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Commercialization Readiness for Bone Filler Scaffold Device to Aid in Dental Applications and Reconstruction

Award Number: SB1DE028213
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: 09/22/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Commercialization Readiness for Bone Filler Scaffold Device to Aid in Dental Applications and Reconstruction - 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. The NuCress™ scaffold has shown in animal studies that it is a better alternative for these autografts, due to its controllable shape and form, enhanced bone formation and early neovascularization, shelf-life stability and tolerance over a range of storage conditions, and a composition that includes only components that have received FDA clearance for use in other devices or are in process of clearance. In situ, the scaffold swells to lock into place in the bone defect, eliminating the need for special instruments to secure it. These scaffolds could reduce costs and convalescent time, benefiting millions of patients. NIDCR-funded Fast Track SBIR results demonstrate superior and fast bone regeneration by the NuCressTM bone filler scaffold for craniomaxillofacial applications in pre-clinical animal studies, setting the stage for the next step of commercialization to benefit patients. Integral to commercialization is FDA approval for the NuCressTM scaffold as a dental medical device (required) and clinical trials (highly desirable). These essential steps require implementing and finalizing manufacturing practices to meet FDA manufacturing regulations (Aim 1), performing biocompatibility and chemical characterization/risk assessment studies, as well as animal studies per FDA guidance to compare performance of the NuCressTM scaffold to a predicate device and untreated control group in critical-sized alveolar ridge defect model (Aim 2), transition from production for research to production for patient treatment in clinics (Aim 3), and planning and preparing for clinical trials in the future (Aim 4). The proposed team has the expertise and experience backed by academic and clinical leaders, globally recognized Contract Research Organizations, and consultants successfully fulling FDA studies and NIDCR-supported clinical study successes.


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 = $346,236 )
2023	2023	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	001	6	8/18/2023	NON-COMPETING CONTINUATION	$674,691
2023	2021	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD STE 3H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	000	4	5/12/2023	COMPETING CONTINUATION	-$328,455
														Subtotal = $346,236

Issue Date FY: 2022 ( Subtotal = $1,763,298 )
2022	2022	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	003	4	2/25/2022	SUPPLEMENT FOR EXPANSION	$39,732
2022	2022	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	006	5	8/19/2022	NON-COMPETING CONTINUATION	$1,314,648
2022	2022	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	004	4	2/28/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	008	5	8/23/2022	SUPPLEMENT FOR EXPANSION	$39,732
2022	2022	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	007	5	8/23/2022	NON-COMPETING CONTINUATION	-$39,732
2022	2021	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	005	4	3/14/2022	COMPETING CONTINUATION	$408,918
2022	2021	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	000	4	11/1/2021	COMPETING CONTINUATION	$0
2022	2021	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	001	4	12/8/2021	COMPETING CONTINUATION	$0
2022	2021	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	002	4	1/4/2022	COMPETING CONTINUATION	$0
														Subtotal = $1,763,298

Issue Date FY: 2021 ( Subtotal = $977,882 )
2021	2021	NUSHORES BIOSCIENCES LLC	1523 S BOWMAN RD # 3-H	LITTLE ROCK	AR	72211	PULASKI	USA	Oral Diseases and Disorders Research	000	4	9/22/2021	COMPETING CONTINUATION	$977,882
														Subtotal = $977,882

Grand Total All Awards = $3,087,416

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Commercialization Readiness for Bone Filler Scaffold Device to Aid in Dental Applications and Reconstruction

Award Number: SB1DE028213

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: 09/22/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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