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Artivion Amends Agreements with Endospan

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Provides Endospan with $25 million of Additional Debt Funding to Obtain FDA Approval for NEXUS
Upfront Payment Associated with Purchase Option Reduced to $135 million, inclusive of loan off-set, and $100 million earnout minimum eliminated 
ATLANTA, July 1, 2024 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced it has amended its credit facility and option purchase agreements with Endospan Ltd. (“Endospan”), an Israeli-based, privately-held developer of the NEXUS® Stent Graft System (“NEXUS”). In 2019, the Company provided a credit facility to Endospan and entered into an option agreement to purchase Endospan upon U.S. Food and Drug Administration (“FDA”) approval of NEXUS. The amendments announced today result in three major changes to the original credit facility and option purchase agreements:

Artivion will provide additional loans to Endospan of up to $25 million in three tranches and anticipates funding the loans with free cash flow;
The upfront payment associated with the purchase option is reduced from $250 million to $175 million, resulting in an upfront acquisition purchase price of $135 million, inclusive of loan off-set; and
The $100 million minimum payout for the earnout is eliminated.

Endospan has developed NEXUS, the first and only approved branched endovascular system to treat aortic arch disease, including both aortic aneurysms and dissections. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysms (TAA), aortic arch disease patients with aneurysms or dissections who receive treatment have previously had little choice but to undergo open-chest surgery with its associated invasiveness and risks, lengthy hospitalizations, and prolonged recuperation. NEXUS transforms a complex surgical aortic arch repair into a minimally invasive endovascular procedure and stands to address an annual global addressable market opportunity of $600 million according to latest estimates.
“Based on our experience with NEXUS in Europe since 2019, we continue to see a significant global opportunity for the NEXUS technology and expect that it will further solidify our position as a global leader in aortic repair,” said Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion. “We view our revised credit facility and option purchase agreements with Endospan as an investment in the next frontier of aortic arch surgery. Should we exercise our option to acquire Endospan, we believe we will be able to meaningfully expand our total addressable market at that time on terms more favorable than existed prior to these amendments.”
Terms of the Amendments Under the terms of the amended Endospan credit facility, Artivion will provide up to an additional $25 million in debt financing to Endospan over three tranches, with the first $7 million drawn at close and subsequent tranches subject to progress toward and achievement of the NEXUS PMA. The terms of the loan are nearly identical to the terms of the original $15 million loan, except that under the amended terms both original and new loans will benefit from a first priority lien in Endospan assets, pari passu with other first lien Endospan liabilities.
If Artivion elects to exercise its option to purchase Endospan as contemplated in the Securities Purchase Option Agreement, then the outstanding principal amount and all accrued interest on the original and new loans would be deducted from the acquisition proceeds paid at closing. Under the amended purchase option, Artivion has the right to acquire Endospan at any time up to 90 days after receiving notice of U.S. FDA approval of NEXUS, for an upfront payment of $175 million, less previously extended loans and accrued interest, and an additional payment in the form of an earnout at two years post exercise of two and one half times (2.5x) incremental year two revenue. There is no longer any minimum earnout payment, and the maximum payment is still $200 million. Additionally, Artivion at its sole discretion may use up to $12.5 million of Artivion equity as part of the upfront payment. 
The amendments to the credit facility and Securities Purchase Option Agreement have been approved by both companies’ boards of directors and Endospan’s Security Holders. There were no changes to the parties existing Exclusive Distribution Agreement. The purchase obligations of the Securities Purchase Option Agreement will become effective if, and only when, Artivion exercises its purchase option. Any purchase of Endospan by Artivion would be subject to customary closing conditions.
Financial CommentaryThe Company does not anticipate the amended agreement with Endospan to have a material impact on its full-year 2024 financial guidance.
About Artivion, Inc.Headquartered in suburban Atlanta, Georgia, Artivion is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, www.artivion.com.
About Endospan Ltd.Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, is a pioneer in the endovascular repair of Aortic Arch Disease including aneurysms and dissections. Endospan has received CE-Mark to commercialize in Europe the NEXUS Stent Graft System, the first endovascular off-the-shelf system to treat Aortic Arch Disease which affects a greatly underserved group of patients diagnosed with a dilative lesion in, or near, the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), Aortic Arch Disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website, www.endospan.com. 
Forward Looking Statements Statements made in this press release and the accompanying presentation that look forward in time or that express management’s beliefs, expectations, or hope are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include those regarding our estimates for the total addressable annual global market for the NEXUS technology; and our beliefs that we continue to see a significant global opportunity for the NEXUS technology and expect that it will further solidify our position as a global leader in aortic repair; we view our revised credit facility and option purchase agreements with Endospan as an investment in the next frontier of aortic arch surgery; and we believe that should we exercise our option to acquire Endospan, we will be able to meaningfully expand our total addressable market at that time on terms more favorable than existed prior to these amendments. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These risks and uncertainties include but are not limited to the risks that the TRIOMPHE clinical trial may not be completed or may fail, may not reach its endpoints, or may be completed on timeframes different than anticipated; that PMA approval for NEXUS may be not achieved at all or on the time frames anticipated or that there be developments in technology by competitors that reduce the total addressable market for the NEXUS technology. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2023, and our subsequent filings with the SEC. Artivion does not undertake to update its forward-looking statements.

