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A crosslinked cartilage-derived matrix for cartilage tissue engineering

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2SB1AR061916-04
Agency Tracking Number: SB1AR061916
Amount: $1,199,997.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAMS
Solicitation Number: PAR16-027
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-01
Award End Date (Contract End Date): 2020-08-31
Small Business Information
2608 ERWIN RD, STE 19A
Durham, NC 27705-4597
United States
DUNS: 783502466
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (919) 912-9839
Business Contact
Phone: (919) 684-2521
Research Institution

Abstract OsteoarthritisOAremains a significant source of significant pain and disabilityaffecting overmillion adults with an economic burden of over $billion per year to the USJoint replacement is a well established procedurebut its finite life span makes this treatment unacceptable for younger or more active individualswho often require additional revision surgeries as they ageBoth complicated revision surgery and initial joint replacement carry progressively increasing morbidity and mortality as patient age increasesleaving few good cost effective treatment options once the replacement wears outPrevious work at Cytex has focused on the development of a construct that addresses these concerns by using aD woven textile to create a highperformanceprecisely engineered implant for treatment of large cartilage lesionsThisD woven scaffold can function immediately after implantationall while encouraging cell ingrowthproliferationand subsequent tissue developmentMoreoverthe implant replaces only the diseased portion of the joint surfaceleaving native bone stock intact should future surgical interventions prove necessaryCommercialization of an efficacious cartilage resurfacing implant would have significant clinical impact for these patients with moderate to severe OAproviding a surgical repair option where none currently existWe 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 painCytex 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 optionsBecause of the success we have seen when applying our technology in vivo in increasingly complex animal modelswe are currently seeking investments to accelerate this technology to market while simultaneously pursuing follow on funding through small business NIH mechanismsTo this endthe 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 implantAs the design and establishment of manufacturing processes for novel technologies is a significant hurdle to win both third party investment and regulatory approvalour goal is to use this Commercialization Readiness Pilot Program to address this impediment while completing our preclinical workSuccessful completion of this work will position Cytex to accelerate its innovative technology towards a commercially available product line NARRATIVE Patients in theage range who suffer from activity limiting OA rarely choose to undergo joint replacement surgery due to the high risks associated with premature implant failure in youngactive patientsThe goal of this proposal is to develop the validated manufacturing processes needed to support the commercialization of Cytex s novel cartilage resurfacing implantswhich can be used to replace diseased cartilage of the hip or kneeproviding clinical solutions where none currently exist

* Information listed above is at the time of submission. *

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