vBloc Now - Registry

The vBloc is a neuromodulation system that consists of the following implantable and external
components:

- Implantable components: Two leads (including one electrode each for the anterior and
posterior intra-abdominal vagal nerve trunks) are implanted laparoscopically on the
intra-abdominal trunks of the vagus nerve and connected to a neuroregulator, which is
implanted subcutaneously on the thoracic sidewall.

- External components: A mobile charger (MC) is connected to a non-invasive transmit coil,
positioned over the implanted neuroregulator and secured in place using a transmit coil
belt to charge and perform status checks on the neuroregulator. The MC is charged using
an AC recharger. A laptop computer (CP) with proprietary software is used to control and
upload data from the neuroregulator through the MC via the programmer cable. The CP is
used by the clinician to change treatment parameters and assess battery recharging
compliance. A torque wrench is used during the implant procedure to secure the leads
into the neuroregulator.

Schedule of events following the baseline study visit include: implant, 2 week follow up, and
1, 3, 6, 9, and 12 month follow up visits. Enrolled subjects will also use the vBloc Achieve
weight management program, which is a remote weight management counseling sessions with a
registered dietitian to discuss healthy diet and exercise habits and weight loss goals.

The vBloc Now registry, together with vBloc Therapy and the vBloc Achieve weight management
program, incorporates specific diets after the implant, routine remote counseling by an
experienced registered dietitian, recommendations for physical activity, and tracking of
weight, food intake, and fitness. The expectation is that patients participating in the vBloc
Now registry, who comply with the diet and behavioral recommendations in combination with use
of the Maestro device, will see an improvement in their overall health, whether it's related
to weight loss, improvements in co-morbidities, or a better quality of life.

Inclusion criteria

1. Signed informed consent

2. Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one
or more obesity related co-morbid conditions

3. Females or males. Note: females of child-bearing potential must have a negative urine
pregnancy test at Screen and also within 14 days of implant procedure followed by
physician-approved contraceptive regimen for the duration of the study period.

4. At least 18 years of age

5. Failure to respond to supervised diet/exercise program(s) in which the subject was
engaged within the last five years

6. Ability to complete all study visits and procedures

Exclusion criteria

1. Patients with cirrhosis of the liver, portal hypertension, or esophageal varices.

2. Patients with a large (>5cm) symptomatic hiatal hernia

3. Patients for whom magnetic resonance imaging (MRI) is planned

4. Patients at high risk for surgical complications

5. Patients who have a permanently implanted, electrical-powered medical device or
gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators,
neurostimulators)

6. Patients for whom shortwave, microwave, or therapeutic ultrasound diathermy is planned
Note: Diathermy is any treatment that uses high-frequency electromagnetic radiation,
electric currents, or ultrasonic waves to produce heat in body tissues. Patients
absolutely CANNOT be treated with any type of shortwave, microwave, or therapeutic
ultrasound diathermy device whether or not it is used to produce heat. These
treatments should not be applied anywhere on the body.

7. Current medical condition that, in the opinion of the investigator, would make the
subject unfit for surgery or that would be exacerbated by intentional weight loss.
Some examples include diagnosis of cancer, recent heart attack, recent stroke or
serious trauma.