iRhythm closes offering worth more than $660M

iRhythm (Nasdaq: IRTC) + announced today that it closed an offering of senior notes worth gross proceeds of $661.25 million.

The San Francisco-based cardiac monitor maker said earlier this week that it intends to offer $450 million in convertible senior notes. Approximately 17 hours later, it upsized that offering to a base of $575 million.

San Francisco–based iRhythm sold the notes — due 2029 — to qualified institutional buyers. Proceeds include the full exercise of an option to buy up to an additional $86.25 million in notes. The notes will be senior, unsecured obligations of iRhythm, with interest payable semi-annually in arrears. They notes mature on Sept. 1, 2029, unless earlier converted, repurchased or redeemed.

Holders can require iRhythm to repurchase for cash all or a portion of the notes at 100% of their principal amount, plus interest.

The company estimates net proceeds of approxi…

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iRhythm proposes $450M offering

iRhythm (Nasdaq: IRTC) + announced today that it intends to offer $450 million in convertible senior notes.

San Francisco-based iRhythm plans to offer the notes — due 2029 — to qualified institutional buyers. It intends to grant initial purchasers a 13-day option to buy up to an additional $67.5 million in notes. The notes will be senior, unsecured obligations of iRhythm, with interest payable semi-annually in arrears. The notes mature on Sept. 1, 2029.

iRhythm may redeem for cash all or part of the notes, at its option, if its reported sale price totals at least 130% of the conversion price for at least 20 trading days during any consecutive 30-day trading period. Holders can require iRhythm to repurchase for cash all or a potion of the notes at 100% of their principal amount, plus interest. The company determines the interest rate, conversion rate, offering price and other terms upon the pricing of the notes.

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iRhythm teams up with Epic to streamline Zio access

The next-generation Zio patch. [Image courtesy of iRhythm Technologies]iRhythm (Nasdaq: IRTC) + announced that it plans to use Epic’s Aura platform to streamline access to its Zio long-term monitoring and telemetry services.

With this collaboration, iRhythm can make Zio more readily available to healthcare providers using Epic. That also applies to the more than 250 million patients in the U.S. who have a health record in Epic.

The company said in a news release that it plans to partner with early adopter customers to integrate Zio into Aura in the fourth quarter of 2024. It expects to begin offering the solution to existing and new Zio customers beginning in early 2025.

iRhythm designed the Zio long-term ambulatory cardiac monitor to detect potential cardiac arrhythmias. Zeus, the company’s advanced, deep-learned AI algorithm, supports the capture and analysis of ECG data recorded by Zio. The company secured…

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iRhythm stock dips on mixed Q4 as guidance ‘may disappoint’ investors

iRhythm Technologies (Nasdaq: IRTC) + shares took a hit today on third-quarter results that came in mixed compared to the consensus forecast.

Shares of IRTC fell 5.5% at $108.75 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remained even.

The San Francisco-based heart monitoring technology maker posted losses of $38.7 million, or $1.26 per share. This came from sales of $132.5 million for the three months ended Dec. 31, 2023. iRhythm nearly doubled its losses from the same period a year ago despite 17.7% sales growth.

Adjusted to exclude one-time items, losses per share came in at 84¢. That fell 24¢ shy of projections on Wall Street, where analysts expected $130.2 million in revenue.

Recent highlights for iRhythm included CE mark for the next-generation Zio system in January. The company reported it…

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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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iRhythm releases strong Q4 prelims, strengthens balance sheet

iRhythm Technologies (Nasdaq: IRTC) + today released a solid preliminary earnings update that included projections of up to 20% revenue growth in 2024.

The wearable cardiac monitors developer saw IRTC shares jump more than 7% in value to $112.91 apiece by the close of trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 1%.

Highlights from iRhythm’s presentation at the 42nd annual J.P. Morgan Healthcare Conference included:

Patient registrations in Q4 2023 were up more than 22% year-over-year; The company closed a five-year, $150 million term loan credit facility to boost its capital structure and ensure ongoing financial flexibility; iRhythm is moving forward with resolving an FDA warning letter over the Zio AT mobile cardiac telemetry device, submitting a 510(k) application to catch up on legacy changes; The compa…
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iRhythm wins CE mark for next-gen Zio ECG system, Zeus software

The next-generation Zio patch. [Image courtesy of iRhythm Technologies]iRhythm Technologies (Nasdaq: IRTC) + announced today that it received CE mark for its Zio system and its supporting Zeus AI algorithm.

