NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Bioengineering;Brain Disorders;Clinical Research;Dementia;Disability Research;Neurodegenerative;Neurosciences

ORG_CITY: Boston

ORG_NAME: PASCALL SYSTEMS, INCORPORATED

PHR: PASCALL is addressing the high incidence of Post-Operative Delirium (POD) in the elderly population (≥60 years-old), particularly those with pre-existing or undiagnosed Alzheimer’s Disease and Related Dementia (ARDR), caused by the lack of accurate neuromonitoring. This project aims to fully address the problem by utilizing two recently developed, highly interpretable brain state markers, the Alpha Modulation Index (AMI) and Slow Frequency Modulation Index (SMI), along with a patient-specific instantaneous responsiveness algorithm (PSIRA) which can inform anesthesia care givers about the dosing required to maintain a target level of unconsciousness, based on AMI and SMI indices. If successful, the system can reduce POD, generate significant saving for Medicare (~$44,000 per patient per year) and eliminating needless suffering including long-term functional and cognitive disability.

PI_NAMEs: BROWN, EMERY N;LE MAU, TUAN  (contact)

PROGRAM_OFFICER_NAME: JOSEPH, LYNDON

PROJECT_TERMS: Address;Age;age related;aged;Aging;Algorithms;Alzheimer's disease patient;Alzheimer's disease related dementia;Anesthesia procedures;Anesthetics;Brain;Caregivers;Caring;Clinical;Clinical Trials;cognitive disability;commercialization;Complex;cost;Data;Data Set;Dementia;design;Development;Devices;dosage;Dose;Elderly;Electroencephalography;Frequencies;functional disability;General Anesthesia;General Practices;Grant;Health;high risk;Hospitals;Incidence;indexing;Injections;innovation;Intravenous;Intravenous Anesthetics;Intuition;Marketing;Medicare;Modeling;Monitor;Neurosciences;novel;older patient;Operative Surgical Procedures;Outcome;Overdose;Patients;Persons;Phase;Population;population based;postoperative delirium;Prevalence;Propofol;Protocols documentation;Pythons;Recommendation;Sedation procedure;Sister;Site;System;Testing;Time;Training;trial planning;Unconscious State;United States;usability;validation studies;wireless

PROJECT_TITLE: Developing an Elderly Patient-Specific, Accurate, Intuitive and Highly Interpretable System for Unconsciousness Management in General Anesthesia Using PASCALL FDA-Cleared Intraoperative EEG Monitor

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-C (10)]


ADMINISTERING_IC: GM

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

ORG_CITY: PHILADELPHIA

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: FLUIDISPEC LLC

ORG_STATE: PA

PHR: A novel microfluidic/nanofluidic system for preparation of small samples, down to the level of single cells, for mass-spectrometry-based protein analysis is proposed. This novel system is expected to improve the ability to measure protein levels of most proteins in single cells and small body fluids samples for use as a research tool and for clinical diagnostics.

PI_NAMEs: TIMPERMAN, AARON T (contact)

PROGRAM_OFFICER_NAME: YEH, ALVIN TIEN-WEI

PROJECT_TERMS: Achievement;adduct;Adsorption;Anions;Automobile Driving;Biological;Biological Models;Biological Process;Body Fluids;Cell Physiology;Cells;Charge;chemical reduction;Clinical;clinical diagnostics;commercial application;cost;cost effective;Coupled;Cytolysis;Data;Democracy;design;Detergents;Devices;Diagnostic;Digestion;Disease;Disease Progression;electric field;Electrophoresis;Excision;Fee-for-Service Plans;Functional disorder;Heterogeneity;Immobilized Enzymes;improved;Injections;innovation;instrumentation;Ions;Length;Lipids;Marketing;Mass Spectrum Analysis;Measurement;Measures;Membrane Proteins;Methods;Microfluidic Microchips;Microfluidics;Modeling;Modification;Molds;Movement;nano;nanoenvironment;nanofluidic;Nanoporous;Nature;novel;Nucleic Acids;Pattern;Peptides;Phase;polypeptide;Post-Translational Protein Processing;Precipitation;Preparation;Process;protein aggregation;Protein Analysis;Protein Denaturation;protein expression;protein purification;Proteins;Proteome;Proteomics;rational design;Reagent;Research;Resolution;response;Sales;Sampling;Scanning;Signal Transduction;single cell analysis;Solubility;Spectrometry, Mass, Electrospray Ionization;Speed;Structure;System;tool;treatment response

PROJECT_TITLE: A Nanofluidic/Microfluidic System for Enhanced Low-Input and Single-Cell Proteomics

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-J (10)]


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

ORG_CITY: BIRMINGHAM

ORG_NAME: ENDOMIMETICS, LLC

ORG_STATE: AL

PHR: Brain aneurysms carry the devastating risk of rupture, leading to death or permanent disability. Currently, the available flow diverters used to treat aneurysms are limited by a significant risk of thromboembolic complications until endothelialization and aneurysm closure has occurred. Medications to prevent clotting place patients at increased risk of bleeding during the several months required to achieve endothelial coverage. Endomimetics, LLC has developed a novel BionanomatrixTM, which, when coated onto flow diverters, could enhance endothelialization and reduce the risk of embolic stroke or brain hemmorhage.

PI_NAMEs: SHERWOOD, JENNIFER  (contact)

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: Acceleration;Address;Adhesions;Adhesives;Aneurysm;Animals;biomaterial compatibility;Blood Platelets;Brain;Brain Aneurysms;Case Study;Cerebral Aneurysm;Cessation of life;Characteristics;Clinic;Clinical;Clinical Trials;Coagulation Process;Collaborations;Control Groups;Data;Development;Devices;disability;Elements;embolic stroke;Endothelial Cells;Endothelium;Environment;evaporation;Formulation;Fright;Guidelines;healing;Hemorrhage;Implant;improved;In Vitro;in vivo;Inflammation;Inflammatory Response;innovation;International;Intracranial Aneurysm;Intracranial Hemorrhages;large scale production;Legal patent;Licensing;Life;Lifelong disability;Ligands;Longitudinal Studies;manufacture;manufacturing process;Marketing;Measures;Medical Device;Methods;migration;Modeling;Morbidity - disease rate;nano;Neck;Nitric Oxide;novel;Organic solvent product;Oryctolagus cuniculus;Patients;Peptides;Persons;Pharmaceutical Preparations;Phase;Pilot Projects;Population;Positioning Attribute;prevent;Procedures;Process;Property;Protocols documentation;Quality Control;recruit;Risk;risk minimization;Risk Reduction;Rupture;Ruptured Aneurysm;Safety;scale up;self assembly;Small Business Innovation Research Grant;Standardization;standardize guidelines;Sterilization;Technology;Testing;Thromboembolism;thrombogenesis;Thrombosis;thrombotic complications;Thrombus;Tissues;Validation;Water

PROJECT_TITLE: Enhanced endothelialization of nanomatrix coated flow diverter for intracranial aneurysms


NIH_SPENDING_CATS: Biotechnology;Brain Disorders;Epilepsy;Neurodegenerative;Neurosciences;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human;Stem Cell Research - Nonembryonic - Human

ORG_CITY: MADISON

ORG_NAME: STEM PHARM, INC.

ORG_STATE: WI

PHR: Project Narrative In Temporal Lobe Epilepsy (TLE), persistent neuroinflammation, largely induced by microglia, is associated with the evolution of chronic epileptic seizures. There is an unmet need for human model systems that can emulate this biology and that can be used in effective drug discovery programs. Stem Pharm is developing novel human iPSC derived neural organoids enriched with microglia to model TLE neuroinflammation. This platform will enable the testing of immunomodulatory therapeutics and interrogation of immune-related genes and proteins in the context TLE neuroinflammation.

PI_NAMEs: LEBAKKEN, CONNIE S (contact)

PROJECT_TERMS: Address;Adult;Aftercare;American;Anti-Inflammatory Agents;Antibodies;Anticonvulsants;assay development;Atrophic;base;Biological Assay;Biological Markers;Biological Models;Biology;biomaterial development;brain tissue;CASP1 gene;Cell model;cell type;Cells;cellular development;Chronic;Clinical;Data;Databases;deprivation;Development;Disease Progression;Dose;drug candidate;drug discovery;Drug Screening;Environment;Epilepsy;Evolution;excitotoxicity;experimental study;Exposure to;Foundations;Genes;genetic signature;Genetic Transcription;Glucose;Goals;hippocampal sclerosis;Hippocampus;Human;human induced pluripotent stem cells;human model;human stem cell-derived;Immune;immune modulating agents;In Vitro;in vitro Model;in vivo;Individual;Inflammation;Inflammatory;innovation;Intractable Epilepsy;Label;Letters;Licensing;Lipopolysaccharides;meter;Microglia;model development;Modeling;Molecular;Morbidity - disease rate;mortality;Mus;NCAM1 gene;Nervous System Disorder;neural;neural stimulation;neuroinflammation;Neurons;new therapeutic target;Nitrogen;novel;Organoids;Outcome;Output;Oxygen;p65;pathogen;Pathogenicity;Pathologic;Patients;Pattern;pharmacologic;Phase;Phosphorylation;Physiological;Play;pre-clinical;prevent;programs;Proteins;receptor;Receptor Signaling;Reproducibility;Research;response;Role;Rosaniline Dyes;Sampling;Sclerosis;screening;Signal Pathway;Signal Transduction;stem;stem cell biology;Stimulus;Technology;Temporal Lobe Epilepsy;Testing;Therapeutic;therapeutic candidate;TLR4 gene;transcriptomics;Translating;Translations;ultraviolet damage;ultraviolet irradiation;Validation;Wisconsin

PROJECT_TITLE: Development and Validation of a CNS Organoid Model of Temporal Lobe Epilepsy for Drug Discovery

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-H (13)]


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD)

ORG_CITY: Houston

ORG_NAME: CELLCHORUS INC.

ORG_STATE: TX

PHR: 8. Project Narrative Advances in computer vision have provided new capabilities for rapid, functional analysis of single cells. We have used these AI-enabled techniques to profile cells used for immunotherapy to understand which therapies perform best and why. In this project, we will create a commercially scalable prototype integrated software system capable of the same analysis on cells that are not fluorescently labelled (label-free). This software will be based on new AI models trained on millions of images of cells and optimized for fast, high-throughput single cell analysis by any customer without computational science backgrounds.

PI_NAMEs: BERDEAUX, REBECCA L (contact);ROYSAM, BADRINATH

PROGRAM_OFFICER_NAME: BALAKRISHNAN, KRISHNA B

PROJECT_TERMS: Acute;analysis pipeline;Antibodies;Apoptosis;artificial intelligence model;Behavior;Biological Assay;Cell Communication;Cell Culture Techniques;Cell Death;Cell division;cell killing;cell motility;Cell Shape;Cell Survival;cell type;Cells;cellular imaging;Cellular immunotherapy;Cessation of life;Classification;Clonal Expansion;cluster computing;Coculture Techniques;Computational Science;Computer software;Computer Vision Systems;Computers;convolutional neural network;coping;data pipeline;Data Set;deep neural network;Detection;Development;Effector Cell;Elements;Event;experimental study;Failure;field study;Fluorescence;fluorescence imaging;Frequencies;Goals;Hour;human-in-the-loop;Image;Image Analysis;Immune;Immunotherapy;in vitro Assay;instrumentation;interest;Label;Laboratories;Location;Lysosomes;Measurement;Memory;Methods;microscopic imaging;Mitochondria;Mitosis;Mitotic;Modeling;Motility;Movement;nano;nanolitre;neoplastic cell;Network-based;neural network;novel;Nuclear;Organelles;Pattern;Peer Review;Performance;Phase;Phase-Contrast Microscopy;Phototoxicity;premature;Proteins;prototype;Publications;Reporter;restoration;Retrieval;Robotics;single cell analysis;software systems;spatiotemporal;Speed;success;System;task analysis;Techniques;Technology;Testing;Time;tool;Training;training data;transcriptomic profiling;Update;usability;Validation;Variant;Video Recording;Visual;Visualization;Work

PROJECT_TITLE: LF-TIMING: Large-scale label-free profiling of cell-cell interactions

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-B (14)]


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Drug Abuse (NIDA only);Electronic Nicotine Delivery Systems;Natural Products;Neurosciences;Prevention;Social Determinants of Health;Substance Misuse;Tobacco;Tobacco Smoke and Health

ORG_CITY: RESTON

ORG_NAME: SPACERX LLC

ORG_STATE: VA

PHR: PROJECT NARRATIVE Only one in ten nicotine dependence successfully achieve nicotine abstinence for 12 months or more after attempting conventional smoking cessation treatments. This is despite the fact that 70% of the 46 million smokers in the United States express a desire to quit. The low success rate can be attributed to the complexity of smoking and vaping behaviors. Quitting involves not only ending nicotine use but also navigating social settings, managing isolation from social networks, and coping with sensory aspects related to oral sensations. To address this unmet need, we are developing a treatment based on the smoking cessation drug candidate cytisine. This treatment can be self-administered as a vape. We propose that this approach would serve as an effective secondary line of therapy for patients with treatment-resistant nicotine addiction. It would allow them to engage in many smoking-related behaviors while simultaneously reducing their nicotine dependence.

