Dupuytren Contracture

- Endo is the first pharmaceutical company to launch an external spatial computing program. - The Spatial Computing Injection Simulator allows hand specialists to interact simultaneously with both physical and digital objects—blending a physical hand model and digital content via an Apple Vision Pro app—to help refine their injection technique. - All members of Endo's orthopedics sales team are able to offer the experience to healthcare providers. MALVERN, Pa., March 26, 2025 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of a first-of-its-kind initiative for a pharmaceutical company: the Spatial Computing Injection Simulator. The simulator leverages the power of spatial computing (also called "mixed reality") to augment a fully immersive learning environment for healthcare providers on Apple Vision Pro. Experience the interactive Multimedia News Release here: Continue Reading Video Demonstration of Endo's Spatial Computing Injection Simulator User view of the spatial computing experience showing prompts, resources, and guidance "The Spatial Computing Injection Simulator represents a major leap forward in enhancing patient care through a groundbreaking educational tool," said Justin Mattice, Senior Vice President & General Manager, Branded Specialty at Endo. "We're proud to pioneer this capability in the pharmaceutical industry, paving the way for future innovations that will help transform how healthcare professionals learn and gain hands-on experience." Endo designed the Spatial Computing Injection Simulator to help hand specialists refine their injection technique in the hand for the administration of XIAFLEX® (collagenase clostridium histolyticum), the only FDA-approved nonsurgical treatment for Dupuytren's contracture when a "cord" can be felt. Do not receive XIAFLEX® if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX®, or to any other collagenase product. The Experience The Spatial Computing Injection Simulator allows providers to interact with both physical objects and digital content simultaneously via a lifelike hand simulator model and an Apple Vision Pro app. During the immersive, 20-minute experience, hand specialists receive "hands on" practice on reconstitution and injection angles, watch procedures in action, practice their injection technique on the hand model, and acquire information on the post-injection process. This can help them refine their technique for the treatment of real patients with XIAFLEX, which is injected into the collagen "cord" causing the hand contracture.1 XIAFLEX represents an important treatment option to help appropriate patients.1 Early Reactions and Reviews Endo recently previewed the technology at two premier medical conferences and generated interest and buzz for the program. At both the American Society for Surgery of the Hand (ASSH) and American Association for Hand Surgery (AAHS) annual meetings, healthcare providers lined up to try on the headsets and test their injection technique. In total, more than 600 hand specialists used the Spatial Computing Injection Simulator during the previews. "Technology like this can make a huge difference for a hand surgeon or advanced practice provider in treating Dupuytren's contracture nonsurgically," said Dr. Jason Fanuele, an orthopedic surgeon who specializes in hand and upper extremity. "In my practice, we value a hands-on approach to learning, and this is the next-best thing to actually doing an injection in someone's hand—maybe even better thanks to the educational resources and context." Now, all members of Endo's orthopedics sales team are able to offer the experience to healthcare providers. Endo worked with technology agency Lucid Dream to create the Apple Vision Pro app and spatial computing experience. About Dupuytren's Contracture Dupuytren's contracture is a lifelong condition that may get worse over time. It's caused by a buildup of collagen in the hand, which forms a rope-like cord that pulls fingers toward the palm so they can't be straightened. As Dupuytren's contracture progresses, it may become difficult for individuals to use their hand(s) for daily tasks and activities.2,3 Dupuytren's contracture affects an estimated 17 million Americans.4,5* WHAT IS XIAFLEX®? XIAFLEX is a prescription medicine used to treat adults with Dupuytren's contracture when a "cord" can be felt. It is not known if XIAFLEX is safe and effective in children under the age of 18. IMPORTANT SAFETY INFORMATION FOR XIAFLEX Do not receive XIAFLEX if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX. XIAFLEX can cause serious side effects, including: Tendon rupture or ligament damage. Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit Nerve injury or other serious injury of the hand. After finger procedures, some people developed tears in the skin (lacerations), and local skin and soft-tissue necrosis (death of skin cells). Some lacerations and necrosis required skin grafting, or other surgery including amputation. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX: hives swollen face breathing trouble chest pain low blood pressure dizziness or fainting Fainting. Fainting (passing out) or near fainting can happen in people who receive XIAFLEX, especially following finger procedures If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. Increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you. Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines if you are unsure. The most common side effects with XIAFLEX for the treatment of Dupuytren's contracture include: swelling of the injection site or the hand bruising or bleeding at the injection site pain or tenderness of the injection site or the hand swelling of the lymph nodes (glands) in the elbow or armpit itching breaks in the skin redness or warmth of the skin pain in the armpit Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. Rx Only Click for full Prescribing Information, including Medication Guide. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Mr. Mattice and Dr. Fanuele and any statements relating to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the research and development and the regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; and the effectiveness of advertising and other promotional campaigns. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. *Dupuytren's contracture prevalence estimation calculation: average Dupuytren's contracture prevalence in the US (5%) multiplied by US population (332 million per 2021 US Census data) = ~17 million. References XIAFLEX® [Prescribing Information]. Rochester, MI: Endo USA, Inc. Hurst LC, Badalamente MA, Hentz VR, et al. N Engl J Med. 2009;361(10),968-979. Bayat A, McGrouther DA. Management of Dupuytren's disease--clear advice for an elusive condition. Ann R Coll Surg Engl. 2006;88(1):3-8. "How common is Dupuytren disease?" Dupuytren Research Group. April 1, 2017. Accessed January 13, 2025. "U.S. and world population clock." U.S. Census Bureau. Updated April 13, 2023. Accessed January 13, 2025. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MALVERN, Pa., March 24, 2025 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today that data related to the use of XIAFLEX® (collagenase clostridium histolyticum, or CCH) for the treatment of recurrence of Dupuytren contracture following surgical correction will be presented during the Triennial Congress of the International Federation of Societies for Surgery of the Hand (IFSSH) and International Federation of Societies for Hand Therapy (IFSHT), taking place March 24-28, 2025. Dupuytren contracture is a progressive hand condition in which a collagen rope-like cord forms beneath the skin of the palm, pulling fingers inward toward the palm.1,2 It affects an estimated 17 million Americans.3,4* "These findings may help healthcare providers manage Dupuytren contracture in patients experiencing a recurrent deformity following initially successful surgery," said Dr. Clayton A. Peimer, Adjunct Clinical Professor of Orthopedics at the Warren Alpert Medical School of Brown University, and lead author of the study. "The use of collagenase in these cases provides an alternative to repeat surgery. I look forward to sharing this information with the medical community so that we can further enhance our understanding of treatment options for recurrent Dupuytren contracture and, ultimately, improve patient outcomes." The presentation covers data from the Phase 4 retrospective study of treatment with XIAFLEX in Dupuytren contracture patients with disease recurrence after surgical correction. The Endo-sponsored presentation is below: Treatment of Dupuytren Contracture Recurrence After Surgery with Collagenase Clostridium Histolyticum: A Retrospective Multicenter Series Authors: Clayton A. Peimer, MD; Marie A. Badalamente, PhD; Philip Blazar, MD; Keith A. Denkler, MD; William Dzwierzynski, MD; Mark Elzik, MD; F. Thomas D. Kaplan, MD; Jason A. Nydick, DO; Gary M. Pess, MD; James Verheyden, MD; Mark A. Vitale, MD; Jeffrey Andrews, MS; Qinfang Xiang, PhD; David Hurley, MD; Lawrence C. Hurst, MD About the Study This Phase 4, multicenter, noninterventional, retrospective study analyzed medical records collected from 10 clinical centers in the United States (U.S.). Patients were included who experienced recurrence of Dupuytren contracture ≥ 6 months after a previously successful surgical correction and were then treated with collagenase clostridium histolyticum (CCH) between January 1, 2010 and August 15, 2020. Primary endpoints were the measured joint contracture change from baseline, at first and last clinical evaluation within 12 months of CCH treatment of metacarpophalangeal and proximal interphalangeal joint contractures. Secondary endpoints were clinical success (percentage of joints with reduction in contracture to 0–5°) and adverse events. Results from this Phase 4 retrospective study demonstrated that CCH was effective and well tolerated for the treatment of Dupuytren contracture recurrence in patients after surgery. Most adverse events were rated as mild in severity and there were no reported treatment-related serious adverse events. About Dupuytren Contracture Dupuytren contracture is a lifelong condition that may get worse over time. It's caused by a buildup of collagen in the hand, which forms a rope-like cord that pulls fingers toward the palm so they can't be straightened. As Dupuytren contracture progresses, it may become difficult for individuals to use their hand(s) for daily tasks and activities.1,2 WHAT IS XIAFLEX®? XIAFLEX is a prescription medicine used to treat adults with Dupuytren's contracture when a "cord" can be felt. It is not known if XIAFLEX is safe and effective in children under the age of 18. IMPORTANT SAFETY INFORMATION FOR XIAFLEX Do not receive XIAFLEX if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX. XIAFLEX can cause serious side effects, including: Tendon rupture or ligament damage. Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit Nerve injury or other serious injury of the hand. After finger procedures, some people developed tears in the skin (lacerations), and local skin and soft-tissue necrosis (death of skin cells). Some lacerations and necrosis required skin grafting, or other surgery including amputation. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX: hives swollen face breathing trouble chest pain low blood pressure dizziness or fainting Fainting. Fainting (passing out) or near fainting can happen in people who receive XIAFLEX, especially following finger procedures If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. Increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you. Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines if you are unsure. The most common side effects with XIAFLEX for the treatment of Dupuytren's contracture include: swelling of the injection site or the hand bruising or bleeding at the injection site pain or tenderness of the injection site or the hand swelling of the lymph nodes (glands) in the elbow or armpit itching breaks in the skin redness or warmth of the skin pain in the armpit Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. Rx Only Click for full Prescribing Information , including Medication Guide . About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Dr. Peimer and any statements relating to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the research and development and the regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; the proposed business combination transaction between Endo and Mallinckrodt; and the effectiveness of advertising and other promotional campaigns. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. *Dupuytren contracture prevalence estimation calculation: average Dupuytren contracture prevalence in the U.S. (5%) multiplied by U.S. population (332 million per 2021 U.S. Census data) = ~17 million. References: Hurst, LC, Badalamente, MA, et al. New England Journal of Medicine.2009;361(10),968-979. Bayat, A, McGrouther, DA. Annals of the Royal College of Surgeons of England. 2006;88(1),3-8. "How common is Dupuytren disease?" Dupuytren Research Group. April 1, 2017. Accessed January 13, 2025. "U.S. and world population clock." U.S. Census Bureau. Updated April 13, 2023. Accessed January 13, 2025. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Mallinckrodt and Endo, pharmaceutical companies that have each encountered business struggles, announced Thursday a $6.7 billion merger that they contend will result in a combined entity with the scale and flexibility to grow. When the deal closes, Endo will become a wholly owned subsidiary of Mallinckrodt. The combined company will take on a yet-to-be-determined name and is expected to trade on the New York Stock Exchange. Its headquarters will be in Dublin, where Mallinckrodt is currently based. Headquarters for the U.S., where the combined company will have most of its operations, will be determined at a later date. Globally, the combined business will have 17 manufacturing facilities, 30 distribution centers, and 5,700 employees. Mallinckrodt and Endo each sell branded and generic products. Mallinckrodt’s portfolio includes Acthar Gel, which has approvals for treating several autoimmune and inflammatory disorders. Endo markets Xiaflex, a drug approved for Dupuytren’s contracture and Peyronie’s disease. Each company also market opioid drugs, and both have been involved in opioid litigation that contributed to financial difficulties. Mallinckrodt reorganized under bankruptcy protection twice, first in 2020 and again in 2023. Mallinckrodt was delisted from the New York Stock Exchange following the second bankruptcy. Endo filed for bankruptcy protection in 2022; its shares trade over the counter. The Malinckrodt/Endo merger is expected to close in the second quarter of this year. On a pro forma basis, the combined business is expected to generate $3.6 billion in revenue in 2025. In the combined company’s first year, about $75 million in pre-tax synergies are expected from integrating the two business as well as R&D savings. The plan is for the combined entity to also shed some operations. The generic pharmaceuticals businesses of both legacy companies will be combined with Endo’s sterile injectables business. That combined business will be spun out at a later date, subject to customary approvals. With the merger, Mallinckrodt’s existing debt is expected to be refinanced while Endo’s debt is expected to remain outstanding. The two companies will finance the transaction with cash on hand as well as $900 million that Goldman Sachs has committed to Endo. Under terms of the merger agreement, Endo shareholders will receive $80 million in cash, subject to possible adjustment. Those shareholders will own 49.9% of the combined company; Mallinckrodt shareholders will own 50.1%. The boards of directors of both companies have approved the transaction, which still needs shareholder and regulatory approvals. When the deal closes, Paul Efron, an Endo board member, will be chair of the combined company’s board. Siggi Olafsson, Mallinckrodt’s current president and CEO, will take on that role for the combined company and will also be a member its board. “Our businesses are highly complementary, with durable, on-market products in our branded portfolios and extensive capabilities across the value chain in our generics businesses,” Olafsson said in a prepared statement. “This exciting combination will create a larger and more diversified entity with the scale and resources needed to unlock the full potential of both companies. Additionally, with a strong pro forma balance sheet and compelling synergy opportunities, we will have greater flexibility to invest in innovation and pursue growth opportunities.”