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Project Grant R44HD102241
Award Date
4/15/20
Completion Date
5/31/27
Dollars Obligated
$5.6M
Overview
Activity
6
Transactions
6
Subawards
Federal Agency
National Institute of Child Health and Human Development
Awardee
Collamedix Inc. (GS4LCAYKAVC7)
Federal Grant Program
93.865
Assistance Type
Project Grant
Place of Performance
Ohio, USA
Description
Update #1
COLLAGEN-BASED TISSUE GUIDANCE BIOFABRIC FOR TREATMENT OF STRESS URINARY INCONTINENCE
Posted 4/15/20, 12:00 AM
Mod #
Description
Reason For Modification
Federal Obligation
(Click to sort descending)
Date
(Click to sort ascending)
Not listed
COLLAGEN-BASED TISSUE GUIDANCE BIOFABRIC FOR TREATMENT OF STRESS URINARY INCONTINENCE IN WOMEN - ABSTRACT THE PREVALENCE OF STRESS URINARY INCONTINENCE (SUI) IN WOMEN IS 22% IN AGES 45-64 YEARS, AND UP TO 41% IN WOMEN OVER 80 YEARS OLD. SYNTHETIC POLYPROPYLENE MESH SLINGS ARE THE CURRENT STANDARD OF CARE TREATMENT, AND THE MARKET FOR THESE DEVICES IS OVER $400M/YEAR. HOWEVER, COMPLICATIONS RATES, INCLUDING CHRONIC PAIN, EXTRUSION, AND EROSION, RANGE FROM 5-15%. THERE HAVE BEEN NUMEROUS CLASS-ACTION LAWSUITS AGAINST MANUFACTURERS, A PAUSE ON SUI SLING SALES IN THE UK AND NEW ZEALAND, AND MANY PATIENTS ARE HESITANT OR UNWILLING TO RECEIVE THESE IMPLANTS. THEREFORE, THERE IS A STRONG CLINICAL NEED TO DEVELOP NEW IMPLANTS TO TREAT THIS DEBILITATING AND LIFE-ALTERING CONDITION IN WOMEN. COLLAMEDIX'S PATENTED ELECTROCHEMICAL COMPACTION FABRICATION PROCESS TRANSFORMS SOLUTIONS OF MEDICAL-GRADE BOVINE TYPE I COLLAGEN INTO CONTINUOUS-LENGTH THREADS ON SPOOLS THAT ARE AMONG THE DENSEST AND STRONGEST FORMS OF RECONSTITUTED COLLAGEN. COLLAGEN MOLECULES ARE STRICTLY ALIGNED IN PARALLEL TO THE LONG AXIS OF THREADS, MIMICKING THE NATIVE TOPOGRAPHY OF LIGAMENT-LIKE TISSUES. WHEN IMPLANTED IN VIVO, HOST COLLAGEN DEPOSITED THROUGHOUT SCAFFOLDS MADE FROM THESE THREADS IS ALSO ALIGNED, INDICATING THAT THE THREADS ACT AS A TEMPLATE, RESULTING IN AN ORDERED TISSUE STRUCTURE, NOT A RANDOMLY ORIENTED SCAR. THE COLLAGEN THREADS ARE RESORBED AND REMODELED OVER TIME AS A STRONG, LIGAMENTOUS TISSUE GROWS THROUGH THE SCAFFOLD. BASED ON THIS TECHNOLOGY, COLLAMEDIX HAS DEVELOPED A TAPE-SHAPED, PURE-COLLAGEN PRODUCT FOR SUI TREATMENT, COLLASLING™, COMPOSED OF BRAIDED PURE-COLLAGEN THREADS. COLLASLING IS IMPLANTED IN THE SAME MANNER AS STANDARD SUI SLINGS AND IMPARTS LESS INFLAMMATION THAN POLYPROPYLENE OVER TIME, AS SHOWN IN LONG-TERM SHEEP STUDIES. WE HAVE COMPLETED THE PRODUCT DESIGN AND HIGH-RISK