W-Z BIOTECH, LLC

859-699-0535

dwang.tx@gmail.com

DONGFANG WANG

P1154729

RK1ZDCXE3LJ7

5SDY5

2025-09-10

2024-09-13

2009-11-03

5SDY5

Active

Non-Manufacturer

2025-07-14

2030-07-14

2026-07-10

DONGFANG WANG

2023-08-10

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Department of Health and Human Services

INTEGRATION OF COMPLIANCE CHAMBERS INTO DIAPHRAGM DISPLACEMENT PUMP TO DOUBLE THE PUMPING FLOW OF PEDIATRIC PARACORPOREAL PULSATILE VENTRICULAR ASSIST DEVICE - THE PARACORPOREAL BERLIN HEART EXCOR IS THE ONLY FDA-APPROVED VENTRICULAR ASSIST DEVICE (VAD) FOR PEDIATRIC PATIENTS. THIS PULSATILE DIAPHRAGM DISPLACEMENT PUMP (DDP) IS SMALL/LIGHT WEIGHT TO FACILITATE PEDIATRIC PATIENT AMBULATION. HOWEVER, EXCOR EFFICIENCY IS ONLY 50% SINCE IT WITHDRAWS AND PUMPS BLOOD AT DIFFERENT TIMES (INTERRUPTED PULSATILE FLOW). THIS GENERATES A HIGH PEAK BLOOD FLOW RATE, WHICH MAY CAUSE BLOOD DAMAGE. A PARACORPOREAL CONTINUOUS FLOW PEDIMAG VAD HAS ALSO BEEN USED IN SMALLER CHILDREN. THIS CENTRIFUGAL PUMP IS HIGHLY EFFICIENT DUE TO THE CONSTANT FLOW THROUGH THE DRAINAGE/INFUSION CANNULAS, BUT THE PEDIMAG PUMP HEAD MUST BE ATTACHED TO A BULKY/HEAVY MOTOR, WHICH HINDERS AMBULATION. WE PREVIOUSLY DEVELOPED A TRANSAPICAL TO AORTA (TAA) DOUBLE LUMEN CANNULA (DLC) FOR A MINIMALLY INVASIVE AMBULATORY LVAD, WHICH SHOWED EXCELLENT 96 HR PERFORMANCE/HEMOCOMPATIBILITY IN NEONATE LAMBS. OUR ULTIMATE GOAL IS TO DEVELOP AN EFFICIENT, MINIMALLY INVASIVE, PARACORPOREAL LVAD SYSTEM FOR PEDIATRIC PATIENTS, WHICH COMBINES THE SMALL SIZE/WEIGHT (AMBULATION POTENTIAL) OF CURRENT INTERRUPTED PULSATILE FLOW PUMP (E.G EXCOR) AND THE CURRENT HIGH EFFICIENCY OF A CONTINUOUS FLOW PUMP (E.G PEDIMAG). THE ENABLING TECHNOLOGY IS A COMPLIANT DIAPHRAGM DISPLACEMENT PUMP (CDDP), WHICH HAS