SALIX PHARMACEUTICALS RELEASES LIVER HEALTH ANNUAL TRENDS REPORT UNDERSCORING CHALLENGES IN CARING FOR GROWING CHRONIC LIVER DISEASE AND CIRRHOTIC PATIENT POPULATION

  • Released During Liver Health Awareness Month and Based Primarily on HCP-Market Research, Salix Pharmaceuticals' Liver Health Annual Trends Report Finds More than One-Third of Gastroenterologists Surveyed Have Seen an Increase in Patient Hospitalizations Due to Cirrhosis Over the Past Year
  • Report Points to Reimbursement Challenges as Negatively Affecting Management of Chronic Liver Disease, as Reported by Survey Respondents

Salix Pharmaceuticals ("Salix"), the gastroenterology business of Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health"), today released the Salix Liver Health Annual Trends Report, Second Edition with the latest information on chronic liver disease (CLD) care and findings that include a continued rise in hospitalizations and mortality from CLD and cirrhosis, as well as gaps in care and knowledge that may prevent early diagnosis and optimal management of CLD, cirrhosis and its complications.

The trends report, which is based on a survey of 400 health care providers (HCPs) who treat patients with CLD, qualitative interviews with HCPs, and secondary research from peer-reviewed publications, reveals shortfalls in the adoption of national treatment guidelines, particularly among primary care physicians (PCPs). Perceived issues with payer coverage (due to prior authorization complexity/rejections) and high out-of-pocket costs/inability to afford treatment were found to be the leading factors negatively impacting treatment initiation or causing treatment disruptions.

"Salix is committed to delivering resources that inform, educate and help health care providers improve the care of people living with chronic liver disease, cirrhosis, and complications such as hepatic encephalopathy," said Nicola Kayel , vice president, GI Marketing, Salix. "This year's report points to a continued rise in mortality from chronic liver disease and cirrhosis, now outpacing diabetes or stroke among those 25-54 years old 1 . It's clear from both patient and provider research that there's a real need for more education and engagement resources to support the management of CLD. It is our hope the Salix Liver Health Annual Trends Report will increase awareness of this growing public health concern, help bridge the knowledge gap, and provide tools for health care providers that may improve identification and management of the disease."

The Salix Liver Health Annual Trends Report is being released in October during Liver Health Awareness Month as part of an effort to equip health care providers with the most current information on liver disease.

"The Global Liver Institute applauds the publication of this year's Liver Health Annual Trends Report which will help bring better understanding of the personal and societal impact of chronic liver disease and potentially help address its under-diagnosis and under-treatment among the approximately 4.5 million adults in the U.S. living with the disease 2 ," said Donna R. Cryer , JD, founder and CEO, Global Liver Institute.

Complete findings from Salix's Liver Health Annual Trends Report as well as health care provider resources to help identify and manage patients with CLD and cirrhosis can be viewed at LiverHEalthNow.com .

Select findings from the report include:

  • 34% of gastroenterologists surveyed report seeing increases in patient hospitalizations due to alcoholic cirrhosis of the liver during the past year
  • 38% of the respondents were unaware of and/or could not name national guidelines for the management of CLD
  • 55% of PCPs and 49% of nurse practitioners/physician assistants in the survey are not comfortable treating overt hepatic encephalopathy (OHE) and seek a consult
  • 50% of providers surveyed report a patient's ability to pay out-of-pocket expenses is very or extremely important to CLD patient outcomes

About the Methodology Behind Liver Health Annual Trends Report
The Liver Health Annual Trends Report on chronic liver disease (CLD) includes information collected from an online survey, qualitative telephone interviews, and secondary research from peer-reviewed publications. An independent third-party recruiting firm invited over 400 health care providers to participate in this research project during May 2022 . Provider participation (N=400) in the survey required individuals to be active in clinical practice and treat more than 4 CLD patients annually and were comprised of the following subgroups: 100 community-based gastroenterologists, 100 institution-based specialists, 100 primary care physicians (PCPs), and 100 nurse practitioners/physician assistants (NPs/PAs). In addition to completing the online survey, 15 physicians and 5 NPs/PAs also completed in-depth telephone interviews (Table 1). Quotes from the in-depth interviews throughout this report represent the opinions of those responders. As it pertains to the online survey, analysis of the data was conducted by utilizing QPSMR data analysis software.

The report strives to be representative of all physician segments' lived experience and the diversity that exists within the United States with respect to patient management and the economic and social factors that impact the management of CLD patients. Due to the limitations of this report, not all findings may be generalizable to the larger CLD provider and patient populations. In addition, this report does not contain all questions asked in the survey and in-depth interviews.

Secondary Research of Peer-Reviewed Publications
Secondary research was conducted utilizing Google and PubMed searches to identify relevant peer-reviewed publications and sources as noted in the report. Furthermore, treatment utilization and claims data were sourced from IQVIA. Secondary research may not reflect all published data. A systematic review was not performed. While included publications are peer reviewed, this secondary research as a whole was not.

To raise awareness and knowledge of CLD and HE, Salix also offers other online resources including:

  • UnderstandingHE.com : offering patients/caregivers HE information and resources on how to work with their health care provider to help manage the disease, a complication of cirrhosis
  • UnseenEpisodes.com : offering health care providers information about the unseen aspects and considerations in managing patients with HE
About Salix

Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey . For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn .

About Bausch Health

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health.

Forward-looking Statements

This news release may contain forward-looking statements about the future performance of the Company, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to the Company's overall business, including those more fully described in the Company's most recent annual report on Form 10-K and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian securities administrators, which factors are incorporated herein by reference.

©2022 Salix Pharmaceuticals or its affiliates.
  SAL.0112.USA.22

1 Xu JQ, Murphy SL, Kochanek KD, Arias E. Deaths: final data for 2019. Natl Vital Stat Rep. 70(8). Hyattsville, MD : National Center for Health Statistics. 2021.
2 Centers for Disease Control and Prevention. Chronic liver disease and cirrhosis. Accessed September 9, 2022 . https://www.cdc.gov/nchs/fastats/liver-disease.htm

Gianna Scalera
salixcommunications@salix.com
(908) 541-2110

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(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

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"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

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AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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(PRNewsfoto/Medtronic plc)

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More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
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Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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