VERIFICATION AND VALIDATION (V & V) STUDIES REQUIRED FOR FDA SUBMISSION, INCLUDING THE FULL BIOCOMPATIBILITY TEST SUITE, LARGE ANIMAL IMPLANT STUDY, AND STERILIZATION METHOD DEVELOPMENT FOR THE COLLASLING. THE AIMS OF THIS STUDY ARE TO COMPLETE THE VALIDATION WORK AND PROTOCOL DEVELOPMENT NEEDED TO SUBMIT AN INVESTIGATIONAL DEVICE EXEMPTION (IDE) TO THE FDA FOR THE COLLASLING AND, ONCE THE IDE IS APPROVED, TO INITIATE AND COMPLETE A 20-PARTICIPANT PHASE I SAFETY PILOT CLINICAL STUDY. THE PILOT STUDY WILL BE CONDUCTED AT THREE HOSPITAL CENTERS: DUKE UNIVERSITY HOSPITAL, CLEVELAND CLINIC, AND METROHEALTH. WOMEN WITH SUI WHO VOLUNTEER FOR THE STUDY WILL BE IMPLANTED WITH COLLASLINGS USING STANDARD SURGICAL TECHNIQUES AND FOLLOWED CAREFULLY. AN INTERIM SAFETY ANALYSIS BASED ON ADVERSE EVENT RATES WILL BE CONDUCTED AT 3-MONTHS POST-SURGERY, AND ALL PARTICIPANTS WILL BE FOLLOWED FOR A MINIMUM OF ONE YEAR TO ASSESS COLLASLING SAFETY AND EFFICACY BY COMPARING OBJECTIVE MEASURES OF CONTINENCE AND PATIENT-REPORTED OUTCOMES TO PREVIOUS STUDIES ON SUI SLINGS. SUCCESSFUL COMPLETION OF THIS PILOT, FIRST-IN-HUMAN TRIAL OF THE COLLASLING WILL ALLOW THE PROJECT TO MOVE FORWARD TO A PHASE II PIVOTAL RANDOMIZED CONTROLLED TRIAL TO ASSESS ITS EFFICACY COMPARED TO THE CURRENT STANDARD OF CARE.
$1.0m
5/28/24
Not listed
COLLAGEN-BASED TISSUE GUIDANCE BIOFABRIC FOR TREATMENT OF STRESS URINARY INCONTINENCE - INNOVATION IN APPROACHES FOR SOFT TISSUE REPAIR AND SUPPORT INVOLVING CONNECTIVE TISSUE LAXITY ARE NEEDED FOR MANY CLINICAL APPLICATIONS. THESE INCLUDE DEVELOPING IMPROVED TREATMENTS FOR FEMALE PELVIC FLOOR DISORDERS, AB- DOMINAL SURGICAL REPAIR (HERNIA), ORTHOPEDIC APPLICATIONS FOR TENDON AND LIGAMENT REPAIRS. SOME OF THESE DISORDERS, SUCH AS STRESS URINARY INCONTINENCE (SUI) IN WOMEN, PELVIC ORGAN PROLAPSE (POP) AND HERNIA REPAIR, ARE TREATED BY USING SYNTHETICS SUCH AS POLYPROPYLENE MESH AS THE STANDARD OF CARE. NONETHELESS THERE IS A HIGH REPORTED INCIDENCE OF COMPLICATIONS RELATING TO THE IMPLANTATION OF POLYPROPYLENE MESH IN PELVIC FLOOR DISORDERS. OTHER BIOMATERIALS, SUCH AS DECELLULARIZED ALLOGRAFTS OR XENOGRAFTS, LACK POROSITY TO ACCOMMODATE TISSUE INTEGRATION; THUS, THEIR PHYSICAL PROPERTIES DIMINISH OVER TIME, RESULTING IN FUNCTIONAL FAILURE. THERE IS, THEREFORE, A STRONG CLINICAL NEED TO DEVELOP INNOVATIVE SOFT-TISSUE REPAIR AND SUPPORT PRODUCTS TO TREAT THESE LIFE-ALTERING CONDITIONS IN WOMEN AND SUCH PRODUCTS WOULD ALSO IMPACT HERNIA, ORTHOPEDIC REPAIRS, AND OTHER FIELDS AS WELL. COLLAMEDIX IS DEVELOPING NEW IMPLANTABLE