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Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST™

MONTREAL and CHARLOTTE, N.C., May 29, 2024 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the United States Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) on May 26, 2024 for CARDAMYST (etripamil) nasal spray, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024. “The FDA’s acceptance of our NDA for CARDAMYST brings Milestone one step closer in our mission in providing a new, convenient and effective treatment option for patients with PSVT,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. “We understand the frequent impact that PSVT has on patients, as well as the underappreciated burden it places on their families and caregivers. Our progress toward providing a sense of security for patients is a result of the dedicated Milestone team, patients, and investigators to whom we are thankful.” The CARDAMYST clinical trial program represents the largest data package ever studied for an acute drug treatment intended for patient self-management of PSVT events. Milestone continues to advance commercial preparations to support the anticipated launch of etripamil with the proposed trade name, CARDAMYST. The brand name is conditionally approved by the FDA. About Paroxysmal Supraventricular Tachycardia An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. About CARDAMYST (etripamil) nasal spray CARDAMYST is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. The clinical trial program for CARDAMYST includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is CARDAMYST (etripamil) nasal spray, a novel calcium channel blocker that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding our ability to bring a new PSVT therapeutic option to market; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA; the timing of the launch of etripamil; and our ability to advance commercial preparations to support the anticipated launch of etripamil. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com  Investor Relations Chris Calabrese, ccalabrese@lifesciadvisors.com Kevin Gardner, kgardner@lifesciadvisors.com

Philips expands global access to its ground-breaking 3D intracardiac echocardiography to Hong Kong

Philips expands global access to its ground-breaking 3D intracardiac echocardiography to Hong Kong Hong Kong selected as the pioneering international location for integrating Philips’ VeriSight Pro 3D Intracardiac Echocardiography (ICE) catheter into routine clinical practice International roll-out underscores Philips’ commitment to driving healthcare innovation and enhancing patient outcomes worldwide Amsterdam, […]

Nordson Corporation Announces Agreement to Acquire Atrion Corporation, a Market Leader in Medical Infusion and Cardiovascular Technologies

WESTLAKE, Ohio–(BUSINESS WIRE)–Nordson Corporation (Nasdaq: NDSN) today announced that it has entered into a definitive agreement to acquire Atrion Corporation (Nasdaq: ATRI), a leader in proprietary medical infusion fluid delivery and niche cardiovascular solutions, for $460.00 per share in cash. This reflects a valuation of 15X Atrion’s 2024 full-year estimated […]

Ceretrieve Announces Groundbreaking Success in FIH Ischemic Stroke Cases

Ceretrieve’s aspiration catheter demonstrated clots removal, completely restoring blood flow in a single pass.YOKNEAM, Israel, May 28, 2024 /PRNewswire/ — Ceretrieve announced today the successful results of the company’s multicenter, single-arm study, showcasing the capabilities of its state-of-the-art aspiration catheter. The study, conducted across two centers, included 20 patients who suffered from acute ischemic stroke (AIS) due to intracranial large vessel occlusion (LVO) and were eligible for thrombectomy within 24 hours of symptom onset. The study was aimed for assessing the safety and initial performance of the Ceretrieve Device.Redefining Stroke Treatment

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A brain clot removed with Ceretrieve’s device

Ceretrieve’s mission is to transform stroke care, save lives, minimize disability, and significantly improve post-stroke quality of life. Ceretrieve’s aspiration catheter is at the forefront of this mission, delivering aspiration capabilities that are far superior when compared to existing devices, allowing clot(s) removal in a single pass, while fully restoring blood flow. Designed for seamless integration within a conventional 6Fr delivery catheter, Ceretrieve’s device offers exceptional trackability and maneuverability, ensuring efficient access to the clot location.
As shown in the study conducted, Ceretrieve’s aspiration catheter not only excelled in performance but also ensured the highest safety standards by reducing the risk of releasing clot fragments further into the brain. In the first-in-human (FIH) study 80% Complete/Near-Complete Perfusion was achieved.The study included two generations of the device, and the results with the improved Gen 2 device are highly impressive: 100% Complete/Near-Complete Perfusion achieved in all treated patients; and 83% First Pass Complete Perfusion (FPE mTICI 3), far exceeding the 30%-40% rate of current gold-standard devices.Ceretrieve’s CEO, Maysa Mustafa: “The promising results of our clinical studies are the culmination of years of hard work and R&D. Our mission to redefine stroke treatment drives everything we do, and these results signify a major leap forward in saving and dramatically improving lives following an ischemic stroke.””The ‘first pass effect’ has been shown to improve patient outcomes” says Dr. Shady Jashan (Galilee Medical Center, Israel) who performed the first neuro thrombectomy procedure with the Ceretrieve device. “Our experience in FIH trials demonstrated that the Ceretrieve device quickly enables complete clot ingestion in first pass even for the most challenging clots and anatomies. This has the potential to dramatically improve patient clinical outcomes.”Prof. Serder Geyik, MD (Florya Medical Park, Turkey): “The term ‘Everything comes with a price’ is not valid for the Ceretrieve device. Ceretrieve’s device aspirates the clot with a giant bore tip- double than the largest catheters in the market, for maximal vacuum effect without paying the price in trackability. In addition, it provides local flow restriction in the middle cerebral artery reducing distal emboli. It is the only device that includes all the features for successful thrombectomy and first pass effect in one single device. “Amir Belson, M.D., Ceretrieve Chair: “With Ceretrieve’s advanced technology, we are seeing significant improvements in patient recovery rates. This innovation is setting a new standard in stroke care, offering patients better outcomes and real hope for recovery.”About Ceretrieve Ceretrieve’s vision is to be the doctor’s first-choice device in treating ischemic stroke offering complete treatment with superior performance in one device. Ceretrieve was established in 2017 in collaboration with The Trendlines Group (SGX:42T) (OTCQX: TRNLY), a leading investment group based in Israel and Singapore, as well as the Israel Innovation Authority (IIA) Incubators Program. Agriline and several angel investors are among the Company’s additional investors.Contact:Maysa Mustafa, CEO[email protected]Photo – https://mma.prnewswire.com/media/2423407/Ceretrieve_case.jpgSOURCE Ceretrieve