Contacts:

Artivion, Inc.
Gilmartin Group LLC

Lance A. Berry
Brian Johnston / Laine Morgan

Executive Vice President & Chief Financial Officer
Phone: 332-895-3222

Phone: 770-419-3355
[email protected]

SOURCE Artivion, Inc.

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Rejuvenate Bio Receives $4M in Funding from the California Institute for Regenerative Medicine (CIRM)

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– Funding will advance development of Rejuvenate’s one-time gene therapy RJB-0402 for the treatment of desmoplakin gene variant arrhythmogenic cardiomyopathy July 01, 2024 08:00 AM Eastern Daylight Time SAN DIEGO–(BUSINESS WIRE)–Rejuvenate Bio, announced today that the California Institute for Regenerative Medicine (CIRM) has awarded the company a $4M grant to […]

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Merit Medical Announces Asset Purchase Agreement with EndoGastric Solutions, Inc.® 

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Asset acquisition expands Merit’s endoscopy portfolio with a minimally invasive solution for patients suffering from chronic gastroesophageal reflux disease (GERD). Asset acquisition projected to add approximately $30 million of revenue, on an annualized basis, in key gastrointestinal endoscopy market that leverages existing commercial footprint.  Merit reaffirms full-year 2024 financial guidance on standalone basis and updates full-year 2024 financial guidance to include projected partial-year impact from this acquisition. SOUTH JORDAN, Utah, July 01, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced it has executed an asset purchase agreement with EndoGastric Solutions, Inc. for a total cash consideration of approximately $105 million. EndoGastric Solutions’ EsophyX® Z+ device delivers a durable, minimally invasive non-pharmacological treatment option for patients suffering from GERD.   GERD is a digestive disorder that occurs when the lower esophageal sphincter doesn’t tighten correctly, allowing acid from the stomach to enter the esophagus. When this occurs chronically, it can result in serious health conditions, such as esophageal damage and cancer. The EsophyX Z+ device treats GERD by restoring the body’s reflux barrier. “This acquisition is consistent with our Continued Growth Initiatives. It enhances our product portfolio in existing clinical specialties while expanding our global footprint in the multi-billion-dollar gastrointestinal market,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We look forward to helping more patients by providing clinicians with a sustained and minimally invasive treatment option for chronic GERD.”   Mr. Lampropoulos continued: “In addition to the strong strategic rationale, we believe the financial profile of this acquisition is compelling. While modestly dilutive to our full year 2024 non-GAAP profitability given the partial-year contribution, we expect the acquisition to be accretive to our non-GAAP gross and operating margins*, non-GAAP net income* and non-GAAP EPS* in the first full year post-closing. Importantly, we reaffirmed our full-year 2024 financial guidance on a stand-alone basis and we look forward to discussing this acquisition and our updated outlook for 2024 on our second quarter earnings report on August 1, 2024.” * Non-GAAP net income; non-GAAP earnings per share; non-GAAP gross margin; non-GAAP operating margin and constant currency revenue are non-GAAP financial measures. A description of these financial measures is included under the heading “Non-GAAP Financial Measures” below. A quantitative reconciliation of such financial measures to comparable GAAP financial measures is not available without unreasonable effort. About EsophyX Z+ Treatment By restoring the body’s reflux barrier, the acquired EsophyX Z+ device is designed to provide relief of GERD symptoms and reduce acid reflux that can cause long-term complications and risk. This is accomplished under endoscopic visualization during a minimally invasive procedure called Transoral Incisionless Fundoplication (TIF 2.0). Recently, the American Gastroenterology Association released a clinical practice update on the evaluation and management of GERD and listed TIF 2.0 as an effective endoscopic option in carefully selected patients.2    TIF 2.0 can also be combined with a surgical hiatal hernia repair, in a procedure referred to as Concomitant Transoral Incisionless Fundoplication (cTIF). During cTIF, an interventional gastroenterologist and a surgeon collaborate to bridge the treatment gap between medication and more invasive-surgical fundoplication. Financial Summary: The assets acquired from EndoGastric Solutions generated approximately $26 million of revenue over the twelve-month period ended December 31, 2023. The acquired assets are expected to contribute revenue, from closing date through December 31, 2024, in the range of $13 to $15 million and are expected to dilute Merit’s previously forecasted non-GAAP operating margin, non-GAAP net income and non-GAAP earnings per share, inclusive of approximately $2.7 million of lower interest income on cash balances used for the total purchase consideration and excluding approximately $6.5 million of non-cash and non-recurring transaction-related expenses, and to be dilutive to Merit’s full-year 2024 GAAP net income and GAAP earnings per share. The acquisition is expected to be accretive to non-GAAP gross margin, non-GAAP operating margin, non-GAAP net income and non-GAAP earnings per share in the first full-year post close, but dilutive to Merit’s GAAP net income and earnings per share for that period. Updated Fiscal Year 2024 Financial Guidance Merit’s updated full-year 2024 financial guidance now reflects the forecasted impacts of the acquisition of EndoGastric Solutions from the closing date through December 31, 2024. Merit is reaffirming prior full-year 2024 financial guidance ranges for the stand-alone Merit business previously announced on April 30, 2024. Based upon the information currently available to Merit’s management, for