RYTEK MEDICAL INC — Department of Health and Human Services STTR Phase I: 102

Description

ABSTRACT The primary objective of surgical therapy for the treatment of patients with any cancer is to remove all cancer cells from within the bodywith the secondary objective of maintaining organ functionThe primary pathological metric used to rate the success of a surgical procedure is evaluation of the surgical margin of the resected tissue specimenpost operativelyThis typically involves cutting the tissue into sections and microscopically exploring these tissue samples for the presence of cancer cells at the marginsCancer cells noted at the margins represent Positive Surgical MarginsPSMsand suggest that cancer cells were left in the body following the procedureAs a resultpatients with PSMs are often exposed to noxious additional procedures to eradicate the cancer cells left behind including radiationchemicalhormonaland additional surgical therapythese all have adverse morbidities that decrease a patientandapos s quality of lifeNo clinical protocols are routinely used to intraoperatively assess surgical margin status during surgical proceduresInsteadmargins are evaluated through microscopic assessment of the tissue following the procedurewhen it is too late to provide additional surgical interventionWe aim to develop an intraoperative device able to assess surgical margin status so that the surgeons can extract additional tissues in real time and ultimately decrease the rates of PSMsWhile our technology can be applied for most cancer surgerieswe are focusing our commercialization efforts on prostate and breast cancer as these are the highest incidence and cause of death for men and womenrespectivelyand because patients with PSMs following these procedures have a much higher rate of recurrence than patients that have negative surgical marginsWe have previously shown that the electrical impedancea property that describes how easily electrical current passes through a tissueof tissue is sensitive to a tissueandapos s cellular arrangement and can be used to distinguish cancer from benign tissue in both prostate and breastWe have developed a prototype flexible endoscopic device capable of sensing electrical impedance of tissue during radical prostatectomy procedures for use in Machine Learning based tissue classification and Electrical Impedance TomographyEITimaging techniquesThis device makes intraoperative focal measurements of margin statusHere we aim to take the significant step of constructing an optimized EII device that can be deployed either laparoscopicallye gprostate surgeryor in open procedurese gbreast surgeryto provide an accurate method of intraoperatively identifying positive surgical marginsWe aim to develop this device and evaluate the technology in an ex vivo study of human prostates to confirm device functionalityBy the end of this program we intend to have developed a low costsingle use probe that can be deployed for intraoperative surgical margin assessmentIn follow on Phase II fundingwe will focus our technical design efforts on developing a custom data acquisition system and visualization platform and preparing for an IDE submission to the FDA PROJECT NARRATIVE The primary objective of cancer surgery is to remove all cancer cells from the body and maintain sufficient organ functionalitycancer left behind in the body following tissue resectionin the form of positive surgical marginsis significantly correlated with cancer recurrenceNo technologies currently on the market are able to intraoperatively evaluate the tissue remaining in the patient to confirm that all cancer has been resectedThe electrical impedance of tissue provides significant contrast between benign and malignant formations and we propose to develop a electrical impedance sensing probe for use in evaluating intraoperative surgical margin status in real time