3D Printing Industry
Surgeons at Israel’s Shaare Zedek Medical Center (SZMC) have successfully transplanted the world’s thinnest artificial cornea into the eye of a patient, according to a Jerusalem Post report . Developed by medical device manufacturer EyeYon , the implant itself was just 50 microns thick and 3D printed from synthetic materials, to ensure that it wouldn’t be rejected by its human host. Having now been used to restore the sight of a local patient, in what’s believed to have been the first procedure of its kind, the device is expected to drastically improve the future availability of corneal transplants. “This is another step toward a future in which the dependence on the availability of human tissue for the purpose of performing corneal transplants in patients who need it will be reduced,” Dr. Liron Berkovich, one of the team behind the transplant, told The Jerusalem Post. “Instead of using a cornea from a person who has died, they will use a custom-made cornea with full availability.”
The transplant patient alongside Prof. David Zadok and Dr. Liron Berkovich. Photo via the Jerusalem Post, SZMC. Improving implant accessibility 
According to EyeYon, the human ocular endothelium can never regenerate, and when it’s injured or shows signs of aging, this can lead to something called a ‘corneal edema.’ Early signs of the condition include pain, swelling and clouded vision, but if left untreated it can cause permanent damage to the eye and affect people’s ability to see. At present, treating corneal edemas tends to rely on donated tissues, meaning that patients often have to wait for months before undergoing corrective surgery. What’s more, such procedures don’t come with a guarantee of success, as the body can reject donor corneas, leaving some of those that undergo treatment continuing to suffer from vision loss. As an alternative to biological implants, EyeYon has now developed ‘ EndoArt ,’ a 3D printed cornea made from a sterile biocompatible acrylic that’s said to be inherent to human tissue. Once applied, the device is designed to attach to the posterior of patients’ corneas, before creating a passive barrier to the fluid that builds up to cause edemas, while allowing for optical nutrition exchange around its sides. By producing the EndoArt synthetically, the firm says it could be possible to make edema treatment more “globally available” in future, while using 3D printing to manufacture it allows the company to continue iterating upon the device’s design. However, prior to its deployment at the SZMC, the implant may have gained Israeli Health Ministry approval following a similar application from EyeYon to the US FDA , but it had only previously been shipped to the Netherlands, India and China. EyeYon’s 3D printed EndoArt corneal implant. Photo via the Jerusalem Post, SZMC. Giving the gift of restored sight   
Having successfully tested its implants on rabbits in lab settings, EyeYon has been seeking to put them into practice by using them to treat human patients, and it chose an SZMC case to do so. The patient in question was a 71-year-old Muslim Arab from Jerusalem, whose body had previously rejected an implant sourced from a cadaver two years ago, thus he continued to suffer from ocular discomfort. Performed by SZMC’s Professor David Zadok and Dr. Liron Berkovich, a corneal disease specialist, the operation saw a two millimeter incision being made into the patient’s eye, through which the device was attached to their endothelial tissue. Since the surgery, the patient’s vision is said to have been restored, and he no longer suffers from the discomfort caused by the swelling of fluids in his eye. As an added bonus, it has been reported that the procedure didn’t require him to stay in the hospital for recovery at all, and he was able to arrive, receive treatment and leave in a single day. Following the successful transplant, Zadok revealed that his department performs 60 to 70 corneal procedures per year, and around half of these could soon involve using synthetic implants instead. On this occasion, EyeYon is believed to have provided the EndoArt free of charge, but it’s expected that any future orders would have to be paid for via Israel’s health service, as part of a commercial transaction. Steve Verze, reported recipient of the world’s first 3D printed eye prosthetic. Photo via Moorfields Eye Hospital. Printing upgraded optical implants
In the past, 3D printing has not just been deployed to create optimized optical transplants, but implants for those patients suffering from damaged eye sockets as well. Late last year, a man from London reportedly became the recipient of the world’s first 3D printed eye transplant via a clinical trial, through which it was hoped that the technology would showcase its ability to slash patient waiting times. At the University of Basel , meanwhile, researchers have come up with a 3D printed eye socket implant , designed to reduce the risk of rejection upon human transplantation. Produced from PEEK using a Prusa i3 3D printer, the porous device is said to be highly customizable, meaning that it can be tailored to meet the needs of individual patients, and better foster cellular regeneration. In the world of veterinary medicine, a team at Chungbuk National University have also previously developed low-cost 3D printed eyes for dogs . Designed to treat those canines that have lost their real eyes due to incurable diseases, the implants can be rapidly 3D printed from off-the-shelf biocompatible resin, potentially making them a cheap and accessible option for use in veterinary procedures. To stay up to date with the latest 3D printing news, don’t forget to subscribe to the 3D Printing Industry newsletter or follow us on Twitter or liking our page on Facebook . For a deeper dive into additive manufacturing, you can now subscribe to our Youtube channel, featuring discussion, debriefs, and shots of 3D printing in-action. Are you looking for a job in the additive manufacturing industry? Visit 3D Printing Jobs for a selection of roles in the industry. Featured image shows the transplant patient alongside Prof. David Zadok and Dr. Liron Berkovich. Photo via the Jerusalem Post, SZMC.

