The FixNip™ Medical Devices Information

Fixnip LTD. is a medical device startup that revives and optimizes the field of breast augmentation through a innovative hypodermic silicone nipple implant. The company provides physicians with a global standard of care for nipple reconstruction through a revolutionary solution that allows women to regain their self-confidence and attain beautiful nipple results when undergoing post-mastectomy breast reconstruction, repairing inverted nipples, or simply looking to aesthetically enhance their nipples. Fixnip offers a simple nipple reconstruction solution, in a groundbreaking implant form, that has predictable and non-shape-shifting results. Combining precise laser cutting, cast molding, clean room technology, and advanced materials such as Nitinol and Soft Medical Silicone, the product feels real to the touch while maintaining its structure longterm. In addition, insertion of the Fixnip implant requires a minimally invasive procedure that can be carried out in an outpatient setting in less than 20 minutes. With loss of projection being the number one most pervasive problem across all currently existing techniques, The patented Nitinol skeleton combined with the soft medical silicon casting found in the Fixnip product maintains mechanical strength and guarantees a dependable and consistent structure that is simultaneously soft, flexible, and natural in look and feel. Fixnip LTD has successfully implemented a long and rigorous POC phase with encouraging results. Nipple implant devices have been designed and manufactured. Congruently, the product has received positive medical opinions from top class plastic surgeons confirming the feasibility and applicability of the product for the market. Regulatory According to a leading expert opinion- the device will require a short 510k FDA review Intellectual Property Status The company’s IP is covered by a patent