LivaNova reports positive study results for neuromod for sleep apnea

LivaNova (Nasdaq: LIVN) + today announced positive outcomes from a study of its nerve stimulator system for treating sleep apnea.

The company said its OSPREY clinical trial achieved a positive predictive outcome and concluded enrollment earlier than anticipated. This means the company projects a greater than 97.5% probability that OSPREY successfully meets its primary endpoint.

London-based LivaNova’s OSPREY trial evaluates its aura6000 hypoglossal nerve stimulator system. It pits the system against a no-stimulation control group in subjects with moderate to severe obstructive sleep apnea (OSA). These patients failed with or are unwilling to use positive airway pressure (PAP) treatment.

Following the milestone, LivaNova said investigators plan to continue long-term follow-ups through the primary endpoint and beyond.

The trial its primary efficacy endpoint as the demonstration that the apnea-hypopnea…

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LivaNova prices $300M offering

LivaNova (Nasdaq: LIVN) + announced that it priced an offering of convertible senior notes worth $300 million in total.

The company plans to offer the notes, due 2029, to qualified institutional buyers. LivaNova also granted initial purchasers an option to purchase up to an additional $45 million in notes. This option comes within a 13-day period beginning on and including the date of first issuance.

LivaNova expects to complete the sale to initial purchasers on March 8, subject to customary closing conditions. They bear interest at a rate of 2.5% per year, payable semiannually in arrears on March 15 and Sept. 15, beginning Sept. 15, 2024. Notes equal approximately $69.40 per share, representing a conversion premium of about 32.5% on LivaNova’s stock price.

The notes mature on March 15, 2029, unless earlier converted, redeemed or repurchased, according to a news release.

LivaNova expects approximate…

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LivaNova stock rises on strong Q4, massive bottom-line uptick

LivaNova (Nasdaq: LIVN) + shares got a boost today on fourth-quarter results that came in well ahead of the consensus forecast.

Shares of LIVN ticked up nearly 9% at $57.28 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down 0.4%.

The London-based medtech company posted profits of $16.3 million, equaling 30¢ per share. It recorded sales of $310.1 million for the three months ended Dec. 31, 2023. LivaNova increased its bottom line more than eight-fold on sales growth of 12.8%.

Adjusted to exclude one-time items, earnings per share 87¢, landing 10¢ ahead of Wall Street projections. Sales also topped the forecasts as analysts expected $287.1 million in revenue.

LivaNova’s cardiopulmonary business led the way with 18.7% growth, followed by neuromodulation at 7.7% clip. The company singled out t…

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LivaNova to lay off 137 in Pennsylvania

LivaNova (Nasdaq: LIVN) + plans to lay off 137 employees at its Pittsburgh, Pennsylvania location by the end of this year.

Shares of LIVN fell 0.7% at $50.37 apiece in midday trading today.

The Pennsylvania Dept. of Labor and Industry included LivaNova in its January notices under the Worker Adjustment and Retraining Notification (WARN) Act. Layoffs began taking effect on Jan. 31 and end at the end of 2024. Listed as a layoff, rather than a closure, the reduction affects employees at the LivaNova USA facility at 620 Alpha Drive #2 in Pittsburgh.

News of the layoffs comes at an interesting time for LivaNova. The company earlier this week appointed a new CEO after a 10-month search to fill its corner office. Vladimir A. Makatsaria, a longtime Johnson & Johnson executive, took over as the company’s CEO and takes up a board seat as well.

Makatsaria takes over amid a time of change at LivaNova. The c…

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LivaNova picks longtime J&J exec as new CEO

New LivaNova CEO Vladimir Makatsaria. [Image from LinkedIn]LivaNova (Nasdaq: LIVN) + announced today that its board of directors appointed Vladimir A. Makatsaria as its CEO and a member of the board.

The appointment goes into effect on March 1, 2024. He succeeds Bill Kozy, who took over the CEO role on an interim basis in April 2023 when Damien McDonald resigned from the corner office.

Makatsaria most recently served as company group chair at Johnson & Johnson MedTech. He took up that position in October 2018 to lead the company’s global Ethicon surgery business. Overall, he spent more than 27 years at the medtech giant, including stints as the company’s group chair for medical devices in Asia Pacific and as the J&J chair for China.

“Vlad is a respected leader in the medical device industry with a proven reputation for delivering results, driving innovation and building great teams,” said Bill K…

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The most important medtech leadership changes of 2023

Former Johnson & Johnson EVP and MedTech Worldwide Chair Ashley McEvoy [Photo courtesy of Johnson & Johnson]

From hirings and firings to promotions, resignations and surprising shake-ups, these were the most important medtech leadership changes of the year.

By Associate Editor Sean Whooley and Managing Editor Jim Hammerand

The leadership change at Johnson & Johnson MedTech was a surprising shift that ended up as the year’s biggest medtech leadership change of 2023.

In October, J&J EVP and J&J MedTech Worldwide Chair Ashley McEvoy announced her resignation from the world’s second-largest device manufacturer. She’s staying on into the first quarter of 2024 while her successor, Tim Schmid, gets settled into his new role.

