Mobius

SBIR PHASE II: SCALE UP AND COMMERCIALIZATION OF LIGNIN-BASED BIODEGRADABLE AND COMPOSTABLE PLASTICS FOR HORTICULTURAL AND AGRICULTURAL APPLICATIONS

**AWARDS ISSUED PRIOR TO JANUARY 20, 2025, WERE FUNDED UNDER PREVIOUS ADMINISTRATIONS AND MAY NOT REFLECT THE PRIORITIES AND POLICIES OF THE CURRENT ADMINISTRATION.** WITH GROWING POPULATIONS AROUND THE WORLD, OUR GLOBAL FOOD SYSTEMS MUST GROW TO SUPPORT A PROJECTED 9.7 BILLION PEOPLE BY 2050, INCREASING CURRENT FOOD PRODUCTION BY 70%. AS IF THIS PROBLEM WASN'T HARD ENOUGH, GROWERS MUST ACHIEVE THIS FEAT USING PRACTICES THAT ARE PRODUCTIVE IN THE SHORT-TERM, PROVIDING HEALTHY AND NUTRITIOUS FOOD, AND SUSTAINABLE IN THE LONG-TERM, REDUCING POLLUTION AND WASTE INTO THE ENVIRONMENT. ONE PRACTICE THAT HAS HELPED GROWERS INCREASE CROP YIELDS IS FERTILIZER. IN 2019, GLOBAL FERTILIZER USE WAS ESTIMATED AT 215 MILLION TONS AND IS EXPECTED TO GROW BY 2.5 MILLION TONS PER YEAR TO ACCOMMODATE INCREASING FOOD PRODUCTION DEMANDS. ONE SEGMENT OF THIS MARKET IS CONTROLLED-RELEASE FERTILIZERS (CRF'S), WHICH COMBAT SOME OF THE ENVIRONMENTAL CHALLENGES THAT TRADITIONAL FERTILIZERS FACE, LIKE EUTROPHICATION AND GREENHOUSE GAS EMISSIONS. BUT THERE ARE SEVERAL BARRIERS PREVENTING THE WIDESPREAD ADOPTION OF CRF'S: HIGH COST OF MATERIALS, COMPLEX MANUFACTURING PROCESSES, LACK OF STANDARDIZATION, LACK OF INFORMATION FOR GROWERS, AND EMERGING CONCERNS AND REGULATIONS REGARDING MICROPLASTIC POLLUTION RESULTING FROM THE VARIOUS POLYMER MATERIALS USED AS COATINGS AND BINDERS.THERE IS AN OPPORTUNITY TO DEVELOP A LOW-COST, BIODEGRADABLE CONTROLLED RELEASE FERTILIZER PLATFORM THAT IS EASILY MANUFACTURABLE USING HIGH-THROUGHPUT CONTINUOUS PROCESSING EQUIPMENT, HELPING THE AGRICULTURE INDUSTRY MEET ITS PRODUCTION GOALS AND SUSTAINABILITY GOALS. OUR GOALS FOR THIS PHASE II PROJECT ARE TO: DEVELOP FORMULATIONS OF BIODEGRADABLE LIGNIN-POLYMERS FOR CONTROLLED RELEASE FERTILIZER APPLICATIONS, DEMONSTRATE CONTINUOUS PRODUCTION OF THESE MATERIALS, EVALUATE NUTRIENT RELEASE EFFICIENCY & PERFORMANCE IN LABORATORY AND GREENHOUSE TRIALS, AND DEVELOP A COMPREHENSIVE IP & COMMERCIALIZATION STRATEGY THROUGH THE TABA PROGRAM. AT THE END OF THIS PROJECT, WE AIM TO HAVE AT LEAST 1 FORMULATION OF LIGNIN POLYMERS WITH NITROGEN, PHOSPHORUS, OR POTASSIUM CONTENTTHAT SHOW TUNABLE RELEASE RATES BETWEEN 2 AND 6 MONTHS, DEMONSTRATING ABOVE- AND BELOW-GROUND PLANT GROWTH, PLANT QUALITY, AND SOIL QUALITY EQUIVALENT TO OR BETTER THAN COMMERCIALLY AVAILABLE CRF'S ON THE MARKET TODAY.

