SBIR-STTR Award

Direct to Phase II

Infectious diseases are caused by micro-organisms, such as bacteria, protozoa, viruses or fungi, which can betransferred through direct or indirect human contact. A viral infection occurs when a host's body is invaded bypathogenic viruses, such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus thatcauses COVID-19 and the current pandemic. This pandemic is the greatest public health challenge since the1918 influenza pandemic and the biggest threat to destabilizing the global economy since World War II.As viruses tend to mutate quicker than other pathogenic agents (and thus newer strains emerge time and again),continuous research is required to combat infectious agents. For preclinical research, the most frequently usedanimal models are mice and rats. They offer an optimal combination of genetic proximity to humans, cost forbreeding and colony maintenance possibilities due to their small size. Mice offer the broadest spectrum ofavailable models. Rats are the second most frequently used mammal animal model. In fact, several SARS-CoV-2 researchers are turning to rats. They are no more susceptible to COVID-19 than mice, but their larger size isan advantage, as, for example, researchers often want to do repetitive bleeding in an experiment but cannot dothat with mice. Furthermore, as vaccine studies often assess how different doses affect antibody responses overseveral days, most toxicology studies of drugs also start in rat.To achieve intermittent infusions in most non-infectious disease research, the current prevailing administrationmodes for small animal research are manual (oral, intravenous, intraperitoneal, subcutaneous) requiringrepeated handling by trained technicians. However, infectious disease researchers desire the least number oftouchpoints possible with their infected animals, especially when sharp needles are involvedThe proposed FluidSync BSL3 system may aid the discovery of new treatments for COVID-19 by enablingcandidate drugs to be administered to model animals infected with SARS-CoV-2 while minimizinginvestigator contact. It may also be used in the development of vaccines and antibodies. The system builds onthe first and only wireless and tether-free administration system that can be used in animals as small as mice.The new system will have new capabilities including i) a medical-grade primary battery and ii) a programmablesystem-on-chip including Bluetooth telemetry transceiver, processor and memory.Ultimately, the FluidSync BSL3 microinfusion system would enable an intelligent instrumented vivarium systemthat addresses many BSL3 user requirements with benefits including increased productivity, reduced researcherexposure to potentially toxic drugs and disease vectors, ease of management of large-scale animal studies, andminimized animal handling to reduce white coat effects.

Public Health Relevance Statement:
Fluid Synchrony LLC SBIR Phase 2 Project Narrative The novel FluidSyncTM BSL3 microinfusion system for studies in rats within a BSL3 lab environment offers both more reliable and reproducible experimental results with a potential reduction in animal handling risks and whitecoat effects for long-term COVID-19 studies. The novel FluidSync BSL3 will address the user requirements for animal researchers in COVID-19 and other infectious diseases in BSL3 vivarium environments. The outcomes will also support drug administration research focused on other clinical indications in academia and pharmaceuticals industry. The results will establish it as the `gold standard' for remote-controlled drug dosing with accurate and yet flexible dosing capabilities in animal models.

Project Terms:
Adrenal Cortex Hormones ; Corticoids ; Corticosteroids ; Affect ; Air ; Animal Experimentation ; Animal Experimental Use ; Animal Research ; Animals ; Laboratory Animals ; Anti-Inflammatory Agents ; Anti-Inflammatories ; Anti-inflammatory ; Antiinflammatories ; Antiinflammatory Agents ; antiinflammatory ; Automation ; Bacteria ; Biological Availability ; Bioavailability ; Biologic Availability ; Physiologic Availability ; Breeding ; Communicable Diseases ; Infectious Disease Pathway ; Infectious Diseases ; Infectious Disorder ; Communication ; Computers ; Dangerousness ; Dexamethasone ; Disease Outbreaks ; Outbreaks ; Disease Vectors ; Drug Industry ; Pharmaceutic Industry ; Pharmaceutical Industry ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Environment ; Exhibits ; fungus ; Gold ; Hemorrhage ; Bleeding ; blood loss ; Human ; Modern Man ; Infection ; Infusion Pumps ; Infusors ; Perfusion Pumps ; External Infusion Pumps ; Intelligence ; Laboratories ; Long-Term Effects ; Longterm Effects ; Magnetic Resonance Imaging ; MR Imaging ; MR Tomography ; MRI ; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance ; NMR Imaging ; NMR Tomography ; Nuclear Magnetic Resonance Imaging ; Zeugmatography ; Maintenance ; Mammals ; Mammalia ; Manuals ; Memory ; Mus ; Mice ; Mice Mammals ; Murine ; Needles ; Oxygen ; O element ; O2 element ; Patients ; Drug Kinetics ; Pharmacokinetics ; Productivity ; Protozoa ; Protozoal ; Public Health ; Wistar Rats ; Rattus ; Common Rat Strains ; Rat ; Rats Mammals ; Research ; Research Personnel ; Investigators ; Researchers ; Risk ; Rodent ; Rodentia ; Rodents Mammals ; Safety ; Stress ; Telemetry ; Telemetries ; Testing ; Time ; Toxicology ; Vaccines ; Virus Diseases ; Viral Diseases ; viral infection ; virus infection ; virus-induced disease ; Virus ; Catheters ; Custom ; Pump ; Acute ; Chronic ; Clinical ; Phase ; Medical ; Death Rate ; Coronavirus ; Coronaviridae ; corona virus ; Link ; Training ; Therapeutic ; fluid ; liquid ; Liquid substance ; Genetic ; infectious organism ; Infectious Agent ; Exposure to ; Inflammatory ; restraint ; instrument ; Intravenous ; programs ; Oral ; intraperitoneal ; Protocol ; Protocols documentation ; Reaction ; subdermal ; subcutaneous ; microorganism ; System ; Infusion ; Infusion procedures ; biocompatibility ; biomaterial compatibility ; develop a vaccine ; development of a vaccine ; vaccine formulation ; vaccine development ; Animal Models and Related Studies ; model of animal ; model organism ; Animal Model ; Toxicities ; Toxic effect ; novel ; 2nd World War ; Second World War ; World War II ; Modeling ; Property ; response ; drug development ; Hormonal Change ; Pathogenicity ; SARS Virus ; SARS corona virus ; SARS-Associated Coronavirus ; SARS-CoV ; SARS-Related Coronavirus ; Severe Acute Respiratory Syndrome Virus ; Severe Acute Respiratory Syndrome corona virus ; Severe Acute Respiratory Syndrome coronavirus ; severe acute respiratory syndrome-CoV ; SARS coronavirus ; Effectiveness ; Address ; Dose ; Academia ; Data ; Implantable Pump ; Mutate ; Reproducibility ; in vivo ; Invaded ; Pharmacological Treatment ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Wireless Technology ; wireless ; pandemic disease ; pandemic ; pandemic influenza ; flu virus pandemic ; influenza virus pandemic ; pandemic flu ; pandemic strain of influenza ; cost ; Outcome ; pre-clinical research ; preclinical research ; Implant ; mouse model ; murine model ; combat ; safety testing ; drug candidate ; flexibility ; flexible ; Sterilization ; operation ; targeted treatment ; targeted drug therapy ; targeted drug treatments ; targeted therapeutic ; targeted therapeutic agents ; targeted therapy ; vaccine trial ; vaccination study ; vaccination trial ; vaccine study ; Antibody Response ; experimental study ; experiment ; experimental research ; Bluetooth ; pathogenic virus ; viral pathogen ; virus pathogen ; side effect ; infection risk ; novel coronavirus ; CoV emergence ; corona virus emergence ; coronavirus emergence ; emergent CoV ; emergent corona virus ; emergent coronavirus ; emerging CoV ; emerging corona virus ; emerging coronavirus ; nCoV ; new CoV ; new corona virus ; new coronavirus ; novel CoV ; novel corona virus ; COVID-19 ; COVID19 ; CV-19 ; CV19 ; corona virus disease 2019 ; coronavirus disease 2019 ; 2019-nCoV ; 2019 novel corona virus ; 2019 novel coronavirus ; COVID-19 virus ; COVID19 virus ; CoV-2 ; CoV2 ; SARS corona virus 2 ; SARS-CoV-2 ; SARS-CoV2 ; SARS-associated corona virus 2 ; SARS-associated coronavirus 2 ; SARS-coronavirus-2 ; SARS-related corona virus 2 ; SARS-related coronavirus 2 ; SARSCoV2 ; Severe Acute Respiratory Distress Syndrome CoV 2 ; Severe Acute Respiratory Distress Syndrome Corona Virus 2 ; Severe Acute Respiratory Distress Syndrome Coronavirus 2 ; Severe Acute Respiratory Syndrome CoV 2 ; Severe Acute Respiratory Syndrome-associated coronavirus 2 ; Severe Acute Respiratory Syndrome-related coronavirus 2 ; Severe acute respiratory syndrome associated corona virus 2 ; Severe acute respiratory syndrome corona virus 2 ; Severe acute respiratory syndrome coronavirus 2 ; Severe acute respiratory syndrome related corona virus 2 ; Wuhan coronavirus ; coronavirus disease 2019 virus ; hCoV19 ; nCoV2 ; COVID-19 treatment ; COVID-19 therapy ; COVID19 