InspireMD Aligns Operations and Leadership Team, Appoints Isaac Blech as Vice Chairman of the Board

  • Enhances Commercial and Development Execution
  • Reduces Operating Cost Structure
  • Strengthens Board of Directors

 

BOSTON, MA – January 22, 2016 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today plans to align its operations and leadership with focus on its largest commercial markets in line with the continued execution of its carotid and neurovascular strategy which was launched in mid 2015.

Key elements of the changes announced today include the recruitment of a new CEO, who will focus on the Company’s immediate commercial and development activities in Europe in order to enhance operational efficiency and further improve the Company’s cost structure. To ensure a smooth leadership transition, the Company’s current CEO, Alan Milinazzo, has agreed to remain through the earlier of the appointment of the new CEO or June 30, 2016.

InspireMD also announced today that Isaac Blech joins the Company as Vice Chairman of the Board. Mr. Blech brings with him over 30 years of experience as a healthcare industry pioneer and investor, developing companies from early to profitable commercial stages, including multiple successful strategic acquisitions. Mr. Blech has an established record for shareholder value creation and has played a key role in some high profile company transformations within the life sciences sector.

Sol Barer, Chairman of the Board of InspireMD commented, “We are very pleased to welcome Isaac Blech as Vice Chairman of InspireMD. Isaac’s experience as an industry pioneer, taking new technologies from development to commercialization, will be instrumental as we continue with our efforts to introduce and develop markets that leverage our proprietary MicroNet™TM technology. We also welcome Isaac’s deep relationships and extensive professional network across multiple fields – including the financial, pharmaceutical, biotechnology and medical device communities – supporting our active efforts to validate our technology and capabilities.” Dr. Barer continued, “Finally, we thank Alan Milinazzo for effectively taking the Company through its challenging transition. We are now well underway as we execute on our carotid and neurovascular strategy and look forward to announcing a new CEO who will focus the Company’s present efforts towards Europe, the heart of our current commercial activities.”

In connection with Mr. Blech’s appointment, the Company agreed to award him options to acquire 780,000 shares of the Company’s common stock on April 30, 2016, with vesting based on both time and the Company’s achievement of milestones. Details of his board engagement are available in a Form 8-K filing along with an amendment to Mr. Milinazzo’s employment agreement which should ensure a smooth executive leadership transition over the coming months.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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.

MGuard™ is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

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

 

About CGuard™ EPS 

The proprietary CGuard™ Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary Embolic Protection Systems. The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.

CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

 

 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

 PCG Advisory
Vivian Cervantes
Investor Relations
Phone: (212) 554-5482

 

InspireMD Receives EU Regulatory Approval for Additional Supplier of CGuardTM Delivery Catheters

BOSTON, MA – December 2, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today receipt of a DEKRA medical device certification for the manufacture and commercialization of its CGuardTM delivery catheter, which now incorporates some design enhancements and a lower cost manufacturing structure to support the scale-up of operations.  The certification also allows the Company to add-on facilities for seamless manufacturing work flow.  DEKRA is a notified body for global certification of products, combining CE Marking with ISO 13485 Quality Management Systems in the testing of medical devices for sale in the European Union (EU).  The delivery catheter is commercialized in conjunction with the Company’s CGuard™ Embolic Prevention System (EPS).

Alan Milinazzo, CEO of InspireMD commented, “We are pleased to receive DEKRA certification for our enhanced CGuardTM delivery catheter, used when delivering the CGuardTM EPS into the carotid anatomy, supporting a more profitable and fluid scaling of our manufacturing operations.  Our CGuardTM system continues to be well received during our initial product launch in key markets around Europe and our recent positive 12 month CARENET data should bolster our commercial efforts going forward.”

Twelve month CGuardTM CARENET (CARotid Embolic protection Study using microNET) trial results demonstrated zero strokes or stroke-related deaths. Further, duplex ultrasound analysis confirmed no changes in the in-stent velocities between 6 and 12 months. This indicates no sign of vessel narrowing and is consistent with the durability of carotid artery treatment seen using CGuardTM.  In addition, the all-comer single center PARADIGM trial continue to show favorable angiographic and clinical outcomes in using the CGuardTM system in treating patients with carotid artery disease.  PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis using CGuard™ Mesh-covered embolic prevention stent system.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

About CGuard™ EPS

The proprietary CGuard™ Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary Embolic Protection Systems.  The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.

CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time

 

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

 

PCG Advisory

Vivian Cervantes

Investor Relations

Phone:  (212) 554-5482

InspireMD Announces Positive Twelve Month Follow-Up CARENET Trial Data at VEITH Symposium 2015

 BOSTON, MA – November 20, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today positive 12 month follow up data from its CGuardTM CARENET (CARotid Embolic protection Study using microNET) trial at the 42nd Annual Symposium on Vascular and Endovascular Issues (VEITH) in New York. Prof. Piotr Musiałek, Co-Principal Investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, Krakow, Poland, presented the 12 month follow up data, an industry first on a mesh covered carotid stent technology.

At the New Techniques, Technologies and Concepts session, Prof. Musialek presented the new data on the InspireMD CGuardTM Mesh Covered Carotid Stent Program. His lecture, entitled “MicroNet™ Covered Embolic Prevention Carotid Stent System: From CARENET And PARADIGM Studies To Routine Clinical Practice,” focused on the CARENET 12 month results, which demonstrated zero strokes or stroke-related deaths at 12 months. Further, duplex ultrasound analysis confirmed no changes in the in-stent velocities between 6 and 12 months. This indicates no sign of vessel narrowing and is consistent with the durability of carotid artery treatment seen using CGuardTM. According to Prof. Musialek, previously demonstrated reduction in both the incidence and the volume of new ischemic lesions, together with the 12 month data that show minimal restenosis concern, suggests that the therapeutic benefits of the CGuardTM technology may extend well beyond the acute procedural period.

Prof. Piotr Musialek commented, “It is very exciting to present the 12 month follow up data from the CGuardTM CARENET study, which continues to validate the use of the MicroNet™TM covered CGuardTM, with zero strokes at 12 months. In addition, the 12 month data showed no change in peak systolic velocity between 6 months and 12 months, suggesting no restenosis concerns. These findings, combined with the results from our recent all-comer single center PARADIGM trial, continue to show the increased therapeutic benefits of the CGuardTM technology in treating patients with carotid artery disease. This technology is a game-changer in today’s practice of carotid revascularization and my colleagues and I look forward to continued use of this unique technology in routine clinical practice.”

Alan Milinazzo, CEO of InspireMD commented, “Twelve month CARENET results further validate that the CGuardTM represents a superior next generation stenting technology, supporting broader application in carotid artery disease treatment, with physicians steadily impressed with its superior clinical data. We plan to leverage compelling CARENET and PARADIGM clinical evidence to expand upon our ongoing, active CGuardTM commercial activities.”

PARADIGM, led by principal investigator Prof. Musialek, is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system, indicated that the CGuard™ system is appropriate for use in an all-comer carotid revascularization population and is associated with an extremely favorable angiographic and clinical outcome.

VEITH Symposium 2015 provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The event features presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

About CGuard™ EPS

The proprietary CGuard™ Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary Embolic Protection Systems. The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.

CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

 

 

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

 

PCG Advisory
Vivian Cervantes
Investor Relations
Phone: (212) 554-5482

 

InspireMD Reports Financial Results for the Third Quarter Ended September 30, 2015

BOSTON, MA – November 10, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced its financial and operating results for the third quarter ended September 30, 2015.

In its third full quarter of a strategic transition into the carotid and neuro interventional markets utilizing its proprietary MicroNet™TM technology, key activities included the announced strategic distributor agreement with global interventional therapies company Penumbra, Inc., strengthened intellectual property coverage, including the issuance of two US patents, and expanded regulatory footprint with CGuard approvals for both Argentina and Colombia. In addition, InspireMD’s development program for its neurovascular flow diverter platform remains on track for pre-clinical results in December 2015 and CE Mark submission in 2H 2016. Broad collaboration discussions advanced steadily facilitated by an external financial and strategic advisor engaged to assist in the review of various strategic alternatives.

