SBIR/STTR Research Award

Regenerative rotator cuff repair in a clinically relevant chronic disease model

Award identifier 4af3a71203090ab2178a8a5ecfd8545b7cf776779e96f19c1cfc37a5b3fa9936Awarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$225,000

Program and phase

STTR · Phase I

Award year

2019

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
Cytex Therapeutics, Inc.
Proposal award date
2019-09-09
Contract end date
2020-08-31
UEI
G9RMDCWJYGL3
Solicitation number
PA18-575
Topic code
NIAMS

Research abstract

ABSTRACT Rotator cuff repairRCRis a common first line surgical solution to symptomatic rotator cuff injurywith overRCRs performed annuallyand growing at a rate ofUnfortunatelyof the cases are complicated by failure and re tear of the repaired tendonwhich commonly results in a significant reduction in activities of daily livingworkand or sports and recreation for the patient due to pain and restricted movementFailed rotator cuff repairs stem from issues associated with suture retentionmaintaining the correct anatomic position of the tendon when reattachedand the lack of enduring mechanical support for the shoulder and repaired tendonwhich is necessary to allow adequate healing time after the surgical procedureThese issues are even more problematic for severe or chronic tears where muscle atrophyfatty infiltrationand retraction from the anatomic insertion site complicate tendon repairsIn this projectwe propose a high performance textile based implant designed to address the deficiencies of current RCRThe innovation of the project is twofoldthe scaffold is designed to mimic the mechanical properties of native tendon andthe partially resorbable structure and the specific utilization of resorbable and non resorbable yarns minimizes the potential generation of particulate debrismaintains discreteinterconnected zones to promote cell infiltrationdifferentiationand integration with both the tendon and bone tissues in their respective zonesWe aim to further the development of this high performance scaffold by varying weaving parameters in order to maximize the biological propertieswhile retaining the mechanical properties of native tendonIn Aimfiber diameter and yarn spacing will be modulated to create implants with different architectures in four combinations that will be studied in vitro via explant cultureand assessed via histological and biomechanical analysisIn Aimthe optimized scaffold will be assessed in an clinically relevant ovine model of chronic tendinopathywhich we have shown to mimic the chronic human conditionAdditionallyby attaching the implant to a completely transected tendonthis model also tests the efficacy of the implant under a severe clinical condition of a complete mechanical deficitThe control cohort will be repaired using advanced suture techniques onlywhich is the current standard of careAtmonthsmobility restorationtendon and bone integrationand repair strength will be assessed via biomechanical testing and histological analysisThe goal of this study is to further the development of a new implant specifically tailored to meet the disparate requirements for both tendon and bone incorporation during repair of severely torn rotator cuff tendonsWe anticipate that this will lead to improved functionality of the injured cuff in these challenging cases and ultimately improve long term clinical outcomes NARRATIVE Rotator cuff repairs suffer from high failure rates due to tendon re tear despite many advances in surgical proceduresTo address this problemparticularly for severe and clinically challenging caseswe propose a high performancetextile based implant that provides mechanical support while promoting healing and integration with native tissuesThe ultimate objective of this project is to refine the properties of the device and then to assess its potential for improving rotator cuff repair in a clinically relevant chronic tendiopathy animal model

Technology keywords

Not reported

Other awards by this recipient

Verified by the same UEI. These are other public SBIR/STTR award pages, not a merged company record.

Awards with the same topic code

Verified by an exact topic code match. This is not a text-similarity match.

Research funding history

22 SBIR/STTR records share this UEI (2007–2023). Reported award amounts total $18,271,228. Reported amounts are not federal obligations.

Phases: Phase I, Phase II, Phase II – Direct to Phase II

Agencies: Department of Health and Human Services, National Science Foundation

Agency intelligence

Department of Health and Human Services

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