**AWARDS ISSUED PRIOR TO JANUARY 20, 2025, WERE FUNDED UNDER PREVIOUS ADMINISTRATIONS AND MAY NOT REFLECT THE PRIORITIES AND POLICIES OF THE CURRENT ADMINISTRATION.** WITH GROWING POPULATIONS AROUND THE WORLD, OUR GLOBAL FOOD SYSTEMS MUST GROW TO SUPPORT A PROJECTED 9.7 BILLION PEOPLE BY 2050, INCREASING CURRENT FOOD PRODUCTION BY 70%. AS IF THIS PROBLEM WASN'T HARD ENOUGH, GROWERS MUST ACHIEVE THIS FEAT USING PRACTICES THAT ARE PRODUCTIVE IN THE SHORT-TERM, PROVIDING HEALTHY AND NUTRITIOUS FOOD, AND SUSTAINABLE IN THE LONG-TERM, REDUCING POLLUTION AND WASTE INTO THE ENVIRONMENT. ONE INNOVATION THAT HAS HELPED GROWERS IMPROVE YIELDS FOR OVER 75 YEARS IS THE USE OF PLASTIC POTS, CONTAINERS, AND TRAYS. THESE LOW-COST, DURABLE PRODUCTS HAVE BEEN USED TO AUTOMATE AND STANDARDIZE MANY PROCESSES, SUCH AS PLANT GERMINATION AND TRANSPORTATION TO RETAILERS, AND ADOPTION HAS BEEN WIDESPREAD ACROSS AGRICULTURE AND HORTICULTURE. IN HORTICULTURE, THE PROMISE OF BIODEGRADABLE BIOPLASTICS CARRY A MASSIVE BENEFIT FOR PLANT HEALTH AND SUSTAINABILITY, BUT THEY ARE PLAGUED BY POOR DURABILITY AND HIGH COSTS - GENERALLY 2-3X THEIR PETROLEUM COUNTERPARTS. THE US ALONE CONSUMES OVER 5 BILLION PETROLEUM-BASED PLASTIC CONTAINERS EACH YEAR (750,000 METRIC TONS OF PLASTIC), RESULTING IN $3.8 BILLION SPENT ON CONTAINERS, AND SCALABLE SOLUTIONS ARE NEEDED TO ADDRESS THIS PROBLEM.THERE IS AN OPPORTUNITY FOR A NEW BIO-BASED MATERIAL PLATFORM TO PRODUCE A FAMILY OF LOW-COST AND BIODEGRADABLE CONTAINERS WITH A RANGE OF MECHANICAL PERFORMANCE, SUSTAINABILITY, AND BENEFICIAL PLANT HEALTH PROPERTIES. OUR GOALS FOR THIS PHASE II PROJECT ARE TO: OPTIMIZE LIGNIN-POLYMER FORMULATIONS THAT MEET THE MANUFACTURING & TECHNICAL SPECIFICATIONS OF OUR CUSTOMERS, DEMONSTRATE EQUIVALENT OR IMPROVED PLANT & SOIL HEALTH, COMPARED TO PETROLEUM-BASED CONTAINERS, AND DEVELOP A COMPREHENSIVE IP & COMMERCIALIZATION STRATEGY THROUGH THE TABA PROGRAM. TO ACCOMPLISH THESE GOALS, WE WILL OPTIMIZE FORMULATIONS OF OUR MATERIALS FOR INJECTION MOLDING PROCESSES AND EVALUATE THESE PROTOTYPES WITH MANUFACTURING AND INDUSTRY PARTNERS. WE WILL ALSO CONDUCT GREENHOUSE TRIALS WITH PARTNERS TO EVALUATE THE PERFORMANCE OF THESE PROTOTYPES IN REAL-WORLD CONDITIONS. AT THE END OF THIS PROJECT, WE AIM TO HAVE AT LEAST 1 COMMERCIAL CONTRACT TO PURCHASE A FORMULATION FOR COMMERCIAL-SCALE INJECTION MOLDING OF CONTAINERS DEMONSTRATING IMPROVED PLANT GROWTH BENEFITS, AND PERFORMING AS WELL OR BETTER THAN PETROLEUM-BASED PLASTICS IN A COMMERCIAL GREENHOUSE OR FIELD ENVIRONMENT.

