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An Implantable Micropump for Enhanced Metronomic Chemotherapy for Leptomeningeal Brain Cancer

Award Number: R44CA268728
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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An Implantable Micropump for Enhanced Metronomic Chemotherapy for Leptomeningeal Brain Cancer - Project Summary The current treatment of leptomeningeal brain cancers, occurring in the space surrounding the brain which is bathed by cerebrospinal fluid (CSF), is highly ineffective. The blood-brain barrier (BBB) limits the diffusion of systemically-delivered drugs into the CSF. For those drugs that do cross the BBB, rapid CSF turnover reduces drug concentration in a matter of hours. The standard of care treatment (twice-weekly lumbar puncture) results in CSF drug concentrations at initially high toxic levels, which then drop through the therapeutic window, and then become sub-therapeutic. There is a great unmet need for a drug-delivery device that maintains chemotherapeutic drug concentrations within the therapeutic window over an extended period, thus significantly improving outcomes and reducing toxic side effects. Fluid Synchrony has developed a 200 µL pump mechanism which enables chronic localized metronomic dosing (frequent small infusions every 3 hours) to maintain drug concentration in the therapeutic window, thereby improving tolerability, safety and effectiveness of treatment. The FDA has granted a humanitarian use device (HUD) designation exclusively to our micropump for intraventricular chemotherapy of leptomeningeal cancers. We will initially target pediatric brain cancer populations, as pediatric populations are overlooked by the medical device industry and current practice is to adapt adult devices which results in unnecessary risk and high costs. There is an urgent unmet need for devices specifically designed for pediatric patients. The FDA has made it a priority to expedite pediatric medical device review, as evidenced by the Pediatric Research Equity Act and the Pediatric Medical Device Safety and Improvement Act. The opportunity to dramatically improve outcomes in pediatric high-risk populations is compelling. This SBIR will leverage capabilities from our demonstrated 200 µL pump to develop a fully integrated 3 mL implantable pump, incorporating established clinical needs. In Phase I we will complete development of an automated, metronomic pump mechanism capable of safe, repeated microinfusions to sustain a safe, therapeutically effective drug concentration, and will perform critical bench tests to demonstrate that pump performance meets user requirements and that the chemodrug topotecan and the pump are mutually compatible. In Phase II we will complete all bench tests and pre-clinical studies necessary to support approval of a feasibility clinical study, and will submit data for IRB/IDE approval of such feasibility clinical study. We will additionally implement full QSR / cGMP, appropriate to support an HDE market application. At the conclusion of this SBIR we will have IRB/IDE approval and be positioned to initiate a clinical study.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	FLUID SYNCHRONY, LLC	892 N FAIR OAKS AVE	PASADENA	CA	91103	LOS ANGELES	USA	Cancer Treatment Research	000	1	8/6/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	FLUID SYNCHRONY, LLC	892 N FAIR OAKS AVE	PASADENA	CA	91103	LOS ANGELES	USA	Cancer Treatment Research	000	1	7/25/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $299,998 )
2022	2022	FLUID SYNCHRONY, LLC	892 N FAIR OAKS AVE	PASADENA	CA	91103	LOS ANGELES	USA	Cancer Treatment Research	000	1	5/27/2022	NEW	$299,998
														Subtotal = $299,998

Grand Total All Awards = $299,998

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An Implantable Micropump for Enhanced Metronomic Chemotherapy for Leptomeningeal Brain Cancer

Award Number: R44CA268728

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/01/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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