Alan Milinazzo, CEO of InspireMD, commented, “With 2015 being a transition year for InspireMD, we continue to execute on our strategic plan with clear focus and a sense of urgency.  We highlight progress made in recent months and look forward to sustainable growth in 2016.  Feedback from the CGuardTM launch remains positive, aided by both the CARENET and PARADIGM clinical data sets that have received prominent attention at major clinical meetings this year.  Recent approvals in Colombia and Argentina also allow us to bring this important technology to key markets around the world as we balance investments in the business with disciplined cash management.”

Mr. Milinazzo continued, “We are pleased to note that our development efforts in the high value neurovascular field are tracking to expectations while we actively advance discussions across indications that leverage our MicroNet™TM technology.  Finally, to ensure that we maximize InspireMD shareholder value, we have engaged TM Asante Healthcare Partners as an outside strategic advisor to further our business development activities.”


Recent Operating Highlights: 

COMMERCIAL

  • Announced full European market launch of CGuardTM in late September at CIRSE 2015 by Penumbra Inc., a global market leader in the interventional neuroradiology and peripheral vascular markets.
  • Reported sequential revenue increase of 85% for CGuardTM.
  • On track for full Penumbra commercial launch of CGuardTM in Q4 of 2015.

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

  • Received regulatory approvals to commercialize CGuardTM in Colombia and Argentina.
  • Received two US patent issuances.
  • Advanced next generation neurovascular flow diverter program with pre-clinical data on-track for December 2015 and CE Mark submission in 2H 2016.
  • Reported positive results from the investigator led PARADIGM trial in an all comers patient population.
  • Awarded 2015 Frost and Sullivan European Innovation Award for Product Development.
  • Advanced broad collaboration discussions across indications – cardiovascular, carotid, and neurovascular – that leverage the MicroNet™TM technology, with facilitation from a recently engaged financial and strategic advisor.

FINANCIAL 

  • Announced one-for-ten reverse stock split effective October 1, 2015.
  • Comprehensive cash management, with steady, measured declines in monthly cash use.
  • Continued implementation of cost containment activities while supporting key development programs.

 

Quarter Ended September 30, 2015 Financial Results

Revenue for the third quarter ended September 30, 2015 increased $0.3 million to $0.6 million compared to $0.3 million during the same period in 2014. The increase was predominately driven by sales of $0.3 million of our new product CGuard™ EPS, our carotid product, which was launched in October 2014. Sales of CGuard™ EPS during the three months ended September 30, 2015 were predominately driven by initial sales to our new strategic distribution partner, Penumbra, Inc.

The company’s gross profit for the quarter ended September 30, 2015 was $0.1 million compared to a gross loss of $0.1 million for the same period in 2014. The improvement of 217.1% was largely attributable to the increase in product revenues and a decrease of write-offs of inventory of MGuard™ Prime EPS. These improvements in gross profit, however, were partially offset by an increase in labor and material costs attributable to higher revenues.

Total operating expenses for the quarter ended September 30, 2015 were $3.5 million, a decrease of 45.3% compared to $6.4 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to MGuard™ Prime EPS’s MASTER II trial, which was suspended in October 2014, a decrease in compensation related expenses and other savings associated with our cost reduction plan.

The loss from operations for the quarter ended September 30, 2015 was $3.4 million, a decrease of 47.4% compared to a loss of $6.5 million for the same period in 2014.

Financial expenses for the quarter ended September 30, 2015 was $0.2 million, a decrease of 27.2% compared to the same period in 2014. This decrease was primarily due to a decrease in interest expenses due to the reduction in principal of our outstanding indebtedness.

