{"id":361585239,"generated_unique_award_id":"ASST_NON_R44HL184709_075","fain":"R44HL184709","uri":"R44HL184709-1782412672","category":"grant","type":"04","type_description":"PROJECT GRANT (B)","description":"DEVELOPMENT OF A NOVEL PEDIATRIC LVAD FOR HOME DISCHARGE OF CHILDREN AWAITING HEART TRANSPLANT - PROJECT SUMMARY OUR ULTIMATE OBJECTIVE IS TO DEVELOP A PEDIATRIC LEFT VENTRICULAR ASSIST DEVICE (P-LVAD) ENABLING CHILDREN WITH END-STAGE HEART FAILURE TO GO HOME WHILE AWAITING A HEART TRANSPLANT OR LIVE WITH THE DEVICE LONG TERM. RECEIVING MECHANICAL CIRCULATORY SUPPORT (MCS) AT HOME WHILE AWAITING A HEART TRANSPLANT IS CRITICAL BECAUSE IT SUBSTANTIALLY IMPROVES THE CHILD’S QUALITY OF LIFE. P-LVAD’S KEY ENABLING TECHNOLOGY IS OUR IMPLANTABLE, ULTRA-LOW-POWER CONSUMPTION, AND HEMCOMPATIBLE BLOOD PUMP ENABLING IMPLANTATION IN CHILDREN. IN THE UNITED STATES, HEART FAILURE (HF) AFFECTS ~35,000 CHILDREN AND HEART TRANSPLANT IS THE STANDARD TREATMENT FOR CHILDREN WITH END-STAGE HEART FAILURE. FOR CHILDREN, BERLIN HEART EXCOR IS THE ONLY MECHANICAL CIRCULATORY SUPPORT SYSTEM AVAILABLE AND IS USED FOR BRIDGE TO TRANSPLANT. DESPITE BERLIN HEART’S SUCCESSES, ITS OVERALL SIZE AND COMPLEXITY REQUIRE HOSPITALIZATION UNTIL TRANSPLANTATION WITH VERY LIMITED PATIENT MOBILITY. BERLIN HEART’S PNEUMATIC BLOOD PUMP IS THE KEY LIMITATION RESULTING IN ITS LARGE SIZE AND HIGH COMPLEXITY; AND THEREFORE, LONG- TERM CHILD HOSPITALIZATION UNTIL TRANSPLANTATION. WHILE AN LVAD (E.G. AN ADULT-SIZED HEARTMATE 3) CAN PROVIDE SUFFICIENT MCS FOR CHILDREN, EXISTING HIGH-POWER CONSUMPTION LVAD BLOOD PUMPS (~8 W) WITH MAGLEV-BASED TECHNOLOGY ARE TOO LARGE FOR CHILD IMPLANTATION AND REQUIRE WEARABLE BATTERIES TOO LARGE AND HEAVY FOR CHILDREN. IN CONTRAST, P-LVAD USES OUR HYBRID MAGNETICALLY LEVITATED BLOOD PUMP COMBINING THE BEST FEATURES OF HYDRODYNAMIC BEARING AND MAGNETIC LEVITATION CREATING AN UNPRECEDENTLY COMPACT, ULTRA-LOW-POWER (~1.0 W), AND HEMOCOMPATIBLE BLOOD PUMP. THEREFORE, P-LVAD’S BLOOD PUMP CAN BE IMPLANTED IN CHILDREN AND OPERATE FROM A CHILD-SIZED, WEARABLE BATTERY. ULTIMATELY, OUR BLOOD PUMP’S KEY INNOVATIONS WILL ENABLE UNPRECEDENTED QUALITY OF LIFE FOR CHILDREN AWAITING A HEART TRANSPLANT AND CREATE THE OPPORTUNITY FOR A DESTINATION THERAPY. P-LVAD FEASIBILITY WAS ESTABLISHED BY PROTOTYPING A CLINICAL-SCALE, PEDIATRIC-SIZED BLOOD PUMP AND ACHIEVING ULTRA-LOW- POWER AND HEMOCOMPATIBLE BLOOD PUMP OPERATION ON THE BENCHTOP AND IN A 3-DAY CHRONIC OVINE STUDY. THIS SBIR DIRECT TO PHASE II PROJECT WILL CREATE THE CLINICAL-SCALE P-LVAD SYSTEM AND COMPLETE PRE-CLINICAL TESTING BY DEVELOPING THE DRIVELINE CONNECTING THE IMPLANTED BLOOD PUMP TO THE EXTERNAL, WEARABLE CONTROLLER (AIM1), DEVELOPING THE EXTERNALLY WORN CONTROLLER AND BATTERY AND THE EXTERNAL HAND-HELD PATIENT MONITOR (AIM 2), DEMONSTRATING DEFINITIVE PERFORMANCE AND BIOCOMPATIBILITY OF THE CLINICAL-SCALE P-LVAD IN A 30-DAY SHEEP STUDY (AIM 3), AND ESTABLISHING LONG-TERM DURABILITY OF THE CLINICAL-SCALE P-LVAD IN A 6-MONTH BENCHTOP ACCELERATED AGING DURABILITY STUDY (AIM 4). AN SBIR PHASE IIB PROJECT WILL COMPLETE BIOCOMPATIBILITY, STERILIZATION, AND PACKAGING TESTING, AND COMPLETE AN EARLY FEASIBILITY STUDY (EFS) FIRST-IN-HUMAN (FIH) STUDY.","subaward_count":0,"total_subaward_amount":null,"total_subsidy_cost":0.0,"total_loan_value":0.0,"total_obligation":1499984.0,"date_signed":"2026-08-10","base_and_all_options":null,"base_exercised_options":null,"non_federal_funding":0.0,"total_funding":1499984.0,"total_account_outlay":531625.0,"total_account_obligation":1499984.0,"account_outlays_by_defc":[{"code":"Q","amount":531625.0}],"account_obligations_by_defc":[{"code":"Q","amount":1499984.0}],"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":1499984.0,"non_federal_funding_amount":0.0,"sam_website":"https://sam.gov/fal/cde130aceabc40edbebf1cb48f3f83d7/view","total_funding_amount":1499984.0}],"transaction_obligated_amount":1499984.0,"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":"2026-08-10","end_date":"2029-07-31","last_modified_date":"2026-09-04"},"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":531625.0,"funding_opportunity":{"number":"PA-24-245","goals":"NOT APPLICABLE"}}