Semler Scientific® Announces Bitcoin Treasury Strategy

SANTA CLARA, Calif., May 28, 2024 /PRNewswire/ — Semler Scientific, Inc. (Nasdaq: SMLR), a pioneer in developing and marketing technology products and services to healthcare providers to combat chronic diseases, announced today that its board of directors has adopted bitcoin as its primary treasury reserve asset. In addition, Semler Scientific announced that it has purchased 581 bitcoins for an aggregate amount of $40 million, inclusive of fees and expenses.
“Our bitcoin treasury strategy and purchase of bitcoin underscore our belief that bitcoin is a reliable store of value and a compelling investment,” said Eric Semler, Semler Scientific’s chairman. “Bitcoin is now a major asset class with more than $1 trillion of market value. We believe it has unique characteristics as a scarce and finite asset that can serve as a reasonable inflation hedge and safe haven amid global instability. We also believe its digital, architectural resilience makes it preferable to gold, which has a market value of approximately 10 times that of bitcoin. Given the gap in value between gold and bitcoin, we believe that bitcoin has the potential to generate outsize returns as it gains increasing acceptance as digital gold.
“Furthermore, we are energized by the growing global acceptance and ‘institutionalization’ of bitcoin — reflected most recently by the Securities and Exchange Commission’s January 2024 approval of 11 bitcoin exchange-traded funds. These funds have reported more than $13 billion of net inflows, with investments from nearly 1,000 institutions, including global banks, pensions, endowments and registered investment advisors. It is estimated that more than 10% of all bitcoins are now held by institutions,” added Mr. Semler.
Semler Scientific’s board and senior management have spent substantial time examining potential uses of cash, including acquisitions. “After studying various alternatives, we decided that holding bitcoin would be the best use of our excess cash,” said Mr. Semler. 
In conjunction with its bitcoin treasury strategy, Semler Scientific will continue to focus on its core medical products and services. “We remain dedicated to our customers and our goal of operating a growing and profitable healthcare company,” said Doug Murphy-Chutorian, MD, Semler Scientific’s chief executive officer. “We are focused on maintaining sales of QuantaFlo® for peripheral arterial disease testing, while seeking a new 510(k) clearance from the FDA with expanded labeling for use as an aid in the diagnosis of other cardiovascular diseases.” 
As Semler Scientific continues to generate revenue and free cash flow from sales of QuantaFlo, it will proactively evaluate its use of excess cash. Bitcoin will serve as Semler Scientific’s principal treasury holding on an ongoing basis, subject to market conditions and the anticipated cash needs of Semler Scientific. 
More information regarding Semler Scientific’s bitcoin treasury strategy will be posted on its website at www.semlerscientific.com. 
About Semler Scientific, Inc:
Semler Scientific, Inc. develops, manufactures and markets innovative products and services to combat chronic diseases. Its flagship product, QuantaFlo®, which is patented and cleared by the U.S. Food and Drug Administration (FDA), is a rapid point-of-care test that measures arterial blood flow in the extremities. The QuantaFlo test aids in the diagnosis of cardiovascular diseases, such as peripheral arterial disease (PAD), and Semler Scientific is seeking a new 510(k) clearance for expanded indications. QuantaFlo is used by healthcare providers to evaluate their patient’s risk of mortality and major adverse cardiovascular events (MACE). Semler Scientific also invests in bitcoin and has adopted bitcoin as its primary treasury reserve asset. Additional information about Semler Scientific can be found at www.semlerscientific.com. 
Forward-Looking Statements
This press release contains “forward-looking” statements. Such statements can be identified by, among other things, the use of forward-looking language such as the words “believe,” “goal,” “may,” “will,” “intend,” “expect,” “anticipate,” “estimate,” “project,” “would,” “could” or words with similar meaning or the negatives of these terms or by the discussion of strategy or intentions. The forward-looking statements in this release include express or implied statements regarding the new bitcoin strategy and its ability to generate outsize returns, Website posting of information regarding the bitcoin strategy, as well as seeking a new 510(k) clearance for QuantaFlo with expanded indications for use, among others. Such forward-looking statements are subject to a number of risks and uncertainties that could cause Semler Scientific’s actual results to differ materially from those discussed here, such as risks inherent with investing in bitcoin, including bitcoin’s volatility; risk of implementing a new treasury strategy; risk that insurance plans and other customers will not continue to license its cardiovascular testing products; risk of changes in the reimbursement landscape for its customers including related to the CMS rate announcement; risk of obtaining a new 510(k) clearance for expanded indications; along with those other risk factors detailed in Semler Scientific’s filings with the Securities and Exchange Commission. These forward-looking statements involve assumptions, estimates, and uncertainties that reflect current internal projections, expectations or beliefs. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. All forward-looking statements contained in this press release are qualified in their entirety by these cautionary statements and the risk factors described above. Furthermore, all such statements are made as of the date of this release and Semler Scientific assumes no obligation to update or revise these statements unless otherwise required by law.
INVESTOR CONTACT:
Renae CormierChief Financial Officer[email protected] 
SOURCE Semler Scientific, Inc.

InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024  

Data demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial Study results to support a Premarket Approval (PMA) application to FDA in H2 2024 U.S. commercial launch of the CGuard™ Prime Carotid Stent System anticipated in H1 2025, if approved TEL AVIV, Israel, and MIAMI, May 28, 2024 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the presentation of positive one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis at this year’s Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany. Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased to have such a significant presence at this year’s LINC conference, highlighted by a presentation of the primary endpoint results from our C-GUARDIANS clinical study. The independently adjudicated major adverse event rates through one-year are the lowest reported to date from any carotid stent or embolic protection device pivotal trial. With these data in-hand, we now have line of sight to a PMA application in the back half of this year, with preparation ongoing for a robust U.S. commercial launch in the first half of 2025, if approved. In addition to these results, we continue to be enthusiastic about our plans to introduce both CAS and TCAR solutions serving the broadest community of specialists serving the carotid revascularization market with the best implant in CGuard Prime.” Dr. Chris Metzger, M.D., System Vascular Chief at OhioHealth, and lead investigator of the C-GUARDIANS trial, stated, “We are very excited that the one-year carefully adjudicated C-GUARDIANS data confirm the extremely low rates of stoke, death, myocardial infarction, and target vessel revascularization in this prospective trial of high-carotid endarterectomy (CEA) risk patients with obstructive carotid disease, including 25% who were symptomatic. These data confirm the potential ‘neuroprotective properties’ of this unique MicroNet technology, offering an outstanding front-line option to consider for each patient with obstructive carotid artery disease.” Presentation details: Title:One-Year Follow-Up Results from the C-GUARDIANS Pivotal Trial of the CGuard™ Carotid Stent SystemPresenter:Dr. D. Christopher Metzger, System Vascular Chief, OhioHealthDate/time:Tuesday, May 28th at 2:53 pm CEST (8:53am EDT)   Presentation Highlights: From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the US and the EU.The primary endpoint is a composite of: (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.Stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a primary endpoint event rate of 1.95%, from procedure through 1-year follow-up.The presentation is available on our website at: Clinical Presentations – InspireMD About LINCLINC, the Leipzig Interventional Course, is strongly committed to contributing to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the “vascular patients” by integrating colleagues of different specialties from around the world who are performing endovascular interventions. For more information, please visit: https://www.leipzig-interventional-course.com/ About C-GUARDIANSThe C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe. The trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, or myocardial infarction (DSMI) through 30‐days post‐index procedure, or ipsilateral stroke from 31‐365-day follow‐up, based on the Clinical Events Committee (CEC) independent adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is

 Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.

— Greek Ministry of Health approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce cardiovascular risk in statin-treated adult patients with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and other high-risk characteristics as studied in REDUCE-IT1 — — Approval marks seventh national reimbursement of VAZKEPA® in Europe — — Vianex S.A., one of the leading pharmaceutical companies in Greece, will commercialize VAZKEPA® as Amarin’s exclusive distributor in the country — DUBLIN, Ireland and BRIDGEWATER, N.J., May 28, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announces that the Greek Ministry of Health has approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor1. As in most European countries, cardiovascular diseases are the main cause of death in Greece2. Today’s approval – which marks the seventh national reimbursement of VAZKEPA® in Europe – provides eligible patients across Greece access to a new treatment option to reduce their cardiovascular risk and help improve their overall heart health. “We are very pleased with this seventh national reimbursement for VAZKEPA® supporting our continued growth opportunity in Europe which is a testament to the strength of our scientific data and the value of our product for patients at-risk for a cardiovascular event,” said Patrick Holt, President & CEO of Amarin. To support the commercialization of VAZKEPA® in Greece, Amarin has entered into an exclusive agreement with Vianex S.A., one of the leading pharmaceutical companies in Greece celebrating its 100-year anniversary this year. Under the terms of the agreement, Vianex S.A. will be the sole and exclusive distributor of VAZKEPA® in the territory to import, register, distribute and commercialize the product. Amarin will be responsible for supplying finished product to Vianex at a transfer price paid to Amarin. Vianex will start commercializing VAZKEPA® in the course of the next weeks. Christos Papadopoulos, Senior Vice President and Head of Commercial Europe at Amarin, commented: “We look forward to working with Vianex in bringing our VAZKEPA® treatment to healthcare providers and patients across Greece. As one of the country’s leading pharmaceutical companies, Vianex has strong commercial capabilities and deep expertise in cardiology and cardiovascular risk management. Their capabilities and experience align well with the opportunity to successfully commercialize VAZKEPA® and its proven ability to reduce cardiovascular risk and improve outcomes for patients.” About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.  About VIANEX S.A. VIANEX S.A.  is a Greek pharmaceutical company, founded in 1971 by the Giannakopoulos’ family that has been involved with the pharmaceutical industry since 1924.  Through its 100-year history, VIANEX produces, imports, markets, packages and distributes a large number of pharmaceuticals, covering various therapeutic classes. It has formed strategic partnerships and alliances with major pharmaceutical entities across the globe. VIANEX owns four state-of-the-art fully specialized Manufacturing Plants that guarantee outstanding production capabilities. It covers the entire spectrum of manufacturing activities while it continuously upgrades the range of services by investing in technological equipment. VIANEX has also been exporting registered products for over 20 years in 114 countries worldwide and is an approved supplier of the World Health Organization. Strategic planning, focus to quality, operational excellence and long-term experience have contributed to a leading position in the Greek Pharmaceutical market, based on a long-term effort, that passes from generation to generation and constantly focuses to the future. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and  potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (https://amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.   Amarin Contact Information Investor & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com 1 https://www.moh.gov.gr/articles/times-farmakwn/epitroph-aksiologhshs-kai-apozhmiwshs-farmakwn/12338-entaksh-farmakwn-ston-katalogo-apozhmioymenwn-farmakwn?fdl=270532 European Commission – Greece Country Health Profile 2023 – access May 2024

Nanox Announces First Quarter of 2024 Financial Results and Provides Business Update