the year ending December 31, 2024, after giving effect to the projected contribution of the assets acquired from EndoGastric Solutions, but absent material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit now expects the following financial results: Revenue and Earnings Guidance*             Updated Guidance(1)Prior Guidance(2)   Year Ending% Change Year Ending% Change  Financial Measure December 31, 2024Y/YDecember 31, 2024Y/Y        Net Sales $1.324 – $1.340 billion5% – 7%$1.312 – $1.325 billion4% – 5% Cardiovascular Segment $1.272 – $1.285 billion4% – 5%$1.272 – $1.285 billion4% – 5% Endoscopy Segment $53.3 – $55.7 million45% – 51%$39.7 – $40.1 million8% – 9%        Non-GAAP        Earnings Per Share $3.22 – $3.317% – 10%$3.28 – $3.359% – 11% *Percentage figures approximated; dollar figures may not foot due to rounding  2024 Net Sales Guidance – % Change from Prior Year (Constant Currency) Reconciliation*           Updated Guidance(1)Prior Guidance(2)   LowHighLow High 2024 Net Sales Guidance – % Change from Prior Year (GAAP) 5.3%6.6%4.3% 5.4% Estimated impact of foreign currency exchange rate fluctuations 0.5%0.5%0.5% 0.5% 2024 Net Sales Guidance – % Change from Prior Year (Constant Currency) 5.8%7.1%4.8% 5.9% *Percentage figures approximated and may not foot due to rounding  (1) “Updated Guidance” reflects Merit’s full-year 2024 financial guidance on standalone basis, plus the forecasted impacts of the acquisition of EndoGastric Solutions, Inc. from closing date through December 31, 2024.  (2) “Prior Guidance” previously introduced on April 30, 2024, and reflects Merit’s full-year 2024 financial guidance on a standalone basis, excluding the acquisition of the assets of EndoGastric Solutions.  Merit does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures (other than revenue) because Merit is unable to predict with reasonable certainty the financial impact of items such as expenses related to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain severance expenses, performance-based stock compensation expenses, corporate transformation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, Merit is unable to address the significance of the unavailable information, which could be material to future results. Specifically, Merit is not, without unreasonable effort, able to reliably predict the impact of these items and Merit believes inclusion of a reconciliation of these forward-looking non-GAAP measures to their GAAP counterparts could be confusing to investors or cause undue reliance. Merit’s financial guidance for the year ending December 31, 2024 is subject to risks and uncertainties identified in this release and Merit’s filings with the U.S. Securities and Exchange Commission (the “SEC”). Second Quarter of Fiscal Year 2024 Financial Results Conference Call: Merit will release its financial results for the quarter ended June 30, 2024, after the close of the stock market on Thursday, August 1, 2024 and will host a conference call at 5:00 p.m. Eastern that day (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific). To access the conference call, please pre-register using the following link. Registrants will receive confirmation with dial-in details. A live webcast and slide deck will also be available at merit.com. Advisors: Oppenheimer & Co. acted as a financial advisor to Merit. Parr Brown Gee & Loveless P.C. served as legal advisor to Merit. Cooley LLP served as legal advisor to EndoGastric Solutions, Inc.  Non-GAAP Financial Measures  Although Merit’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America, Merit’s management believes that the non-GAAP financial measures referenced in this release may provide investors with useful information regarding the underlying business trends and performance of Merit’s ongoing operations and can be useful for period-over-period comparisons of such operations. Non-GAAP financial measures referenced in this release include:  constant currency revenue; non-GAAP gross profit and margin; non-GAAP operating income and margin; non-GAAP net income; and non-GAAP earnings per share. Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating and financial results to prior periods, to evaluate changes in the results of its operating segments, and to measure and allocate financial resources internally. However, Merit’s management does not consider such non-GAAP measures in isolation or as an alternative to measures determined in accordance with GAAP.  Readers should consider non-GAAP measures referenced in this release in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. These non-GAAP financial measures generally exclude some, but not all, items that may affect Merit’s net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Merit believes it is useful to exclude such items in the calculation of non-GAAP earnings per share, non-GAAP gross profit and margin, non-GAAP operating income and margin, and non-GAAP net income because such amounts in any specific period may not directly correlate to the underlying performance of Merit’s business operations and can vary significantly between periods as a result of factors such as acquisition or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain severance expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, corporate transformation expenses, governmental proceedings or changes in tax or industry regulations, gains or losses on disposal of certain assets, and debt issuance costs. Merit may incur similar types of expenses in the future, and the non-GAAP financial information referenced in this release should not be viewed as a statement or indication that these types of expenses will not recur. Additionally, the non-GAAP financial measures referenced in this release may not be comparable with similarly titled measures of other companies. Merit urges readers to review the reconciliations of its non-GAAP financial measures to their most directly comparable GAAP financial measures and not to rely on any single financial measure to evaluate Merit’s business or results of operations.  