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Feasibility study of a nanostructural system for bone regeneration in preparation for dental implants

Award Number: R44DE028213
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2019
PERIOD OF PERFORMANCE END DATE: 07/31/2022

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Feasibility study of a nanostructural system for bone regeneration in preparation for dental implants - Project Summary Current bone grafting techniques for functional rehabilitation with dental implants have limitations – high- cost, difficulties with fixation and stabilization, insufficient bone regeneration, high morbidity using autogenous block grafts and prolonged healing of up to 9 months. Existing synthetic bone fillers cannot match defect shape and volume, are weakly resorbed (if at all), are not easily and quickly modifiable in size and shape during surgery, cannot promote early and enhanced neovascularization and osseointegration; and are poorly suited for advanced reconstruction. Current technologies cannot be modulated to match existing bone architecture – a critical feature for improved healing. Although pre-implant reconstructive surgeries are commonly performed, an estimated 7% of patients are unable to receive dental implants due to these limitations. We propose to prove that our NuCressTM scaffold is a revolutionary advancement in bone healing and a transformational technology for dentists, periodontists and oral surgeons. We seek to prove in preclinical studies that dental implants or other bone regeneration treatments for tooth salvage treatments can be performed at a fraction of the cost and healing times required for today’s technologies. We propose to demonstrate the ability of our technology to support regeneration of mineralized tissues that recapitulate the mechanical, physical and biological properties of craniofacial bones and corresponding microenvironments, to facilitate improved dental implant success. We hypothesize that the NuCress™ scaffold technology will outperform currently available options in rabbit and canine bone regeneration models. After producing optimized scaffolds with enhanced porosity similar to calvarial bone, we will compare the NuCress™ scaffold to a predicate and untreated control groups in models of critical sized calvarial defects, in an established sinus model, an established pre-clinical socket model, an established pre-clinical segmental defect model, and an established pre-clinical dental implant model. Successful Phase I and II SBIR studies will lead to first in human trials in dental implant patients and seek FDA approval to provide a superior option to facilitate improved dental implant success.


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: 2023 ( Subtotal = $328,455 )
2023	2020	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD STE 3H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	001	3	5/12/2023	SUPPLEMENT FOR EXPANSION	$177,317
2023	2020	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD STE 3H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	002	3	5/12/2023	SUPPLEMENT FOR EXPANSION	$71,837
2023	2020	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD STE 3H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	000	3	5/12/2023	NON-COMPETING CONTINUATION	$79,301
														Subtotal = $328,455

Issue Date FY: 2022 ( Subtotal = -$408,918 )
2022	2020	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	003	3	3/14/2022	SUPPLEMENT FOR EXPANSION	-$71,837
2022	2020	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	000	3	10/18/2021	NON-COMPETING CONTINUATION	$0
2022	2020	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	001	3	3/14/2022	NON-COMPETING CONTINUATION	-$159,764
2022	2020	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	002	3	3/14/2022	SUPPLEMENT FOR EXPANSION	-$177,317
														Subtotal = -$408,918

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	001	3	9/17/2021	NON-COMPETING CONTINUATION	$0
2021	2020	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	000	3	10/21/2020	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,071,609 )
2020	2020	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	005	3	9/11/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	004	3	8/25/2020	SUPPLEMENT FOR EXPANSION	$71,837
2020	2020	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	006	3	9/21/2020	SUPPLEMENT FOR EXPANSION	$177,317
2020	2020	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	003	3	7/29/2020	NON-COMPETING CONTINUATION	$822,455
2020	2019	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	001	2	5/22/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
2020	2019	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	002	2	5/29/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
2020	2018	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	000	1	1/12/2020	NEW	$0
														Subtotal = $1,071,609

Issue Date FY: 2019 ( Subtotal = $676,207 )
2019	2019	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	001	2	8/2/2019	EXTENSION WITH OR WITHOUT FUNDS	$571,677
2019	2019	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	002	2	8/6/2019	EXTENSION WITH OR WITHOUT FUNDS	$104,530
2019	2018	NUSHORES BIOSCIENCES LLC	4301 WEST MARKHAM STREET, #831	LITTLE ROCK	AR	72205	PULASKI	USA	Oral Diseases and Disorders Research	000	1	7/8/2019	NEW	$0
														Subtotal = $676,207

Issue Date FY: 2018 ( Subtotal = $225,000 )
2018	2018	NUSHORES BIOSCIENCES LLC	4623 CRESTWOOD DR	LITTLE ROCK	AR	72207	PULASKI	USA	Oral Diseases and Disorders Research	001	1	7/30/2018	NEW	-$20,656
2018	2018	NUSHORES BIOSCIENCES LLC	4623 CRESTWOOD DR	LITTLE ROCK	AR	72207	PULASKI	USA	Oral Diseases and Disorders Research	000	1	7/27/2018	NEW	$245,656
														Subtotal = $225,000

Grand Total All Awards = $1,892,353

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Feasibility study of a nanostructural system for bone regeneration in preparation for dental implants

Award Number: R44DE028213

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2019

PERIOD OF PERFORMANCE END DATE: 07/31/2022

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