Vericel Corp. (VCEL)

[Giovinco]

VCEL vs HSGX You should read this
http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUyNzUxMzF8Q2hpbGRJRD02OTk1NTQ=

HSGX trial was designed several years ago when there was no FDA guidance.
Using current criteria (Dual threshold responder not required, just like MACI), how would Phase 3 NeoCart trial have done?
NeoCart would have demonstrated statistically significant results vs
microfracture on relevant IKDC & KOOS scales/endpoints at BOTH 1 year & 2 years

As I said yesterday, the market completely misread the numbers.
Microfracture patients performed significantly better than expected, and better than in most previous published studies (62% response vs. 50% projected in statistical plan) and real world experience. 1-year endpoint would have been statistically significant if two microfracture patients had not been responders. Clinicians in this trial requested current MCID analysis, which demonstrated superiority at 1 year

In > 2.2 cm lesions (MACI trial had mean lesion size of 4.8 !!!) : NeoCart 76% response rate vs 52% for microfracture (*p= 0.0145)

Failure Observations (% of patients at 1 year with scores below baseline)
– IKDC: 2.5% for NeoCart; 12.7% for microfracture
– KOOS: 3.7% for NeoCart; 3.7% for microfracture
– BOTH: 1.2% for NeoCart; 3.8% for microfracture

(Originally Posted on SA)