PI_NAMEs: LEE, PETER H (contact)

PROGRAM_OFFICER_NAME: NGUYEN, TAM L

PROJECT_TERMS: Abstinence;abuse liability;addiction;Address;Adolescent;Adult;Aftercare;Age;Agonist;American;Attention;Attenuated;Behavior;Behavioral Assay;Biological Sciences;Biosensor;Brain;Brain region;Caring;Centers for Disease Control and Prevention (U.S.);Cessation of life;Child;Cigarette;Clinical Trials;Collaborations;combustible cigarette;combustible tobacco;Complex;conditioning;coping;Corpus striatum structure;cytisine;Development;Disease;Dopamine;dosage;drug candidate;Drug Kinetics;Electronic cigarette;electronic cigarette use;Electronic Nicotine Delivery Systems;electronic vape;environmental tobacco smoke exposure;Epidemic;Esthesia;Evaluation;experience;Financial Hardship;Foundations;Grant;high risk;improved;in vivo;Individual;individualized medicine;innovation;insight;Intervention;Knowledge;Laboratories;Learning;long term abstinence;Measures;Medical;Methods;Monitor;Moods;mouse model;Mus;neurochemistry;Neuropharmacology;Nicotine;nicotine cessation;nicotine craving;Nicotine Dependence;nicotine replacement;nicotine self-administration;nicotine use;nicotine vapor;Nicotinic Receptors;Non-Rodent Model;novel;novel strategies;Nucleus Accumbens;Oral;Oral Administration;Outcome;Patient Compliance;Patients;Pharmaceutical Preparations;Phase;Plasma;Positioning Attribute;premature;pressure;Prodrugs;Productivity;Psychological reinforcement;Public Health;Reporting;Resistance;response;Risk;Rodent Model;sample fixation;Self Administration;sensor;Sensory;Small Business Innovation Research Grant;Smoke;Smoker;Smoking;smoking cessation;Smoking Cessation Intervention;social;social anxiety;Social isolation;Social Network;Substance abuse problem;success;System;Techniques;Testing;therapeutically effective;Time;tobacco products;Tobacco smoke;Tobacco use;Training;United States;United States Food and Drug Administration;vape pens;vaping;vaping nicotine;vapor;Ventral Striatum;Youth

PROJECT_TITLE: Revolutionizing Nicotine Vaping and Electronic Nicotine Delivery Systems Addiction Treatment through Innovative E-Vape Administration of Cytisine to Enhance Patient Adherence and Treatment Completion.

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-S (14)]


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Cancer;Immunization;Orphan Drug;Ovarian Cancer;Rare Diseases;Women's Health Research

ORG_CITY: Santa Barbara

ORG_NAME: RESONANT THERAPEUTICS, INC.

ORG_STATE: CA

PHR: PROJECT NARRATIVE Ovarian cancer is most lethal gynecologic cancer for which treatment are limited. Approval of the antibody-drug conjugate (ADC), mirvetuximab soravtansine, for ovarian cancer expanded treatment options, but only for a sub-population of patients that express high levels of the ADC target. Resonant Therapeutics is developing an ADC against an intriguing tumor target that is exceptionally effective in preclinical in vivo studies and has the potential to expand therapeutic options for ovarian cancer patients.

PI_NAMEs: DELGADO, OLIVER  (contact);STEWART, SHAUN M

PROGRAM_OFFICER_NAME: BOZZA, WILLIAM PATRICK

PROJECT_TERMS: Antibodies;Antibody-drug conjugates;Binding;cancer cell;Cancer cell line;Cancer Patient;cancer therapy;Carboplatin;Cell Line;Cell surface;Cells;Cessation of life;Characteristics;Clinical;conventional therapy;cytotoxic;design;Development;Diagnosis;Disease;Dose;Drug resistance;effective therapy;Evaluation;Exatecan;FDA approved;Female;FOLR1 gene;Goals;Government;Human;Immune;Immune checkpoint inhibitor;Immune response;Immunohistochemistry;Immunosuppression;in vivo;Lead;Malignant Female Reproductive System Neoplasm;Malignant neoplasm of ovary;Malignant Neoplasms;member;Modeling;nectin;neoplastic cell;novel;novel therapeutics;overexpression;patient derived xenograft model;patient population;patient subsets;Patients;Persons;Phase;Population;pre-clinical;programmed cell death ligand 1;programmed cell death protein 1;programs;receptor;research clinical testing;resistance mechanism;response;Role;Sampling;Small Business Innovation Research Grant;standard of care;Surface;Target Populations;targeted delivery;Text;Therapeutic;therapeutic development;therapy resistant;Tissue Microarray;Tissues;Toxic effect;treatment strategy;tumor;tumor microenvironment;United States;Work

PROJECT_TITLE: Development of a Novel Nectin Targeting Antibody-drug Conjugate for Ovarian Cancer Therapy

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CDPT-R (12)]


ADMINISTERING_IC: HL

ED_INST_TYPE: ORGANIZED RESEARCH UNITS

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cardiovascular;Heart Disease;Heart Disease - Coronary Heart Disease;Regenerative Medicine

ORG_CITY: Boulder

ORG_DEPT: MISCELLANEOUS

ORG_NAME: UNIVERSITY OF COLORADO

ORG_STATE: CO

PHR: Narrative Myocardial infarction (MI) and the progression to heart failure is a major public health concern that puts a large economic burden on the healthcare system. We propose an innovative approach to treat patients after an MI, where injectable biomaterials are injected into the heart early after MI to provide mechanical and biological signals that can improve the healing response. We evaluate our approach in a clinically-relevant animal model of MI, which if successful represents a translational therapy that could impact the welfare of many patients.

PI_NAMEs: BURDICK, JASON A (contact)

PROGRAM_OFFICER_NAME: LUNDBERG, MARTHA

PROJECT_TERMS: Acute;Advanced Development;Animal Model;Biochemical;Biocompatible Materials;Biological;biomaterial development;Biophysics;Blood Vessels;cardiac repair;Cell Communication;Cells;Chemotactic Factors;Clinical;Clinical Trials;clinically relevant;Collagen;density;Deposition;design;Development;Economic Burden;Engineering;Exhibits;fabrication;Family suidae;functional improvement;Gel;Germ Cells;healing;Healthcare Systems;Heart;Heart failure;heart function;Hydrogels;improved;improved outcome;Infarction;Injectable;Injections;innovation;interstitial;Invaded;Ischemia;Left Ventricular Remodeling;Mechanics;Microfluidics;Modeling;Myocardial Infarction;Myocardial Reperfusion;Myocardium;Nature;particle;Particle Size;Patients;Peptide Hydrolases;Phase;Population;Porosity;Property;Public Health;recruit;Reperfusion Therapy;response;Rodent;scale up;Signal Transduction;Stromal Cells;Structure;Thinness;tissue repair;translational therapeutics;Translations;welfare;Work

PROJECT_TITLE: Engineered Granular Hydrogels for Endogenous Tissue Repair

STUDY_SECTION: BMBI

STUDY_SECTION_NAME: Biomaterials and Biointerfaces Study Section[BMBI]


ADMINISTERING_IC: HD

IC_NAME: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT

NIH_SPENDING_CATS: Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Neurosciences;Patient Safety;Pediatric;Rehabilitation

ORG_CITY: CHARLESTON

ORG_NAME: FRD ACCEL, LLC

ORG_STATE: SC

PHR: Project Narrative Preterm and term infants with brain injury frequently have difficulty learning to feed by mouth and may benefit from transcutaneous vagus nerve stimulation (taVNS) paired with the motor activity of feeding to boost brain circuits involved with feeding. The proposed study will test a novel taVNS-paired bottle system in a blinded, randomized, controlled, multisite trial in infants who have reached term age and failed to learn to feed. The BabyStrong feeding system may improve oral feeding volumes and help avoid a long hospital stay while trying to feed or placement of a gastrostomy tube (G-tube) in order to be discharged home with their families.

PI_NAMEs: JENKINS, DOROTHEA DENISE (contact);RUSCITO, JOE

PROGRAM_OFFICER_NAME: MITCHELL, MEGAN S

PROJECT_TERMS: Acceleration;Acetylcysteine;Address;Age;Air;Anesthesia procedures;Antioxidants;Award;blind;Blinded;Bluetooth;Bottle feeding;Brain;Brain Injuries;Brain Stem;Breakthrough device;care providers;Cell Nucleus;Cervical;Clinical;commercialization;Competence;Complex;Computers;Corticospinal Tracts;Custom;Data;Development;Devices;Diffusion;Disease;Dose;Ear;Electrodes;Electronics;Enteral;Exclusion Criteria;Failure;Family;FDA approved;Feedback;feeding;Feeds;Frustration;Gastrostomy;Gestational Age;Glutathione;glycemic control;Goals;high risk infant;Home;Hospital Costs;Hospitalization;Hospitals;Hydrogels;Implant;improved;improved outcome;Infant;Infant Care;infant of diabetic mother;Learning;Learning Difficulty;Legal patent;Length of Stay;Magnetic Resonance Spectroscopy;Manufacturer;Marketing;Measures;Methods;Monitor;Motor Activity;motor learning;motor rehabilitation;Motor Skills;multi-site trial;Multicenter Trials;nasogastric feeding;neonate;neural growth;Neuronal Plasticity;neuropathology;novel;novel strategies;novel therapeutics;Nurses;open label;operation;Operative Surgical Procedures;Oral;Oral cavity;Oxidative Stress;Parents;Pattern;Phase;phase II trial;Physiologic pulse;Pilot Projects;pilot trial;placebo group;Placebos;postnatal;Pregnancy;Process;Protocols documentation;Randomized;Randomized, Controlled Trials;Rehabilitation therapy;Research Design;Safety;safety testing;Scanning;skills;Small Business Technology Transfer Research;standard of care;Stomach;Stroke;stroke patient;sucking;System;Technology;Testing;Time;Tragus;Tube;vagus nerve stimulation;Vagus nerve structure;Vision;white matter;Work

PROJECT_TITLE: BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CCHI-J (10)]


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Chronic Liver Disease and Cirrhosis;Digestive Diseases;Hepatitis;Liver Disease

ORG_CITY: PHOENIX

ORG_NAME: FAKNOSTICS, LLC

ORG_STATE: AZ

PHR: Narrative Chronic liver diseases are a major public health concern, affecting over 4.5 million Americans and resulting in untreatable liver fibrosis, which can progress to cirrhosis, hepatocellular carcinoma, and ultimately liver failure and death. FAKnostics is developing novel inhibitors that block paxillin interactions with focal adhesion kinase (FAK), which acts downstream of master profibrogenic regulator TGF-β to activate hepatic stellate cells and promote fibrosis. Successful inhibition of paxillin-FAK could interrupt the fibrogenic cascade, attenuating the development of liver fibrosis and leading to the first effective therapy capable of modifying the progression of chronic liver disease.

