LivaNova inOn February 5, it was announced that its board of directors appointed Vladimir A. Makatsaria as Chief Executive Officer and member of the board.

This appointment will take effect onEffective March 1, 2024.His predecessor was Bill Kozy. Kozy temporarily took over as CEO in April 2023 after Damien McDonald resigned from the position.

Vladimir a . Makatsaria

Makatsaria recently served as the Group Chairman of Johnson & Johnson MedTech. He took on this role in October 2018, leading the company’s global Ethicon surgical business. Overall,He has worked at this medical technology giant for more than 27 years.Also once served asJohnson & Johnson MedicalChairman, Global Head of Surgical (Ethicon) Business Unit,Including serving as the Chairman of the company's Asia-Pacific Medical Device Group and the Chairman of Johnson & Johnson's China operations.

Makatsaria has accumulated an outstanding career in the medical device industry. Since joining Johnson & Johnson in 1996, he has been promoted through various positions and served as the Managing Director for Russia and the CIS countries, as well as the Vice President of Strategic Affairs for Europe, the Middle East, and Africa.

MakatsariaThe educational background includes a Bachelor's degree in Physiology, a Master's degree in Healthcare Administration, and an MBA in Strategic Management from the University of Minnesota. This solid educational foundation has supported an extensive career in both healthcare and business management.

LivaNova Board Chairman Bill Kozy said, "Vlad is a respected leader in the medical device industry, renowned for delivering results, driving innovation, and building great teams. The Board and I are highly confident that Vlad is the right CEO to advance the company’s strategic plans and achieve our long-term growth objectives."

Makatsaria Takes Over During LivaNova's Period of Transformation.The company announced last month that it plans to gradually scale down its Advanced Circulatory Support (ACS) business unit. This orderly reduction is part of the company's effort to focus on its core Cardiopulmonary (CP) and Neuromodulation divisions.

Just last month, LivaNova PLC, a global giant in ECMO medical devices, announced that in order to further concentrate resources and strengthen its core cardiopulmonary (CP) and neuromodulation businesses,The company has decided to orderly scale down its Advanced Circulatory Support (ACS) business unit.In the first nine months of 2023, the ACS business contributed approximately 4% of the company's net revenue. The closure of this business is expected to be fully completed by the end of 2024.

It is understood that LivaNova's Advanced Circulatory Support (ACS) business unit includes a range of products primarily aimed at providing support for patients with cardiac and respiratory issues. These include systems and devices such as the LifeSPARC system, Hemolung system, and various surgical kits like ProtekDuo, TandemHeart, TandemLung, and TandemLife. These products meet the needs of extracorporeal life support (ECLS) and mechanical circulatory support (MCS), offering solutions such as oxygenators, specialized and standard cannulas, blood pumps, pre-connected circuits, and accessories.

"I look forward to collaborating with the global team to deliver meaningful medical technologies to the patients we serve and to fully realize LivaNova's potential," Makatsaria said. "I want to thank the board and Bill Kozy for giving me the opportunity to serve as CEO of LivaNova."

In April 2023, LivaNova experienced a highly publicized executive departure, with Chief Executive Officer Damien McDonald resigning.

An analyst pointed out that McDonald's decision came after being disappointed with the progress of several LivaNova projects, including the Caisson transcatheter mitral valve replacement and heart failure indications for vagus nerve stimulation, as well as a trial for difficult-to-treat depression that failed to end early, thereby not supporting Medicare coverage.

In September 2023, LivaNova announced that Marco Dolci, the current President of the Cardiopulmonary (CP) Business Unit (BU), plans to retire before December 31, 2023. Dolci will continue to perform his duties until the end of the year for a smooth transition. Afterwards, Franco Poletti will serve as the interim General Manager of CP. In addition, Poletti will immediately assume the role of Vice President of CP Europe.

LivaNova will hire a leading international executive recruitment firm to assist in finding a permanent successor for the CP President. The new successor is now taking office with countless expectations.

Matson analyzed that the new CEO could cut costs related to pipeline plans, further reduce expenses in management and sales, and might even sell the company to a strategic or private equity firm. "We believe the new CEO has an opportunity to create value."

LivaNova is a global medical technology company focused on innovative cardiovascular and neuromodulation solutions. In 2015, Cyberonics, a leader in neuromodulation medical devices, acquired the Italian company Sorin Biomedica for $2.7 billion. The merger led to the creation of the new company LivaNova, which was listed on the NASDAQ in the United States in October of the same year. At that time, the company’s main businesses were divided into three major areas: cardiac surgery (50.4%), neuromodulation (28.9%), and cardiac rhythm management (20.5%).

In the 2023 Medical Design and Outsourcing ranking of the top 100 global medical device companies, LivaNova ranked 72nd.

LivaNova's strengths lie in the fields of extracorporeal circulation and neuromodulation, such as heart-lung machines and VNS. For other products, in the face of fierce market competition, the company decisively abandons those without core competitiveness. For example, in 2017, it sold its cardiac rhythm management business to MicroPort Medical, including non-core competitive products such as defibrillators, cardiac resynchronization therapy devices, and pacemakers. Another example is that at the end of 2019, the company made a tough decision to terminate the previously focused transcatheter mitral valve replacement (TMVR) project. To address safety and efficacy issues, the company spent a long time redesigning the product but ultimately did not achieve good results. This greatly increased the time and funds required to bring the product to market.

Last month, LivaNova decided to scale back its Advanced Circulatory Support (ACS) business to focus on its core product offerings. Over the years, LivaNova has attracted acquisition interest from giants like Medtronic and Johnson & Johnson, highlighting its significant advantages in the innovative product sector. As a future leader in global cardiovascular and neuromodulation solutions, LivaNova will further concentrate on its core strengths, improve operational management, and strive to develop superior products and treatment solutions.

In the ECMO market, the three leading companies—Maquet/Getinge, Medtronic, and LivaNova—have long dominated the field, while other emerging brands are gradually joining the competition.Among them, Maquet's ECMO products account for about 80% of the market share in China, holding a significant position. Notably, the membrane lung material used by various ECMO manufacturers is solid hollow fiber membrane, which is exclusively supplied globally by Membrana, a subsidiary of 3M.

In addition,In the global market, foreign companies that have laid out ECMO include Germany's Xenios/Fresenius, Germany's Medos Medizintechnik, Italy's Eurosets, Japan's JMS Co., Ltd., Abbott, and others. Among them, Fresenius and Medos Medizintechnik have already been listed in China.

In recent years, with the strong support of national policies in China, several companies have started to make arrangements in the ECMO field and achieved phased progress. In China, the main application scenarios of ECMO are in the intensive care medicine and cardiology departments of tertiary hospitals, and its use has already expanded to emergency, respiratory, thoracic surgery, and other departments. ECMO has been applied in perioperative support for complex high-risk PCI, auxiliary support for airway surgeries, and perioperative support for heart and lung transplants. In the future, ECMO will be extended to grassroots hospitals for patient treatment.At present, China's ECMO technology has gradually achieved breakthroughs in centrifugal pumps, oxygenators, oxygenation membrane materials, and complete machines.

List of ECMO Companies Approved by China's NMPA 

Image Source: Heart Future

Among domestic companies, except forThe Hannuo Medical, Changzheng Medical, and Seton Medical have been approved for marketing. Several other companies are also actively innovating and developing, including Feidun Medical (Suzhou), Weishengkang Medical (Suzhou), and Xinying Medical (Suzhou), which are not yet on the market.

And this time, with the new "leader" taking office, can their outstanding leadership and experience accumulated over the years at Johnson & Johnson be evaluated to help LivaNova, which seems to be on a downward trend, rise again?

▲ Source of the article:Medical Device Innovation Network

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