Schmid, a 30-year J&J vet who was most recently company group chair of J&J MedTech Asia Pacific, said he’s “committed to building ev…

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LivaNova to wind down advanced circulatory support unit, focus on cardiopulmonary, neuromod

LivaNova (Nasdaq: LIVN) + announced today that it intends to begin winding down its advanced circulatory support (ACS) business unit.

The orderly wind-down is part of an effort to focus on the company’s core cardiopulmonary (CP) and neuromodulation units. ACS generated approximately just 4% of LivaNova’s net revenue for the nine months ended Sept. 30, 2023. The company expects to complete the wind-down by the end of 2024.

London-based LivaNova intends to retain all ACS standalone cannulae products and related accessories. That includes the ProtekDuo, transseptal arterial and venous cannulae and corresponding insertion kits. LivaNova plans to transition these offerings into its CP business unit portfolio during the first quarter of 2024.

Other ACS product lines, including the LifeSPARC and Hemolung systems, will have operations and services discontinued by the end of the year. LivaNova expects to supp…

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Another medtech reports a cybersecurity incident

LivaNova (NASDAQ: LIVN) + says it’s the latest victim of a cybersecurity incident.

The London-based device developer disclosed the cybersecurity incident in a Securities and Exchange Commission filing this week, saying the incident disrupted portions of its information technology systems and business operations.

“Promptly after detecting the issue, the company began an investigation with assistance from external cybersecurity experts and is coordinating with law enforcement,” LivaNova said in the filing. “The company continues to assess what information and systems were impacted and is executing its incident response plan, including implementing remediation measures to mitigate the impact of the incident.”

“The company has and will continue to take actions to remediate the issue, such as taking certain systems offline,” the company continued.

LivaNova said it expe…

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LivaNova adds former NuVasive CEO to its board

New LivaNova board director J. Christopher Barry. [Image from NuVasive]LivaNova (Nasdaq: LIVN) + announced today that it appointed J. Christopher Barry as a new board director.

Barry’s appointment becomes effective today and he joins the board’s Audit and Compliance Committee. In turn, Andrea Saia intends to retire from the board on Dec. 31, 2023. Saia initially joined the board of the London-based medtech company as a director in 2016.

With the changes, the LivaNova board will include 10 directors until Saia’s retirement at the end of the year.

“The LivaNova board of directors is pleased to welcome Chris Barry,” said Bill Kozy, interim CEO and chair of LivaNova. “Chris has spent his career in the medical technology industry, and we look forward to adding his commercial expertise and ability to drive long-term growth to the board. Additionally, on behalf of the entire board, I’d like to thank Andr…

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LivaNova president of cardiopulmonary is retiring

LivaNova (Nasdaq: LIVN) +  announced today that Marco Dolci intends to retire from his position as president of the cardiopulmonary business unit.

Dolci plans to retire by Dec. 31, 2023, continuing in his role to support the transition of responsibilities through the end of the year. The company appointed Franco Poletti to serve as interim GM of cardiopulmonary to support the transition. He’ll do so in addition to his current role as VP of cardiopulmonary for Europe, effective immediately.

The London-based medtech company plans to retain a leading international executive search firm to help find a permanent successor. It’s another high-profile executive departure for the company, which saw CEO Damien McDonald resign in April.

LivaNova noted Dolci’s role in the progress of its Essenz perfusion system, which just last month hit another regulatory milestone.

“On behalf of the board, the exec…

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LivaNova wins FDA clearance, CE mark for Essenz in-line blood monitor

The Essenz in-line blood monitor. [Image courtesy of LivaNova]LivaNova (Nasdaq: LIVN) + announced today that it received FDA 510(k) clearance and CE mark for its Essenz in-line blood monitor.

Essenz ILBM provides accurate and continuous measurement of essential blood parameters throughout cardiopulmonary bypass (CPB) procedures. It integrates into the next-generation Essenz perfusion system. Essenz enables perfusionists to access and manage reliable blood parameters directly from the system’s cockpit. It eliminates the need for additional monitors or holders.

London-based LivaNova says that existing blood-gas analyzers only reflect the patient’s clinical condition at the exact moment a sample is drawn. This sample can quickly change and the analysis becomes irrelevant. Essenz ILBM provides in-line, continuous monitoring for the duration of a procedure. LivaNova said this allows for the delivery of a patient-t…

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LivaNova stock rises on Q2 beats, increased 2023 guidance

LivaNova (Nasdaq: LIVN) + shares are on the rise today on second-quarter results that came in ahead of the consensus forecast.

Shares of LIVN ticked up 8.3% at $58.04 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even.

The London-based medtech company posted profits of $1.2 million in the quarter. That equals 2¢ per share on sales of $293.9 million for the three months ended June 30, 2023.

LivaNova recorded a 92.7% bottom-line slide while achieving sales growth of 15.6%.

Adjusted to exclude one-time items, earnings per share came in at 78¢, landing 24¢ ahead of Wall Street projections. Sales also beat expectations, with analysts forecasting $265.5 million in revenue.

LivaNova saw the largest revenue growth in its cardiopulmonary business, which rose by 19.7% year-over-year. That also r…

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