Tuesday, October 3, 2023
Tuesday, October 3, 2023

Contact: 561.316.3330

FDA Clears CorNeat EverPatch, World’s First Non-degradable, Synthetic Tissue Substitute for Ophthalmic Surgery

CorNeat Vision’s EverPatch, a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). The CorNeat EverPatch is the first synthetic, non-degradable tissue-integrating matrix for use in ophthalmic surgeries. It is composed of a non-woven, polymer matrix which integrates with surrounding tissue and is intended to reinforce the sclera and aid the physical reconstruction of the ocular surface. This groundbreaking synthetic tissue substitute is designed to address the critical needs of ocular surgeons, providing a sterile and non-degradable solution for patients worldwide.

The CorNeat EverPatch is poised to displace the use of donor and processed tissue, commonly utilized in ocular surgeries but posing the risk of disease transmission.

Dr. Gilad Litvin, CorNeat Vision’s Chief Medical Officer and Co-Founder stated: “The ideal graft material should be long-lasting, sterile, immunologically inactive, cosmetically acceptable, and readily available. The CorNeat EverPatch was designed with these goals in mind. Our novel ophthalmic patch is significantly thinner than processed patch tissue, provides better handling as it does not ‘cheesewire’ when sutured, and has holes that allow for accurate positioning and anchoring. These holes also facilitate direct conjunctival adhesion to the sclera thus supporting its bio-integration. Thus far, we have received extremely positive feedback from surgeons and are excited for U.S. surgeons to have this tool available.”

Almog Aley-Raz, CorNeat Vision’s CEO and VP R&D responded to the news: “We are extremely excited to introduce the CorNeat EverPatch to the U.S. market. It is the first device that leverages the EverMatrix™, our core tissue-integrating material platform technology, originally developed for our corneal prosthesis program. EverMatrix™ presents a significant business opportunity as it is the only synthetic non-degradable patch material in ocular surgery. This biocompatible material has the potential for wider use in soft tissue reinforcement, biomechanical integration of implants with surrounding tissue, fabrication of membranes, and concealment of implants and sensors. I cannot overemphasize the potential impact of this technology on human health. This recent FDA clearance of our first device for ophthalmic use advances us toward our ultimate goal of promoting human health and equality.”

The CorNeat EverPatch will be launched initially in leading ophthalmic centers in the U.S. in Q3 2023, expanding nationwide later in the year.

Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.


4SC Receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby.  We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”

Abyrx Receives FDA Clearance for MONTAGE ® Settable Bone Putty for Use in Cardiothoracic Surgery

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

By using this website you agree to accept Medical Device News Magazine Privacy Policy