privilege of contributing to the development and commercialization of many life changing innovations, and I believe CGuard™ EPS fits well within this category,” said Mr. Slosman. “There exists a significant and growing body of clinical evidence demonstrating the superiority of CGuard™ relative to most other carotid artery disease treatment options, and we believe we have significant opportunity in front of us to greatly expand the availability of this technology to physicians and patients. We will continue to work vigorously toward this goal.”

“I would like to thank the Board for the opportunity to serve as Chief Executive Officer, as well as the entire InspireMD team, without whom we could not have achieved important corporate and clinical milestones,” said Dr. Barry. “I believe in the potential of CGuard™ EPS, which incorporates the company’s proprietary MicroNet™ technology, to help so many patients globally who suffer from carotid artery disease. We have established a solid foundation from which to drive future growth and success.”

Mr. Slosman joins InspireMD from Integra LifeSciences, a leading innovator in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery. At Integra he served as Business Consultant overseeing commercial strategy and market development for the Integra’s international business. Before that, he served as President of ITAMAR Medical, a developer of cardiovascular and sleep diagnostic technologies. Prior to ITAMAR, Mr. Slosman served as Chief Executive Officer of Ovalum, Ltd., a privately held medical device company focused on arterial conditions. Earlier in his career, Mr. Slosman served as Chief Executive Officer of Phormax Medical, Inc., Senior Executive Vice President and Chief Commercial Officer at Emerge Interactive in addition to senior commercial leadership positions at Johnson & Johnson, GE Healthcare and Baxter.     

 

About InspireMD, Inc.

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

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

 

Forward-looking Statements

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

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com