The former Johnson & Johnson MedTech executive took over the London-based company in February 2024. Since then, the company has continued to deliver in the perfusion space with its Essenz heart-lung machine, and in epilepsy, while also pursuing new avenues in neuromodulation.
LivaNova hopes to enter the large obstructive sleep apnea (OSA) market with its differentiated proximal hypoglossal nerve stimulation (p-HGNS) technology, too. aura6000 is an investigational implantable p-HGNS system that could rival Inspire Medical’s neurostimulator as an alternative to traditional CPAP sleep respiratory systems. LivaNova submitted the technology to the FDA earlier this year.
Finally, the company expects CMS to reconsider coverage for difficult-to-treat depression after submitting a request earlier this year.
Makatsaria and LivaNova’s leadership outlined the company’s plan for growth during a November Investor Day event. He spoke to MassDevice recently about the company’s roadmap and where it’s headed down the line.
The following has been lightly edited for space and clarity.
Where does the roadmap at LivaNova start?
Vladimir Makatsaria: “Importantly, today, we have two strong, well-performing businesses that are leaders in the space in which they compete. They have performed very well over the last two years, with double-digit revenue growth, significant expansion in margins and cash flow. This creates a strong foundation for us to build on.
“Where are we going? It’s a company that will be at the benchmark of medtech, top-line and bottom-line growth in a sustainable way. The way to get there is to broaden our portfolio to enter larger and faster-growing markets with significant unmet patient needs — the markets where we have the right to win.”
The next step
VM: “Obstructive sleep apnea is our next step into that strategic roadmap. It’s a billion-dollar marketplace with double-digit growth and with still a lot of space to grow because of the significant unmet need in the patient population… Then, we have upside with depression, where [there is] also very significant unmet patient need. Unlike obstructive sleep apnea, [there is] currently no alternative for a significant part of that patient population with difficult-to-treat depression. We believe we have a very promising therapy. Pending CMS approval, this will be the second addition to our current portfolio. [It’s a] high unmet need in both sleep apnea and depression. They have high-growth and large markets.”
An overview
VM: “[It’s] the right to win. If you think about neuromodulation as our superpower, with all the capabilities that we already have with epilepsy — manufacturing, R&D, market access functions and so on, that gives us opportunity to expand our neuromodulation capability to different disease states. So at the end of [the roadmap], we will have a company with a more sustained, accelerated top-line growth and bottom-line growth.”
The importance of the Cardiopulmonary business
VM: “Cardiopulmonary plays an important part in our portfolio today. It’s a market leader in the space. It competes, and there are three major growth drivers for that business. We have a 70% market share globally in our heart-lung machine business, and we launched a new product called Essenz at the end of 2023. The first growth driver for the future will be to upgrade the installed base around the world to this new heart-lung machine that has the capability to not just be a piece of equipment, but to be a smart machine, to be a learning machine, to be kind of a center of the cardiovascular operating room with intelligence.”
“While we have 70% market share in the heart-lung machine, on the disposable side – mainly oxygenators — we have about 40% market share. We have very good momentum. We’ve gained about 10% market share points over the last couple of years. We still have a lot of space to grow and the excellence of execution and supply chain manufacturing, and then innovation in that space. With the launch of a new oxygenator that is clinically differentiated, that will be the growth driver or enabler of market share.”
What have the clinical efforts looked like for sleep apnea?
VM: “In our trial, the patient population was significantly more complex and difficult than in the comparable pivotal trials. We did not exclude complete concentric collapse patients, which, in the scientific literature, is about 30% of all the patient population and sleep apnea. Today, complete concentric collapse patients are not indicated for the current procedure. With us, there will be no contraindication for concentric collapse. That creates an opportunity for more patients to be treated.
“Second, our patient population had higher [body mass index], [oxygen desaturation index] and [apnea-hypopnea index] in the clinical trial, so [it had] more severe patients with sleep apnea. The responder rate was comparable to other clinical trials in the industry, but with a more severe patient population. We believe that that is a significant opportunity for more complex patients to be treated.”
Next steps and differentiators for sleep apnea at LivaNova?
VM: “Just after we completed the OSPREY study, we started to improve the algorithm of titration, and we brought in several patients who are non-responders in the trial. A significant percentage of these non-responders, with a new titration algorithm, became responders. We continue to study this from the clinical point of view.”
“It’s a breakthrough from the clinical perspective, because it gives us a path to show that our responder rate could be significantly higher than anything on the market today… It’s a shorter procedure, because it’s you implant the device more proximally, so it’s easier to access. It’s easier to implant the device. There are a number of clinical and technical benefits that the device has that we believe is, is differentiating from anything today on the market.”
Moving into neuromodulation for depression
VM: “We believe that, just in the U.S., 1.2 million patients could benefit from this technology. The procedure showed continuous improvement from year one to year two. Secondly, and importantly for this type of patient, it showed durability of impact. If patients were responders in year one, they’re likely to stay responders in year two. The durability of that was over 80%, which, in this type of patient population, is very high.
“We’ll continue to partner with CMS and share data and share our knowledge and exchange views on this. I am optimistic that we will continue to progress on this matter. If we get reimbursement, it will be a huge win for patients, and it will give us an opportunity to expand into a new market with a differentiated portfolio. Most importantly, it would impact millions of patients.”
Where LivaNova stands under Makatsaria’s leadership
VM: “If you ask me what I’m most proud of, I would say it’s the people at LivaNova. I think there’s obviously tremendous work, and we’ve delivered the results of the company, the outlook for the future, the financial outlook, but more importantly, the strategy. The work comes from over 3,000 employees around the world who are doing an incredible job, and that is the source of my biggest pride.”
