FESARIUSTHERAPEUTICS INC.

www.fesariustherapeutics.com

http://www.fesariustherapeutics.com

703-489-0703

tom.roueche@fesariustherapeutics.com

TOM ROUECHE

P1950320

7EV34

Active

U.S./Canada Manufacturer

2024-10-17

2029-10-17

2025-10-09

TOM ROUECHE

+1 703-489-0703

2024-08-20

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Department of Health and Human Services

AN ADVANCED DERMAL REGENERATION SCAFFOLD FOR SKIN LOSS DUE TO BURN WOUNDS - ABSTRACT THE GOLD STANDARD TREATMENT FOR LARGE FULL THICKNESS SKIN LOSS (FTSL) DUE TO BURNS INVOLVES AUTOLOGOUS TISSUE TRANSFER IN WHICH THE PATIENT SERVES AS THEIR OWN DONOR. HOWEVER, SUCH TREATMENT MAY BE CHALLENGING DUE TO LIMITED AVAILABILITY OF FULL THICKNESS SKIN DONOR SITES; THUS MOST OF THESE WOUNDS ARE CLOSED USING SPLIT THICKNESS SKIN GRAFTS (STSG), WHICH CONTAIN ONLY A FRACTION OF THE NATIVE DERMAL THICKNESS, LEADING TO SUBOPTIMAL FUNCTIONAL OUTCOMES. DERMAL REPLACEMENT SCAFFOLDS (DRS) AIM TO RECREATE DERMIS, THEREBY RESTORING NORMAL SKIN ANATOMY. THESE CELL-FREE PRODUCTS SERVE AS A SCAFFOLD FOR THE INFILTRATION OF CELLS FROM THE WOUND BED THAT ORGANIZE TO A FUNCTIONAL, VASCULARIZED NEODERMIS TISSUE, ABLE TO SUPPORT A STSG. THE CRITICAL BARRIER TO PROGRESS IN THIS FIELD IS TO CREATE A SCAFFOLD THAT 1) PROMOTES RAPID CELLULAR INFILTRATION AND ANGIOGENESIS REQUIRED FOR NEODERMIS FORMATION IN FULL THICKNESS WOUNDS, AND 2) INCREASES THE EFFICIENCY AND QUALITY OF HEALING IN ACUTE LARGE BURNS. TO ADDRESS THIS SIGNIFICANT CLINICAL GAP, FESARIUS THERAPEUTICS, INC. HAS DEVELOPED DERMISPHERE™, AN INNOVATIVE DRS PRODUCT THAT WILL REGENERATE DERMIS IN FULL THICKNESS SKIN LOSS WOUNDS SIGNIFICANTLY AND MEANINGFULLY FASTER (≤7 DAYS) THAN THE REGENERATION ACHIEVED USING THE MARKET-LEADING DRS PRODUCT, INTEGRA® (14-28 DAYS). OUR CUSTOMER INTERVIEW PROCESS HAS REVEALED ADDITIONAL