COMPLIANCE CHAMBERS INTEGRATED INTO THE DRAINAGE AND INFUSION OUTLETS TO DOUBLE BLOOD FLOW. THE CDDP WILL BE HIGH PERFORMING DUE TO: 1) NONINTERRUPTED/CONTINUOUS BLOOD FLOW; 2) INFUSION/DRAINAGE COMPLIANCE CHAMBERS THAT DECREASE CDDP AFTERLOAD/INCREASE CDDP PRELOAD. THE LOWER PEAK DRAINAGE/INFUSION FLOW OF THE CDDP WILL ALSO REDUCE BLOOD TRAUMA. PRELIMINARY DATA SHOWED THAT ADDING COMPLIANCE CHAMBERS INCREASED PUMPING FLOW FROM 1.1 TO 2.6 L/MIN AND DECREASED PEAK FLOW RATE. THE PHASE I SBIR OBJECTIVE IS TO DESIGN AND FABRICATE A CDDP WORKING PROTOTYPE WITH OPTIMAL COMPLIANCE CHAMBERS SIZE. THIS CDDP WILL BE TESTED IN LAMBS WITH OUR PREVIOUSLY DEVELOPED TAA DLC. SPECIFIC AIM 1: TO DESIGN, FABRICATE, AND BENCH TEST A CDDP. COMPLIANCE CHAMBERS WILL BE INTEGRATED INTO THE CDDP DRAINAGE AND INFUSION OUTLETS. THE CDDP WILL BE MADE OF POLYCARBONATE HOUSING WITH A POLYURETHANE DIAPHRAGM IN THE MIDDLE. A TRICUSPID VALVE WILL CONNECT THE CDDP HOUSING TO THE TWO SMALL SILICONE COMPLIANCE CHAMBERS. THE FINAL PROTOTYPE WILL BE TESTED FOR 1 WEEK IN A 37% GLYCERIN MOCK LOOP FOR PERFORMANCE/RELIABILITY/DURABILITY. SPECIFIC AIM 2: TO TEST THE CDDP WORKING PROTOTYPE IN LAMBS. THE CDDP WILL BE COMBINED WITH THE TAA DLC TO FORM A LESS INVASIVE, AMBULATORY LVAD, WHICH WILL BE TESTED IN 10-15 KG LAMBS (N=9) TO EVALUATE 6 HR PERFORMANCE/RELIABILITY AND INITIAL BIOCOMPATIBILITY. PROTOTYPE DESIGN/FABRICATION/BENCH TESTING WILL BE DONE AT W-Z BIOTECH, AND THE LAMB STUDIES WILL BE DONE AT THE UNIVERSITY OF KENTUCKY. RATHER THAN FINE-TUNING EXISTING TECHNOLOGY, OUR CDDP IS A NOVEL INVENTION, WHICH WILL ENABLE A PULSATILE PARACORPOREAL VAD WITH DOUBLED EFFICIENCY. THIS TECHNOLOGY CAN ALSO BE USED IN ADULTS AND MAY SIGNIFICANTLY IMPACT CARDIOGENIC SHOCK/BRIDGE TO HEART TRANSPLANT MANAGEMENT.