Constant Currency Revenue  Merit’s constant currency revenue is prepared by converting the current-period reported revenue of subsidiaries whose functional currency is a currency other than the US dollar at the applicable foreign exchange rates in effect during the comparable prior-year period and adjusting for the effects of hedging transactions on reported revenue, which are recorded in the US dollar.   Non-GAAP Gross Profit and Margin  Non-GAAP gross profit is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets and inventory mark-up related to acquisitions. Non-GAAP gross margin is calculated by dividing non-GAAP gross profit by reported net sales.   Non-GAAP Operating Income and Margin  Non-GAAP operating income is calculated by adjusting GAAP operating income for certain items which are deemed by Merit’s management to be outside of core operations and vary in amount and frequency among periods, such as expenses related to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain severance expenses, performance-based stock compensation expenses, corporate transformation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations. Non-GAAP operating margin is calculated by dividing non-GAAP operating income by reported net sales.  Non-GAAP Net Income  Non-GAAP net income is calculated by adjusting GAAP net income for the items set forth in the definition of non-GAAP operating income above, as well as for expenses related to debt issuance costs, gains or losses on disposal of certain assets, changes in tax regulations, and other items.   Non-GAAP EPS  Non-GAAP EPS is defined as non-GAAP net income divided by the diluted shares outstanding for the corresponding period.  ABOUT MERIT  Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 700 individuals. Merit employs approximately 7,000 people worldwide.  CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s forecasted plans, revenues, net sales, net income (GAAP and non-GAAP), operating income and margin (GAAP and non-GAAP), gross profit and margin (GAAP and non-GAAP), earnings per share (GAAP and non-GAAP), and other financial measures, future growth and profit expectations or forecasted economic conditions, or the implementation of, and results which may be achieved through, Merit’s Continued Growth Initiatives program or other expense reduction initiatives, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Annual Report”) and other filings with the SEC. Such risks and uncertainties include inherent risks and uncertainties associated with Merit’s integration of the assets and operations acquired from EndoGastric Solutions and its ability to achieve anticipated financial results, product development and other anticipated benefits of the EndoGastric Solutions acquisition; uncertainties as to whether Merit will achieve sales, gross and operating margins, net income and earnings per share performance consistent with its forecasts associated with that acquisition; disruptions in Merit’s supply chain, manufacturing or sterilization processes; reduced availability of, and price increases associated with, commodity components and other raw materials; adverse changes in freight, shipping and transportation expenses; negative changes in economic and industry conditions in the United States or other countries, including inflation; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; risks associated with Merit’s ongoing or prospective manufacturing transfers and facility consolidations; fluctuations in interest or foreign currency exchange rates; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; consequences associated with a Corporate Integrity Agreement executed between Merit and the U.S. Office of Inspector General – Department of Health and Human Services; difficulties, delays and expenditures relating to development, testing and regulatory approval or clearance of Merit’s products, including the pursuit of approvals under the European Union Medical Device Regulation, and risks that such products may not be developed successfully or approved for commercial use; litigation and other judicial proceedings affecting Merit; the potential of fines, penalties or other adverse consequences if Merit’s employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; changes in customer purchasing patterns or the mix of products Merit sells; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations, including reforms to the procedures for approval or clearance of Merit’s products by the U.S. Food & Drug Administration or comparable regulatory authorities in other jurisdictions; changes in tax laws and regulations in the United States or other jurisdictions; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; concentration of a substantial portion of Merit’s revenues among a few products and procedures; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; dependance on distributors to commercialize Merit’s products in various jurisdictions outside the United States; volatility in the market price of Merit’s common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; failure to introduce products in a timely fashion; price and product competition; fluctuations in and obsolescence of inventory; and other factors referenced in the 2023 Annual Report and other materials filed with the SEC. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements. TRADEMARKS  Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.   REFERENCES 1. Sharma et al. 2023. “Healthcare Resource Utilization and Costs Among Patients With Gastroesophageal Reflux Disease, Barrett’s Esophagus, and Barrett’s Esophagus–Related Neoplasia in the United States.” Journal of Health Economics and Outcomes Research 10, no. 1 (March): 51 ̶ 58. Accessed June 11, 2024. doi: 10.36469/001c.68191. (PMID: 58829388)2. 2. Yadlapati, Gyawali, and Pandolfino. 2022. “AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review.” Clinical Gastroenterology and Hepatology 20, no. 5 (May): 984 ̶ 94.e1. Accessed June 11, 2024. doi: 10.1016/j.cgh.2022.01.025. (PMID: 35123084)