MEDICAL DEVICES BASED ON PURE COLLAGEN THREADS FORMED BY A NOVEL, PATENTED ELECTROCHEMICAL COMPACTION PROCESS. MEDICAL-GRADE SOLUBILIZED BOVINE TYPE I COLLAGEN IS ELECTROCOMPACTED INTO THREADS THAT ARE AMONG THE MOST DENSE AND STRONGEST FORMS OF RECONSTITUTED COLLAGEN. THEREFORE, THESE THREADS CAN BE WOVEN OR FILAMENT-WOUND INTO COMPLEX SHAPES TO MAKE A BIOFABRIC (COLLAFABRIC™) TO FORM A WIDE VARIETY OF BIOABSORBABLE IMPLANTS THAT HAVE AMPLE POROSITY FOR TISSUE INGROWTH AND RAPID INTEGRATION. COLLAFABRIC PRODUCES A NEW TISSUE GROWTH RESPONSE IN THE BODY WHILE IT IS BEING BROKEN DOWN; THUS, IT PERFORMS BETTER THAN SYNTHETIC PLASTIC IMPLANTS, WHILE AVOIDING NEGATIVE SIDE EFFECTS, INCLUDING EXTRUSION, EROSION, AND CHRONIC INFLAMMATION. COLLAMEDIX AND CO-INVENTORS AT CASE WESTERN RESERVE UNIVERSITY HAVE CONDUCTED EXTENSIVE PRELIMINARY BIOCOMPATIBILITY STUDIES ON COLLAFABRIC IN RATS, RABBITS, AND RECENTLY ON SHEEP, THAT SHOWED EXCELLENT TISSUE INTEGRATION AND STRENGTH EVEN AT 6 MONTHS. THE FIRST FAMILY OF PRODUCTS PRODUCED FROM COLLAFABRIC WILL BE FOR THE TREATMENT OF SUI AND POP IN WOMEN, FOLLOWED BY PRODUCTS FOR OTHER APPLICATIONS. THE AIM OF THIS PROJECT IS TO COMPLETE THE DEVELOPMENT OF A SUI TREATMENT FOR WOMEN BASED ON COLLAFABRIC. THE PROPOSED ACTIVITIES AND DATA COLLECTION ARE BASED ON DIRECT FEEDBACK FROM FDA. THE DESIGN OF EXISTING COLLAFABRIC PROTOTYPES WILL BE OPTIMIZED AND THE DESIGN FROZEN. THE DESIGN WILL THEN BE VERIFIED AND VALIDATED, INCLUDING PACKAGING VALIDATION, STERILIZATION VALIDATION, BIOCOMPATIBILITY TESTING, AND IN VIVO IMPLANT TESTING, WITH COMPARISON TO AN EXISTING PREDICATE, IN A 6-MONTH SHEEP STUDY. THE END RESULT OF THIS WORK WILL BE AN FDA 510(K) APPLICATION.
$0
3/13/23
Not listed
COLLAGEN-BASED TISSUE GUIDANCE BIOFABRIC FOR TREATMENT OF STRESS URINARY INCONTINENCE - INNOVATION IN APPROACHES FOR SOFT TISSUE REPAIR AND SUPPORT INVOLVING CONNECTIVE TISSUE LAXITY ARE NEEDED FOR MANY CLINICAL APPLICATIONS. THESE INCLUDE DEVELOPING IMPROVED TREATMENTS FOR FEMALE PELVIC FLOOR DISORDERS, AB- DOMINAL SURGICAL REPAIR (HERNIA), ORTHOPEDIC APPLICATIONS FOR TENDON AND LIGAMENT REPAIRS. SOME OF THESE DISORDERS, SUCH AS STRESS URINARY INCONTINENCE (SUI) IN WOMEN, PELVIC ORGAN PROLAPSE (POP) AND HERNIA REPAIR, ARE TREATED BY USING SYNTHETICS SUCH AS POLYPROPYLENE MESH AS THE STANDARD OF CARE. NONETHELESS THERE IS A HIGH REPORTED INCIDENCE OF COMPLICATIONS RELATING TO THE IMPLANTATION OF POLYPROPYLENE MESH IN PELVIC FLOOR DISORDERS. OTHER BIOMATERIALS, SUCH AS DECELLULARIZED ALLOGRAFTS OR XENOGRAFTS, LACK