PI_NAMEs: FALLON, MICHAEL B;MARLOWE, TIMOTHY A (contact);PARK, HYO-JIN

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Acceleration;Actins;Adaptor Signaling Protein;Adsorption;Adult;Advanced Development;advanced disease;Affect;Alcoholic Liver Diseases;alpha helix;American;Animal Model;Animals;antifibrotic treatment;Attenuated;Binding;Biochemical;Biological Assay;Biophysics;candidate identification;Cause of Death;cell motility;Cells;Cessation of life;Cholestasis;chronic liver disease;Cirrhosis;Clinic;Clinical;Clinical Trials;Collagen;Common bile duct structure;Complex;cytokine;Cytoskeleton;Data;design;Development;Disease;Down-Regulation;Drug Kinetics;effective therapy;efficacy evaluation;efficacy validation;Ensure;Evaluation;Excretory function;Exhibits;Extracellular Matrix;Extracellular Matrix Proteins;FDA approved;fibrogenesis;Fibronectins;Fibrosis;Focal Adhesion Kinase 1;Focal Adhesions;Formulation;Funding;Future;genetic regulatory protein;Goals;Hepatic Stellate Cell;improved;In Vitro;in vivo;inhibitor;Injections;Injury;Interruption;kinase inhibitor;Lead;lead optimization;Life;Ligation;Link;Lipids;Liver;liver development;Liver Failure;Liver Fibrosis;liver transplantation;manufacture;Measurement;Mediating;Medical;Melanoma;Metabolic dysfunction;Metabolism;meter;Modeling;mouse model;Myofibroblast;myristoylation;nanoformulation;nonalcoholic steatohepatitis;novel;Oncology;overexpression;Patients;paxillin;peptide drug;Peptides;Permeability;Pharmaceutical Chemistry;Phase;Phosphotransferases;pre-clinical;pre-Investigational New Drug meeting;Primary carcinoma of the liver cells;Process;Production;Property;Protein Tyrosine Kinase;Public Health;recruit;Regulation;Roentgen Rays;Role;Safety;safety study;Sampling;scaffold;Scaffolding Protein;Series;Signal Transduction;Slice;Small Business Technology Transfer Research;Smooth Muscle;Steatohepatitis;Stress Fibers;Structure;Structure-Activity Relationship;subcutaneous;success;Testing;TGFB1 gene;Therapeutic;Toxic effect;Toxicology;Transforming Growth Factor beta;Transforming Growth Factors;tumor;Up-Regulation;Viral hepatitis;Work

PROJECT_TITLE: Novel Paxillin-FAK Inhibitors for the Treatment of Liver Fibrosis

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-R (10)]


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

ORG_CITY: DALLAS

ORG_NAME: QUALIA OTO, INC.

PHR: Project Narrative Cochlear implants (CIs) have been one of the most prevailing neural prostheses, yet a significant number of CI recipients still experience only poor to moderate speech understanding. Current CIs have trouble achieving simultaneous atraumatic insertion and effective placement of intracochlear electrodes, and we are tackling these challenges by using a novel approach using shape-memory polymers (SMPs) as a mechanically-adaptive element for CI electrode arrays. This project will validate that the SMP-inlaid CI electrode arrays will lead to more reliable cochlear implantation alongside favorable electrode placement.

PI_NAMEs: MAENG, JIMIN  (contact)

PROGRAM_OFFICER_NAME: MILLER, ROGER

PROJECT_TERMS: Address;Affect;Animal Model;Auditory;Auditory Perception;Basilar Membrane;biomaterial compatibility;Bionics;Cavia;Chinchilla (genus);Clinical;Cochlea;Cochlear implant procedure;Cochlear Implants;Electrodes;Elements;Evaluation;experience;fabrication;Fracture;Hearing;hearing preservation;Hearing Tests;Histologic;Hour;Human;Image;Implant;implantation;Implanted Electrodes;improved;International;Labyrinth;Lateral;Length;Letters;Measures;Mechanics;Memory;microCT;microscopic imaging;Modeling;Modiolus;neural prosthesis;Neurons;novel strategies;Operative Surgical Procedures;Performance;Phase;Polymers;Positioning Attribute;Preclinical Testing;preservation;Research;Residual state;response;Scala Tympani;Services;Shapes;Small Business Innovation Research Grant;Speech;spiral ganglion;Structure;success;Surgeon;System;Technology;Temporal bone structure;Time;Trauma;Validation;Variant;X-Ray Computed Tomography

PROJECT_TITLE: Shape-Adaptive Cochlear Implant Electrode Arrays

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-M (12)]


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Depression;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Mental Health;Mental Illness;Racial and Ethnic Minority Health Research;Social Determinants of Health;Telehealth

ORG_CITY: LEWES

ORG_NAME: ANISE HEALTH INC

ORG_STATE: DE

PHR: Narrative There is a dearth of attention to Asian American (AA) issues in mental health research and clinical practices, resulting in underutilization of mental health services and low treatment adherence by AAs. This contributes to increased healthcare costs, significant health inequity, and worse quality of life. Evidence-based practices (EBP) in psychotherapy must be adapted to incorporate sociocultural factors such as race-based trauma and bicultural tension which have been demonstrated to negatively impact the mental well-being of AAs. Anise Health is pioneering the technology-enabled delivery of culturally-adapted mental health care for AAs. Anise is developing proprietary care models that incorporate cultural factors into EBP, a library of digital tools for providers and patients to leverage in treatment and provider training programs on culturally-sensitive clinical models and tools which will drive long-term clinical outcomes in mental health treatments for AAs.

PI_NAMEs: KEUM, BRIAN TAEHYUK ;ZHANG, ALICE  (contact)

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: acceptability and feasibility;Address;Adherence;American;Anise Seed;anti-Asian;Anxiety;anxiety symptoms;Asian Americans;Attention;Caring;Cause of Death;Client;Clinical;clinical practice;Clinical Protocols;Clinical Trials;clinically significant;commercialization;Communities;Conflict (Psychology);Control Groups;Cultural Sensitivity;Data;depressive symptoms;Development;Diagnosis;digital;digital health;Digital Libraries;digital mental health;digital platform;digital tool;Drops;Ethnic Population;evidence base;Evidence based practice;experience;Foreigner;Foundations;Future;Goals;Hate;Health;Health Care Costs;health care service;Health Expenditures;health inequalities;Health Personnel;Improve Access;improved;innovation;Institution;intergenerational;intersectionality;Intervention;Library Materials;Lived experience;Marketing;Mental Depression;Mental Health;Mental Health Services;Methods;Minority;Minority Groups;Modeling;National Institute on Minority Health and Health Disparities;Outcome;Outcome Measure;pandemic disease;patient engagement;patient retention;Patients;personalized medicine;Phase;phase 1 study;premature;Prevalence;Provider;Psychopathology;Psychotherapy;Quality of life;Race;racial population;racism;Reporting;Research;satisfaction;Small Business Technology Transfer Research;social culture;sociocultural determinant;Stereotyping;Stress;stress symptom;stressor;substance use;Suicide;Technology;Testing;Time;tool;Training;Training Programs;Trauma;treatment adherence;treatment planning;usability;Violence;Well in self;young adult

PROJECT_TITLE: Anise Health: Culturally-Sensitive Digital Mental Health for Asian Americans

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 SCIL-D (10)]


ADMINISTERING_IC: AI

ED_INST_TYPE: SCHOOLS OF MEDICINE

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Genetics;HIV/AIDS;Infectious Diseases

ORG_CITY: CHAPEL HILL

ORG_DEPT: BIOCHEMISTRY

ORG_NAME: UNIV OF NORTH CAROLINA CHAPEL HILL

ORG_STATE: NC

PHR: Project Narrative HIV latency is fundamentally controlled by epigenetic regulations at the HIV promoter, which is essential for us to make efforts for the control of stable HIV reservoirs. This proposal will investigate how a distinct epigenetic molecular signaling –protein decrotonylation- regulates HIV latency and how a better understanding of decrotonylation signaling can be applied to design selective HDCR inhibitors to better disrupt latent HIV reservoirs. Discovery of such a specific HDCR inhibitor will not only help us better understand the biochemical basis of catalytic selection of HDCR over HDAC but also can be utilized to improve latency reversal for the cure of HIV in the future.

PI_NAMEs: JIANG, GUOCHUN  (contact)

PROGRAM_OFFICER_NAME: LAWRENCE, DIANE M

PROJECT_TERMS: Acetylation;Acetyltransferase;Active Sites;Amino Acids;antiretroviral therapy;Benzamides;Binding;Biochemical;Brain;CD4 Positive T Lymphocytes;Cells;Chromatin;Clinical Research;Clustered Regularly Interspaced Short Palindromic Repeats;Coenzyme A;Complex;Data;Deacetylase;Deacetylation;design;Development;Docking;Enzymes;EP300 gene;Epigenetic Process;epigenetic regulation;Fluorine;Future;Genetic Transcription;Goals;HDAC3 gene;Health;Histone Acetylation;Histone Deacetylase;Histone Deacetylase Inhibitor;Histone Deacetylation;histone methylation;Histones;HIV;HIV Antibodies;HIV Long Terminal Repeat;HIV-1;improved;Infusion procedures;inhibitor;interest;knock-down;Knock-out;latent HIV reservoir;latent infection;lonely individuals;Measures;Methylation;Microglia;Modernization;Molecular;mutant;Myeloid Cells;NF-kappa B;novel;overexpression;Persons;pharmacologic;Play;Post-Translational Protein Processing;prevent;promoter;Protein Acetylation;Proviruses;Reader;Reagent;Regulation;Role;Signal Pathway;Signal Transduction;Signaling Protein;Site;Specificity;Structure;T-Lymphocyte;Tertiary Protein Structure;Testing;Transactivation;Transcription Elongation;Viral reservoir;Vorinostat;Zinc

PROJECT_TITLE: Histone decrotonylation uniquely regulates HIV latency

STUDY_SECTION: HVCD

STUDY_SECTION_NAME: HIV Molecular Virology, Cell Biology, and Drug Development Study Section[HVCD]


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Clinical Research;Mental Health;Neurosciences;Pediatric

ORG_CITY: Shoreview

ORG_NAME: CHAMPAIGN IMAGING, LLC

ORG_STATE: MN

PHR: The project will make new tools for magnetic resonance imaging of children. It will help make the scan quieter and correct for movement if the child cannot keep their head still. This will make it easier for children to participate in brain research and eventually lead to quicker and safer scans at the hospital or clinic.

PI_NAMEs: CORUM, CURTIS ANDREW (contact)

PROGRAM_OFFICER_NAME: DURKIN, JACLYN MARIE

PROJECT_TERMS: Acoustics;Address;Adult;age related;Algorithms;Anesthesia procedures;Attention;autism spectrum disorder;Brain;brain research;Callback;Caregivers;Child;Childhood;Clinic;Clinical;Clinics and Hospitals;Computer software;cost;Dedications;Dementia;density;Development;Diffusion;Drops;Ear;Electronics;Environment;Evaluation;Exclusion;experience;Face;Family;Feedback;Fourier Transform;Functional Magnetic Resonance Imaging;General Anesthesia;Head;Healthcare Systems;Image;Image Enhancement;image reconstruction;improved;Loudness;Magnetic Resonance;Magnetic Resonance Imaging;Marketing;Methodology;Methods;Mission;Modeling;Morphologic artifacts;Motion;Movement;neuroimaging;next generation;Noise;novel;Parkinson Disease;Patients;Pediatric Hospitals;pediatric patients;Perfusion;Phase;Physiologic pulse;Play;Population;Product Packaging;Protocols documentation;Protons;radiologist;reconstruction;Research;Research Personnel;research study;Resolution;RF coil;Scanning;Sedation procedure;sound;success;Technology;technology validation;Time;tool;transmission process;usability;Validation;Vendor

PROJECT_TITLE: Next Generation Pediatric Neuroimaging (NGPN) Development


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Hematology;Infectious Diseases;Orphan Drug;Precision Medicine;Rare Diseases;Sepsis

ORG_CITY: CHAMPAIGN

ORG_NAME: PRENOSIS, INC.

ORG_STATE: IL

PHR: Principal Investigator/Program Director (Last, first, middle): Reddy, Jr., Bobby Project Narrative: The overall hypothesis of the current project is that the Prenosis Immunix platform, which includes the ImmunoScan Multiplex Rapid Test, can deploy precision medicine patient stratification solutions to the point of care in real time. The overall goal is to leverage the NOSIS biobank, Prenosis’ existing biomarker testing pipeline, and our network of hospital sites to validate ImmunoScan immunoassays and generate mapping functions to Luminex Immunoassays (Aim 1); validate a parsimonious model for point-of-care endotyping (Aim 2); and demonstrate in a prospective study the ability of Immunix to classify patients into host response endotypes in real time at the point of care (Aim 3). Successful completion of this project will show that the Immunix platform is fully capable of patient stratification and set the stage for running precision medicine clinical trials in acute care, a prospect whose innovation and significance cannot be overstated.

