Nc7 Incorporated

BUDGET PERIOD 1 (PHASE 2 - “STRATEGIC PLAN + ENERGY AUDITS”) WILL FOCUS ON CONDUCTING THE AMERICAN SOCIETY OF HEATING, REFRIGERATING AND AIR-CONDITIONING ENGINEERS (ASHRAE) LEVEL 2 ENERGY AUDITS OF ALL THE SCHOOLS/SCHOOL FACILITIES IN THE PORTFOLIO, AND ON DEVELOPING A COMPREHENSIVE STRATEGIC PLAN FOR IMPLEMENTING ENERGY IMPROVEMENTS. BY THE END OF BUDGET PERIOD 1, ENERGY AUDITS AND THE STRATEGIC PLAN SHOULD PROVIDE A CLEAR PATHWAY TO PRIORITIZE ENERGY IMPROVEMENTS, ACCESS PRIVATE SECTOR FUNDING (IF NEEDED) AND/OR TAX CREDITS AND REALIZE HIGH-IMPACT HEALTH AND SAFETY BENEFITS FOR BUDGET PERIOD 2. BUDGET PERIOD 2 (PHASE 3 - “IMPLEMENTATION”) WILL IMPLEMENT THE ENERGY IMPROVEMENTS IDENTIFIED AT THE END OF PHASE 2. PHASE 3 SHOULD DIRECTLY ADVANCE THE MEASURABLE GOALS OF ENERGY SAVINGS AND HIGH-IMPACT HEALTH AND SAFETY BENEFITS. THE PLANNED PROJECT WILL TRANSFORM NUMEROUS FACILITIES ACROSS MARION COUNTY SCHOOL DISTRICT (MCSD) AS IT ADDRESSES SIGNIFICANT DEFERRED MAINTENANCE ISSUES THAT CURRENTLY DO NOT HAVE ALLOCATED FUNDING AND CONTINUE TO REMAIN UNADDRESSED. THESE SIGNIFICANT PLANNED IMPROVEMENTS WILL BE ENERGY-SAVINGS DRIVEN AND SIGNIFICANTLY LOWER CURRENT UTILITY CONSUMPTION.