Israeli surgeons carry out “world’s thinnest 3D printed cornea” transplant

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NES ZIONA, Israel, Feb. 22, 2022 /PRNewswire/ -- EyeYon Medical, a leading start-up company that develops innovative ophthalmic medical devices, announces Dr. Bakalash as Chief Medical Officer of EyeYon Medical . Dr. Bakalash is a seasoned biotechnology entrepreneur and an ophthalmic surgeon with more than two decades of demonstrated leadership in business, science, and medicine. Dr Sharon Bakalash, EyeYon Medical’s Chief Medical Officer
Dr. Bakalash comments: "I am excited about being a part of a dedicated team focused on the development of both the revolutionary EndoArt® – a first of its kind synthetic corneal endothelium, and the HyperCL™. I look forward to applying my experience in clinical development and medical affairs to show how these cutting-edge technologies answer age-old unmet needs in anterior segment surgeries. " 
Nahum Ferera, CEO & Co-Founder of EyeYon Medical said: "I am honored to have Dr. Sharon Bakalash as a leader for our global clinical activity, after successful demonstration of both safety and efficacy of the innovative EndoArt® & HyperCL™, the upcoming years will include extensive clinical activity. There is no better person than Sharon to lead these breakthrough innovations. I've known Sharon for years and her experience, professionalism, and personality is a perfect match for EyeYon Medical's multi-talented team." Before this step in, Dr. Bakalash headed several biotechnology companies in the ophthalmic space, including TissueGen - a drug delivery company located in Dallas, Texas. She also served as the chief medical officer of Beyeonics Surgical and Beyeonics Vision for several years and is the founder of SB Strategic Development Consultants Group, which provides clinical development, strategic planning and business development guidance. During these stints, she's worked closely with start-ups, venture funds, and global pharma companies, across the pharmaceutical, drug delivery and surgical device arenas. Prior to that, Dr. Bakalash served in various roles of increased responsibilities within the pharmaceutical industry. In her last role at Novartis, she was responsible for the US early development portfolio for both Ophthalmology and ENT-forming development strategies, enabling pipeline enrichment from both external and internal innovation. Earlier on, she headed business development at Alcon, where she evaluated, negotiated, and oversaw numerous transactions - spanning acquisitions, joint ventures, and a wide variety of co-development frameworks. Dr. Bakalash was a part of the Harvard University Office of Technology Development ( http://otd.harvard.edu/ ), out-licensing innovations stemming from the medical school. Dr. Bakalash holds an MD from Ben Gurion University, a PhD in Neuroimmunology from the Weizmann Institute of Science, and a business degree from Northeastern University. Dr. Bakalash has also completed a post-doctoral fellowship at Harvard University. About EyeYon Medical
EyeYon Medical is a start-up company developing a variety of ophthalmic products for vision-threatening conditions. EyeYon Medical's flagship product is an Artificial Endothelial Layer - EndoArt®, a synthetic implant, attached to the posterior corneal surface to treat chronic corneal edema secondary to endothelial dysfunction. EyeYon Medical also developed the HyperCL™, an FDA-approved unique contact lens that acts as a premium therapeutic contact lens for a variety of corneal conditions which require eye drop treatment. For more information, please visit EyeYon Medical . Contact:

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EyeYon Medical Appoints Dr. Sharon Bakalash MD, PhD As Chief Medical Officer