therapy ; COVID19 treatment ; SARS-CoV-2 therapy ; SARS-CoV-2 treatment ; coronavirus disease 2019 therapy ; coronavirus disease 2019 treatment ; severe acute respiratory syndrome coronavirus 2 therapy ; severe acute respiratory syndrome coronavirus 2 treatment ; treat COVID-19 ; treat COVID19 ; treat SARS-CoV-2 ; treat coronavirus disease 2019 ; treat severe acute respiratory syndrome coronavirus 2 ; Long COVID ; Long COVID-19 ; Long coronavirus disease ; Long coronavirus disease 2019 ; Post Acute Sequelae of COVID19 ; Post Acute Sequelae of SARS-CoV-2 ; Post Acute Sequelae of SARS-CoV2 ; Post Acute Sequelae of severe acute respiratory syndrome coronavirus 2 ; Post-Acute Sequelae of SARS-CoV-2 Infection ; adverse sequelae of COVID ; adverse sequelae of COVID-19 ; adverse sequelae of coronavirus disease ; adverse sequelae of coronavirus disease 2019 ; long haul COVID ; long haul COVID-19 ; long haul coronavirus disease ; long haul coronavirus disease 2019 ; long haul sequelae of COVID-19 ; long haul sequelae of coronavirus disease 2019 ; long-hauler syndrome ; long-term COVID ; long-term COVID-19 ; long-term coronavirus disease ; long-term coronavirus disease 2019 ; long-term sequelae of COVID-19 ; long-term sequelae of SARS-CoV-2 ; long-term sequelae of coronavirus disease 2019 ; long-term sequelae of severe acute respiratory syndrome coronavirus 2 ; longterm COVID ; longterm COVID-19 ; longterm coronavirus disease ; longterm coronavirus disease 2019 ; post COVID syndrome ; post COVID-19 syndrome ; post acute COVID syndrome ; post acute COVID-19 ; post acute COVID-19 syndrome ; post acute SARS-CoV-2 ; post acute coronavirus disease 2019 ; post acute coronavirus disease 2019 syndrome ; post acute coronavirus disease syndrome ; post acute severe acute respiratory syndrome coronavirus 2 ; post coronavirus disease 2019 syndrome ; post coronavirus disease syndrome ; post-acute sequelae following SARS-CoV-2 infection ; post-acute sequelae of COVID-19 ; post-acute sequelae of coronavirus disease 2019 ; vaccine-induced antibodies ; vaccine antibodies ; vaccine induced antibodies ; COVID-19 patient ; COVID infected patient ; COVID patient ; COVID positive patient ; COVID-19 infected patient ; COVID-19 positive patient ; COVID19 patient ; COVID19 positive patient ; SARS-CoV-2 infected patient ; SARS-CoV-2 patient ; SARS-CoV-2 positive patient ; coronavirus disease 2019 infected patient ; coronavirus disease 2019 patient ; coronavirus disease 2019 positive patient ; coronavirus disease infected patient ; coronavirus disease patient ; coronavirus disease positive patient ; coronavirus patient ; patient infected with COVID ; patient infected with COVID-19 ; patient infected with SARS-CoV-2 ; patient infected with coronavirus disease ; patient infected with coronavirus disease 2019 ; patient infected with severe acute respiratory syndrome coronavirus 2 ; patient with COVID ; patient with COVID-19 ; patient with COVID19 ; patient with SARS-CoV-2 ; patient with coronavirus disease ; patient with coronavirus disease 2019 ; patient with severe acute respiratory distress syndrome coronavirus 2 ; severe acute respiratory syndrome coronavirus 2 infected patient ; severe acute respiratory syndrome coronavirus 2 patient ; severe acute respiratory syndrome coronavirus 2 positive patient ; COVID-19 susceptibility ; COVID-19 predisposition ; COVID-19 vulnerability ; Coronavirus disease 2019 predisposition ; Coronavirus disease 2019 susceptibility ; Coronavirus disease 2019 vulnerability ; Predisposed to COVID-19 ; Predisposed to SARS-CoV-2 ; Predisposed to Severe acute respiratory syndrome coronavirus 2 ; SARS-CoV-2 predisposition ; SARS-CoV-2 susceptibility ; SARS-CoV-2 vulnerability ; Severe acute respiratory syndrome coronavirus 2 predisposition ; Severe acute respiratory syndrome coronavirus 2 susceptibility ; Severe acute respiratory syndrome coronavirus 2 vulnerability ; predisposed to Coronavirus disease 2019 ; susceptible to COVID-19 ; susceptible to Coronavirus disease 2019 ; susceptible to SARS-CoV-2 ; susceptible to Severe acute respiratory syndrome coronavirus 2 ; SARS-CoV-2 infection ; COVID-19 infection ; COVID19 infection ; SARS-CoV2 infection ; Severe acute respiratory syndrome coronavirus 2 infection ; coronavirus disease 2019 infection ; infected with COVID-19 ; infected with COVID19 ; infected with SARS-CoV-2 ; infected with SARS-CoV2 ; infected with coronavirus disease 2019 ; infected with severe acute respiratory syndrome coronavirus 2 ;