The net loss for the quarter ended September 30, 2015 totaled $3.6 million, or $0.48 per basic and diluted share, compared to a net loss of $6.8 million, or $1.96 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the quarter ended September 30, 2015 was $2.8 million, or $0.36 per basic and diluted share, a decrease of 51.6% compared to a non-GAAP net loss of $5.7 million, or $1.65 per basic and diluted share, for the same period in 2014.  The non-GAAP net loss for the quarter ended September 30, 2015 primarily excludes $0.6 million of share-based compensation and $0.3 million of expense related to the impairment of the value of our royalties buyout option associated with MGuard™ Prime EPS. The non-GAAP net loss for the quarter ended September 30, 2014 primarily excludes $1.1 million of share-based compensation.

 

Nine Months Ended September 30, 2015 Financial Results

Revenue for the nine months ended September 30, 2015 decreased $0.1 million to $1.8 million compared to $1.9 million during the same period in 2014. The 2015 period included an expected decline in sales of MGuard™ Prime EPS associated with the trend of doctors increasingly using drug eluting stents rather than bare metal stents in STEMI offset by sales of our new product CGuard™ EPS, which was launched in October 2014. The sales of CGuard™ EPS during the nine months ended September 30, 2015 included initial sales to our new strategic distribution partner, Penumbra, Inc. which commenced during the third quarter.

The company’s gross loss for the nine months ended September 30, 2015 was $0.2 million, a decrease of 141.0% compared to a gross profit of $0.4 million for the same period in 2014. The decrease was largely attributable to an increase in labor and material costs attributable to higher costs for CGuard™ EPS and write-offs of inventory due to the trend of increased usage of DES stents in STEMI patients, longer shelf life requirements and the transition to the rapid exchange delivery system for CGuard from the over the wire platform.

Total operating expenses for the nine months ended September 30, 2015 were $11.7 million, a decrease of 40.4% compared to $19.6 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to MGuard’s MASTER II trial, a decrease in compensation related expenses and other savings associated with our cost reduction plan.

The loss from operations for the nine months ended September 30, 2015 was $11.9 million, a decrease of 38.3% compared to a loss of $19.3 million for the same period in 2014.

Financial expenses for the nine months ended September 30, 2015 decreased 18.6% to $0.9 million from $1.1 million during the same period in 2014. This decrease was primarily due to a decrease in interest expenses due to the reduction in principal of our outstanding indebtedness.

The net loss for the nine months ended September 30, 2015 totaled $12.7 million, or $1.89 per basic and diluted share, compared to a net loss of $20.3 million, or $5.93 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the nine months ended September 30, 2015 was $9.5 million, or $1.40 per basic and diluted share, a decrease of 44.7% compared to a non-GAAP net loss of $17.1 million, or $5.00 per basic and diluted share, for the same period in 2014.  The non-GAAP net loss for the nine months ended September 30, 2015 primarily excludes $2.6 million of share-based compensation and $0.6 million of expense related to an impairment of a royalties buyout asset. The non-GAAP net loss for the nine months ended September 30, 2014 primarily excludes $3.2 million of share-based compensation.

 

Cash and Cash Equivalents 

As of September 30, 2015, cash and cash equivalents were $6.5 million, compared to $6.3 million as of December 31, 2014.


Quarterly Conference Call Details

The company has scheduled a conference call to discuss third quarter 2015 financial results for today at 8:30 AM Eastern.  To participate in the conference call, please dial (888) 243-4451 (United States) or (412) 542-4135 (International) and request the InspireMD call.  A live webcast of the call will also be available on the Investor Relations section of the Company’s website at https://www.inspiremd.com/en/investors/investor-relations/.  Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the webcast will be available approximately two hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at https://www.inspiremd.com/en/investors/investor-relations/ for a limited time.  A dial-in replay of the call will also be available to those interested until November 24, 2015.  To access the replay, dial (877) 344-7529 (United States) or (412) 317-0088 (International) and enter code: 10075630.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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

 

PCG Advisory
Vivian Cervantes
Investor Relations
Phone:  (212) 554-5482

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)
(U.S. dollars in thousands, except per share data