PI_NAMEs: REDDY, BOBBY  (contact)

PROGRAM_OFFICER_NAME: KODURI, SAILAJA

PROJECT_TERMS: acute care;Aliquot;Angiopoietin-2;biobank;Biological;Biological Assay;Biological Markers;Biological Process;biomarker panel;Blood;Classification;Clinical;Clinical Data;Clinical Trials;cohort;CXCL10 gene;CXCR3 gene;Data Set;Development;Disease;disease heterogeneity;Enrollment;Etiology;Freezing;Functional disorder;Goals;Heterogeneity;Hospitals;IL8 gene;Immune response;Immunoassay;Infection;innovation;Link;Machine Learning;Maps;Marketing;Measurement;Modeling;novel;novel therapeutics;Observational Study;Patient Care;patient stratification;patient subsets;Patients;Plasma;point of care;precision medicine;precision medicine clinical trials;Principal Investigator;programs;prospective;Prospective Studies;protein biomarkers;PTX3 protein;rapid test;Research Personnel;response biomarker;Running;Sampling;Sepsis;sepsis induced ARDS;Site;Testing;therapeutic development;Time;tool;Validation

PROJECT_TITLE: Clinical Validation of a Point-of-Care Precision Medicine Endotyping Platform

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 HSS-J (10)]


ADMINISTERING_IC: EY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Antimicrobial Resistance;Bioengineering;Biotechnology;Clinical Research;Emerging Infectious Diseases;Eye Disease and Disorders of Vision;Infectious Diseases;Networking and Information Technology R&D (NITRD);Wound Healing and Care

ORG_CITY: MONROVIA

ORG_NAME: CHROMOLOGIC, LLC

PHR: Project Narrative: In ability to accurately identify pathogen leads to proliferation of antibiotic resistant microbial strains, persistence of infections and ultimately treatment failures. For instance, over 15% of enterococcal isolates are now vancomycin resistant (VRE); an organism known to cause endophthalmitis, a vision-threatening infection. To address this, we have integrated Scalable Metagenomics Alignment Research Tool (SMART) adaptive sequencing algorithm developed by University of Washington (UW) and licensed to ChromoLogic (CL), with a host-DNA depleting sample preparation and library preparation protocols that enable ocular sample-to pathogen identification (EYE-Path™) in less than 3 hours. Current bacterial culture can take up to 48 hours and often requires specialized skills and expertise. EYE-Path™ offers real-time metagenomics platform for the detection of low abundant microbial DNA in the setting of high host background. ChromoLogic aims to optimize high-throughput operations, establish the system software architecture, and achieve CLIA review as a Laboratory Developed Test (LDT). The goal is to offer it as a CLIA waived in-vitro diagnostic device, initially as a "Software as a Service" product and eventually as an FDA-cleared pathogen-agnostic IVD. EYE-Path™ holds the potential provide a rapid, comprehensive pathogen-agnostic diagnosis that is cost-effective.

PI_NAMEs: KYUBWA, ESPOIR  (contact);VAN GELDER, RUSSELL N.

PROGRAM_OFFICER_NAME: LEE, PAEK-GYU

PROJECT_TERMS: Address;Algorithms;Antibiotic Resistance;Antibiotics;Antimicrobial Resistance;Architecture;Bacterial Infections;Bioinformatics;Biological Assay;Biopsy;Biotechnology;Businesses;California;Cells;Certification;CLIA certified;Clinical;Clinical Research;clinical research site;Cloud Computing;combat;Communicable Diseases;computational platform;Computer software;Conjunctivitis;Consumption;Cornea;Corneal Ulcer;cost effective;Data;Dedications;deep sequencing;design;detection limit;detection platform;Devices;Diagnosis;Diagnostic;Diagnostic Equipment;diagnostic strategy;Diagnostic tests;DNA;DNA analysis;DNA sequencing;Doctor of Medicine;Doctor of Philosophy;Endophthalmitis;Enterococcus;Environment;Equipment;experience;Eye;Eye Infections;Future;Goals;Gram-Negative Bacteria;Hour;in-vitro diagnostics;Infection;Infectious Agent;innovation;Keratitis;Laboratories;Letters;Libraries;Licensing;Life;Liquid substance;Los Angeles;Manuals;Medical;Medicine;meetings;Metagenomics;Methods;microbial;Microbial Antibiotic Resistance;Multi-site clinical study;nanopore;novel;Nucleic Acids;operation;Ophthalmology;optimal treatments;Organism;Output;Panuveitis;pathogen;Pathology;Patients;Pharmaceutical Preparations;Phase;point of care;Preparation;Process;professor;Proliferating;Protocols documentation;quality assurance;Reagent;Research;Research Personnel;RNA Sequences;robotic system;Robotics;Running;sample collection;Sampling;screening;sequencing platform;Site;skills;software as a service;software development;software systems;success;Swab;System;Testing;Time;tool;Treatment Failure;treatment planning;Universities;Validation;Vancomycin Resistance;Vision;Vitreous humor;Washington

PROJECT_TITLE: NGS based metagenomic screening of ocular infections


NIH_SPENDING_CATS: Bioengineering;Biotechnology

ORG_CITY: SAINT LOUIS

ORG_NAME: AURAGENT BIOSCIENCE, LLC

ORG_STATE: MO

PHR: Project Narrative Fluorescence-based Western blot is a powerful assay in biomedical and biological research laboratories, but it is currently hampered by limited detection sensitivity. Here we propose to optimize and validate a platform we call PF-Western that can significantly outperform existing Western blot technologies at a lower cost.

PI_NAMEs: CRICK, SCOTT L (contact)

PROGRAM_OFFICER_NAME: SALVADOR MORALES, CAROLINA

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Alzheimer's Disease;Antibodies;Applications Grants;Biological;Biological Assay;biological research;Biomedical Research;Cells;Clinical;Complex;Complex Mixtures;Computer software;cost;Cost Savings;Data;Data Analyses;design;Detection;detection limit;detection method;detection sensitivity;Development;Diagnostic;Disease;Drug resistance;Dyes;electric field;Electronics;End Point Assay;Fluorescence;Fluorescent Probes;fluorophore;Formulation;Goals;head-to-head comparison;Immunoassay;improved;Infection;Laboratories;Laboratory Research;Lasers;Malignant Neoplasms;Measurement;Mechanics;Membrane;meter;Methodology;Methods;multiplex detection;Mus;Names;Noise;Optics;Organism;Oryctolagus cuniculus;Performance;plasmonics;Play;polyvinylidene fluoride;Procedures;Proteins;Protocols documentation;prototype;Pyroxylin;Reader;Reading;Reagent;Reporter;Reproducibility;Research Personnel;Sampling;Sensitivity and Specificity;Signal Transduction;Specificity;Streptavidin;System;Techniques;Technology;Testing;Titrations;tool;Variant;Vendor;Western Blotting;Work

PROJECT_TITLE: Low-Cost Platform for Ultrasensitive Fluorescent Immunoblot


NIH_SPENDING_CATS: Biotechnology;Genetics

ORG_CITY: INDIANAPOLIS

ORG_NAME: E&E BIOCLUB LLC

ORG_STATE: IN

PHR: PROJECT NARRATIVE This application aims to develop a scalable and cost-effective process that can produce high- quality mRNA consistently. To achieve this goal, combinatorial approaches, including host cell engineering, targeted RNA design, and a compatible affinity purification procedure, will be employed to overcome current challenges.

PI_NAMEs: YU, HAO  (contact)

PROGRAM_OFFICER_NAME: CHO, THOMAS Y

PROJECT_TERMS: Address;Affect;Affinity Chromatography;analog;Bacteriophages;Base Pairing;Cells;cellular engineering;Chemical Structure;Chemicals;circular RNA;Clinical;Code;combinatorial;Complex;cost;cost effective;design;DNA-Directed RNA Polymerase;Engineering;Enzymes;Escherichia coli;flexibility;Future;Genes;Genetic Transcription;Goals;Heterogeneity;In Vitro;in vivo;interest;Length;magnesium ion;Mainstreaming;manufacture;manufacturing capabilities;manufacturing process;Medicine;Messenger RNA;Methods;nuclease;nucleoside triphosphate;Nucleotides;Phase;Play;Predisposition;preservation;Procedures;Process;Production;Productivity;Property;Proteins;Reagent;Recombinant DNA;Recombinant Proteins;recombinant RNA;Recombinants;Research;Ribonucleases;Ribonucleosides;RNA;RNA Caps;RNA chemical synthesis;RNA Degradation;RNA delivery;RNA purification;RNA Stability;RNA vaccine;scaffold;Scheme;Specificity;Standardization;Structure;success;System;Technology;therapeutic RNA;Transcript;Transcription Process;tripolyphosphate;vector

PROJECT_TITLE: Producing Recombinant mRNA in Escherichia coli

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MBBC-G (10)]


NIH_SPENDING_CATS: Arthritis;Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Orphan Drug;Pain Research;Prevention;Rare Diseases;Vaccine Related;Vector-Borne Diseases;West Nile Virus;Zika Virus

ORG_CITY: NEW HAVEN

ORG_NAME: L2 DIAGNOSTICS, LLC

ORG_STATE: CT

PHR: PROJECT NARRATIVE Chikungunya is a disease transmitted by Aedes mosquitoes that can cause severe and prolonged morbidity. We have found a mosquito salivary protein, AgBR1, that can be used as a vaccine and protects against Aedes mosquito-borne flavivirus infection (ZIKV and WNV) in mice. The goal of this project is to test AgBR1 as a vaccine against another Aedes-transmitted virus -- Chikungunya virus (CHIKV).

PI_NAMEs: FIKRIG, EROL  (contact)

PROGRAM_OFFICER_NAME: DUPUY, LESLEY CONRAD

PROJECT_TERMS: Acceleration;Active Immunization;Acute;Adjuvant;Adult;Aedes;Africa;Alpha Virus;Americas;Analgesics;Antibodies;Antigens;antipyretic;arboviral disease;Arboviruses;Arthralgia;Arthritis;arthropod-borne;Asia;Attenuated;Benchmarking;Biological;Bite;Blood;Borrelia;Breeding;Caring;Cavia;Cells;chikungunya;chikungunya infection;Chikungunya virus;Clinical;Clinical effectiveness;clinical efficacy;Clinical Trials;comparative;Country;Culicidae;Data;Disease;disease transmission;Dose;Effectiveness;efficacy evaluation;efficacy study;Europe;Evaluation;Exanthema;Family;Fatigue;feeding;Fever;Flavivirus;Flavivirus Infections;Formulation;Goals;Hamsters;Headache;Histology;Human;Immune Sera;Immunization;Immunize;Immunocompetent;Immunocompromised Host;Immunodeficient Mouse;immunogenic;Immunologics;improved;Infection;Joints;Leishmania;Liquid substance;Macaca;member;Messenger RNA;Modality;Modeling;Morbidity - disease rate;mosquito-borne;Mosquito-borne infectious disease;mouse model;mRNA lipid nano particle vaccine;Mus;Nausea;neutralizing antibody;nonhuman primate;Passive Immunization;pathogen;Pathogenesis;Peripheral;Phase;phase 2 study;Physiological;prevent;Prevention;Program Development;protective effect;Proteins;Recombinant Proteins;Recombinants;reduce symptoms;Regimen;Reporting;response;Running;Saliva;Salivary Proteins;Schedule;Serum;success;Swelling;Symptoms;Tanzania;Testing;Tissues;Togaviridae;transmission process;United States National Institutes of Health;universal vaccine;Vaccination;vaccine candidate;Vaccine Design;vaccine development;Vaccines;vector;vector-based vaccine;Viral;viral transmission;Viremia;Virus;Virus Diseases;Water;West Nile;West Nile virus;ZIKA;Zika Virus;ZIKV infection

PROJECT_TITLE: The mosquito salivary protein AgBR1 as vaccine candidate against Chikungunya

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-D (10)]


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

NIH_SPENDING_CATS: Breast Cancer;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;Genetics;Health Services;Human Genome;Networking and Information Technology R&D (NITRD);Pediatric;Prevention;Women's Health Research

ORG_CITY: ALBANY

ORG_NAME: NEST GENOMICS

PHR: Project Narrative The proposed project uses hereditary cancer as a model to help patients and clinicians better understand and adhere to guidelines-recommended care for the prevention and surveillance of genetic disease. Our software platform will streamline clinician workflows and help them stay current on frequently updated evidence using EMR integrated clinical decision support. It will aid patients by: improving their understanding of cancer risks, increasing follow through with recommended screening and prevention options, facilitating sharing results and care plans between clinicians, and lowering cancer-related psychological distress.