REQUIREMENTS FROM A DRS THAT ARE CURRENTLY UNMET/PARTIALLY MET: (1) ABILITY TO CLOSE THE WOUND IN A SINGLE PROCEDURE (2) ABILITY TO TEMPORIZE THE WOUND, (3) ABILITY TO CLOSE DIFFICULT TO HEAL WOUNDS. OUR PRELIMINARY DATA HAVE DEMONSTRATED IN A SWINE MODEL OF FTSL THAT DERMISPHERE, UNLIKE ANY OTHER COMMERCIALLY AVAILABLE DRS, SUCCESSFULLY SUPPORTS COMPLETE STSG TAKE WHEN THE TWO COMPONENTS ARE APPLIED SIMULTANEOUSLY. IN ADDITION, A SMALL ANIMAL MODEL OF FTSL SHOWED THAT DERMISPHERE SUPPORTED RAPID AND SUSTAINED LATERAL AS WELL AS VERTICAL CELL INVASION, RESULTING IN SUCCESSFUL STSG “TAKE” IN CHALLENGING CASES OF WOUND BEDS WITH AVASCULAR PORTIONS. A REMAINING CHALLENGE IN ACUTE BURN WOUNDS, UNLIKE OTHER CAUSES OF FTSL, IS THAT SIMULTANEOUS GRAFTING IS OFTEN NOT FEASIBLE. ADDING A PROTECTIVE LAYER THAT CAN BE REMOVED WHEN IT IS CLINICALLY FEASIBLE TO PERFORM THE GRAFT, DAYS TO WEEKS LATER, WILL SIGNIFICANTLY IMPROVE THE CLINICAL UTILITY OF DERMISPHERE AND IMPROVE WOUND HEALING. ONCE DERMIS HAS REGENERATED IT CAN BE COVERED WITH A THIN SKIN AUTOGRAFT, YIELDING SKIN THAT IS MORE FLEXIBLE, FUNCTIONAL, RESILIENT AND AESTHETICALLY SUPERIOR THAN WOUNDS HEALED WITH INTEGRA OR STSG ALONE. GIVEN THE SUCCESSFUL COMPLETION OF THESE PRELIMINARY STUDIES, DERMISPHERE IS NOW PRIMED TO EXPAND ITS INDICATION INTO CHALLENGING FULL THICKNESS WOUNDS SUCH AS BURNS TO EXPAND THE SCOPE OF PRODUCT USE. THE OVERALL GOAL OF THIS SBIR PHASE I PROPOSAL IS TO DEMONSTRATE FEASIBILITY OF DERMISPHERE AS A DEVICE FOR THE MANAGEMENT OF ACUTE MAJOR BURN WOUNDS. THE DATA GENERATED IN THESE STUDIES WILL DIRECTLY INFORM PHASE II DEVELOPMENT WORK INCLUDING CONDUCTING POWERED ANIMAL EFFICACY STUDIES. THE RESULTING COMMERCIALIZATION WILL SIGNIFICANTLY IMPROVE CLINICAL OUTCOMES, DECREASE THE NUMBER OF RECONSTRUCTIVE PROCEDURES NECESSARY, AND REDUCE PATIENT SUFFERING AND COSTS.

