{"id":270367620,"generated_unique_award_id":"ASST_NON_R43HL162109_075","fain":"R43HL162109","uri":"R43HL162109-1725861178","category":"grant","type":"04","type_description":"PROJECT GRANT (B)","description":"DEVELOPMENT OF A MINIMALLY INVASIVE PARTIAL CIRCULATORY SUPPORT DEVICE FOR CHRONIC USE - PROJECT SUMMARY THE NAUTILUS PUMP IS A CENTRIFUGAL, TOTALLY IMPLANTABLE, COMPACT, LONG-LASTING PARTIAL CIRCULATORY ASSIST DEVICE IMPLANTED VIA A MINIMALLY INVASIVE PACEMAKER POCKET APPROACH TO SUPPORT LV FUNCTION FOR LATE-STAGE HEART FAILURE INTERVENTION. THE NAUTILUS PUMP WILL BE CONNECTED TO THE SYSTEMIC CIRCULATION BY ATTACHMENT OF THE PUMP’S INFLOW PORT TO A CANNULA PLACED INTO THE SUBCLAVIAN VEIN AND POSITIONED IN THE LEFT ATRIUM VIA A TRANSSEPTAL APPROACH, AND THE OUTFLOW PORT TO A VASCULAR GRAFT ANASTOMOSED TO THE SUBCLAVIAN ARTERY. THIS REVOLUTIONARY PARTIAL SUPPORT PUMP IS BEING DESIGNED TO ELIMINATE THE NEED FOR INVASIVE TECHNIQUES TO IMPLANT FULL SUPPORT DEVICES (STERNOTOMY OR THORACOTOMY) AND ELIMINATE THE NEED FOR PERCUTANEOUS CABLES AND/OR DRIVELINES. THE NAUTILUS PUMP AND SYSTEM WILL BE A MINIMALLY INVASIVE, LOW ENERGY CONSUMPTION SYSTEM THAT WILL NOT IMPOSE EXCESSIVE AFTERLOAD ON THE LV, THEREFORE MAINTAINING PULSATILITY. FURTHERMORE, IT WILL RETAIN NATIVE HEART VENTRICULAR MUSCLE INTEGRITY, OFFERING THE BEST ENVIRONMENT FOR LV RECONDITIONING. ANOTHER FEATURE TO BE INTEGRATED TO THE PUMP IS THE NEXT-GENERATION TRANSCUTANEOUS ENERGY TRANSFER (TET) SYSTEM, WHICH DOES NOT REQUIRE DIRECT EXTERNAL COIL SKIN CONTACT TO POWER THE PUMP. THIS IS A REMARKABLE FEATURE THAT IS NOT PRESENT IN ANY OTHER COMPETITORS’ SYSTEMS. LEVERAGING PUMP AFFINITY LAWS, WHICH GOVERN CENTRIFUGAL PUMP PERFORMANCE AND ARE USEFUL TO MODIFY PUMPS FOR NEW AND DIFFERENT REQUIRED DUTIES, AND THE COMPANY’S EXTENSIVE INTELLECTUAL PROPERTY PORTFOLIO, THE NAUTILUS PUMP IS BEING DESIGNED BASED ON OUR FULL SUPPORT ASSIST PUMP. IT WILL COMBINE PERMANENT MAGNETIC LEVITATION WITH A LOW SHEAR HYDRODYNAMIC BEARING TO PRODUCE AN ULTRA-LOW POWER CONSUMPTION PUMP THAT STILL RETAINS THE SUPERIOR BLOOD HANDLING CHARACTERISTICS OF FULL MAGLEV TECHNOLOGY. THIS HIGHLY EFFICIENT PUMP IS THEN COMBINED WITH IMPLANTABLE GRADE BATTERIES AND A LIGHT, EXTERNAL MOBILE WIRELESS POWER SOURCE, MAKING IT A TOTALLY IMPLANTED AND WIRELESSLY POWERED SYSTEM THAT DOES NOT REQUIRE A PERCUTANEOUS DRIVELINE, DIRECT SKIN CONTACT, OR BULKY EXTERNAL BATTERIES. IN-VIVO PRELIMINARY STUDIES USING THE FULL CIRCULATORY SUPPORT PUMP DEVICE VALIDATED ALL THE INNOVATIVE FEATURES IN THIS GRANT PROPOSAL, SUCH AS A HIGH-EFFICIENCY PUMP WITH A LOW HEMOLYSIS RATE. THIS SBIR PHASE I PROPOSED GRANT OBJECTIVES ARE ADDRESSED IN TWO SPECIFIC AIMS THAT WILL BE EXECUTED FOR EIGHT MONTHS. IN AIM 1, THE NAUTILUS PUMP WILL BE DESIGNED, AND A PROTOTYPE IS FABRICATED TO ACCOMMODATE 2 – 3 L/MIN FLOWS AT PHYSIOLOGIC PRESSURES. IN AIM 2, IN-VITRO STUDIES, USING A RECIRCULATING BLOOD TEST LOOP, WILL BE PERFORMED TO DETERMINE RED BLOOD CELL HEMOLYSIS, PLATELET AND LEUKOCYTE ACTIVATION, VWF DEGRADATION, AND FUNCTION, AS WELL AS OVERALL BLOOD HEMOSTATIC POTENTIAL, COMPARED TO OUR FULL CIRCULATORY SUPPORT PUMP AND THE BPX-80 BIO PUMP™ (MEDTRONIC - MINNEAPOLIS, MN, US). THE CONCLUSION OF THE PROPOSED AIMS WILL DEMONSTRATE THE FEASIBILITY AND HEMOCOMPATIBILITY OF THE NAUTILUS PUMP DESIGN. IT WILL SET THE STAGE FOR A PHASE II SBIR GRANT APPLICATION WHERE THE PERFORMANCE, SAFETY, AND SUITABILITY OF THE DEVICE WILL BE EVALUATED IN AN IN-VIVO SETTING, IN ADDITION TO THE DEVELOPMENT OF