Three months ended     Nine months ended   
September 30,   September 30,
2015 2014   2015   2014
Revenues $632 $273 $1,794 $1,948
Cost of revenues 543 349 1,954 1,558
Gross Profit (Loss) 89 (76) (160) 390
Operating Expenses:
Research and development 781 2,460 2,880 7,485
Selling and marketing 588 1,806 2,600 5,030
General and administrative 1,713 2,139 5,270 7,126
Restructuring and impairment expenses 418 964
Total operating expenses 3,500 6,405 11,714 19,641
Loss from operations (3,411) (6,481) (11,874) (19,251)
Financial expenses 228 313 856 1,051
Loss before tax expenses (3,639) (6,794) (12,730) (20,302)
Tax expenses (Income) 2 (19) 1 3
Net Loss $(3,641) $(6,775) $(12,731) $(20,305)
Net loss per share – basic and diluted $(0.48) $(1.96) $(1.89) $(5.93)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 7,630,985 3,458,152 6,753,011 3,425,162

 

 

 

RECONCILIATION OF NON-GAAP NET LOSS (2)

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


Nine months ended
Three months ended  
September 30,   September 30,
2015 2014   2015   2014
GAAP Net Loss $(3,641) $(6,775) $(12,731) $(20,305)
Non-GAAP Adjustments:
Share-based compensation expenses 601 1,052 2,600 3,151
Impairment of royalties buyout 260 576
Royalties buyout expenses and amortization 22 20 80 60
Non-cash financial expenses (income)(3) (47)
Total Non-GAAP Adjustments 883 1,072 3,256 3,164
Non-GAAP Net Loss $(2,758) $(5,703) $(9,475) $(17,141)
Non-GAAP net loss per share – basic and diluted $(0.36) $(1.65) $(1.40) $(5.00)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 7,630,985 3,458,152 6,753,011 3,425,162

 

 

 

CONSOLIDATED BALANCE SHEETS (4)
(U.S. dollars in thousands)
ASSETS September 30, December 31,
2015 2014
Current Assets:
Cash and cash equivalents $6,509 $6,300
Accounts receivable:
Trade, net 664 635
Other 199 359
Prepaid expenses 108 150
Inventory 1,081 1,924
Total current assets 8,561 9,368
Non-current assets:
Property, plant and equipment, net 516 622
Deferred issuance costs 102 153
Funds in respect of employee rights upon retirement 466 498
Long term prepaid expenses 20 66
Royalties buyout 96 752
Total non-current assets 1,200 2,091
Total assets $9,761 $11,459

 

 

 

LIABILITIES (NET OF CAPITAL DEFICIENCY)

September 30,

December 31,

2015

2014

Current liabilities:
Accounts payable and accruals:
Trade $834 $909
Other 2,403 3,576
Advanced payment from customers 170 179
Current maturity of loan 4,123 3,809
Total current liabilities 7,530 8,473
Long-term liabilities:
Liability for employees rights upon retirement 658 687
Long -term loan 2,147 5,086
Total long-term liabilities 2,805 5,773
Total liabilities 10,335 14,246
Equity:
Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 7,632,752 and 4,136,889 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively 7 4
Additional paid-in capital 119,561 104,620
Accumulated deficit (120,142) (107,411)
Total capital deficiency (574) (2,787)
Total liabilities net of capital deficiency $9,761 $11,459

 

 

 

(1) All 2015 financial information is derived from the Company’s 2015 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission, all 2014 financial information is derived from the Company’s 2014 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) Our non-GAAP net loss is presented as management uses this supplemental non-GAAP financial measure to evaluate performance period over period, analyze the underlying trends in our business, and establish operational goals and forecasts that are used in allocating resources. We believe by presenting this additional measurement, we are providing investors with greater transparency to the information used by our management for our financial and operational decision-making, as well as allowing investors to see our results “through the eyes” of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.

(3) Non-cash financial income relates to the issuance of shares as a result of the anti-dilution rights of our March 2011 investors.
(4) All September 30, 2015 financial information is derived from the Company’s 2015 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, 2014 financial information is derived from the Company’s 2014 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2014 filed with the Securities and Exchange Commission.

