Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

Exclusion Criteria

• •1. Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL.
• •2. Have a history of previous meniscus injury that currently needs to be treated or has been treated surgically.
• •3. Have evidence of arthritis ≥ Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3.
• •4. Elevated AST or ALT liver enzymes at time of screening
• •5. Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study.
• •6. Known drug or alcohol dependence currently or within the last year.
• •7. Participating concurrently in another clinical study or have participated in a clinical study within the last 90 days, or intend to during the course of the study.
• •8. Any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate postoperative rehabilitation.
• •9. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.
• •10. Known allergic reaction to simvastatin.
• •11. Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.