NexoBrid^® Clinical Efficacy

The safety and efficacy of NexoBrid were evaluated in three clinical studies.¹

93% of adults treated with NexoBrid achieved ≥95% eschar removal vs 4% with gel vehicle¹

≥95% Eschar Removal with NexoBrid vs Gel Vehicle

Study 1: 93% of subjects treated with NexoBrid achieved ≥95% eschar removal vs 4% with gel vehicle

See Study Design

NexoBrid achieved ≥95% eschar removal 2.8 days sooner than SOC* in adults¹

Median Time to ≥95% Eschar Removal

See Study Design

Only 4% of adults treated with NexoBrid required follow up excision vs 72% with SOC¹*

Incidence of Excision for Eschar Removal

Study 1: NexoBrid resulted in a 98.9% decrease in the probability of excision for eschar removal vs SOC

See Study Design

NexoBrid achieved ≥95% wound closure in 31 days vs 36 days with SOC¹*^||¶

Median Time to ≥95% Wound Closure
(Safety Endpoint)

Study 1: The median time to ≥95% wound closure was 31 days for NexoBrid vs 36 days for SOC

See Study Design

*Standard of care (SOC) included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.

†The statistical test that resulted in this p-value was Fisher’s Exact Test.

‡The statistical test that resulted in this p-value was Wilcoxon-Gehan Test.

§The statistical test that resulted in this p-value was Wald Chi-Square.

||Study 1 used Kaplan-Meier methods to estimate median time to ≥95% wound closure for all target wounds (TWs) on a subject. This was a noninferiority endpoint.

¶Subjects were not evaluated frequently enough after achieving ≥95% wound closure to adequately assess time to 100% wound closure.

Review Study 2:
NexoBrid compared to SOC in adult patients¹

Review the Data

Review Study 3:
NexoBrid compared to SOC in Pediatric Patients¹

Review the Data

Only 15% of DPT wounds in adults treated with NexoBrid required follow up excision vs 63% with SOC¹*

Incidence of Excision for Eschar Removal Performed on DPT Wounds

Study 2: NexoBrid resulted in an 89.7% decrease in the probability of excision for eschar removal vs SOC

See Study Design

NexoBrid resulted in a significant reduction of DPT wound autografts vs SOC (18% with NexoBrid vs 34% with SOC)²*

DPT Wounds Requiring Autografts

Study 2: NexoBrid resulted in an 18% reduction of DPT wound autografts vs 34% with SOC

See Study Design

The mean percent of DPT wound area autografted was significantly lower with NexoBrid vs SOC (8.4 ± 21.3 with NexoBrid vs 21.5 ± 34.8 with SOC)²*

DPT Wound Area Autografted

See Study Design

NexoBrid achieved ≥95% wound closure in 33 days vs 24 days with SOC²*^‡^§

Median Time to ≥95% Wound Closure (Per Subject)

Study 2: NexoBrid achieved ≥95% wound closure in 33 days vs 24 days with SOC

See Study Design

†The statistical test that resulted in this p-value was Logistic Regression Model.

‡Study 2 used Kaplan-Meier methods to estimate median time to ≥95% wound closure in randomized subjects.

§Subjects were not evaluated frequently enough after achieving ≥95% wound closure to adequately assess time to 100% wound closure.

||The statistical test which resulted in this p-value was the log rank test.

¶The statistical test that resulted in this p-value was the Analysis of Covariance (ANCOVA) Model.

Review Study 1:
NexoBrid Compared to SOC and gel vehicle in adult patients

Review the Data

Review Study 3:
NexoBrid compared to SOC in Pediatric Patients¹

Review the Data

NexoBrid achieved ≥95% eschar removal 5 days sooner than SOC in pediatric patients.¹*

Median Time to ≥95% Eschar Removal in Pediatrics

Study 3: Median time to ≥95% eschar removal in pediatric patients was 5 days sooner with NexoBrid vs SOC

See Study Design

Only 8% of pediatric patients treated with NexoBrid^® required follow up excision vs 64% with SOC¹^‡

Incidence of Excision for Exchage Removal in Pediatrics

Study 3: NexoBrid resulted in an 97.5% decrease in the probability of excision for eschar removal vs SOC

See Study Design

NexoBrid achieved ≥95% wound closure in 32 days vs 34 days with SOC¹^†^||

Median Time to ≥95% Wound Closure in Pediatrics
Safety Endpoint

Study 3: In pediatrics, NexoBrid achieved ≥95% wound closure in 32 days vs 34 days with SOC

See Study Design

*Eschar removal was considered ≥95% total debridement per treated wound.

