Landmark Study Targets Minimally Invasive Treatment of Small- to Mid-Sized Abdominal Aortic Aneurysms
Kirkland, WA – August 7, 2023 – Astute Imaging, a leading provider of AI imaging solutions for the healthcare industry, has announced a strategic agreement with Nectero Medical, the developer of the innovative Nectero EAST® (Endovascular Aneurysm Stabilization Treatment) System. Under this partnership, Nectero Medical will utilize Astute Imaging’s cutting-edge imaging technologies in its Phase II/III clinical trial for the treatment of small- to mid-sized abdominal aortic aneurysms (AAA). .
“Astute Imaging and Nectero Medical have been longstanding partners, with Astute Imaging providing advanced imaging services for Nectero Medical’s Phase I clinical trial outside the US.,” said Wael Elseaidy, Ph.D., CEO of Astute Imaging. “We are thrilled about Nectero Medical’s FDA clearance for their IND application to initiate a Phase II/III clinical trial of the Nectero EAST System to treat small-to-mid-sized AAA. Astute Imaging is poised to showcase its technology and services in this prime opportunity.”
Astute Imaging, a pioneering leader in the implementation of image-based real-world-evidence (RWE) and AI technologies, empowers healthcare companies in accelerating pre- and post-regulatory requirements. Leveraging their AI-driven imaging services and advanced surgery planning tool, Preview ®, alongside the image-based registry platform, PEMS ®, Astute Imaging ensures seamless tracking of devices and treatment outcomes post-implantation.
“Astute Imaging’s AI-driven, image-based RWE platform is a major, disruptive technology for medical device companies, enabling near real-time visibility of implanted device performance,” said Ewald de Vries, CTO of Astute Imaging. “This is especially important when coupling the imaging data with outcomes data from electronic medical records (EMR).”
Astute Imaging’s AI technology empowers predictive analysis of device and treatment performance over time, leveraging the invaluable data stored in the company’s image-based registry, PEMS®. With a vast repository of tagged images and measurements spanning more than two decades and encompassing over 340,000 cardiovascular cases, Astute Imaging’s breakthrough imaging AI technologies expertly track devices and treatments, ensuring unparalleled insights into their long-term efficacy.
“Astute Imaging’s technologies and team were instrumental in helping us successfully complete the First-in-Human (FIH) study of 21 patients treated outside of the US,” said Jack Springer, president & CEO, Nectero Medical. “Primary safety and early efficacy results were recently published in the Journal of Vascular Surgery. We look forward to continuing our partnership with Astute Imaging through the execution of the Phase II/III Clinical Trial in an effort to bring the Nectero EAST System, a potentially transformative therapy for small to mid-sized AAA, to patients as quickly as possible.”
Astute Imaging recently announced a notable expansion of its AI-enabled real-world-evidence (RWE) image-guided therapy platform for providers. This expansion aims to foster even stronger collaboration between providers and industry partners, ultimately accelerating the availability of innovative treatments for patients.
“We believe this will also aid medical device and biotech companies in meeting the new EUMDR and FDA post-market surveillance regulatory requirements. We are very excited about our ongoing partnership with Nectero Medical,” added Elseaidy.
About Nectero Medical, LLC
Nectero Medical is developing a novel treatment to stabilize growth and prevent rupture of small- to mid-sized abdominal aortic aneurysms (AAA). The Nectero EAST®, Endovascular Aneurysm Stabilization Treatment, System, delivers a proprietary Stabilizer Infusion Solution to the site of the aneurysm. The technology allows for earlier intervention in a much safer manner. By preventing further degradation of the aneurysm wall and strengthening the surrounding aortic tissue, the Nectero EAST System may allow patients to live out their normal lifespan without the need for challenging endovascular aneurysm repair (EVAR) or surgery. For further information, visit www.necteromedical.com.
About Astute Imaging
Astute Imaging is a healthcare IT solutions company focusing on developing disruptive AI solutions to advance image-guided therapy and procedure planning for cardiovascular and interventional radiology. Astute Imaging also provides cloud-based AI technologies for medical devices companies to streamline their product development, pre-market approvals, and post-market surveillance. To learn more about Astute Imaging and its suite of solutions, visit www.astuteimaging.com
Media Contact:
Laurie Hallwyler