PI_NAMEs: SNIR, MORAN  (contact)

PROGRAM_OFFICER_NAME: RIDER, RENEE ANNE

PROJECT_TERMS: Acceleration;acceptability and feasibility;Adherence;Adolescent and Young Adult;Advocate;Area;Automated Clinical Decision Support;Bilateral;Breast Magnetic Resonance Imaging;Businesses;Cancer Center;Cancer Patient;cancer risk;care coordination;Caring;Clinical;clinical decision support;clinical development;Collaborations;Colonoscopy;Communities;Computer software;Computerized Medical Record;Continuity of Patient Care;Dana-Farber Cancer Institute;Data;data integration;Development;Documentation;Education;Employment;empowerment;Ensure;experience;Face;Family;family building;Frequencies;Friends;Future;Genetic;Genetic Diseases;genetic information;Genetic Structures;genetic testing;genomic data;Genomic medicine;Genomics;Goals;Guideline Adherence;Guidelines;Head;Health system;Hereditary Malignant Neoplasm;implementation evaluation;implementation outcomes;improved;Informed Consent;Infrastructure;Inherited;integrated care;Intervention;Knowledge;Life;life span;Malignant Neoplasms;Mammography;Managed Care Programs;Mastectomy;Measures;medical schools;medical specialties;Modeling;non-genetic;Operative Surgical Procedures;Outcome;Ovariectomy;Patient Care;patient screening;Patients;personalized care;Phase;Population;Prevention;provider behavior;psychological distress;Rana;randomized trial;Recommendation;Relative Risks;Research;Research Personnel;Risk;Risk Reduction;Schools;screening;screening guidelines;Secure;Service delivery model;Small Business Technology Transfer Research;software development;support tools;Syndrome;Test Result;Testing;Time;tool;Update;uptake;young adult

PROJECT_TITLE: Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary Cancer


ORG_CITY: OMAHA

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF NEBRASKA MEDICAL CENTER

ORG_STATE: NE

PHR: Relevance: Neurological disorders are prevalent in middle-aged people living with HIV infection. To date, the molecular cause(s) for these varied disorders remain poorly understood, and specific pharmacological treatment to blunt their development remain elusive. This project brings together the expertise of Drs. Keshore R. Bidasee (metabolism and vascular biology), Santhi Gorantla (humanized mice and HIV-1 infection) and Huangui Xiong (brain electrophysiology and HIV) to demonstrate that accumulation of the cytotoxic glycolysis byproduct methylglyoxal (MG) is triggering these diverse early-onset neurological disorders using the clinically relevant HIV-infected humanized mouse and show that scavenging MG using novel arginine-rich cyclic peptides that can attenuate these disorders.

PI_NAMEs: BIDASEE, KESHORE R (contact);GORANTLA, SANTHI

PROGRAM_OFFICER_NAME: DALEY, WILLIAM PATRICK

PROJECT_TERMS: Adhesions;aging population;Alzheimer's Disease;Anti-Retroviral Agents;antiretroviral therapy;Anxiety;Arginine;Astrocytes;Attention;Attentional deficit;Attenuated;Axon;Behavior;Biological Assay;Biology;Blood Vessels;Brain;Brain region;Cardiovascular Diseases;Cell Line;cell type;Cells;Central Nervous System Diseases;clinically relevant;comorbidity;Cyclic Peptides;cytotoxic;Darkness;Data;Dendrites;Dependovirus;Development;Disease;early onset;efficacy evaluation;Electrophysiology (science);emtricitabine;Endothelium;Enzymes;Excitatory Postsynaptic Potentials;Exhibits;Extravasation;feeding;field study;Frequencies;Fumarates;Gene Transfer;Genus Hippocampus;Glycolysis;Harvest;Hippocampus;HIV;HIV Infections;HIV-1;Human;humanized mouse;Impairment;in vivo;Incidence;Infection;Inflammation;inflammatory marker;insight;Intervention;Lactoylglutathione Lyase;Learning;Light;Link;Measures;Mediating;Memory;Metabolism;Microglia;middle age;millisecond;Molecular;mouse model;Movement;Mus;Nervous System Disorder;Nervous System Physiology;Neurodevelopmental Disorder;Neurons;novel;object recognition;Older Population;Output;Peptides;Performance;Periodicity;Persons;Pharmaceutical Preparations;pharmacologic;Pharmacological Treatment;Physiologic pulse;Plasma;prepulse inhibition;processing speed;Proteins;Protocols documentation;Pyruvaldehyde;Reaction;Regimen;Reporting;response;sex;Slice;Structure-Activity Relationship;Symptoms;Synapses;Synaptic Transmission;Tenofovir;Testing;Thalamic structure;Time;Universities;Up-Regulation;vascular inflammation

PROJECT_TITLE: Neurological Disorders in HIV-1 Infection

STUDY_SECTION: HCCS

STUDY_SECTION_NAME: HIV Comorbidities and Clinical Studies Study Section[HCCS]


NIH_SPENDING_CATS: Assistive Technology;Behavioral and Social Science;Bioengineering;Chronic Obstructive Pulmonary Disease;Clinical Research;Clinical Trials and Supportive Activities;Lung;Networking and Information Technology R&D (NITRD);Physical Activity;Physical Rehabilitation;Prevention;Rehabilitation

ORG_CITY: JACKSONVILLE

ORG_NAME: NOVIS PRODUCTS, LLC

ORG_STATE: FL

PHR: Narrative: This NIH STTR grant proposal targets the prevalent problem of chronic obstructive pulmonary disease (COPD) by introducing the RMT Complete—a comprehensive respiratory muscle strength training device and mobile application designed to overcome limitations in existing devices. Novis Products, LLC endeavors to develop an all-in-one, cost-effective device with integrated features like adherence monitoring, biofeedback, and pressure measurement. In Phase I, the proposal focuses on assessing the device's usability to guide device enhancements, laying the groundwork for an advanced respiratory training solution, and paving the way for Phase II clinical trials and commercialization to address challenges in COPD treatment and adherence monitoring.

PI_NAMEs: ZAMBRANA, NELSON  (contact)

PROGRAM_OFFICER_NAME: SHENOY, SIDDHARTH KAUP

PROJECT_TERMS: Address;Adherence;Adult;Affect;age stratification;Applications Grants;Biofeedback;Breathing;Businesses;care costs;Chronic Obstructive Pulmonary Disease;Clinical;commercialization;Consultations;cost;cost effective;cost estimate;Data;data access;Data Analyses;Data Collection;Deglutition;design;Development;Devices;Disease;Dyspnea;economic cost;economic implication;effective therapy;Exercise;Exhibits;Family;Feedback;Florida;Foundations;Funding;Goals;Health Care Costs;Health Promotion;Healthcare Market;Impairment;improved;Individual;instrument;interest;Interview;Life;Marketing;Measurement;Measures;mechanical load;Minority;mobile application;Modification;Monitor;Muscle;Muscle Contraction;muscle strength;National Heart, Lung, and Blood Institute;neural;Outcome;Participant;Patient Compliance;Patients;Perception;Personal Satisfaction;Phase;Phase II Clinical Trials;Physical activity;Preparation;pressure;Prevention;primary outcome;prototype;Quality of life;Regimen;rehabilitation strategy;Rehabilitation therapy;research clinical testing;resistance exercise;respiratory;Respiratory Disease;Respiratory Muscles;Respiratory physiology;Rest;satisfaction;Secure;Shapes;social;strength training;success;Symptoms;System;Technology Transfer;telehealth;Testing;Time;Training;treatment adherence;Treatment outcome;United States;United States National Institutes of Health;Universities;usability;user-friendly;virtual;Visual;Visualization;Work

PROJECT_TITLE: All-in-one measurement and exercise respiratory strength trainer with biofeedback and adherence tracking capability.


ORG_CITY: SEATTLE

ORG_NAME: FRED HUTCHINSON CANCER CENTER

ORG_STATE: WA

PHR: PROJECT NARRATIVE Dr. Reeves and collaborators will study the mechanisms that create and sustain the HIV reservoir, a population of latently infected cells that persists during suppressive antiretroviral therapy (ART) and prevents cure of HIV. This proposal will integrate many existing and novel human experimental data using a mathematical model approach that incorporates virus and cell population sizes as well as evolution. The goal is to provide insight into mechanisms driving five stages of HIV infection and inform future therapeutics to allow HIV cure.

PI_NAMEs: REEVES, DANIEL  (contact)

PROGRAM_OFFICER_NAME: NOVAK, LEIA KAYE

PROJECT_TERMS: Adopted;Antigens;antiretroviral therapy;Apoptosis;Automobile Driving;Biology;CD4 Positive T Lymphocytes;CD8-Positive T-Lymphocytes;Cell Count;Cell Proliferation;Cells;Chronic;chronic infection;Clonality;Clone Cells;Data;Data Set;data sharing;design;Development;DNA;Equilibrium;Evolution;experience;Future;Goals;HIV;HIV Infections;Human;Immune;Immune system;Immune Targeting;Immunologic Stimulation;Individual;Infection;insight;Interruption;latent HIV reservoir;Length;Link;Maintenance;mathematical model;Modeling;Mutation;next generation;novel;Persons;Phase;Play;Population;Population Sizes;prevent;Primary Infection;Proliferating;Provirus Integration;Proviruses;Publishing;Research;response;RNA;RNA Sequences;Role;Structure;T cell receptor repertoire sequencing;T cell reconstitution;T-Cell Proliferation;T-Cell Receptor;Therapeutic;therapeutic target;Time;viral fitness;Viral Load result;viral rebound;Viremia;Virus;Virus Diseases;virus genetics;Virus Replication;Work

PROJECT_TITLE: Phylodynamic mechanisms of HIV reservoir seeding and maintenance

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IIDB-X (03)]


NIH_SPENDING_CATS: Bioengineering;Cancer;Cervical Cancer;Comparative Effectiveness Research;Prevention;Primary Health Care;Rare Diseases;Social Determinants of Health;Women's Health Research

ORG_CITY: Oakland

ORG_NAME: ANANYA HEALTH INC

PHR: Narrative  Cervical cancer is the fourth most common cancer in women, and accounted for 341,800 deaths in 2020, where approximately 90% occurred in low- and middle-income countries (LMICs). The lack of treatment options in LMICs is a major gap in the screen-and-treat strategy highlighted by the World Health Organization’s cervical cancer elimination initiative, as existing technologies that have successfully driven down case counts in affluent countries are not suited for clinics staffed with lower- and mid-level health workers with limited resources and infrastructure. In response to the treatment gap and to National Cancer Institute’s Notice of Special Interest (NOT-CA-21-062): “Cancer Prevention, Diagnosis, and Treatment Technologies for Low-Resource Settings,” this Phase II SBIR project furthers the development of Ananya Health’s CRCL System, a highly portable, affordable, self-contained cryotherapy unit that is specifically designed with a user-centered focus to overcome infrastructure and resource constraints and enable widespread primary care treatment of cervical precancerous lesions in LMICs.

PI_NAMEs: CHANG, WEI-HSIANG  (contact);PARVATIYAR, ANUBHUTI

PROGRAM_OFFICER_NAME: ZHAO, MING

PROJECT_TERMS: Accreditation;Adopted;Adoption;Animals;biomaterial compatibility;Cancer Etiology;cancer prevention;care outcomes;Cervical;Cervical Cancer Screening;Cervical Intraepithelial Neoplasia;Cervix Uteri;Cessation of life;Clinic;clinical efficacy;Clinical Research;Cold Therapy;cost;cost effective;Country;cryogenics;Cryosurgery;Dependence;design;design verification;Development;Device Designs;Devices;Diagnosis;Disease Progression;effective therapy;Electronics;Ensure;Environment;Equipment;Evaluation;evaporation;falls;Feedback;follow-up;Freezing;Funding;Gases;Geometry;Growth;Gynecologist;Health;Health Personnel;Hospitals;Hour;Human;in vivo;Income;Infrastructure;innovation;inorganic phosphate;Instruction;interest;Interview;Iron;Kenya;Laboratories;Lead;Left;Lesion;Liquid substance;Lithium;loop electrosurgical excision procedure;low and middle-income countries;Malignant neoplasm of cervix uteri;Malignant Neoplasms;Manufacturer;Marketing;Medical;Membrane;Methods;mortality;Mucous Membrane;National Cancer Institute;necrotic tissue;Patient Care;Patients;Performance;Persons;Pharmacy facility;Phase;Poison;porcine model;portability;premalignant;prevent;Primary Care;Process;Production;Protocols documentation;Readiness;rechargeable battery;Recommendation;Resource-limited setting;Resources;response;Safety;Small Business Innovation Research Grant;Specific qualifier value;standard of care;success;supply chain;System;Technology;Temperature;Testing;Thermal Ablation Therapy;Tissues;Training;Treatment outcome;treatment response;treatment services;tumor progression;Update;usability;Vagina;Validation;verification and validation;Woman;World Health Organization

PROJECT_TITLE: Portable, low-cost cryotherapy system that does not require consumable cryogen gas for the treatment of cervical precancerous lesions

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-S (11)]


NIH_SPENDING_CATS: HIV/AIDS;Infectious Diseases

ORG_CITY: CINCINNATI

ORG_NAME: CINCINNATI CHILDRENS HOSP MED CTR

ORG_STATE: OH

PHR: Project Narrative: This project will define important pathways that allow infectious HIV particles to assemble. Experiments in this project will expand upon the recent discovery that the tubular recycling endosome is required for HIV-1 envelope protein incorporation. This work will provide fundamental new knowledge related to envelope trafficking and particle assembly, identify the key host proteins involved, and provide new targets for antiretroviral therapy.

