INCIPIAN LLC — Department of Health and Human Services SBIR Phase I: NIDCR

Description

DESCRIPTION provided by applicant Approximately in people or million people in USA suffer from deviated septum and related nasal obstruction Nasal septoplasty a surgical approach is reserved as the last resort for patients with severe symptoms so patients only opt to receive septoplasty as part of a cosmetic rhinoplasty Those with less severe symptoms would stick with long term pharmacologic treatments which ultimately overburden the current health care system It is estimated that at least septoplasties are performed annually ranking in the top ten of the most common surgical procedures performed in the U S Recently laser cartilage reshaping LCR has been demonstrated clinically as a minimally invasive alternative procedure Despite the simplicity of the procedure LCR has not been widely adopted by the clinicians due to the following barriers a lack of availability of cost effective laser system fr cartilage reshaping and b heat related tissue damage from lack of proper cooling method Our ultimate goal is to address these barriers by delivering a safe and user friendly laser therapy system for routine septoplasty in cost effective manner In this Phase SBIR proposal we will build and test a clinic ready prototype new laser system and a probe with tissue cooling feature for septoplasty cartilage re shaping Upon successful completion the device will be used to carry out a first pilot human trial in future Phase proposals PUBLIC HEALTH RELEVANCE Approximately in people or million people in USA suffer from deviated septum and related nasal obstruction It is estimated that at least septoplasties to correct septal deviations are performed annually ranking in the top ten of the most common surgical procedures performed in the U S These surgical interventions can add to the cost of care and patient down time The proposed product based on a novel laser reshaping of cartilage will enable office based minimally invasive treatments at affordable cost