Image-guided automated ultrafast laser device for laryngeal surgery to expand treatment options and improve patient outcomes

FemtoVox is building an image-guided automated ultrafast laser technology for voice box (larynx) surgery. Current solutions using scalpels or traditional lasers aren’t automated (take longer), cause more damage (more complications, longer wound healing), are imprecise (require repeat surgeries) and can set patients’ airways on fire (higher liability). Our system provides real-time cross-sectional imaging using optical coherence tomography (OCT). This allows surgeons to select the exact excision depth and automate laser scanning to remove the defined tissue volume with higher precision. In contrast to existing solutions, ultrafast lasers produce no collateral damage (due to their extremely short picosecond or femtosecond pulse durations). Overall, our solution will be better: improved clinical outcomes, higher efficiencies and increased throughput. With industry-leading experience commercializing automated ultrafast laser ophthalmic surgical devices (Intralase, LenSx, Vialase), we have the expertise, vendor relationships and professional network to commercialize this device. We aim to target the $1.8B spent annually (US) on laryngeal surgery. Our technology is the superior solution for the ~120,000 larynx surgeries performed annually in the US. In addition to these existing cases, there’s a large and compelling opportunity for the ~400,000 annual larynx benign lesion diagnoses, which are rarely operated on (~5% of diagnoses) due to collateral damage concerns, which leaves many patients (and surgeons) with no solutions. In the long term, we envision a platform technology for broader ENT deployment (rhinology, oral cavity, throat). With the potential to greatly improve laryngeal surgical outcomes, this technology aligns closely with the NIH’s mission of improving health-related outcomes. We see the larynx as a well-suited beachhead for the first non- ophthalmic ultrafast laser application for several reasons. Firstly, laryngologists or comprehensive ENTs operating on the larynx are very familiar with lasers; however, current lasers cause too much collateral damage, 25% of existing laser surgeries require re-treatment and conservative speech therapy has high failure rates. Secondly, the larynx has very sensitive tissue for which automation and higher precision can preserve more tissue. Lastly, larynx tissue is quite thin and optically transmissible, ideal for OCT imaging. The project has three specific aims in its Phase I stage. The first aim is to demonstrate the superiority of ultrafast lasers in minimizing collateral damage in laryngeal tissue. The second aim focuses on characterizing ultrafast laser-based coagulation using the Chick Chorioallantoic Membrane (CAM) as a preclinical in vivo model. The third and final aim is to demonstrate sub-surface excisions in cadaveric laryngeal tissue, a groundbreaking capability that could revolutionize laryngeal surgery as many benign lesions are sub-epithelial. Completion of all these aims will define the optimal instrument design and operating parameters to advance into Phase II in vivo animal studies.