Accelerates Deployment of Nanox.ARC in United States Signed two commercial agreements for Nanox.AI  Management to host conference call and webcast Tuesday, May 28, 2024 at 8:30 AM ET PETAH TIKVA, Israel, May 28, 2024 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the first quarter ended March 31, 2024 and provided a business update. First Quarter 2024 Highlights and Recent Developments: Generated $2.6 million in revenue in the first quarter of 2024, compared to $2.4 million in the first quarter of 2023.In the first quarter of 2024, we have continued to make strides in our U.S operational performance.Secured agreements for Nanox.AI with Dandelion Health and Covera Health.Hosted a live demonstration of the Nanox.ARC, scanning a patient at Dynamic Medical Imaging in New Jersey in early April, which showcased the clinical utility of the Nanox.ARC in real time.Entered into an agreement with US-based Swissray, a leading provider of radiology services, to further strengthen Nanox’s customer support infrastructure.Continued to generate clinical data supporting the use of Nanox.ARC for chest and other musculoskeletal indications. “The entire Nanox team performed at a high level in the first quarter of 2024, marking positive strides commercializing the full Nanox technology suite worldwide, while also strengthening our customer support network and building the clinical data to support the use of the Nanox.ARC for an expanded array of musculoskeletal indications,” said Erez Meltzer, Nanox Chief Executive Officer. “We have also strengthened the crucial Nanox.AI product suite, receiving a new FDA clearance for Health FLD in February, and securing agreements with leading healthcare AI data platforms Dandelion Health and Covera. Alongside our commercial efforts in the US, we are also advancing in other geographies. The entire Nanox team is focused on acceleration into the rest of 2024.” Financial results for three months ended March 31, 2024 For the three months ended March 31, 2024 (the “reported period”), the Company reported a net loss of $12.2 million, compared to a net loss of $11.8 million for the three months ended March 31, 2023 (which is referred as the “comparable period”), representing an increase of $0.4 million. The increase was largely due to onetime income that was recorded in the comparable period due to a decrease in the Company’s earn-out liabilities in the amount of $4.7 million and an increase in gross loss in the amount of $0.5 million, which was offset by a decrease of $1.1 million in the research and development expenses, a decrease of $0.4 million in the sales and marketing expenses, a decrease of $2.8 million in the general and administrative expenses and increase of $0.4 in the Company’s financial income. The Company reported revenue of $2.6 million in the reported period, compared to $2.4 million in the comparable period. During the reported period, the Company generated revenue through teleradiology services, the sales and deployment of its imaging systems and the sale of its AI solutions.  The Company’s gross loss during the reported period totaled $2.1 million (gross loss margin of (81%)) on a GAAP basis, as compared to $1.5 million (gross loss margin of (62%)) in the comparable period. Non-GAAP gross profit for the reported period was $0.6 million (gross profit margin of approximately 22%), as compared to $1.0 million (gross profit margin of approximately 43%) in the comparable period. The Company’s revenue from teleradiology services for the reported period was $2.4 million in the reported and comparable periods. The Company’s GAAP gross profit from teleradiology services for the reported period was $0.3 million (gross profit margin of approximately 14%), as compared to $0.5 million (gross profit margin of approximately 21%) in the comparable period. Non-GAAP gross profit of the Company’s teleradiology services for the reported period was $0.9 million (gross profit margin of approximately 37%) as compared to $1.1 million (gross profit margin of approximately 45%) in the comparable period. The decrease was attributable mainly to an increase in the cost of the engaged radiologists due to increases in reading rates. During the reported period the Company generated revenue through the sales and deployment of its imaging systems which amounted to $48 thousand for the reported period, with a gross loss of 0.4 million on a GAAP and non-GAAP basis. The revenue stems from the sale and deployment of our 2D systems in Africa and our ARC systems in the U.S. The Company’s revenue from its AI solutions for the reported period was $97 thousand with a gross loss of $2.0 million on a GAAP basis, as compared to revenue of $49 thousand with a gross loss of $2.0 million in the comparable period. Non-GAAP gross profit of the Company’s AI solutions for the reported period was $29 thousand, as compared to a loss of $20 thousand in the comparable period. During the reported period, Nanox AI continued to complete pilot programs with health organizations and other prospects in anticipation of full deployment of its products. Research and development expenses net for the reported period were $5.2 million, as compared to $6.3 million in the comparable period, reflecting a decrease of $1.1 million. The decrease was mainly due to a research grant of $0.9 million that was received as part of the NHSX project, decrease of $0.2 million in salaries and wages, decrease of $0.2 million in share-based compensation which was offset by an increase of $0.3 million in the expenses related to our research and development activities. Sales and marketing expenses for the reported period were $0.8 million, as compared to $1.2 million in the comparable period, reflecting a decrease of $0.4 million in the Company’s marketing expenses. General and administrative expenses for the reported period were $5.0 million, as compared to $7.8 million in the comparable period. The decrease of $2.8 million was mainly due to a decrease in our legal expenses in the amount of $2.2 million, largely as result of the finalization of the SEC investigation and the settlement of the class action and a decrease in the cost of the directors’ and officers’ liability insurance premium in the amount of $0.4 million. Non-GAAP net loss attributable to ordinary shares for the reported period was $8.1 million, as compared to $10.5 million in the comparable period. The decrease of $2.4 million was mainly due to a decrease in non-GAAP operating expenses of $2.4 million and an increase of $0.4 million in our non-GAAP interest income which was mitigated by a decrease of $0.6 million in our non-GAAP cost of goods sold. Non-GAAP gross profit for the reported period was $0.6 million, as compared to $1.0 million in the comparable period. Non-GAAP research and development expenses, net for the reported period, were $4.6 million, as compared to $5.5 million in the comparable period. Non-GAAP sales and marketing expenses for the reported period were $0.6 million, as compared to $1.0 million in the comparable period. Non-GAAP general and administrative expenses for the reported period were $4.3 million as compared to $5.4 million in the comparable period. The difference between the GAAP and non-GAAP financial measures above is mainly attributable to amortization of intangible assets, share-based compensation, change in contingent earnout liability and legal fees in connection with the class-action litigation and the SEC investigation. A reconciliation between GAAP and non-GAAP financial measures for the three months periods ended March 31, 2024, and 2023 is provided in the financial results that are part of this press release. Liquidity and Capital Resources As of March 31, 2024, the Company had total cash, cash equivalents, restricted deposits and marketable securities of $73.3 million, compared to $82.8 million as of December 31, 2023. The decrease of $9.5 million during the reported period was primarily due to negative cash flow from operations of $9.4 million. Other Assets As of March 31, 2024 and December 31, 2023, the Company had property and equipment of $42.3 million. As of March 31, 2024, the Company had intangible assets of $78.0 million as compared to $80.6 million as of December 31, 2023. The decrease was attributable to the periodic amortization of intangible assets in the amount of $2.6 million.  