👨🎨🎨🍕🇮🇱 The inventor of fixnip. the new innovative nipple reconstruction medical device
When my children are asked what their dad’s job is , they say:
Our father is the first “Nippleologist” in the world
www.Fixnip.com
[email protected]
+972526886666
I. FixNip at a Glance
Founded in 2015, FixNip Ltd. is a privately held medical device company based in Caesarea, Israel, focused on the development and manufacturing of a platform technology for soft tissue reinforcement based on unique designs assembling nitinol skeleton embedded in soft silicon structure.
The FixNip NRI is indicated for the reconstruction of the nipple-areola complex in plastic and reconstructive surgery of the nipple.
FixNip NRI received CE marking approval in 2020, was implanted successfully in a first-in-human clinical trial and is ready for commercialization in selected markets in Europe. Distribution contract has been signed with GC Aesthetics for European market. It is the only implant in the market to address this need competing only with the surgical technique of skin flaps which fails to demonstrate long-term projected nipple structure.
In December 2018, the company had a Pre-IDE meeting with FDA to assess the regulatory pathway in the US, towards FDA approval. The current plan is to pursue a 510(k) process yet in parallel prepare for a breakthrough designation submission in case a De-Novo submission will be needed.
FixNip is financially backed by strong European venture capital JPIF ventures and by the Israeli Innovation Authority.
FixNip Ltd.成立于2015 年,是一家私人医疗设备公司,总部位于以色列凯
撒利亚,致力于开发和制造用于软组织加固的平台技术,该技术基于独特的设计,
将嵌入在软硅中的镍钛合金骨架组装在一起
FixNip NRI™适用于乳头整形和重建手术中的乳头-乳晕复合体。FixNip NRI
于2020 年获得CE 标记批准,已成功植入人体首次临床试验,并已准备在欧洲部
分市场进行商业化。它是市场上唯一可以满足这种需求的植入物,只能与皮瓣的
手术技术竞争,而皮瓣的手术技术无法证明乳头的长期投射。
Invited by: Lena Sanosian
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