Artificial Intelligence to Assist with Patient Enrollment for AngioDynamics’ AlphaVac System Study on Pulmonary Embolism Treatment

July 25, 2022

AngioDynamics, The PERT Consortium™ and Viz.ai partner on APEX Study to bring innovative treatment to patients with PE

LATHAM, NY, July 25, 2022 – AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, and The PERT Consortium™, a multi-disciplinary team of physicians and clinicians guiding and influencing pulmonary embolism (PE) care, education, and research in institutions across the United States, have announced a new partnership with Viz.ai. 

The partnership with Viz.ai, the leading AI-powered disease detection and intelligent care coordination platform, will facilitate patient enrollment for AngioDynamics’ Study evaluating the treatment of PE with the AlphaVac Multipurpose Mechanical Aspiration F1885 System (“APEX-AV Study”) using Viz.ai’s clinical trial platform, Viz RECRUIT.

The APEX-AV Study, launched in April 2022 in partnership with The PERT Consortium™, is evaluating the safety and efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of acute intermediate-risk PE.

The APEX-AV Study is a single-arm Investigational Device Exemption study that is enrolling patients with confirmed acute, intermediate-risk PE at up to 20 sites in the United States. The primary efficacy endpoint of the APEX-AV Study is the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint is the rate of Major Adverse Events (MAEs), including device-related death and major bleeding within the first 48 hours. Patients will be followed for 30 days post-index procedure.

“The addition of Viz RECRUIT to the APEX-AV Study team is the perfect marriage of artificial intelligence blended with new technology to streamline enrollment in this important trial in the PE space,” said Brent Keeling, M.D., PERT president and APEX-AV principal investigator.

Viz RECRUIT facilitates clinical trial enrollment by using artificial intelligence to identify eligible clinical trial candidates and connects the research team to the clinical care team — all in a secure, HIPAA-compliant environment. With access to hospital imaging, Viz RECRUIT identifies trial-eligible patients in real time, allowing for around the clock discovery with notifications sent to the clinical and research teams wherever they are. Viz.ai’s cloud-based technology broadens the recruitment funnel in both size and diversity by identifying existing patients at hub and spoke hospitals that are trial-eligible, as well as screening patients as they are evaluated. This capability will allow for more efficient enrollment and will streamline workflows and communication at APEX-AV Study sites.

By using AI to automatically identify patients at the time of clinical evaluation, Viz RECRUIT enables real-time recruitment within the health system. Viz RECRUIT’s ability to embed clinical research into the care continuum may speed up enrollment rates*. This translates into timely completion of clinical trials and accelerates the path to market for life-saving therapies.

“We are honored to be the partner of choice alongside AngioDynamics and The PERT Consortium™ helping clinical sites participating in the APEX-AV Study identify potential PE patients, assess eligibility at the time of clinical evaluation, and enable real-time recruitment within the health system,” said Jayme Strauss, Chief Clinical Officer at Viz.ai. “This partnership furthers our company's mission to increase access to lifesaving treatments.”

Viz.ai has collaborated with the APEX-AV Study research coordinators to create a customized workflow designed to facilitate patient enrollment. Artificial intelligence is trained to recognize clinical signals that indicate that a patient could be eligible for the APEX-AV Study. When a potentially eligible candidate is identified within the healthcare system, the research team is alerted within minutes through the platform. This enables the team to evaluate that patient quickly and efficiently for enrollment.

“We are proud to provide this service to our study sites to make sure the right patients have the opportunity to participate in the APEX-AV Study quickly and efficiently,” said Juan Carlos Serna, Senior Vice President, Scientific & Clinical Affairs, AngioDynamics.

Sources: *Jankowitz B. et al 2021,SNIS-E-022;

About the AlphaVac MMA F1885 System

The AlphaVac MMA F1885 System is an emergent first-line device that is currently cleared for the removal of thromboemboli from the venous system. The System includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly. The APEX-AV study was designed to provide safety and efficacy data for a clearance specific to PE. Risk information: https://bit.ly/Angio-risk-info [ML3] [ML4]

The AlphaVac MMA F1885 System when used for treatment of pulmonary embolism is an investigational device. Limited by United States law to investigational use.

About Viz.ai

Viz RECRUIT is part of the Viz.ai intelligent care coordination platform that unifies synchronized care collaboration, high fidelity mobile image viewing, automated workflows and improved visibility at decision-making moments. The Viz.ai mission is to fundamentally improve how healthcare is delivered in the world, through intelligent software that promises to reduce time to treatment, improve access to care, and increase the speed of diffusion of medical innovation. Viz.ai is already helping to coordinate care across a broad list of clinical applications, including neurovascular and cardiovascular diseases in more than 1,000 hospitals.

Viz.ai’s life science portfolio, including Viz RECRUIT, expands the power of the AI-powered Viz Platform to pharmaceutical and medical device companies who are leaning into digital transformation to bring life-saving therapies to market more efficiently. The company was named to the Forbes 2021 Next Billion-Dollar Startups list of the 25 fastest-growing venture-backed startups and has been on the Forbes AI 50 list for three consecutive years. For more information visit viz.ai.

About The PERT ConsortiumTM

The purpose of The PERT ConsortiumTM is to serve the general public by undertaking activities to advance the status of PE care and promote research in the treatment of pulmonary embolism. Specifically, the Consortium’s purpose is to:

Promote the adoption of the PERT model in healthcare institutions across the United States to ensure the prompt diagnosis and treatment of pulmonary embolism.

Expand the current body of scientific literature on the diagnosis and treatment of pulmonary embolism through the funding of scientific endeavors.

Educate the general public and healthcare professionals regarding pulmonary embolism diagnosis, treatment, and care.

By focusing solely on the entity of pulmonary embolism – its etiology, pathophysiology, prevention, management approach, outcomes of specific treatments, and follow-up pathways – it is the intention of the Consortium to increase awareness of treatment options available to patients with PE, to reduce its incidence worldwide, to improve health outcomes, and to positively influence the impact of this terrible disease.

About AngioDynamics, Inc.

AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients.

The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.

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