 

InspireMD to Report Financial Results for the Third Quarter Ended September 30, 2015 on Tuesday, November 10th

BOSTON, MA – November 2, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today that it will release its full financial results for the third quarter ended September 30, 2015 on Tuesday, November 10th before the market open, followed by a conference call at 8:30 a.m. ET to review its financial results and business outlook.

Participants should call (888) 243-4451 (United States) or (412) 542-4135 (International) and request the InspireMD call. A live webcast of the call will also be available on the Investor Relations section of the Company’s website at https://www.inspiremd.com/en/investors/investor-relations/.  Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the webcast will be available approximately two hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at https://www.inspiremd.com/en/investors/investor-relations/ for a limited time.  A dial-in replay of the call will also be available to those interested until November 24, 2015.  To access the replay, dial (877) 344-7529 (United States) or (412) 317-0088 (International) and enter code: 10075630.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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

 

PCG Advisory
Vivian Cervantes
Investor Relations
Phone:  (212) 554-5482

InspireMD Announces CGuardTM Approval in Argentina

CGuardTM Clinical Data Presented at TCT 2015 Carotid Scientific Sessions

 

BOSTON, MA – October 19, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today that it has received regulatory approval to commercialize the CGuardTM Embolic Prevention System for the treatment of carotid artery disease in Argentina.  The approval was granted by the Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT). Research and Markets estimates the global carotid stent market to grow at a compound average annual rate of 13% in 2014-2019.  The Latin American region is expected to expand at a strong rate, driven by endovascular procedure volume growth and the adoption of premium priced products, according to Millenium Research Group.

Alan Milinazzo, CEO of InspireMD commented, “We are pleased with the approval of CGuardTM in Argentina, adding a second key market to our Latin American footprint following our approval in Colombia in early October.  With CGuardTM, we offer an enhanced minimally invasive solution to carotid artery disease treatment, supported by positive clinical experience.  Last week, at Transcatheter Cardiovascular Therapeutics (TCT), the largest educational meeting in interventional cardiovascular medicine, clinical data on CGuardTM was presented at carotid scientific sessions, with very positive physician feedback.”

At TCT 2015, previously presented results from the Company’s CARENET (CARotid Embolic protection using MicroNet™) trial and investigator led PARADIGM study were highlighted.  In addition, at the main carotid session, Carotid Disease and Treatment, an ad hoc poll of physician attendees by TCT Co-Director William Gray, MD, indicated a preference for a mesh covered design in the treatment of the majority of carotid patients.  The Company’s mesh covered CGuardTM system is CE Mark approved.

Six month results from CARENET showed a 3.6% MACCE (major adverse cardiac and cerebrovascular event) rate vs. comparative data of 8.09%.  Six month ultrasound analysis also indicated healthy healing without restenosis concern with patent external and internal carotid arteries.  The all comer PARADIGM study continues to document both the short term and long term benefits of using the MicroNet™TM covered CGuardTM technology in patients with carotid artery disease.

 

About InspireMD, Inc.

InspireMD (www.inspiremd.com) seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

About CGuard EPS

The proprietary CGuard Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard and MGuard Prime coronary Embolic Protection Systems.  The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.
MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.

  

About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system.  At EuroPCR 2015, Dr. Musialek summarized his clinical presentation of 71 CGuard procedures in unselected all-comer patients in the PARADIGM evaluation as:  1) stent system success and procedure success rate of 100%; 2) periprocedural complications of 0%, and remained at 0% at 30 days; and 3) no MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.

 

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
Email: craigs@inspiremd.com

 

PCG Advisory
Vivian Cervantes
Investor Relations
Phone:  (212) 554-5482

InspireMD to Present at Dawson James Securities Growth Stock Conference

BOSTON, MA – September 8, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today that Chief Executive Officer, Alan Milinazzo, will present at the Dawson James Securities Growth Stock Conference on October 15, 2015.  The presentation will take place at 9:00 A.M. ET in the Wyndham Grand Hotel in Jupiter, Florida.

 
About InspireMD, Inc.

InspireMD (www.inspiremd.com) seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.


About Dawson James Securities

Dawson James Securities, Inc., a member of FINRA/SIPC, is a full service investment bank headquartered in Boca Raton, FL. http://www.dawsonjames.com.


