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All Federal Grant Awards
Project Grant R44NS097113
Award Date
4/1/16
Completion Date
8/31/27
Dollars Obligated
$4.5M
Overview
Activity
26
Transactions
26
Subawards
Similar Awards
Federal Agency
National Institute of Neurological Disorders and Stroke
Awardee
Biocircuit Technologies Inc. (E9KLDNMNYJK5)
Federal Grant Program
93.853
Assistance Type
Project Grant
Place of Performance
Atlanta, GA 30309, USA
Update #1
Update #2
MICROHOOK NERVE TAPE: A NERVE REPAIR COAPTATION AID
Posted 7/24/18
5
1
2
3
4
5
Mod #
Description
ReasonForModification
Federal Obligation
Date
Not listed
LINE EXTENSION AND EXPANDED PRECLINICAL EVIDENCE FOR NERVE TAPE, A SUTURELESS NERVE REPAIR COAPTATION DEVICE - PROJECT SUMMARY BIOCIRCUIT TECHNOLOGIES' NERVE TAPE IS A BIOLOGIC WRAP WITH INTEGRATED MICROHOOKS FOR SUTURELESS REPAIR OF INJURED NERVES. THIS SBIR PHASE IIB PROJECT COMPRISES ACTIVITIES CRITICAL FOR PROMOTING ADOPTION OF NERVE TAPE UPON COMMERCIAL LAUNCH. NERVE INJURIES ARE COMMON AND RESULT IN PARALYSIS, SENSORY LOSS, AND CHRONIC PAIN. IN CURRENT REPAIR TECHNIQUES, THE ENDS OF A CUT NERVE ARE MICROSUTURED BACK TOGETHER UNDER HIGH MAGNIFICATION BY A SPECIALIZED SURGEON. MICROSUTURE REPAIR TECHNIQUES ARE TECHNICALLY CHALLENGING AND TIME INTENSIVE, AND REPAIR QUALITY IS NOT CONSISTENT. NERVE TAPE WAS DEVELOPED AS A SIMPLE AND EASY-TO-USE ALTERNATIVE TO MICROSUTURE REPAIR. THE DEVICE CONSISTS OF FLEXIBLE COLUMNS OF MICROSCALE NITINOL HOOKS EMBEDDED IN A BIOLOGIC WRAP. THE DEVICE EASILY WRAPS TO ALIGN AND HOLD TOGETHER THE TWO ENDS OF A SEVERED NERVE. THE MICROHOOKS ARE DESIGNED FOR SAFE, SHALLOW PENETRATION INTO OUTER CONNECTIVE TISSUE LAYERS OF THE NERVE, EVENLY DISTRIBUTING TENSION FOR A FIRM HOLD. NERVE TAPE IS EASILY AND QUICKLY APPLIED, RELIABLY AND SAFELY ALIGNING NERVE ENDS FOR CONSISTENT, HIGH-QUALITY REPAIRS. TO PROMOTE ADOPTION OF NERVE TAPE UPON COMMERCIAL LAUNCH, THE PROPOSED WORK WILL 1) EXTEND THE SIZE RANGE OF THE DEVICE FOR GREATER MARKET CAPTURE AND 2) GATHER KEY PRECLINICAL DATA TO GUIDE SURGEON PERCEPTION AND SUPPORT KEY MARKETING CLAIMS. TO ADDRESS COMMONLY INJURED NERVES SUCH AS SMALL DIGITAL, FACIAL, AND BRANCHED MOTOR NERVES, THE NERVE TAPE SIZE RANGE WILL BE EXPANDED TO INCLUDE 1-2MM NERVE DIAMETERS. ADDITION OF THE NEW SIZE REQUIRES DESIGN OPTIMIZATION AND SUBSEQUENT VERIFICATION AND VALIDATION TESTING TO SUPPORT REGULATORY CLEARANCE OF THE SMALLER SIZED DEVICE. SEPARATELY, PERFORMANCE DATA IN SPECIFIC SCENARIOS WILL BE COLLECTED TO PROACTIVELY DISPEL PERCEIVED CLINICIAN CONCERNS THAT MIGHT HINDER ADOPTION. SPECIFICALLY, NERVE TAPE'S PERFORMANCE WILL BE DEMONSTRATED IN AREAS OF FLEXION (USING A RABBIT KNEE FLEXION MODEL) AND IN LONG-TERM IMPLANT SCENARIOS (USING A 9-MO. PIG MODEL). FINALLY, WE WILL GATHER EVIDENCE OF NERVE TAPE'S SUPERIOR EFFICIENCY AND REPAIR QUALITY CONSISTENCY. THESE ADVANTAGES WILL BE DEMONSTRATED THROUGH A RABBIT TRANSECTED NERVE REPAIR STUDY COMPARING SURGICAL TIME AND REGENERATION OUTCOMES ACHIEVED BY SURGEONS OF VARIED MICROSURGERY EXPERIENCE USING NERVE TAPE OR CONVENTIONAL MICROSUTURE-BASED REPAIR. THE STEPS PROPOSED IN THIS PROJECT WILL POSITION NERVE TAPE FOR MAXIMAL MARKET PENETRATION AFTER COMMERCIAL LAUNCH, ENABLING WIDESPREAD ADOPTION AS A NERVE REPAIR DEVICE THAT REDUCES SURGICAL TIME AND COMPLEXITY FOR CONSISTENT, HIGH-QUALITY REPAIRS AND IMPROVED RECOVERY OUTCOMES.
