Sound Life Sciences, Inc. — Department of Health and Human Services SBIR Phase I: NIDA

Description

PROJECT SUMMARY ABSTRACT Opioid use disorderOUDand mortality from opioid overdose are significant public health concernsDeaths from opioid overdose are highly preventable with early detection and administration of naloxoneA key challenge of the epidemic is that overdose victims often die because they are alone or among untrained or impaired bystanders and thus do not receive timely resuscitationThere is an urgentunmet need for a low barriereasily scalable solution that can identify opioid overdoses in real time and rapidly connect victims to naloxone therapyThe goal of Sound Life SciencesSLSFast Track proposal is to commercialize an innovative overdose detection software product that can be downloaded on any commodity smartphone and can detect opioidinduced respiratory failurei eoverdoseand summon helpThe software only productSecondChanceconverts a smartphone into a short range active sonar system capable of monitoring breathing and detecting overdoseSecondChance requires no additional hardware and leverages the native speaker microphone array inside the phone and proprietary overdose detection signal processing algorithmsThe software enables an individual to monitor themselves when they are at risk for an overdose andin the event of an overdoseSecondChance can summon helpeither from a friend or family member or from emergency medical servicesEMSSound Life Scienceslong term goal is to keep individuals with OUD safe until they are able to access treatment and achieve durable recoveryIn Phase I of this Fast Track applicationSLS will convert the SecondChance prototypefor which feasibility has been establishedinto a minimum viable productMVPbased on rapid iteration guided by feedback and usability testingIn Phase IIusing human factors engineering approachesSLS will complete the SecondChance System and systematically validate each componentthe patient monitoring appthe HIPAA compliant data collection and storage infrastructureand the emergency services integrationThe Phase II studies will culminate in aksubmission to the FDAThe SecondChance System will be marketed to naloxone manufacturerslocal governments and people with OUD to ensure rapid dissemination to at risk individualsGiven the number of people with OUD and costs associated with opioid overdosethere is a substantial market for the SecondChance System PROJECT NARRATIVE We propose to develop the Second Chance SystemSCSa highly innovative software only solution that solves the unmet clinical need of connecting unwitnessed opioid overdose victims to life saving naloxone therapyBy converting a smartphone into a contactless portable respiratory monitor capable of summoning helpthe SCS can rapidly reach millions of people with opioid use disorder andat low costpotentially save thousands of lives and billions of dollars in health care costs associated with opioid overdoseThe Sound Life Sciences team is experiencedcapital efficientcapable of executing on its vision of developing a product to a total addressable market estimated to be worth $million yearwith multiple options for a successful exit