Laza Medical: Corporate Overview, Products, and Technology Platform

Clinical Need and Industry Context

The Challenge in Intraprocedural Cardiac Imaging

In interventional cardiology, electrophysiology, and structural heart therapies—such as transcatheter valve repairs, replacements, and left atrial appendage closures—real-time ultrasound guidance (e.g., transesophageal echocardiography or intracardiac echocardiography) is essential for guiding catheters, placing devices, and visualizing cardiac structures.

However, conventional intraprocedural ultrasound systems present notable operational constraints: * High Operator Dependency: Acquiring and interpreting real-time 2D and 3D ultrasound views requires extensive specialized training and manual dexterity. * Staffing Shortages: High demand for expert echocardiographers and imaging specialists creates scheduling bottlenecks and limits patient access. * Ergonomic and Workflow Friction: Traditional systems require continuous manual input, tethering clinicians to the ultrasound machine and creating complex coordination requirements between interventionalists and imaging operators.

Laza Medical's Mission

Laza Medical was founded to eliminate these constraints by building an intelligent, automated imaging platform that delivers expertise through software and robotics rather than demanding constant manual intervention from highly specialized operators.

Core Product Platform and Features

The Laza Medical System is an integrated ultrasound imaging solution built for structural heart, electrophysiology, and diagnostic cardiac applications. The system incorporates four core technological pillars:

1. AI-Powered 3D Heart Modeling

• Real-Time Spatial Awareness: Utilizes artificial intelligence algorithms to generate dynamic, real-time 3D digital models of the patient's heart during procedures.
• Continuous Anatomical Context: Provides interventional teams with continuous visual reference points for cardiac chambers, valves, and surrounding anatomical features.
• Simplified Image Interpretation: Translates complex acoustic ultrasound signals into intuitive spatial visualizations, helping operators interpret anatomy without manual image manipulation.

2. Echo-Based Procedural Guidance

• Anatomy and Device Tracking: Incorporates algorithmic tracking that monitors the position of therapeutic catheters and implantable devices relative to cardiac anatomy.
• Step-by-Step Navigation: Intended to guide clinicians through specific procedural milestones by highlighting anatomical targets and tracking interventional tools in real time.

3. Robotic Probe Control

• Automated Navigation: Features precision robotic controls engineered to position and orient the ultrasound probe automatically or semi-automatically.
• Reduced Manual Input: Minimizes the physical burden on clinicians by automating probe adjustments during multi-step interventions.
• Consistent View Acquisition: Enhances repeatability and stability of ultrasound views throughout lengthy interventions.

4. Seamless User Interface

• Procedure-Specific Workflows: Designed around specific clinical tasks, displaying relevant anatomical views and tracking metrics tailored to the current stage of the procedure.
• Operator Autonomy: Streamlines controls to allow interventionalists direct oversight over imaging views, fostering operational confidence and clinical autonomy.

Products, Services, and Clinical Value Proposition

Target Applications

• Structural Heart Interventions: Transcatheter aortic valve replacement (TAVR), mitral valve repair/replacement (TMVR), tricuspid valve therapies, and left atrial appendage occlusion (LAAO).
• Electrophysiology (EP): Catheter ablation for atrial fibrillation and complex ventricular arrhythmias requiring precise cardiac map registration and anatomical boundary definition.
• Diagnostic Cardiology: Advanced 3D echocardiographic visualization for complex cardiac conditions.

Strategic Value Drivers

• Simplified Procedures: Real-time 3D reconstruction and device tracking streamline image interpretation, reducing cognitive load on clinical teams.
• Increased Clinician Autonomy: By automating probe navigation and simplifying view selection, the platform allows imaging specialists to focus on high-value clinical decision-making while giving interventionalists direct control over necessary views.
• Expanded Healthcare Access: By lowering the training barrier required to capture high-quality intraprocedural images, the system enables broader adoption of structural heart and EP procedures across varied hospital environments and community health settings.

Corporate Milestones, Financing, and Regulatory Status

Commercial and Regulatory Status

• Investigational Device: The Laza Medical System is an investigational technology and is not yet approved for commercial sale in any jurisdiction.
• First-in-Human Milestones: Laza Medical has achieved First-in-Human clinical utilization of its real-time AI heart modeling technology for ultrasound-guided cardiac procedures, validating early safety and feasibility concepts.

Financing and Enterprise Backing

• Incubation: Incubated by Shifamed, LLC, a California-based medical technology incubator known for founding and developing cardiovascular startups.
• Series A Funding: Closed a $36 million Series A financing round to advance development, expand engineering and clinical teams, and fund ongoing clinical evaluation.

Executive and Engineering Leadership

Laza Medical is led by executive officers and medical experts with backgrounds in medical robotics, digital health, and cardiovascular imaging:

• Pablo Garcia Kilroy (General Manager): Former VP of Digital Solutions at Johnson & Johnson, co-founder and technology founder of Verb Surgical (joint venture between J&J and Google), with over 20 years of leadership in surgical robotics and medical device R&D.
• Joel Haaf (VP, Market Development): Former commercial leader at Philips, Abbott, and Invitrogen, with experience launching intracardiac echocardiography platforms.
• Tyler Ralston, PhD (VP, Ultrasound Engineering): Advanced imaging pioneer with over 100 patents, former executive leadership at Oxford Nanoimaging, Butterfly Network, and Hyperfine.
• Joan Savall, PhD (VP, Robotics and Systems): Former robotics lead at Verb Surgical, Atomic Machines, and J&J MedTech, specializing in haptics and surgical robotics.
• David Paik, PhD (Sr. Director, Medical Imaging and AI): Former Stanford University radiology professor and AI researcher, author of over 150 scientific publications in computer-assisted medical imaging.
• Marc Bitoun (VP, Research and Development): Former engineering leader at NuVera Medical and Kalila Medical, specializing in catheter, ultrasound, and steerable medical systems.
• Abhi Mukherjee (Sr. Director, Regulatory/Quality Assurance): Former regulatory consultant and leader at Verb Surgical, Cardinal Health, Ethicon, and Stryker.
• Mary Lynn Gaddis (Sr. Director, Clinical Affairs): Former cardiology nurse and clinical director at Volcano/Philips, Baxter, and Verb Surgical.
• Farid Gholitabar, MD, FACC (Medical Director, AI & Data Science): Board-certified cardiologist with data science expertise from UC Berkeley, bridging clinical cardiology with machine learning application.