SUSTAINED RELEASE GEL ENABLING ONE-STAGE TREATMENT OF PROSTHETIC JOINT INFECTION

SUSTAINED RELEASE GEL ENABLING ONE-STAGE TREATMENT OF PROSTHETIC JOINT INFECTION

EXTENDED-RELEASE INJECTABLE GEL FOR MULTI-DAY TREATMENT OF POSTOPERATIVE PAIN - PRINCIPAL INVESTIGATOR: OVERSTREET, DEREK J. ABSTRACT SONORAN BIOSCIENCES, INC. SBIR PA-23-230: PHASE II OVER 14 MILLION PATIENTS UNDERGOING SURGICAL PROCEDURES IN THE US ANNUALLY REQUIRE TREATMENT OF MODERATE-TO-SEVERE POSTOPERATIVE PAIN LASTING AT LEAST THREE DAYS. THE GOAL OF THIS PROJECT IS TO ENABLE OPIOID- FREE TREATMENT OF PAIN IN THESE PATIENTS USING AN INJECTABLE EXTENDED-RELEASE GEL-FORMING FORMULATION OF BUPIVACAINE. CURRENTLY AVAILABLE ALTERNATIVES HAVE INADEQUATE EFFICACY BEYOND 24 HR, LEAVING A WINDOW OF TIME WHEN PAIN EMERGES AND IS FREQUENTLY TREATED WITH OPIOIDS. PRESCRIPTION OPIOID USE POSES SERIOUS RISKS OF ADVERSE EVENTS TO PATIENTS AND IS CONTRIBUTING TO THE ONGOING NATIONWIDE OPIOID CRISIS. AN EXTENDED-RELEASE LOCAL ANESTHETIC ACTING FOR THREE DAYS OR MORE WOULD HAVE CONSIDERABLE IMPACT BY SIMPLIFYING POSTOPERATIVE RECOVERY, AVOIDING OPIOID-RELATED ADVERSE EVENTS, ELIMINATING A COMMON PATHWAY TO NEW AND PERSISTENT OPIOID USE, AND PREVENTING UNSAFE STORAGE OF UNUSED ORAL OPIOIDS. ACHIEVING ANALGESIC EFFICACY USING AN EXTENDED-RELEASE LOCAL ANESTHETIC REQUIRES SUPPLYING EFFECTIVE DRUG CONCENTRATIONS IN A VOLUME OF TISSUE SURROUNDING THE SURGICAL SITE. COMPETING DELIVERY TECHNOLOGIES FAIL TO ACCOMPLISH THIS, DESPITE APPARENTLY WELL-TIMED RELEASE KINETICS, DUE TO ONE OF TWO INHERENT LIMITATIONS. FIRST, MATERIALS APPLIED IN THE SURGICAL WOUND SPACE, SUCH AS ORGANIC POLYMER SOLUTIONS AND SOLID IMPLANTS, MUST RELY ON DIFFUSION INTO SURROUNDING TISSUE RESULTING IN LIMITED DISTRIBUTION. ALTERNATIVELY, LIQUID-BASED SYSTEMS SUCH AS LIPOSOMES OR PRODRUGS CAN BE INJECTED INTO A SUFFICIENT VOLUME OF TISSUE, BUT ARE SUSCEPTIBLE TO WASHOUT, LEADING TO OFF-TARGET RELEASE. WE HAVE DEVELOPED A PROPRIETARY EXTENDED RELEASE CARRIER, SB GEL, WHICH CAN BE INJECTED AS AN AQUEOUS SOLUTION AND FORMS A SOFT GEL UPON CONTACT WITH TISSUE. THIS COMBINATION OF INJECTABILITY AND RETENTION AT THE INJECTION SITE ENABLES SB GEL TO SUSTAIN A SUFFICIENT VOLUME OF TISSUE WITH EFFECTIVE LOCAL ANESTHETIC CONCENTRATIONS AND AVOID WASHOUT. IN A PHASE I SBIR PROJECT, WE ESTABLISHED THE FEASIBILITY OF SBG004, A FORMULATION OF SB GEL WITH 4 WT% BUPIVACAINE. PRELIMINARY DATA INDICATE THAT SBG004 PROVIDES EXTENDED RELEASE IN VIVO FOR 7 DAYS, OUTPERFORMED PLAIN LOCAL ANESTHETICS AND CURRENT EXTENDED RELEASE COMPETING PRODUCTS IN SOFT AND HARD TISSUE MODELS OF PAIN FOR 72-96 HR, AND IS WELL-TOLERATED BOTH LOCALLY AND SYSTEMICALLY, INCLUDING LOW CMAX AT HIGH DOSES. WE NOW PROPOSE TO COMPLETE A PHASE II PROJECT TO CONTINUE THE DEVELOPMENT OF SBG004. IN AIM 1, WE WILL COLLECT FURTHER DATA COMPARING SBG004 AGAINST COMPETING PRODUCTS, INCLUDING DATA ON WEIGHT-BEARING BEHAVIOR AFTER KNEE SURGERY AND THE CONCENTRATIONS OF LOCAL ANESTHETIC PROVIDED IN SURROUNDING TISSUE. IN AIM 2, WE WILL CONDUCT DOSE RANGE-FINDING TOXICITY STUDIES IN TWO SPECIES TO ESTIMATE A MAXIMUM TOLERATED DOSE AND INFORM THE DESIGN OF DEFINITIVE IND-ENABLING STUDIES. IN AIM 3, WE WILL MANUFACTURE A BATCH OF SBG004 AT 500 UNIT SCALE FOR USE IN IND-ENABLING STUDIES. IN AIM 4, WE WILL COMPLETE A GLP TOXICITY STUDY AND A GLP CARDIOPULMONARY SAFETY STUDY WHICH FULFILL REGULATORY REQUIREMENTS AND INFORM THE DESIGN OF FUTURE CLINICAL STUDIES.