A TRANSEPTAL CANNULA.","subaward_count":0,"total_subaward_amount":null,"total_subsidy_cost":0.0,"total_loan_value":0.0,"total_obligation":428204.0,"date_signed":"2022-02-11","base_and_all_options":null,"base_exercised_options":null,"non_federal_funding":0.0,"total_funding":428204.0,"total_account_outlay":428204.0,"total_account_obligation":428204.0,"account_outlays_by_defc":[{"code":"Q","amount":428204.0}],"account_obligations_by_defc":[{"code":"Q","amount":428204.0}],"record_type":2,"cfda_info":[{"applicant_eligibility":"Local (includes State-designated Indian Tribes; excludes institutions of higher education and hospitals), Public nonprofit institution/organization (includes institutions of higher education and hospitals), Individual/Family, Small business (less than 500 employees), Private nonprofit institution/organization (includes institutions of higher education and hospitals)\n. Any nonprofit organization engaged in biomedical research and institutions or companies organized for profit may apply for almost any kind of grant. Only domestic, non-profit, private or public institutions may apply for NRSA Institutional Research Training Grants. An individual may apply for an NRSA or, in some cases, for a research grant if adequate facilities to perform the research are available. SBIR grants can be awarded only to United States small business concerns (entities that are independently owned and operated for profit or owned by another small business that itself is independently owned and operated for profit, or owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these and have no more than 500 employees including affiliates). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions except under rare and unique circumstances where foreign components are thoroughly justified and necessary to the overall completion of the project. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. Normally, SBIR projects must be performed at least 67% by the applicant small business in Phase I and at least 50% of the Project in Phase II. STTR grants can be awarded only to United States small business concerns (entities that are independently owned and operated for profit and have no more than 500 employees) that formally collaborate with a university or other non-profit research institution in cooperative research and development. The principal investigator of an STTR award may be employed with either the small business concern or collaborating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant small business concern and is willing to devote at least 10% effort (1.2 calendar months) to the project. At least 40% of the project is to be performed by the small business concern and at least 30% by the non-profit research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions except under rare and unique circumstances where foreign components are thoroughly justified and necessary to the overall completion of the project.","beneficiary_eligibility":"Any nonprofit or for-profit organization, company or institution engaged in biomedical research.  