PI_NAMEs: SPEARMAN, PAUL W. (contact)

PROGRAM_OFFICER_NAME: MCDONALD, DAVID JOSEPH

PROJECT_TERMS: Adaptor Signaling Protein;antiretroviral therapy;Binding;Biochemical;Biological;Biological Assay;Cell fusion;cell type;Cells;Cytoplasm;Cytoplasmic Tail;Data;Dependence;Endosomes;env Gene Products;Event;experimental study;gag Gene Products;Generations;Genetic Techniques;Goals;HIV;HIV envelope protein;HIV-1;imaging approach;Integration Host Factors;intervention effect;Investigation;Knock-out;Knowledge;Label;Laboratories;Link;live cell microscopy;Macrophage;Measurement;Mediating;Membrane;Modeling;mutant;N-terminal;novel;particle;Pathway interactions;Peptides;permissiveness;Process;Productivity;Protein Biosynthesis;protein transport;Proteins;quantitative imaging;recruit;Recycling;Ribosomes;Role;Rough endoplasmic reticulum;Scaffolding Protein;Site;T-Lymphocyte;Techniques;trafficking;Travel;Tubular formation;Viral;Virus Replication;Visualization;Work

PROJECT_TITLE: Viral and Cellular Determinants of HIV-1 Assembly


NIH_SPENDING_CATS: Adolescent Sexual Activity;Behavioral and Social Science;Caregiving Research;Climate-Related Exposures and Conditions;Clinical Research;Clinical Trials and Supportive Activities;Contraception/Reproduction;Dissemination and Implementation Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Mental Health;Nutrition;Pediatric;Pediatric - AIDS;Prevention;Sexually Transmitted Infections;Social Determinants of Health;Teenage Pregnancy;Women's Health Research

ORG_CITY: SAN FRANCISCO

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

PHR: Project Narrative/Public Health Relevance Statement The incidence of HIV and sexually transmitted infections (STIs) remains high among adolescent girls and young women (AGYW) in Western Kenya, driven by upstream structural factors like food insecurity (Fl) and poverty. Our multi-disciplinary team proposes to conduct a cluster randomized controlled trial among 800 AGYW-caregivers dyads in Western Kenya to test the impact of our innovative school- and household-based Shamba Maisha intervention package (with agricultural commodities, training in sustainable farming practices at school-based demonstration farms, and caregiver-adolescent relationship strengthening training) on STI and HIV prevention outcomes. This rigorous study may provide a model for a multi-pronged approach to halt the cycle of Fl, and poor HIV-related outcomes among AGYW, in line with NIH priority for HIV health research.

PI_NAMEs: ONONO, MARICIANAH ATIENO;VELLOZA, JENNIFER ;WEISER, SHERI DAWN (contact)

PROGRAM_OFFICER_NAME: KAMATH, SUSANNAH M A

PROJECT_TERMS: Absenteeism;adaptive intervention;Address;Adolescent;adolescent HIV prevention;Adolescent HIV risk;adolescent mental health;adolescent sexual health;Adult;Affect;Africa South of the Sahara;Age;Agriculture;AIDS prevention;Anxiety;arm;Assessment tool;caregiver stress;Caregiver well-being;Caregivers;Chlamydia;Climate;climate change;climate disaster;climate impact;climate-related health;Cluster randomized trial;Communication;Communities;Control Groups;Cost Analysis;Country;County;Data;design;Diet;Distal;Economics;Education;Effectiveness;effectiveness evaluation;efficacy evaluation;empowerment;Enrollment;Epidemic;Event;experience;extreme weather;Farm;Female Adolescents;Fertilizers;food insecurity;food security;gender-based violence;girls;Goals;Gonorrhea;Harm Reduction;Health;HIV;HIV risk;Home;Household;Human;implementation barriers;implementation cost;implementation facilitators;implementation process;improved;Incidence;Individual;infection risk;innovation;Intervention;Kenya;lens;Life;Mental Depression;Mental Health;Methods;Modeling;multidisciplinary;novel;Nutritional;Outcome;parent-child communication;Parents;Pathway interactions;Personal Satisfaction;Persons;Pilot Projects;Population;Poverty;poverty alleviation;pre-exposure prophylaxis;Pregnancy;Pregnancy Tests;prevent;primary caregiver;primary outcome;process evaluation;Program Sustainability;programs;Publishing;Pump;Quality of life;Randomized;Randomized, Controlled Trials;recruit;Reporting;Reproductive Health;Research;resilience;Safe Sex;Schools;secondary outcome;Self Efficacy;self esteem;Sex Behavior;sexual and reproductive health;Sexually Transmitted Diseases;STI prevention;structural determinants;Surveys;Sustainable Development;Testing;theories;Training;transactional sex;United States National Institutes of Health;Unsafe Sex;uptake;Vulnerable Populations;Water;Work;young woman

PROJECT_TITLE: Assessing the effects of a multisectoral agricultural intervention on the reproductive and sexual health of adolescent girls and young women

STUDY_SECTION: HIBI

STUDY_SECTION_NAME: HIV/AIDS Intra- and Inter-personal Determinants and Behavioral Interventions Study Section[HIBI]


NIH_SPENDING_CATS: Biotechnology;Lung;Orphan Drug;Pulmonary Fibrosis;Rare Diseases

ORG_CITY: PHOENIX

ORG_NAME: FAKNOSTICS, LLC

PHR: Project Narrative Idiopathic pulmonary fibrosis (IPF) is a highly fatal fibrotic lung disorder that has a poor prognosis and limited current therapeutic options. FAKnostics, LLC has developed a lead candidate, FN-2012, that targets focal adhesion kinase (FAK), a protein which is responsible for driving the hallmarks of lung fibrosis, including secretion of collagen and fibronectin. This project will advance this therapy for IPF patients by accelerating the chemical manufacturing, toxicological testing, and efficacy testing in preclinical models of IPF.

PI_NAMEs: KNOX, KENNETH S;MARLOWE, TIMOTHY A (contact)

PROGRAM_OFFICER_NAME: VUGA, LOUIS J

PROJECT_TERMS: Acceleration;Affect;Affinity;aged;alpha helix;Apoptosis;Automobile Driving;Biological Assay;Bleomycin;Canis familiaris;cell motility;Cells;Chemicals;Chemistry;Clinical;Clinical Trials;Collagen;Connective Tissue Diseases;Crystallization;Cyclic GMP;Cytolysis;cytotoxicity;Development;Dose;Drug Kinetics;effective therapy;efficacy evaluation;efficacy testing;Elderly;Enzymes;Extracellular Matrix Proteins;Fibroblasts;Fibronectins;Fibrosis;fibrotic lung;first-in-human;Focal Adhesion Kinase 1;Focal Adhesions;Funding;Gene Expression Profiling;Goals;Half-Life;Health;Human;idiopathic pulmonary fibrosis;In Vitro;in vivo;inhibitor;kinase inhibitor;large scale production;Lead;lead candidate;Left;Lethal Dose 50;Lung;lung development;Lung Diseases;Lung Transplantation;manufacture;manufacturing process;Maximum Tolerated Dose;Membrane;men;Metabolic;Metabolism;Methods;Microsomes;Modeling;mouse model;Mus;Myofibroblast;nanomolar;nintedanib;No-Observed-Adverse-Effect Level;novel;novel therapeutics;old mice;Particle Size;Patients;paxillin;Peptide Hydrolases;Peptides;Permeability;Pharmaceutical Preparations;Pharmacology;Pharmacology Study;Phase;Phenotype;Phosphotransferases;Pirfenidone;pre-clinical;Pre-Clinical Model;pre-Investigational New Drug meeting;Preparation;Production;Prognosis;Property;Protein Tyrosine Kinase;Proteins;Pulmonary Fibrosis;pulmonary function decline;Quality of life;Rattus;Regimen;Resistance;Rheumatoid Arthritis;Role;Safety;scaffold;Scaffolding Protein;scale up;Schedule;Scleroderma;Series;Slice;Small Business Technology Transfer Research;Solubility;stapled peptide;Stress;Structure of parenchyma of lung;subcutaneous;Testing;Therapeutic;Toxic effect;Toxicokinetics;Toxicology;uptake;Work;young woman

PROJECT_TITLE: Non-catalytic FAK inhibitors as novel therapeutics for lung fibrosis

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 RCCS-B (11)]


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Bioengineering;Foodborne Illness;Rare Diseases;Social Determinants of Health

ORG_CITY: HAYWARD

ORG_NAME: ONDAVIA, INC.

PHR: Project Narrative This project addresses the pressing public health concern of uranium contamination in drinking water. By developing a novel Surface-Enhanced Raman Spectroscopy (SERS)-based platform for real-time uranium quantification, this research aims to provide accurate and rapid monitoring tools. In the long term, this innovative technology will significantly improve water quality assessment, contributing to better public health protection and environmental preservation.

PI_NAMEs: PETERMAN, MARK C (contact)

PROGRAM_OFFICER_NAME: HENRY, HEATHER F

PROJECT_TERMS: Achievement;Address;Adhesions;Adoption;Affect;Amines;aqueous;Arsenic;Calibration;Capital;Cells;Chemicals;Chemistry;chromium hexavalent ion;Clinical;commercialization;Complex;contaminated drinking water;contaminated water;cost;Couples;Data;Decision Making;Dedications;Detection;detection limit;detection platform;Development;Devices;Disclosure;drinking water;Dyes;Effectiveness;Environment and Public Health;Environmental Health;Equipment;exposed human population;exposure route;Family;field study;Future;global health;Gold;Health;Health protection;Hot Spot;improved;In Situ;Inductively Coupled Plasma Mass Spectrometry;Industrialization;industry partner;innovation;innovative technologies;Ionic Strengths;Isotope Labeling;Laboratories;Malignant Bone Neoplasm;Malignant neoplasm of liver;Marketing;Measurement;Methods;Monitor;nanoscale;National Institute of Environmental Health Sciences;Neurologic;Nitrates;novel;Oils;Oxygen;Performance;Persons;Phase;Population;portability;preservation;Process;programs;Public Health;Radioactive;Raman Spectrum Analysis;Reagent;real time monitoring;remediation;renal damage;reproductive;Research;Research Design;Risk;Sampling;Signal Transduction;Site;skills;Small Business Innovation Research Grant;Source;Spectrum Analysis;stem;Superfund;Surface;System;Techniques;Technology;Testing;Time;tool;United States National Institutes of Health;Uranium;Validation;Variant;Vulnerable Populations;Water;water quality;water sampling

PROJECT_TITLE: Field-deployable analyzer for aqueous uranyl concentration

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-S (12)]


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Biotechnology;Complementary and Integrative Health;Genetics;Orphan Drug;Primary Immunodeficiencies;Rare Diseases

ORG_CITY: Berkeley

ORG_NAME: RESVITA BIO, INC.

PHR: Project Narrative Netherton syndrome (NS) is a rare hereditary disorder that results in skin, hair, and immune abnormalities due to insufficient activity of LEKTI (Lympho-epithelial Kazal-type inhibitor), a serine protease inhibitor. This project extends the proof-of-concept studies of an engineered bacteria that treat NS through continuous delivery of LEKTI fragments to illustrate efficacy in in vitro and murine models. This project will bring the lead therapy to the cusp an IND application, potentially transforming the well-being of NS patients.

