UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): June 10, 2015

 

Vericel Corporation

(Exact name of registrant as specified in its charter)

 

Michigan

 

001-35280

 

94-3096597

(State or other jurisdiction

 

(Commission

 

(I.R.S. Employer

of incorporation)

 

File Number)

 

Identification No.)

 

64 Sidney St.
Cambridge, Massachusetts

 

02139

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (734) 418-4400

 

Not Applicable
Former name or former address, if changed since last report

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 7.01. Regulation FD Disclosure.

 

On June 10, 2015, Vericel Corporation (the “Company”) issued a press release announcing plans to submit a biologics license application to the U.S. Food and Drug Administration for its product MACITM. A copy of this press release is filed herewith as Exhibit 99.1.

 

Item 9.01.  Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.

 

Description

99.1

 

Press release dated June 10, 2015.

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Vericel Corporation

 

 

Date: June 11, 2015

By:

/s/ Gerard Michel

 

 

Name: Gerard Michel

 

 

Title: Chief Financial Officer and Vice President, Corporate Development

 

3



 

Exhibit Index

 

Exhibit No.

 

Description

99.1

 

Press release dated June 10, 2015.

 

4


Exhibit 99.1

 

 

Jun 10, 2015

 

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.

 

About Vericel Corporation

 

Vericel Corporation (formerly Aastrom Biosciences, Inc.) is a leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. The company markets two autologous cell therapy products in the U.S.: Carticel® (autologous cultured chondrocytes), an autologous chondrocyte implant for the treatment of cartilage defects in the knee, and Epicel® (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep-dermal or full-thickness burns comprising greater than or equal to 30% of total body surface area. Vericel is also developing MACI™, a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy. For more information, please visit the company’s website at www.vcel.com.

 



 

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, intended product development, clinical activity timing, integration of the acquired business, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with clinical trial and product development activities, regulatory submission and approval requirements, the availability and allocation of resources among different potential uses, estimating the commercial potential of our products and product candidates and growth in revenues and perceived market demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission (“SEC”) on March 25, 2015, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

 

CONTACT:

Investors:

 

 

 

Chad Rubin

 

 

 

The Trout Group

 

 

 

crubin@troutgroup.com

 

 

 

(646) 378-2947

 

 

 

or

 

 

 

Lee Stern

 

 

 

The Trout Group

 

 

 

lstern@troutgroup.com

 

 

 

(646) 378-2922

 

 

 

Media:

 

 

 

Bill Berry

 

 

 

Berry & Company

 

 

 

bberry@berrypr.com

 

 

 

(212) 253-8881