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Remedy Pharmaceuticals Gets Rights To Acute Stroke Drug Back From Biogen; Announces Clinically Meaningful and Statistically Significant Results From Pre-specified Subgroup and Post Hoc Analyses of Phase 3 Study

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NEW YORK, May 29, 2024 /PRNewswire/ — Remedy Pharmaceuticals, a pioneer in stroke drug development, announced that prespecified subgroup analyses from the Phase 3 CHARM clinical trial of CIRARA (IV glibenclamide) showed meaningful improvements in functional outcomes on the modified Rankin Scale (mRS), which were further validated in post hoc analyses.
The findings follow the early termination of the pivotal Phase 3 trial by Cambridge-based Biogen after a strategic realignment of resources, and the return of the program to Remedy.
The CHARM clinical trial was a multicenter, multinational, double-blind, randomized, placebo-controlled Phase 3 study involving patients aged 18-85 with a large hemispheric infarction (LHI), as indicated by an Alberta Stroke Program Early Computed Tomographic (CT) Score (ASPECTS) value of 1-5 (on a scale of 0-10) or an ischemic core volume of 80-300 ml by CT perfusion (CTP) or magnetic resonance imaging (MRI) diffusion weighted imaging. Patients were eligible if study drug was expected to start within 10 hours after they were last known well and were randomly assigned in a 1:1 ratio of CIRARA or placebo. A total of 535 patients were enrolled, including 431 patients aged 18-70 (the efficacy analysis population) and 81 patients aged 71-85.
Despite neutral top-line results, in pre-specified analyses, patients who received rtPA, underwent endovascular thrombectomy (EVT), were enrolled using CTP/MRI, had wake-up strokes, or were enrolled in the U.S., all had directionally improved functional outcomes in favor of CIRARA. A pre-specified analysis in patients with an NIH Stroke Scale (NIHSS) ≤20 (n=274) yielded statistically significant improvements in functional outcomes (Odds Ratio 1.66, p=0.03). With EVT therapy increasingly used in LHI, the Odds Ratio of 1.75 in the EVT subset, while not statistically significant, was particularly encouraging.
Building on these findings, post hoc analyses examining the impact of stroke severity on outcomes were performed and revealed significant findings:

In the mITT population with CTP/MRI lesion volume

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Beckman Coulter Secures FDA Clearance for Heart Failure Assay on DxI 9000 Immunoassay Analyzer

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New Access NT-proBNP Assay Detects Heart Failure Biomarker in Less than 11 Minutes Patient Results Evaluated Within Context of Clinically RelevantAge-Based Cutoffs, Disease Comorbidity Data and Gender ParametersBREA, Calif., May 29, 2024 /PRNewswire/ — Beckman Coulter, a global leader in clinical diagnostics, today announced U.S. Food and Drug Administration clearance of its Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay for the assessment of heart failure in less than 11 minutes on the Beckman Coulter DxI 9000 Immunoassay Analyzer*. The Access NT-proBNP assay aids in diagnosing patients suspected of having acute heart failure in emergency departments as well as assessing the severity and risk stratification of patients with heart failure and acute coronary syndrome.

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The award-winning DxI 9000 Immunoassay Analyzer sets a new standard for today’s busy labs addressing today’s speed, reliability, reproducibility, quality, and menu expansion demands.

According to the Heart Failure Society of America, nearly 6.5 million Americans over the age of 20 have heart failure, accounting for approximately 8.5% of all heart disease deaths in the United States. Beckman Coulter’s Access NT-proBNP assay measures concentrations of N-terminal pro B-type natriuretic peptide in serum or plasma that originates in a person’s heart. High levels of natriuretic peptides can indicate heart failure.  

As recommended in the latest heart failure guidelines from the American College of Cardiology and the American Heart Association, the Access NT-proBNP assay provides age-based cutoffs for diagnosis of heart failure to ensure results are evaluated in the appropriate clinical context for each patient. In addition to age, other patient factors such as gender, obesity and kidney failure can affect natriuretic peptide levels. The Access NT-proBNP assay provides clinical performance information for these subsets of patients to assist clinicians’ sample data interpretation and diagnoses.
“We continue to be excited by the quality, sensitivity and specificity of the assays being developed for DxI 9000 Analyzer,” Kathleen Orland, Senior Vice President, General Manager, Chemistry, and Immunoassay for Beckman Coulter.  “FDA clearance of the Access NT-proBNP assay is just the latest confirmation of the platform’s capability to develop ever increasingly more sensitive and clinically relevant diagnostics. The combination of DxI 9000 Analyzer’s expanding menu of assays and its operational excellence, highlighted by ZeroDaily Maintenance, PrecisionVision Technology, and IntelliServe is driving laboratory demand around the globe.”  About Beckman Coulter. Inc. A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what’s now to what’s next. We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Headquartered in Brea, Calif., with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher.  Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow’s science and technology to improve human health.Follow and connect with Beckman Coulter Diagnostics via LinkedIn, X, and Facebook.*Full name DxI 9000 Access Immunoassay Analyzer© 2024 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. 2024-12984.SOURCE Beckman Coulter Diagnostics

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Penn Presbyterian Medical Center Becomes First Hospital in the Northeast to Adopt Advanced Robotic Technology for Heart Treatment

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ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the first in the Northeast United States to offer the Genesis System. Genesis is the latest advancement in Robotic Magnetic Navigation technology. Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias. Tens of millions of individuals worldwide suffer from arrhythmias – abnormal heart rhythms that result when the heart beats too quickly, too slowly, or with an irregular pattern. When left untreated, arrhythmias may significantly increase the risk of stroke, heart failure, and sudden cardiac arrest. “Our adoption of advanced robotic technology significant enhances our ability to precisely diagnose and treat patients suffering from complex cardiac arrhythmias,” said Dr. Benjamin D’Souza, Cardiac Electrophysiologist at Penn Presbyterian Medical Center. “We are committed to leveraging cutting-edge innovations to provide patients with the best care. Our team has leveraged the precision and safety of robotics to treat patients that often have few other options for care. With unmatched accuracy, we can tailor treatments to each patient’s unique anatomy, enhancing safety and efficacy.” “We are excited to partner with Penn Presbyterian to pioneer the Genesis Robotic System in the Northeast,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to supporting Penn Presbyterian in growing a highly successful and impactful robotic heart care program that advances patient care, clinical research and technology advancement.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com

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

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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

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

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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, […]

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

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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 […]

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Ceretrieve Announces Groundbreaking Success in FIH Ischemic Stroke Cases

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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

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Semler Scientific® Announces Bitcoin Treasury Strategy

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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.

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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  

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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

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

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— 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

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