A hemostatic product for the operating room

19 December 2024

An early Christmas thought in 2009 makes Johan Bender found the company GATT. In barely twelve years, the company develops an innovative blood-strengthening product, for which large pharmaceutical firms line up. In May 2022, GATT is taken over by Ethicon, which moves to the Nijmegen Noviotech Campus. The success story illustrates why it is precisely in the Lifeport region that such companies are emerging.

Four days before Christmas, entrepreneur and pharmacist Johan Bender pays a quick visit to a conference. Outside on that Monday in 2009, it is overcast and cold. In the heated conference room, Bender reflects on a failed project to use a spray to quickly close surgical wounds. And about another project to protect cannabis products from degradation with a special coating. The lab personnel constantly complain about that coating because it really does stick everything together: the glassware at the table, even the lab technicians' hands. Awful stuff...

At exactly two-thirty on that afternoon, the sun breaks through in Bender's mind. Perhaps one and one is three after all. Could he perhaps use that coating to stick human tissue together? That would be ideal for surgeons who want to close surgical wounds quickly after an operation, for example, without leaks. Just take a piece of sticky tape with that 'sticky coating' off the roll and stick it on. He envisions it: a roll of biodegradable duct tape as a standard tool in every operating room.

The Nijmegen company that emerged from this idea - GATT Technologies - will be acquired less than fifteen years later in May 2022 by Ethicon, part of the American pharmaceutical company Johnson & Johnson. It is a success story from Lifeport Regio Arnhem Nijmegen, illustrating how cooperation between entrepreneurs, knowledge institutions, government and investors leads to innovations and improvements in health care and additional employment.

Scientists increase opportunities

After Christmas, Bender engages his network to check whether his idea makes sense. He first knocks on the door of Prof. Jan van Hest, professor of Organic Chemistry at Radboud University. Van Hest examines the sticky substance - the polymer based on polyethyl oxazoline, PEO for short. He pushes, twists and tinkers with it, to conclude that it is quite promising. Compared to another substance already used in health care - PEG - it sticks more than twice as well.

“Then you want to know if the substance is pure and widely producible,” Bender says. “That's essential if you want to market a product. Also essential: whether the substance is safe for humans.” For answers to both questions, he can turn to Radboud University and Radboudumc. For the research on patient safety and medical need - is it a product that the medical world is really waiting for - a valuable and lasting cooperation arises with Prof. Harry van Goor, gastrointestinal surgeon at the Radboudumc. Through Van Goor, there will be access to the Department of Surgery, Medical Imaging, the Central Animal Laboratory and other departments that may be important for research and development of the product. At this very early stage, the cross-linking of entrepreneur and knowledge institutions is essential. Bender and Van Goor become a twofold unit through product development. “We have always had the ultimate clinical application in mind,” says van Goor. “That requires mutual trust and an open, critical attitude toward each other in which it is sometimes allowed to crackle. That helped us a lot in the end, because it's better to kill a hopeless project right away than to come to the conclusion after ten years that you are working on something that nobody needs.”

ERDF contribution

Another essential component: funding. Without money, no research, let alone product development. The further development of the promising surgical tape requires a lot of money. Banks and traditional investment funds are not stepping in at this stage because they consider it too risky. The European Regional Development Fund (ERDF East) will step in with more than one and a half million euros in 2012. “This is exactly what ERDF East is meant for,” says program manager Hans Ahoud. “ERDF East receives money from the European community to strengthen the regional economy in Gelderland and Overijssel. The idea is that promising innovations in the region will be brought to the market faster with our subsidies in order to create new jobs, especially in SMEs. This involves risky, early financing that does not always succeed, but if it does - as in the case of GATT - has positive effects for the region. In doing so, we explicitly assess whether the innovations fit within the spearheads we have formulated as provinces and regions. For Lifeport, as we call the innovation network around Arnhem-Nijmegen, it is mainly about Health, Hightech and Energy. GATT fits perfectly into this picture. We helped the company get started at the time. Then they were able to take the next steps.”

From patch to patch

Besides investments from Bender and Oost NL, the ERDF grant proved of great value as some unexpected issues came to light. When scaling up, the substance could not be produced pure enough and the plaster turned out to work less well in practice than thought. Van Goor: “We saw that the plaster did not stick well but could stop bleeding. Then we began to have robust discussions about the future in full transparency and confidence.” “In which we actually quickly exchanged the plaster for a patch, a bleeding sponge,” says Bender. “The main consideration here was that you can demonstrate the effect of such a patch much better and faster, even during surgery, than the effect of a patch that, for example, prevents seam leaks from a stuck bowel after surgery. At that time around 2015, a blood-stabilizing agent, a hemostat, came on the market that we felt was not nearly as good as ours. So in that respect, too, the switch from a patch to a plaster was obvious.”

Responding to the new direction, Van Goor developed a bleeding model using surplus livers from the slaughterhouse, which greatly reduced the need for animal testing. This model allowed for extensive trials and comparisons with existing hemostatics, so that by 2020 a solid dossier had been built up on the blood-clotting sponge. With excellent results!

East NL strengthens regional economy

At that time, GATT has already gone through several new rounds of financing, with Oost NL in particular being a constant factor. Oost NL is the development company of the eastern Netherlands that, on behalf of the provinces of Gelderland and Overijssel, strengthens the regional economy with targeted investments. “Then we look especially at companies that are committed to smart energy, accessible health care and sustainable food,” says Viktor Mattousch, investment manager at Oost NL. “Preferably in cooperation with private investors, so that we can increase our financial clout and also immediately try to pave the way to follow-up financing already. We don't work with subsidies like ERDF, but with investments from which we prefer to get extra money and then invest it in new promising companies. For example, in GATT until 2020 we have invested a total of more than two million euros.”

The game is already on the wagon in 2020, as gradually the product's excellent results were also noticed by major players in the hemostatic market, such as Baxter, CRBard and Ethicon, a subsidiary of Johnson & Johnson. Says Bender, “We had also been testing our own patch with existing products and that led to approaches and intensified contacts. Then a phase of strategic weighing and negotiation begins, a 'tricky' period. If you sell too quickly, you get too little for your work. But if you go further with your product development, you also have to test it in people. That requires high investments, and money was not easy to come by at that time. Eventually we did choose that further development route, for which we used, among other things, a bridging loan from Oost NL and a million-dollar investment from my brother Andy Bender's American investment company Northstar.”

GATT acquired, product on the market

Then things move quickly. In early 2021 it will be known that the first patients in the Radboudumc, UMC Groningen and Erasmus MC have been treated with GATT-Patch with good results. Van Goor: “The patch can fill bleeding cavities when tissue has been cut away. The sponge can be cut to size, torn or rolled up, making it easy to handle in operating rooms. It also allows blood to clot much faster than existing products and - big plus - it also does not contain human clotting products like many other hemostatics at the time.”

After intensive negotiations with several parties, a deal will be struck in May 2022. Ethicon, a subsidiary of Johnson & Johnson, is acquiring GATT. The acquisition price is not disclosed, but for a premarket implantable medical device with the potential for annual sales of roughly $100 million to $250 million, it must have been a substantial amount. Johnson & Johnson will not reveal the deal until late 2023 when Ethicon has received CE mark approval for the patch and thus can enter the European market with it. Bender's modified Christmas idea could take operating rooms by storm. FDA approval is still some time away, but when the green light is given, America can also get its hands on the patch.

Welfare and prosperity

Importantly for Lifeport, ERDF and Oost NL, Ethicon has chosen the Noviotech Campus in Nijmegen as a production site for the patch. Bender, now associated with Ethicon as a consultant: “There we found sufficient space and cleanrooms needed to make our products. Meanwhile, we have already created about sixty jobs there and we continue to grow. It is great that in this region we were able to seamlessly make the transition from small office to chemical research, clinical trials, the start-up of the company and the expansion to a large production site. Everything was always within a few square miles.”

John van Sambeek, Health strategist at the Economic Board agrees: “The whole ecosystem around Lifeport Arnhem-Nijmegen is aimed at tackling social problems in Health, Hightech and Energy in particular. In a good innovation network, entrepreneurs can come up with solutions to these problems, if necessary they are linked to scientists and knowledge institutions, they get help with financing and investments, and they can test and validate their products and services in 'living labs' that we have designed. We facilitate and orchestrate where we can.”

“Innovative ideas are essential for a healthy and sustainable future,” says Jan van Dellen, director of the Economic Board. “Not everyone realizes that, but realizing them also creates new jobs. Look at GATT, which has gone from idea to product and many jobs here in record time. Healthcare and the economy both benefit. That is what we stand for, the linking of welfare and prosperity. With nearly 800,000 inhabitants in 18 municipalities in the Arnhem Nijmegen region, Lifeport is the fifth metropolitan region of the Netherlands. With a gross regional product of 27 billion euros, we are of national and international significance. We are not a copycat, but create our own identity in conjunction with our surrounding regions such as Brainport, Utrecht-Wageningen, Twente and the German Ruhr area. Our identity is green, healthy, sustainable and innovative. GATT's success story illustrates this excellently.”

 

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