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The Shockwave study aims to confirm the benefits of coronary intravascular lithotripsy (IVL) in women. Co-principal investigator Dr. Margaret McEntegart, director of Complex PCI and CTO programs at Columbia University Medical Center/NewYork-Presbyterian Hospital, completed the final enrollment during a live case at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C. The study, which includes 400 participants across 48 sites in five countries, is set to release primary endpoint results in 2025, with continued patient follow-up through three years. “The completion of enrollment in EMPOWER CAD is a major milestone in our desire to improve cardiovascular outcomes for women with challenging calcified lesions,” said McEntegart. “Not only will this study yield valuable insights on the performance of coronary IVL in female patients, but as the first prospective all-comers study of coronary IVL, we also hope to gain additional insights about the utility of the technology in more complex patients.” Women comprise about a quarter of cardiovascular clinical trial participants, limiting gender-specific data essential for treatment advancements. Female patients undergoing PCI face a higher risk of procedural complications, emphasizing the need for targeted studies. “We are eager to analyze the data and share results next year, with a goal of helping to close the gap in treatment outcomes between men and women,” said Alexandra Lansky, Professor of Medicine, section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program at Yale University School of Medicine and co-principal investigator of EMPOWER CAD. “EMPOWER represents a significant step forward in women’s heart health. We also look forward to seeing the participating female interventional cardiologists and clinical researchers in the study continue to take on clinical trial leadership roles in the years to come.” Most notably, 71% of enrolling sites are led by female principal investigators. “We are proud of, and grateful to, all of the dedicated investigators who enrolled this study well ahead of all our expectations, showcasing their commitment to the important issue of women’s cardiovascular care,” Shockwave Medical Chief Medical Officer Nick West said. “This study is a critical step toward closing the gender gap in heart disease treatment, and we recognize the urgent need for clinical data that reflect the unique challenges that women with cardiovascular disease face.”

New APPEAR-C3G data show Fabhalta sustained proteinuria reduction at 12 months1 Upon Fabhalta initiation, improvement observed in estimated glomerular filtration rate (eGFR) slope – a key measure of kidney function – vs. patients' historic rapid decline1 Fabhalta also showed a favorable safety profile with no new safety signals1 Fabhalta is the only oral alternative complement pathway inhibitor to selectively target the underlying cause of C3G, an ultra-rare kidney disease with no approved treatments2-5 Novartis continues to advance multi-asset renal portfolio; C3G regulatory submissions completed in EU, China and Japan, and expected in US by year-end EAST HANOVER, N.J., Oct. 26, 2024 /PRNewswire/ -- Novartis today presented 12-month data from the Phase III APPEAR-C3G study at American Society of Nephrology (ASN) Kidney Week 2024 showing that patients with C3 glomerulopathy (C3G) treated with oral Fabhalta® (iptacopan) in addition to supportive care experienced clinically meaningful, sustained results at one year.1 These data confirm treatment with Fabhalta resulted in clinically meaningful proteinuria reduction, which was seen as early as 14 days, and sustained at 12 months. Similarly, in an open-label period of the study, proteinuria reduction was seen in participants who were switched to Fabhalta. In addition, improvement in estimated glomerular filtration rate (eGFR) slope was observed upon Fabhalta initiation compared to patients' historic rapid decline based on results from a prespecified exploratory analysis. Fabhalta showed a favorable safety profile, with no new safety signals.1 APPEAR-C3G evaluated the efficacy and safety of twice-daily oral Fabhalta in adult patients with C3G. The study was comprised of a 6-month randomized, double-blind treatment period with Fabhalta compared to placebo, followed by an additional 6-month open-label treatment period where all participants received Fabhalta.1 Results previously presented at the 2024 European Renal Association (ERA) Congress demonstrated a statistically significant and clinically meaningful 35.1% proteinuria reduction vs. placebo on top of supportive care at 6 months.6 Longer-term data show sustained results with oral Fabhalta "As a clinician treating young people living with C3G, I see firsthand the challenges with therapies used to treat this condition today, underscoring the vital need for dedicated treatment for these patients," said Carla Nester, M.D., M.S.A., F.A.S.N., Professor of Pediatrics-Nephrology at the University of Iowa and APPEAR-C3G Co-Investigator. "I am encouraged to see these data, which reinforce the clinically meaningful impact on kidney health measures we saw at 6 months. As the only oral complement inhibitor intended to treat C3G, Fabhalta could provide new hope for people living with this condition." "These results mark an important milestone for the management of C3G, as the first study to shed light on longer-term treatment