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InspireMD Announces Expected Retirement of its CFO Craig Shore and CFO Transition in 2025

MIAMI, Dec. 12, 2024 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that Craig Shore, Chief Financial Officer, has decided to retire from the Company after a successor CFO is identified and appointed. Mr. Shore will remain as CFO until his successor is appointed and will assist in a smooth and orderly transition.

NewAmsterdam Pharma Announces Pricing of Upsized $416.5 Million Public Offering of Ordinary Shares and Pre-Funded Warrants

NAARDEN, the Netherlands and MIAMI, Dec. 11, 2024 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the pricing of the previously announced underwritten public offering of (i) 12,117,347 of the Company’s ordinary shares, nominal value €0.12 per share (the “Ordinary Shares”), at a public offering price of $24.50 per share and (ii) to certain investors that so choose in lieu of Ordinary Shares, pre-funded warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per pre-funded warrant, which represents the per share public offering price for the Ordinary Shares less the $0.0001 per share exercise price for each such pre-funded warrant (“Pre-Funded Warrants,” such offering, the “Offering”). The proceeds to the Company from the Offering, before deducting underwriting discounts and commissions and offering expenses payable by the Company, are expected to be approximately $416.5 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 2,550,000 Ordinary Shares at the public offering price, less underwriting discounts and commissions. The Offering is expected to close on or about December 13, 2024, subject to satisfaction of customary closing conditions. Jefferies, Goldman Sachs & Co., Leerink Partners, TD Cowen, Guggenheim Securities and William Blair are acting as joint book-running managers for the Offering. The Offering is being made pursuant to a registration statement on Form S-3, including a base prospectus, that was initially declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on July 12, 2024 and a related registration statement that was filed with the SEC on December 11, 2024 pursuant to Rule 462(b) under the Securities Act of 1933 (and which became automatically effective upon filing). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the Offering were filed with the SEC and are available free of charge by visiting EDGAR on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and the accompanying prospectus may also be obtained free of charge from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at Prospectus-ny@ny.email.gs.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, or by telephone at (855) 495-9846, or by email at TD.ECM_Prospectus@tdsecurities.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by telephone at (800) 621-0687, or by email at prospectus@williamblair.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well-tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well-tolerated. Forward-Looking Statements Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the consummation of the proposed Offering. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflicts; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the SEC. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; and the Company’s ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law. Company ContactMatthew PhilippeP: 1-917-882-7512 matthew.philippe@newamsterdampharma.com Media ContactSpectrum Science on behalf of NewAmsterdamJaryd Leady P:1-856-803-7855jleady@spectrumscience.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696 austin.murtagh@precisionaq.com

RapidPulse Receives FDA Approval to Begin IDE Study in Ischemic Stroke Using Innovative Cyclic Aspiration System – Recently Completed Clinical Trial Shows Significantly Higher First Pass and Frontline Success Rates

MIAMI, Dec. 11, 2024 (GLOBE NEWSWIRE) — RapidPulse, Inc., a Delaware corporation headquartered in Miami, Florida focused on improving the treatment success rate for acute ischemic stroke (AIS) announced that the United States Food and Drug Administration (FDA) agreed that RapidPulse can begin enrollment in an Investigational Device Exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow U.S. and European patient enrollment in 2025 to commence in a study designed to demonstrate the RapidPulse patented method of precisely pulsed aspiration is safe and effective in the treatment of AIS. RapidPulse’s technology is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits.

Genetesis Launches CardioFlux Membership Program to Revolutionize Preventive Cardiac Care and Eliminate Heart Disease

Proactive, personalized monitoring of myocardial fitness at regular intervals, powered by MCG technology, represents paradigm shift in the prevention of heart disease City of Mason’s Biohealth Corridor selected as home of first ever CardioFlux Imaging Institute MASON, Ohio, Dec. 11, 2024…

IRADIMED CORPORATION on Forbes’ List of America’s Most Successful Small-Cap Companies for 2025

WINTER SPRINGS, Fla., Dec. 10, 2024 (GLOBE NEWSWIRE) — IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD), today announced it has been ranked 24th on Forbes’ list of America’s Most Successful Small-Cap Companies 2025. Iradimed is a leader in the development of innovative magnetic resonance imaging (“MRI”) medical devices and the only provider of a non-magnetic intravenous (“IV”) infusion pump system and non-magnetic patient vital signs monitoring systems that are designed for use during MRI procedures.

