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Brainomix Showcases Growing Evidence for its Novel AI-Based Imaging Biomarkers in Lung Fibrosis

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The company unveiled a series of new studies highlighting the prognostic value of its imaging biomarkers in patients with fibrotic lung disease
The studies reflect the company’s expanding Life Science partnerships and academic collaborations with luminary research centers in the lung space

OXFORD, England and CHICAGO, May 22, 2024 /PRNewswire/ — Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, announced a series of new studies that were presented this week at the American Thoracic Society (ATS) Conference in San Diego.
“The studies presented this week at ATS are a reflection of our continual focus on scientific excellence and academic collaboration with both world-class institutions as well as with Life Science partners,” noted Dr Michalis Papadakis, CEO and Co-Founder of Brainomix. “The results highlight the prognostic value of our novel Brainomix lung imaging biomarkers to accurately predict disease progression in Idiopathic Pulmonary Fibrosis (IPF) and non-IPF patients.”
Key abstracts accepted and presented at ATS included:

“Diagnosis and the role of imaging biomarkers in predicting outcomes for patients with Non-IPF Fibrotic ILD,” was a research collaboration with Heidelberg University in which a cohort of 347 patients with non-IPF over a 10-year period was analyzed with Brainomix’s novel lung imaging biomarker, the weighted reticulovascular score (WRVS). The results indicated WRVS was a strong predictor for death and independent risk factor for 10% Forced Vital Capacity (FVC) decline. “This study has demonstrated the prognostic value of the Brainomix WRVS imaging biomarker, which can be a valuable predictor of progressive disease in this cohort of patients with fibrotic non-IPF ILD,” noted Prof Dr Michael Kreuter, Director for the Lung Center Mainz.
“Differences in lung biomarker scores between treatment groups in post-hoc analysis of the ATLAS inhaled pirfenidone solution (AP01) for IPF clinical trials” was a research collaboration with Avalyn Pharma, a Seattle-based clinical-stage biopharmaceutical company. Brainomix lung imaging biomarkers (including WRVS) were studied in a post-hoc analysis of Avalyn’s phase 1b clinical trial of inhaled pirfenidone (ATLAS study) in patients with IPF, with results showing that WRVS was associated with risk of future IPF progression in the low-dose pirfenidone group. “This research can assist in the optimisation of AI imaging tools to enrich clinical trials for progressive patients, to facilitate matching treatment arms and further explore novel trial end points,” Dr Peter George, Senior Medical Director at Brainomix and Clinical Lead for ILD at Royal Brompton Hospital in London.
“Lung CT biomarkers can stratify patients at risk of Idiopathic Pulmonary Fibrosis progression at 52 weeks: post-hoc analysis from a randomised control trial” was a research collaboration with AstraZeneca using the Phase 2 IPF tralokinumab clinical trial. WRVS was shown to accurately predict patients at baseline at risk of 52-week FVC decline. “These data suggests that our WRVS biomarker may enable more sophisticated design of future clinical trials,” said Ross Stewart, Senior Business Development Manager, Pharma Partnerships, at Brainomix.

About Brainomix
Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company with offices in the UK, Ireland and the USA, and operations in more than 30 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients.
To learn more about Brainomix and its technology visit www.brainomix.com, and follow us on Twitter, LinkedIn and Facebook.
Contacts
Jeff Wyrtzen, Chief Marketing & Business Development Officer[email protected]M +44 (0)7927 164210T +44 (0)1865 582730
Media enquiries
Charles ConsultantsSue Charles[email protected]M +44 (0)7968 726585
Logo – https://mma.prnewswire.com/media/1989193/Brainomix_Logo.jpg
SOURCE Brainomix

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Orchestra BioMed to Participate in Jefferies Global Healthcare Conference

