Description
Fixnip offers a simple nipple reconstruction solution, in a groundbreaking implant form, that has predictable and non-shape-shifting results. It is comprised of a “floral shaped” nitinol frame with a silicone capping which allows for anchoring of the implant to adjacent tissue, softer feel and encapsulation of the nitinol frame. The implant provides the physician with a stable platform to design the nipple structure. 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. Bring new hope for millions of woman world- wide.
About
The FixNip NRI™ - Nipple Reconstruction Implant, is an implantable hypodermic, silicone implant specially designed for aesthetic improvement of the female nipple. It is comprised of a “floral shaped” nitinol frame with a silicone capping which allows for anchoring of the implant to adjacent tissue, softer feel and encapsulation of the nitinol frame. The implant provides the physician with a stable platform to design the nipple structure.
The implant is currently provided in a single size (“one size fits all”) however, additional size will be considered based on market input.
The FixNip NRI™ is implanted by a trained physician to support soft tissue where weakness exists, during nipple reconstruction procedure. It is provided sterile, intended for a single use and cannot be re-sterilized.
The FixNip NRI™ is only intended for aesthetic reconstructive purposes and is not intended for use, for example, to preserve or improve the ability to breastfeed.
mdc medical device certification GmbH
Notified Body 0483
Fixnip LTD. is a medical device startup that revives the field of breast augmentation through a line of innovative hypodermic silicone nipple implants. The company provides physicians with a global standard of care for nipple-areola reconstruction through a revolutionary solution that allows women to attain beautiful nipple results and regain their self-confidence when undergoing post-mastectomy breast reconstruction, following breast cancer.