Lindus Health Releases “All-in-One Cardiovascular CRO” Offering for Clinical Trials Serving Cardiovascular Health

NEW YORK, Dec. 10, 2024 /PRNewswire/ — Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, has launched their “all-in-one” contract research organization (CRO), site, and technology offering bespoke to the unique needs of…

Medera’s Novoheart Releases Latest Cardiac Screening Innovation CTScreen v1.5 to Advance High-Throughput, Automated Human-Based Drug Testing

Innovation installed by AstraZeneca for advancing human heart-based R&D for investigational cardiovascular therapiesFeatures improved automation, environmental control, and flexible testing protocols, setting a new benchmark for human-based cardiac screeningLatest enhanced 96-well technology enables rapid, high-throughput screening on bioengineered human heart tissues, with significant cost and efficiency gains BOSTON and GOTHENBURG, Sweden, Dec. 10, 2024 (GLOBE NEWSWIRE) — Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat or currently incurable diseases with significant unmet needs, and Novoheart, its wholly owned pre-clinical subsidiary pioneering human-based cardiac tissue engineering for disease modelling and drug screening, are pleased to announce the launch of the industry’s most advanced automated cardiac screening platform, CTScreen v1.5, which has been adopted by AstraZeneca for advancing toward clinical trials. CTScreen™ is designed to put living, bioengineered human cardiac tissue strips (CTS) that accurately mimic human heart function. This automated system can detect the effects of new treatments early in the development process, streamlining the path from discovery to clinical trials and supporting the goals of the FDA Modernization Act 2.0. This reinforces Medera’s commitment and mission to advance human-based research alternatives to animal testing, improve efficiency and success as well as reduce costs of drug development. Kevin Costa, Ph.D., Chief Scientific Officer and co-founder of Medera’s Novoheart, stated, “CTScreen’s new capabilities reflect our commitment to customer feedback and continual innovation. We’re thrilled to see AstraZeneca lead the way with these enhanced tools, which we hope will support the discovery of life-saving drugs.” The new system accommodates the latest 96-well μCTS plate, offering an industry standard high-throughput format for screening miniature human heart tissues. The μCTS plate is specially designed so that beating heart micro-tissues automatically self-assemble from pipetted stem cells, making the cardiac tissue engineering process accessible to any cell biology laboratory. The standard 96-well format is also compatible with commercial liquid handling robotics for further automation and simplification. The upgraded CTScreen™ platform accommodates up to 96 tissue samples at once, enabling rapid screening with reduced cell requirements – benefitting drug developers by increasing data output while significantly lowering the cost per test.  This CTScreen v1.5 upgrade provides industry partners with powerful new tools, including automated controls, improved physiologic conditions, and versatile testing protocols that allow more sophisticated cardiac screening. Novoheart’s innovations, such as motorized positioning for the 96-well plate and precise, programmable stimulation options, make this system a leader in the field for user-friendly, efficient cardiac testing. Anish Konkar, Ph.D., Head of Bioscience, Early Cardiovascular, Renal and Metabolism (CVRM) at AstraZeneca, stated, “The CTScreen system is an important addition to our cardiovascular research toolkit. Medera and Novoheart’s expertise make them invaluable partners, and we look forward to seeing the potential research breakthroughs this collaboration will drive.” “Our collaboration with AstraZeneca has grown over several years, and we are delighted they chose to continue using Novoheart’s latest CTScreen technology as they advance their R&D. We believe our technology can push the limits of what’s possible in drug discovery,” remarked Ronald Li, Ph.D., Medera’s CEO and Founder. “The clinical implications of the automated cardiac screening platform are significant as it is poised to accelerate targeted treatments towards the clinic.” On September 5, 2024, Medera and Keen Vision Acquisition Corporation (“KVAC”) (Nasdaq: KVAC, KVACW), announced they had entered into a definitive merger agreement. About Medera Medera (www.medera.bio) is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat or currently incurable diseases with significant unmet needs, utilizing next-generation gene and cell-based approaches in combination with bioengineered human-based technology (including the mini-Heart platform). Medera operates via the two preclinical and clinical business units, Novoheart and Sardocor, respectively. Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart’s versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart’s technology platform their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor’s lead therapeutic candidates that are currently in clinical trials. Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-induced Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor’s pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases. About Keen Vision Acquisition Corporation Keen Vision Acquisition Corp (“KVAC”), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance (“ESG”) imperatives. EF Hutton LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are serving as Capital Markets Advisors for KVAC. www.kv-ac.com Forward-Looking Statements Certain statements included in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are also forward-looking statements. In some cases, you can identify forward-looking statements by words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “strategy,” “future,” “opportunity,” “may,” “target,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “preliminary,” or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements include, without limitation, KVAC’s, Medera’s, or their respective management teams’ expectations concerning the outlook for their or Medera’s business, productivity, plans, and goals for future operational improvements and capital investments, operational performance, future market conditions, or economic performance and developments in the capital and credit markets and expected future financial performance, including expected net proceeds, expected additional funding, the percentage of redemptions of KVAC’s public shareholders, growth prospects and outlook of Medera’ operations, individually or in the aggregate, including the achievement of project milestones, commencement and completion of commercial operations of certain of Medera’s projects, as well as any information concerning possible or assumed future results of operations of Medera. Forward-looking statements also include statements regarding the expected benefits of the transactions contemplated by the merger (“Transaction”). The forward-looking statements are based on the current expectations of the respective management teams of Medera and KVAC, as applicable, and are inherently subject to uncertainties and changes in circumstance and their potential effects. