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Genzyme Carticel Dropped First-Line Indication Made Up Under 12% Of Sales

This article was originally published in The Gray Sheet

Executive Summary

The dropped first-line indication of Genzyme Tissue Repair's Carticel knee cartilage repair product represented less than 12% of sales of the product, or less than $2 mil., the company maintains.

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Medical Device Start-Up News, September 2012

This month we cover MxBiodevices LLC, which has completed two clinical trials of its injectable wound repair scaffold that is injected just under the wound surface to provide a healing structure; and Histogenics Corp., which is in a Phase III clinical trial in articular cartilage repair.

In Cartilage Repair Histogenics Resets The Stage

In July Histogenics Corp. raised $49 million in a Series A recap round that will help it complete a Phase III clinical trial in articular cartilage repair. The deal also shows that Histogenics’ novel strategy for getting through the mid-stage funding gap was a success.

GENZYME CARTICEL BLA APPROVAL WILL BOOST INSURANCE COVERAGE, PRODUCT SALES, COMPANY SAYS; FDA REQUIRES POSTMARKET STUDIES TO EVALUATE LONG-TERM EFFICACY

FDA approval of Genzyme Tissue Repair's Carticel knee cartilage repair product on Aug. 25 is expected to result in an increased in insurance coverage and higher sales, the company says. Agency sign-off on a biological license application for Carticel for the repair of cartilage defects of the knee made it the first such product to receive formal approval.

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