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Biomaterial augmented microfracture repair of full-thickness chondral defects04

Award Number: R44AR066427
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/02/2015
PERIOD OF PERFORMANCE END DATE: 02/28/2019

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Biomaterial augmented microfracture repair of full-thickness chondral defects04 - ¿ DESCRIPTION (provided by applicant): The goal of this project is to provide a synthetic biomaterial capable of giving long-term repair of full-thickness chondral lesions with the aim of helping to reduce the 600,000 joint replacements carried out each year in the USA. Our company has developed a synthetic biomaterial technology with proven biocompatibility in treating over 33,000 patients for bone repair. This highly biocompatible technology is designed to provide an in situ organized environment for the regeneration of new tissue and has recently been shown to provide excellent repair in a pre- clinical osteochondral model. In this study, the regenerate tissue not only repaired the subchondral bone but also produced well-integrated hyaline cartilage and re-established the tide-mark zone. Building on the preliminary results from the pre-clinical osteochondral study and our patent protected position on the material's use with microfracture, Phase I of this proposal seeks initially to establish proper surgical method for implantation of the biomaterial in lesions with sizes spanning those normally treated by microfracture (1 to 4cm2). An ovine model is chosen to conform to preferences expressed by the FDA. Having established proper fixation technique in Phase I, the Phase II of the proposal derives data for use in a pre-clinical safety and efficacy study. Data from this accepted ovine model will form the basis of approach to the FDA to obtain an investigational device exemption (IDE) necessary to enter human clinical trials to support Pre-Market Authorization (PMA) for the commercial product. This treatment modality represents a safe, cost-effective long-term solution to an increasing patient population.


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: 2019 ( Subtotal = $0 )
2019	2017	ARTERIOCYTE, INC.	45 SOUTH ST STE 2/B	HOPKINTON	MA	01748	MIDDLESEX	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	4	5/15/2019	NON-COMPETING CONTINUATION	$0
2019	2017	ARTERIOCYTE, INC.	45 SOUTH ST STE 2/B	HOPKINTON	MA	01748	MIDDLESEX	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	11/20/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $302,276 )
2017	2017	ARTERIOCYTE, INC.	7100 EUCLID AVE STE 150	CLEVELAND	OH	44103	CUYAHOGA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	4	8/4/2017	NON-COMPETING CONTINUATION	$302,276
2017	2016	ARTERIOCYTE, INC.	7100 EUCLID AVE STE 150	CLEVELAND	OH	44103	CUYAHOGA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	3/3/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$508,141
2017	2016	ISTO TECHNOLOGIES INC	1155 OLIVETTE EXECUTIVE PKWY STE 200	SAINT LOUIS	MO	63132	SAINT LOUIS	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	3/3/2017	EXTENSION WITH OR WITHOUT FUNDS	-$508,141
														Subtotal = $302,276

Issue Date FY: 2016 ( Subtotal = $508,141 )
2016	2016	ISTO TECHNOLOGIES INC	1155 OLIVETTE EXEC PKWY #200	SAINT LOUIS	MO	63132	SAINT LOUIS	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	8/25/2016	EXTENSION WITH OR WITHOUT FUNDS	$508,141
														Subtotal = $508,141

Issue Date FY: 2015 ( Subtotal = $224,960 )
2015	2015	ISTO TECHNOLOGIES INC	1155 OLIVETTE EXEC PKWY #200	SAINT LOUIS	MO	63132	SAINT LOUIS	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	7/2/2015	NEW	$224,960
														Subtotal = $224,960

Grand Total All Awards = $1,035,377

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Biomaterial augmented microfracture repair of full-thickness chondral defects04

Award Number: R44AR066427

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/02/2015

PERIOD OF PERFORMANCE END DATE: 02/28/2019

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