San Francisco-based iRhythm designed the next-generation Zio long-term ambulatory cardiac monitor to detect potential cardiac arrhythmias. Zeus, the company’s advanced, deep-learned AI algorithm, supports the capture and analysis of ECG data recorded by Zio. The company secured CE mark based on compliance to EU medical device regulation (MDR) standards.

Zio builds on the previous-generation Zio XT with long-term, continuous cardiac monitoring. It provides an end-to-end experience for patients with potential arrhythmias and demonstrates 99% patient compliance. iRhythm launched the next-generation monitor in the U.S. in September and expects widespread availability this year.

As the company’s smallest, light…

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November 2023 Medical Device Handbook: Breaking new ground in medtech



 

How Abbott designed the world’s first dual-chamber leadless pacemaker system

J&J used RWE for expanded indications — and you can, too

Moon Surgical thinks Maestro’s light touch can win the surgical robotics arms race

Breaking new ground in medtech

This year has brought a flurry of firsts from medical device manufacturers as they develop new and improved products despite continued supply chain and economic challenges.

These device innovations have been in the works for years, pushed forward by teams ranging from small startups to the world’s largest medtech companies — and all with help from outsourcing partners.

All of these industry players have come together once again in our latest edition of the Medical Design & Outsourcing Medical Device Handbook to offer uniquely relevant and actionable advice for device designers and engineers.

This edit…

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iRhythm grows sales by 20% in mixed Q3, offers positive FDA warning letter update

iRhythm Technologies (Nasdaq: IRTC) + shares ticked up today on third-quarter results that came in mixed compared to the consensus forecast.

Shares of IRTC rose 4.4% at $82.66 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 1.7%.

The San Francisco-based cardiac monitoring technology developer posted losses of $27.1 million. That equals 89¢ per share on sales of $124.6 million for the three months ended Sept. 30, 2023.

iRhythm recorded a nearly $6 million bottom-line slide deeper into the red despite sales growth of 20%.

Adjusted to exclude one-time items, losses per share totaled 79¢. That fell 13¢ shy of expectations on Wall Street. Sales, however, beat analysts’ projections of $122.6 million.

iRhythm President and CEO Quentin Blackford said in a news release that strong volume…

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Sticky business: Six wearable device adhesion tips from iRhythm CTO Mark Day

How to find the right balance between performance and patient comfort in wearable device adhesion.

iRhythm’s next-generation Zio cardiac monitoring patch can be worn for up to 14 days. [Photo courtesy of iRhythm]

iRhythm’s next-generation Zio cardiac monitoring patch is smaller, lighter and thinner — three qualities that also assist the wearable device’s adhesion.

Adhesion is a one of the leading challenges for wearable device developers. iRhythm Chief Technical Officer Mark Day discussed how his team designed the latest Zio patch to balance performance and patient comfort.

“So much of what we want to do is try and think about unmet needs and patient monitoring,” Day said in an interview with Medical Design & Outsourcing. “It’s really about raising the bar of performance by miniaturizing to ensure that we can get an already very compliant device even better.&…

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iRhythm launches next-gen Zio monitor, enhanced long-term monitoring service

The next-generation Zio patch. [Image courtesy of iRhythm Technologies]iRhythm Technologies (Nasdaq: IRTC) + announced today that launched its next-generation Zio monitor in the U.S.

In the launch, San Francisco-based iRhythm also included an enhanced Zio long-term continuous monitoring (LTCM) service.

Zio, the company’s smallest, lightest and thinnest cardiac monitor, aims to enhance the cardiac monitoring experience for patients. The company said its new service enhancements also benefit healthcare providers.

iRhythm says it began shipping already and expects widespread availability across the U.S. by early 2024.

The Zio LTCM service features the Zio patch ECG monitoring device and the Zeus (Zio ECG utilization software) system. Zeus, iRhythm’s advanced AI algorithm, supports the capture and analysis of ECG data recorded by Zio monitor. With the patch and software, the platform also offers a co…

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iRhythm sales are up more than 20% amid increasing Zio demand

The iRhythm Zio AT [Image courtesy of iRhythm]iRhythm (Nasdaq: IRTC) + shares rose after hours today on second-quarter results that topped the consensus forecast.

Shares of IRTC ticked up 5.6% to $103 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.8%.

The San Francisco-based wearable cardiac monitor maker posted losses of $18.5 million in the quarter. That equals 61¢ per share on sales of $124.1 million for the three months ended June 30, 2023.

iRhythm recorded a more than $5 million bottom-line gain while remaining in the red. It posted sales growth of 21.6%.

Adjusted to exclude one-time items, losses per share came in at 43¢. That beat Wall Street forecasts by 35¢, while revenues topped expectations of $120.3 million.

iRhythm reported its second-highest quarter ever for Z…

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