PI_NAMEs: ZARGAR, AMIN  (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: 3-Dimensional;absorption;Address;Adrenal Cortex Hormones;Anti-Bacterial Agents;Bacteria;causal variant;Cell Therapy;Cells;Childhood;Clinical;Corynebacterium glutamicum;Couples;Data;Dehydration;design;Development;Disease;dosage;effective therapy;Emollients;Engineering;Ensure;enzyme replacement therapy;Equilibrium;Evaluation;Evolution;Experimental Designs;FDA approved;Formulation;Generations;Genes;Genetic Diseases;Genetic Engineering;Genetic Transcription;Genomics;Goals;Growth;Hair;Half-Life;Hereditary Disease;Hour;Human;Immune;Immune response;Immune system;In Vitro;Infection;inhibitor;innovation;Investigational Drugs;Investigational New Drug Application;Kininogenase;Laboratories;Lead;Lesion;Libraries;Metabolic Pathway;Modeling;mortality;mouse model;Mutation;Netherton syndrome;Output;Patients;peptide drug;Performance;Personal Satisfaction;Phase;Phenotype;postnatal;pre-Investigational New Drug meeting;Probiotics;Process;Production;Productivity;Protease Inhibitor;Protein Secretion;Proteins;Proteolysis;Research;response;Safety;safety and feasibility;Serine Protease;Serine Proteinase Inhibitors;Severities;Shapes;Site;Skin;skin barrier;skin damage;skin lesion;Small Business Innovation Research Grant;small molecule;small molecule inhibitor;Surface;symptom management;Testing;Therapeutic;Therapeutic Effect;Topical application;Toxic effect;Transgenic Organisms;translational therapeutics;Validation;Water

PROJECT_TITLE: Skin probiotics to treat Netherton Syndrome

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MSOS-D (10)]


NIH_SPENDING_CATS: Genetics;Human Genome

ORG_CITY: BERKELEY

ORG_NAME: SURVEY GENOMICS, INC.

PHR: Project Narrative Survey Genomics is revolutionizing tissue biology with Cytope-drop, a groundbreaking assay platform for spatially-resolved, single-cell multiomic profiling of tissue sections. This innovative technology is compatible with existing droplet-based sequencing platforms and offers a low-cost, user-friendly, and high-throughput platform to understand how cells organize and communicate. By elucidating cellular interactions in healthy and diseased tissues, including tumors, Cytope-drop promises to advance disease understanding, patient stratification, and biomarker discovery for monitoring disease progression and therapeutic response.

PI_NAMEs: PHAM, LIN  (contact)

PROGRAM_OFFICER_NAME: NOVA, IAN CURTIS

PROJECT_TERMS: Address;advanced disease;Antigens;Autoimmunity;B-cell receptor repertoire sequencing;Bar Codes;base;Basic Science;Biological Assay;Biology;biomarker discovery;Capital;Cell Communication;Cell membrane;Cell Surface Proteins;cell type;Cells;Chemistry;Chromatin;Clinical Research;commercial launch;commercialization;Communication;Computer software;cost;Cryopreservation;Data;Defect;design;Detection;Development;Diffusion;Disease;Disease Pathway;Disease Progression;DNA;Drops;Embryo;Ensure;Equipment;Excision;experience;fabrication;Feedback;Fibrosis;flexibility;Flow Cytometry;Fluorescent in Situ Hybridization;Formalin;Formulation;Foundations;Functional disorder;Future;Genetic Transcription;Genomics;Health;Homeostasis;Image;Individual;Infiltration;innovation;innovative technologies;insight;Institution;Label;large scale production;Lateral;Life;Location;malformation;Malignant Neoplasms;Manuals;manufacture;manufacturing capabilities;manufacturing process;Maps;Marketing;Messenger RNA;meter;Methodology;Methods;Microtomy;Molecular;Molecular Biology;Molecular Profiling;Monitor;mRNA delivery;multimodal data;Multiomic Data;multiple omics;Neighborhoods;Nerve Degeneration;novel;Oligonucleotides;Optics;Organ;Outcome;Paraffin;Paraffin Embedding;patient stratification;Phase;Population Heterogeneity;Positioning Attribute;Predisposition;pressure;Process;Protein Analysis;protein expression;Proteins;Quality Control;Reagent;Recovery;Reproducibility;Research Personnel;Resolution;response;risk mitigation;RNA;Role;Sampling;Scientist;seal;sequencing platform;single cell analysis;single cell sequencing;single-cell RNA sequencing;Solid;Spatial Distribution;spatial relationship;Special Equipment;stability testing;stem;Surveys;System;Techniques;Testing;Tissue Embedding;Tissues;tool;trafficking;Transcript;transcriptome;transcriptomics;Translational Research;treatment response;treatment strategy;tumor;user-friendly;vector;Vendor;Work

PROJECT_TITLE: Pioneering assays for spatially-resolved single-cell multiomics

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-G (15)]


NIH_SPENDING_CATS: Aging;Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related

ORG_NAME: ORLANCE, INC.

PI_NAMEs: BAGLEY, KENNETH C (contact);FULLER, DEBORAH H.

PROGRAM_OFFICER_NAME: GORDON, JENNIFER L

PROJECT_TERMS: Acceleration;Address;Antibodies;Antibody Response;Antigens;Cessation of life;Clinical Trials;Cold Chains;cost effective;Coupled;Cryopreservation;Development;Disease;DNA;DNA delivery;DNA Vaccines;Dose;Dryness;Elderly;Electroporation;Epidermis;flu;Formulation;Future;future pandemic;gene gun;Genetic;Gold;Head;Hemagglutinin;Hospitalization;Human;Human Resources;Immune response;Immunity;Immunocompetent;Immunocompromised Host;immunogenicity;improved;Infection;Infection prevention;Influenza;influenza virus strain;influenza virus vaccine;Injections;Lead;lipid nanoparticle;manufacture;Marketing;Modality;Modeling;mortality;Mucosal Immune Responses;Mucous Membrane;Mus;Needles;Needlestick Injuries;Neuraminidase;neutralizing antibody;next generation;nonhuman primate;novel;novel vaccines;Nucleic Acid Vaccines;old mice;Pain Free;Painless;pandemic disease;pandemic potential;particle;Phase;phase 2 study;plasmid DNA;Play;point of care;pre-clinical;Pre-Clinical Model;prevent;Primate Diseases;protective efficacy;research clinical testing;response;RNA vaccine;scale up;seasonal influenza;Seasons;Site;skills;Skin;T cell response;T-Lymphocyte;Technology;Temperature;Time;universal influenza vaccine;Update;vaccine delivery;Vaccine Design;vaccine efficacy;vaccine formulation;vaccine immunogenicity;vaccine-induced antibodies;Vaccines;Viral;Virus;Virus Replication;Vulnerable Populations;Widespread Disease

PROJECT_TITLE: Enhanced Seasonal Influenza Vaccine Targeting Variable and Conserved Antigens


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Brain Disorders;Caregiving Research;Clinical Research;Dementia;Neurodegenerative;Neurosciences;Palliative Care

ORG_CITY: SAN JOSE

ORG_NAME: BEAVER HEALTH, INC.

PHR: Project Narrative As the number of people living with dementia is expected to double to 13.8 million by 2060, the strain on dementia family caregivers will be further intensified, especially for minoritized caregivers who are affected disproportionately and face cultural barriers in accessing support. This project aims to develop a family- centered, culturally responsive AI-enabled conversational assistant to support ADRD caregivers in real-time with 1) personalized, culturally relevant ADRD caregiving guidance and 2) a coordination capability within their family care network. Successful completion will support the development of a novel, real-time multicomponent intervention delivery for AD/ADRD caregivers and their family that addresses a significant market gap to increase health equity.

PI_NAMEs: WANG, EMILY S. (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Accent;Address;Adherence;Affect;Age;Alzheimer's Disease;Alzheimer's disease related dementia;Area;Behavior;Black race;Caregiver Burden;Caregivers;caregiving;Caring;Code;commercialization;Communication;Community Healthcare;Custom;Data Set;deep learning;Dementia;Dementia caregivers;Development;efficacy study;Emotional;Environment;environmental change;ethnic diversity;evidence base;experience;Face;Facebook;Family;Family Caregiver;Family member;Feedback;Foundations;Friends;Geography;Goals;Health;health equity;Home;Improve Access;improved;Intake;interest;Internet;Intervention;intervention delivery;Interview;knowledge base;Latinx;Left;Marketing;Measures;Memory;Methods;Minority;Modeling;Modification;multi-component intervention;Multilingualism;Natural Language Processing;new technology;novel;Online Systems;Outcome;Participant;Peer Review;Persons;Phase;Positioning Attribute;preference;Process;prototype;Psyche structure;Psychiatry;Psychology;racial diversity;recruit;remote health care;response;Schedule;Secure;skills;social stigma;Source;Speech;speech recognition;Support Groups;System;Testing;Text;Text Messaging;Time;tool;Training;Update;usability;user-friendly;virtual;Voice;Work

PROJECT_TITLE: COMPASS: A Family-Centered, Culturally Responsive Conversational AI Assistant to Support ADRD Caregivers and Family Care Networks in Real-Time


NIH_SPENDING_CATS: Antimicrobial Resistance;Behavioral and Social Science;Biodefense and Related Countermeasures;Clinical Research;Emerging Infectious Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Racial and Ethnic Minority Health Research;Sexually Transmitted Infections;Social Determinants of Health;Women's Health Research

PHR: PROJECT NARRATIVE Doxycycline taken as post-exposure prophylaxis (doxy-PEP) is an important new tool to address the sexually transmitted infection (STI) epidemic in the US; doxy-PEP has demonstrated substantial efficacy in reducing new bacterial STIs in men who have sex with men (MSM) and transgender women (TW) in three randomized controlled trials. However, doxy-PEP will only be effective if offered to and used by MSM and TW at highest risk for recurrent STIs, particularly persons who are younger, living with HIV, and racial/ethnic minorities who are also at greater risk of health disparities. This study will create a multi-city, demographically diverse cohort to address key questions about the effectiveness of guideline-driven doxy-PEP and antimicrobial resistance consequences with longer term use.

PI_NAMEs: CELUM, CONNIE L;LUETKEMEYER, ANNE FREY (contact)

PROGRAM_OFFICER_NAME: CHUANG, ELEANORE JENNIFER

PROJECT_TERMS: access disparities;Address;Adherence;Affect;Age;Age Years;Antibiotics;Antimicrobial Resistance;arm;Bacteria;Black race;Caring;Characteristics;Chlamydia;Cities;Clinic;Clinical;clinically relevant;cohort;Communities;Data;Decision Making;Disparity;Doxycycline;Effectiveness;efficacy trial;Enrollment;Ensure;Epidemic;Equity;ethnic minority;Ethnic Origin;experience;follow-up;Gender Identity;Geography;Goals;Gonorrhea;Guidelines;health disparity;High Risk Woman;HIV;Hour;Incidence;Individual;Inequity;infection risk;Interview;Knowledge;Latinx;literate;Longitudinal cohort;Longitudinal trends;men of color;men who have sex with men;Methods;minority children;Modeling;Molecular;Nose;Participant;Pattern;people of color;Persons;Phenotype;Pneumonia;Population;pre-exposure prophylaxis;Prophylactic treatment;Provider;Public Health;Qualitative Methods;Race;racial minority;randomized trial;Randomized, Controlled Trials;Recommendation;Recurrence;Research;Resistance;Risk;Safety;Sampling;San Francisco;sex;sexual encounter;Sexual Health;Sexually Transmitted Diseases;Site;Staphylococcus aureus;Subgroup;Surveys;Syphilis;Testing;Tetracyclines;Time;tool;transgender women;Unsafe Sex;uptake

PROJECT_TITLE: The Doxy-PEP Impact Study: a multi-city US longitudinal cohort to evaluate doxy-PEP field effectiveness, investigate associated antimicrobial resistance, and establish doxy-PEP to need ratios

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 SCIL-A (03)]


ADMINISTERING_IC: OH

IC_NAME: NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

ORG_CITY: PULLMAN

ORG_NAME: APPLIED DESIGN TECHNOLOGIES

ORG_STATE: MI

PHR: PROJECT NARRATIVE In this SBIR, Applied Design Technologies aims to develop an innovative, comfort focused N95 respirator that significantly enhances respiratory protection and comfort for individuals working in high-risk environments. By addressing the critical issues of comfort, fit, communication and breathability, this technology will bolster the adoption of effective respiratory protection measures, contributing to improved public health outcomes and reducing the burdens of respiratory illness and infection transmission.