295923.00

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0.00

2023-05-11

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Department of Health and Human Services

PEDIATRIC TRANSAPICAL DOUBLE LUMEN CANNULA WITH INTEGRATED COMPLIANCE CHAMBERS DOUBLES FLOW OF PARACORPOREAL PULSATILE VAD - PEDIATRIC PATIENTS WITH SEVERE HEART FAILURE REQUIRE A VENTRICULAR ASSIST DEVICE (VAD). THE PARACORPOREAL BERLIN HEART EXCOR IS STILL THE ONLY FDA-APPROVED VAD FOR PEDIATRIC PATIENTS. THIS DIAPHRAGM DISPLACEMENT PUMP IS SMALL/LIGHT WEIGHT TO FACILITATE AMBULATION. HOWEVER, EXCOR WITHDRAWS AND PUMPS BLOOD AT DIFFERENT TIMES FOR INTERRUPTED PULSATILE BLOOD FLOW, WITH ITS DRAINAGE AND INFUSION CANNULAS FUNCTIONING ONLY HALF THE TIME (50% EFFICIENCY). EXCOR ALSO GENERATES A HIGH PEAK BLOOD FLOW RATE, WHICH MAY CAUSE BLOOD DAMAGE. A PARACORPOREAL CONTINUOUS FLOW (PEDIMAG/CENTRIMAG) VAD HAS ALSO BEEN USED WITH BERLIN HEART CANNULAS IN SMALLER CHILDREN, BUT ITS BULKY/HEAVY MOTOR HINDERS AMBULATION. PEDIATRIC PARACORPOREAL VADS REQUIRE TWO SEPARATE CANNULAS FOR WITHDRAWAL AND INFUSION AND THEIR INSTALLATION REQUIRES AN INVASIVE MEDIAN STERNOTOMY, WHICH COMPLICATES LATER SURGERY FOR HEART TRANSPLANT OR REPAIR. OUR ULTIMATE GOAL IS TO DEVELOP A MINIMALLY INVASIVE, HIGH EFFICIENCY PARACORPOREAL PULSATILE DIAPHRAGM DISPLACEMENT VAD SYSTEM FOR PEDIATRIC PATENTS. THE ENABLING TECHNOLOGY IS A TRANSAPICAL DOUBLE LUMEN CANNULA (DLC) WITH INTEGRATED COMPLIANCE CHAMBERS THAT FEATURES: 1) SINGLE TRANSAPICAL CANNULATION VIA LESS INVASIVE, SMALL LEFT THORACOTOMY; 2) TWO INTEGRATED COMPLIANCE CHAMBERS THAT: A) CONTINUOUSLY WITHDRAW/INFUSE BLOOD TO INCREASE EFFICIENCY FOR HIGHER BLOOD FLOW RATES; B) ADJUST CONTINUOUS FLOW FLUCTUATION FOR DESIRED PULSATILITY; C) REDUCE PEAK BLOOD FLOW RATE TO MITIGATE BLOOD TRAUMA; D) REDUCE INFUSION LUMEN PEAK PRESSURE, DECREASING PUMP AFTERLOAD TO ENHANCE PUMP OUTPUT; E) ALLOW SMOOTH WITHDRAWAL TO INFUSION TRANSITION FOR HIGH FREQUENCY PUMPING. BENCH TESTING OF AN INITIAL TRANSAPICAL DLC WITH INTEGRATED COMPLIANCE CHAMBERS PROTOTYPE WITH EXCOR SHOWED DOUBLE PUMPING FLOW WITH DECREASED PEAK PUMP FLOW. THE PHASE I SBIR OBJECTIVE: WE WILL REDESIGN A TRANSAPICAL DLC WITH OPTIMAL MINIMAL COMPLIANCE CHAMBERS AND CONDUCT PERFORMANCE TESTING IN LAMBS. SPECIFIC AIM 1: TO DESIGN, FABRICATE, AND BENCH TEST THE HIGH EFFICIENCY, TRANSAPICAL DLC WITH INTEGRATED COMPLIANCE CHAMBERS. THE TRANSAPICAL DLC COMPLIANCE CHAMBERS WILL BE INTEGRATED INTO THE DRAINAGE AND INFUSION OUTLETS. THE 24 FR MAIN DLC BODY WILL BE ONE-PIECE REINFORCED POLYURETHANE. THE SUPER-ELASTIC SILICONE COMPLIANCE CHAMBERS WILL BE VERY SMALL WITH 50% STROKE VOLUME. THE FINAL PROTOTYPE WILL BE TESTED FOR 1 WEEK IN AN EXCOR MOCK LOOP WITH 37% GLYCERIN FOR PERFORMANCE/RELIABILITY/DURABILITY. SPECIFIC AIM 2: TO TEST THE NEW 24 FR TRANSAPICAL DLC WITH COMPLIANCE CHAMBERS IN AN EXCOR VAD CIRCUIT IN LAMBS (N=8). THESE LAMB (10-15 KG) STUDIES WILL INVESTIGATE EASE OF TRANSAPICAL DEPLOYMENT, 6 HR IN VIVO PERFORMANCE/RELIABILITY, AND INITIAL BIOCOMPATIBILITY. PROTOTYPE DESIGN/FABRICATION/BENCH TESTING WILL BE DONE AT W-Z BIOTECH, AND THE ANIMAL STUDIES WILL BE DONE AT THE UNIVERSITY OF KENTUCKY. UPON COMPLETION, THE COMMERCIALIZED TRANSAPICAL DLC WITH INTEGRATED COMPLIANCE CHAMBERS WILL PROVIDE A LESS INVASIVE PARACORPOREAL PULSATILE VAD WITH DOUBLED EFFICIENCY. THIS TECHNOLOGY CAN ALSO BE USED IN ADULTS AND MAY SIGNIFICANTLY IMPACT CARDIOGENIC SHOCK/BRIDGE TO HEART TRANSPLANT MANAGEMENT.

