Progress to Date:

Successful bench science.  Numerous pre-clinical studies were conducted to ensure safety and assess the toxicology of the Z-Lig device.  This verification process included biomaterials biosafety evaluation, leachable residues risk assessment, sterility assurance, bioburden and pyrogen testing, and a viral safety evaluation.  Additionally, biomechanical studies were conducted to demonstrate that porcine derived tissue has comparable biomechanical properties to allograft tissue.

Successful primate study.  The Z-Lig was implanted in a group of rhesus monkeys prior to human implantation to test the device in a model immunologically similar to humans.  The results of this study demonstrated that the Z-Lig device has been converted to eliminate immunological rejection, can function long-term as an ACL, and can undergo the process of host incorporation and ligamentization.

Successful completion of U.S. Phase I IDE clinical trial.  An FDA approved IDE study was conducted with l0 patients.  The purpose of this pilot clinical trial was to demonstrate the safety of the Z-Lig device.  The results of the trial demonstrated the safety of the device, and indicated the Z-Lig’s potential for use as an ACL reconstruction device.  Recently the company was able to perform a longer term follow up on a cohort of patients where the device continued to demonstrate safety and function after five years of implantation.

FDA approval to conduct a multi-center pivotal clinical trial.  Results of the pilot clinical trial have led to FDA approval of the clinical trial design for a Phase III multi-center pivotal clinical trial for the U.S.  The pivotal trial design will involve 326 patients with up to two-year follow up at up to ten clinical sites.  Half of the patients will receive the Z-Lig, while the other half will receive an allograft control.  Upon successful completion of the pivotal trial, pre-market approval of the Z-Lig device will be requested from the FDA.  Successful completion of this trial will lead to approval to market this device in the U.S.

Intellectual property.  An extensive intellectual property portfolio protects Z-Lig and Z-Process™ technologies.  Aperion has obtained 21 issued patents and has twelve patents pending.

Commercialization. The company has recently completed its commercialization facility in San Antonio, Texas. The facility is targeted to be ISO certified in late 2009 in preparation for producing clinical grade product in early 2010.