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NEW HOPE, Pa., May 22, 2024 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that company management will present and be available for one-on-one meetings at the Jefferies Global Healthcare Conference being held in New York, NY, June 4-6, 2024. Details of the presentation are below. Format: Fireside Chat Date: Wednesday, June 5, 2024 Time: 4:00 PM ET (Track 1) Webcast: https://wsw.com/webcast/jeff302/obio/1835536 A replay of the webcast will be available on the Events section of the Orchestra BioMed website for 90 days following the presentation. About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Bob YedidLifeSci Advisors516-428-8577Bob@lifesciadvisors.com   Media Contact:Kelsey Kirk-EllisOrchestra BioMed484-682-4892Kkirkellis@orchestrabiomed.com

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First Heart Rhythm Patients in Southern Italy Treated with Advanced Robotic Technology

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ST. LOUIS, May 22, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that Hospital Santa Maria della Pietà, in Nola in the Metropolitan City of Naples, has established the first robotic cardiac heart program in Southern Italy. Patients suffering from heart rhythm disorders are now being successfully treated with robotic ablation procedures using this advanced technology, and Hospital Santa Maria della Pietà is the first hospital in Italy to adopt the cutting-edge Genesis Robotic Magnetic Navigation (RMN) system. “As electrophysiologists, our primary goal is to improve the lives of our patients,” said Dr. Mario Volpicelli, Head of the Electrophysiology Unit of the hospital. “With the Genesis RMN system, we now have an unprecedented level of precision and control during cardiac ablation procedures, allowing us to target arrhythmias with unmatched accuracy while minimizing risk to our patients.” 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. “The adoption of the Genesis Robotic Magnetic Navigation system marks a significant milestone in our commitment to providing the highest standard of care to our patients.” added Giuseppe Russo, General Manager of the Hospital Santa Maria della Pietà. “We are proud to lead the way in Italy, revolutionizing cardiac treatment through innovative robotic technology.” added Luigi Caliendo, Chief of the Cardiology Department of the Hospital. “We are honored to partner with Hospital Santa Maria della Pietà in bringing the benefits of robotics to patients in Italy,” said David Fischel, Stereotaxis Chairman and CEO. “The adoption of the Genesis system reflects our shared commitment to advancing standard of care, innovation, and patient-focused solutions in electrophysiology.” 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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CVRx to Present at the William Blair 44th Annual Growth Stock Conference

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MINNEAPOLIS, May 22, 2024 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, today announced that the management team will present at the William Blair 44th Annual Growth Stock Conference on Wednesday, June 5, 2024. The Company is scheduled to present at 8:40am Central Time the same day via webcast. A live audio webcast of the conference presentation will be available online at the investor relations page of the Company’s website at ir.cvrx.com. About CVRx, Inc. CVRx is focused on the development and commercialization of the Barostim™ System, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact: Mark Klausner or Mike VallieICR Westwicke443-213-0501ir@cvrx.com Media Contact: Laura O’NeillFinn Partners402-499-8203laura.oneill@finnpartners.com

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Milestone Pharmaceuticals Partners with Arrhythmia Alliance on SVT Awareness

