December 21, 2015 10:08am

Patient Inclusion/exclusion criteria rules enhances HSGX’s ability to attract qualified patient candidates while maintaining the integrity of clinical evaluation of its product candidate for knee cartilage repair - BUY

 

The FDA has accepted the HSGX's amendment filed in 11/15 to the NeoCart P3 clinical trial protocol to expand the eligible patient population.

 

The Bottom Line: Revisions include:

  • Patients with trochlear lesions will now be included in the trial;
  • The upper age limit of patients eligible to participate in the trial will be increased from 55 years to 59 years;
  • The time between a prior procedures, such as ligament reconstruction and meniscal tears, and a patient's participation in the study will be reduced from six months prior to arthroscopy, which is the final step prior to enrollment, to three months prior to arthroscopy;
  • Patients with asymptomatic lesions in non-study locations that are larger than the study lesion will no longer be excluded from the trial.

 

HSGX is FLAT at $2.97 as Monday morning’s session began … I believe the “modification” is a POSITIVE as patient Inclusion/exclusion criteria rules the protocol … BUY