Vericel Provides Business Updates At 2017 Cell & Gene Meeting On The Mesa
Published: Oct 05, 2017
CAMBRIDGE, Mass., Oct. 05, 2017 (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 provided a general business update during a previously announced webcast presentation at the 2017 Cell & Gene Meeting on the Mesa.
As part of the update the Company announced that, effective October 1, 2017, UnitedHealthcare updated its medical policy for autologous chondrocyte implantation in the knee to include MACI® (autologous cultured chondrocytes on porcine collagen membrane). At this time, the number of covered lives for commercial plans providing access to MACI is approximately equivalent to the number of covered lives for commercial plans that previously covered Carticel® (autologous cultured chondrocytes), the Company’s first generation autologous chondrocyte implant product. Based on the expanded medical policy coverage for MACI and the continued momentum of MACI uptake following launch, the Company announced plans for a further expansion of the MACI sales force in 2018. The Company will provide additional updates on its commercial business during its upcoming third-quarter 2017 earnings webcast and conference call.
During the presentation the Company also announced that it had met with the U.S. Food and Drug Administration (FDA) on September 29, 2017 for a scheduled Type B meeting to discuss the potential for an accelerated approval pathway for ixmyelocel-T for the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM) utilizing existing Phase 2 clinical trial data. Ixmyelocel-T has received orphan drug, fast track development and regenerative medicine advanced therapy designation from the FDA in this indication. The FDA indicated that the Company should plan to conduct at least one additional adequate and well-controlled clinical study to support a Biologics License Application for ixmyelocel-T. Consistent with its previously disclosed strategy to focus investments on its high-growth commercial business, the Company does not plan to conduct any additional clinical studies for ixmyelocel-T unless fully funded by a partner.
MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellular scaffold product that is indicated for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane. Autologous cultured chondrocytes are human-derived cells which are obtained from the patient's own cartilage for the manufacture of MACI.
Ixmyelocel-T is an investigational autologous expanded multicellular therapy manufactured from the patient's own bone marrow using Vericel's proprietary, highly automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue. Ixmyelocel-T has received orphan drug, fast track development, and regenerative medicine advanced therapy (RMAT) designation by the U.S. Food and Drug Administration for use in the treatment of advanced heart failure due to DCM.
About Vericel Corporation
Vericel develops, manufactures, and markets expanded autologous cell therapies for the treatment of patients with serious diseases and conditions. The company markets two cell therapy products in the United States. Vericel is marketing MACI® (autologous cultured chondrocytes on porcine collagen membrane), 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. Vericel is also marketing Epicel® (cultured epidermal autografts), 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. For more information, please visit the company's website at www.vcel.com.
Epicel®, Carticel® and MACI® are registered trademarks of Vericel Corporation. © 2017 Vericel Corporation. All rights reserved.
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, regulatory progress, 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 competitive developments, clinical trial and product development activities, regulatory approval requirements, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, sales force expansion, payer access and our ability to secure consistent reimbursement for our products, and our ability to supply or meet customer 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, 2016, filed with the Securities and Exchange Commission ("SEC") on March 13, 2017, 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.
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