Mallinckrodt Plc

– Pooled analysis from Phase 3 clinical trials highlights liver transplant rates in adult patients with HRS with rapid reduction in kidney function treated with TERLIVAZ1 – DUBLIN, Oct. 26, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at Kidney Week 2024, the annual meeting of the American Society of Nephrology (ASN) taking place in San Diego from October 23-27, 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,3 making it a very rare condition; and rates of hospitalizations are increasing.4 Please see Limitation of Use and Important Safety Information, including Boxed Warning, below. The poster presentation highlights a pooled analysis of data from the CONFIRM and REVERSE Phase 3 placebo-controlled trials of TERLIVAZ.5 The analysis examined the rates of hepatorenal syndrome-acute kidney injury (HRS-AKI) reversal, renal replacement therapy (RRT), and liver transplant (LT) among a subpopulation of patients listed for LT at baseline who met FDA label guidelines for treatment with TERLIVAZ (SCr <5 mg/dL, ACLF grade 0–2, and MELD score <35).5 In this patient subpopulation, treatment with TERLIVAZ increased the rate of HRS-AKI reversal and reduced the need for RRT at all time points assessed.5 The increase in HRS-AKI reversal with TERLIVAZ did not negatively impact the LT rate in patients listed for LT at baseline.5 The rate of HRS-AKI reversal was 43% in the TERLIVAZ group (n=53) and 20% in the placebo group (n=35).5 The rate of RRT in the TERLIVAZ and placebo groups was 28% and 46% by Day 30; 32% and 54% by Day 60; and 36% and 54% by Day 90, respectively.5 The LT rate was similar in the TERLIVAZ and placebo groups at all time points assessed: 53% and 51% by Day 30; 66% and 57% by Day 60; and 66% and 63% by Day 90, respectively.5 The limitations of this study include, but are not limited to, small sample sizes, variables in methodology, and possible errors and omissions within the data sets.5 "This analysis of data from our Phase 3 trials furthers our understanding of the appropriate patient subpopulations and the potential impact of treatment on liver transplantation rates," said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer. "For these critically ill patients with HRS-AKI, a liver transplant is the definitive treatment, and we know there are significant challenges associated with RRT; which makes continued research important." This study was sponsored by Mallinckrodt Pharmaceuticals. Presentation details can be found below: Poster #PO0102-2: Hepatorenal syndrome-acute kidney injury reversal and liver transplant rates in patients treated with terlipressin5 Presenter: Justin Belcher Session Type: Poster Presentation Session Title: AKI: Clinical, Outcomes, and Trials - Management Session Date and Time: Saturday, October 26, 2024; 10:00 a.m. – 12:00 p.m. PT INDICATION AND LIMITATION OF USE TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit. IMPORTANT SAFETY INFORMATION WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%. Contraindications TERLIVAZ is contraindicated: In patients experiencing hypoxia or worsening respiratory symptoms. In patients with ongoing coronary, peripheral, or mesenteric ischemia. Warnings and Precautions Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms. Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure. Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks. Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions. Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus. Adverse Reactions The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. Please click here to see full Prescribing Information, including Boxed Warning. ABOUT HEPATORENAL SYNDROME (HRS) Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.2 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,3 making it a very rare condition; and rates of HRS hospitalizations are increasing.4 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of less than two weeks and greater than 80 percent mortality within three months.6 ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 908-577-4531 [email protected] Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark, TERLIVAZ, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400773 10/24 References 1 TERLIVAZ® (terlipressin) for Injection. Prescribing Information. Mallinckrodt Hospital Products Inc. 2023. 2 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: . Accessed October 2024. 3 United States Census Bureau: Quick Facts. Available at: . Accessed October 2024. 4 Singh J., Dahiya D.S., Kichloo A., et al. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. 2018-2024 doi.org/10/1080/07853890. 5 Belcher J.M., Regner K.R., Mujtaba M.A., et al. Hepatorenal syndrome-acute kidney injury reversal and liver transplant rates in patients treated with terlipressin. Abstract to be presented at the American Society of Nephrology (ASN) 2024 Annual meeting. October 2024. 