Lazzaro Medical Scaffold System for improved treatment of tracheobronchomalacia

SUMMARY: Acquired tracheobronchomalacia (TBM) occurs when the internal supporting infrastructure of the trachea and bronchi break down, causing the airway to collapse on itself. TBM is progressive in nature and can lead to ventilator dependency and even death. Since TBM is a purely structural issue in the trachea and bronchi, pharmaceutical interventions have little to no effect. Previously, the only solution was a highly invasive open tracheobronchoplasty that resulted in high morbidity, a long recovery period, and high mortality, limiting its via- bility for broad patient treatment. Dr. Richard Lazzaro pioneered the first minimally invasive robotic TBM repair (R-TBP), a procedural innovation that opened a surgical option for people who would not have previously been surgical candidates. However, today, only the most skilled surgical hands can do the portion of the surgery that is extremely technical. The complexity entails custom fabricating square surgical mesh into geometries that con- form and anatomically reconstruct the patient’s trachea and bronchi. Though a mainstream, minimally invasive, robotically assisted procedure was successfully created, a commercially viable scaffold system designed for TBM repair is needed to enable mainstream thoracic surgeons to easily and safely perform this surgery. Lazzaro Medical has developed a patented scaffold system designed to be easily sutured onto the posterior external trachea and bronchi to help recreate a more anatomically correct airway. The LM Scaffold System™ is comprised of one tracheal scaffold and two bronchial scaffolds specially designed and optimized to reinforce the soft tissue of the airway. As part of an overall go-to-market plan, additional preclinical studies are planned as follows: Aim 1. Method development and validation. We will partner with Inotiv to develop and validate an appropriate in vivo TBM methodology. Tasks include (1.1) replication of ex vivo TBM model in canine cadavers; (1.2) acute feasibility of mesh application to healthy tracheas in live dogs. Aim 2. Product development, verification, and validation of the LM Scaffold SystemTM. We will advance development of the LM Scaffold prototype in parallel with method development and validation activities in Aim 1. Tasks include (2.1) benchtop verification of device specifications throughout iterations in accordance with FDA guidelines; and (2.2) iterative prototype development throughout the method development and validation process. Aim 3. Evaluation of pivotal preclinical efficacy and safety in a TBM ovine model. We will partner with Inotiv to establish IDE-enabling in vivo efficacy and safety using a TBM canine model. Tasks include (3.1) in vivo chronic non-GLP evaluation of feasibility using a control arm, induced arm with no treatment, and induced arm with LM Scaffold SystemTM treatment; and (3.2) GLP chronic 30, 90, and 180 day safety study. Next Steps. Upon completion of IDE-enabling studies, we will have sufficient data for submission and approval to start first in human trials of the LM Scaffold System™.