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MONTREAL and CHARLOTTE, N.C., May 22, 2024 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced it will partner with Arrhythmia Alliance to raise awareness of supraventricular tachycardia (SVT).  SVT Awareness Day will be held on Wednesday June 5, 2024, during World Heart Rhythm Week (June 4-10), to raise awareness of SVT, a type of arrhythmia or rapid heart rhythm that leaves people with palpitations (“racing heart rate”), breathlessness, and anxiety. SVT can cause the heart to beat much faster than normal, up to as high as 250 beats per minute (a normal heart rate for the average adult is 60 to 100 beats per minute). “We are honored to partner with the Arrhythmia Alliance on educational initiatives for SVT Awareness Day. These efforts align perfectly with our mission to develop and commercialize innovative cardiovascular solutions that can improve the lives of people living with complex and life-altering heart conditions,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We are immensely thankful for the work of the Arrhythmia Alliance in filling the gap in SVT education in support of patients.” To address some of the challenges facing people who are affected by SVT, Arrhythmia Alliance and its partners have developed certain resources for patients with SVT; these resources include virtual coffee mornings for people living with SVT, Live X Chat, and Facebook Live, all aimed at raising awareness of the condition and helping people seek medical advice and treatments. Additionally, there will be a release of educational videos from patients and healthcare providers to accompany the above resources. Activities will include: An estimated two million people in the United States are currently diagnosed with SVT, also referred to as PSVT or paroxysmal supraventricular tachycardia. SVT 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, often forcing patients to limit their daily activities. The uncertainty of when an episode of SVT will occur 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 current lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. SVT episodes can be short-lived for just a few minutes or last several hours. Diagnosis can be challenging as the timing of irregular heart rhythm is unpredictable, and, therefore, is difficult to identify unless an electrocardiogram can record an episode at the time it occurs. Another challenge is that despite treatment some people with SVT continue to have symptoms. In addition, some may stop taking medication because they cannot tolerate the side effects. For additional information on SVT, visit SVT Heart to Heart provided by Milestone Pharmaceuticals. About Arrhythmia Alliance Arrhythmia Alliance is a coalition of patients, caregivers, healthcare professionals, policy makers and all those involved in or affected by cardiac arrhythmias (heart rhythm disorders). For more information, visit https://heartrhythmalliance.org/aa/us/. World Heart Rhythm Week Arrhythmia Alliance World Heart Rhythm Week is an annual Awareness Week that focuses on raising awareness of all arrhythmias (irregular heart rhythms) including Sudden Cardiac Arrest, Atrial Fibrillation, SVT, and Syncope (unexplained loss of consciousness). For more information, visit: https://heartrhythmalliance.org/aa/us/get-involved/world-heart-rhythm-week. 