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Boston Scientific Announces Conference Call Discussing Second Quarter 2024 Results

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MARLBOROUGH, Mass., July 1, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) will webcast its conference call discussing financial results and business highlights for the second quarter ended June 30, 2024, on Wednesday, July 24, 2024, at 8:00 a.m. ET. The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the second quarter on July 24 prior to the conference call.
A live webcast and replay of the webcast will be accessible at htts://investors.bostonscientific.com. The replay will be available approximately one hour following the completion of the event.
About Boston ScientificBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.  
CONTACTS:Chanel HastingsMedia Relations+1 (508) 382-0288[email protected]
Jon MonsonInvestor Relations+1 (508) 683-5450[email protected] 
SOURCE Boston Scientific Corporation

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InspireMD Announces Full Exercise of Series H Warrant Tranche for Gross Proceeds of $17.9 Million

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Series H warrants exercisable following release of positive outcomes results related to one-year follow-up from the Company’s C-GUARDIANS pivotal trial. Participating warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members. Represents first of four milestone-driven warrant tranches pursuant to private placement financing of up to $113.6 million announced in May 2023. TEL AVIV, Israel and WESTIN, Fla., July 01, 2024 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the completion of the full exercise of 12.9 million Series H warrants. The Series H warrants were converted primarily into pre-funded warrants. The gross proceeds to the company from the warrant exercise were $17.9 million, and $16.9 million after fees. The Series H warrants were issued as part of the transformational private placement financing of up to $113.6 million that InspireMD announced in May 2023. The Series H warrants became exercisable following the release of positive results related to one-year follow-up from the Company’s C-GUARDIANS pivotal trial of the CGuard Carotid Stent System. Participating warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members. Marvin Slosman, chief executive officer of InspireMD, stated, “We are grateful for the continued support of these highly regarded healthcare investors, who have elected to exercise 100% of the available Series H warrants. This capital strengthens our business and helps fuel our growth, including advancing our CGuard Prime Carotid Stent System through to potential FDA approval and U.S. launch in the first half of next year. CGuard is a highly differentiated stent implant that delivers superior short- and long-term patient outcomes, as reflected in the best-in-class evidence that was reported at both the VIVA 2023 and LINC 2024 conferences. Looking ahead, we are working to catalyze these milestones to continue building momentum toward commercialization, while advancing both our CAS and TCAR programs to address the broadest range of physicians and patient needs of any company within the field of carotid revascularization.” 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 Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com. Forward-looking StatementsThis press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-Guardians U.S. IDE clinical trial, including one-year results from such trial presented at LINC 2024, as well as the timing and outcome of any subsequent results, PMA or potential launch, and statements relating to expectations regarding future warrant exercises or expected proceeds therefrom. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; 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; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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 ShoreChief Financial OfficerInspireMD, Inc.888-776-6804craigs@inspiremd.com Chuck Padala, Managing DirectorLifeSci Advisors646-627-8390chuck@lifesciadvisors.cominvestor-relations@inspiremd.com