349345.00

0.00

0.00

2023-08-04

View on USAspending

Department of Health and Human Services

AN ADVANCED DERMAL REGENERATION SCAFFOLD FOR RECONSTRUCTIVE SURGERY - PROJECT SUMMARY/ABSTRACT DUE TO THE INABILITY OF THE DERMIS TO REGENERATE ON ITS OWN, LARGE FULL THICKNESS SKIN LOSS CANNOT BE RESTORED NATURALLY. THE CURRENT GOLD STANDARD TREATMENT INVOLVES AUTOLOGOUS TISSUE TRANSFER IN WHICH THE PATIENT SERVES AS THEIR OWN DONOR, WHICH MAY BE CHALLENGING DUE TO LIMITED AVAILABILITY OF FULL THICKNESS SKIN DONOR SITES AND DONOR- SITE MORBIDITY. DERMAL REPLACEMENT SCAFFOLDS (DRS) AIM TO RECREATE DERMIS, THEREBY PREVENTING WOUND CONTRACTION. HOWEVER, BECAUSE CURRENTLY AVAILABLE DRS LACK UNIQUE CUES TO GUIDE CELL INFILTRATION, THEY MAY FAIL TO VASCULARIZE SUFFICIENTLY. THE CRITICAL BARRIER TO PROGRESS IN THIS FIELD IS TO CREATE A SCAFFOLD THAT 1) PROMOTES RAPID CELLULAR INFILTRATION AND ANGIOGENESIS AS REQUIRED FOR NEODERMAL FORMATION IN FULL THICKNESS WOUNDS, AND 2) INCREASES THE INCIDENCE AND QUALITY OF HEALING IN BOTH TYPICAL/HEALTHY WOUNDS AND DIFFICULT TO HEAL SITES. TO ADDRESS THIS SIGNIFICANT CLINICAL GAP, FESARIUS THERAPEUTICS, INC. IS DEVELOPING DERMISPHERE™, AN INNOVATIVE DRS PRODUCT THAT WILL REGENERATE DERMIS IN FULL THICKNESS SKIN LOSS WOUNDS MUCH FASTER (=7 DAYS, I.E. >75% FASTER) THAN THE REGENERATION ACHIEVED USING THE MARKET-LEADING DRS PRODUCT, INTEGRA®. ONCE DERMIS HAS REGENERATED IT CAN BE COVERED WITH A THIN EPIDERMAL SKIN AUTOGRAFT, YIELDING SKIN THAT IS MORE FLEXIBLE, FUNCTIONAL, AND RESILIENT THAN WOUNDS HEALED WITH SPLIT THICKNESS SKIN GRAFTS ALONE. THE COMMERCIALIZATION OF DERMISPHERETM IS EXPECTED TO IMPROVE CLINICAL PRACTICE IN THE SURGICAL FIELDS WHERE FULL THICKNESS SKIN LOSS IS COMMON INCLUDING, BUT NOT LIMITED TO, TRAUMA, BURNS, INFECTION AND POST ONCOLOGIC RECONSTRUCTIVE SURGERY, BY SIGNIFICANTLY DECREASING THE TIME REQUIRED TO ACHIEVE A HEALED WOUND IN A SCENARIO OF LARGE FULL THICKNESS SKIN LOSS, WHICH WILL DIRECTLY RESULT IN DECREASED PATIENT SUFFERING AS WELL AS LOWER EXPENDITURE OF VALUABLE HEALTH CARE RESOURCES. OUR PRELIMINARY DATA SUGGESTS THAT THE CURRENT DERMISPHERE™ FORMULATION WILL SUPPORT ALL THESE UNMET CLINICAL SCENARIOS. WE HAVE DEMONSTRATED IN A SWINE MODEL OF FULL THICKNESS SKIN LOSS THAT DERMISPHERE™ SUCCESSFULLY SUPPORTS COMPLETE SPLIT THICKNESS SKIN GRAFT (STSG) TAKE WHEN THE TWO COMPONENTS ARE APPLIED SIMULTANEOUSLY. IN ADDITION, A SMALL ANIMAL MODEL OF FULL THICKNESS SKIN LOSS SHOWED THAT DERMISPHERE™ SUPPORTED RAPID AND SUSTAINED LATERAL AS WELL AS VERTICAL CELL INVASION, RESULTING IN SUCCESSFUL STSG “TAKE” IN CHALLENGING CASES OF WOUND BEDS WITH AVASCULAR PORTIONS AND WAS ABLE TO REVASCULARIZE TEMPLATES UP TO 3MM THICK. WE HAVE RECENTLY BROUGHT THE DERMISPHERE™ DERMAL REGENERATIVE TEMPLATE FORMULATION TO DESIGN FREEZE USING A CGMP-MATERIAL BASED FORMULATION THAT IS TERMINALLY STERILIZED AND ARE FAST PROGRESSING IN OUR TECHNOLOGY TRANSFER TO A CONTRACT MANUFACTURING ORGANIZATION. THE OVERALL OBJECTIVE OF THIS DIRECT TO PHASE II SBIR IS TO COMPLETE A POWERED, CLINICALLY RELEVANT LARGE ANIMAL STUDY (AIM 1), SCREEN THE DERMISPHERE™ PRODUCT IN CHALLENGING WOUNDS (AIM 2), PERFORM BIOCOMPATIBILITY TESTING (AIM 3), AND PERFORM USER VALIDATION STUDIES (AIM 4). COMPLETION OF THESE AIMS WILL RESULT IN THE ADVANCEMENT OF DERMISPHERE™ TECHNOLOGY TOWARDS 510(K) APPROVAL AND FIRST IN HUMAN STUDIES.

