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Vericel Corporation

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Nick Colangelo, President & CEO, maintained guidance for the regulatory process for MACI. He stated, "We also a submitted a Biologics License Application for MACI for the treatment of cartilage defects of the knee, which was accepted for review by the FDA in the first quarter. The FDA provided a PDUFA goal date of January 3, 2017, and stated that it is not currently planning to hold an advisory committee meeting to discuss the application. The FDAs acceptance of the MACI BLA for review represents another important milestone for our goal of providing a new treatment option for the repair of symptomatic cartilage defects in the knee of adult patients, and we look forward to continuing to work closely with the FDA during the BLA review process."
Source: Q1 2015 earnings conference call, 5/14/15.

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Vericel Announces FDA Acceptance for Filing of BLA for MACI for the Treatment of Symptomatic Cartilage Defects in the Knee
CAMBRIDGE, Mass., March 07, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that the U.S. Food and Drug Administration has accepted for filing its recently submitted Biologics License Application (BLA) for MACI™ (matrix applied characterized autologous cultured chondrocytes), the company's investigational autologous cellular product intended for the treatment of symptomatic cartilage defects of the knee in adult patients. The FDA provided a PDUFA (Prescription Drug User Fee Act) goal date of January 3, 2017. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

"The FDA's acceptance of the MACI BLA for review represents another important milestone toward our goal of providing a new treatment option for the repair of symptomatic cartilage defects of the knee in adult patients," said David Recker, MD, chief medical officer of Vericel. "We look forward to continuing to work closely with the FDA during the BLA review process for MACI in the United States."
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Source: press release, 3/07/16. http://investors.vcel.com/releasedetail.cfm?releaseid=959112

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Vericel Submits Biologics License Application to the FDA for MACI for the Treatment of Cartilage Defects in the Knee
CAMBRIDGE, Mass., Jan. 04, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for MACI™ (matrix applied characterized autologous cultured chondrocytes), the company's investigational autologous cellular product intended for the treatment of symptomatic cartilage defects of the knee in adult patients.

"The BLA submission for MACI represents an important step toward our goal of providing a new treatment option for the repair of symptomatic cartilage defects of the knee in adult patients," said David Recker, MD, chief medical officer of Vericel. "We look forward to continuing to work closely with the FDA during the BLA filing and review process for MACI in the United States."
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Source: press release, 1/04/16. http://investors.vcel.com/releasedetail.cfm?releaseid=948603

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Vericel Announces Plan to Submit Biologics License Application to FDA by Year-End 2015 for MACI for the Treatment of Cartilage Defects in the Knee

CAMBRIDGE, Mass., June 10, 2015 (GLOBE NEWSWIRE) -- Vericel Corporation (Nasdaq:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that following discussions with the U.S. Food and Drug Administration (FDA) the company plans to submit a Biologics License Application (BLA) to the FDA by the end of 2015 for MACI™ for the treatment of focal chondral cartilage defects in the knee.

"We have had very productive discussions with the FDA regarding the regulatory pathway for the submission of the MACI BLA in the United States," said David Recker, MD, chief medical officer of Vericel. "Our planned MACI BLA submission reflects Vericel's commitment to deliver innovative therapies for patients with serious cartilage injuries in the knee."

MACI (matrix-applied characterized autologous cultured chondrocytes) is a third-generation autologous chondrocyte implantation (ACI) product for the treatment of cartilage defects in the knee. MACI was the first tissue-engineered product approved under the Advanced Therapy Medicinal Product guidelines by the European Commission. The pivotal Phase 3 clinical trial supporting MACI registration in Europe (the Superiority of MACI Implant to Microfracture Treatment, or SUMMIT study) demonstrated a statistically significant and clinically meaningful improvement in the co-primary endpoint of pain and function for patients treated with a MACI implant compared to microfracture at two years.
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Source: press release, 6/10/15. http://investors.aastrom.com/releasedetail.cfm?ReleaseID=917281

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
MACI SurgeryFocal chondral cartilage defects (knee)Cell replacement therapeuticCartilage

Mechanism of action: MACI (matrix-applied characterized autologous cultured chondrocytes) is a third-generation autologous chondrocyte implantation (ACI) product for the treatment of focal chondral cartilage defects in the knee.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-01-03

Results:

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FDA Approves MACI for the Treatment of Symptomatic Cartilage Defects of the Knee in Adults

First Tissue-Engineered Autologous Cellularized Scaffold Product Approved by the FDA

Conference Call Today at 9:00am Eastern Standard Time

CAMBRIDGE, Mass., Dec. 14, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved MACI® (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.

"The treatment of articular cartilage defects in the knee is challenging because articular cartilage in adults has minimal capacity to repair itself," said David Recker, MD, chief medical officer of Vericel. "While orthopedic surgeons have long understood that autologous chondrocyte implantation can regenerate cartilage tissue, the previous surgical procedure was technically complex and time consuming, and the indicated patient population was limited. MACI is the first product to show a statistically significantly greater improvement in KOOS pain and function scores compared to microfracture, a commonly performed alternative surgical treatment for cartilage repair, in a well-controlled Phase 3 clinical study. With the introduction of MACI, orthopedic surgeons will have a simplified treatment option available for a broader patient population supported by solid clinical evidence."

The approval of MACI is based on the SUMMIT study (Superiority of MACI implant versus Microfracture Treatment in patients with symptomatic articular cartilage defects in the knee), a two-year prospective, multicenter, randomized, open-label, parallel-group study which demonstrated a statistically significantly (p=0.001) greater improvement in KOOS pain and function (SRA) scores in the MACI group compared to the microfracture group at two years. Patients from the two-year SUMMIT study had the option to enroll in a three-year follow-up study (extension study). A majority of the patients who completed the SUMMIT study also participated in the extension study. Overall efficacy data support a long-term clinical benefit from the use of MACI in patients with cartilage defects of the knee.

MACI is the first FDA-approved cellularized scaffold product that applies tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient's own knee.

"Bringing an important new therapy to orthopedic surgeons and patients is a significant milestone for Vericel, and I would like to thank the FDA for working closely with us to make MACI available for these patients," said Nick Colangelo, president and CEO of Vericel. "We believe that the introduction of MACI, along with investments to expand our commercial organization and implement new patient support programs, positions Vericel to generate significant growth in 2017 and beyond."

Conference Call Information
Today's conference call will be available live at 9:00am (EST) in the Investors section of the Vericel website at http://investors.vcel.com/events.cfm. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation investor call. If calling from outside the U.S., please use the international phone number (253) 237-1173. If you are unable to participate in the live call, the webcast will be available until December 13, 2017. A replay of the call will also be available until 12:00pm (EDT) on December 18, 2016 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 39558058.
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Source: press release, 12/14/16. http://investors.vcel.com/releasedetail.cfm?ReleaseID=1004125

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