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Idorsia’s JERAYGO (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension

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Idorsia receives approval from the European Commission (EC) for JERAYGO™ (aprocitentan) as the first and only endothelin receptor antagonist (ERA) for the treatment of resistant hypertension.JERAYGO is a new oral antihypertensive therapy – the first in almost 40 years – that is working via a new therapeutic pathway. Allschwil, Switzerland – July 1, 2024Idorsia Ltd (SIX: IDIA) announced today that the European Commission (EC) has approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.1 The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control.1 Hypertension is one of the leading causes of cardiovascular disease worldwide, impacting an estimated 1.3 billion people globally.2 Approximately 10% of these people have uncontrolled BP, despite receiving at least three antihypertensive medications from different classes, at optimal doses and they are categorized in hypertension guidelines as having resistant hypertension.3,4 Prof. Krzysztof Narkiewicz, MD, PhD, Head of the Department of Hypertension and Diabetology, Medical University of Gdansk, Poland, commented:“JERAYGO is an oral antihypertensive therapy that is tackling a new therapeutic pathway – the endothelin system. JERAYGO has demonstrated clinically meaningful rapid and long-term reduction in blood pressure. What I was particularly impressed with, this effect was shown in patients with resistant hypertension, whose blood pressure remained uncontrolled despite receiving at least three antihypertensive medications as background therapy. In Europe, there are millions of patients with resistant hypertension, and they are at a higher risk of heart attack, heart failure, stroke, end-stage renal disease and death due to their high blood pressure. With JERAYGO, doctors now a have an effective new treatment option to help control blood pressure in these patients.” Alberto Gimona, MD, Head of Global Clinical Development & Medical Affairs, commented:“We are very proud to have gained approval for JERAYGO, the first innovative anti-hypertensive drug in 40 years, acting on the endothelin pathway, which we believe is a key player in patients with resistant hypertension. We have seen a clinically meaningful and consistent blood pressure lowering across blood pressure measurement methodologies and in subgroups of patients with serious comorbidities – for example in patients with chronic kidney disease. We also saw a marked reduction in albuminuria with JERAYGO as evidenced by a decrease in baseline UACR. I’m very pleased that the wealth of data we have generated with JERAYGO is well reflected in the label. We will now work to expand marketing authorization by also applying for JERAYGO approval in the UK, Canada, and Switzerland.” André Muller, Chief Executive Officer of Idorsia commented:“With aprocitentan, we have a largely unencumbered asset approved in the US and Europe. We continue to carefully evaluate all our funding options including potential collaborations for the commercialization of aprocitentan, while preparing to make aprocitentan available in these two key markets.” About the Phase 3 PRECISION study1,5The efficacy of aprocitentan was evaluated in one randomized, double-blind (DB), placebo-controlled Phase 3 multicenter study. Patients with uncontrolled blood pressure (systolic blood pressure [SBP] ≥140 mmHg) despite the use of at least three antihypertensive medicinal products and following exclusion of pseudo-resistant hypertension (e.g., white coat effect, inappropriate blood pressure measurement, secondary causes of hypertension) were considered to have resistant hypertension. The patients were switched to standardized background antihypertensive therapy consisting of an angiotensin receptor blocker (valsartan 160 mg), a calcium channel blocker (amlodipine 5 or 10 mg), and a diuretic (hydrochlorothiazide 25 mg) throughout the study. Patients with concomitant use of beta-blockers continued this treatment throughout the study, in addition to the standardized background antihypertensive therapy and study treatment. A total of 730 patients received either aprocitentan 12.5 mg, aprocitentan 25 mg, or placebo once daily during the initial 4-week DB treatment (part 1). Thereafter, patients received aprocitentan 25 mg once daily during the 32-week single-blind treatment (part 2). At the end of the 32 weeks, patients were re-randomized to receive either aprocitentan 25 mg or placebo, once daily, during the 12-week double-blind withdrawal (DB-WD) treatment (part 3). The primary efficacy endpoint was the change in sitting SBP (SiSBP) from baseline to Week 4 during DB treatment (part 1), measured at trough by unattended automated office blood pressure (uAOBP). The key secondary endpoint was the change in SiSBP measured at trough by uAOBP from DB-WD baseline (Week 36) to Week 40 (part 3). Patients had a mean age of 61.7 years (range 24 to 84 years; 34.1% were ≥ 65 and < 75 years; 9.9% were ≥ 75 years) and 59.5% were male. Patients were White (82.9%), African American (11.2%) or Asian (5.2%). The mean body weight was 97.6 kg (range 46 to 196 kg) and mean BMI was 33.7 kg/m2 (range 18 to 64 kg/m2). Patients had a medical history of type 2 diabetes mellitus (54.1%), ischemic heart disease (30.8%), central nervous system vascular disorders (23.0%), chronic kidney disease stages 3 and 4 (22.2%; 19.3% of patients had eGFR 30–59 mL/min/1.73 m2 and 2.9% had eGFR 15–29 mL/min/1.73 m2), congestive heart failure (19.6%), and sleep apnea syndrome (14.1%). 