1887448.00

0.00

0.00

2020-04-19

View on USAspending

Small Business Administration

ECONOMIC INJURY DISASTER GRANT

6000.00

0.00

0.00

2020-09-09

View on USAspending

Department of Health and Human Services

DERMISPHERE????????????: AN ADVANCED DERMAL REGENERATION SCAFFOLD FOR RECONSTRUCTIVE SURGERY, PHASE II

1679149.00

0.00

0.00

2023-08-15

View on USAspending

Department of Health and Human Services

DERMISPHERE?: AN ADVANCED DERMAL REGENERATION SCAFFOLD FOR RECONSTRUCTIVE SURGERY, CRP - PROJECT SUMMARY/ABSTRACT DUE TO THE INABILITY OF THE DERMIS TO REGENERATE ON ITS OWN, LARGE FULL THICKNESS SKIN LOSS CANNOT BE RESTORED NATURALLY. THE CURRENT GOLD STANDARD TREATMENT INVOLVES AUTOLOGOUS TISSUE TRANSFER IN WHICH THE PATIENT SERVES AS THEIR OWN DONOR, WHICH MAY BE CHALLENGING DUE TO LIMITED AVAILABILITY OF FULL THICKNESS SKIN DONOR SITES AND DONOR- SITE MORBIDITY. DERMAL REPLACEMENT SCAFFOLDS (DRS) AIM TO RECREATE DERMIS, THEREBY PREVENTING WOUND CONTRACTION. BEING CELL-FREE PRODUCTS, THESE SERVE AS A SCAFFOLD FOR THE INFILTRATION OF CELLS FROM THE WOUND BED THAT ORGANIZE TO A FUNCTIONAL, VASCULARIZED NEODERMIS TISSUE, ABLE TO SUPPORT A SKIN GRAFT WHICH IS IMPLANTED AS A SECOND STEP PROCEDURE, RESULTING IN A HEALED WOUND WITH NORMAL SKIN DERMAL/EPIDERMAL ARCHITECTURE. HOWEVER, BECAUSE CURRENTLY AVAILABLE DRS LACK UNIQUE CUES TO GUIDE SUCH CELL INFILTRATION, THEY MAY FAIL TO VASCULARIZE SUFFICIENTLY. THE CRITICAL BARRIER TO PROGRESS IN THIS FIELD IS TO CREATE A SCAFFOLD THAT 1) PROMOTES RAPID CELLULAR INFILTRATION AND ANGIOGENESIS AS REQUIRED FOR NEODERMAL FORMATION IN FULL THICKNESS WOUNDS, AND 2) INCREASES THE INCIDENCE AND QUALITY OF HEALING IN BOTH TYPICAL/HEALTHY WOUNDS AND DIFFICULT TO HEAL SITES. TO ADDRESS THIS SIGNIFICANT CLINICAL GAP, FESARIUS THERAPEUTICS, INC. IS DEVELOPING DERMISPHERE™, AN INNOVATIVE DRS PRODUCT THAT WILL REGENERATE DERMIS IN FULL THICKNESS SKIN LOSS WOUNDS MUCH FASTER (=7 DAYS, I.E. >75% FASTER) THAN THE REGENERATION ACHIEVED USING THE MARKET-LEADING DRS PRODUCT, INTEGRA®. ONCE DERMIS HAS REGENERATED IT CAN BE COVERED WITH A THIN EPIDERMAL SKIN AUTOGRAFT, YIELDING SKIN THAT IS MORE FLEXIBLE, FUNCTIONAL, AND RESILIENT THAN WOUNDS HEALED WITH SPLIT THICKNESS SKIN GRAFTS ALONE. THE COMMERCIALIZATION OF DERMISPHERETM IS EXPECTED TO IMPROVE CLINICAL PRACTICE IN THE SURGICAL FIELDS WHERE FULL THICKNESS SKIN LOSS IS COMMON INCLUDING, BUT NOT LIMITED TO, TRAUMA, BURNS, INFECTION AND POST ONCOLOGIC RECONSTRUCTIVE SURGERY, BY SIGNIFICANTLY DECREASING THE TIME REQUIRED TO ACHIEVE A HEALED WOUND IN A SCENARIO OF LARGE FULL THICKNESS SKIN LOSS, WHICH WILL DIRECTLY RESULT IN DECREASED PATIENT SUFFERING AS WELL AS LOWER EXPENDITURE OF VALUABLE HEALTH CARE RESOURCES. THE OBJECTIVE OF THIS COMMERCIAL READINESS PILOT (CRP) IS TO COMPLETE LATE-STAGE DEVELOPMENT AND ENABLE FESARIUS TO ACHIEVE 510(K) CLEARANCE. DEVELOPMENT OF SCALED MANUFACTURING CAPABILITIES OF THE DERMISPHERETM PRODUCT REPRESENTS ONE OF THE MOST IMPORTANT OBSTACLES THAT MUST BE SURMOUNTED IN ORDER TO ACHIEVE BROAD-SCALE CLINICAL IMPACT OF THIS PROMISING TECHNOLOGY. THE SPECIFIC AIMS FOR THIS PROPOSED PROJECT ARE TO (1) ESTABLISH AND VALIDATE A CGMP-COMPATIBLE MANUFACTURING PROCESS WHICH WILL PREPARE THE DERMISPHERETM PRODUCT FOR COMMERCIAL RELEASE (2) DESIGN AND VALIDATE PACKAGING AND VALIDATE STERILIZATION OF THE DERMISPHERETM PRODUCT; (3) COMPLETE REAL-TIME AND ACCELERATED STABILITY VALIDATION FOR DERMISPHERETM AND ITS BARRIER PACKAGING; AND (4) SUBMIT THE 510(K) APPLICATION AND OBTAIN CLEARANCE FROM THE FDA.

796397.00

0.00

0.00

2020-05-01

Paid in Full

100

63767

63767

Unanswered

Unknown/NotStated

Unanswered

Unanswered

64496.07