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

Description

Abstract Project Summary This proposed supplement expands the commercialization and market assessment activities for the original Phase I grant through the Innovation CORPs Program at NIHThe expected primary benefit from I Corps is having dedicated time and mentored direction towards relevant interviews in the endoscopic spacethis is expected to provide invaluable information about the needsin depth technical knowledgethe market playersand acquisition process for endoscopic accessories and minimally invasive surgery in healthcare facilitiesThough AMI has experience in the space with respect to feeding tubesa significant focus for the company has been to get involved more in the gastrointestinal surgical spaceThe I Corps program would help jumpstart the limited exposure so far achievedAdditionallyit is expected that updates from other companies in the program will provide a different perspective on both interview logistics and approach to commercializationAMI has always been an agile company when evaluating commercial markets and strategiesand welcomes the opportunity to modify refine the commercialization strategy to improve the successful launch of the Flexible Pancreatic AblationFPAsystemIt is recognized that needstechnologiesand regulations are dynamicand as AMI has in the past changed its approach to commercializationsuch as emerging markets in TubeClear or modifying hardware designs to better adapt to new FDA regulationsit is prepared to do so in this programOriginal Project abstractThis Phase I SBIR develops and tests feasibility of the FPA system to endoscopically treat pancreatic tumorsThe FPA deploys through an endoscope and into heterogeneous pancreatic tissue with a vibrating head consisting of an array of fineflexible tines that expand into a predetermined shapeThe vibration and geometry of the tines improve tissue penetration and trajectory accuracy to enable complete tumor ablation without destroying healthy tissuePublic Health ProblemPancreatic cancer is a deadly disease with poor prognosis and short survivalAlthough it accounts forof new cancer cases overall each yearan occurrence nearlyless than breast cancerthe estimated number of deaths insurpassed that of breast cancermaking it the third most deadly cancerestimated deathsin the U SThis is due in part to its typically late stage diagnosiswhich limits eligibility for the preferred treatment of surgical resection to onlyof patientsResection is preferred because other percutaneous methods such as laparoscopy using radiofrequency ablationRFAhave shown similar risks but lower efficacy due to anatomical obstructions and surgical routeEndoscopic techniques are advancingbut are so far limited in scope or capabilitiesRFA needles generate set ellipsoidal ablation zones which may not match the shape of tumorsUnlike other organsdamaged pancreatic tissue cannot regeneratethereforehealthy tissue must be preserved if possibleThe pancreatic tissue heterogeneity can also complicate procedures with lengthythinflexible ablation probessoft structures can compress and relaxresulting in uncertainty in insertion depthand harder structures can resist piercing and redirect the probe pathAn advanced endoscopic accessory is needed that can fully ablate pancreatic tumors while minimizing patient complications and destruction of healthy tissueand provide an effective treatment choice for theof patients with limited options for survivalPhase I HypothesisFeasibility of improved endoscopic therapy of pancreatic cancer is demonstrated by deployment of tines and production of spherical ablation zones using the FPA tool in vitro and in vivoSpecific AimsAimDevelop FPA handheld prototype and demonstrate improved FPA effector expansion with vibrationAcceptance CriteriaFPA maintains desired effector expansion and reduction of force with vibration in all endoscopic phantom insertionsAimShow efficacy of tissue ablation in vitro and insertion testing in heterogeneous modelsAcceptance CriteriaValidate thermal models and demonstrate improved lesion shape to needle ablation in vitroDemonstrate effective deployment in heterogeneous tissuesAimEndoscopic demonstration of ablation zone in pancreas using FPA in preliminary preclinical studyAcceptance CriteriaIn vivoNablation volume is withinof simulationsNo adverse effects from ablation procedure duringday survival Project NarrativeRelevancePancreatic cancer is one of the most deadly forms of cancer in the United StatesDue to its late diagnosisonlyof patients diagnosed with the disease are eligible for surgical resectionwhich is considered the preferred method of treatmentRadiofrequency ablation is a common cancer treatment modality for patients ineligible for open surgeryThere is a lack of ablation probes which may be used to generate spherical heating zones which closely match the geometry of typical tumorsThis project develops the Flexible Pancreatic Ablation Systema device that deploys through the working channel of standard endoscopes to access pancreatic tissue and deploy a flexible probe to fully ablate tumorswithout sacrificing healthy tissueThe supplement proposed here expands the commercialization and market assessment efforts to take the technology to market