Chitosan Endoluminal Hemostatic Dressing

AbstractPost-operative bleeding remains the major complication of transurethral and open prostatic surgical procedures. Prolonged bleeding from these procedures causes delayed healing and longer hospitalization which significantly increases the cost of patient care. Moreover, prolonged urethral catheterization due to significant post-operative hematuria is one of the major causes of discomfort and increases the morbidity to the patients after prostatic surgery. Our goal is to develop an advanced hemostatic urinary catheter device (HUCD) assembly to control and prevent prostatic bleeding via transurethral application enabling significant reduction in catheter indwelling time and providing for reduced length of hospital stay following prostatic surgery. In our Phase II study we successfully developed a chitosan endoluminal hemostatic dressing (CEHD) that used a standard Foley catheter for delivery. CEHD success in preclinical testing was demonstrated by i) 75% hemostatic efficacy at 3 minutes in fullly stopping bleeding in a swine splenic capsular stripping model; ii) deliverability in the swine bladder neck model, iii) 100% urethra patency, iv) prolonged dressing to wet tissue adherence (andgt; 48 hours), iv) compliance of the dressing with the urinary tissue, v) 100% removal of the dressing in less than 168 hours by dissolution or flushing; and vi) non-inferiority to TURP hemostasis standard of care.The Phase IIB study will address Foley catheter delivery limitations in the Phase II study by 1) development, to design lock, acceptance andamp; verification of a hemostatic urinary catheter device (HUCD) composed of an advanced balloon catheter with removable sheath (BCRS) and CEHD; 2) demonstrate design- locked HUCD manufacturability (3 Lots), stability, sterility, biocompatibility, safety and efficacy to support an IDE submission for Phase 1 clinical investigation. NarrativeThe HUCD development will rapidly control bleeding and enable reduction in hospital days required for observation following prostatectomy. As well as reducing discomfort associated with extended catheterization, the HUCD development has the potential to significantly reduce the overall cost of hospitalization associated with bleeding following prostatectomy by hundreds of millions of dollars. This development, that addresses the serious unmet need of effective prostatectomy bleeding control, will reduce prostatectomy related morbidity and assist with reduction in mortality.