63.0% of patients had four or more antihypertensive medicinal products. Key PRECISION findings1,5Doses of aprocitentan 12.5 and 25 mg showed a statistically significant reduction vs placebo on SiSBP at Week 4. The treatment effect was consistent for sitting diastolic blood pressure (SiDBP). The persistence of the BP-lowering effect of aprocitentan was shown in DB-WD treatment (part 3). In patients re-randomized to placebo, the mean SiSBP increased, whereas in patients re-randomized to aprocitentan 25 mg the mean effect on SiSBP was stable, resulting in a statistically significant difference. The treatment effect was consistent for SiDBP. The effect was also consistent across SBP and DBP measured by ambulatory BP monitoring (ABPM) and assessed as daytime, night-time, and 24h periods at Week 4 and Week 40. A substantial proportion (i.e., at least 90%) of the BP-lowering effect was observed within the first two weeks of treatment with aprocitentan. The effect of aprocitentan was consistent across subgroups of age (including patients ≥ 75 years), sex, race (including patients with Black or African American origin), BMI, baseline urine albumin-to-creatinine ratio (UACR), baseline eGFR and medical history of diabetes. The most frequently reported adverse reactions with aprocitentan were edema/fluid retention (mostly peripheral edema) (9.1%, 12.5 mg; 18.4%, 25 mg) and hemoglobin decreased (3.7%, 12.5 mg; 1.2%, 25 mg). JERAYGO is contraindicated for use in women who are pregnant, breast-feeding and in women of childbearing potential who are not using reliable contraception, and patients with severe hepatic impairment. For more information on the marketing authorization of JERAYGO in the European Union, please review the Summary of Product Characteristics (SmPC). Notes to the editor About aprocitentanThe team at Idorsia has been working on the research and development of endothelin receptor antagonists for more than 30 years, successfully bringing three other molecules from this class to patients in different indications. Endothelin (ET)-1, via its receptors (ETA and ETB), mediates a variety of effects such as vasoconstriction, fibrosis, cell proliferation, and inflammation and is upregulated in hypertension. Aprocitentan is a dual ERA that inhibits the binding of ET-1 to ETA and ETB receptors and hence the effects mediated by these receptors.1 References JERAYGO™ Summary of Product Characteristics. 2024.NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet 2021; 398:957-80.Noubiap JJ, et al. Global prevalence of resistant hypertension: a meta-analysis of data from 3·2 million patients. Heart 2019; 105: 98–105.Williams B, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J 2018; 39: 3021–104.Schlaich MP, et al. A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension. The Lancet, 2022; Dec 3;400(10367):1927-1937. About Prof. Krzysztof Narkiewicz, MD, PhDProfessor Krzysztof Narkiewicz is the Head of the Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland. His research has been focused on the role of the sympathetic nervous system and metabolic factors in regulation of cardiovascular function in physiological and pathological states, and on prevention and treatment of cardiometabolic diseases including hypertension, diabetes, coronary artery disease, congestive heart failure and obstructive sleep apnea. He has published over 700 full-text publication; ( > 39 000 citations; h-index: 69). He was the President of the Scientific Council of the European Society of Hypertension (2009-2011). He was a member of the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) preparing the 2007, 2013 and 2018 Guidelines for the Management of Arterial Hypertension. He also contributed to the 2023 ESH hypertension guidelines. Prof. Krzysztof Narkiewicz serves as a consultant to Idorsia. About IdorsiaIdorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contactInvestors & MediaAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com • media.relations@idorsia.com • www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
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Elucid Moves into New Headquarters in Preparation for Commercial Launch

