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A crosslinked cartilage-derived matrix for cartilage tissue engineering

Award Number: SB1AR061916
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: 09/17/2012
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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A crosslinked cartilage-derived matrix for cartilage tissue engineering - Abstract Osteoarthritis (OA) remains a significant source of significant pain and disability, affecting over 30 million adults with an economic burden of over $130 billion per year to the US. Joint replacement is a well-established procedure, but its finite life span makes this treatment unacceptable for younger or more active individuals, who often require additional revision surgeries as they age. Both complicated revision surgery and initial joint replacement carry progressively increasing morbidity and mortality as patient age increases, leaving few good cost-effective treatment options once the replacement wears out. Previous work at Cytex has focused on the development of a construct that addresses these concerns by using a 3D woven textile to create a high- performance, precisely engineered implant for treatment of large cartilage lesions. This 3D woven scaffold can function immediately after implantation, all while encouraging cell ingrowth, proliferation, and subsequent tissue development. Moreover, the implant replaces only the diseased portion of the joint surface, leaving native bone stock intact should future surgical interventions prove necessary. Commercialization of an efficacious cartilage resurfacing implant would have significant clinical impact for these patients with moderate to severe OA, providing a surgical repair option where none currently exist. We have made outstanding progress in pre-clinical large animal studies and showed that our approach using biomimetic scaffolds rapidly restores function to the joint and alleviates pain. Cytex’s cartilage resurfacing implants can be manufactured to match complex geometries and custom curvatures found in the hip and knee joints and are specifically designed for large arthritic lesions that are untreatable with current cartilage repair options. Because of the success we have seen when applying our technology in vivo in increasingly complex animal models, we are currently seeking investments to accelerate this technology to market while simultaneously pursuing follow-on funding through small business NIH mechanisms. To this end, the purpose of this proposal is to develop and validate manufacturing equipment and processes in compliance with cGMP standards to prepare for commercial production of our implant. As the design and establishment of manufacturing processes for novel technologies is a significant hurdle to win both third-party investment and regulatory approval, our goal is to use this Commercialization Readiness Pilot Program to address this impediment while completing our preclinical work. Successful completion of this work will position Cytex to accelerate its innovative technology towards a commercially available product line.


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 = -$28 )
2023	2019	CYTEX THERAPEUTICS INC	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	6	11/21/2022	NON-COMPETING CONTINUATION	-$28
														Subtotal = -$28

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	6	2/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $400,000 )
2019	2019	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	6	8/21/2019	NON-COMPETING CONTINUATION	$400,000
														Subtotal = $400,000

Issue Date FY: 2018 ( Subtotal = $681,344 )
2018	2018	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	5	8/21/2018	NON-COMPETING CONTINUATION	$399,997
2018	2017	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	11/9/2017	COMPETING CONTINUATION	$281,347
														Subtotal = $681,344

Issue Date FY: 2017 ( Subtotal = $400,000 )
2017	2017	CYTEX THERAPEUTICS INC	2608 ERWIN RD, STE 19A	DURHAM	NC	27705	DURHAM	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	9/1/2017	COMPETING CONTINUATION	$400,000
														Subtotal = $400,000

Grand Total All Awards = $1,481,316

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A crosslinked cartilage-derived matrix for cartilage tissue engineering

Award Number: SB1AR061916

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: 09/17/2012

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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