Shareholders’ Equity As of March 31, 2024, and December 31, 2023, the Company had approximately 57.8 million shares outstanding. Conference Call and Webcast Details Tuesday, May 28, 2024 @ 8:30am ET Individuals interested in listening to the conference call may do so by joining the live webcast on the Investors section of the Nanox website under Events and Presentations. Alternatively, individuals can register online to receive a dial-in number and personalized PIN to participate in the call. An archived webcast of the event will be available for replay following the event. About Nanox: Nanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. Nanox’s vision is to increase access, reduce costs and enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment, which Nanox believes is key to helping people achieve better health outcomes, and, ultimately, to save lives. The Nanox ecosystem includes Nanox.ARC— a multi-source Digital Tomosynthesis system that is cost-effective and user-friendly; an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic disease (Nanox.AI); a cloud-based infrastructure (Nanox.CLOUD); and a proprietary decentralized marketplace, through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts; and a comprehensive teleradiology services platform (Nanox.MARKETPLACE). Together, Nanox’s products and services create a worldwide, innovative, and comprehensive solution that connects medical imaging solutions, from scan to diagnosis. For more information, please visit www.nanox.vision. Forward-Looking Statements: This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, those relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to continue to develop of the Nanox imaging system; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox imaging system and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; and (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces, including the continuation and escalation of the military conflicts in Israel and current war between Israel and Hamas; (x) the costs incurred with respect to and the outcome of litigation Nanox is currently subject to and any similar or other claims and potential litigation it may be subject to in the future; and (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses and non-GAAP basic and diluted loss per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, change in contingent earnout liability and legal fees in connection with class-action litigation and the SEC investigation. The Company’s management and board of directors utilize these non-GAAP financial measures to evaluate the Company’s performance. The Company provides these non-GAAP measures of the Company’s performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company’s results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, these non-GAAP measures should not be considered measures of the Company’s liquidity. A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release.          NANO-X IMAGING LTD.UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands except share and per share data)         March 31,2024  December 31, 2023   U.S. Dollars in thousands Assets      CURRENT ASSETS:      Cash and cash equivalents  44,921   56,377 Restricted deposit  46   46 Marketable securities  28,043   26,006 Accounts receivables net of allowance for credit losses of $55 as of March 31, 2024 and December 31, 2023, respectively.  1,442   1,484 Inventories  2,952   2,356 Prepaid expenses  1,004   1,274 Other current assets  625   1,092 TOTAL CURRENT ASSETS  79,033   88,635          NON-CURRENT ASSETS:        Restricted deposit  323   327 Property and equipment, net  42,328   42,343 Operating lease right-of-use asset  4,370   4,573 Intangible assets  77,954   80,607 Other non-current assets  1,869   2,163 TOTAL NON-CURRENT ASSETS  126,844   130,013 TOTAL ASSETS  205,877   218,648          Liabilities and Shareholders’ Equity        CURRENT LIABILITIES:        Current maturities of long term loan  3,341   3,490 Accounts payable  1,860   3,303 Accrued expenses  3,267   3,920 Deferred revenue  496   543 Current maturities of operating lease liabilities  883   861 Other current liabilities  3,762   3,407 TOTAL CURRENT LIABILITIES  13,609   15,524          NON-CURRENT LIABILITIES:        Non-current operating lease liabilities  3,819   4,045 Deferred tax liability  2,859   2,953 Other long-term liabilities  629   612 TOTAL NON-CURRENT LIABILITIES  7,307   7,610 TOTAL LIABILITIES  20,916   23,134          COMMITMENTS AND CONTINGENCIES                 SHAREHOLDERS’ EQUITY:        Ordinary Shares, par value NIS 0.01 per share 100,000,000 authorized at March 31, 2024 and December 31 2023, 57,779,033 and 57,778,628 issued and outstanding at March 31, 2024 and December 31, 2023, respectively  165   165 Additional paid-in capital  517,388   515,887 Accumulated other comprehensive loss  (118)  (305)Accumulated deficit  (332,474)  (320,233)TOTAL SHAREHOLDERS’ EQUITY  184,961   195,514 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY  205,877   218,648      NANO-X IMAGING LTD.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ANDCOMPREHENSIVE LOSS(U.S. dollars in thousands except share and per share data)      Three Months EndedMarch 31,   2024  2023 REVENUE  2,553   2,447          COST OF REVENUE  4,607   3,970          GROSS LOSS  (2,054)  (1,523)         OPERATING EXPENSES:        Research and development, net  5,220   6,286 Sales and marketing  800   1,153 General and administrative  5,042   7,808 Change in contingent earnout liability  –   (4,660)Other expense (income), net  9   (32)TOTAL OPERATING EXPENSES  11,071   10,555 OPERATING LOSS  (13,125)  (12,078)         REALIZED LOSS FROM SALE OF MARKETABLE SECURITIES  –   (178)FINANCIAL INCOME, net  790   401 OPERATING LOSS BEFORE INCOME TAXES  (12,335)  (11,855)         INCOME TAX BENEFIT  94   94 NET LOSS  (12,241)  (11,761)         BASIC AND DILUTED LOSS PER SHARE  (0.21)  (0.21)Weighted average number of basic and diluted ordinary shares outstanding (in thousands)  57,901   55,157 Comprehensive Loss:        Net loss  (12,241)  (11,761)Other comprehensive gain (loss):                 Reclassification of net losses realized in income statement  –   178 Unrealized gain from available for-sale securities  187   414 Total comprehensive loss  (12,054)  (11,169)                   NANO-X IMAGING LTD.UNAUDITED CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY(U.S. dollars in thousands, except share and per share data)                  Ordinary shares  Additional  Accumulatedother         Number ofshares  Amount  paid-incapital  comprehensiveloss  Accumulateddeficit  Total BALANCE AT JANUARY 1, 2024  57,778,628   165   515,887   (305)  (320,233)  195,514 Changes during the period:                        Issuance of ordinary shares upon exercise of options  405   *   24   –   –   24 Share-based compensation  –   –   1,477   –   –   1,477 Unrealized gain from marketable securities  –   –   –   187       187 Net loss for the period  –   –   –   –   (12,241)  (12,241)BALANCE AT MARCH 31, 2024  57,779,033   165   517,388   (118)  (332,474)  184,961  * Less than $1.   