$777.6k
8/26/26
Not listed
LINE EXTENSION AND EXPANDED PRECLINICAL EVIDENCE FOR NERVE TAPE, A SUTURELESS NERVE REPAIR COAPTATION DEVICE - PROJECT SUMMARY BIOCIRCUIT TECHNOLOGIES' NERVE TAPE IS A BIOLOGIC WRAP WITH INTEGRATED MICROHOOKS FOR SUTURELESS REPAIR OF INJURED NERVES. THIS SBIR PHASE IIB PROJECT COMPRISES ACTIVITIES CRITICAL FOR PROMOTING ADOPTION OF NERVE TAPE UPON COMMERCIAL LAUNCH. NERVE INJURIES ARE COMMON AND RESULT IN PARALYSIS, SENSORY LOSS, AND CHRONIC PAIN. IN CURRENT REPAIR TECHNIQUES, THE ENDS OF A CUT NERVE ARE MICROSUTURED BACK TOGETHER UNDER HIGH MAGNIFICATION BY A SPECIALIZED SURGEON. MICROSUTURE REPAIR TECHNIQUES ARE TECHNICALLY CHALLENGING AND TIME INTENSIVE, AND REPAIR QUALITY IS NOT CONSISTENT. NERVE TAPE WAS DEVELOPED AS A SIMPLE AND EASY-TO-USE ALTERNATIVE TO MICROSUTURE REPAIR. THE DEVICE CONSISTS OF FLEXIBLE COLUMNS OF MICROSCALE NITINOL HOOKS EMBEDDED IN A BIOLOGIC WRAP. THE DEVICE EASILY WRAPS TO ALIGN AND HOLD TOGETHER THE TWO ENDS OF A SEVERED NERVE. THE MICROHOOKS ARE DESIGNED FOR SAFE, SHALLOW PENETRATION INTO OUTER CONNECTIVE TISSUE LAYERS OF THE NERVE, EVENLY DISTRIBUTING TENSION FOR A FIRM HOLD. NERVE TAPE IS EASILY AND QUICKLY APPLIED, RELIABLY AND SAFELY ALIGNING NERVE ENDS FOR CONSISTENT, HIGH-QUALITY REPAIRS. TO PROMOTE ADOPTION OF NERVE TAPE UPON COMMERCIAL LAUNCH, THE PROPOSED WORK WILL 1) EXTEND THE SIZE RANGE OF THE DEVICE FOR GREATER MARKET CAPTURE AND 2) GATHER KEY PRECLINICAL DATA TO GUIDE SURGEON PERCEPTION AND SUPPORT KEY MARKETING CLAIMS. TO ADDRESS COMMONLY INJURED NERVES SUCH AS SMALL DIGITAL, FACIAL, AND BRANCHED MOTOR NERVES, THE NERVE TAPE SIZE RANGE WILL BE EXPANDED TO INCLUDE 1-2MM NERVE DIAMETERS. ADDITION OF THE NEW SIZE REQUIRES DESIGN OPTIMIZATION AND SUBSEQUENT VERIFICATION AND VALIDATION TESTING TO SUPPORT REGULATORY CLEARANCE OF THE SMALLER SIZED DEVICE. SEPARATELY, PERFORMANCE DATA IN SPECIFIC SCENARIOS WILL BE COLLECTED TO PROACTIVELY DISPEL PERCEIVED CLINICIAN CONCERNS THAT MIGHT HINDER ADOPTION. SPECIFICALLY, NERVE TAPE'S PERFORMANCE WILL BE DEMONSTRATED IN AREAS OF FLEXION (USING A RABBIT KNEE FLEXION MODEL) AND IN LONG-TERM IMPLANT SCENARIOS (USING A 9-MO. PIG MODEL). FINALLY, WE WILL GATHER EVIDENCE OF NERVE TAPE'S SUPERIOR EFFICIENCY AND REPAIR QUALITY CONSISTENCY. THESE ADVANTAGES WILL BE DEMONSTRATED THROUGH A RABBIT TRANSECTED NERVE REPAIR STUDY COMPARING SURGICAL TIME AND REGENERATION OUTCOMES ACHIEVED BY SURGEONS OF VARIED MICROSURGERY EXPERIENCE USING NERVE TAPE OR CONVENTIONAL MICROSUTURE-BASED REPAIR. THE STEPS PROPOSED IN THIS PROJECT WILL POSITION NERVE TAPE FOR MAXIMAL MARKET PENETRATION AFTER COMMERCIAL LAUNCH, ENABLING WIDESPREAD ADOPTION AS A NERVE REPAIR DEVICE THAT REDUCES SURGICAL TIME AND COMPLEXITY FOR CONSISTENT, HIGH-QUALITY REPAIRS AND IMPROVED RECOVERY OUTCOMES.