†The statistical test that resulted in this p-value was Wilcoxon-Gehan Test.

‡Standard of care (SOC) included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.

§The statistical test that resulted in this p-value was Logistic Regression Model using a re-randomization test.

||The estimated median time to reach 100% wound closure on a target wound level was 44 days for the NexoBrid arm and 43 days for the SOC arm.

¶Study 3 used Kaplan-Meier methods to estimate median time to ≥95% wound closure in randomized subjects.

Review Study 1:
NexoBrid Compared to SOC and gel vehicle in adult patients

Review the Data

Review Study 2:
NexoBrid compared to SOC in adult patients¹

Review the Data

Cookie Notice

NexoBrid^® Clinical Efficacy

Study 1 (Detect)¹ Adult Three-arm study 3:3:1 Ratio NexoBrid (n=75) vs SOC* (n=75) vs Gel Vehicle (n=25)

Study 2¹ Adult Two-arm study 1:1 Ratio NexoBrid (n=75) vs SOC* (n=81)

Study 3 (CIDS)¹ Pediatric Two-arm study 1:1 Ratio NexoBrid (n=72) vs SOC* (n=73)

93% of adults treated with NexoBrid achieved ≥95% eschar removal vs 4% with gel vehicle¹

NexoBrid achieved ≥95% eschar removal 2.8 days sooner than SOC* in adults¹

Only 4% of adults treated with NexoBrid required follow up excision vs 72% with SOC¹*

NexoBrid achieved ≥95% wound closure in 31 days vs 36 days with SOC¹*^||¶

Review Study 2:
NexoBrid compared to SOC in adult patients¹

Review Study 3:
NexoBrid compared to SOC in Pediatric Patients¹

Only 15% of DPT wounds in adults treated with NexoBrid required follow up excision vs 63% with SOC¹*

NexoBrid resulted in a significant reduction of DPT wound autografts vs SOC (18% with NexoBrid vs 34% with SOC)²*

The mean percent of DPT wound area autografted was significantly lower with NexoBrid vs SOC (8.4 ± 21.3 with NexoBrid vs 21.5 ± 34.8 with SOC)²*

NexoBrid achieved ≥95% wound closure in 33 days vs 24 days with SOC²*^‡^§

Review Study 1:
NexoBrid Compared to SOC and gel vehicle in adult patients

Review Study 3:
NexoBrid compared to SOC in Pediatric Patients¹

NexoBrid achieved ≥95% eschar removal 5 days sooner than SOC in pediatric patients.¹*

Only 8% of pediatric patients treated with NexoBrid^® required follow up excision vs 64% with SOC¹^‡

NexoBrid achieved ≥95% wound closure in 32 days vs 34 days with SOC¹^†^||

Review Study 1:
NexoBrid Compared to SOC and gel vehicle in adult patients

Review Study 2:
NexoBrid compared to SOC in adult patients¹

Important Safety Information

Indication

Important Safety Information

Contraindications

Important Safety Information

Indication

Important Safety Information

Contraindications

Warnings and Precautions

Hypersensitivity Reactions

Coagulopathy

Adverse Reactions

Use in Special Populations

Geriatric Use

NexoBrid® Clinical Efficacy

Study 1 (Detect)1 Adult Three-arm study 3:3:1 Ratio NexoBrid (n=75) vs SOC* (n=75) vs Gel Vehicle (n=25)

Study 21 Adult Two-arm study 1:1 Ratio NexoBrid (n=75) vs SOC* (n=81)

Study 3 (CIDS)1 Pediatric Two-arm study 1:1 Ratio NexoBrid (n=72) vs SOC* (n=73)

93% of adults treated with NexoBrid achieved ≥95% eschar removal vs 4% with gel vehicle1

NexoBrid achieved ≥95% eschar removal 2.8 days sooner than SOC* in adults1

Only 4% of adults treated with NexoBrid required follow up excision vs 72% with SOC1*

NexoBrid achieved ≥95% wound closure in 31 days vs 36 days with SOC1*||¶

Review Study 2: NexoBrid compared to SOC in adult patients1

Review Study 3: NexoBrid compared to SOC in Pediatric Patients1

Only 15% of DPT wounds in adults treated with NexoBrid required follow up excision vs 63% with SOC1*

NexoBrid resulted in a significant reduction of DPT wound autografts vs SOC (18% with NexoBrid vs 34% with SOC)2*

The mean percent of DPT wound area autografted was significantly lower with NexoBrid vs SOC (8.4 ± 21.3 with NexoBrid vs 21.5 ± 34.8 with SOC)2*

NexoBrid achieved ≥95% wound closure in 33 days vs 24 days with SOC2*‡§

Review Study 1: NexoBrid Compared to SOC and gel vehicle in adult patients

Review Study 3: NexoBrid compared to SOC in Pediatric Patients1

NexoBrid achieved ≥95% eschar removal 5 days sooner than SOC in pediatric patients.1*

Only 8% of pediatric patients treated with NexoBrid® required follow up excision vs 64% with SOC1‡

NexoBrid achieved ≥95% wound closure in 32 days vs 34 days with SOC1†||

Review Study 1: NexoBrid Compared to SOC and gel vehicle in adult patients

Review Study 2: NexoBrid compared to SOC in adult patients1

Important Safety Information

Indication

Important Safety Information

Contraindications

Important Safety Information

Indication

Important Safety Information

Contraindications

Warnings and Precautions

Hypersensitivity Reactions

Coagulopathy

Adverse Reactions

Use in Special Populations

Geriatric Use

NexoBrid^® Clinical Efficacy

Study 1 (Detect)¹ Adult Three-arm study 3:3:1 Ratio NexoBrid (n=75) vs SOC* (n=75) vs Gel Vehicle (n=25)

Study 2¹ Adult Two-arm study 1:1 Ratio NexoBrid (n=75) vs SOC* (n=81)

Study 3 (CIDS)¹ Pediatric Two-arm study 1:1 Ratio NexoBrid (n=72) vs SOC* (n=73)

93% of adults treated with NexoBrid achieved ≥95% eschar removal vs 4% with gel vehicle¹

NexoBrid achieved ≥95% eschar removal 2.8 days sooner than SOC* in adults¹

Only 4% of adults treated with NexoBrid required follow up excision vs 72% with SOC¹*

NexoBrid achieved ≥95% wound closure in 31 days vs 36 days with SOC¹*^||¶

Review Study 2:
NexoBrid compared to SOC in adult patients¹

Review Study 3:
NexoBrid compared to SOC in Pediatric Patients¹

Only 15% of DPT wounds in adults treated with NexoBrid required follow up excision vs 63% with SOC¹*

NexoBrid resulted in a significant reduction of DPT wound autografts vs SOC (18% with NexoBrid vs 34% with SOC)²*

The mean percent of DPT wound area autografted was significantly lower with NexoBrid vs SOC (8.4 ± 21.3 with NexoBrid vs 21.5 ± 34.8 with SOC)²*

NexoBrid achieved ≥95% wound closure in 33 days vs 24 days with SOC²*^‡^§

Review Study 1:
NexoBrid Compared to SOC and gel vehicle in adult patients

Review Study 3:
NexoBrid compared to SOC in Pediatric Patients¹

NexoBrid achieved ≥95% eschar removal 5 days sooner than SOC in pediatric patients.¹*

Only 8% of pediatric patients treated with NexoBrid^® required follow up excision vs 64% with SOC¹^‡

NexoBrid achieved ≥95% wound closure in 32 days vs 34 days with SOC¹^†^||

Review Study 1:
NexoBrid Compared to SOC and gel vehicle in adult patients

Review Study 2:
NexoBrid compared to SOC in adult patients¹