A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

FDA post-approval study designed to collect prospective data in a real-world setting to
evaluate long-term safety and effectiveness of the LAP BAND® System in patients with a BMI of
≥ 30 kg/m2 and < 40 kg/m2 and one or more comorbid conditions. The Apollo-001 Study is a
prospective, 10 year, multicenter study of patients who have decide to undergo implantation
of the LAP-BAND AP® system. Outcomes include device explants, changes in weight, comorbid
condition status, device- and procedure-related AEs, and reoperations.

The LBMI study was part of the condition of approval (CoA) for the Lap-Band device. It was
terminated because it was no longer required to fulfill the condition of approval for the
device. Apollo was able to fulfill the condition of approval (CoA) for the Lap-Band device by
using data from published literature and another recently completed study (OSB Lead-Hero-002
study) which had long-term safety and effectiveness data addressing the conditions of
approval.

Inclusion Criteria:

1. LAP-BAND® System placed in a facility in the United States

2. BMI ≥ 30 kg/m2 and < 40 kg/m2 prior to LAP-BAND® placement

3. Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement

4. Aged 18 or older

Exclusion Criteria:

1. Prior bariatric surgery.

2. Participating in another ongoing clinical study in which concomitant diagnostic or
therapeutic intervention that would reasonably be expected to alter patterns of care,
use of medications or the outcomes under study.

3. Vulnerable patients or those unable to exercise free informed consent.

4. Inability to complete the questionnaires.

5. Patients who are addicted to alcohol and/or drugs.