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 etripamil, a novel calcium channel blocker nasal spray 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: Milestone’s ability to develop and commercialize innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. 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; whether and when, if at all, our NDA for etripamil will be approved by the FDA; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful, 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 (SEC), including in its annual report on Form 10-K for the year ended March 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 SEC. 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

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MiNK Presents AgenT-797 Clinical Activity in Immune-Compromised Transplant Patient with Severe ARDS at ATS Annual Meeting

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NEW YORK, May 22, 2024 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced presentation of clinical data on agenT-797 in a complex case of severe acute respiratory distress (ARDS) at the American Thoracic Society (ATS) Annual Meeting. These translational and mechanistic insights build on an expanding dataset of clinical activity for patients with severe ARDS. “Consistent with our prior publication of the survival benefit of agenT-797 in severe respiratory distress, the observed improvement in this case further demonstrates the potential of allogeneic iNKT cells in this setting,” said Dr. Terese Hammond, University of California Los Angeles. “New therapeutic options, like allogeneic cell therapies, are urgently needed to address the critical unmet need in immune-compromised individuals with respiratory distress. I believe this growing body of data illuminates how iNKTs may have an impactful role in treating acute critical illness and merits further investigation.” Clinical Findings Patient: A 26-year-old chronically immunosuppressed patient post-renal transplant contracted COVID-19 and progressed to severe hypoxemic respiratory failure, requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).Treatment: A single dose of 1×10^9 allogeneic iNKT cells (agenT-797) on hospital day 13.Outcomes: Clinical changes showed a rapid decrease in inflammatory cytokines, including IL-18 following agenT-797 administration, consistent with the data observed in the Phase 1 trial of agenT-797 in COVID-19 ARDS (Hammond, T.C., Nat Commun 2024). The patient was extubated on day 37 and discharged home from the hospital on day 60, weaned off hemodialysis and returned to normal activities of daily living (ADLs) within 6 months of dosing. The full poster presentation can be found on the Publications page of the MiNK website at https://minktherapeutics.com/publications/. About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels. Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of agenT-797 and iNKT cells the mechanism of action, potency and safety, interim or top-line data, including statements regarding clinical data of agenT-797, the anticipated benefits of agenT-797 and clinical development plans and timelines. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Investor Contact 917-362-1370 investor@minktherapeutics.com Media Contact 781-674-4428 communications@minktherapeutics.com