$956.1k
8/28/25
Not listed
LINE EXTENSION AND EXPANDED PRECLINICAL EVIDENCE FOR NERVE TAPE, A SUTURELESS NERVE REPAIR COAPTATION DEVICE - PROJECT SUMMARY WE WILL FINALIZE DEVELOPMENT OF A MICROHOOK-BASED DEVICE FOR QUICK AND CONSISTENTLY EFFECTIVE REPAIR OF NERVE INJURIES. THIS "MICROHOOK NERVE TAPE" CONSISTS OF AN ARRAY OF MICROSCALE HOOKS, DISTRIBUTED ACROSS A FINE, FLEXIBLE MESHWORK AND EMBEDDED IN A BIOLOGIC BACKING. THIS DEVICE WILL BE USED DURING NERVE REPAIR SURGERIES IN PLACE OF MICROSUTURES TO WRAP AROUND AND BIND THE APPROXIMATED ENDS OF A SEVERED NERVE (OR THE ENDS OF A NERVE GRAFT). THE SHORT MICROHOOKS PENETRATE ONLY INTO THE OUTER, CONNECTIVE TISSUE LAYERS OF THE NERVE, FORMING AN EFFECTIVE MECHANICAL ATTACHMENT AND DISTRIBUTING TENSION EVENLY ACROSS THE DEVICE. MICROHOOK NERVE TAPE CAN BE APPLIED EASILY AND LOWERS SURGERY TIME AND COMPLEXITY AS COMPARED TO THE CURRENT CLINICAL STANDARD OF MICROSUTURE REPAIR. THE EASE AND INTUITIVENESS OF MICROHOOK NERVE TAPE APPLICATION WILL ENABLE CONSISTENT HIGH-QUALITY REPAIRS TO OPTIMIZE RECOVERY AFTER NERVE INJURIES. IN PHASE I, WE REFINED THE DEVICE DESIGN TO PRODUCE A SET OF PROTOTYPES CONSISTING OF A STAINLESS STEEL-BASED MICROHOOK MESH LAMINATED WITHIN A BIOLOGIC LAYER OF PORCINE SMALL INTESTINAL MUCOSA (SIS). IN BIOMECHANICAL TESTING, NERVES WERE HELD TOGETHER BY THE DEVICE WITH STRENGTH COMPARABLE TO THAT OF MICROSUTURE REPAIRS. IN IN VIVO RABBIT TESTING, THE DEVICE WAS WELL TOLERATED BY THE SURROUNDING TISSUE, AND NERVES THAT WERE CUT AND REPAIRED WITH MICROHOOK NERVE TAPE REGENERATED COMPARABLY VS. MICROSUTURE REPAIRED NERVES. WE SUBSEQUENTLY DEVELOPED AN ENHANCED NITINOL- BASED VERSION OF THE DEVICE MORE SUITABLE TO CLINICAL TRANSLATION, AND WE DEMONSTRATED THE SUPERIOR PERFORMANCE OF THIS DEVICE IN BIOMECHANICAL TESTING. IN PHASE II WE WILL FINALIZE THE DESIGN OF THE MICROHOOK NERVE TAPE DEVICE WITH NITINOL-BASED MICROHOOKS, AND WE WILL DEVELOP EFFICIENT MANUFACTURING AND PRODUCTION METHODS. WE WILL CONDUCT EXTENSIVE VALIDATION TESTING OF SAFETY AND EFFICACY IN COMPREHENSIVE RABBIT STUDIES AND APPLY FOR FDA 510(K) CLEARANCE. THE FINAL COMMERCIALIZATION-READY PRODUCT WILL BE AN FDA- APPROVED NERVE REPAIR DEVICE THAT CAN BE STORED ON THE SHELF FOR USE DURING NERVE REPAIR PROCEDURES. MICROHOOK NERVE TAPE WILL REDUCE THE TECHNICAL DEMANDS AND TIME COSTS OF NERVE REPAIR, WHILE IMPROVING REPAIR CONSISTENCY AND OVERALL QUALITY.