POROSITY TO ACCOMMODATE TISSUE INTEGRATION; THUS, THEIR PHYSICAL PROPERTIES DIMINISH OVER TIME, RESULTING IN FUNCTIONAL FAILURE. THERE IS, THEREFORE, A STRONG CLINICAL NEED TO DEVELOP INNOVATIVE SOFT-TISSUE REPAIR AND SUPPORT PRODUCTS TO TREAT THESE LIFE-ALTERING CONDITIONS IN WOMEN AND SUCH PRODUCTS WOULD ALSO IMPACT HERNIA, ORTHOPEDIC REPAIRS, AND OTHER FIELDS AS WELL. COLLAMEDIX IS DEVELOPING NEW IMPLANTABLE MEDICAL DEVICES BASED ON PURE COLLAGEN THREADS FORMED BY A NOVEL, PATENTED ELECTROCHEMICAL COMPACTION PROCESS. MEDICAL-GRADE SOLUBILIZED BOVINE TYPE I COLLAGEN IS ELECTROCOMPACTED INTO THREADS THAT ARE AMONG THE MOST DENSE AND STRONGEST FORMS OF RECONSTITUTED COLLAGEN. THEREFORE, THESE THREADS CAN BE WOVEN OR FILAMENT-WOUND INTO COMPLEX SHAPES TO MAKE A BIOFABRIC (COLLAFABRIC™) TO FORM A WIDE VARIETY OF BIOABSORBABLE IMPLANTS THAT HAVE AMPLE POROSITY FOR TISSUE INGROWTH AND RAPID INTEGRATION. COLLAFABRIC PRODUCES A NEW TISSUE GROWTH RESPONSE IN THE BODY WHILE IT IS BEING BROKEN DOWN; THUS, IT PERFORMS BETTER THAN SYNTHETIC PLASTIC IMPLANTS, WHILE AVOIDING NEGATIVE SIDE EFFECTS, INCLUDING EXTRUSION, EROSION, AND CHRONIC INFLAMMATION. COLLAMEDIX AND CO-INVENTORS AT CASE WESTERN RESERVE UNIVERSITY HAVE CONDUCTED EXTENSIVE PRELIMINARY BIOCOMPATIBILITY STUDIES ON COLLAFABRIC IN RATS, RABBITS, AND RECENTLY ON SHEEP, THAT SHOWED EXCELLENT TISSUE INTEGRATION AND STRENGTH EVEN AT 6 MONTHS. THE FIRST FAMILY OF PRODUCTS PRODUCED FROM COLLAFABRIC WILL BE FOR THE TREATMENT OF SUI AND POP IN WOMEN, FOLLOWED BY PRODUCTS FOR OTHER APPLICATIONS. THE AIM OF THIS PROJECT IS TO COMPLETE THE DEVELOPMENT OF A SUI TREATMENT FOR WOMEN BASED ON COLLAFABRIC. THE PROPOSED ACTIVITIES AND DATA COLLECTION ARE BASED ON DIRECT FEEDBACK FROM FDA. THE DESIGN OF EXISTING COLLAFABRIC PROTOTYPES WILL BE OPTIMIZED AND THE DESIGN FROZEN. THE DESIGN WILL THEN BE VERIFIED AND VALIDATED, INCLUDING PACKAGING VALIDATION, STERILIZATION VALIDATION, BIOCOMPATIBILITY TESTING, AND IN VIVO IMPLANT TESTING, WITH COMPARISON TO AN EXISTING PREDICATE, IN A 6-MONTH SHEEP STUDY. THE END RESULT OF THIS WORK WILL BE AN FDA 510(K) APPLICATION.
$0
3/13/23
Not listed
COLLAGEN-BASED TISSUE GUIDANCE BIOFABRIC FOR TREATMENT OF STRESS URINARY INCONTINENCE - INNOVATION IN APPROACHES FOR SOFT TISSUE REPAIR AND SUPPORT INVOLVING CONNECTIVE TISSUE LAXITY ARE NEEDED FOR MANY CLINICAL APPLICATIONS. THESE INCLUDE DEVELOPING IMPROVED TREATMENTS FOR FEMALE PELVIC FLOOR DISORDERS, AB- DOMINAL SURGICAL REPAIR (HERNIA), ORTHOPEDIC APPLICATIONS FOR TENDON AND LIGAMENT