EyeYon Medical announced that it has received CE Mark for its EndoArt after clinical trials demonstrated safety and efficacy for treating chronic corneal edema. EyeYon says the EndoArt is the world’s first and only synthetic implant that replaces the human endothelium that the human body can never regenerate. The current standard of care involves corneal transplantation of human tissue. This unique implant enables doctors to treat endothelial-related chronic corneal edema with a minimally invasive surgery that erodes the use of human tissue. Last month, the EndoArt became the only ophthalmic device in the world to receive both China’s Innovative Device Status and the Breakthrough Device Designation from the US FDA. The EndoArt is designed to replace dysfunctional endothelium in patients awaiting human donor tissue as a first-line treatment for patients with chronic corneal edema. A nonfunctioning endothelium results in excess fluid flowing into the cornea, resulting in severe vision loss, pain and irreversible scarring of the human tissue. The implant has been in clinical trials, including human clinical trials, in selected medical centers in Europe, including in IVRC in Heidelberg, Instituto de Microcirugia Ocular (IMO) in Barcelona, and AMC in Amsterdam. Other clinical trials are underway in India and Israel. With more than 13 million on the waiting list for corneal transplant, the current standard of care, the EndoArt was created in an effort to eliminate global shortages of corneal donations. “We are proud to receive CE mark for our unique EndoArt implant, which is set to transform the way patients with chronic corneal edema are treated,” Nahum Ferera, Co-Founder and CEO of EyeYon Medical, said in a company news release. “This important approval enables us to work closely with healthcare providers across Europe to help patients who suffer from corneal edema regain their sight and quality of life with a simple, accessible and cutting-edge solution. We would like to thank our European partners for the journey we shared over the past years to advance our technology in the continent.”
“The EndoArt opens up a new vision for the future: availability, ease of use, and cost reduction in treating patients with endothelial failure,” commented Ruth Lapid-Gortzak MD, PhD, trial Principal Investigator from the Amsterdam University Medical Centers, one of the centers leading in-human trials of the EndoArt implant in Europe. “Our trials have demonstrated decrease in corneal thickness in all patients; and in patients with visual potential, there has been an improvement in visual acuity with no evidence of detrimental metabolic effect in the recipient cornea. The EndoArt has clear benefits as no tissue or tissue bank is needed, and no tissue rejection issues or transmission of infections can occur. We are very excited about its addition to the arsenal of corneal surgery.”
“The CE Mark clearance signifies a new milestone in our journey to transform the treatment of corneal edema across the world,” Dr. Ofer Daphna, Co-founder, Chief medical director and the inventor of the EndoArt, said in the news release. “We are pleased to provide a safe, innovative and minimally-invasive treatment option to patients with chronic corneal edema. We are confident that our solution will help eliminate the long waiting list for available human donor corneas worldwide.”
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EyeYon Medical Receives CE Mark for its EndoArt Implant to Treat Chronic Corneal Edema

The co-founders of EyeYon Medical. Courtesy. Israeli startup EyeYon Medical, a developer of ophthalmic products, announced on Monday that it has received a CE Mark for its minimally invasive, suture-free EndoArt implant after clinical trials demonstrated its safety and efficacy for treating chronic corneal edema. Founded in 2011 by Dr. Ofer Daphna, CEO Nahum Ferera MD, and Dr. Arie Marcovich, MD., EyeYon Medical develops advanced products and devices to treat acute problems in the ophthalmic world. The EndoArt was created in an effort to eliminate global shortages of corneal donations. EndoArt is the world’s first and only synthetic implant which replaces the human endothelium that the human body can never regenerate. . A nonfunctioning endothelium results in excess fluid flowing into the cornea, resulting in severe vision loss, pain and irreversible scarring of the human tissue. The current standard of care involves the corneal transplantation of human tissue. This unique implant enables doctors to treat endothelial-related chronic corneal edema with a minimally invasive surgery that erodes the use of human tissue. Last month, the EndoArt became the only ophthalmic device in the world to receive both China’s Innovative Device Status and the Breakthrough Device Designation from the U.S. Food and Drug Administration. EyeYon Medical also raised $25 million in March 2021, bringing the total amount of capital raised by the company to $36 million. “This important approval enables us to work closely with healthcare providers across Europe to help patients who suffer from corneal edema regain their sight and quality of life with a simple, accessible and cutting-edge solution. We would like to thank our European partners for the journey we shared over the past years to advance our technology in the continent,” said Nahum Ferera, co-Founder and CEO of EyeYon Medical. The implant has been in clinical trials, including human clinical trials, in selected medical centers in Europe, such as IVRC in Heidelberg, Instituto de Microcirugia Ocular (IMO) in Barcelona, and AMC in Amsterdam. Other clinical trials are underway in India and Israel. “The EndoArt opens up a new vision for the future: availability, ease of use, and cost reduction in treating patients with endothelial failure,” added Ruth Lapid-Gortzak MD, PhD, trial principal investigator from the Amsterdam University Medical Centers, one of the centers leading in-human trials of the EndoArt® implant in Europe.“Our trials have demonstrated a decrease in corneal thickness in all patients and in patients with visual potential, there has been an improvement in visual acuity, with no evidence of detrimental metabolic effect in the recipient cornea. The EndoArt® has clear benefits as no tissue or tissue bank is needed, and no tissue rejection issues or transmission of infections can occur. We are very excited about its addition to the arsenal of corneal surgery.”
“The CE Mark clearance signifies a new milestone in our journey to transform the treatment of corneal edema across the world,” said Dr. Ofer Daphna, co-founder, chief medical director and the inventor of the EndoArt. “We are pleased to provide a safe, innovative and minimally-invasive treatment option to patients with chronic corneal edema. We are confident that our solution will help eliminate the long waiting list for available human donor corneas worldwide.”

Israel’s EyeYon Medical Receives CE Mark For Its Synthetic Implant

EyeYon Medical Raises $25 Million in Series C Funding
Latest round brings the company’s valuation to $36 million. Michael Barbella, Managing Editor04.12.21
EyeYon Medical  is $25 million richer, thanks to a Series C funding round that raised capital from several investors. “The overwhelming interest in joining our latest funding round reflects the confidence that investors have in our unique and disruptive technology and its tremendous ability to address the clinical challenges and the huge market opportunity in the growing corneal implants market,” Nahum Ferera, co-founder and CEO of EyeYon Medical, said in a news release. “Together with our team of clinical and medical device experts, we have developed a novel solution which has already shown groundbreaking results and safety in human trials. The latest investments position EyeYon Medical as a global pioneer in the ophthalmology space and in corneal care.”
The money will be used to expand clinical trials of EyeYon Medical’s flagship product, EndoArt. EndoArt is the first synthetic implant that enables doctors to treat chronic corneal edema with a minimally invasive surgery that erodes the use of human tissue, according to EndoArt. With more than 13 million on the waiting list for corneal transplant, the EndoArt was created in an effort to ease global shortages of corneal donations. Clinical trials, which are already underway in selected medical centers across Europe (IVRC in Heidelberg, Instituto de Microcirugia Ocular (IMO) in Barcelona, and AMC in Amsterdam) and in Israel (Soroka Medical Center, Rambam Health Care Campus, Tel Aviv Sourasky Medical Center and Barzilai Medical Center) have demonstrated the safety and efficacy of EyeYon Medical’s groundbreaking technology. The funding was led by a global strategic leader in the ophthalmic industry and CR-CP Life Science Fund, according to EyeYon. Other participants in the round include Global Health Sciences (GHS) Fund (Quark Venture LP and GF Securities), BPC and existing investors Triventures, Rimonci, Pontifax and Diamond BioFund. The latest round brings the company’s valuation to $36 million. Following the new investments, EyeYon Medical will expand its clinical trials with the aim to receive regulatory approval in the United States, China, and Europe and leverage the company’s professional network and the demand for the product. “These resources will enable us to accelerate the clinical and regulatory phases in our key markets,” said Dr. Ofer Daphna, co-founder and the inventor of the EndoArt. “EndoArt will simplify corneal surgical procedures and can potentially empower any anterior segment surgeon to perform the surgery with a vision to eliminate the worldwide long waiting list for available human donor corneas.”
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EyeYon Medical Raises $25 Million in Series C Funding

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EyeYon Medical operates as an Israeli start-up company. It develops innovative medical devices for the treatment of corneal edema. It has developed a contact lens constructed so that it extracts fluid from the cornea, thereby relieving the edema. The lens also improves vision by smoothing the cornea and preventing edema from making bending in the cornea. The company was founded in 2011 and is based in Jerusalem, Israel.

Name	Work History	Title	Status
Dr. Ofer Daphna		Founder	Current
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Name	Firm	Work History	Other Seats
Michal Geva			EyeYon
Richel Liu			EyeYon

Name	Michal Geva	Richel Liu
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