Vericel Corp. engages in the research, product development, manufacture, and distribution of patient-specific, expanded cellular therapies for use in the treatment of patients with diseases. Its product portfolio includes MACI and Epicel. The MACI portfolio is FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient's own knee. The Epicel portfolio provide skin replacement for patients who have deep dermal or full thickness burns. The company was founded on March 24, 1989 and is headquartered in Cambridge, MA.
相关临床试验
16
2 进行中
药物批准
3
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
2
12.5%
已完成
10
62.5%
招募中
2
12.5%
终止
2
12.5%
- MediWound reported second-quarter 2026 revenue of $3.1 million, down 45.6% year over year, primarily reflecting the timing of BARDA-funded development revenue. - The EscharEx Phase III VALU trial in venous leg ulcers remains on track, with interim sample-size reassessment and enrollment completion expected by the end of Q1 2027. - An updated independent U.S. market assessment, expanded to include pressure ulcers, now projects $1.05 billion in annual peak sales for EscharEx. - Vericel reported NexoBrid's strongest quarter since launch, with approximately 80 U.S. burn centers ordering the product, and MediWound reaffirmed full-year 2026 revenue guidance of $24 million to $26 million.
- Vericel Corporation received FDA approval for commercial MACI manufacturing at its new Burlington, Massachusetts facility, marking a significant regulatory milestone for the cell therapy company. - The approval enables commercial production to begin in the second quarter of 2026, substantially increasing manufacturing capacity to meet growing demand for the cartilage repair therapy. - The expanded manufacturing capability positions Vericel to potentially commercialize MACI outside the United States for the first time. - The state-of-the-art facility strengthens Vericel's supply chain for its autologous cultured chondrocyte therapy used to repair knee cartilage defects.
- MediWound's EscharEx VALUE Phase III trial for venous leg ulcers continues enrollment targeting 216 patients, with interim assessment and completion expected by year-end 2026. - The company plans to expand EscharEx development into diabetic foot ulcers and pressure ulcers in 2026 following positive regulatory feedback from FDA and EMA. - NexoBrid manufacturing facility expansion is now fully operational with sixfold increased production capacity, positioning the company for anticipated regulatory approvals in 2026. - MediWound reported $17 million in 2025 revenue and updated guidance projecting growth to $24-26 million in 2026, $32-35 million in 2027, and $50-55 million in 2028.
- The FDA has approved a supplemental Biologics License Application for arthroscopic delivery of MACI, an autologous cultured chondrocytes on a porcine collagen membrane, for knee cartilage repair. - This approval expands MACI's delivery options, offering a less invasive arthroscopic approach for repairing symptomatic cartilage defects up to 4 cm2. - MACI Arthro is the only restorative biologic cartilage repair product approved for arthroscopic administration, potentially increasing market penetration. - Vericel Corporation anticipates that MACI Arthro will support sustained revenue growth by addressing a larger segment of the treatable market.
- The FDA has approved NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness and full-thickness thermal burns. - This approval is based on the Phase 3 CIDS trial and other pediatric data, offering a non-surgical option for severe burn injuries in children. - NexoBrid, a biologic product containing proteolytic enzymes, is now available for both adult and pediatric patients for eschar removal. - Vericel anticipates expanding its customer base to include approximately 20 pediatric burn centers in the United States.