REPAIRS. SOME OF THESE DISORDERS, SUCH AS STRESS URINARY INCONTINENCE (SUI) IN WOMEN, PELVIC ORGAN PROLAPSE (POP) AND HERNIA REPAIR, ARE TREATED BY USING SYNTHETICS SUCH AS POLYPROPYLENE MESH AS THE STANDARD OF CARE. NONETHELESS THERE IS A HIGH REPORTED INCIDENCE OF COMPLICATIONS RELATING TO THE IMPLANTATION OF POLYPROPYLENE MESH IN PELVIC FLOOR DISORDERS. OTHER BIOMATERIALS, SUCH AS DECELLULARIZED ALLOGRAFTS OR XENOGRAFTS, LACK POROSITY TO ACCOMMODATE TISSUE INTEGRATION; THUS, THEIR PHYSICAL PROPERTIES DIMINISH OVER TIME, RESULTING IN FUNCTIONAL FAILURE. THERE IS, THEREFORE, A STRONG CLINICAL NEED TO DEVELOP INNOVATIVE SOFT-TISSUE REPAIR AND SUPPORT PRODUCTS TO TREAT THESE LIFE-ALTERING CONDITIONS IN WOMEN AND SUCH PRODUCTS WOULD ALSO IMPACT HERNIA, ORTHOPEDIC REPAIRS, AND OTHER FIELDS AS WELL. COLLAMEDIX IS DEVELOPING NEW IMPLANTABLE MEDICAL DEVICES BASED ON PURE COLLAGEN THREADS FORMED BY A NOVEL, PATENTED ELECTROCHEMICAL COMPACTION PROCESS. MEDICAL-GRADE SOLUBILIZED BOVINE TYPE I COLLAGEN IS ELECTROCOMPACTED INTO THREADS THAT ARE AMONG THE MOST DENSE AND STRONGEST FORMS OF RECONSTITUTED COLLAGEN. THEREFORE, THESE THREADS CAN BE WOVEN OR FILAMENT-WOUND INTO COMPLEX SHAPES TO MAKE A BIOFABRIC (COLLAFABRIC™) TO FORM A WIDE VARIETY OF BIOABSORBABLE IMPLANTS THAT HAVE AMPLE POROSITY FOR TISSUE INGROWTH AND RAPID INTEGRATION. COLLAFABRIC PRODUCES A NEW TISSUE GROWTH RESPONSE IN THE BODY WHILE IT IS BEING BROKEN DOWN; THUS, IT PERFORMS BETTER THAN SYNTHETIC PLASTIC IMPLANTS, WHILE AVOIDING NEGATIVE SIDE EFFECTS, INCLUDING EXTRUSION, EROSION, AND CHRONIC INFLAMMATION. COLLAMEDIX AND CO-INVENTORS AT CASE WESTERN RESERVE UNIVERSITY HAVE CONDUCTED EXTENSIVE PRELIMINARY BIOCOMPATIBILITY STUDIES ON COLLAFABRIC IN RATS, RABBITS, AND RECENTLY ON SHEEP, THAT SHOWED EXCELLENT TISSUE INTEGRATION AND STRENGTH EVEN AT 6 MONTHS. THE FIRST FAMILY OF PRODUCTS PRODUCED FROM COLLAFABRIC WILL BE FOR THE TREATMENT OF SUI AND POP IN WOMEN, FOLLOWED BY PRODUCTS FOR OTHER APPLICATIONS. THE AIM OF THIS PROJECT IS TO COMPLETE THE DEVELOPMENT OF A SUI TREATMENT FOR WOMEN BASED ON COLLAFABRIC. THE PROPOSED ACTIVITIES AND DATA COLLECTION ARE BASED ON DIRECT FEEDBACK FROM FDA. THE DESIGN OF EXISTING COLLAFABRIC PROTOTYPES WILL BE OPTIMIZED AND THE DESIGN FROZEN. THE DESIGN WILL THEN BE VERIFIED AND VALIDATED, INCLUDING PACKAGING VALIDATION, STERILIZATION VALIDATION, BIOCOMPATIBILITY TESTING, AND IN VIVO IMPLANT TESTING, WITH COMPARISON TO AN EXISTING PREDICATE, IN A 6-MONTH SHEEP STUDY. THE END RESULT OF THIS WORK WILL BE AN FDA 510(K) APPLICATION.
