Study of RNS60 on Pain and Function After Knee Anterior Cruciate Ligament Surgery

Inclusion Criteria:

- Medically stable as determined by the Investigator.

- Normal 12-lead ECG prior to surgery.

- Women of childbearing potential who have a negative pregnancy test (urine HCG) before
surgery.

- Capable of understanding the purpose and risks of the study and provide written,
informed consent.

- Patients scheduled to undergo ACL reconstruction surgery of the knee.

- ACL injury occurred no more than 12 months prior to surgery.

Exclusion Criteria:

- Morbid obesity.

- History of any clinically significant autoimmune disease: inflammatory bowel disease,
diabetes, lupus or severe asthma.

- Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ
carcinoma of the cervix that has been adequately treated).

- Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver,
central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or
metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of
normal), history of myocardial infarction, congestive heart failure, or arrhythmias
within 6 months prior to enrollment.

- Steroid therapy within 60 days prior to enrollment.

- Use of any immunomodulatory drugs during the study.

- Participation in any investigational therapy within one year prior to enrollment,
unless given approval by PI.

- Known or suspected current or past alcohol or drug abuse within one year prior to
enrollment.

- Any medical, psychiatric or other condition that could result in a subject not being
able to comply with protocol requirements.

- Concomitant Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL),
Posterior Cruciate Ligament (PCL) injury, or meniscus tear on the relevant knee.

- Previous surgery on the relevant knee or concomitant surgery on other joints.