Vericel Announces Publication of Positive Results from Phase 3 Debride and Protect (DETECT) Study of Thermal Burn Patients Treated with NexoBrid

Rhea-AI Summary

Vericel Corporation announces positive results from Phase 3 DETECT study on NexoBrid treatment for severe burns, with over 90% of patients achieving complete eschar removal and reduced need for surgery.

Positive

• Over 90% of patients treated with NexoBrid achieved complete eschar removal compared to 4% in the control group.
• Surgical excision was significantly lower in the NexoBrid group compared to the standard of care group (4% vs. 72%).
• NexoBrid demonstrated a shorter median time to complete eschar removal compared to standard of care treatment (1.02 days vs. 3.83 days).
• NexoBrid was found to be safe and well-tolerated without negative effects on wound closure and scarring.

Negative

• None.

Data published in the Journal of Burn Care & Research show treatment with NexoBrid resulted in early complete eschar removal in more than 90% of treated patients, and reduced surgery when compared to Gel Vehicle and standard of care

Results demonstrate that NexoBrid is safe and well-tolerated without deleterious effects on wound closure and scarring

CAMBRIDGE, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the recent publication of results from the Phase 3 DETECT study assessing the safety and efficacy of NexoBrid® (anacaulase-bcdb) in the Journal of Burn Care & Research.

“These data demonstrate the ability of NexoBrid to provide patients with severe thermal burns safe and effective enzymatic eschar removal that is superior to current debridement methods,” said Dr. Jon Hopper, Chief Medical Officer of Vericel. “We are pleased that NexoBrid is now available to U.S. burn surgeons to treat severe burn patients and we believe the publication of these results, coupled with real-world clinical experience, will help establish NexoBrid as the new standard of care for eschar removal.”

The three-arm DETECT study consisted of 175 adult patients with deep thermal burns covering 3-30% of total body surface area, who were randomized to NexoBrid, surgical or non-surgical standard of care (SOC), or placebo Gel Vehicle (GV) treatment arms in a 3:3:1 ratio. The primary endpoint was complete eschar removal at the end of the debridement phase and secondary outcomes were the need for surgery and time to complete eschar removal. Key findings include:

• More than 93% of the patients treated with NexoBrid achieved complete eschar removal following one application of NexoBrid compared with 4% in the GV arm (P<0.0001);
• Surgical excision was lower in the NexoBrid arm when compared to the SOC group (4% vs. 72%; P<0.001);
• The estimated median time to complete eschar removal was 1.02 and 3.83 days for the NexoBrid and SOC treatment arms, respectively (P<0.0001); and
• NexoBrid appeared safe and well tolerated without deleterious effects on wound closure and scarring.

Data from this study ultimately served as the foundation for the FDA approval of NexoBrid for commercial use in the U.S.

About NexoBrid
NexoBrid (anacaulase-bcdb) is a botanical drug product containing proteolytic enzymes indicated for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns. To learn more about NexoBrid, please visit www.NexoBrid-US.com.

About Vericel Corporation
Vericel is a leader in advanced therapies for sports medicine and severe burn care. The Company manufactures and markets two cell therapy products and one specialty biologic product in the United States. MACI^® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel^® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel also holds an exclusive license for North American rights to NexoBrid^® (anacaulase-bcdb), a biological orphan product containing proteolytic enzymes, which is indicated for the removal of eschar in adults with deep partial-thickness and/or full-thickness burns. For more information, please visit www.vcel.com.

Epicel^® and MACI^® are registered trademarks of Vericel Corporation. NexoBrid^® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2023 Vericel Corporation. All rights reserved.

Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Vericel’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Investor Contact:
Eric Burns
ir@vcel.com
+1 (734) 418-4411

Media Contact:
Julie Downs
jdowns@vcel.com