PI_NAMEs: ESTKOWSKI, CHRISTOPHER  (contact)

PROGRAM_OFFICER_NAME: O'NEILL, EDUARDO

PROJECT_TITLE: ClearWorks Particulate Respirator


ADMINISTERING_IC: EB

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

ORG_CITY: EL CERRITO

ORG_NAME: ODMR TECHNOLOGIES, INC.

PHR: ODMR Technologies, in collaboration with UNM, are developing millimeter-sized diamond quantum sensors for magnetoencephalography (MEG). These sensors can operate in Earth’s magnetic field and at ambient temperatures which enables close contact, ~1 mm, with a patient’s scalp and potentially removes the need of a magnetically shielded environment, expanding MEG access beyond elite hospitals.

PI_NAMEs: ACOSTA, VICTOR MARCEL;JARMOLA, ANDREJS  (contact)

PROGRAM_OFFICER_NAME: ASHMONT, KARI RICH

PROJECT_TERMS: absorption;Address;Adult;Alkali Metals;Brain;Brain imaging;Cells;Child;Collaborations;Cone;cost;cranium;cryogenics;Detection;Development;Diamond;Electrodes;Electroencephalography;Environment;Epilepsy;falls;ferrite;Fluorescence;Frequencies;Functional Imaging;Functional Magnetic Resonance Imaging;Glass;Goals;Head;Helium;Helmet;high standard;Hospitals;Human;Image;imaging system;improved;innovation;interest;Liquid substance;magnetic field;Magnetism;Magnetoencephalography;Maps;Measurement;meter;Methods;microwave electromagnetic radiation;millimeter;millisecond;miniaturized device;nano;Nervous System Disorder;neural;Neurons;Nitrogen;Noise;Non-Invasive Detection;operation;Optics;Patients;Performance;Phase;Planet Earth;Pump;quantum sensing;quantum sensor;Resolution;Scalp structure;Schizophrenia;sensor;sensor technology;Shapes;Signal Transduction;Skin;Source;superconducting quantum interference device;Surface;Syncope;Techniques;Technology;Temperature;Testing;Traumatic Brain Injury;vapor;Visual

PROJECT_TITLE: Diamond quantum sensor for magnetoencephalography

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-C (10)]


NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Digestive Diseases;Liver Disease;Organ Transplantation;Transplantation

ORG_CITY: NORTH CHARLESTON

ORG_NAME: SYLVATICA BIOTECH, INC.

PHR: NARRATIVE One in five liver patients on the waitlist for a transplant die before a new liver is found, and many more patients are never listed but could benefit from liver replacement. There are currently no “bridge-to-transplant” technologies for patients with liver failure (unlike ventricular assist devices for heart failure, and dialysis for kidney failure), and the ability to preserve donor livers, and organs in general, could eventually be lifesaving for hundreds of thousands, if not millions, of people around the world. To help overcome these barriers, we enhance our established supercooling preservation modality to achieve ice-free subzero storage at colder temperatures, to dramatically extend organ preservation times to at least 72 hours for clinical scale livers and ultimately enable cross-country (and theoretically global) organ sharing.

PI_NAMEs: BAICU, SIMONA C;TAYLOR, MICHAEL JOHN (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: 3-Dimensional;Acceleration;Acute Liver Failure;Air;allotransplant;aqueous;biomaterial compatibility;blood perfusion;Blood Vessels;Clinical;clinical practice;Clinical Trials;cold temperature;Country;Cryopreservation;Cryoprotective Agents;Custom;Development;Devices;Dialysis procedure;drug discovery;Equilibrium;expectation;experience;Family suidae;FDA approved;Flushing;Freezing;Gases;Goals;Graft Rejection;Growth;Heart;Heart failure;Heart-Assist Devices;Hepatocyte;High temperature of physical object;high throughput screening;Hour;Human;Ice;Impairment;improved;innovation;Ischemia;Kidney;Kidney Failure;left ventricular assist device;Legal patent;Length;Letters;Life;Liquid substance;Liver;Liver Failure;liver preservation;liver transplantation;Lung;Medical;Mental Depression;Methods;Modality;Modeling;mortality;natural hypothermia;Nature;next generation;novel;novel strategies;Oils;Organ;Organ Preservation;Organ Procurements;Organ Size;Patients;Perfusion;Persons;Phase;phase change;Physiological;Pilot Projects;pre-clinical;Preparation;preservation;Protocols documentation;prototype;Publishing;Quality of life;Randomized;Rattus;Renal dialysis;Research;Risk;Running;Science;Scientist;seal;Services;Shipping;Slice;standard of care;Stretching;Techniques;Technology;Temperature;Testing;Thermodynamics;Time;Toxicology;transplant model;Transplant Recipients;Transplant Surgeon;Transplantation;United Network for Organ Sharing;Validation;Ventilator;ventricular assist device;Waiting Lists;Water;Whole Blood;Work

PROJECT_TITLE: Enhanced supercooling for extending non-freezing preservation in preclinical porcine and human donor livers

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-R (10)]


NIH_SPENDING_CATS: Autoimmune Disease;Bioengineering;Clinical Research;Diabetes;Networking and Information Technology R&D (NITRD);Nutrition

ORG_CITY: THOUSAND OAKS

ORG_NAME: ACTIOX LLC

PHR: Building on our Phase I foundation, this SBIR Phase II project is poised to revolutionize precision nutrition by advancing a miniaturized, wearable device that monitors key health indicators. We are set to enhance public health by enabling continuous, individualized monitoring of glucose, ketones, and sodium, essential for managing chronic diseases and promoting long-term well-being. This innovative tool will empower individuals with actionable insights into their unique metabolic responses, paving the way for personalized healthcare that aims to extend life and reduce illness.

PI_NAMEs: TEHRANI, FARSHAD  (contact)

PROGRAM_OFFICER_NAME: ARREAZA-RUBIN, GUILLERMO

PROJECT_TERMS: Achievement;Address;Algorithms;Biological Markers;biomaterial compatibility;Biosensor;Blood;Calibration;Chronic Disease;Clinical;Clinical Research;Clinical Trials Design;commercialization;Continuous Glucose Monitor;cost;Custom;Data;Data Analyses;Data Analytics;data exchange;design;Development;Devices;Diameter;Diet;Dietary Factors;Dietary Practices;Dimensions;Disease Management;Electrolytes;Electronics;empowerment;Engineering;Ensure;Equipment;Evaluation Reports;experience;Feasibility Studies;Foundations;Glucose;glucose monitor;Goals;Health;Height;Human;human study;human subject;improved;In Vitro;in vivo;Individual;individual response;innovation;insight;Intervention;Ketones;Life;Life Style;lifestyle factors;Manuals;manufacture;manufacturing process;manufacturing scale-up;Marketing;Measurement;Metabolic;Metabolism;Methods;miniaturize;minimally invasive;mobile app development;mobile application;Modeling;Monitor;monitoring device;Needles;Nutritional;Outcome;Pain Free;Patients;Performance;Personal Satisfaction;personalized health care;Phase;Physiological;Population;Population Heterogeneity;Potentiometry;power consumption;precision nutrition;printed circuit board;Process;Production;Public Health;Recommendation;Research Design;response;Safety;scale up;Scheme;Secure;sensor;Series;Skin;Small Business Innovation Research Grant;Sodium;Solid;success;System;Techniques;Technology;Testing;Thick;Time;tool;transmission process;usability;user-friendly;Validation;wearable device;wearable health device;wearable sensor technology;Work

PROJECT_TITLE: A Sensor Patch for Continuous Monitoring of Sodium, Glucose, and Ketones Concurrently and in Real-Time

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 EMS-S (10)]


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Mental Health;Networking and Information Technology R&D (NITRD)

ORG_CITY: HONOLULU

ORG_NAME: NALU SCIENTIFIC, LLC

ORG_STATE: HI

PHR: NARRATIVE PET is an increasingly precise and useful functional imaging technique and diagnostic tool, and each technical advance has typically brought new capabilities as well as increased accuracy and precision. One of the most effective methods of improving diagnostic capabilities, and reducing patient exposure is through high-precision time-of-flight positron emission tomography (TOF-PET). The proposed SyMPET technology has the potential to dramatically increase contrast and image quality, by providing a readout system that overcomes the limitations of existing techniques.

PI_NAMEs: MACCHIARULO, LUCA  (contact)

PROGRAM_OFFICER_NAME: DURKIN, JACLYN MARIE

PROJECT_TERMS: Architecture;Biological Models;Calibration;Collaborations;commercialization;Computer software;cost;Data;data acquisition;Data Set;density;Dependence;design;Detection;detector;Development;Devices;diagnostic tool;diagnostic value;digital;Disease;Early Diagnosis;Electronics;Ensure;Environment;Evaluation;fabrication;Feasibility Studies;flexibility;Frequencies;Functional Imaging;Geometry;Harvest;Image;image reconstruction;imaging capabilities;imaging system;Imaging Techniques;improved;Individual;integrated circuit;Legal patent;Length;Light;machine learning model;Measures;Methods;microchip;microelectronics;Modeling;Modification;next generation;Noise;novel;operation;Patient imaging;Patients;Performance;Phase;photomultiplier;Positron-Emission Tomography;power consumption;Prevention;Production;prototype;Readiness;Resolution;sensor;Shapes;Side;signal processing;Silicon;simulation;Specific qualifier value;Structure;System;Techniques;Technology;Testing;Time;tool;ultra high resolution;Validation;Variant;Walking;Work

PROJECT_TITLE: Design and Development of SyMPET: System on chip Modular readout for high-resolution TOF-PET

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-Z (10)]


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Lung;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurosciences;Sleep Research

ORG_CITY: SAN DIEGO

ORG_NAME: POWELL MANSFIELD, INC.

ORG_STATE: CA

PHR: Project Narrative We will establish how well a novel, quick, and painless way of measuring muscle activity from the mouth and throat works for detecting sleep apnea. This technology is called transmembraneous electromyography (tmEMG). Leveraging two innovative technologies, a new probe capable of recording muscle activity by lightly touching the muscle, as well as a machine learning model for signal interpretation, we will conduct an initial observational feasibility study in phase 1, followed by a larger observational cohort study in phase 2 to assess the performance of deep learning enhanced tmEMG. The study will address a critical unmet need in sleep apnea diagnostics; the availability of an inexpensive, accurate diagnostic test for screening at point of care in under-resourced areas or pre-operatively, helping to resolve a significant healthcare inequity.

PI_NAMEs: KOOLA, JEJO DAVID;MANDEVILLE, ROSS  (contact)

PROGRAM_OFFICER_NAME: DIXIT, SHILPY

PROJECT_TERMS: accurate diagnosis;accurate diagnostics;Address;Adult;Age;Algorithms;Area;California;Cardiovascular system;case control;Characteristics;Classification;Clinic;Clinical;clinical examination;cohort;Cohort Studies;Collaborations;computerized data processing;cost;cost effective;Country;Dangerousness;data acquisition;data integration;deep learning;deep learning algorithm;design;Detection;Development;Devices;Diagnosis;Diagnostic;diagnostic accuracy;diagnostic signature;Diagnostic tests;diagnostic tool;Disease;Early Intervention;Electromyography;Ethnic Origin;Evaluation;Feasibility Studies;Gender;Goals;Health;health care availability;health care disparity;health care settings;Health Insurance Portability and Accountability Act;health record;Human;Impaired cognition;improved;indexing;Individual;innovation;innovative technologies;Investments;Legal patent;machine learning model;Marketing;Measures;meetings;Methodology;Methods;Modality;motor control;Multicenter Studies;multimodal data;Muscle;Needles;neuromuscular;neuromuscular function;new technology;Notification;novel;novel diagnostics;observational cohort study;Obstructive Sleep Apnea;Oral;Oral cavity;Pain;Painless;patient population;Patient Triage;Patients;Pattern;Perception;Performance;Perinatal;Peripheral nerve injury;personalized medicine;Persons;Pharyngeal structure;Phase;phase 1 study;phase 2 study;Pilot Projects;Play;point of care;point-of-care diagnostics;Polysomnography;Population;Population Heterogeneity;Probability;Process;prospective;Prospective Studies;Prospective, cohort study;prototype;Quality of life;Race;recruit;Reporting;Research;Research Design;Resources;response;Risk;screening;sensor;Signal Transduction;Site;Sleep;Sleep Apnea Syndromes;Sleep Disorders;Small Business Technology Transfer Research;System;Technology;Testing;Time;Touch sensation;Translations;trial readiness;Universities;uptake;Validity and Reliability;Work

PROJECT_TITLE: BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CCHI-J (10)]