Every year, more than 600,000 operations are performed to alter the shape of the structural cartilage frameworks of the ear (otoplasty) and nose (rhinoplasty and septoplasty) for both functional and aesthetic purposes, accounting for more than $1 billion in expenditure. Current methods of reshaping cartilage in the head, face and upper airway require carving, cutting, suturing, or crushing this viscoelastic biologic charged polymer into a new desired shape in order to balance the innate forces that resist deformation. The results are highly variable and dependent on the skills and techniques of the surgeon. In addition to the usual risk factors related to conventional surgical interventions, there is an increased healthcare cost due to hospital expenses and loss of productivity due to patient down-time for recovery (e.g., anesthesia, O.R. fees, overnight stays). Praxis Biosciences, LLC aims to develop and deliver a paradigm-shifting minimally-invasive electromechanical cartilage re-shaping device without the unnecessary risks and costs of traditional "cut and suture" surgery. In addition, the minimally invasive ultra low-cost nature of the proposed technology will allow surgeons to "titrate" and perform sequential treatments over time on a given patient in order to alter facial cartilage shape in a measured step-wise fashion, avoiding drastic and noticeable changes that occur with conventional surgery. The proposed device is based on the fact that cartilage mechanical properties change in response to low-level, low-current DC electric fields. Efficacy has already been demonstrated in vivo animal models. In this phase I SBIR proposal, we will build and test a clinic-ready prototype for cartilage re-shaping. Upon successful completion, the device will be used to carry out a first pilot human trial in future Phase II proposals.
More than 600,000 operations are performed each year to treat nasal airway obstruction or to correct external ear deformities. These surgical interventions can add to the cost of care and patient down-time. The proposed product based on a novel electro-mechanical forming of cartilage will enable office-based minimally- invasive treatments at affordable cost.