Investor Contacts:

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804

Email: craigs@inspiremd.com

 

PCG Advisory

Vivian Cervantes

Investor Relations

Phone:  (212) 554-5482

 

 

InspireMD Announces CGuardTM Approval in Colombia

BOSTON, MA – October 5, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today that it has received regulatory approval to commercialize the CGuardTM Embolic Prevention System for the treatment of carotid artery disease in Colombia. The approval was granted by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). The global carotid stent market is expected to grow at a compound average annual rate of 13% in 2014-2019, according to Research and Markets. By region, the Latin American market is expected to expand at a strong rate, driven by endovascular procedure volume growth and the adoption of premium priced products, according to Millennium Research Group.

Alan Milinazzo, CEO of InspireMD commented, “CGuardTM approval in Colombia is an important milestone for the Company and another critical validation for our technology. We are methodically, and successfully, bringing this important technology to key markets around the world.”

As previously noted, six month results from the Company’s CGuardTM clinical trial, CARENET (CARotid Embolic protection using MicroNet™) showed a 100% procedural success rate with a 3.6% MACCE (major adverse cardiac and cerebrovascular event) rate vs. comparative data of 8.09%. Six month ultrasound analysis also indicated healthy healing without restenosis concern with patent external and internal carotid arteries. In addition, the investigator-led all comer PARADIGM study continues to document both the short term and long term benefits of using the MicroNet™TM covered CGuardTM technology in patients with carotid artery disease.

Mr. Milinazzo concluded, “We are well focused on driving our business forward, with other recent announcements that include the full commercial launch of CGuardTM in Europe with our strategic distribution partner, Penumbra, Inc. (NYSE: PEN), expanding intellectual property coverage, continuing broad collaboration discussions that leverage our MicroNet™TM technology while advancing our development program for our neurovascular platform, and our highly disciplined cash management program.”


About InspireMD, Inc.

InspireMD (www.inspiremd.com) seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.


About CGuard EPS

The proprietary CGuard Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard and MGuard Prime coronary Embolic Protection Systems. The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.

CGuard EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.


About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system. At EuroPCR 2015, Dr. Musialek summarized his clinical presentation of 71 CGuard procedures in unselected all-comer patients in the PARADIGM evaluation as: 1) stent system success and procedure success rate of 100%; 2) periprocedural complications of 0%, and remained at 0% at 30 days; and 3) no MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.


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
Email: craigs@inspiremd.com

PCG Advisory
Vivian Cervantes
Investor Relations
Phone: (212) 554-5482

InspireMD Announces One-for-Ten Reverse Stock Split

BOSTON, MA – October 1, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today a one-for-ten reverse split of its common stock, effective as of 12:00 am Eastern Time on October 1, 2015.  Beginning with the opening of trading on October 1, 2015, the Company’s common stock will trade on the NYSE MKT on a split adjusted basis.  In addition, the number of authorized shares of the Company’s common stock was decreased from 125 million to 50 million.

As previously disclosed, at InspireMD’s Annual Meeting on September 9, 2015, the Company’s stockholders authorized the Board of Directors to amend the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split at a ratio of one-for-ten and to reduce the number of authorized shares of its common stock.

Upon the effectiveness of the reverse stock split, every ten (10) shares of InspireMD common stock outstanding automatically combine into one (1) new share of common stock with no change in par value per share. Proportionate adjustments will be made to (i) the per share exercise price and the number of shares of common stock that may be purchased upon exercise of outstanding stock options and warrants to purchase shares of the Company’s common stock and (ii) the number of authorized shares of common stock reserved for future issuance under the Company’s equity compensation plans.

The Company’s common stock will continue to trade on the NYSE MKT under the symbol “NSPR.” The new CUSIP number for the common stock following the reverse stock split is 45779A507.

No fractional shares will be issued following the reverse stock split. Any fractional shares resulting from the reverse stock split will be rounded up to the next whole share.