DEVELOPING NOVEL 3D PRINTED GRAFTS FOR NASAL RECONSTRUCTION - ABSTRACT COMPLEX NASAL RECONSTRUCTION OFTEN REQUIRES SIGNIFICANT DONOR CARTILAGE TO AUGMENT AND RECONSTRUCT LARGE DEFECTS. THE SCARCITY OF SEPTAL CARTILAGE COMPELS SURGEONS TO RESORT TO HARVESTING COSTOCHONDRAL RIB CARTILAGE FOR NASAL GRAFTS. CADAVERIC COSTOCHONDRAL GRAFTS OR SYNTHETIC MATERIALS (BOTH PERMANENT AND RESORBABLE) ARE OCCASIONALLY USED. EACH APPROACH CARRIES ITS OWN SIGNIFICANT DRAWBACKS, UNDERSCORING THE UNMET NEED AMONG SURGEONS FOR A SOLUTION THAT COMBINES THE EASE OF USE AND UNLIMITED SUPPLY OF SYNTHETIC GRAFTS, WITH THE MECHANICAL PROPERTIES OF NATIVE CARTILAGE. MOBIUS BIOTECH HAS DEVELOPED A NOVEL 3D PRINTED POLYCAPROLACTONE (PCL) NASAL GRAFT THE RESORB3D SPREADER GRAFT (RSG), USING RESORB3D, ITS INNOVATIVE PLATFORM TECHNOLOGY TO PRODUCE RESORBABLE IMPLANTS FOR NASAL AND FACIAL RECONSTRUCTION. THE RSG IS A STANDARDIZED OFF THE SHELF GRAFT DESIGNED WITH A BILEVEL PORE GEOMETRY, WITH SMALLER PORES FOR TISSUE INGROWTH AND LARGER PORES TO ACCOMMODATE CARTILAGE TISSUE BIOPSIES AND ENGINEERED TO MIMIC THE MECHANICAL PROPERTIES OF COSTOCHONDRAL CARTILAGE. BY MINIMIZING THE NEED FOR CARTILAGE HARVESTING SURGERIES, THE RSG WILL SIGNIFICANTLY REDUCE THE OVERALL RISK, COST, AND SURGICAL TIME FOR COMPLEX NASAL RECONSTRUCTION, THUS BENEFITING A BROAD RANGE OF STAKEHOLDERS INCLUDING PATIENTS, SURGEONS, HOSPITALS, AND INSURERS. THE SPECIFIC AIMS OF THIS SBIR WILL EVALUATE AND TEST THE RSG PROTOTYPES IN AN IN VIVO RABBIT ANIMAL MODEL, FOCUSING ON TISSUE INTEGRATION, INFLAMMATION, AND NASAL RECONSTRUCTION EFFICACY AS COMPARED TO PDS PLATES. THE MECHANICAL AND MATERIAL PROPERTIES OF BOTH RSG AND PDS WILL ALSO BE COMPARED TO COSTOCHONDRAL GRAFTS TO ASSESS IMPLANT EXTRUSION RISKS. CURRENTLY, PDS PLATES ARE THE ONLY AVAILABLE RESORBABLE IMPLANTS USED BY SURGEONS TO AUGMENT SEPTAL CARTILAGE DURING NASAL RECONSTRUCTION. AIM 1 WILL COMPARE THE MATERIAL AND MECHANICAL PROPERTIES OF RSG AND PDS PLATES TO NASAL SEPTAL AND RIB COSTOCHONDRAL CARTILAGE. AIM 2 WILL COMPARE IN VIVO TISSUE INTEGRATION, INFLAMMATORY RESPONSE, AND MECHANICAL PERFORMANCE OF THE RSG VS PDS PLATES IMPLANTED BILATERALLY IN A RABBIT RHINOPLASTY MODEL. OUTCOMES WILL DETERMINE MECHANICAL PROPERTIES AND IN VIVO PERFORMANCE OF RSG VS PDS PLATES DURING RESORPTION/DEGRADATION POST IMPLANTATION. AIM 3 WILL HELP MOBIUS BIOTECH ENGAGE WITH A REGULATORY CONSULTANT TO UNDERSTAND FDA REQUIREMENTS, START WORKING ON A DESIGN HISTORY FILE (DHF) AND BETTER PREPARE FOR THE SBIR PHASE II.