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BOSTON–(BUSINESS WIRE)–Elucid, a pioneering medical technology company providing physicians with imaging analysis software based on ground truth histology to support treatment of cardiovascular disease, today announced it has moved its headquarters to 399 Boylston Street in the heart of Boston’s Back Bay neighborhood. The move into the modern space comes […]

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VenoStent Completes $20 Million Series A with $4 Million Investment from Norwest Venture Partners

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Company Builds on Momentum with New $3.6 Million NIH SBIR Grant to Fund U.S. Clinical Trial of Breakthrough Medical Device Showing Promise in Improving Dialysis Patient Outcomes
HOUSTON, June 27, 2024 /PRNewswire/ — VenoStent, Inc., a clinical-stage medical device company developing a novel therapeutic device for improving dialysis patient outcomes, announced today that it closed an additional $4 million from Norwest Venture Partners to round out its Series A financing at $20 million with Good Growth Capital and IAG Capital Partners co-leading the deal. In addition, the company was awarded a $3.6 million Small Business Innovation Research (SBIR) Phase II Grant by the National Institutes of Health (NIH), which will help fund its multi-center, 200-patient, randomized controlled trial (RCT) in the US.
Norwest General Partner Dr. Zack Scott and Investor Dr. Ehi Akhirome are joining the company as board observers. Dr. Scott and Dr. Akhirome bring deep medtech expertise from previous experience as a surgeon and physician scientist, respectively.
“2024 has been a momentous year for VenoStent so far. In the span of a few months, we initiated our first clinical sites, enrolled the first patients in our large RCT and closed our Series A with Norwest,” said Tim Boire, Ph.D., VenoStent CEO and co-founder. “We also received the NIH grant, which enables us to execute our trial with the highest degree of quality and rigor to make it as scientifically robust and impactful to patients as possible. Each of these are major company milestones that collectively represent many years of intensive and fruitful R&D and collaboration. These recent milestones will propel our company forward to an exciting next phase.”
As a clinical-stage therapeutic medical device company, VenoStent has developed a bioabsorbable perivascular wrap, SelfWrap, that goes around arteriovenous (AV) access sites at the time of AV fistula creation surgery. The bioabsorable wrap is intended to accelerate the usability and increase the durability of the fistula sites for chronic kidney disease (CKD) patients requiring hemodialysis. SelfWrap uses the body’s own healing mechanisms to mimic the arterial environment in veins, which experience a 10x increase in pressure and flow during AV creation and causes the veins to become unusable in dialysis.
In May 2023, SelfWrap was approved by the U.S. Food and Drug Administration to begin its U.S. Investigational Device Exemption (IDE) study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistulas Study. The study is designed to show how SelfWrap can improve clinical outcomes for CKD patients requiring hemodialysis. Based on the compelling results from the company’s first-in-human clinical trial, the FDA granted SelfWrap a Breakthrough Device Designation in May 2022.
“Over half a million people in the U.S. rely on hemodialysis to survive and require an arteriovenous fistula creation surgery in order to receive the treatment. However, the AV fistula procedure has a one-year failure rate of more than 60%, which significantly impacts patients’ survival rates and quality of life,” said Norwest’s Dr. Scott. “VenoStent’s groundbreaking technology for AV fistula formation, SelfWrap, has the potential to significantly improve these odds. We look forward to working with the VenoStent team as it proves the efficacy of this breakthrough technology in order to improve the lives of hundreds of thousands of CKD patients.”
“Norwest’s investment is tremendous validation for VenoStent, and we are thrilled to have both Zack and Ehi joining the company’s board,” said VenoStent COO and Co-Founder, Geoffrey Lucks. “Zack and Ehi have extensive knowledge in our space, and their added value will match the capital and cache of Norwest dollar-for-dollar.”
About VenoStentVenoStent, Inc. (www.venostent.com) is a therapeutic medical device company developing a bioabsorbable wrap, SelfWrap, to transform outcomes in vascular surgery, starting with hemodialysis access. The device is intended to improve the usability and durability of arteriovenous fistulas (AVFs), the artery-vein connections that are surgically created in the arms of CKD patients to enable life-saving dialysis treatments. SelfWrap has been finely tuned through a decade of development to provide optimal mechanical support, improving hemodynamics and outward vein growth, and ultimately leading to improved quality and length of life for end-stage renal disease (ESRD) patients. Headquartered in Houston, Texas, VenoStent is venture backed by Good Growth Capital, IAG Capital Partners and Norwest Venture Partners, amongst others.
About Norwest Venture PartnersNorwest Venture Partners is a global venture and growth equity investment firm managing more than $15.5 billion in capital. Since its inception, Norwest has invested in more than 700 companies and currently partners with more than 230 companies in its venture and growth equity portfolio. The firm invests in early- to late-stage businesses across key sectors with a focus on enterprise, consumer and healthcare. The Norwest team offers a deep network of connections, extensive operating experience, and a wide range of impactful services to help CEOs and founders scale their businesses. Norwest has offices in Menlo Park and San Francisco, Calif.; Mumbai, India; and Tel Aviv, Israel. For more information, please visit www.nvp.com.
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