PREFIX FEASIBILITY Study - PRojection & Safety Evaluation of the FIXNip Nipple Reconstruction Implant

Inclusion Criteria:

• Female Subject age 22 years or older
• Subject of childbearing potential must agree to use medically accepted methods of contraception throughout the study and have a negative pregnancy test at screening
• History of breast cancer treated with total mastectomy only, with implant-based or autologous breast reconstruction seeking reconstruction of the nipple-areolar complex.
• Local tissue thickness at the intended nipple location of at least 10 mm, confirmed by both pinch test and ultrasound-based assessment. Tissue thickness requirement must extend across the entire implant coverage area.
• At least 12 months have elapsed since the last course of chemotherapy with absolute neutrophil count of ≥2
• At least 12 months have elapsed since the last breast and nipple reconstruction surgery.
• Local tissue thickness at the intended nipple location of at least 10 mm, confirmed by both pinch test and ultrasound-based assessment. Tissue thickness requirement must extend across the entire implant coverage area.
• At least 12 months have elapsed since the last course of chemotherapy with absolute neutrophil count of ≥2
• At least 12 months have elapsed since the last breast and nipple reconstruction surgery.

Exclusion Criteria:

• Subject with active malignant disease.
• Subject undergoing active treatment with targeted therapies or immunotherapies (e.g. Abemaciclib, Pembrolizumab)
• Any medical condition that in the opinion of the investigator may be associated with unduly high risk of intra-or post-operative complications (e.g., insulin dependent diabetes, connective tissue disorder, chronic lung or severe cardiovascular disease).
• Any history of radiation therapy to the chest wall or the breast(s). Subjects with a residual native nipple- areola complex, including those who have undergone nipple-sparing mastectomy.
• Any history of failed nipple flap reconstruction
• Subjects with a residual native nipple-areola complex, including those who have undergone nipple-sparing mastectomy.
• Subjects who are currently using tissue expanders or who plan to undergo tissue expander placement during the study period.
• History of hypertrophic scarring or keloid formation.
• Current use of any medications that can interfere with wound healing, impair the immune system functionality or impair blood clotting mechanisms.
• Active infection within the last 90 days.
• Subject who is pregnant, nursing, or planning pregnancy during the study period.
• Subject with known connective tissue disease.
• Diagnosis of the following rheumatic diseases or syndromes with the patient on systemic treatmen systemic lupus erythematosus, Sjogren's syndrome, scleroderma, polymyositis or any connective tissue disorder, rheumatoid arthritis crystalline arthritis, arthritis, infec infections arthritis, spondyloarthropathies, and any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome.
• Subject is chronically treated with steroids or had steroid therapy in the past 3 months prior to the study (regardless of route of administration).
• Subjects exhibiting psychological characteristics that, in the opinion of the Investigator and/or consulting physician(s) is incompatible with the risks associated with the surgical procedure, prosthesis, and compliance with protocol requirements.
• Past or current capsular contracture, defined as Baker III or IV
• Subject who is currently participating in, or has participated in, any other investigational drug or device study within 90 days prior to enrollment will be excluded, to allow an appropriate washout period and to ensure the valid collection and interpretation of data under this protocol.
• Subject with known allergies to silicone and/ or nitinol.
• Subjects who are current smokers or who have used nicotine-containing products (including cigarettes, e-cigarettes/vaping, cigars, pipes, nicotine patches, or chewing tobacco) within 3 months prior to enrollment will be excluded, due to the increased risk of impaired wound healing and skin and soft tissue ischemia.
• Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes.