Vericel Announces FDA Approval of New State-of-the-Art Advanced Therapy Manufacturing Facility

Vericel (NASDAQ:VCEL) announced FDA approval to commercially manufacture MACI at its new Burlington, Massachusetts cell therapy facility.

Rhea-AI Summary

Vericel (NASDAQ:VCEL) announced FDA approval to commercially manufacture MACI at its new Burlington, Massachusetts cell therapy facility. The approval permits commercial production to begin in Q2 2026, increases manufacturing capacity to support long-term growth, and enables potential MACI commercialization outside the U.S.

This milestone strengthens the company’s supply chain and positions Vericel to scale MACI production to meet rising demand for restorative cartilage repair therapies.

Positive

• FDA approval for commercial MACI manufacturing
• Commercial production scheduled to start in Q2 2026
• Increased manufacturing capacity to support long-term growth
• Enables potential MACI commercialization outside the U.S.
• New state-of-the-art facility located in Burlington, MA

Negative

• Commercial launch timing depends on successful scale-up in Q2 2026

Argus Mar 4 session

+1.66% close to close Open Argus

Details

News Market Reaction – VCEL

On Mar 4, the day this news came out, VCEL closed 1.66% above the previous close.

Data tracked by StockTitan Argus for the Mar 4 session.

Key Figures

MACI production start: Second quarter 2026 2025 total revenue: $276.3M 2025 MACI revenue: $239.5M +5 more

MACI production start

Second quarter 2026

Commercial manufacturing at Burlington facility

2025 total revenue

$276.3M

Full-year 2025 reported

2025 MACI revenue

$239.5M

Full-year 2025, +21% YoY

2025 gross margin

79%

Record Q4 2025 gross margin

2025 adjusted EBITDA

$70.9M (26% margin)

Full-year 2025

Cash balance

$200M

Year-end 2025, no debt

2026 revenue guidance

$316–$326M

Company outlook for 2026 total revenue

Shares outstanding

50,763,319

Common shares as of Feb 19, 2026 (10-K)

Previous Fda approval Reports

2 past events · Latest: Aug 26

Same Type 2 events

1. Aug 26

   MACI Arthro approval

   24h Move

   +1.3%

   FDA approval of MACI Arthro, expanding label to arthroscopic procedures.

2. Aug 15

   NexoBrid pediatric nod

   24h Move

   +0.3%

   FDA approval expanding NexoBrid use to pediatric severe burn patients.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fda, autologous cultured chondrocytes, porcine collagen membrane, cell therapy

4 terms

fda regulatory

"today announced that the U.S. Food and Drug Administration (FDA) has granted approval"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

autologous cultured chondrocytes medical

"MACI® (autologous cultured chondrocytes on porcine collagen membrane) commercial manufacturing"

Autologous cultured chondrocytes are a patient’s own cartilage cells that are collected, grown in a lab to increase their number, and then re-implanted to repair damaged cartilage. For investors, these therapies matter because they represent a personalized medical product with potential for premium pricing, complex manufacturing and regulatory hurdles, and significant impact on surgical demand, reimbursement and long-term treatment costs—factors that affect commercial value and risk.

porcine collagen membrane medical

"autologous cultured chondrocytes on porcine collagen membrane) commercial manufacturing"

A porcine collagen membrane is a thin, flexible medical barrier made from pig-derived collagen that’s used in surgeries and dental procedures to support tissue repair and guide healing—think of it as a temporary biological patch or scaffold placed over a wound or implant. Investors care because demand, regulatory approvals, manufacturing scale, safety record and social or supply concerns can directly affect sales, reimbursement and the commercial risk for companies that make or use these products.

cell therapy medical

"state-of-the-art cell therapy manufacturing facility in Burlington, Massachusetts."

Cell therapy uses living human or animal cells as the medicine: cells are collected, sometimes grown or altered, and then given to a patient to repair, replace, or boost damaged tissue or immune function. For investors, cell therapies can transform markets because they may offer one-time or highly effective treatments that command premium prices, but they also carry high development, manufacturing and regulatory costs and commercial risks, like building a custom factory rather than making a simple product.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Company Achieves Significant Regulatory and Operational Milestone

Substantially Increases Manufacturing Capacity to Support Long-Term Growth

Enables Potential MACI Commercialization Outside of the U.S.

CAMBRIDGE, Mass., March 04, 2026 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for MACI^® (autologous cultured chondrocytes on porcine collagen membrane) commercial manufacturing at its state-of-the-art cell therapy manufacturing facility in Burlington, Massachusetts. The approval enables Vericel to begin commercial production of MACI at its new facility in the second quarter of 2026, positioning the Company to expand capacity to meet increasing demand for its restorative cartilage repair product and potentially commercialize MACI outside of the United States.

“This FDA approval reflects a major achievement for Vericel and underscores the Company’s operational and scientific expertise in complex cell therapy manufacturing,” said Nick Colangelo, President and Chief Executive Officer of Vericel. “Bringing our Burlington facility online for commercial MACI production strengthens our supply chain and supports our mission to deliver innovative, high-quality therapies to patients. We look forward to building on this foundation as we continue to scale our business and create long-term value for patients and shareholders.”

About Vericel Corporation
Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets. The Company combines innovations in biology with medical technologies, resulting in a highly differentiated portfolio of innovative cell therapies and specialty biologics that repair injuries and restore lives. Vericel markets three products 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 eschar removal in adults and pediatric patients with deep partial-thickness and/or full-thickness thermal 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. © 2026 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Vericel (VCEL) announce about FDA approval for MACI on March 4, 2026?

Vericel received FDA approval to manufacture MACI commercially at its Burlington facility. According to the company, this approval allows commercial production to begin in Q2 2026 and supports expanded capacity and potential international commercialization.

When will Vericel (VCEL) begin commercial production of MACI at the Burlington facility?

Commercial MACI production is scheduled to begin in Q2 2026 at Burlington. According to the company, the FDA approval enables the facility to start commercial manufacturing and scale capacity to meet demand.

How does the FDA approval affect Vericel's (VCEL) capacity to supply MACI?

The approval substantially increases Vericel’s capacity to produce MACI commercially. According to the company, bringing the Burlington facility online strengthens the supply chain and positions the company to meet rising restorative cartilage repair demand.

Does the FDA approval allow Vericel (VCEL) to sell MACI outside the United States?

The approval enables potential commercialization of MACI outside the U.S., but does not itself grant foreign approvals. According to the company, the facility positions Vericel to pursue international commercialization opportunities.

What strategic benefits did Vericel (VCEL) cite for the new Burlington manufacturing facility?

Vericel said the Burlington facility strengthens its supply chain and operational expertise for cell therapy manufacturing. According to the company, this supports scaling MACI production and creating long-term value for patients and shareholders.