SBIR/STTR Award attributes
Executive Summary Nearlypatients in the US undergo lower extremity amputations annually secondary to peripheral arterial diseasePADcomplicated by critical limb ischemiaCLITo increase a patient s post operative quality of lifesurgeons attempt to salvage as much limb tissue as possible while also considering the likelihood of primary wound healing at a given level of amputationLOAThe principal challenge in this decision is that surgeons overestimate the likelihood of healing at the selected LOAThereforein the first yeartoof amputations eventually require re amputation to a more proximal levelThis additional treatment prolongs the patient s return to walkingworsening their condition and deteriorating their mental healthThe burden to the healthcare system is immenseThe average cost for each amputation is over $as evidenced by a recent publication that shows diabetic foot ulcer complicationsmainly attributed to amputationcost more than the five most costly forms of cancerDespite these factsthere are no objective studies for selection of LOA in patients with PADTo address this critical problemSpectral MDSMDhas developed a point of care imaging deviceDeepViewwhich simultaneously performs multispectral imagingMSIand PhotoplethysmographyPPGimaging across the visible and infrared spectrum to obtain a quantitative microvascular tissue assessmentThese optical measurements are integrated using artificial intelligenceAIalgorithms to provide a quantitative aid to the physician s determination of tissue viability at a proposed amputation siteIf used for routine assessment prior to amputationSMD expects DeepView to reduce the rate of reamputation byresulting in up tofewer re amputations per year while improving quality of life for amputees and reducing associated health costsThe central objective for SMD s Phase I SBIR is to perform a feasibility clinical study to demonstrate the DeepView device will achieve greater thanaccuracy in identifying the healing potential of tissue at the amputation siteThis hypothesis will be tested by the following specific aimsAimComplete a Feasibility Study creating a database of pre amputation imagesThis data will be used for construction of the AI algorithm to predict amputation site healing potentialAimIdentify MSI and PPG features that can accurately predict amputation site healing potentialAimUsing Aim I clinical datafinalize the AI algorithm architecture and estimate sample size needed for a Phase II Pivotal Study in which the necessary training data to achieve at leastsensitivity andspecificity will be obtainedAs of this Supplement requestSMD has initiated a clinical study for feasibility and enrolled the first subjectThrough collaboration with the clinical study site Principal InvestigatorPIDrDennis GableSMD developed the protocol and trained his research staff at the study siteBaylor Medical Center Planoin the use of the DeepView deviceSMD anticipates enrollment of five subjects each month over the nextmonthsThe I Corps team will consist of the following membersMichael DiMaioMDRoleC Level Corporate OfficerDrDiMaioMD is Founder and Chief Executive Officer of SMD and has led SMD in obtaining over $M in non dilutive government funding and private investmentsHis distinguished career includes extensive experience as an entrepreneurclinicianand scientistWith overyearsexperience as a cardiovascular surgeonDrDiMaio has a widespread network of physicians and hospitals from which to draw contacts for customer interviewsJeffrey ThatcherPhDRolePIDrThatcher is the Chief Scientist at SMD and is a leader in the development of diagnostic imaging for soft tissue diseasesHe led SMD in conceptualizing and inventing SMD s core imaging technology undergoing clinical trials in three wound diagnostics applications includingburnsdiabetic ulcersand amputationWensheng FanMSRoleIndustry ExpertWensheng Fan is Executive Vice President and Chief Technology Officer at SMDHe is an executiveentrepreneurand innovator with overyears of experience in natural speech recognition and real time imaging systemsAt SMDhe leads market engagementstrategic financial planningand device development Narrative In patients with peripheral arterial diseasereported rates of re amputation due to non healing of a primary amputation are very significant approximatelyof below the knee amputations require eventual revisionwith even higher rates established for amputations at the level of the footThere are no gold standard tests for selection of level of amputationLOAto aid clinical judgmentTo address this critical problemSpectralMD is developing the DeepView Genimaging device that integrates multispectral imaging and a machine learning algorithm to quantitatively measure microvascular blood flow and tissue healing potential to assist in the clinical selection of LOA and minimize the incidence of re amputation and its associated morbidity and mortality