Ordinary shares  Additional  Accumulatedother         Number ofshares  Amount  paid-incapital  comprehensivedeficit  Accumulateddeficit  Total   U.S. Dollars in thousands BALANCE AT JANUARY 1, 2023  55,094,237   158   477,953   (1,974)  (259,457)  216,680 Changes during the period:                        Issuance of ordinary shares upon exercise of options  56,108   –   176   –   –   176 Unrealized gain from marketable securities, net  –   –   –   592       592 Share-based compensation  –   –   1,043   –   –   1,043 Net loss for the period  –   –   –   –   (11,761)  (11,761)BALANCE AT MARCH 31, 2023  55,150,345   158   479,172   (1,382)  (271,218)  206,730  * Less than $1.     NANO-X IMAGING LTD. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(U.S. dollars in thousands)      Three Months EndedMarch 31,   2024  2023        CASH FLOWS FROM OPERATING ACTIVITIES:      Net loss for the period  (12,241)  (11,761)Adjustments required to reconcile net loss to net cash used in operating activities:        Share-based compensation  1,477   1,043 Amortization of intangible assets  2,653   2,653 Exchange rate differentials  (174)  (19)Change in contingent earnout liability  –   (4,660)Depreciation  286   255 Deferred tax liability, net  (94)  (94)Realized loss from sale of marketable securities  –   178 Amortization of premium, discount and accrued interest on marketable securities  73   324 Impairment of property and equipment  25   145 Changes in Operating Assets and Liabilities:        Inventories  (676)  – Accounts receivable  42   (331)Prepaid expenses and other current assets  737   1,404 Other non-current assets  219   142 Accounts payable  (1,443)  706 Operating lease assets and liabilities  (1)  (7)Accrued expenses and other liabilities  (298)  (559)Deferred Revenue  (47)  (107)Other long-term liabilities  17   14 Net cash used in operating activities  (9,445)  (10,674)         CASH FLOWS FROM INVESTING ACTIVITIES:        Purchase of property and equipment  (141)  (1,495)Proceeds from maturity of marketable securities  12,874   10,289 Purchase of marketable securities  (14,797)  – Proceeds from sale of marketable securities  –   822 Net cash provided by (used in) investing activities  (2,064)  9,616          CASH FLOWS FROM FINANCING ACTIVITIES:        Proceeds from Issuance of ordinary shares upon exercise of options  24   176 Net cash provided by financing activities  24   176 EFFECT OF CHANGES IN EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS  29   (11)NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS  (11,456)  (893)CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS AT BEGINNING OF THE PERIOD  56,377   38,529 CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS AT END OF THE PERIOD  44,921   37,636          SUPPLEMENTARY INFORMATION ON ACTIVITIES INVOLVING CASH FLOWS                 Cash paid for interest  37   40          Cash paid for income taxes  –   –          SUPPLEMENTARY INFORMATION ON ACTIVITIES NOT INVOLVING CASH FLOWS –                 Operating lease liabilities arising from obtaining operating right-of use assets  –   572  UNAUDITED RECONCILIATION OF GAAP AND NON-GAAP RESULTS(U.S. dollars in thousands (except per share data)) Use of non-GAAP Financial Measures The unaudited condensed consolidated financial information is prepared in conformity with GAAP. The Company uses information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses and non-GAAP basic and diluted loss per share. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, change in contingent earnout liability and legal fees in connection with the class-action litigation and the SEC investigation. The Company believes that separate analysis and exclusion of the one-off or non-cash impact of the above reconciling items (as applicable) adds clarity to the constituent parts of its performance. The Company reviews these non-GAAP financial measures together with GAAP financial measures to obtain a better understanding of its operating performance. It uses the non-GAAP financial measures for planning, forecasting, and measuring results against the forecast. The Company believes that the non-GAAP financial measures are useful supplemental information for investors and analysts to assess its operating performance. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Reconciliation of GAAP net loss attributable to ordinary shares to Non-GAAP net loss attributable to ordinary shares and Non-GAAP basic and diluted loss per share (U.S. dollars in thousands)   Three Months Ended   March 31,   2024  2023        GAAP net loss attributable to ordinary shares  12,241   11,761 Non-GAAP adjustments:        Less: Class-action litigation and SEC investigation  32   2,236 Less: Amortization of intangible assets  2,653   2,653 Less (Add): Change in contingent earnout liability  –   (4,660)Less: Share-based compensation  1,477   1,043 Non-GAAP net loss attributable to ordinary shares  8,079   10,489 Non-GAAP BASIC AND DILUTED LOSS PER SHARE  0.14   0.19 WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES (in thousands)  57,901   55,157  Reconciliation of GAAP cost of revenue to Non-GAAP cost of revenue (U.S. dollars in thousands) GAAP cost of revenue  4,607   3,970 Non-GAAP adjustments:        Amortization of intangible assets  2,556   2,556 Share-based compensation  53   14 Non-GAAP cost of revenue  1,998   1,400  Reconciliation of GAAP gross loss to Non-GAAP gross profit (U.S. dollars in thousands) GAAP gross loss  (2,054)  (1,523)Non-GAAP adjustments:        Amortization of intangible assets  2,556   2,556 Share-based compensation  53   14 Non-GAAP gross profit  555   1,047  Reconciliation of GAAP gross loss margin to Non-GAAP gross profit margin (in percentage of revenue) GAAP gross loss margin  (80)%  (62)%Non-GAAP adjustments:        Amortization of intangible assets  100%  104%Share-based compensation  2%  1%Non-GAAP gross profit margin  22%  43% Reconciliation of GAAP research and development expenses to Non-GAAP research and development expenses (U.S. dollars in thousands) GAAP research and development expenses, net  5,220   6,286 Non-GAAP adjustments:        Share-based compensation  589   788 Non-GAAP research and development expenses, net  4,631   5,498  Reconciliation of GAAP sales and marketing expenses to Non-GAAP sales and marketing expenses (U.S. dollars in thousands) GAAP sales and marketing expenses  800   1,153 Non-GAAP adjustments:        Amortization of intangible assets  97   97 Share-based compensation  146   78 Non-GAAP sales and marketing expenses  557   978  Reconciliation of GAAP general and administrative expenses to Non-GAAP general and administrative expenses (U.S. dollars in thousands) GAAP general and administrative expenses  5,042   7,808 Non-GAAP adjustments:        Class-action litigation and SEC investigation  32   2,236 Share-based compensation  689   163 Non-GAAP general and administrative expenses  4,321   5,409  Contacts Media Contact:Ben ShannonICR WestwickeNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Westwickemike.cavanaugh@westwicke.com

