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LumenGuides Achieves Two Major Milestones in Autonomous Lung Diagnostics

First successful animal pilot and prestigious IIA grant mark breakthrough moments for revolutionary Naviscope technology

A Turning Point for Autonomous Lung Diagnostics

We are thrilled to announce two transformative milestones that validate LumenGuides' vision and accelerate our mission to revolutionize early lung cancer detection. These achievements represent years of innovation, dedication, and collaboration coming to fruition.

Founded earlier this year, LumenGuides has rapidly emerged as a pioneer in autonomous bronchoscopy technology. Our Naviscope system — the world's first autonomous, radiation-free, single-use navigation platform — is designed to overcome the limitations of current diagnostic methods and reach peripheral lung lesions that have historically been inaccessible.

🎯 Milestone #1: First Pre-Clinical Animal Pilot

September 4, 2025 | Shamir Medical Center (Asaf Harofeh)

On September 4, 2025, our team achieved a historic breakthrough: Naviscope successfully navigated deep into the lung of our first in-vivo animal model at Shamir Medical Center. This wasn't just a test — it was proof of concept for a technology that could transform interventional pulmonology.

What Made This Achievement Groundbreaking:

  • ✓ Autonomous Navigation: The device independently advanced through multiple airway branches without manual guidance
  • ✓ Precision Under Motion: Maintained accuracy despite continuous respiratory movement
  • ✓ Zero Radiation: No fluoroscopy, CT, or external imaging required
  • ✓ Operator-Independent: Success not dependent on physician skill level or experience

This validation confirms that our fiber-optic sensor technology (FBGs) combined with AI-powered guidance can deliver on the core promise: reaching peripheral lung lesions safely, precisely, and without the limitations of current bronchoscopy systems.

🏆 Milestone #2: Israel Innovation Authority Grant

September 11, 2025 | Maximum R&D Grant Awarded

Just one week after our successful animal pilot, we received exceptional news: LumenGuides has been awarded the maximum Seed Track R&D grant of ₪5.5M from the Israel Innovation Authority (IIA).

What This Grant Represents:

  • National Endorsement: Recognition of our technology's potential impact on healthcare
  • Team Validation: Confidence in our leadership and execution capabilities
  • Clinical Vision: Support for our clear regulatory pathway and clinical strategy
  • Accelerated Development: Resources to advance toward GLP studies and design freeze

This grant is more than funding — it's a powerful vote of confidence from one of the world's leading innovation authorities. It validates our approach and accelerates our timeline toward clinical trials and regulatory approval.

About LumenGuides & Naviscope Technology

LumenGuides is pioneering the next generation of interventional pulmonology through Naviscope — an autonomous, radiation-free, single-use navigation system designed specifically for early lung cancer detection.

How Naviscope Works:

Our revolutionary platform combines three breakthrough technologies:

  1. Fiber-Optic Sensors (FBGs): Provide real-time 3D airway mapping from inside the lungs
  2. AI-Powered Guidance: Enables autonomous navigation through complex bronchial pathways
  3. Single-Use Design: Eliminates cross-contamination risks and reduces procedural costs

Current bronchoscopy systems — even robotic ones — fail to reach approximately 40% of peripheral lung nodules. Naviscope is designed to bridge this critical gap, accessing lesions that were previously unreachable without invasive surgery.

Our Roadmap: What's Next

With these milestones achieved, we're accelerating toward commercial readiness

📋 GLP Pre-Clinical Studies

Comprehensive validation studies to demonstrate safety and efficacy

🔧 Design Freeze

Finalize platform specifications for regulatory submission

🏥 30-Patient Clinical Pilot

Multi-site clinical trial demonstrating real-world performance

📄 FDA 510(k) Submission

Clear regulatory pathway to U.S. market approval

Join Us in Reshaping Lung Diagnostics

We are currently raising $1.5M to complete our $4M Seed Round, building on the ~$1M already raised. This round is scheduled to close on February 1, 2026.

Why Invest in LumenGuides?

  • 💡 First-of-its-kind autonomous bronchoscopy platform
  • ✅ Proven technology with successful in-vivo validation
  • 🏆 Maximum IIA grant demonstrating national confidence
  • 📈 Clear FDA 510(k) regulatory pathway
  • 🌍 Addressing $62.5B global market opportunity
  • 👥 Experienced leadership team with proven track record

We welcome the opportunity to discuss how you can join us in this transformative journey.

The Impact: Why This Matters

Lung cancer remains the leading cause of cancer deaths worldwide, with early detection being the single most critical factor in patient survival. Yet current diagnostic methods leave a dangerous gap:

  • 40% of peripheral nodules remain inaccessible to standard bronchoscopy
  • Competing procedures can exceed $20,000 and carry higher risks
  • Radiation exposure from fluoroscopy and CT guidance poses cumulative health risks
  • Operator dependency creates inconsistent outcomes across facilities

Naviscope addresses each of these challenges head-on. By combining robotics, AI, and fiber-optic sensing, we're creating a paradigm shift in how clinicians detect and treat early-stage lung cancer — potentially saving thousands of lives each year.

"This is not just about better technology — it's about giving patients a fighting chance through earlier, more accurate diagnosis."