6 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in the United States and the Potential of Terlipressin. Liver Transpl. 2021;27:1191-1202. . SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Oct. 16, 2024 /PRNewswire/ -- According to The Insight Partners study on the Radiation Oncology Market is observing significant growth owing to the increasing prevalence of cancer. The report runs an in-depth analysis of market trends, key players, and future opportunities. In general, the radiation oncology market consists of different products that are expected to contribute to market growth in the coming years. Download Sample Report: Overview of Report Findings 1. Market Growth: The radiation oncology market is expected to reach US$ 23.62 billion by 2031 from US$ 8.92 billion in 2023; it is anticipated to register a CAGR of 13.0% from 2023 to 2031. Radiation oncology is the specialized medical treatment of cancer using radiation therapy. Radiation oncology is high-energy radiation therapy with X-rays or high energy particles to kill cancer cells or shrink tumors. Radiation oncologists coordinate with other healthcare workers to identify a suitable personalized treatment plan, which depends on factors such as the nature, site, and stage of the cancer and the patient's general condition. Treatment can be done internally in the form of brachytherapy or externally through radiation, known as external beam therapy. 2. Cancer is one of the common health conditions significantly impacting societies worldwide. According to the World Health Organization (WHO), it is the leading cause of death across the world; it was the cause of 20 million new cancer cases and 9.7 million deaths in 2022. The number of new cancer cases is further expected to reach ~35 million new cancer cases by 2050. As per the WHO 2024 report, lung cancer is the most common cause of mortality globally, followed by colorectal cancer, liver cancer, breast cancer, and stomach cancer, which are responsible for 18.7%, 9.3%, 7.8%, 6.9%, and 6.8% of the total cancer related deaths, respectively. The incidences of the top 10 cancer types are mentioned in the table below. Figure 1. Statistics at Glance, Global, 2022 Source: Global Cancer Observatory The increasing incidence of cancer results in a huge demand for effective treatment options. Radiotherapy is one of the continuously evolving treatment options with effective outcomes for cancer patients. The method of intervention utilizes high doses of radiation such as X-rays and gamma rays to kill cancer cells. Radiation therapy is mainly prescribed in patients with the early stages of cancer, while it can also be used at any point in the treatment. Various types of external beam radiotherapy are used for the treatment of different cancer types. For instance, brachytherapy is used for the treatment of breast cancer, cervix cancer, eye cancer, prostate cancer, and head & neck cancer. Further, systemic radiation therapy, also known as radioactive iodine therapy, is used for the treatment of thyroid cancer. Thus, the increasing prevalence of cancer and the evolution of radiotherapy in oncology bolsters the radiation oncology market growth. 3. Technological Advancements in Radiation Oncology: Radiotherapy focuses on destroying cancerous cells, with the maximum possibility of sparing healthy cells, which was achieved over a period with continuous advancements in imaging technologies such as magnetic resonance imaging (MRI), computed tomography (CT), and positron emission tomography (PET). These imaging technologies, combined with developments in 3D conformal radiotherapy, help identify tumor cells and provide information on their exact position and size. Trending radiation therapies that signify developments in radiotherapy technologies are mentioned below: Flash Therapy: Flash therapy is being investigated for safety and effectiveness. Unlike earlier approaches that require dose administration over multiple days or weeks, this therapy involves delivering the entire dose of massive radiation at once very quickly. Healthy cells recover well with time, killing only cancer cells. Identify the Key Trends Affecting This Market - Download Sample PDF: Image-guided radiation therapy (IGRT): This technology allows for the real-time imaging of tumors and their surrounding healthy tissues before each treatment session, ensuring that the radiation beams are accurately targeted at the tumors and minimizing damage to nearby organs. Intensity-modulated radiation therapy (IMRT): IMRT allows for the delivery of varying intensities of radiation to different parts of the tumor, allowing for better dose distribution and sparing of healthy tissue. Stereotactic body radiation therapy (SBRT): SBRT involves delivering high doses of radiation