ACTUATED MEDICAL, INC. — Department of Health and Human Services SBIR Phase I: 300

Description

The SBIR Fast track developstestsand commercializes theActive Disposable Cap for EndoscopeACETip Stabilization and Complete Visualization and Dissection of Serrated Sessile PolypsThe disposable system includes a distal connecting capallowing a clinician to manipulate tissue and perform targeted aspiration during complex polypectomies using proximal controlswithout occupying the endoscopic working channelPublic Health ProblemIn the U Scolorectal cancer is one of the most deadly and costly forms of cancerCurrent endoscopy tools are inadequate to consistently enable full resection of colon polypsEven polyps andltmm have an estimatedincomplete resection rateLargerandgtcmcomplicated polypse gflat sessile lesionsare particularly prone to recurrence and malignancyimpacting patient care and healthcare costsRates of standard piecemeal resectionwhich is significantly associated with residual polypincreases fromat andltcm tofor polyps andgtcmEndoscopic submucosal dissectionESDenabled en bloc removal of andgtcm polyps inof casesand showed atumor recurrencein one Japanese studythough this expertise is limited outside this geographic regionIn nearly all other countriesrates of en bloc ESD are well belowand ESD procedures take overminutes compared tominutes for piecemeal resectionOpen surgical resection further increases risks and costsThe goal of this proposed project is allowing a safe and effective en bloc ESD with full lesion removal to be performed rapidlyPhase I HypothesisACE enables en bloc resection of large simulated polyps and acceptable forces on tissues in vitroand demonstrates improved working capabilities in vivo with any damage to porcine colon limited to the mucosaAimACE demonstrates improved polypectomy functionality and demonstrates safety from perforation in bench modelsAcceptance CriteriaFavorable clinician response on ACE capabilities and performance based onpoint Likert scaleandsuccessful en bloc resections ofcmdifficult lesions in vitroAimConfirm safety and efficacy feasibility of ACE in pilot preclinical studyAcceptance CriteriaPilot in vivo studyNsuccessfully achieves simulatedcm polyp removal en bloc in porcine model with no significant colon damage or adverse events at up tohours post procedurePhase II HypothesisACE is safe and effective for improving endoscopic access and stabilityand complete lesion removalduring complex polypectomies in the colonAimVerification and validation to support regulatory submissionsAcceptance CriteriaPass acceptance criteria on each individual testAcceptance criteria are set on an individual test basis using a riskbased approachAimDemonstrate faster en bloc resection and same or better safety with ACE versus endoscope onlySubmission of the De Novo premarket application to the FDAAcceptance CriteriaACE reduces en bloc resection procedure time relative to endoscope only resectionNpandltandltwith the same or less visual and histological mucosal damage and no adverse eventsFDA De Novo submission Project NarrativeRelevanceAt leastmillion endoscopic polyp removalpolypectomyprocedures are performed in the U Sannually as part of a regimen for prevention of colorectal cancerone of the leading causes of cancerrelated deathsIn the case of large polypscmthe limitations of the endoscope and accessory tools within the narrow operational field often necessitate either less desirable piecemeal resectionincreasing the risk of incomplete removalor open surgical resection referralThe proposed Active Cap System for Endoscopes is a disposable accessory device that enables physician controlled tissue manipulation and aspiration during polypectomy without occupying the working channel of the endoscopeThe goal is to safely reduce procedural time and the number of open surgery referrals for small or large polypswhile ensuring complete polyp removal