Hemostatic sealant solutions innovator GATT Technologies announced today the successful first-in-man of its lead product GATT-Patch, used to resolve bleeding in a patient undergoing liver resection surgery by Radboud university medical center Nijmegen (Radboudumc). This first patient marks the start of a multicenter clinical trial that will be conducted by three leading academic medical centers in the Netherlands: Radboudumc, The University Medical Center Groningen, who have both already treated patients in the trial, and Erasmus Medical Centrum Rotterdam Mis intending to join shortly. Oost NL is a shareholder in GATT Technologies, via the investment fund Topfonds Gelderland.
"This product fills an important clinical need. Having fast and effective solutions to manage complex bleeding is crucial to prevent complications for patients during or after surgery. Hemostats and sealants are used when other methods to contain the bleeding are ineffective or insufficient. Current products on the market have limitations in their ease of use, may not always be able to stop the bleeding, and are also costly. This product aims to address all these limitations." said Professor dr. Hans de Wilt, surgeon at Radboudumc and principal investigator of the GATT-Patch clinical trial. "Radboudumc is committed to pioneering new innovations that substantially increase standard of care and change the way complex surgeries are performed."
The start of its first clinical trial marks an important milestone for the company: "Based on our patented synthetic polymer technology, we are convinced of the opportunities of our platform. All pre-clinical work performed in the past years has confirmed safety and superior performance of GATT-Patch. It is very exciting to now see our lead product used on patients, which will give us vital data regarding the safety and performance of GATT-Patch in a clinical setting" said Johan Bender, founder and CTO of GATT.
Dr. Stuart Head, Chief Medical Officer of GATT, commented: "Principal investigators Professor dr. de Wilt (Radboudumc), Professor dr. Porte (University Medical Center Groningen), and Professor dr. Verhoef (Erasmus Medical Center) and their teams are a fantastic group to work with. Their expertise in the field has already proven very valuable during the preparation for this trial, and we feel confident that further execution of the trial is in good hands. We hope we can continue to leverage their feedback as we continue to build out our platform".
Geert van Gansewinkel, CEO of GATT, added: "The first-in-man procedure marks a very important step for us, as we move from a pre-clinical to a clinical stage medical device company with our lead product GATT-Patch. Being a class III medical device company, the pre-clinical path has been extensive. We are very excited about now being able to prove our performance in a clinical setting. Following this trial, we will be performing additional trials: upon finalizing our European trial, we will continue to the US to target FDA approval, and we will evaluate the broad potential of GATT-Patch for use in other surgical procedures, such as soft tissue, cardiovascular, lung, kidney, pancreas and beyond. Also, we are preparing trials for our follow up products such as GATT-Powder, which will target large surface area and hard to access bleedings, and GATT-Gel for high-pressure vessel sealing. We see tremendous opportunity for this polymer-based platform to become the next global frontier in managing complex surgical bleeding and sealing."