Interview: Fréderic Mouret on Bypass Solution and End-to-side anastomosis device

Karim Mouneimne Thank you for agreeing to share your medical device experience. I hope our readers will learn from you and get to know you more.

Fréderic Mouret is a seasoned medical device entrepreneur with 20 years of experience. He is currently the president and the CEO of Protomed SA in France, a medical device development group specialized in the development of minimally invasive and interventional devices. Is this correct? Is it still the case?

Fréderic Mouret Yes. Our company is growing in minimally invasive surgery and cardiovascular devices. We are developing more and more projects in this field.

Karim Mouneimne  On June 9th, 2022, we heard some good news regarding Bypass Solution, which won an innovation award given by the Marseille Hospital group, APM, and the Marseille University Technology Transfer Office, SATT. I believe Bypass Solution is currently developing a side-to-end anastomosis device for iliofemoral artery reconstruction and you are the lead R&D group in this development. Could you please tell us a little bit more about Bypass Solution?

Fréderic Mouret Bypass Solution is developing an End-to-side anastomosis device for vascular access and bypass. It was founded in October 2020. I am the CEO of this company. This startup company is relying on Protomed to do the R&D. With my support and the support of all our knowledge at Protomed, we are helping Bypass Solution grow into the next phases of device. The company has been funded by a family office based in Singapore since the beginning, and we just closed a round for €1.4 million Euros in dilutive and €1.6 million Euros in non dilutive financing. This funding will help us go to First-In-Man (FIM) with the technology, and that already a great achievement.

Karim Mouneimne This is exciting news – €3 million in financing for a startup company! That is great.

Fréderic Mouret Thank you.

Karim Mouneimne Congratulations, it was probably a lot of hard work to get to this point. Was it your intention to bring the company to a First-In-Man? Has this always been the strategy?

Fréderic Mouret Yes, It is definitely the strategy of the company. We want to bring it at least to First-in-Man, and then market the bypass part of the device. What we also want to do, is to develop our technology as a platform that can be used in various cardiovascular surgeries. For instance, we know that we can use this solution for bypass, not only for Fem-Pop (femoro-popliteal bypass), but also for aorto-iliac bypass and other vascular bypass.

Moreover, we think that this technology could be really beneficial for arterio-venous fistulas, anastomosis of cardiac support devices and why not for access of large port devices in the cardiovascular area, like TAVI devices. So definitely our goal is to focus on bypass, but also offer our technology to other areas in the cardiovascular space.

Karim Mouneimne So, anywhere where you see a need for end-to-side vascular reconstruction is basically your target regardless of the indication. Can you tell us a little bit about what you are trying to solve with this technology platform and how it will help patients?

Fréderic Mouret Sure. I would say in our first indication, which is femoro-popliteal bypass, we are in a situation where we have very long lesions into the leg of the patient. The issue is that percutaneous technology and vascular technology are not performing well. Today, we are using open surgery to be able to operate on these patients. These patients are very old and have lot of comorbidities. We are in a situation where we are doing the most aggressive surgery to the most fragile patients.

So, we have decided to develop a percutaneous approach to do the bypass. We are going to deploy, through a percutaneous approach, an anastomosis system that will allow you to have a bypass going out of the artery that you can suture to another artery. It is very beneficial to the patient because we can expect to decrease the procedure time significantly. We’re also going to potentially decrease the infection rate because there are no more large incisions, which will also decrease the hospital stay. And the good thing is that we still expect to have the benefits of surgery. The patency rate in surgery is very good for patients but with very, very small comorbidities of the procedure. That’s really our target.

Karim Mouneimne Today, for a typical indication, how long is the patient stay in a hospital, and what would this technology achieve? Is it completely an outpatient procedure, or something in between?

Fréderic Mouret We are trying to get to an outpatient procedure. Today, it takes about 8 to 10 days and it’s a technique which is only available to cardiovascular surgeons. Our goal is to migrate to a percutaneous approach, meaning that potentially our device would be used in an outpatient procedure by not only surgeons, but potentially cardiologists and cardiologists will be able to do it.

Karim Mouneimne This is the very hot topic indeed. Is the challenge both the implant side and the delivery system, or do you feel like one is more challenging than the other? From a technical point of view, what would be the most challenging part?

Fréderic Mouret The delivery system. The implant is based on a very well-known technology. It’s a covered stent with a vascular prosthesis, which is something that we have know for many years. We know the benefits of this technology. But the delivery system, being able to deliver percutaneously a device that it is going out of the artery, is really a challenge. We are struggling a lot in this area, but we have had good results so far.

Karim Mouneimne Well, it’s all about new technology. It’s always challenging, right? But once you’ve overcome that challenge, I think you’re in a very good position to expand to other areas.

Fréderic Mouret Yes, and our company, Protomed, is really used to developing delivery devices. We are working with various startups that are working on implants, and we are developing their delivery system. So, I’m really confident that we are going to make it, because we have expertise in this domain.

Karim Mouneimne Good for you. I’d like to hear how you came up with this idea, a little bit of a history from ID to proof of concept and to where you are today. Often, we don’t see or we fail to see the length of time it takes to get to success, right? I mean, sometimes we feel like it’s an idea, and boom, that’s it. You’re already basically running with the ball. But it’s really a different story, right. It’s a much longer and more mature process. Can you tell us more about the process of maturity?.

Fréderic Mouret When you are talking about long process, I mean this is it, yes, it is definitely. This design idea came from Professor Yves Alimi, who is a Vascular surgeon in Marseille. We have been working with him since 2004 on various projects. He has been working hard at developing new anastomosis for vascular surgery. It has been very, very long. It was very difficult to find the right technology and the best way to deploy implants, and it took really a lot of time. We were about to completely abandon this project and not discuss it anymore. But he came up with a new idea  four years ago, and he said “I think it’s a better way to develop the anastomosis”. So, we started working again, developing new concepts.

And we conducted some tests at ViVitro Labs in Marseille to see where we were in terms of the leak proof quality of the anastomosis. It was interesting, the work we’ve done with you. Finally, we went to a concept that was working. We had a design and new patents. We did this first trial, which was really beneficial because it allowed us to find an investor to fund the development and create the company.

In the past two years, we have been focusing on completing the device proof of. Now, we have two patents on the design. We are working on new patents for the delivery systems, and we are starting work on the design output, and the design freeze of the device which we target in 12 to 18 months, and potentially go to the First-In-Man in the next three years.

Karim Mouneimne Out of all the work that you did in the proof of concept and maturation of this technology, which point was the most convincing for the investor?

Fréderic Mouret I think it was when we made the first animals and cadavers, and had very good results with very poor-quality devices, but it was clearly evident for the investor. We knew that this investor is really involved in the cardiovascular area. They are already involved and have invested in different devices in cardiovascular areas. So, when they saw this idea that was not completely crazy and was about to work, they really decided to invest in the company. It was a small investment round at that time, but it allowed us to raise more money with public grants in France and this made the difference. Sometimes a very small investment from an investor can do very great job with leveraging grants and subsidies.

Karim Mouneimne Absolutely, absolutely. I completely agree with you.

This Cardiovsacular Device Pioneer Interview is Part 1 of  3. Part 2 of the interview will continue in December.

Read about other Cardiovascular Pioneers here.

Disclosure

Protomed Labs SASU was a full subsidiary of the Protomed SA, before being acquired by ViVitro Labs in July 2019. Karim Mouneimne is currently on the board of Protomed SA.