to small, well-defined tumors in a limited number of treatment sessions, leading to better local control of a tumor. Proton therapy: Proton therapy uses protons instead of traditional X-rays to deliver radiation to the tumor, allowing for more precise targeting of the tumor and sparing of healthy tissue. Adaptive radiation therapy: This technology allows for adjustments to the treatment plan based on changes in the tumor size or position during treatment, ensuring that the radiation dose is continuously optimized for maximum effectiveness. Artificial intelligence (AI) is also being incorporated into cancer treatment for treatment planning, CT scan image labeling, and other applications. Additionally, various types of radiation therapy equipment are integrated with AI to benefit patients and healthcare professionals alike. In March 2024, RefleXion Medical, Inc. and Limbus AI, Inc. collaborated for the integration of Limbus Contour (AI driven solution), into the RefleXion X1 radiotherapy treatment planning system. This integration will reduce the most significant bottleneck in the patient treatment planning process, which involves delineating the tumor target from surrounding critical organs and other healthy tissue. Therefore, developments in radiotherapy technologies and the increasing integration of artificial intelligence to support more controlled and quicker treatments are expected to bring new growth trends in the radiation oncology market in the coming years. 4. Geographical Insights: In 2023, Asia Pacific led the market with a substantial revenue share, followed by North America and Europe. Asia Pacific is expected to register the highest CAGR during the forecast period. Market Segmentation Based on type, the radiation oncology market is bifurcated into external beam radiation therapy and internal beam radiation therapy. The external Beam radiation therapy segment is subsegmented into 3D conformal radiotherapy, stereotactic technology, proton beam therapy, and others. The internal beam radiotherapy segment is subsegmented into brachytherapy, systemic beam radiation therapy, and others. The external beam radiotherapy segment held a larger share of the market in 2023. By application, the radiation oncology market is segmented into breast cancer, prostate cancer, lung cancer, head and neck cancer, cervical cancer, and others. The breast cancer segment dominated the market in 2023. The radiation oncology market is segmented into five major regions: North America, Europe, APAC, Middle East & Africa, and South & Central America. Purchase Premium Copy of Global Radiation Oncology Market Growth Report (2021-2031) at: Competitive Strategy and Development Key Players: Major companies operating in the radiation oncology market include Varian Medical Systems Inc, Elekta AB, Accuracy Incorporated, IBA Worldwide (Ion Beam Applications SA), Becton Dickinson & Co, Perspective Therapeutics Inc, Nordion, Mevion Medical Systems, NTP Radioisotopes, and Mallinckrodt Plc. Trending Topics: Personalized medicine, Radiomics, stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) techniques, and combining radiation therapy with immunotherapy, among others. Headlines on Radiation Oncology "Varian has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as CE mark, for Halcyon and Ethos radiotherapy systems." "Varian has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for TrueBeam and Edge radiotherapy systems." "Atlantic Health System and Mevion Medical Systems announced Atlantic Health System's plans to acquire and install a MEVION S250-FIT Proton Therapy System." "Accuray Incorporated entered agreement with TrueNorth Medical Physics LLC to provide radiation oncology departments with third-party support designed to enhance their department's capabilities." "Curium extended its current partnership with NRG I PALLAS for new irradiation services in Petten, Netherlands to produce non-carrier added lutetium-177 (Lu-177)." Obtain Analysis of Key Geographic Markets - Download Report PDF: North America, particularly the U.S., holds a dominant position in the global radiation oncology market. The combination of well-established healthcare infrastructure, high healthcare spending, and an advanced pool of radiation oncology professionals makes the region a key player in driving growth. The projected compound annual growth rate (CAGR) of 12.6% from 2023 to 2031 suggests that North America will continue to lead the market in the coming years, with ongoing support from healthcare authorities and institutions. Overall, with increasing investments in research and development, advancements in technology, and support from both public and private sectors, the radiation oncology market is on a solid growth trajectory, playing a vital role in the ongoing fight against cancer. Conclusion The increasing prevalence of