$1.2m
9/17/24
Not listed
MICROHOOK NERVE TAPE: A NERVE REPAIR COAPTATION AID - PROJECT SUMMARY WE WILL FINALIZE DEVELOPMENT OF A MICROHOOK-BASED DEVICE FOR QUICK AND CONSISTENTLY EFFECTIVE REPAIR OF NERVE INJURIES. THIS "MICROHOOK NERVE TAPE" CONSISTS OF AN ARRAY OF MICROSCALE HOOKS, DISTRIBUTED ACROSS A FINE, FLEXIBLE MESHWORK AND EMBEDDED IN A BIOLOGIC BACKING. THIS DEVICE WILL BE USED DURING NERVE REPAIR SURGERIES IN PLACE OF MICROSUTURES TO WRAP AROUND AND BIND THE APPROXIMATED ENDS OF A SEVERED NERVE (OR THE ENDS OF A NERVE GRAFT). THE SHORT MICROHOOKS PENETRATE ONLY INTO THE OUTER, CONNECTIVE TISSUE LAYERS OF THE NERVE, FORMING AN EFFECTIVE MECHANICAL ATTACHMENT AND DISTRIBUTING TENSION EVENLY ACROSS THE DEVICE. MICROHOOK NERVE TAPE CAN BE APPLIED EASILY AND LOWERS SURGERY TIME AND COMPLEXITY AS COMPARED TO THE CURRENT CLINICAL STANDARD OF MICROSUTURE REPAIR. THE EASE AND INTUITIVENESS OF MICROHOOK NERVE TAPE APPLICATION WILL ENABLE CONSISTENT HIGH-QUALITY REPAIRS TO OPTIMIZE RECOVERY AFTER NERVE INJURIES. IN PHASE I, WE REFINED THE DEVICE DESIGN TO PRODUCE A SET OF PROTOTYPES CONSISTING OF A STAINLESS STEEL-BASED MICROHOOK MESH LAMINATED WITHIN A BIOLOGIC LAYER OF PORCINE SMALL INTESTINAL MUCOSA (SIS). IN BIOMECHANICAL TESTING, NERVES WERE HELD TOGETHER BY THE DEVICE WITH STRENGTH COMPARABLE TO THAT OF MICROSUTURE REPAIRS. IN IN VIVO RABBIT TESTING, THE DEVICE WAS WELL TOLERATED BY THE SURROUNDING TISSUE, AND NERVES THAT WERE CUT AND REPAIRED WITH MICROHOOK NERVE TAPE REGENERATED COMPARABLY VS. MICROSUTURE REPAIRED NERVES. WE SUBSEQUENTLY DEVELOPED AN ENHANCED NITINOL- BASED VERSION OF THE DEVICE MORE SUITABLE TO CLINICAL TRANSLATION, AND WE DEMONSTRATED THE SUPERIOR PERFORMANCE OF THIS DEVICE IN BIOMECHANICAL TESTING. IN PHASE II WE WILL FINALIZE THE DESIGN OF THE MICROHOOK NERVE TAPE DEVICE WITH NITINOL-BASED MICROHOOKS, AND WE WILL DEVELOP EFFICIENT MANUFACTURING AND PRODUCTION METHODS. WE WILL CONDUCT EXTENSIVE VALIDATION TESTING OF SAFETY AND EFFICACY IN COMPREHENSIVE RABBIT STUDIES AND APPLY FOR FDA 510(K) CLEARANCE. THE FINAL COMMERCIALIZATION-READY PRODUCT WILL BE AN FDA- APPROVED NERVE REPAIR DEVICE THAT CAN BE STORED ON THE SHELF FOR USE DURING NERVE REPAIR PROCEDURES. MICROHOOK NERVE TAPE WILL REDUCE THE TECHNICAL DEMANDS AND TIME COSTS OF NERVE REPAIR, WHILE IMPROVING REPAIR CONSISTENCY AND OVERALL QUALITY.