275355.00

0.00

0.00

2024-09-21

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Department of Health and Human Services

DEVELOPMENT OF A MINIMALLY INVASIVE SINGLE CANNULATION, COMPACT SINGLE PORT PULSATILE VENTRICULAR ASSIST DEVICE (SPPVAD) FOR TOTAL LV SUPPORT - CARDIOGENIC SHOCK (CS) IS A SERIOUS CONDITION OF LOW CARDIAC OUTPUT WITH A 40-50% MORTALITY. IN SEVERE CS, HYPOPERFUSION CAUSES MULTI-ORGAN FAILURE AND HIGH LEFT VENTRICLE (LV) PRELOAD/WALL STRESS EXACERBATES CARDIAC INJURY/PREVENTS RECOVERY. TEMPORARY MECHANICAL CIRCULATORY SUPPORT (MCS) IS NEEDED TO RESTORE PERFUSION AND UNLOAD THE LV, BRIDGING THE CS PATIENT TO RECOVERY, LONG-TERM LV ASSIST DEVICE (LVAD), OR HEART TRANSPLANT. VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION IS MOST OFTEN USED IN SEVERE CS, BUT IT FAILS TO UNLOAD LV IN > 50% OF THESE PATIENTS WITH NO IMPROVED OUTCOMES. MINIMALLY INVASIVE, PERCUTANEOUS MCS DEVICES ALSO DO NOT IMPROVE SEVERE CS OUTCOMES SINCE THEY DO NOT COMPLETELY RESTORE THE CIRCULATION. NON-PERCUTANEOUS MCS DEVICES PROVIDE TOTAL SUPPORT BUT REQUIRE OPEN CHEST SURGERY AND ARE NOT AMBULATION FRIENDLY. IMPELLA 5.5 HAS BECOME THE PREFERRED MCS DEVICE FOR CS. YET, PATIENTS WITH AN IMPELLA 5.5 MUST STAY IN ICU WITH VERY LIMITED AMBULATION. THUS, A BIG MARKET GAP EXISTS FOR AN IDEAL TEMPORARY MCS DEVICE THAT: 1) IS MINIMALLY INVASIVE, 2) PROVIDES TOTAL LV SUPPORT, AND 3) ENABLES EASY AMBULATION. OUR GOAL IS TO DEVELOP A NEW TEMPORARY MCS SYSTEM THAT PROVIDES TOTAL LV SUPPORT VIA A MINIMALLY INVASIVE TECHNIQUE WITH EASY AMBULATION, ENABLING PATIENT DISCHARGE FOR AT-HOME MCS. OUR DEVICE WILL PROVIDE ONE MONTH MCS (POTENTIAL FOR UP TO 3 MONTHS) TO BRIDGE SEVERE CS PATIENT TO FURTHER TREATMENT, RECOVERY, DURABLE VAD, OR HEART TRANSPLANT. OUR ENABLING TECHNOLOGY IS A SINGLE PORT, PULSATILE VENTRICULAR ASSIST DEVICE (SPPVAD) SYSTEM THAT INCLUDES VALVED SINGLE LUMEN CANNULA (VSLC), VALVELESS SINGLE PORT DIAPHRAGM DISPLACEMENT PUMP (SPDDP), AND COMPACT/PORTABLE CONSOLE. OUR SPPVAD SYSTEM HAS FOLLOWING NOVEL DESIGN:1) ONE VSLC FOR WITHDRAWAL AND INFUSION; 2) SINGLE LUMEN DESIGN DOUBLES USABLE AREA TO REDUCE CIRCUIT BLOOD RESISTANCE FOR >6 L/MIN PUMPING; 3) ONE TRANSAPICAL TO AORTA CANNULATION FOR MINIMALLY INVASIVE INSTALLATION; 4) ONLY ONE PORT REDUCES PUMP SIZE FOR EASY AMBULATION; 5) SIMPLE VALVELESS PUMP GEOMETRY FOR BETTER DURABILITY AND 1-MONTH MCS. IN THE PHASE I SBIR, OUR SPPVAD SYSTEM ACHIEVED >6 L/MIN PULSATILE FLOW IN BENCH TEST AND 6 HR TOTAL LV UNLOADING IN SHEEP. SPECIFIC AIM 1: OPTIMIZE AND FABRICATE VSLC, VALVELESS SPDDP, AND COMPACT/PORTABLE CONSOLE FOR THE SPPVAD SYSTEM. THE VSLC WILL BE MADE OF REINFORCED POLYURETHANE (PU). INLET VALVES WILL BE IN LV FOR BLOOD WITHDRAWAL. A TRI- LEAFLET OUTLET VALVE ON VSLC TIP WILL BE IN AORTA FOR BLOOD DELIVERY. THE SPDDP WILL BE MADE OF POLYCARBONATE WITH A PU DIAPHRAGM. A COMPACT/PORTABLE CONSOLE WILL ALSO BE DEVELOPED. SPECIFIC AIM 2: BENCH TEST THE SPPVAD SYSTEM FOR PERFORMANCE, DURABILITY, AND HEMOCOMPATIBILITY. THE SPPVAD SYSTEM WILL BE TESTED IN MOCK LOOP FOR PERFORMANCE/DURABILITY AND IN AN IN VITRO LOOP WITH BOVINE BLOOD TO QUANTIFY HEMOLYSIS. SPECIFIC AIM 3: PERFORM 4-WEEK PRECLINICAL TESTING OF SPPVAD SYSTEM IN SHEEP. A NEAR COMMERCIAL QUALITY SPPVAD SYSTEM WILL BE TESTED IN SHEEP (N=10) FOR SAFETY/BIOCOMPATIBILITY/RELIABILITY. OUR NOVEL SPPVAD SYSTEM FILLS A LARGE UNMET NEED FOR AMBULATORY, AT-HOME TEMPORARY TOTAL LV SUPPORT TO IMPROVE PATIENT OUTCOMES.

1280230.00

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0.00

2021-03-19

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Department of Health and Human Services

DEVELOPMENT OF A MINIMALLY INVASIVE SINGLE CANNULATION, COMPACT SINGLE PORT PULSATILE VENTRICULAR ASSIST DEVICE (SPPVAD) FOR TOTAL LV SUPPORT - CARDIOGENIC SHOCK (CS) IS A SERIOUS CONDITION OF REDUCED CARDIAC OUTPUT (CO) WITH A MORTALITY AS HIGH AS 40-50%. IN SEVERE CS, END ORGAN HYPOPERFUSION FROM LOW CO CAUSES MULTI-ORGAN FAILURE AND ELEVATED LEFT VENTRICLE (LV) PRELOAD INCREASES LV WALL STRESS. FOR SEVERE CS, VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION IS MOST OFTEN USED AND IS FASTEST WAY TO REESTABLISH CIRCULATION, BUT IT FAILS TO UNLOAD LV IN > 50% OF THESE PATIENTS. PERCUTANEOUS MECHANICAL CIRCULATORY SUPPORT (MCS) DEVICES ARE USED IN SEVERE CS BUT MAY NOT FULLY STABILIZE CIRCULATION. NON-PERCUTANEOUS MCS DEVICES SUPPLY TOTAL CARDIAC SUPPORT BUT REQUIRE OPEN CHEST SURGERY FOR INSTALLATION. OUR GOAL IS TO DEVELOP A COMPACT, SINGLE PORT, PULSATILE VENTRICULAR ASSIST DEVICE (SPPVAD) FOR TOTAL LV SUPPORT THAT EMPLOYS A MINIMALLY INVASIVE SINGLE CANNULATION TECHNIQUE FOR IMPLANTATION. COMPARED TO A CONTINUOUS FLOW LVAD, OUR SPPVAD SYSTEM MAY FURTHER UNLOAD THE LV WHEN SYNCHRONIZED WITH THE NATIVE HEART FOR COUNTERPULSATION. OUR ENABLING TECHNOLOGIES THAT FORM THE SPPVAD SYSTEM ARE A VALVED SINGLE LUMEN CANNULA (VSLC) AND A VALVELESS SINGLE PORT DIAPHRAGM DISPLACEMENT PUMP (SPDDP). OUR INNOVATIVE SPPVAD SYSTEM FEATURES: 1) MINIMALLY INVASIVE TRANS-APICAL TO AORTA INSTALLATION BY ONE VSLC CANNULATION THROUGH SMALL LEFT THORACOTOMY; 2) SMALLER SPDDP WITHOUT INLET/OUTLET VALVES AND LARGE DEAD SPACE; 3) LOWER BLOOD RESISTANCE DUE TO SHORTER PATHWAY THROUGH LV VIA THE VSLC THAT SERVES AS BOTH INLET AND OUTLET CANNULA; 4) DEPENDABLE TOTAL LV UNLOADING; 5) POTENTIAL LV INTERNAL/STROKE WORK DECREASE