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, (i) the risk that the Transaction may not be completed in a timely manner or at all, which may adversely affect the price of KVAC’s securities; (ii) the risk that the Transaction may not be completed by KVAC’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by KVAC; (iii) the failure to satisfy the conditions to the consummation of the Transaction, including the adoption of the Merger Agreement by the shareholders of KVAC and the receipt of certain regulatory approvals; (iv) market risks; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; (vi) the effect of the announcement or pendency of the Transaction on Medera’s business relationships, performance, and business generally; (vii) the outcome of any legal proceedings that may be instituted against Medera or KVAC related to the Merger Agreement or the Transaction; (viii) failure to realize the anticipated benefits of the Transaction; (ix) the inability to maintain the listing of KVAC’s securities or to meet listing requirements and maintain the listing of Medera’s securities on Nasdaq; (x) the inability to implement business plans, forecasts, and other expectations after the completion of the Transaction, identify and realize additional opportunities, and manage its growth and expanding operations; (xi) risks related to Medera’s ability to develop, license or acquire new therapeutics; (xii) the risk that Medera will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (xiii) the risk of product liability or regulatory lawsuits or proceedings relating to Medera’s business; (xiv) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; (xv) risks related to regulatory review, and approval and commercial development; (xvi) risks associated with intellectual property protection; (xvii) Medera’s limited operating history and risk that it may never successfully commercialise its products; (xviii) Medera expects to continue to incur significant losses and may never achieve or maintain profitability; and (xix) the risk that additional financing in connection with the Transaction may not be raised on favorable terms. The foregoing list is not exhaustive, and there may be additional risks that neither KVAC nor Medera presently knows or that KVAC and Medera currently believe are immaterial. You should carefully consider the foregoing factors, any other factors discussed in this press release and the other risks and uncertainties described in the “Risk Factors” section of KVAC’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities Exchange Commission (“SEC”) on March 29, 2024, the risks to be described in the registration statement, which includes a preliminary proxy statement/prospectus, initially filed with the SEC on September 24, 2024 (File No. 333-282312) and those discussed and identified in filings made with the SEC by KVAC from time to time. Medera and KVAC caution you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth in this press release speak only as of the date of this press release. Neither Medera nor KVAC undertakes any obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs. In the event that any forward-looking statement is updated, no inference should be made that Medera or KVAC will make additional updates with respect to that statement, related matters, or any other forward-looking statements. Any corrections or revisions and other important assumptions and factors that could cause actual results to differ materially from forward-looking statements, including discussions of significant risk factors, may appear, up to the consummation of the Transaction, in KVAC’s public filings with the SEC, and which you are advised to review carefully. Important Information for Investors and Shareholders In connection with the Transaction, KVAC and Medera filed a registration statement (File No.: 333-282312) with the SEC, which includes a prospectus with respect to the securities to be issued in connection with the Transaction and a proxy statement to be distributed to holders of KVAC’s ordinary shares in connection with KVAC’s solicitation of proxies for the vote by KVAC’s shareholders with respect to the Transaction and other matters to be described in the Registration Statement (the “Proxy Statement”). After the SEC declares the registration statement effective, KVAC plans to mail copies to shareholders of KVAC as of a record date to be established for voting on the Transaction. This press release does not contain all the information that should be considered concerning the Transaction and is not a substitute for the registration statement, Proxy Statement or for any other document that KVAC may file with the SEC. Before making any investment or voting decision, investors and security holders of KVAC are urged to read the registration statement and the Proxy Statement, and any amendments or supplements thereto, as well as all other relevant materials filed or that will be filed with the SEC in connection with the Transaction as they become available because they will contain important information about, Medera, KVAC and the Transaction. Investors and security holders will be able to obtain free copies of the registration statement, the Proxy Statement and all other relevant documents filed or that will be filed with the SEC by KVAC through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by KVAC may be obtained free of charge from KVAC’s website at https://www.kv-ac.com or by directing a request to info@kv-ac.com. The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release. Participants in the Solicitation KVAC, Medera and their respective directors, executive officers and other members of management and employees may, under the rules of the SEC, be deemed to be participants in the solicitations of proxies in connection with the Transaction. For more information about the names, affiliations and interests of KVAC’s directors and executive officers, please refer to KVAC’s annual report on Form 10-K filed with the SEC on March 29, 2024, which can be found at https://www.sec.gov/ix?doc=/Archives/edgar/data/1889983/000121390024027973/ea0201104-10k_keenvision.htm and registration statement, Proxy Statement and other relevant materials initially filed with the SEC in connection with the Transaction on September 24, 2024 (File No.: 333-282312). Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, which may, in some cases, be different than those of KVAC’s shareholders generally, will be included in the registration statement and the Proxy Statement and other relevant materials when they are filed with the SEC when they become available. Shareholders, potential investors and other interested persons should read the registration statement and the Proxy Statement and other such documents carefully, when they become available, before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in the Transaction shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Contacts Investor Relations Stephanie Carrington ICR Healthcare Stephanie.Carrington@icrhealthcare.com (646) 277-1282  Media Relations Sean Leous ICR Healthcare Sean.Leous@icrhealthcare.com (646) 866-4012