Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity

This is a prospective, multi-center, randomized, single blind, bilateral paired study
evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device
for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin
removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by
moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest;
prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of
the skin at the jawline at rest. Subjects are blinded to needle gauge and density.

There will be two cohorts of subjects: one group of subjects will receive a single treatment
and the second - multiple treatments. All subjects will be followed for 180 days with several
intermediate visits at 3, 7, 30, 60, and 90-days.

Inclusion Criteria:

- Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator

- One or more of the following conditions assessed by Investigator using provided
Severity Scales:

- Nasolabial fold severity at rest ≥2 and ≤4;

- Marionette line prominence at rest ≥2 and ≤4;

- Oral commissure drooping at rest ≥2 and ≤4;

- Jawline sagging at rest ≥2 and ≤4 .

- Moderate-to-Severe wrinkles at rest at least in one of the following areas - the
upper lip, chin and cheeks.

Exclusion Criteria:

- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma,
vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be
treated

- History of keloid formation or hypertrophic scarring

- History of trauma or surgery to the treatment areas in the past 6 months

- Scar present in the areas to be treated

- Silicone or synthetic material injections in the areas to be treated

- Injection of FDA-approved dermal fillers in the past two years

- Injection of fat in the past year

- History of treatment with dermabrasion, ablative laser, or radiofrequency in the past
year

- History of treatment with non-ablative laser in the past 6 months

- History of treatment with botulinum toxin injections in the areas to be treated within
the prior 6 months

- Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment

- Active, chronic, or recurrent infection

- History of compromised immune system or currently being treated with immunosuppressive
agents

- History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics
(e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or
epinephrine

- Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior
to treatment

- Treatment with aspirin or other blood thinning agents within 14 days prior to
treatment

- History or presence of any clinically significant bleeding disorder

- Co-morbid condition that in the Investigator's opinion could limit ability to
participate in the study or to comply with follow-up requirements

- History of drug and/or alcohol abuse

- Any issue that, at the discretion of the Investigator, would interfere with assessment
of safety or efficacy or compromise the subject's ability to undergo study procedures
or give informed consent

- Treatment with an investigational device or agent within 30 days before treatment or
during the study period