Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail)

The purpose of this study is to assess the clinical feasibility of DeviceFarm, Inc.'s
RenewalNail™ system and the treatment protocol that was developed based on extensive
laboratory testing on human cadaver nails. The Protocol calls for three 45-minute treatments
performed over a week to achieve mycological cure. Mycological cure will be assessed with two
consecutive mycological culture tests done over a week following the third treatment. Two
consecutive negative mycology culture results confirm the elimination of fungus causing
onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm
in the study. Clear nail growth will be documented and assessed by photography for 5 months
after treatment.

Inclusion Criteria:

- Subjects who are between 21 to 75 years (inclusive) of age;

- Subjects who are in good general health and free from any clinically significant
disease that might interfere with the study evaluations;

- Subjects with established clinical diagnosis of distal subungual onychomycosis;

- Subjects with at least one big toe nail involved with 20-75% infection;

- Subjects with both positive KOH and culture for onychomycosis dermatophytes in
screening of nail samples;

- Subjects whose infection is confirmed to be caused by T. rubrum or T. mentagrophytes;

- Subjects who are willing and able to refrain from employing other (non-study)
treatments (traditional or alternative) for his or her toenail onychomycosis
throughout study participation;

- Subjects who are willing and able to refrain from the use of nail cosmetics such as
clear and/or colored nail lacquers during the week of treatment (from Study Visits 1
through 3);

- Subjects who are willing and able to give written informed consent and able to adhere
to procedures and visit schedules;

- Women of childbearing potential who are currently sexually active must agree to use a
medically accepted method of contraception while receiving protocol specified
treatment. Methods include condoms (male or female), diaphragm or cervical cap with
spermicide, medically prescribed intrauterine device, oral or systemic hormonal
contraceptive, surgical sterilization (e.g., hysterectomy or tubal ligation);

- Women of childbearing potential who are not currently sexually active must agree to
use a medically accepted method of contraception should they become sexually active
while participating in the study;

- Women of childbearing potential must have a negative pregnancy test prior to start of
study.

Exclusion Criteria:

- Subjects with onychomycosis infection involving lunula of the affected toenail(s) or
spikes of disease extending to nail matrix in the affected big toenail;

- Subjects whose foot is too large (larger than US men's size 13) or too small (smaller
than US women's size 3) to properly fit into the plasma treatment device;

- Subjects whose affected big toenail cannot become normal in the opinion of the
investigator;

- Subjects who received topical antifungal treatment of the nails within 2 weeks before
study initiation;

- Subjects who received systemic antifungal treatment within 3 months before study
initiation;

- Simultaneous participation in another clinical study or participation in another
clinical study in the 30 days directly preceding treatment;

- Subjects who are immunocompromised (e.g. adrenal insufficiency, diabetes mellitus,
febrile neutropenia, and the human immunodeficiency virus infected);

- Subjects with any pacemakers, or any metallic implants or prostheses in the vicinity
of the treatment site (such as ankle, foot, etc.);

- Subjects with any clinically significant condition or situation, other than the
condition being studied that, in the opinion of the investigator, would interfere with
study evaluations or optimal participation in the study;

- Subjects who feel they cannot sit for 45 minutes at a time during the treatment;

- Subjects who are part of the staff personnel directly involved with this study or who
are family members of the investigational study staff;

- Subjects with known allergy to any of the tested treatment products [i.e.
perfluorocarbons and plastic polycarbonate];

- Women who are pregnant, breastfeeding, or planning pregnancy prior to the end of study
participation;