Chronic Limb-Threatening Ischemia

ISM-001 is a potential first-in-class antibody that may lead to a new treatment pathway for patients with peripheral arterial disease (PAD) Company enters strategic collaboration with Pfizer Ignite to accelerate IND-enabling regulatory studies NOTTINGHAM, England, Oct. 15, 2024 /PRNewswire/ -- IsomAb Ltd, a UK-based biotechnology company developing isoform-specific disease modifying antibody treatments for serious and life-threatening diseases, today announced the nomination of a Development Candidate for peripheral arterial disease (PAD). ISM-001 is a potential first-in-class, therapeutic antibody designed to neutralise VEGF-A165b, the anti-angiogenic VEGF-A splice isoform which acts as a brake on development of new blood vessels leading to chronic limb threatening ischaemia (CLTI). ISM-001 is being advanced into a program of pre-clinical studies necessary for gaining approval to enter first-in-human clinical trials. IsomAb has also entered into a strategic collaboration with Pfizer Ignite to support preclinical development and IND-enabling studies for ISM-001. Pfizer Ignite is an end-to-end service for biotech companies with therapeutics in Pfizer's strategic focus areas that leverages Pfizer's significant R&D capabilities, scale and expertise to accelerate the development of breakthrough therapies. IsomAb will retain ongoing decision-making autonomy and full rights to the program throughout the collaboration. More than 230 million people worldwide are living with PAD; key risk factors for developing the disease are type 2 diabetes, obesity, high blood pressure and high cholesterol levels. CLTI develops in patients due to lack of resources in primary care and of effective treatments, which results in a high risk of amputation; this has been estimated at 25% at one year1. Jackie Turnbull, CEO of IsomAb Ltd, said: "Today's announcement represents an important milestone for IsomAb and we continue to be encouraged by the potential of ISM-001 as a first-in-class treatment for patients with PAD, especially type 2 diabetics with CTLI at high risk of amputation. We appreciate the devastating loss of losing a limb and the impact on the lives of patients who have very limited treatment options. Given Pfizer's strong commitment, extensive capabilities and deep expertise in developing new therapeutics, we are proud to partner with them to support the development of ISM-001, a transformative treatment for patients with PAD. We look forward to realising the full potential of ISM-001." Kathy Fernando, SVP, Global Head of Pfizer Ignite said: "We look forward to collaborating with IsomAb to advance the preclinical and IND-enabling studies for ISM-001. Pfizer has a strong history developing and implementing trials for vascular diseases, and we plan to leverage this expertise to support and advise IsomAb on their journey to translate compelling science into a potential new first-in-class treatment option for patients with peripheral arterial disease." 1 - Eur J Vasc Endovasc Surg (2020) 60, 643 - 644 Read more about IsomAb at SOURCE IsomAb Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Shockwave E8 Augments IVL's Capabilities for Physicians Treating Peripheral Arterial Disease Above and Below the Knee SANTA CLARA, Calif., Sept. 16, 2024 /PRNewswire/ -- Shockwave Medical, Inc., part of Johnson & Johnson MedTech* and a global leader in the field of circulatory restoration, announced the full U.S. launch of the Shockwave E8 Peripheral IVL Catheter, following clearance by the U.S. Food and Drug Administration (FDA). The Shockwave E8 catheter is designed to optimize the treatment of patients with calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI). Continue Reading Shockwave E8 Peripheral IVL Catheter PAD affects more than eight million people aged 40 and older in the United States.1 People suffering from PAD have not only impaired quality of life but also increased risk of heart attack or stroke.2 CLTI is the most advanced and serious form of PAD, impacting nearly 2 million patients in the U.S. It is associated with 40% major amputations at 1 year, and a 50% mortality rate at 5 years,3 worse than most forms of cancer. "Shockwave's newest peripheral catheter offers significant improvements that will help physicians refine their treatment algorithm and better support challenging patients with heavily calcified disease," said Venita Chandra†, M.D., Vascular Surgeon and Clinical Associate Professor, Division of Vascular Surgery, Stanford Health Care. "The catheter's ability to treat long lesions and its extended reach enable safe and effective treatment of some of our most difficult-to-treat patients, including those with CLTI, a complicated and severe disease state with a high mortality rate." With four hundred pulses delivered twice per second, and eight emitters across an 80cm balloon, Shockwave E8 can treat longer lesions more efficiently. With an increased catheter working length of 150cm, physicians can extend their IVL treatment to reach below-the-knee and very distal lesions. Combined with Shockwave L6, Shockwave M5+, and Shockwave S4 IVL catheters, the addition of Shockwave E8 offers physicians a complete IVL portfolio to treat challenging calcified lesions across the entire peripheral anatomy. "Shockwave E8 represents our commitment to physician-guided innovation while maintaining the simplicity and effectiveness of our IVL technology," said Isaac Zacharias, President, Shockwave Medical. "We have received very positive physician feedback on Shockwave E8 and look forward to establishing it as our new workhorse peripheral IVL catheter for physicians addressing challenging calcium above and below the knee." About Shockwave Medical Shockwave Medical, part of Johnson & Johnson MedTech, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at . Follow us at @JNJMedTech and on LinkedIn. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, regarding the Shockwave E8 catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Shockwave Medical, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. Neither Shockwave Medical, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. * Comprising the surgery, orthopaedics, vision, and cardiovascular businesses within Johnson & Johnson's MedTech segment. † Dr. Chandra is a paid consultant for Shockwave Medical. She has not been compensated in connection with this press release. 1 2 3 Media Ryan Carbain [email protected] Investors Tracy Menkowski [email protected] SOURCE Johnson & Johnson MedTech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Latham, New York-based AngioDynamics designed Auryon for the treatment of peripheral artery disease (PAD). That includes critical limb ischemia (CLI) and in-stent restenosis (ISR). Auryon uses revolutionary solid-state laser technology to treat PAD lesions and occlusions effectively. AngioDynamics describes it as the first laser atherectomy system to efficiently treat lesions of any type, length or location (above and below the knee) with minimal impact on vessel walls. The system uses a 355nm wavelength laser platform, enabling the use of short UV laser pulses with targeted biological reactions. These offer effectiveness in treating PAD while minimizing the risk of perforation. It also preserves the ability to vaporize lesions without thermal ablation. It also features aspiration and off-set capability in certain catheter sizes. This enables clinicians to address the risk of embolization and to treat all lesion types. The system also answers a need for non-surgical intervention options for PAD, AngioDynamics says. Auryon received FDA 510(k) clearance in 2020 and has treated more than 50,000 patients in the U.S. to date. CE mark enables AngioDynamics to bring its PAD treatment to Europe and expands the company’s reach within the valuable market. “The CE mark approval of the Auryon System is a significant milestone that underscores our commitment to bringing safe and effective solutions to healthcare professionals treating peripheral artery disease,” said Laura Piccinini, AngioDynamics SVP and GM of endovascular therapies and international. “This approval validates the clinical value of the Auryon System and allows us to expand our presence in Europe, as the prevalence of PAD continues to grow across the region. We are committed to supporting physicians with innovative technologies that empower them to deliver the best possible care when treating some of the most challenging cases of this disease.”