Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

The study is designed with each subject serving as his or her own control. A total of up to
75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm
x 1.5-mm or 2.5-mm x 2.5-mm tip. One lesion will be randomized as a untreated control and no
NPS energy will be delivered. All treated lesions will receive at least one NPS treatment and
evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially
Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at
60 days post-primary or secondary treatment.

Inclusion Criteria:

- Males or females

- Presents with at least 2 and up to 5 clinically visible SH lesions

- Understands that 1 lesion will remain untreated to act as a reference

- Lesions must measure no greater than 2.5 x 2.5 at the outside margin

- Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion

- Selection of the non-treated reference lesion will be randomly identified

- Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90
days

- Agrees to photographic or other image capture methods of both the treated and
untreated lesions.

- Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until
the end of the NPS study

- Has no evidence of active infection in the designated tissue prior to treatment and
reports no infection within 90 days

- Is not allergic to Lidocaine or Lidocaine-like products

Exclusion Criteria:

- Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or
automatic defibrillator

- Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior
to exposure to the NPS device

- SH lesions are located within the eye orbit or on the nose

- Active infection or history of infection in designated test area within 90 days prior
to study initiation

- Use of oral steroid and/or retinoid use within the last 12 months

- Prior treatment to the identified SH lesions targeted for the study which occurred
within 6 months prior to study start

- Is known to be immune-compromised and/or received immunosuppressant therapy within 6
months prior to study start

- Taking blood thinning medications

- Has Insulin dependent diabetes

- Is known to be pregnant or lactating female