WITH COUNTERPULSATION PUMPING. W-Z BIOTECH MADE AN INITIAL PROTOTYPE OF SPPVAD SYSTEM, WHICH HAD 3.1 L/MIN PUMPING FLOW AGAINST 80 MM HG AFTERLOAD IN MOCK LOOP TESTING. OUR OBJECTIVE IN THIS PHASE I SBIR IS TO DEVELOP/FABRICATE NEW WORKING PROTOTYPE OF SPPVAD SYSTEM (VSLC AND SPDDP) AND TO TEST SPPVAD SYSTEM PROTOTYPE IN MOCK LOOP AND SEVERE CS SHEEP MODEL. SPECIFIC AIM 1: TO DEVELOP/FABRICATE/BENCH TEST NEW WORKING PROTOTYPE OF SPPVAD SYSTEM (VSLC AND SPDDP). THE 22 FR VSLC MAIN BODY WILL BE MEMORY ALLOY WIRE REINFORCED POLYURETHANE (PU). TWO ONE-WAY INLET VALVES ON VSLC WALL WILL BE IN LV FOR BLOOD WITHDRAWAL. TWO ONE-WAY OUTLET VALVES ON VSLC WALL NEAR TIP AND A ONE-WAY OUTLET VALVE ON VSLC TIP WILL BE IN ASCENDING AORTA FOR BLOOD DELIVERY. THE SPDDP WILL HAVE RIGID PU HOUSING, A SOFT, FLEXIBLE PU DIAPHRAGM MEMBRANE, AND A 50 ML PUMP VOLUME. ONLY ONE 3/8” BLOOD PORT WILL BE MADE ON SPDDP FOR DIRECT CONNECTION TO VSLC. THIS SPPVAD SYSTEM WILL BE TESTED IN A BENCH MOCK LOOP. SPECIFIC AIM 2: TO TEST SPPVAD SYSTEM PROTOTYPE IN A SEVERE CS SHEEP MODEL. OUR SEVERE CS SHEEP MODEL WILL BE USED TO TEST OUR SPPVAD SYSTEM PROTOTYPE FOR EASE OF INSERTION/DEPLOYMENT, LV UNLOADING PERFORMANCE, COUNTERPULSATION CAPACITY, AND 6 HR RELIABILITY (N=5). THE SPPVAD SYSTEM PROTOTYPE DESIGN/FABRICATION/IN VITRO TESTING WILL BE DONE AT W-Z BIOTECH WHILE THE IN VIVO ANIMAL STUDIES WILL BE DONE AT UNIVERSITY OF KENTUCKY. UPON PROJECT COMPLETION, THE COMMERCIALIZED SPPVAD SYSTEM WILL PROVIDE TOTAL LV SUPPORT TO SEVERE CS PATIENTS VIA ONLY A MINIMALLY INVASIVE SINGLE CANNULATION.

225000.00

0.00

0.00

2018-08-28

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Department of Health and Human Services

DEVELOPMENT OF A PERCUTANEOUS PULMONARY ARTERY DRAINAGE DEVICE TO UNLOAD LV DURING VA ECMO SUPPORT FOR SEVERE CARDIOGENIC SHOCK

224991.00

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