$1.3m
3/16/21
Not listed
COLLAGEN-BASED TISSUE GUIDANCE BIOFABRIC FOR TREATMENT OF STRESS URINARY INCONTINENCE - INNOVATION IN APPROACHES FOR SOFT TISSUE REPAIR AND SUPPORT INVOLVING CONNECTIVE TISSUE LAXITY ARE NEEDED FOR MANY CLINICAL APPLICATIONS. THESE INCLUDE DEVELOPING IMPROVED TREATMENTS FOR FEMALE PELVIC FLOOR DISORDERS, AB- DOMINAL SURGICAL REPAIR (HERNIA), ORTHOPEDIC APPLICATIONS FOR TENDON AND LIGAMENT REPAIRS. SOME OF THESE DISORDERS, SUCH AS STRESS URINARY INCONTINENCE (SUI) IN WOMEN, PELVIC ORGAN PROLAPSE (POP) AND HERNIA REPAIR, ARE TREATED BY USING SYNTHETICS SUCH AS POLYPROPYLENE MESH AS THE STANDARD OF CARE. NONETHELESS THERE IS A HIGH REPORTED INCIDENCE OF COMPLICATIONS RELATING TO THE IMPLANTATION OF POLYPROPYLENE MESH IN PELVIC FLOOR DISORDERS. OTHER BIOMATERIALS, SUCH AS DECELLULARIZED ALLOGRAFTS OR XENOGRAFTS, LACK POROSITY TO ACCOMMODATE TISSUE INTEGRATION; THUS, THEIR PHYSICAL PROPERTIES DIMINISH OVER TIME, RESULTING IN FUNCTIONAL FAILURE. THERE IS, THEREFORE, A STRONG CLINICAL NEED TO DEVELOP INNOVATIVE SOFT-TISSUE REPAIR AND SUPPORT PRODUCTS TO TREAT THESE LIFE-ALTERING CONDITIONS IN WOMEN AND SUCH PRODUCTS WOULD ALSO IMPACT HERNIA, ORTHOPEDIC REPAIRS, AND OTHER FIELDS AS WELL. COLLAMEDIX IS DEVELOPING NEW IMPLANTABLE MEDICAL DEVICES BASED ON PURE COLLAGEN THREADS FORMED BY A NOVEL, PATENTED ELECTROCHEMICAL COMPACTION PROCESS. MEDICAL-GRADE SOLUBILIZED BOVINE TYPE I COLLAGEN IS ELECTROCOMPACTED INTO THREADS THAT ARE AMONG THE MOST DENSE AND STRONGEST FORMS OF RECONSTITUTED COLLAGEN. THEREFORE, THESE THREADS CAN BE WOVEN OR FILAMENT-WOUND INTO COMPLEX SHAPES TO MAKE A BIOFABRIC (COLLAFABRIC™) TO FORM A WIDE VARIETY OF BIOABSORBABLE IMPLANTS THAT HAVE AMPLE POROSITY FOR TISSUE INGROWTH AND RAPID INTEGRATION. COLLAFABRIC PRODUCES A NEW TISSUE GROWTH RESPONSE IN THE BODY WHILE IT IS BEING BROKEN DOWN; THUS, IT PERFORMS BETTER THAN SYNTHETIC PLASTIC IMPLANTS, WHILE AVOIDING NEGATIVE SIDE EFFECTS, INCLUDING EXTRUSION, EROSION, AND CHRONIC INFLAMMATION. COLLAMEDIX AND CO-INVENTORS AT CASE WESTERN RESERVE UNIVERSITY HAVE CONDUCTED EXTENSIVE PRELIMINARY BIOCOMPATIBILITY STUDIES ON COLLAFABRIC IN RATS, RABBITS, AND RECENTLY ON SHEEP, THAT SHOWED EXCELLENT TISSUE INTEGRATION AND STRENGTH EVEN AT 6 MONTHS. THE FIRST FAMILY OF PRODUCTS PRODUCED FROM COLLAFABRIC WILL BE FOR THE TREATMENT OF SUI AND POP IN WOMEN, FOLLOWED BY PRODUCTS FOR OTHER APPLICATIONS. THE AIM OF THIS PROJECT IS TO COMPLETE THE DEVELOPMENT OF A SUI TREATMENT FOR WOMEN BASED ON COLLAFABRIC. THE PROPOSED ACTIVITIES AND DATA COLLECTION ARE BASED ON DIRECT FEEDBACK FROM FDA. THE DESIGN OF EXISTING COLLAFABRIC PROTOTYPES WILL BE OPTIMIZED AND THE DESIGN FROZEN. THE DESIGN WILL THEN BE VERIFIED AND VALIDATED, INCLUDING PACKAGING VALIDATION, STERILIZATION VALIDATION, BIOCOMPATIBILITY TESTING, AND IN VIVO IMPLANT TESTING, WITH COMPARISON TO AN EXISTING PREDICATE, IN A 6-MONTH SHEEP STUDY. THE END RESULT OF THIS WORK WILL BE AN FDA 510(K) APPLICATION.
$1.3m
3/16/21