cancer and the rising initiatives to support development in radiation oncology are driving the growth of the radiation oncology market. Key trends such as integration of artificial intelligence and radiomics, developing techniques like stereotactic body radiotherapy ushering in effective, targeted, and simplified treatments for different types of cancer. The growing integration between radiation therapy and immunotherapy is opening new avenues for better efficacy against different types of cancers. In addition, improved access and experience for patients are offered by telemedicine and remote monitoring. Overall, the radiation oncology market is quite promising because research and development, which are already underway, are likely to further elaborate on treatment modalities for enhancing patient outcomes as well as the access rate to care. Therefore, the above-mentioned trends are going to evolve and will play a much more crucial role in changing the scenario in the future as far as cancer treatment is concerned. The report from The Insight Partners, therefore, provides several stakeholders—including radiation oncology equipment manufacturers, radiation oncology systems distributors, and others—with valuable insights into how to successfully navigate this evolving market landscape and unlock new opportunities. Require A Diverse Region or Sector? Customize Research to Suit Your Requirement: The radiation oncology market is categorized based on treatment types and applications. In terms of treatment types, the market is divided into external beam radiation therapy and internal beam radiation therapy. In 2023, external beam radiation therapy held a larger market share due to its widespread use and well-established role in cancer treatment. However, the internal beam radiation therapy segment, which involves the direct delivery of radiation to the tumor site through sources placed inside the body, is expected to register a higher compound annual growth rate (CAGR) during the period from 2023 to 2031. This growth can be attributed to its increasing use in certain cancers and its ability to provide targeted therapy with reduced damage to surrounding healthy tissues. Related Report Titles: Breast Cancer Diagnostics Market Size and Forecasts 2021 - 2031 Liver Cancer Diagnostics Market Analysis, Size, Share, Growth, Trends, and Forecast by 2031 Pancreatic Cancer Therapy Market Report 2031 Peptide Cancer Vaccine Market Size and Forecasts 2021 – 2031 Prostate Cancer Devices Market Size and Forecasts 2021 – 2031 Lung Cancer Market Size and Forecasts 2021 – 2031 Overhead Cranes Market Growth, Size, Share, Trends, Key Players Analysis, and Forecast till 2031 Cervical Cancer Diagnostic Tests Market Size and Forecasts 2021 - 2031 About Us: The Insight Partners is a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We specialize in industries such as Semiconductor and Electronics, Aerospace and Defense, Automotive and Transportation, Biotechnology, Healthcare IT, Manufacturing and Construction, Medical Device, Technology, Media and Telecommunications, Chemicals and Materials. Contact Us: If you have any queries about this report or if you would like further information, please contact us: Contact Person: Ankit Mathur E-mail: [email protected] Phone: +1-646-491-9876 Press Release: Logo: SOURCE The Insight Partners WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

– The INOmax EVOLVE DS is our next-generation nitric oxide delivery system that combines mini-cylinder technology, automation, integration, and interaction into one device1 – – The INOmax EVOLVE DS is now available for contracting and distribution for use in U.S. hospitals – DUBLIN, Oct. 10, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the rollout of the U.S. Food and Drug Administration (FDA) cleared INOmax® EVOLVE™ DS delivery system for the delivery of INOmax® (nitric oxide) gas, for inhalation. This nationwide rollout follows the successful introduction of the INOmax EVOLVE DS Pilot program. The INOmax EVOLVE DS is our next-generation inhaled nitric oxide delivery system with a fully integrated design and includes a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, mini-cylinders, and more.1 The INOmax EVOLVE DS is intended to help meet the needs of neonatal intensive care unit (NICU) patients and healthcare professionals by offering improved automation, which enhances safety features, and a streamlined design that elevates the user experience.1 Please see Applications and Device Warnings below. INOmax is an FDA-approved treatment that is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.2 INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.2 Please see additional Important Safety Information for INOmax below. "We are excited to enter the nationwide rollout phase of our next-generation INOmax delivery system