Registered Stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form do not need to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Action Stock Transfer Corp, will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. Action Stock Transfer Corp can be reached at (801) 274-1088.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on July 29, 2015, a copy of which is also available at www.sec.gov or at www.inspiremd.com under the SEC Filings tab located on the Investors page.

 

About InspireMD, Inc.

InspireMD (www.inspiremd.com) seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

About CGuard EPS

The proprietary CGuard Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard and MGuard Prime coronary Embolic Protection Systems.  The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.
MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.
CGuard EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

 

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
Email: craigs@inspiremd.com

 

PCG Advisory
Vivian Cervantes
Investor Relations
Phone:  (212) 554-5482

 

InspireMD Announces Full Market Launch of CGuardTM Distributed by Penumbra at CIRSE Annual Congress

BOSTON, MA – September 28, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today the full market launch of the CGuardTM Embolic Prevention System for the treatment of carotid artery disease by its strategic distribution partner, Penumbra, Inc. (NYSE: PEN), at the CIRSE Annual Congress in Lisbon, Portugal.  Penumbra, a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices to the neurovascular and peripheral vascular communities, leverages its direct European commercialization team to launch CGuardTM Distributed by Penumbra.  The 2015 Congress marks the 30th year of CIRSE, Cardiovascular and Interventional Radiological Society of Europe, which aims to be a leader in interventional radiology (IR) education, drawing over 6,500 attendees from the medical community across 90 countries.

At CIRSE 2015, Penumbra hosted a well-attended physician symposium titled, “CGuardTM – MicroNet™ Covered Embolic Prevention Stent System: A Game-Changer in CAS” led by Prof. Piotr Musialek on Sunday, September 27th.  Dr. Musialek is principle investigator in the all comer PARADIGM study that continues to document both the short term and long term benefits of using the MicroNet™ covered CGuard technology in patients with carotid artery disease.  In-booth demonstrations, teaching materials, and clinical case studies were also featured for conference attendees.

Alan Milinazzo, CEO of InspireMD, commented, “We are excited that our partner, Penumbra, has begun its full commercial launch of CGuard at CIRSE, a respected venue for learning about new technologies in the IR, vascular, and neurovascular community.  Early feedback from physician attendees has been positive, with follow on meetings scheduled, in addition to discussions on additional possible uses of the MicroNet™TM technology in the neurovascular space.”  Milinazzo continued, “The Penumbra commercial team is strong and growing, with a well-established footprint across all specialists that manage carotid artery disease.  We are confident of successful commercial progress in the coming months and look forward to supporting Penumbra as we introduce this breakthrough technology to our customers.”

In addition, Jim Pray, President, International of Penumbra, stated, “The Penumbra team believes that the CGuard technology will give our customers a new, proven alternative to traditional treatment options for patients with carotid artery disease.  We have been trained on the CGuard technology and are officially launching it here at the CIRSE meeting this week.  We look forward to working with our customers to provide them with this exciting new carotid embolic prevention system.”

 

About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system.  At EuroPCR 2015, Dr. Musialek summarized his clinical presentation of 71 CGuard procedures in unselected all-comer patients in the PARADIGM evaluation as:  1) stent system success and procedure success rate of 100%; 2) periprocedural complications of 0%, and remained at 0% at 30 days; and 3) no MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.

 

About Penumbra, Inc.

Penumbra, Inc. (www.penumbrainc.com) is a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices. The company has a broad portfolio of products that address challenging medical conditions and significant clinical need across two major markets, neuro and peripheral vascular. Penumbra has approximately 1,000 employees and sells its products to hospitals primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets.

 

About InspireMD, Inc.

InspireMD (www.inspiremd.com) seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

About CGuard EPS

The proprietary CGuard Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard and MGuard Prime coronary Embolic Protection Systems.  The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.
MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.
CGuard EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

 

 

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
Email: craigs@inspiremd.com

 

PCG Advisory
Vivian Cervantes
Investor Relations
Phone:  (212) 554-5482

 

Penumbra, Inc
Penumbra Media Relations:
Merryman Communications
Betsy Merryman
Phone: 310-560-8176
Email: betsy@merrymancommunications.com