targeting the underlying mechanism of this disease via the alternative complement pathway," said Andrew Bomback, M.D., M.P.H., Associate Professor of Medicine at Columbia University Irving Medical Center and APPEAR-C3G Co-Investigator and Steering Committee Member. "I am optimistic that these iptacopan APPEAR-C3G findings bring us a step closer to revolutionizing the treatment paradigm in this ultra-rare disease with no approved therapies." Approximately 50% of C3G patients progress to kidney failure within 10 years of diagnosis, at which point they require lifelong dialysis and/or kidney transplantation.4,7 Fabhalta, the only oral Factor B inhibitor of the alternative complement pathway, has potential to be the first US Food and Drug Administration (FDA) approved treatment for C3G.2,4,5 Regulatory submissions for Fabhalta in C3G are completed in the EU, China and Japan, and expected in US by year-end. Transforming patient care in kidney disease "We are thrilled to share these data, which demonstrate the potential of Fabhalta in C3G, and look forward to working with regulatory authorities with the goal of bringing this innovative medicine to this patient community," said David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. "Building on the longstanding experience of Novartis in nephrology and our first rare kidney disease approval in IgA nephropathy earlier this year, these results in C3G show continued advancement of our broad, industry-leading portfolio, which aims to transform care for these patients." Fabhalta, discovered at Novartis, received FDA approval in December 2023 for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) and accelerated approval in August 2024 for the reduction of proteinuria in certain adults with primary IgA nephropathy (IgAN).2 Fabhalta is being studied in a broad range of rare kidney diseases, including C3G, atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN). Studies are ongoing to evaluate the safety and efficacy profiles in these investigational indications and support potential regulatory submissions. In addition to Fabhalta, Novartis is advancing the late-stage development of two additional IgAN therapies with highly differentiated mechanisms of action: atrasentan, an investigational oral endothelin A receptor antagonist that received FDA filing acceptance in Q2 2024, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody that is currently in Phase III development. A conference call to update investors on the Novartis renal portfolio will take place on Monday, October 28, 2024, at 8:00 am ET. Details can be found at Event calendar | Novartis. About APPEAR-C3G APPEAR-C3G (NCT04817618) is a Phase III multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of twice-daily oral Fabhalta (200 mg) in C3G patients. The study comprises a 6-month double-blind period in which adult patients were randomized 1:1 to receive Fabhalta or placebo on top of supportive care, followed by a 6-month open-label period in which all patients receive Fabhalta (including those who were previously on placebo). The primary endpoint for the double-blind period was proteinuria reduction from baseline at 6 months for Fabhalta compared to placebo as measured by 24-hour urine protein to creatinine ratio (UPCR).1,8 In addition to the results from adult patients with C3G, enrollment is ongoing in a separate cohort of adolescent patients with C3G.8 The majority of treatment-emergent adverse events (TEAEs) over the 12-month study period were mild to moderate in severity and there were no deaths, no cases of meningitis and/or meningococcal sepsis and no discontinuations due to TEAEs.1 About C3 glomerulopathy (C3G) C3G is an ultra-rare, progressive kidney disease that initially presents mostly in children and young adults.3,4,9 Each year, approximately 1-2 people per million worldwide are newly diagnosed with C3G, a form of membranoproliferative glomerulonephritis (MPGN).3 In C3G, overactivation of the alternative complement pathway – part of the immune system – causes deposits of C3 protein to build up in kidney glomeruli, which are a network of blood vessels that filter waste and remove extra fluids from the blood.9,10 This triggers inflammation and glomerular damage that results in proteinuria (protein in urine), hematuria (blood in urine) and reduced kidney function.9,11 Indication FABHALTA® (iptacopan) is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease progressing quickly. It is not known if FABHALTA is safe and effective in children with IgAN. FABHALTA has been approved based on a reduction of proteinuria. Continued approval may require results from an ongoing study to determine whether FABHALTA slows decline in kidney function. Important Safety Information FABHALTA is a medicine that affects part of the immune system and may lower one's ability to fight infections. FABHALTA increases the chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. These serious infections may quickly become life-threatening or fatal if not recognized and treated early. Patients must complete or update vaccinations against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before the first dose of FABHALTA. If patients have not completed vaccinations and FABHALTA therapy must be started right away, they should receive the required vaccinations as soon as possible. If patients have not been vaccinated and FABHALTA must be started right away, they should also receive antibiotics