CHOLESTEROL REMOVAL AS A TREATMENT FOR DRY AGE-RELATED MACULAR DEGENERATION - ABSTRACT THE LEADING CAUSE OF BLINDNESS IN PEOPLE OVER 50 IN INDUSTRIALIZED NATIONS INCLUDING THE UNITED STATES IS AGE-RELATED MACULAR DEGENERATION (AMD). EARLY AMD IS CHARACTERIZED BY CHOLESTEROL ACCUMULATION UNDER THE NEUROSENSORY RETINA CALLED SUB-RETINAL DRUSENOID DEPOSITS OR UNDER THE RETINAL PIGMENT EPITHELIUM CALLED DRUSEN. VISION LOSS OCCURS IN ADVANCED AMD, WITH “WET” AMD COMPRISING 20% OF CASES DRIVEN BY ANGIOGENESIS, OR FROM “DRY” AMD (80% OF CASES) DRIVEN BY CHOLESTEROL ACCUMULATION AND ACCOMPANYING CELL DEATH (GEOGRAPHIC ATROPHY). MOBIUS HAS AN EXPERT TEAM IN CHOLESTEROL BIOLOGY, LIPID TRANSPORT IN THE EYE, LIPOPROTEIN NANOPARTICLE (NANODISC) PRODUCTION, AND HUMAN THERAPEUTICS TO TACKLE CHOLESTEROL REMOVAL FROM THE EYE. THE PHASE 1 GOAL IS TO DEMONSTRATE THE FEASIBILITY OF OPTIMIZED NANODISC TECHNOLOGY TO FACILITATE CHOLESTEROL REMOVAL, AND DEMONSTRATE THERAPEUTIC POTENTIAL TO TREAT CHOLESTEROL ACCUMULATION TO TREAT DRY AMD. THE AIMS OF PHASE 1 WILL BE TO INITIALLY DESIGN THE OPTIMAL PROTOTYPE NANODISC FOR CHOLESTEROL REMOVAL, AND THEN TEST THAT PROTOTYPE IN CELLS AND PRE-CLINICAL MODELS OF RELEVANCE IN AMD.

SBIR PHASE I: DEVELOPMENT OF LIGNIN-BASED BIODEGRADABLE PLASTIC ALLOYS VIA SOLVENT FREE REACTIVE EXTRUSION

AUTOMATED DAILY DOSE RECONSTRUCTION AND DELIVERY VERIFICATION FOR EXTERNAL BEAM RADIOTHERAPY

SWITCHABLE BIODEGRADATION: DEVELOPMENT OF AN ENZYME-ACCELERATED BIODEGRADATION SYSTEM FOR LIGNIN-POLYMER ALLOYS

IMPROVING SUSTAINABILITY AND EFFICIENCY IN HORTICULTURE WITH DEGRADABLE LIGNIN-POLYMER CONTAINERS

TO COVER EXPENSES WITH MOBIUS TRIO CULTURAL TOUR IN BRAZIL FOR A PERIOD OF 12 DAYS.