We spoke with Dr. Laura Figulla, Co-Founder, CEO and Managing Director of coramaze technologies GmbH, about the novelty of the mitramaze® valve repair system, the challenges of launching an innovative product and her plans for commercial expansion.
Can you tell us about your background and experience prior to co-founding coramaze technologies?
As someone coming from a family of cardiologists, there is a little bit of legacy to be fulfilled. I studied medicine and business administration and received a master’s degree in management & accounting, as well as an interdisciplinary PhD in health economics. Prior to coramaze technologies, I was employed for 8+ years in the life sciences team of a top global management consulting company, where I became an expert on innovation management, business strategy and financial management with a focus on med tech.
How did you kick off coramaze technologies and what is your role in the company?
Before actually co-founding coramaze technologies, I kicked off the mitramaze® research project with Prof. Till Neumann, and then later on, in 2013, we actually started the company together. Till and I have a long-standing relationship through our joint research on the health economics of transcatheter aortic valve implantation (TAVI) between 2009-2012.
As for my role, formally I am the CEO and Managing Director, and, as such, I serve as the interface between the Board of Directors, the shareholders and the company. My biggest responsibility is to secure all the resources so that R&D can truly focus on developing a successful product. This ranges from recruiting the right team members, to building the right infrastructure, to managing legalities, and, most importantly, secure sufficient funding.
How does the company stand out in comparison to others in the heart valve repair space?
Many other heart valve repair companies are mimicking standard surgical procedures. Their devices try to change the anatomy, be it by fully replacing the valve or by putting something into the annulus and cinching it.
What makes the mitramaze device different is that it uses a unique spacer technology, which is designed to leave the native structures intact, to restore the coaptation of the valve leaflets and thus, to close the gap between the leaflets without manipulating the surrounding structures. The device will be easy to use and we can deploy and implant percutaneously. The intervention will be quite intuitive with a short procedural time.
What are some of the key challenges you face as coramaze technologies brings innovative product(s) to market?
Funding is a huge challenge. With limitless funding, I am convinced our R&D team could find an engineering solution for almost every medical ailment, but due to budget restrictions, we have a lot of time pressure and need to prioritize smartly and lean. Another challenge is to gauge the value of our product when there is only current marginal measurable evidence to do so.
Additionally, spacer technologies are very pioneering and truly out of the box. They have limited literature and no predecessors, especially from proceeding surgical approaches. This means, we will have to educate the scientific community about the healthcare value of spacers, which, although challenging, helps our company stand out in the competitive mitral valve repair market.
Lastly, as a growing company, we need to find the right team members. Fortunately, we’re on a great track in that we have very committed, supportive investors and are well on our way to building a world class team.
What is the impact that reimbursement creates for product launches and commercial expansion plans?
We knew during the early phase of development that we wanted to factor potential reimbursement into our development strategy. This is important, because, for example, we might have to brand our device according to the accepted code to make sure we meet all of the criteria.
In that sense, we were extraordinarily early in getting the support of ValueConnected to assess reimbursement and build a tool that could help us decide which markets to target first. We needed to figure out where we could get the most reimbursement and where to find established reimbursement structures that we could leverage.
As far as the commercial expansion plans are concerned, it is very important that we better understand the reimbursement needs that should be addressed in order to be successful in that specific market and their clinical pathway.
How and why did you start a project with ValueConnected?
We got in touch after receiving a personal recommendation from our VP of Clinical Affairs. Our main project was to better understand the current reimbursement landscape of specific EU countries which may impact current device development. We needed to ensure all clinical and economic data were being collected and optimally used for commercialization and to bridge reimbursement.
What were the strategic results of the work with ValueConnected and how was your experience working with us?
The report results have informed us which EU country provides the highest reimbursement for our device, and specifies what achieves higher reimbursement . The strategic implications for us are still pending however until product launch. ValueConnected is now part of our trusted network of service providers.
Would you recommend ValueConnected to your colleagues? And if so, why?
Yes, we have referred ValueConnected, because they understand our device and know how to effectively communicate with us.
What do you envision are the next steps after working with ValueConnected?
We would like to continue working together with ValueConnected, specifically to have them review our clinical study protocols to include economic data endpoints.
Please note that the mitramaze device is currently under development and not available for clinical use neither in the EU nor US. The information provided in the interview reflect the current status of the development programme. Coramaze technologies is not liable for misuse of this information and can not exclude that the finished device will differ from the current version.