FAIR HOUSING ASSISTANCE PROGRAM_STATE AND LOCAL

SUSTAINED-RELEASE GEL FOR MULTI-DAY CONTROL OF POSTOPERATIVE PAIN - PRINCIPAL INVESTIGATOR: OVERSTREET, DEREK J. ABSTRACT SONORAN BIOSCIENCES, INC. SBIR PA-21-259: PHASE I ABOUT 14 MILLION SURGERIES ANNUALLY IN THE UNITED STATES ARE ASSOCIATED WITH MODERATE-TO- SEVERE POSTOPERATIVE PAIN LASTING AT LEAST THREE DAYS AT REST. PAIN HAS BEEN REPORTED TO BE ONE OF THE MOST COMMON REASONS FOR DELAYED DISCHARGE FOLLOWING INPATIENT PROCEDURES AND FOR UNPLANNED HOSPITAL ADMISSIONS FOLLOWING OUTPATIENT PROCEDURES. TREATMENT OF POSTOPERATIVE PAIN PRESENTS A CHALLENGING SCENARIO FOR CLINICIANS BECAUSE IT IS RESOURCE-INTENSIVE AND FREQUENTLY INVOLVES OPIOID MEDICATIONS WHICH ARE ASSOCIATED WITH ADVERSE EFFECTS. MOREOVER, POORLY MANAGED PAIN LEADS TO PATIENT SUFFERING AND INCREASED RISKS OF COMPLICATIONS. CURRENT BEST PRACTICES SUPPORT THE USE OF MULTIMODAL ANALGESIA REGIMENS WHICH RELY ON MULTIPLE CLASSES OF DRUGS TO OFFSET THE NEED FOR OPIOIDS. LOCAL ANESTHETICS ARE A CRITICAL COMPONENT OF MULTIMODAL ANALGESIA BECAUSE THEY CAN PROVIDE A POTENT REDUCTION OF PAIN IN A LOCAL AREA WHILE HAVING A FAVORABLE SAFETY PROFILE. UNFORTUNATELY, LOCAL ANESTHETIC MOLECULES ONLY REMAIN ACTIVE FOR UP TO EIGHT HOURS AND AVAILABLE EXTENDED-RELEASE PRODUCTS HAVE LIMITED EFFICACY BEYOND 12-24 HR POSTOPERATIVELY. THE MARKET LEADER IS EXPAREL (LIPOSOMAL BUPIVACAINE), WHICH IS ON PACE TO REACH $500 MILLION IN SALES IN 2021. THERE REMAINS A SIGNIFICANT NEED AND COMMERCIAL OPPORTUNITY FOR A LOCAL ANESTHETIC THAT PROVIDES ANALGESIA FOR AT LEAST THREE DAYS, WHICH WOULD CARRY OVER INTO THE HOME SETTING, POTENTIALLY ENABLING PATIENTS TO BE DISCHARGED SAFELY WITHOUT OPIOID PRESCRIPTIONS. WE HAVE DEVELOPED A PROPRIETARY SUSTAINED-RELEASE CARRIER, SB GEL, WHICH CAN BE MIXED WITH THE LOCAL ANESTHETIC BUPIVACAINE AT THE TIME OF USE AND APPLIED AS AN AQUEOUS SOLUTION THAT FORMS A SOFT GEL IN THE SURGICAL SITE. SB GEL PROVIDES DIFFUSION-BASED RELEASE OF BUPIVACAINE OVER MULTIPLE DAYS AND DISSOLVES IN VIVO IN ABOUT THREE WEEKS. IN A PIG SKIN AND MUSCLE INCISION MODEL, BUPIVACAINE-LOADED SB GEL PROVIDED ANALGESIA LASTING FOR 120 HOURS. SIGNIFICANTLY GREATER FORCE AT THE INCISION WAS TOLERATED IN SITES RECEIVING SB GEL + BUPIVACAINE COMPARED TO THOSE RECEIVING EXPAREL AT 24, 48, 72, 96, AND 120 HOURS POSTOPERATIVELY. WE NOW PROPOSE TO COMPLETE A PHASE 1 PROJECT TO ESTABLISH THE FEASIBILITY OF BUPIVACAINE- LOADED SB GEL AS THE BEST-IN-CLASS EXTENDED-RELEASE LOCAL ANESTHETIC. IN AIM 1, WE WILL STUDY THE DOSE RESPONSE OF SB GEL + BUPIVACAINE, COMPARE THE EFFECTIVENESS OF SB GEL + BUPIVACAINE AGAINST ALL OF THE FDA-APPROVED EXTENDED-RELEASE LOCAL ANESTHETICS, AND EVALUATE EFFECTS ON WOUND HEALING. IN AIM 2, WE WILL EVALUATE SAFETY, INCLUDING SYSTEMIC TOXICITY, SYSTEMIC EXPOSURE TO BUPIVACAINE, AND TOXICITY TO MUSCLE AND PERIPHERAL NERVES. SUCCESSFUL COMPLETION OF THE PROJECT WILL RESULT IN READINESS FOR SCALED-UP MANUFACTURING AND FUTURE IND-ENABLING TOXICOLOGY STUDIES.

ANTIMICROBIAL-RELEASING GELS FOR PREVENTING INFECTION IN TOTAL JOINT ARTHROPLASTY

SURFACE-COVERING GELS FOR BROAD-SPECTRUM ANTIMICROBIAL PROTECTION FOLLOWING OPEN

DRUG FREE COMMUNITIES SUPPORT PROGRAM

SMALL, RURAL SCHOOL ACHIEVEMENT PROGRAM

SMALL, RURAL SCHOOL ACHIEVEMENT PROGRAM

SMALL, RURAL SCHOOL ACHIEVEMENT PROGRAM

SMALL, RURAL SCHOOL ACHIEVEMENT PROGRAM

SMALL, RURAL SCHOOL ACHIEVEMENT PROGRAM

SMALL, RURAL SCHOOL ACHIEVEMENT PROGRAM

IMPACT AID PROGRAM, TITLE VIII, SECTION 8003

IMPACT AID PROGRAM, TITLE VIII, SECTION 8003

IMPACT AID PROGRAM, TITLE VIII, SECTION 8003