mdc medical device certification GmbH
Notified Body 0483
FixNip LTD. is a medical device startup that aims to provide physicians with a global standard of care for nipple-areola complex (NAC) reconstruction and bring new hope for millions of women worldwide. This revolutionary solution enables women who have undergone post-mastectomy breast reconstruction to regain their self-confidence and positive body image by finalizing the look of the reconstructed breast with a beautiful and natural-looking nipple.
FixNip's groundbreaking Nipple Reconstruction Implant (NRI) offers a simple NAC reconstruction solution that has predictable and non-shape-shifting results. The implant is comprised of a “floral shaped” nitinol frame that is coated with a silicone capping specially designed to allow for anchoring of the implant to adjacent tissue and maintaining a soft feel. This provides the physician with a stable platform on which to design the nipple structure, which can be done in an outpatient setting through a minimally invasive procedure that can be carried out in less than 20 minutes.
Loss of nipple projection is the most pervasive problem across all currently existing NAC reconstruction techniques. The combination of FixNip's patented nitinol frame with the soft medical-grade silicone coating that make up the FixNip NRI maintains mechanical strength to guarantee a dependable and consistent nipple structure while remaining soft, flexible, and natural in look and feel.
13 Bareket Industrial Park St, Caesarea, Israel