MediciNova Announces Two Poster Presentations at the 92nd EAS Congress 2024, the Annual Meeting of the European Atherosclerosis Society Regarding the Use of MN-001 (Tipelukast) for Cardiometabolic Conditions

LA JOLLA, Calif., May 28, 2024 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova conducted two poster presentations at the 92nd European Atherosclerosis Society (EAS) 2024 Congress held online May 26-29, 2024. MediciNova’s Chief Medical Officer, Kazuko Matsuda, MD PhD MPH presented an update on the Company’s “STUDY PROTOCOL TO EVALUATE MN-001’S (TIPELUKAST) EFFICACY, SAFETY AND TOLERABILITY IN SUBJECTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD) (Abstract # 810) “, which included Clinical background, Study objectives, Study design, Inclusion Criteria and Study status of Phase 2 clinical trial ongoing in the US. As of 25 April 2024, 33 patients were enrolled, 19 patients were randomized, 14 patients completed the study. Three subjects reported serious adverse events (SAE) and were all considered “Unlikely related” or “Unrelated“ to study drug. MediciNova’s Dr. Huicheng Qi presented “MN-002, THE METABOLITE OF MN-001 (TIPELUKAST) PROMOTES MACROPHAGE CHOLESTEROL EFFLUX (Abstract # 856)”, demonstrating positive data regarding cholesterol efflux capacity by MN-001 (Tipelukast) and MN-002. This is a collaborative effort between MediciNova and Professor Masatsune Ogura at Department of Clinical Laboratory Technology, Juntendo University and Professor Takashi Miida at Department of Clinical Laboratory Medicine, Juntendo University. Objectives of this study are to evaluate the effects of MN-001 and its major active metabolite MN-002 on cholesterol efflux capacity in THP-1 *1macrophages. ABCA1 *2 and ABCG1 *3 is known to play important roles in the reverse cholesterol transport system. Macrophages derived from THP-1 *3 cells were used to analyze the effect of MN-001 and MN-002 on ABCA1 and ABCG1 mRNA expression was measured by RT-PCR and protein expression was measured by Western blotting. Next, the effects of MN-002 on Apolipoprotein AI (ApoA1) *4 dependent and High-Density Lipoprotein (HDL) dependent cholesterol efflux in THP-1 macrophages were determined, respectively. Finally, analyzed the involvement of Protein Kinase A (PKA) in the mechanism of action of MN-002 using a PKA inhibitor. The data presented in the abstract demonstrated the following: MN-002 enhances ApoA1 and HDL mediated cholesterol efflux. MN-002 increased 44.3% in ApoA1-mediated cholesterol efflux capacity compared to the control group (DMSO).MN-002 increased 15.3% in HDL-mediated cholesterol efflux capacity compared to the control group (DMSO). MN-002 increases ABCA1 and ABCG1 protein levels in dose-dependent manner MN-002 increased ABCA1 protein expression in a dose-dependent manner compared to the control group (DMSO); ABCA1 protein increased approximately 2-fold with 10 µM of MN-002. MN-002 increased ABCG1 protein expression in a dose-dependent manner compared to the control group (DMSO); ABCG1 protein increased approximately 2.8-fold with 10 µM of MN-002. MN-002 increases ABCA1/ ABCG1/ LXR-alpha mRNA levels.  MN-002 increased ABCA1 mRNA expression in a time and dose-dependent manner compared to the control group (DMSO). mRNA expression of ABCA1 increased about 3-fold with 24 hours exposure of 10 µM MN-002.MN-002 increased ABCG1 mRNA expression in a time and dose-dependent manner compared to the control group (DMSO). mRNA expression of ABCA1 by increased 5.4-fold with 24 hours exposure of 10 µM MN-002MN-002 increased LXR-alpha mRNA expression in a time- and dose-dependent manner compared to the control group (DMSO). mRNA expression of ABCA1 increased 2.4-fold with 24 hours exposure of 10 µM MN-002. MN-002 increases ABCA1 protein level independent of PKA signaling pathway. MN-002 increased ABCA1 protein expression compared to the control group (DMSO); conditions in which a PKA inhibitor did not cancel the effect of MN-002 to increase ABCA1 protein expression. Kazuko Matsuda, M.D., Ph.D., M.P.H., Chief Medical Officer, MediciNova, Inc., commented, “We are very pleased to present our clinical trial status and positive research outcomes at the EAS Congress 2024. We have randomized almost half of the randomization goal with our ongoing Phase 2 clinical trial. With the collaborative research with Juntendo University regarding the mechanism of action of MN-001/MN-002 in lipid metabolism, we identified that MN-002, the major metabolite of MN-001 (Tipelukast), had significant positive effects on both ABCA1, ABCG1 expression.” *1 About THP-1 THP-1 is a human leukemia monocytic cell line, which has been extensively used to study monocyte/macrophage functions, mechanisms, signaling pathways, and nutrient and drug transport. *2 About ABCA1: ATP-binding cassette transporter ABCA1 (member 1 of human transporter sub-family ABCA), also known as the cholesterol efflux regulatory protein (CERP) is a protein which in humans is encoded by the ABCA1 gene. This transporter is a major regulator of cellular cholesterol and phospholipid homeostasis. ABCA1 is an integral cell membrane protein that protects against cardiovascular disease. *3 About ABCG1 The primary function of ATP-binding cassette transporter G1 (ABCG1) is to efflux cholesterol to spherical high-density lipoproteins (HDL). ABCG1 also effluxes cholesterol to low-density lipoproteins (LDL), liposomes and cyclodextrin and it exports sphingomyelin, phosphatidylcholine and oxysterols to HDL and albumin. *4 About Apolipoprotein AI (ApoA1) Apolipoprotein A-I (Apo A-I) is a major protein that has specific roles in the lipid metabolism. It promotes cholesterol efflux by accepting fats from cells to the liver for excretion. About NAFLD, Type 2 Diabetes Mellitus (T2DM), and Hypertriglyceridemia NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD. There is sufficient clinical and epidemiological evidence supporting the assertion that NAFLD is strongly associated with an increased prevalence and incidence of cardiovascular disease, T2DM, chronic kidney disease, and malignancy. The presence of dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both) is reported in 20 – 80% of NAFLD cases. About MN-001 MN-001 (tipelukast) is a novel, orally bioavailable, small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development, and MN-001’s inhibitory effect on 5-LO and the 5-LO/LT pathway is a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, MN-001 was found to inhibit triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake. About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN 001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT:David H. Crean, Ph.D.Chief Business OfficerMediciNova, Incinfo@medicinova.com

Terumo Cardiovascular Announces 510(K) Clearance for the CDI OneView™ Monitoring System

All-new modular, expandable design displays up to 22 vital patient parameters with real-time convenienceANN ARBOR, Mich., May 28, 2024 /PRNewswire/ — Terumo Cardiovascular, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI OneView Monitoring System. The next-generation CDI Systems platform provides visibility of key patient parameters during cardiopulmonary bypass surgery, critical to perfusion safety and improving patient outcomes.

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Built on decades of proven technology, Terumo’s new CDI OneView System delivers exceptional performance and convenience for real-time decision making in the cardiovascular operating room. The CDI OneView System measures or displays up to 22 vital patient parameters — including oxygen delivery, cardiac index, area under the indexed oxygen delivery curve, oxygen extraction ratio and measured flow.

The new CDI OneView System measures or displays up to 22 key parameters, the newest of which are measured flow (Q), cardiac index (CI), regional cerebral oxygen saturation (rSO2), oxygen extraction ratio (O2ER), Area Under the DO2 Curve (AUC), and measured arterial oxygen saturation (SaO2).  

This innovative system offers maximum configurability and flexibility in how the parameters can be viewed and prioritized to best suit clinical needs and preferences, while continuing to provide the critical information on which clinicians have come to rely.
“The world’s leading cardiac centers have trusted CDI Systems for over 30 years. With the launch of the new CDI OneView System, Terumo Cardiovascular continues to bring value and enhanced patient care to healthcare providers and critically ill cardiac patients,” said Robert DeRyke, President and CEO of Terumo Cardiovascular.  “The CDI OneView System technology is the latest extension of Terumo’s commitment to delivering data-focused solutions to the perfusion community.”  New features and functions of Terumo’s latest patient parameter monitoring system were influenced by extensive perfusionist input from leading global cardiovascular institutions. In response to the growing needs of healthcare providers, the new CDI OneView System now provides real-time O2ER, CI, VO2 and DO2 information to help perfusionists maintain a safe threshold for those parameters. Independently published and reviewed clinical research indicates that maintaining optimal levels during cardiopulmonary bypass can help to reduce the incidence of acute kidney injury.1, 2About Terumo Cardiovascular Terumo Cardiovascular manufactures and markets medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass and intra-operative monitoring. The company is headquartered in Ann Arbor, Michigan, with manufacturing operations in the U.S., Asia, and Latin America. It is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiovascular surgery specialties. For more information, visit www.terumocv.comAbout Terumo Corporation Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.Refer to this device’s Instructions For Use (IFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.9065361.  Oshita, T et al. A Better Predictor of Acute Kidney Injury After Cardiac Surgery: The Largest Area Under the Curve Below the Oxygen Delivery Threshold During Cardiopulmonary Bypass. J Am Heart Assoc. 2020;9: e015566. DOI: 10.1161/JAHA.119.015566.2.  Condello, I, etal. Association between oxygen delivery and cardiac index with hyperlactatemia during cardiopulmonary bypass. JTCVS Techniques. 2020; Vol 2: 92-99.SOURCE Terumo Cardiovascular