{"id":270376066,"generated_unique_award_id":"ASST_NON_R44HL177945_075","fain":"R44HL177945","uri":"R44HL177945-4147005002","category":"grant","type":"04","type_description":"PROJECT GRANT (B)","description":"DEVELOPMENT OF A TOTALLY IMPLANTED LEFT VENTRICULAR ASSIST DEVICE - PROJECT SUMMARY/ABSTRACT IN THE UNITED STATES (US) ~6.5 MILLION PEOPLE HAVE HEART FAILURE (HF), THERE ARE ~1 MILLION NEW CASES EACH YEAR, AND ~250,000 PATIENTS DIE OF HEART FAILURE EACH YEAR. WHILE A HEART TRANSPLANT IS THE STANDARD TREATMENT, THE LIMITED SUPPLY OF DONOR ORGANS SEVERELY LIMITS THIS OPTION. A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IS CURRENTLY AN ACCEPTED TREATMENT OPTION FOR HF PATIENTS, HOWEVER, ONLY ~2-3% OF THE OVER 100,000 POTENTIAL LVAD RECIPIENTS CHOOSE AN LVAD EACH YEAR IN THE US BECAUSE OF THE SERIOUS COMPLICATIONS AND POOR QUALITY OF LIFE. THE PERCUTANEOUS DRIVELINE (PERMANENT SKIN PUNCTURE) AND CONTINUOUSLY WORN EXTERNAL BATTERIES POWERING THE HIGH- POWER CONSUMPTION BLOOD PUMP (~8 W) ARE MAJOR CAUSES OF COMPLICATIONS AND POOR QUALITY OF LIFE. COMPLICATIONS EXPERIENCED BY LVAD RECIPIENTS INCLUDE INFECTION, STROKE, BLEEDING, AND PUMP THROMBOSIS. INFECTION IS A MAJOR CONCERN, WITH UP TO 44% OF LVAD RECIPIENTS DEVELOPING AN INFECTION. QUALITY OF LIFE RESTRICTIONS INCLUDE LIMITED PHYSICAL ACTIVITY, INABILITY TO SUBMERSE IN WATER, AND CONTINUOUSLY WORN EXTERNAL LVAD EQUIPMENT. OUR OBJECTIVE IS TO DEVELOP A TOTALLY-IMPLANTED LEFT VENTRICULAR ASSIST DEVICE (TI-LVAD) ACHIEVING REDUCED COMPLICATIONS AND ENHANCED PATIENT QUALITY OF LIFE TO ENCOURAGE MORE PATIENTS TO ADOPT AN LVAD AS A BRIDGE-TO- TRANSPLANT, BRIDGE-TO-RECOVERY, OR DESTINATION THERAPY. THE TI-LVAD’S ULTRA-LOW-POWER BLOOD PUMP, IMPLANTABLE BATTERY, AND WIRELESS TRANSCUTANEOUS CHARGING ELIMINATES THE PERCUTANEOUS DRIVELINE AND WILL PROVIDE PATIENTS UP TO 12 HOURS OF CONTINUOUS FREEDOM FROM WEARING AN EXTERNAL POWER SUPPLY. THE KEY ENABLING TECHNOLOGY OF THE TI-LVAD IS A HYBRID MAGNETICALLY LEVITATED BLOOD PUMP COMBINING THE BEST FEATURES OF HYDRODYNAMIC BEARING AND MAGNETIC LEVITATION CREATING AN ULTRA-LOW-POWER AND BIOCOMPATIBLE BLOOD PUMP. THE TI-LVAD RECEIVED FDA BREAKTHROUGH DEVICE DESIGNATION IN JANUARY 2020. TI-LVAD FEASIBILITY HAS BEEN ESTABLISHED BY DEMONSTRATING ULTRA-LOW-POWER AND BLOOD COMPATIBLE PUMP OPERATION FOR UP TO 30 DAYS IN A BOVINE MODEL. THIS SBIR DIRECT TO PHASE II PROJECT AIMS TO FINALIZE THE TI-LVAD DESIGN AND COMPLETE ALL PRE-CLINICAL TESTING. WE AIM TO ACHIEVE THIS BY: 1) DEVELOPING THE IMPLANTED CONTROLLER, EXTERNAL PHYSICIAN PROGRAMMER, AND EXTERNAL HAND-HELD PATIENT MONITOR, 2) DESIGNING AND EVALUATING THE IMPLANTED RECEIVER COIL AND EXTERNAL WIRELESS CHARGER, 3) PERFORMING TI-LVAD BOVINE TESTING TO ASSESS PERFORMANCE AND BIOCOMPATIBILITY, AND 4) CONDUCTING BENCHTOP DURABILITY TESTING.","subaward_count":0,"total_subaward_amount":null,"total_subsidy_cost":0.0,"total_loan_value":0.0,"total_obligation":2086049.0,"date_signed":"2025-02-21","base_and_all_options":null,"base_exercised_options":null,"non_federal_funding":0.0,"total_funding":2086049.0,"total_account_outlay":1173476.0,"total_account_obligation":2086049.0,"account_outlays_by_defc":[{"code":"Q","amount":1173476.0}],"account_obligations_by_defc":[{"code":"Q","amount":2086049.0}],"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":2086049.0,"non_federal_funding_amount":0.0,"sam_website":"https://sam.gov/fal/cde130aceabc40edbebf1cb48f3f83d7/view","total_funding_amount":2086049.0}],"transaction_obligated_amount":2086049.0,"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":"2025-03-01","end_date":"2028-02-29","last_modified_date":"2026-05-21"},"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":1173476.0,"funding_opportunity":{"number":"PA-23-230","goals":"NOT APPLICABLE"}}