Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss

Inclusion Criteria:

• Subject is willing to sign an informed consent form
• Subject is within the age group of 22-55 years (including both ages)
• Subject is male
• Subject has AGA with a Stage IIa-V Hamilton-Norwood classification
• Subject's skin is within Fitzpatrick Skin Types I-IV

Exclusion Criteria:

• Subjects who have used any formulation or application/administration or type oftreatment for disorders of the skin or scalp within 180 days prior to screening,including but not limited to the following treatments:

1. Anti-inflammatory medications, including topical steroids
2. Antifungal
3. Skin, nail, hair rejuvenation supplementation, or IV infusions (includes vitamin,minerals, herbals, etc.)
4. Hair growth shampoos, conditioners, and topicals
5. Topical, dermal or oral minoxidil, finasteride, or dutasteride
6. Hair growth stimulation treatments, i.e. PRP, stem cells, exosomes, growthfactors, microneedling, mesotherapy
7. LED or low level laser therapy treatments, ie. laser helmets, laser caps, andlaser combs
8. Infrared saunas

• Subjects with alopecia other than AGA, such as alopecia areata, alopecia totalis,telogen effluvium, anagen effluvium, and acquired cicatricial alopecia
• Subjects with a history of bleeding disorders
• Subjects on anticoagulant medications (aspirin, warfarin, heparin)
• Subject on autoimmune suppressant medications or suffering autoimmune diseases (e.g.humira)
• Subjects with an active infection at the local site
• Subjects with keloidal tendencies
• Subjects with chronic dermatological conditions affecting the scalp (e.g. eczema,psoriasis, etc.)
• Subjects with hepatic or renal disease, epilepsy, or any other major medical illness*
• Subjects that have undergone evaluation to rule out other causes of hair loss, becauseunderlying causes (e.g., iron deficiency, lupus, thyroid disease, telogen effluvium,post-pregnancy, polycystic ovary, chemotherapy, etc.) would preclude assessment ofperformance in an androgenetic alopecia trial
• Subjects who are photosensitive or are using photosensitive drugs or topicals.
• Subjects who are taking anxiolytics medications
• Subjects who have been on hormone inhibitors or on hormone replacement therapy in thelast 180 days
• Subjects who are at high risk of seizures
• Subjects who have a malignancy or a history of malignancies affecting the scalp
• Subjects that have undergone hair transplantation, scalp reduction, radiation to thescalp or chemotherapy within their lifetime.
• Subjects with current hair weaves, hair extensions, scalp tattoos, or who useocclusive wigs.
• Subjects who have used semi-permanent hair products (e.g. color, texturizers orrelaxers) within 30 days prior to screening.
• Subjects with hair shorter than one-half inch (approximately 1.2 cm).
• Subjects who are unable to make regular follow-up visits.
• Subjects who are immediate family members (spouse, parent, child, or sibling;biological or legally adopted) of personnel directly affiliated with the study at theinvestigative sites, or individuals who are directly affiliated with the study at theinvestigative sites, or individuals directly affiliated with the study sponsor.