AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast

Augmentation Subjects Inclusion Criteria:

• Female patients > 22 years and < 65 years of age.
• Patients with a BMI < 35.
• Patients undergoing an aesthetic fat grafting procedure to the breast (breastaugmentation) with or without a breast implant.
• Patients must be able to provide written informed consent, understand and be willingto comply with study-related procedures and follow-up visits.
• Patients must be non-smokers.
• Patients with available/adequate harvest sites for fat grafting.
• Anticipated harvested fat volume between 200 and 700 cc.
• Anticipated fat injection volume between 50 and 350 cc per breast.
• Anticipated breast implant volume between 200 and 550 cc.
• Patients must agree to maintain their weight (i.e., within 5%) by not making any majorchanges in diet or lifestyle during the study.

Exclusion Criteria:

• Skin rash in the treatment area.
• Patients who smoke or use nicotine products.
• Patients with bleeding disorders or currently taking anticoagulants.
• Patients with history of trauma or surgery to the treatment area.
• Patients with history of breast cancer.
• Active, chronic, or recurrent infection.
• Compromised immune system.
• Hypersensitivity to analgesic agents.
• Co-morbid condition that could limit ability to participate in the study or to complywith follow-up requirements.
• Untreated drug and/or alcohol abuse.
• Pregnant or breastfeeding.
• Any issue that, at the discretion of the Investigator, would contra-indicate thepatient's participation.
• Patients who do not wish to have the study area (breast) photographed. Reconstruction Subjects Inclusion Criteria:
• Female patients > 18 years and < 65 years of age.
• Patients with a BMI < 35.
• Patients undergoing a fat grafting procedure to the breast in a second or third stageof a staged breast reconstruction, with or without a breast implant.
• Patient is at least 1 year post-completion of chemotherapy.
• Patients must be able to provide written informed consent, understand and be willingto comply with study-related procedures and follow-up visits.
• Patients must be non-smokers.
• Patients with available/adequate harvest sites for fat grafting.
• Anticipated harvested fat volume between 200 and 700 cc.
• Anticipated fat injection volume between 50 nd 350cc per breast.
• Anticipated breast implant volume (if applicable) between 200 and 550 cc.
• Patients must agree to maintain their weight (i.e., within 5%) by not making any majorchanges in diet or lifestyle during the study. Exclusion Criteria:
• Skin rash in the treatment area.
• Patients who smoke or use nicotine products.
• Patients with bleeding disorders or currently taking anticoagulants.
• Patients undergoing active treatment for breast cancer.
• Active, chronic, or recurrent infection.
• Compromised immune system.
• Hypersensitivity to analgesic agents.
• Co-morbid condition that could limit ability to participate in the study or to complywith follow-up requirements.
• Untreated drug and/or alcohol abuse.
• Pregnant or breastfeeding.
• Any issue that, at the discretion of the Investigator, would contra-indicate thepatient's participation.
• Patients who do not wish to have the study area (breast) photographed.