$0
12/8/23
Not listed
LINE EXTENSION AND EXPANDED PRECLINICAL EVIDENCE FOR NERVE TAPE, A SUTURELESS NERVE REPAIR COAPTATION DEVICE - PROJECT SUMMARY WE WILL FINALIZE DEVELOPMENT OF A MICROHOOK-BASED DEVICE FOR QUICK AND CONSISTENTLY EFFECTIVE REPAIR OF NERVE INJURIES. THIS "MICROHOOK NERVE TAPE" CONSISTS OF AN ARRAY OF MICROSCALE HOOKS, DISTRIBUTED ACROSS A FINE, FLEXIBLE MESHWORK AND EMBEDDED IN A BIOLOGIC BACKING. THIS DEVICE WILL BE USED DURING NERVE REPAIR SURGERIES IN PLACE OF MICROSUTURES TO WRAP AROUND AND BIND THE APPROXIMATED ENDS OF A SEVERED NERVE (OR THE ENDS OF A NERVE GRAFT). THE SHORT MICROHOOKS PENETRATE ONLY INTO THE OUTER, CONNECTIVE TISSUE LAYERS OF THE NERVE, FORMING AN EFFECTIVE MECHANICAL ATTACHMENT AND DISTRIBUTING TENSION EVENLY ACROSS THE DEVICE. MICROHOOK NERVE TAPE CAN BE APPLIED EASILY AND LOWERS SURGERY TIME AND COMPLEXITY AS COMPARED TO THE CURRENT CLINICAL STANDARD OF MICROSUTURE REPAIR. THE EASE AND INTUITIVENESS OF MICROHOOK NERVE TAPE APPLICATION WILL ENABLE CONSISTENT HIGH-QUALITY REPAIRS TO OPTIMIZE RECOVERY AFTER NERVE INJURIES. IN PHASE I, WE REFINED THE DEVICE DESIGN TO PRODUCE A SET OF PROTOTYPES CONSISTING OF A STAINLESS STEEL-BASED MICROHOOK MESH LAMINATED WITHIN A BIOLOGIC LAYER OF PORCINE SMALL INTESTINAL MUCOSA (SIS). IN BIOMECHANICAL TESTING, NERVES WERE HELD TOGETHER BY THE DEVICE WITH STRENGTH COMPARABLE TO THAT OF MICROSUTURE REPAIRS. IN IN VIVO RABBIT TESTING, THE DEVICE WAS WELL TOLERATED BY THE SURROUNDING TISSUE, AND NERVES THAT WERE CUT AND REPAIRED WITH MICROHOOK NERVE TAPE REGENERATED COMPARABLY VS. MICROSUTURE REPAIRED NERVES. WE SUBSEQUENTLY DEVELOPED AN ENHANCED NITINOL- BASED VERSION OF THE DEVICE MORE SUITABLE TO CLINICAL TRANSLATION, AND WE DEMONSTRATED THE SUPERIOR PERFORMANCE OF THIS DEVICE IN BIOMECHANICAL TESTING. IN PHASE II WE WILL FINALIZE THE DESIGN OF THE MICROHOOK NERVE TAPE DEVICE WITH NITINOL-BASED MICROHOOKS, AND WE WILL DEVELOP EFFICIENT MANUFACTURING AND PRODUCTION METHODS. WE WILL CONDUCT EXTENSIVE VALIDATION TESTING OF SAFETY AND EFFICACY IN COMPREHENSIVE RABBIT STUDIES AND APPLY FOR FDA 510(K) CLEARANCE. THE FINAL COMMERCIALIZATION-READY PRODUCT WILL BE AN FDA- APPROVED NERVE REPAIR DEVICE THAT CAN BE STORED ON THE SHELF FOR USE DURING NERVE REPAIR PROCEDURES. MICROHOOK NERVE TAPE WILL REDUCE THE TECHNICAL DEMANDS AND TIME COSTS OF NERVE REPAIR, WHILE IMPROVING REPAIR CONSISTENCY AND OVERALL QUALITY.
$0
12/8/23