Abbott Laboratories reports developments across a global healthcare portfolio that includes diagnostics, medical devices, nutritionals and branded generic medicines. Recurring updates cover cardiovascular technologies such as Ultreon coronary imaging, pulsed field ablation and cardiac pacing systems; diabetes and other medical devices; nutritional products; and diagnostic testing.
Abbott news also includes financial results, guidance, product clearances, clinical data presentations, commercial integrations and portfolio changes. Following the completed Exact Sciences acquisition, oncology diagnostics are a recurring theme, including Cologuard, Oncotype DX, Oncodetect, Riskguard and Cancerguard tests for cancer screening, recurrence risk and treatment support.
Abbott (NYSE: ABT) has launched the world’s first glucose sport biosensor, the Libre Sense, designed specifically for athletes to monitor glucose levels in real-time. This innovative product, derived from Abbott’s FreeStyle Libre technology, allows athletes aged 16 and older to optimize their nutrition during sports activities like cycling and running. The biosensor provides continuous streaming data via a mobile app and can be worn for up to 14 days. Initially available in eight European countries, this product aims to enhance athletic performance by helping users manage energy levels effectively.
Abbott (NYSE: ABT) announced the initiation of the LIFE-BTK clinical trial, the first U.S. Investigational Device Exemption trial for a fully resorbable device targeting critical limb ischemia (CLI) in patients with advanced peripheral artery disease (PAD). The Esprit BTK Everolimus Eluting Resorbable Scaffold System aims to improve treatment outcomes by reducing the chance of artery re-narrowing. The FDA granted breakthrough device designation to this technology, which will be assessed for safety and efficacy in 225 patients globally. This trial could mark significant progress in treating PAD.
Abbott (NYSE: ABT) has announced the availability of its FreeStyle Libre 2 continuous glucose monitoring system to Medicare patients. This next-generation system has received approval from the U.S. Centers for Medicare & Medicaid Services for coverage, allowing eligible individuals with diabetes to access this life-changing technology. The FreeStyle Libre 2 sensor is easy to apply, lasts 14 days, and provides real-time glucose readings. Abbott aims to enhance access and affordability for all patients, making it the #1 sensor-based glucose monitoring system in the U.S.
Abbott (NYSE: ABT) has received FDA Emergency Use Authorization for its BinaxNOW™ COVID-19 Ag Card, a rapid test priced at $5 that delivers results in 15 minutes. This portable test enhances mass testing capabilities and relies on proven lateral flow technology. A complementary mobile app, NAVICA™, will allow users to display their test results digitally. Abbott plans to ramp up production to 50 million tests per month by October, contributing significantly to national testing efforts amid the pandemic.
Abbott (NYSE: ABT) has commenced the TactiFlex PAF IDE study to evaluate its investigational TactiFlex Ablation Catheter for treating paroxysmal atrial fibrillation (PAF). With over 16 million individuals affected by AFib globally, the study aims to enroll 355 patients across multiple sites worldwide. The catheter employs contact force technology for enhanced procedural effectiveness. Presently, the device is under clinical evaluation and not yet commercially available, aligning with Abbott's commitment to providing advanced medical solutions for improving patient care.
Abbott has received FDA approval for its Patient Controller app, enabling users with neurological conditions to manage therapy via personal Apple smartphones. This integration aims to enhance the patient experience by eliminating the need for separate devices and facilitating remote therapy management, particularly crucial during the COVID-19 pandemic. The app will be compatible with Abbott's neuromodulation technologies, offering convenience for patients with chronic pain and movement disorders. The rollout is expected in the coming weeks, aligning with Abbott's commitment to advancing digital healthcare solutions.
Abbott reported Q2 2020 sales of $7.3 billion, down 8.2% reported and 5.4% organic. Diluted EPS was $0.30 GAAP and $0.57 adjusted. For 2020, Abbott projects full-year diluted EPS of at least $2.00 GAAP and $3.25 adjusted. Key approvals include the TriClip™ heart valve repair device and FreeStyle® Libre 2 for diabetes monitoring. Notably, Nutrition sales grew 3.1% organically due to strong performance in Adult Nutrition, while Diagnostics surged 23.2%, driven by COVID-19 testing. However, Medical Devices showed a 29% decline.
Abbott (NYSE: ABT) announced a settlement with Edwards Lifesciences Corporation to resolve all patent disputes related to transcatheter mitral and tricuspid repair products. The agreement dismisses all ongoing cases and prohibits future litigation in this field for ten years. Abbott will receive a one-time payment and ongoing payments based on Pascal sales through 2025, plus a potential milestone payment in 2026. This resolution lifts injunctions against Edwards' sales of their repair systems, allowing both companies to focus on business growth.
Abbott (NYSE: ABT) announced on June 26, 2020, that its LightLab Initiative revealed optical coherence tomography (OCT) significantly influences treatment decisions in coronary artery blockages. The study showed that 88% of physicians altered their treatment strategies based on OCT imaging, which provides high-resolution images and detailed insights into arteries. The initial data involved 2,203 procedures across 12 medical centers, emphasizing OCT's value over traditional angiography in procedural planning and patient care.
On June 25, 2020, Abbott (NYSE: ABT) released late-breaking data regarding its structural heart therapies, including the MitraClip™, TriClip™, and Tendyne™ systems. Clinical findings affirm the safety and effectiveness of the MitraClip, showcasing significant MR reduction in over 87% of primary MR patients. Tendyne also showed 93.2% MR elimination at two years. The TriClip demonstrated 87.1% TR reduction and a low one-year mortality rate of 7.1%. The data presented at the PCR e-Course underscores Abbott's commitment to advancing less invasive treatment options for heart valve diseases.