We talked to Jens Kirsch, CEO of terraplasma medical, about his experience in our German Accelerator Life Sciences focused program last fall and the company’s future plans for FDA approval of their device for the wound care market in the U.S.
We are a startup focusing on a medical application based on a platform technology for cold plasma and this can be used in a lot of different medical applications. We already proved the technology by introducing a device for wound treatment in the summer of 2019 by marketing this device and we’ve been getting really good feedback so far. In the future, we are planning to access other medical applications based on the same technology.
The U.S. is the biggest healthcare market and a first step for the wound care business. It’s two times the size of the European market, so it is very important to have a strong presence and market the device.
We wanted to get specific insight into the U.S. market: How does it work on the business side? How are reimbursements structured? How does wound care work in practice? Wound care is a difficult market in every country because there are so many different medical specialties working on that: dermatologists, wound managers, vascular surgeons, etc. It’s a broad range down to the homecare nurse. Then you have all those different players: hospitals, private clinics, homecare providers, nursery centers. Our first goal was to get a feeling of what the focus for our device could be and the business case for us. The second goal was to get a better understanding of how to get FDA approval and if there are other ways to be approved. We’ve been getting a lot of feedback there. And of course, we’ve made a lot of contacts with doctors. Cold plasma is not that established yet in the U.S. healthcare market and we were able to promote the idea through numerous introductions which were very helpful.
It was of course our hope in the beginning that we could spend time in the U.S. for the deep dive and have face-to-face meetings. Due to COVID-19, this was not possible so I think the team made the best out of it. And it was really nice to see that you could establish great relationships over only virtual meetings. Of course, getting into contact with doctors and potential partners in their clinics and giving them the device to play around with would have been better.
In the beginning, we started with a plan of what we want to achieve and what we want to do, who we’d like to approach over the course of the program and this worked really well.
This was really great! Even though it was only virtual, we had a good relationship and it was always fun talking to them which is important because we had calls each week. We could also discuss critical things. They encouraged me to think outside the box and consider different solutions and also putting their opinion directly on the table. They were trying to test me a bit along the lines of “how far would you go?” – like sparring partners.
Regarding the U.S. market, we identified a great strategy for the FDA pathway and we are now getting the details together with Greg Dombal, who was our German Accelerator mentor and coach, to get a pre-submission meeting with the FDA to discuss our strategies (for device approval). That’s the first next step. Besides that, we are trying to get two doctors that we’ve reached out to during the last year to use our devices in the U.S.. Even though our device has not been approved yet, they can use it for IRB-based studies (Institutional Review Board). We already have two studies running in the U.S. so they can more or less use some of the existing things already.
Getting into contact with those doctors and getting in touch with key opinion leaders was a very important step for us to get into the market.
It’s important to really listen and to learn about the different business models that are possible in the U.S. healthcare system compared to the European or especially to the German market. Talk to different FDA experts to get a feeling on alternative approaches to approval if a classical one is not possible.
Of course, I would recommend this. I think it is a really great opportunity to gain insight into the U.S. market which you would not be able to get in this time and in this density as it is possible in this program.
I think the most important part was that we were really focusing on the typical wound care devices which are already in the market and of course they are not a good predicate device for us because there is no cold plasma treatment in the U.S. at the moment. And we were then looking into other medical applications and there are some, where cold plasma is used in the U.S. and now we want to find a way to use those devices as predicate devices. So we’ve worked with the feedback we’ve got during the program and adjusted our strategy accordingly.
It was difficult for me in the beginning to really focus on one thing. Because our technology can be used for different medical applications, and I was looking in all possible directions which we could go for in the U.S. and it was too much. We would have had to talk to so many different people. So, focusing on your main business application for the U.S. is really important, especially in a virtual setting where you don’t have the time after work to sit with a beer and discuss other interesting potentials.
I think besides typical abilities like being motivated and passionate and an emphatic leader it is really important for a good entrepreneur to be able to improvise and adapt to new requirements, to listen and learn from others, and to be able to overcome throwbacks.