to take for as long as their doctor tells them. If patients have been vaccinated against these bacteria in the past, they might need additional vaccinations before starting FABHALTA. Their doctor will decide if they need additional vaccinations. Vaccines do not prevent all infections caused by encapsulated bacteria. Patients should call their doctor or get emergency medical care right away if they have any of these signs and symptoms of a serious infection: fever with or without shivers or chills, fever with chest pain and cough, fever with high heart rate, headache and fever, confusion, clammy skin, fever and a rash, fever with breathlessness or fast breathing, headache with nausea or vomiting, headache with stiff neck or stiff back, body aches with flu-like symptoms, or eyes sensitive to light. Doctors will give their patients a Patient Safety Card about the risk of serious infections. Patients must carry it with them at all times during treatment and for 2 weeks after their last dose of FABHALTA. The risk of serious infections may continue for a few weeks after their last dose of FABHALTA. It is important for patients to show this card to any doctor who treats them. This will help doctors diagnose and treat patients quickly. FABHALTA is only available through a program called the FABHALTA Risk Evaluation and Mitigation Strategy (REMS). Before patients can take FABHALTA, their doctor must enroll in the FABHALTA REMS program, counsel patients about the risk of serious infections caused by certain bacteria, give patients information about the symptoms of serious infections, make sure that patients are vaccinated against serious infections caused by encapsulated bacteria and that they receive antibiotics if they need to start FABHALTA right away and are not up to date on vaccinations, as well as give patients a Patient Safety Card about the risk of serious infections. Patients should not take FABHALTA if they are allergic to FABHALTA or any of the ingredients in FABHALTA. Patients should not take FABHALTA if they have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b when starting FABHALTA. Before taking FABHALTA, patients should tell their doctor about all their medical conditions, including if they have an infection or fever, have liver problems, are pregnant or plan to become pregnant (it is not known if FABHALTA will harm an unborn baby), or are breastfeeding or plan to breastfeed as it is not known if FABHALTA passes into breast milk. Patients should not breastfeed during treatment and for 5 days after the final dose of FABHALTA. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FABHALTA with certain other medicines may affect the way FABHALTA works and may cause side effects. Patients should know the medicines they take and the vaccines they receive. Patients should keep a list of them to show their doctor and pharmacist when they get a new medicine. FABHALTA may cause serious side effects, including those mentioned above as well as increased cholesterol and triglyceride (lipid) levels in the blood. Doctors will do blood tests to check patients' cholesterol and triglycerides during treatment with FABHALTA. Doctors may start patients on medicine to lower cholesterol if needed. The most common side effects of FABHALTA in adults include headache; nasal congestion, runny nose, cough, sneezing, and sore throat (nasopharyngitis); diarrhea; pain in the stomach (abdomen); infections (bacterial and viral); nausea; and rash. Please see full Prescribing Information, including Boxed WARNING and Medication Guide. Novartis in kidney disease At Novartis, our journey in nephrology began more than 40 years ago when the development and introduction of cyclosporine helped reimagine the field of transplantation and immunosuppression. We continue today with a broad renal R&D portfolio targeting the underlying causes of disease to preserve kidney function. We aim to help transform the lives of people living with kidney diseases, enabling them to live longer without the need for dialysis or transplantation. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," "progress," "accelerated," "targets," "continued," "contingent," "progressive," "evolving," "enable," "innovation," "ongoing," "evaluating," "evolve," "committed," "advance," "advancing," "commitment," "to developing," "to provide, "development," "to address," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Fabhalta or the other investigational or approved products described in this press release, or regarding potential future revenues from such product. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Fabhalta or the other investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Smith RJ, Kavanagh D, Vivarelli M, et al. Efficacy and safety of iptacopan in patients with C3 glomerulopathy: 12-Month results from the Phase 3 APPEAR-C3G study. Presented at American Society of Nephrology (ASN) Kidney Week 2024; October 23-27, 2024; San Diego, CA. FABHALTA prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2024. Schena FP, Esposito P, Rossini M. A Narrative Review on C3 Glomerulopathy: A Rare Renal Disease. Int J Mol Sci. 2020;21(2):525. Martín B, Smith RJH. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. C3 Glomerulopathy. GeneReviews® [Internet]. Updated 2018. University of Washington, Seattle; 1993-2024. Available from: . Accessed September 2024. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276. Kavanagh D, Bomback A, Vivarelli M, et al. Efficacy and Safety of Iptacopan in Patients with C3 Glomerulopathy: Results from the Phase 3 APPEAR-C3G Trial. Presented at European Renal Association (ERA) Congress; May 25, 2024; Stockholm, Sweden. Smith RJH, Appel GB, Blom AM, et al. C3 Glomerulopathy – understanding a rare complement-driven renal disease. Nat Rev Nephrol. 2019;15(3):129-143. ClinicalTrials.gov. Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy. (APPEAR-C3G). Available from: . Accessed September 2024. Caravaca-Fontán F, Lucientes L, Cavero T, Praga M. Update on C3 Glomerulopathy: A Complement-Mediated Disease. Nephron. 2020;144(6):272-280. Ravindran A, Fervenza FC, Smith RJH, Sethi S. C3 Glomerulopathy Associated with Monoclonal Ig is a Distinct Subtype. Kidney Int. 2018;94(1):178-186. Medjeral-Thomas NR, O'Shaughnessy MM, O'Regan JA, et al. C3 Glomerulopathy: Clinicopathologic Features and Predictors of Outcome. Clin J Am Soc Nephrol. 2014;9(1):46-53. ### SOURCE Novartis Pharmaceuticals Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The CathWorks FFRangio® System to Be Featured in Multiple Scientific Presentations Including the First Ever Prospective RCT Comparing an Angio-based Physiology Tool Versus FFR in Japan NEWPORT BEACH, Calif., Oct. 25, 2024 /PRNewswire/ -- CathWorks, a global leader in digital health innovations, announced today the schedule of key events for the company during the upcoming Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) conference taking place October 27 to 30 at the Walter E. Washington Convention Center in Washington, DC. Continue Reading CathWorks announces key events for TCT 2024 The CathWorks FFRangio® System will be featured in scientific presentations, an educational symposium, and will be available for hands-on demonstrations and peer-to-peer education during Meet the Expert sessions hosted by leading physicians. For the first time ever, the CathWorks booth will include its own media studio where key opinion leaders will be invited to share their candid thoughts on various hot topics in the physiology and cardiovascular space. Scientific Presentations On Sunday, Professor Hitoshi Matsuo from Gifu Heart Center in Gifu, Japan will present data from the PROVISION1 study, the first ever Japanese prospective randomized controlled trial (RCT) comparing clinical outcomes of an angio-based physiology technology versus wire-based FFR. Professor Hitoshi Matsuo stated, "This study can play a pivotal role in how patients with coronary artery disease are diagnosed and treated going forward. If this study demonstrates that the clinical evaluation with FFRangio yields the same treatment decisions as those based on traditional invasive FFR and that there is no significant difference in prognoses, FFRangio, the wire-free, easier and less costly assessment tool can be routinely utilized intraprocedurally for patients with intermediate lesions, and effectively replace wire-based FFR." On Tuesday, Dr. Kazuhiro Dan from Ichinomiyanishi Hospital in Ichinomiya, Japan will present an update on the Comparison Between Angiogram-Based Physiological Assessment System and Intravascular Ultrasound Imaging Measurements. On Wednesday, Professor Guy Witberg from Rabin Medical Center in Tel Aviv, Israel will share two-year data of over 1,500 patients from the FFRangio global registry during his Real World Outcomes of FFRangio Guided Treatment for Coronary Artery Disease in Acute vs. Chronic Coronary Syndromes presentation. Educational Symposium The Monday lunchtime symposium entitled CathWorks FFRangio: Coronary Physiology Redefined, will be chaired by Dr. Allen Jeremias from St. Francis Hospital, Roslyn, NY. The world-renowned faculty will include Dr. William F. Fearon (Stanford University Medical Center, Stanford, CA), Dr. Ajay J. Kirtane (Columbia University Irving Medical Center, New York, NY) and Professor Hitoshi Matsuo (Gifu Heart Center, Gifu, Japan). The expert physician panel will share the continually evolving artificial intelligence behind the FFRangio System aimed at simplifying the user experience, highlights from the PROVISION study and the pivotal role the FFRangio technology plays in physiology-guided PCI. "We are extremely pleased to see the FFRangio System featured prominently during TCT, highlighting its rapidly growing adoption and seamless integration in catheterization labs around the globe. We look forward to continuing to partner with the interventional cardiology community to make FFRangio the standard of care," said Ramin Mousavi, President and CEO of CathWorks. To learn more about different CathWorks activities at TCT 2024 and reserve your spot at the lunchtime symposium, visit TCT 2024 - CathWorks FFRangio System or the CathWorks booth #1819 during the conference. ABOUT CATHWORKS CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit and follow @CathWorks on X and LinkedIn. Prospective Randomized trial of clinical Outcomes of angiography-based fractional flow reserve guidance Versus wIre-baSed fractIOnal flow reserve guidance (PROVISION) study is an investigation of the Utility of Coronary Angiography (FFRangio) in Comparison to Coronary Fractional Flow Reserve (FFR) in the Determination of Treatment Planning and the Clinical Prognosis in Patients with Chronic Phase Coronary Artery Disease Investors: Mike Feher [email protected] Media: Sarita Monico [email protected] SOURCE CathWorks WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED