The Silicon Review
Hemostasis is a biological process in the human body that stops blood loss when there is an injury. Lack of hemostasis may lead to bleeding-related complications and fatality during surgery. There is a rise in the need for a new hemostatic approach because the demand level is high on the battlefield and in hospitals. The academic focus in recent years has paved the way for improvements in existing processes and new developments. Uncontrolled bleeding can be fatal, and it causes a rise in costs and risks in an emergency setting. In an operating room, many surgeries such as general, cardiovascular, and orthopedic procedures have a high incidence mainly due to severe blood loss requiring an effective hemostatic intervention.
Globally various companies have developed quality hemostasis solutions, but GATT Technologies stands out from the rest. GATT Technologies has developed a platform of hemostatic and sealant solutions based on a proprietary and patented synthetic formula. The company’s first products will include a fast-acting hemostatic and sealant patch (GATT-Patch) and a powder (GATT-Powder). In addition, GATT is expanding its portfolio to include spray and tape solutions. This comprehensive suite of products is designed to control bleeding in general, cardiovascular and lung surgeries, minimally invasive laparoscopic/robotic procedures, and cases of intestinal anastomotic leakage. GATT is also developing solutions such as bone bleeding/regeneration.
In conversation with Geert van Gansewinkel, CEO of GATT Technologies
Q. What is the medical need you are addressing?
Bleeding-related complications during surgery are frequent and pose severe risks for patients. Studies have shown that in nearly 30% of surgeries, bleeding-related complications occur. In more than 20% of cases, blood transfusions are needed. Failure to effectively address bleeding-related complications can lead to prolonged surgery, impaired wound healing, increased risk of infections, re-operations, and even mortality. Surgeons have various techniques and solutions at their disposal to control bleeding, but these are oftentimes ineffective to fully address the problem. Surgeons can control bleeding situations by applying mechanical techniques, such as applying pressure and ligature. However, these are often ineffective or impractical (for example, when the tissue is frail or there is limited space to suture). In these cases, surgeons will use so-called hemostats or sealants. Many of these solutions are in the market, but oftentimes they do not address the more challenging situations. Their ease of use can be limited (for example needing long pressure time) and/ or are expensive.
Q. What is your solution for addressing the medical need?
GATT Technologies has developed a synthetic technology platform with the potential of becoming the next frontier in managing complex bleeding situations. GATT’s patented polymer-based technology enables the company to produce hemostats and sealants that are more adhesive, quicker, more user-friendly, and more cost-effective than current solutions on the market. Additionally, the solutions will allow use in many more clinical situations than currently available products. Products are aimed to be used for open surgery as well as for laparoscopic/ robotic use. Based on its platform technology, the first product GATT has developed, GATT-Patch, will be going into the clinical phase in April 2021. GATT-Patch is designed to become the leading standard, with its strong adhesiveness, ability to provide hemostasis in seconds rather than minutes, and flexibility, allowing it to be used on all kinds of organ and wound surfaces.
How does your solution outperform current hemostatic and sealant solutions?
Our solution brings a number of differentiators when compared to existing products:
Our platform technologies enable us to create multiple hemostats and sealants. The first product we developed is GATT-Patch, intended to target complex bleeding situations such as liver, spleen, soft tissue, and cardio-vascular. We are also developing GATT-Powder, which will target bleeding situations of larger surface areas or areas that are harder to access. We are also working on a liquid solution that will target sealing on suture lines, such as in high-pressure vessel bleeding situations.
Q. What does the future hold for your company? Are exciting things on the way?
GATT Technologies is currently a pre-market company. In March of 2020, we completed a series B financing round. Leveraging that funding, we moved into the pre-clinical phase with our first product, GATT-Patch. We performed all biocompatibility tests required to prove the product is safe to start clinical trials. At the end of 2020, we submitted our Investigation Medical Device Dossier for approval, and we will be starting our first clinical trial in Europe in April of 2021. We expect to finalize the trial and submit the files for European commercial approval by the end of 2021. In parallel, we will also prepare for trials in the US. We have already been in discussions with the FDA and will be preparing a trial in the US. Whilst our initial focus will be on liver surgery, we will subsequently be expanding to many other indications. Meanwhile, we are also pushing forward with our other products. We have been working on GATT-Powder, for which we will be starting to build up our first pre-clinical proof points. Finally, a liquid solution is also being developed. As we move closer to commercialization, we are also starting to build our commercial capabilities. We are evaluating different commercializing models, and over the course of the year, we will be working towards establishing a commercial plan and building the commercial team and resources. As we are looking to commercialize, we are also investing in scaling up our supply chain.
Meet the leaders behind the success of GATT Technologies
GATT Technologies was founded in 2011 by Johan Bender. Johan is a pharmacist by training, and has extensive experience in building medical device companies, pharma formulation IP, and medical testing laboratory companies. Johan was responsible for the inception of GATT’s technology, and is the holder of its patents. Since March 2020, Johan is Chief Technology Officer, focusing on further building out the platform. Geert van Gansewinkel is Chief Executive Officer of GATT. He joined the team in March 2020. Geert is a senior executive with more than 20 years of experience in strategy consulting, entrepreneurship and general management. He worked as a technology and strategy consultant for Accenture and The Boston Consulting Group. In 2013, he became entrepreneur and partner at life sciences compliance software company Polaris, building and managing the European and Asian businesses. He played a key role in the sale of the business to IQVIA in 2017, where he continued working in various roles, initially global commercial head for compliance solutions, owning global sales, marketing and customer success, and most recently general manager for the Dutch business. Geert holds a Master of Science degree in International Business Administration from the University of Maastricht, and an MBA degree from IESE in Barcelona.
“GATT’s platform solutions address surgical bleedings where applying pressure or suturing is not feasible or sufficiently efficient. This need is increasing with the strong global growth in surgical procedures and the introduction and expansion of robotic and laparoscopic surgeries.”