for NICU patients and the hospital staff responsible for their care," said Lisa French, Executive Vice President & Chief Commercial Officer. "This innovation milestone reflects our long-standing commitment to providing delivery system options with comprehensive safety features.1 We will continue to work closely with our customers to support availability of the INOmax EVOLVE DS delivery system." A few of the many INOmax EVOLVE DS features include1: 1.4-lb mini-cylinders Automated pre-use checkout Pre-high-calibrated NO/NO2 gas sensor modules and automatic low calibration Automatic cylinder switching when empty Electronic blender with automatic activation when a minimum amount of oxygen flow has been detected Electronic medical record connectivity that transfers over 100 data parameters3 Touchscreen display with an easy-to-use interface The comprehensive INOmax EVOLVE DS Pilot program provided users the opportunity for an extensive review of our next-generation delivery system. We appreciate each hospital's feedback including one Respiratory Therapist's (RT) statement that, "After using the INOmax EVOLVE DS during the pilot introduction, and in current use, it is evident that Mallinckrodt took the input from bedside RTs into account. The smaller cylinders and streamlined design make it easier to move the device around the hospital and store supplies."1 INOmax has a well-established efficacy and safety profile with more than 20 years on the market and over 875,000 patients treated globally.2,4 In 2023, the INOmax EVOLVE DS was awarded the Human Factors and Ergonomics Society Stanley Caplan User-Centered Product Design Award, presented to teams that have demonstrated outstanding innovation and design for products, software, and systems. Mallinckrodt accepted the award on February 15, 2024. If a customer is interested in learning more about the INOmax EVOLVE DS, they can reach out to their local representative or visit INOmax.com for the latest updates. APPLICATIONS The INOmax EVOLVE DS delivery system delivers INOmax (nitric oxide) gas, for inhalation. The EVOLVE DS must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and is indicated for use in term and near term (>34 weeks gestation) neonates with hypoxic respiratory failure (HRF) associated with clinical or echocardiographic evidence of pulmonary hypertension. The EVOLVE DS is indicated for a maximum of 14 days of use. DEVICE WARNINGS Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the eINOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert. Do not discontinue INOmax delivery if the high NO2 alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate. Do not use equipment that is not specified as part of the system or that is not designed for INOmax mixtures. Using equipment that is not specified can cause the system to malfunction. If an alarm occurs, safeguard the patient first before performing troubleshooting procedures. Use only INOmax, pharmaceutical grade NO. Rx Only For technical assistance or for information on the INOmax EVOLVE DS delivery system, call (877) 566-9466. IMPORTANT SAFETY INFORMATION (Cont'd) Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation. Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues. In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema. Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration. INOmax must be administered using a calibrated FDA-cleared Nitric Oxide delivery system. Please see Full Prescribing Information . ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market, and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to INOmax (nitric oxide) gas, the INOmax EVOLVE™ DS delivery system, the potential of these products to improve health and treatment outcomes, their potential impact on patients and the availability of the INOmax EVOLVE™ DS delivery system in U.S. hospitals in the future. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements, including the clinical guidelines and protocols, and hospital policies and practices; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with INOmax (nitric oxide) gas and the INOmax EVOLVE™ DS delivery system; and other risks identified and described in more detail in the "Risk Factors" section and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K , Quarterly Reports on Form 10-Q, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 908-577-4531 [email protected] Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400582 10/24 References 1 INOmax EVOLVETM DS Operation Manual. Mallinckrodt Pharmaceuticals. 2 INOmax. Package insert. INO Therapeutics LLC; 2023. 3 EVOLVE DS. Serial Data Protocol for versions 01.04.09 and later. Technical Bulletin. TB-23001. Mallinckrodt Pharmaceuticals. 2023. 4 Data on File – Ref-01753. Mallinckrodt Pharmaceuticals. SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED