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News We’re Watching: LivaNova Names CEO; Surgical Robot Goes To Space, And More

Executive Summary

Medtech Insight's News We're Watching highlights medtech industry developments we are following: LivaNova named a new CEO, Roche confirmed plans to launch a continuous glucose monitor, Virtual Incision sent its surgical robot into orbit, and Synchron announced a deal with Acquandas to advance its brain interface technology.

LivaNova Names Makatsaria As Its New CEO

LivaNova announced on 5 February that its board of directors named Vladimir Makatsaria as CEO.

Makatsaria has spent nearly three decades in leadership roles at Johnson & Johnson, most recently as company group chairman of J&J’s Ethicon Global Business. He was also the company group chairman of Medical Devices Asia Pacific and president of Europe Middle East Africa at J&J.

“Today, begins a new chapter,” Makatsaria wrote on his LinkedIn page. “The team at LivaNova is committed to innovating for the future, advancing the quality of care in neurological and cardiac health. I am excited for this new chapter for me and for the LivaNova team, its customers and the many patients we’ll serve together.”

Makatsaria will succeed Bill Kozy, who served as LivaNova’s interim CEO since April 2023. Kozy will continue to serve as LivaNova’s chair of the board as he has since 2021.

Kozy took over from Damien McDonald, who resigned abruptly on 14 April.

UK-based LivaNova manufactures and markets products for advanced circulatory support and cardiopulmonary bypass. It also markets vagus nerve stimulation devices to treat depression and epilepsy and is developing an implantable hypoglossal nerve stimulation device to treat sleep apnea.

LivaNova sold its surgical heart valve business to private equity investors in 2020. (Also see "LivaNova Sells Surgical Heart Valve Business To Gyrus Capital For $73M" - Medtech Insight, 4 Dec, 2020.)


Roche Set To Launch CGM In Europe In 2024

Roche expects to launch its Accu-Check SmartGuide continuous glucose monitor in Europe in 2024, Roche Diagnostics CEO Matthew Sause confirmed during a sales and earnings call on 1 February.

SmartGuide is the company’s first-generation CGM. The company has not offered more detail on the design of the device or if it has plans to introduce it outside of Europe.

Executives will probably say a lot more about SmartGuide during an investor meeting on 22 May. Roche is also hosting a symposium at the upcoming Advanced Therapeutics & Treatments for Diabetes (ATTD) meeting in Florence on March 6. (Also see "News We’re Watching: Intuitive Plans da Vinci 5 Launch; Roche’s CGM Plan; ReWalk Rebrands, And More" - Medtech Insight, 29 Jan, 2024.)

Analysts will be curious to know more about SmartGuide’s form factor, accuracy, duration and how it will be differentiated from other CGM systems on the market, Wells Fargo analyst Larry Biegelsen wrote on 1 February.

Biegelsen also hopes to learn how SmartGuide will be integrated with insulin pumps as well as Roche’s mySugr mobile app. (Also see "Speaking To Mobiquitiy About The Whats And Hows For Digital Platforms" - Medtech Insight, 2 May, 2023.)


Robotics Space Race Is Gathering Pace – Virtual Incision Claims First Place.

Virtual Incision has launched its MIRA tabletop surgical robot into space.

The company is sending MIRA to the International Space Station. It is carried by a Northrop Grumman-manufactured/Orbital Sciences Corporation-designed Cygnus cargo spaceship launched by a SpaceX Falcon 9 rocket from Cape Canaveral, Florida.

SpaceMIRA, the renamed version of MIRA equipped for zero gravity, will be an opportunity for Virtual Incision to test out both the robot’s automated and remote surgical capabilities.

The company hopes that, by performing such a bold tech demonstration, Virtual Incision can prove itself as the system-of-choice for clinics that are either geographically remote, or lacking surgeons.

Over the past few years, there have been several stories in the surgical robotics universe about system installations in commercially less significant geographies.

Typically, these commercial plays are made by surgical robotics companies for two reasons: to address unmet needs and to assess market fit in areas with lower reimbursement or other niche needs.


Synchron Advances Brain Interface With Acquandas Investment

Neurotech start-up Synchron announced on 1 February it has acquired a minority equity stake in Acquandas, a manufacturer that specializes in components for the health care industry.

“As we pioneer functional endovascular neurotechnology, this investment strengthens our technology innovation and supply chain for our unique product offerings, beginning with brain-computer interfaces,” said Synchron CEO Tom Oxley.

Synchron’s Stentrode device uses a minimally invasive endovascular procedure, similar to placing stents, that avoids open brain surgery, the company said. The FDA has given breakthrough device designation to Stentrode, which is being tested in six patients in the COMMAND trial under the first investigational device exemption for any company assessing a permanently implanted BCI.

The early feasibility study assesses safety while evaluating quantified efficacy measures of the Synchron Switch motor neuroprosthesis in patients with severe paralysis, Synchron said in September 2023.

Synchron could eventually compete against Elon Musk’s Neuralink, which announced on 29 January that its brain-computer interface has been implanted in a human for the first time. The US Food and Drug Administration approved human clinical trials for Neuralink’s BCI in May.

Neuralink’s device is implanted directly into the patient’s brain tissue through open brain surgery whereas Synchron uses a less invasive approach.

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