Vericel Announces Publication of Positive Results from Phase 3 Debride and Protect (DETECT) Study of Thermal Burn Patients Treated with NexoBrid
28 Settembre 2023 - 2:30PM
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 NexoBridNexoBrid (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 CorporationVericel 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 StatementsThis 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 Burnsir@vcel.com+1 (734)
418-4411
Media Contact:Julie Downsjdowns@vcel.com
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