Only domestic for-profit small business firms may apply for SBIR and STTR programs.","cfda_federal_agency":"NATIONAL INSTITUTES OF HEALTH, HEALTH AND HUMAN SERVICES, DEPARTMENT OF","cfda_number":"93.837","cfda_objectives":"The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. To foster heart and vascular research in the basic, translational, clinical and population sciences, and to foster training to build talented young investigators in these areas, funded through competitive research training grants. Small Business Innovation Research (SBIR) program: To stimulate technological innovation; use small business to meet Federal research and development needs; foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons; and increase private-sector commercialization of innovations derived from Federal research and development funding. Small Business Technology Transfer (STTR) program: To stimulate technological innovation; foster technology transfer through cooperative R&D between small businesses and research institutions, and increase private sector commercialization of innovations derived from federal R&D.","cfda_obligations":"(Grant) FY 24$1,525,396,994.00; FY 25$1,564,175,161.00; FY 26 est $0.00; - (Cooperative Agreement) FY 24$129,058,340.00; FY 25$125,864,272.00; FY 26 est $0.00; - ","cfda_popular_name":"","cfda_title":"Cardiovascular Diseases Research","cfda_website":"https://www.nhlbi.nih.gov/about/scientific-divisions/division-cardiovascular-sciences","federal_action_obligation_amount":428204.0,"non_federal_funding_amount":0.0,"sam_website":"https://sam.gov/fal/cde130aceabc40edbebf1cb48f3f83d7/view","total_funding_amount":428204.0}],"transaction_obligated_amount":428204.0,"funding_agency":{"id":830,"has_agency_page":true,"toptier_agency":{"name":"Department of Health and Human Services","code":"075","abbreviation":"HHS","slug":"department-of-health-and-human-services"},"subtier_agency":{"name":"National Institutes of Health","code":"7529","abbreviation":"NIH"},"office_agency_name":"NIH National Heart, Lung, and Blood Institute"},"awarding_agency":{"id":830,"has_agency_page":true,"toptier_agency":{"name":"Department of Health and Human Services","code":"075","abbreviation":"HHS","slug":"department-of-health-and-human-services"},"subtier_agency":{"name":"National Institutes of Health","code":"7529","abbreviation":"NIH"},"office_agency_name":"NIH National Heart, Lung, and Blood Institute"},"period_of_performance":{"start_date":"2022-02-11","end_date":"2023-02-10","last_modified_date":"2024-10-04"},"recipient":{"recipient_hash":"dc5d420c-b029-313d-bb90-62613cef04ab-R","recipient_name":"CORVION, INC.","recipient_uei":"DP46YALMA9E8","recipient_unique_id":null,"parent_recipient_hash":null,"parent_recipient_name":null,"parent_recipient_uei":null,"parent_recipient_unique_id":null,"business_categories":["Category Business","Small Business"],"location":{"location_country_code":"USA","country_name":"UNITED STATES","state_code":"TX","state_name":"TEXAS","city_name":"WEBSTER","county_code":"201","county_name":"HARRIS","address_line1":"16910 N TEXAS AVE STE A6","address_line2":null,"address_line3":null,"congressional_code":"36","zip4":"4036","zip5":"77598","foreign_postal_code":null,"foreign_province":null}},"executive_details":{"officers":[{"name":null,"amount":null},{"name":null,"amount":null},{"name":null,"amount":null},{"name":null,"amount":null},{"name":null,"amount":null}]},"place_of_performance":{"location_country_code":"USA","country_name":"UNITED STATES","county_code":"201","county_name":"HARRIS","city_name":"WEBSTER","state_code":"TX","state_name":"TEXAS","congressional_code":"36","zip4":"4036","zip5":"77598","address_line1":null,"address_line2":null,"address_line3":null,"foreign_province":null,"foreign_postal_code":null},"total_outlay":428204.0,"funding_opportunity":{"number":"PA-20-260","goals":"TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS.  SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D."}}