GC Aesthetics®, Inc. (GCA), a privately-held medical technology company providing aesthetic solutions for global healthcare markets, announces successful surgical and patient care results in its multi-centric safety and efficacy study for nipple reconstruction using the novel silicone implant, FixNip NRI™.
The FixNip NRI™ – Nipple Reconstruction Implant is an implantable hypodermic, silicone implant specially designed for aesthetic improvement of the female nipple.
Breast cancer is the most common cancer globally in 20211 and, in many cases, the treatment includes a total mastectomy. Breast reconstruction is often the final stage of patient recovery, and the nipple is an essential part of the restoration of the shape and appearance of the breast. Reconstruction of the breast Nipple-Areolacomplex (NAC) remains a significant challenge for surgeons in reconstructive surgery, and yet it is critical for long-term patient satisfaction.
Commenting on the recent surgeries performed using the FixNip NRI™:
The interim results of the first in-human study confirm our assumptions regarding the safety of the device and the long-lasting projection of the nipple,” said Prof. Michael Scheflan, a world-renowned expert in the field of aesthetic and reconstructive plastic surgery. For decades, Dr. Scheflan has been involved in the treatment, research, development, and implementation of advanced methods of plastic surgery. “This is another milestone in our ongoing efforts to improve and enhance the aesthetic outcome. It is very satisfying to see how the search for nipple-areola complex reconstruction, combined with the efforts of surgeons and innovators, has led to a solution that is easily utilized, safe and produces satisfying results.”
The revolutionary product has unique characteristics that mimic a natural nipple touch and look. This can help significantly to relieve the psychological burden and impaired quality of life for women treated with total or partial mastectomy. “FixNip is a disruptive innovation for breast reconstruction and specifically nipple restoration,” commented Pr. Michael Atlan, internationally recognized French Plastic Surgeon leading the GCA multi-centric safety and efficacy pilot.
“During the first procedures, I can confirm the effectiveness and results. It can make a very meaningful difference for surgeons and patients. This prosthesis provides a natural solution that is maintained over time. The first tests in France are very encouraging, and complications are very rare. Patient feedback is excellent because it only requires one step, and a small scar that is safe for breast reconstruction.”
Prof. Michael Atlan
Internationally recognized French Plastic Surgeon
“Breast reconstruction represents a substantial portion of the breast implant market, opening significant opportunities for this technology, We will be launching FixNip NRI™ in early 2022, in European Markets first. GCA is excited to bring this revolutionary product to plastic surgeons and patients as part of a complete breast reconstruction solution, improving the lives of women and significantly raising the standards for breast surgery recovery.”
Carlos Reis Pinto
CEO of GC Aesthetics, GC Aesthetics®