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Philips ePatch and AI analytics platform rolled out to 14 hospitals across Spain to monitor heart patients

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May 22, 2024 Philips wearable ePatch and AI analytics platform help detect potentially life-threatening irregular heartbeatsThe solution helps University Hospital Vall d’Hebron achieve reduced average length of stay, relieve emergency room pressure, and reduce costs Amsterdam, the Netherlands, and Madrid, Spain – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the successful nationwide rollout of its ambulatory cardiac monitoring service in Spain using its unique wearable ePatch paired with its AI-driven Cardiologs analytics platform. 14 Spanish healthcare providers across the country are now using the company’s ePatch extended wear Holter monitors to detect life-threatening heart arrhythmias such as atrial fibrillation (AF). The solution has been proven to detect heart arrhythmias missed by traditional Holter monitors, enhance patient comfort, improve care access, and potentially better clinical outcomes, in addition to reducing overall costs. Philips’ ePatch provides reliable data for up to 14 days of continuous monitoring. When paired with Philips’ AI-driven Cardiologs analytics platform, the solution empowers the hospitals’ cardiology and neurology teams with an end-to-end solution that enhances their ability to detect and diagnose AF – a potentially life-threatening [1] cardiac arrhythmia and also the world’s most common. AF significantly increases the risk of stroke, dementia, and heart failure, yet often goes undetected due to its lack of noticeable symptoms and infrequent occurrence intervals. “The key advantage for healthcare professionals lies in its user-friendly interface and high-quality 14-day continuous recording capabilities,” said Dr. Jorge Pagola, Neurologist Postdoctoral Researcher at University Hospital Vall d’Hebron, Barcelona, Spain. “Applied as a chest patch in just a few minutes, it seamlessly integrates an analysis program, facilitating swift examination of recordings. Thanks to its AI-based analysis assistant, AF events can be classified for rapid review by our team. Patients experience enhanced comfort as they are free from cumbersome cables of the conventional Holter, allowing them to dress, shower, and carry out their daily activities without any hindrance.” Dr. Jorge Pagola further explains, “Using the ePatch program, we expedited hospital discharge for 80 patients in 2023. This initiative led to a reduced average length of stay, relieved emergency room pressure, and an estimated total cost reduction of € 28.800 in 2023 [2].” Pilot programs in major hospitals across SpainIn addition to Hospital Vall d’Hebron, where Philips’ ePatch is being used to detect post-discharge AF in patients, pilot projects demonstrating the device’s effectiveness in cardiology and neurology are being conducted at other major hospitals in Madrid, Barcelona, Bilbao, Alicante, Madrid, Cadiz, and Navarra [3]. Applications include monitoring patients for AF after cardiac ablation therapy or heart valve replacement procedures, and studies of the link between magnesium insufficiency and AF. In some Spanish hospitals, the ease-of-use and cost benefits of Philips ePatch are helping reduce waiting lists that built up during the COVID-19 pandemic, making a tangible difference to people’s access to care. In total, more than 1500 patients are currently being monitored with Philips ePatch devices in Spain. “This innovative new service allows clinical teams to conveniently monitor patients as they go about their everyday activities for extended periods of time, collecting the real-life data that helps reveal the patient’s true condition,” said Miquel Barras, Ambulatory Monitoring & Diagnostics Lead for Philips in Spain. In a recent US study comparing the diagnostic abilities of 7-day and 14-day monitoring with Philips’ extended wear ePatch compared to conventional 24-hour Holter monitoring, the ePatch detected 2x more clinically significant heart arrhythmias during 7 days of monitoring and more than 2.5x as many over 14 days [4]. [1] Heart.org[2] Data on file in hospital Vall d’Hebron[3] Madrid: Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Infanta Elena, Hospital de La Princesa, University Hospital Quironsalud Madrid, Hospital Universitario Rey Juan Carlos. Barcelona: Vall d’Hebron University Hospital, Hospital Clínic de Barcelona, Hospital de Sant Joan Despí Moisès Broggi, Hospital Sant Joan de Déu Barcelona, Hospital Universitari de Bellvitge, Hospital de Sant Pau. Bilbao: Hospital Universitario Cruces. Alicante: Hospital General Universitario de Elche. Cadiz: Hospital Universitario De Jerez. Navarra: Hospital General de Navarra.[4] Parikh, P, Grigoriadis, C, Dunn, A. et al. Diagnostic Yield of 24-hour Holter vs 7-day and 14-day ePatch Extended Wear Holter. J Am Coll Cardiol. 2023 Mar, 81 (8_Supplement) 149. Research conducted by Philips ECG Solutions.https://doi.org/10.1016/S0735-1097(23)00593-4 For further information, please contact: César García RequenaPhilips IbéricaTel: +34 670 264 471Email: cesar.garcia.requena@philips.com Joost Maltha External RelationsTel: +31 6 10 55 8116  Email: joost.maltha@philips.com About Royal Philips Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,100 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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OSE Immunotherapeutics and Boehringer Ingelheim expand collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases

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OSE Immunotherapeutics and Boehringer Ingelheim expand collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases   Nantes, France – Ingelheim, Germany – 22 May 2024, 7:30am CET – Today OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) and Boehringer Ingelheim announced a major expansion of their partnership. Two new projects to develop first-in-class treatments will be added to the ongoing anti-SIRPα immuno-oncology programs. The first involves broadening the therapeutic evaluation of an already partnered asset to reach more patients and the other a new asset acquisition: Reflecting an amendment of the existing collaboration and license agreement for the anti-SIRPα immuno-oncology compounds BI 765063 and BI 770371, which are being investigated in Phase I clinical studies in advanced solid tumors, development will now also be pursued in cardiovascular-renal-metabolic (CRM) diseases.A new preclinical program will be launched to develop immune-cell activating treatments based on OSE’s cis-targeting1 anti-PD1/cytokine platform via an asset acquisition. Affecting over one billion lives globally2, CRM diseases cause 20 million deaths annually. They are interconnected, co-exist, and can amplify one another, resulting in a significant burden on patients’ lives. Cancer accounts for nearly 10 million deaths and for many cancer patients there are no or only limited treatment options. The new development programs bolster Boehringer Ingelheim’s pipeline and reflects the company’s unwavering commitment to explore and progress new therapies to address unmet patient needs, including in CRM diseases and cancer. The cis-targeting anti-PD1/cytokine platform asset will further enrich Boehringer Ingelheim’s array of novel potential immune-modulatory cancer treatments. The development of the ongoing anti-SIRPα compounds for a new indication adds to the company’s comprehensive CRM pipeline with the initiation of a Phase 2 clinical study planned for later this year. “We are very pleased to expand our pipeline of potential first-in-class CRM disease therapies, as well as our pipeline of first-in-class T-cell based anti-cancer therapies,” said Clive R. Wood, Corporate Senior Vice President and Global Head of Discovery Research at Boehringer Ingelheim. “The expansion of our partnership with OSE reflects our joint mission to improving patient outcomes in two of the biggest threats to global health.” Nicolas Poirier, CEO of OSE Immunotherapeutics, commented: “We are excited about adding two highly innovative new development programs to our fruitful collaboration with Boehringer Ingelheim. We look forward to working with the scientists at Boehringer Ingelheim on the new development programs that have the potential to bring new breakthrough therapy options to patients with CRM diseases and cancer.” OSE Immunotherapeutics will receive EUR 13.5. million in upfront payment and a potential near-term milestone of EUR 17.5 million for the purchase of a novel, cis-targeting anti-PD-1/cytokine asset in preclinical stage. Regarding the two ongoing anti-SIRPα programs BI 765063 and BI 770371 the parties agreed on partial royalty buy-out monetizing with a one-time payment of EUR 25.3 million. Furthermore, Boehringer is granted an option for an additional buy-out during further development triggering a one-time payment plus the increase of one sales milestone. All other agreed development, regulatory and sales milestone payments of up to €1.1 billion remain as agreed between the parties under the initial agreement. About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at   www.boehringer-ingelheim.com. About OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors.OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors.OSE-127 – lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics).FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals, Inc.).BI 765063 and BI 770371 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC).OSE-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation. OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Pro-resolutive mAb platform focused on targeting and advancing inflammation resolution and optimizing the therapeutic potential of targeting Neutrophils and Macrophages in I&I. OSE-230 (licensed to AbbVie) is the first candidate generated by the platform, additional discovery programs ongoing on new pro-resolutive GPCRs.Myeloid Checkpoint platform focused on optimizing the therapeutic potential of myeloid cells in IO by targeting immune regulatory receptors expressed by Macrophages and Dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidates generated by the platform. Ongoing additional discovery programs, in particular with positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs.Cytokine platform focused on leveraging the Cis-Delivery of cytokine in IO and I&I. BiCKI® is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI®-IL-7v is the most advanced BiCKI® candidate targeting anti-PD1xIL-7. Ongoing additional discovery programs on Cis-Demasking technologies. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Boehringer Ingelheim T+49 (6132) 77-90815 reinhard.malin@boehringer-ingelheim.com Boehringer Ingelheim Binger Str. 17355218 Ingelheim am Rhein More informationboehringer-ingelheim.com OSE Immunotherapeutics Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 Cis-targeting: Bispecific antibodies have the capability to target cells either in a cis- or in a trans-binding orientation. During trans-binding, the antibody recognizes two different antigens, each expressed on a different cell population, and can link two different cell populations with each other (e.g. T-cell engagers). Cis-binding bispecific antibody targets two antigens expressed on the very same cell enabling preferential activation of the desired immune cell types while minimizing the activation of others (Segués A. et al. International Review of Cell and Molecular Biology 2022).2 Schechter M, Melzer Cohen C, Yanuv I, et al. Epidemiology of the diabetes-cardio-renal spectrum: a cross-sectional report of 1.4 million adults. Cardiovascular Diabetology. 2022;21(1):104. doi:10.1186/s12933-022-01521-9
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Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk

Coronary/Structural Heart Regulatory by Comments are Disabled

Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1The Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream, and will be made available on Roche’s installed base of over 90,000 serum work area (SWA) systems worldwide. The test has been developed in collaboration with Amgen. Basel, 22 May 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue. “While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,2” said Matt Sause, CEO of Roche Diagnostics. “Lp(a) is a critical marker for people at risk of cardiovascular disease, but medicine has had limited solutions to adequately address the problem. Through our collaboration with Amgen, Roche is paving the way to make elevated Lp(a) an actionable biomarker.” “Lp(a) testing rates are markedly low, and existing lab tests may not consistently and accurately measure Lp(a) levels,3” said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. “By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardised testing and equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease.” Once approved, the new Tina-quant® test is expected to be made available to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy. About Lp(a)Globally, as many as one in five people have elevated Lp(a),1 where lifestyle interventions such as diet and exercise have no significant impact. While Lp(a) levels can be influenced by non-genetic factors including menopause, kidney and liver disease and hyperthyroidism, they are predominantly ( >90%) determined by genetic variations in the LPA gene.4 Raised Lp(A) is particularly prevalent among women, and people of African descent.5,6 High levels of Lp(a) have been shown to promote the buildup of lipids in artery walls, leading to the development of plaques, and have been associated with an increased risk of cardiovascular (CV) events4. Lp(a) testing is therefore an important tool for clinicians, enabling them to make a more accurate assessment of CV risk, and it is expected to become a part of regular diagnostic testing in the coming years. Professional bodies around the world, including the National Lipid Association, Canadian Cardiovascular Society, European Atherosclerosis Society, European Society of Cardiology, and the Beijing Heart Society have recommended that Lp(a) measurement should be considered at least once in every adult person’s life. As Lp(a) has no single, defined molecular weight, there is a consensus in the scientific community that, ideally, Lp(a) levels should be measured in terms of the number of molecules per litre of blood (nmol/L). This contrasts with widely available tests that measure the molecular weight of Lp(a) in the blood (mg/L). About Tina-quant® Lp(a) RxDx assay The FDA has granted Breakthrough Device Designation to the Tina quant Lp(a) RxDx assay for use in selecting patients with elevated Lp(a) and a history of atherosclerotic disease for treatment with an Lp(a) lowering drug. A lipoprotein (a) test involves a routine blood draw during which a small sample of blood is used for measurement. This test measures the number of Lp(a) molecules per litre in a person’s bloodstream, which paves the way for Lp(a) to serve as an actionable biomarker in future. If approved, it will be available on selected cobas® platforms. Currently, there is no FDA authorised Lp(a) assay measuring Lp(a) in nmol/L available in the US. This assay will be part of Roche’s wider portfolio of tests for cardiovascular diseases. Together, these tests provide healthcare professionals the opportunity to make informed decisions, allowing patients to access new and innovative treatments. About Breakthrough Device DesignationThe Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.  About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Tsimikas S and Marcovina S, Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic of the Week, J Am Coll Cardiol. 2022 Aug, 80 (9) 934–946 ​​ https://www.jacc.org/doi/full/10.1016/j.jacc.2022.06.019[2] Beaglehole, R., Reddy, S., Leeder, S.R. (2007). Poverty and human development: the global implications of cardiovascular disease. Circulation 116, 1871–1873.[3] Zheng W, Chilazi M, Park J, et al. Assessing the Accuracy of Estimated Lipoprotein(a) Cholesterol and Lipoprotein(a)‐Free Low‐Density Lipoprotein Cholesterol. Journal of the American Heart Association. 2022;11(2). d oi: 10.1161/jaha.121.023136[4] Kronenberg F. et al, Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement, European Heart Journal, Volume 43, Issue 39, 14 October 2022, Pages 3925–3946, https://doi.org/10.1093/eurheartj/ehac361[5] Simony SB, Mortensen MB, Langsted A, Afzal S, Kamstrup PR, Nordestgaard BG. Sex differences of lipoprotein(a) levels and associated risk of morbidity and mortality by age: The Copenhagen General Population Study. Atherosclerosis. 2022 Aug;355:76-82. doi: 10.1016/j.atherosclerosis.2022.06.1023. Epub 2022 Jun 27. PMID: 35803767.[6] Mehta A, Jain V, Saeed A, Saseen JJ, Gulati M, Ballantyne CM, Virani SS. Lipoprotein(a) and ethnicities. Atherosclerosis. 2022 May;349:42-52. doi: 10.1016/j.atherosclerosis.2022.04.005. PMID: 35606075. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25  Simon GoldsboroughPhone: +44 797 32 72 915  Karsten KleinePhone: +41 79 461 86 83  Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262  Yvette PetillonPhone: +41 79 961 92 50 Dr. Rebekka SchnellPhone: +41 79 205 27 03   Roche Investor Relations Investor Relations North America
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Novo Nordisk Foundation and Technical University of Denmark press release: Bacteria in our gut could play a role in cardiometabolic disease: A new initiative aims to find out

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A new Denmark-based research initiative aims to establish a potential causal link between the gut microbiome – the combined genetic material of the communities of bacteria and other microbes in the human gut – and the development of cardiometabolic diseases (CMD) such as obesity, type 2 diabetes, and cardiovascular disease. The goal is to generate knowledge that can lead to new prevention or treatment options for people living with, or at risk of, CMD.
COPENHAGEN, Denmark, May 22, 2024 /PRNewswire/ — The Novo Nordisk Foundation has committed DKK 150 million (USD 22 million) for the first phase of the Microbiome Health Initiative, a virtual research centre anchored at the Technical University of Denmark (DTU), north of Copenhagen. Professor Fredrik Bäckhed from the University of Gothenburg will be employed part-time at DTU to lead the initiative, with Professor Tine Rask Licht from DTU National Food Institute as co-Director.
Research has already shown associations between several gut bacteria or metabolites – substances produced by microbes – and CMD. In Phase 1, the initiative will therefore focus on collaborative research projects that investigate the specific effects of these bacteria or metabolites and advance understanding on how microbiome interventions could reduce the risk of CMD or help manage it. This phase will run from 2024-2028.
“Our task is to verify a causal connection between the intestinal microbiome and diseases such as cardiovascular disease and diabetes,” says Professor Licht.
“These links have been partially elucidated in laboratory trials and animal experiments, but there is yet no solid evidence of causal relationships in humans. Once we have this knowledge, the next step in the project will be to find and develop new strategies to treat or prevent these major diseases. Such new strategies will rely on modification of our gut microbiome, for example by adding new microbes, or new dietary components.”
The initiative also involves leading scientists at the University of Copenhagen, Amsterdam University Medical Centre, and the Weizmann Institute of Science in Israel, and clinicians at Odense University Hospital and Steno Diabetes Centre Copenhagen. Together, they cover a broad range of disciplines, including microbial physiology, bioinformatics, aetiology of CMD, and human interventions.
While DTU’s strength in the project is research into the impact of diet on the structure and activity of the human microbiome, the other research centres in the initiative have extensive expertise in CMD research, microbiome research, and translation into clinical settings.
“The interdisciplinary approach of the project makes it possible to coordinate research between the strongest international environments,” says Professor Bäckhed. “It is unique that we can coordinate efforts between universities and hospitals to develop the most promising treatment concepts.”
‘A whole new set of tools’Despite major advances in research and treatment, the prevalence of CMD has doubled in the last 30 years. This group of conditions – including obesity and type 2 diabetes – and associated complications such as heart attack and stroke are now the leading cause of death worldwide.
Also in the last years, advances in microbiome research have led to new understanding regarding the impact of microbes and their metabolic output on human physiology, immunity, and disease processes. In the case of CMD, evidence strongly suggests that the gut microbiome – partly due to the metabolites the microbes produce – plays a critical role, and that by making small changes, individuals could reduce their risk of, for example, developing diabetes or suffering a heart attack. This initiative aims to generate significant new knowledge that, in the future, could lead to approved microbiome-based solutions such as supplements or improved dietary guidance to prevent or treat CMD.
“The Danish microbiome research field is strong but, in order to take the critical next steps, we need an ambitious, interdisciplinary approach that also includes leading international experts,” says Birgitte Holst, Scientific Director in Medical Science at the Novo Nordisk Foundation.
“If this initiative succeeds in establishing a causal link between the microbiome and CMD, it could lead to a whole new set of tools for managing these devastating diseases and help resolve a major global health challenge.”
Phase 2, which is subject to approval following a mid-term evaluation of Phase 1, would run from 2026-2030. In this phase, the initiative would support human intervention studies and invest in infrastructure to support the development of microbes, microbial compounds, or targeted supplements for therapeutic purposes.
Editor’s Notes
About DTU National Food Institute
DTU National Food Institute conducts research into and disseminates – through advice, innovation and teaching – sustainable and value-creating solutions in the area of food and health for the benefit of society. The DTU National Food institute’s vision is to make a difference by generating future prosperity through research into food and health. The institute prevents disease and promotes health, develops new and better food products for a growing population and creates sustainable technological solutions. The institute’s tasks are carried out in a unique interdisciplinary cooperation in e.g. nutrition, chemistry, toxicology, microbiology, epidemiology, modelling and technology.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
www.novonordiskfonden.dk/en
SOURCE Novo Nordisk Foundation

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