Exactice Medical and ImSonic Announce Product Development and Supply Agreement for AIM Device in Transseptal Procedures

Collaboration Designed to Generate Advanced Prototype for Preclinical Testing and Seek 510(k) Clearance

Exactice Medical Press Release

SAN DIEGO -- Exactice Medical, Inc. today announced a definitive agreement with ImSonic Medical, Inc. to complete advanced prototype development of its AIM device—the industry’s first combined imaging and transseptal access solution, designed to make transseptal procedures faster, safer, and more cost-effective. Exactice’s proprietary AIM device combines 2D/3D intracardiac echocardiography (ICE) with a fully integrated, deployable steerable needle guide. The needle guide remains continuously within the ultrasound plane of view, eliminating the need for operator coordination of two devices with intermittent visualization. This streamlined design simplifies transeptal access, improves precision targeting of the septum, reduces risk of an off-target puncture, and optimizes procedural workflow. Under this agreement, Exactice secures exclusive rights to develop, commercialize, and distribute ImSonic’s advanced imaging technology as incorporated into the AIM device for use in electrophysiology and interventional cardiology procedures.

“Through our collaboration with ImSonic, we are incorporating best-in-class ICE imaging into the AIM device to deliver a simpler, more precise, and highly streamlined approach to transseptal procedures,” said Michael Naumann, MD, founder and President of Exactice. “The AIM device represents the next generation of image guidance and transseptal access. Combined with ImSonic’s state-of-the-art imaging technology, advanced catheter design, and development capabilities, we believe the AIM device has the potential to transform one of the fastest-growing areas in cardiology by delivering a more efficient workflow and greater value for clinicians, patients, and healthcare systems. Following completion of our preclinical animal studies, we plan to pursue 510(k) clearance for the device.”

ImSonic specializes in the development and manufacturing of advanced technologies for medical imaging and interventional procedures, with a focus on integrating diagnosis and therapy into unified solutions. The company emphasizes disposable, single-use devices that support noninvasive and minimally invasive interventions. Leveraging its proprietary 2D/3D intracardiac echocardiography (ICE) catheter imaging technology, along with deep expertise in catheter design and manufacturing, ImSonic provides a strong technical foundation to support Exactice in the development of the AIM device. “Partnering with Exactice enables us to apply our imaging and catheter technologies to an innovative solution with significant clinical potential,” said Xiaohui Hao, PhD, founder and Chief Executive Officer of ImSonic. “We see significant synergy between our technologies, with the potential to accelerate growth and innovation in the transseptal market.”

About the AIM Device

More than one million transseptal (TS) procedures are performed worldwide each year, underscoring the growing need for safer, faster, and more precise access across the atrial septum. The Advanced Intravascular Maneuvering (AIM) device is purpose-built to meet this need, offering clear advantages over conventional two device approaches. Exactice’s 14Fr AIM device integrates proprietary intracardiac echocardiography (ICE) imaging into a single, streamlined solution for transseptal access—designed to simplify procedures, enhance precision, and improve overall efficiency.

About Exactice

Exactice Medical is committed to revolutionizing cardiac procedures through innovation. The company is developing the AIM device, the first fully integrated solution combining imaging and transseptal access, designed to improve procedural precision, enhance safety, and deliver better outcomes for patients undergoing transseptal cardiac interventions.

About ImSonic

ImSonic Medical is focused on advancing interventional procedures through the development of innovative technologies that integrate diagnosis and treatment into a single platform, with a particular emphasis on disposable solutions. The company is also incorporating AI-driven capabilities into its ultrasound imaging platform to support the full clinical workflow, from planning and real-time guidance to treatment monitoring, evaluation, and follow-up.