iRhythm Technologies Inc. Archives - Medical Design Sourcing

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…

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…

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…

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…

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…

iRhythm faces another subpoena from the DOJ

Wearable cardiac monitor developer iRhythm (Nasdaq: IRTC) + disclosed its third subpoena in more than two years from federal investigators.

The news raised some questions from analysts, who were otherwise positive about iRhythm’s first-quarter earnings report yesterday evening.

San Francisco–based iRhythm said that on April 4, it received a subpoena duces tecum from the U.S. Department of Justice Civil Division’s Consumer Protection Branch. Company officials told analysts that they were fully cooperating. They said it was too early to speculate on the nature or timing of the inquiry.

Analysts noted that Boston Scientific said in its most recent quarterly report that it received a subpoena from the DOJ on April 5 seeking documents and information relating to its ambulatory electrocardiography monitoring (AECG) business. Boston Scientific is also cooperating.

BTIG analysts stuck with their Buy r…

Real-world study backs iRhythm Zio XT

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]iRhythm Technologies (Nasdaq:IRTC) today announced findings supporting its Zio XT wearable heart monitoring technology.

San Francisco-based iRhythm presented multiple new studies at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC).

The Camelot study compared effectiveness of ambulatory monitors for arrhythmia diagnosis. It demonstrated that long-term continuous monitoring with iRhythm Zio XT is associated with the highest diagnostic yield and fastest time to clinical diagnosis compared to all other ambulatory cardiac monitors (ACMs) when looking at specified arrhythmias.

Additionally, Zio XT demonstrated the lowest likelihood of retesting compared to all other ACMs. It also recorded the lowest acute healthcare resource utilization compared to all other ACMs.

Camelot used real-world Medicare data. It sought to evaluate the yi…

iRhythm sees years of sustainable growth

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]Wearable cardiac monitor developer iRhythm (NASDAQ:IRTC) saw its stock shoot up today, a day after reporting positive Q4 2022 news.

IRTC shares were up more than 10% at $97.26 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 8%.

San Francisco–based iRhythm reported a record number of new account openings for Zio XT heart monitoring patch in the fourth quarter. In addition, the company saw patient registration growth of more than 20% compared to Q4 2021.

CEO Quentin Blackford also pointed to the company successfully working with CMS to secure a national Medicare rate that “positions us well to focus on further market penetration and providing our technology to all patients who may benefit.”

“Despite challenges during 2022, we have made significant progress to advance our mission …

iRhythm sees years of sustainable growth

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]Wearable cardiac monitor developer iRhythm (NASDAQ:IRTC) saw its stock shoot up today, a day after reporting positive Q4 2022 news.

IRTC shares were up more than 10% at $97.26 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 8%.

San Francisco–based iRhythm reported a record number of new account openings for Zio XT heart monitoring patch in the fourth quarter. In addition, the company saw patient registration growth of more than 20% compared to Q4 2021.

CEO Quentin Blackford also pointed to the company successfully working with CMS to secure a national Medicare rate that “positions us well to focus on further market penetration and providing our technology to all patients who may benefit.”

“Despite challenges during 2022, we have made significant progress to advance our mission …

iRhythm wants to be a $1 billion a year company in 5 years

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]iRhythm Technologies (Nasdaq:IRTC) officials think their company’s wearable heart monitoring tech could serve millions more patients, tripling company revenue to more than $1 billion by 2027.

That was a big takeaway from the company’s 2022 Analyst & Investor Day news release today.

“Our technology platform is well suited to meet the needs of an evolving healthcare landscape while transforming a market that has not been disrupted in the last ten years,” said iRhythm CEO Quentin Blackford.

iRhythm today reaffirmed its 2022 guidance, predicting top-line growth of 29–30% to reach $415–420 million. Analysts polled on Yahoo! Finance predicted $418.64 million.

Investors appear to have been looking for more. IRTC shares were down more than 10% to $139.09 apiece in morning trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical d…

iRhythm Technologies stock jumps on Q2 earnings beat

iRhythm Technologies (Nasdaq:IRTC) posted second-quarter results that beat the consensus forecast on Wall Street.

The San Francisco–based developer of the Zio ambulatory cardiac monitor reported a loss of $23.9 million, or $0.80 per share, on sales of $102.1 million for the quarter ended June 30, 2022. Revenue was up 25.6% year-over-year, primarily driven by volume growth of the Zio XT and AT single-use monitors and increases in Medicare pricing.

Adjusted to exclude one-time items, earnings per share were $0.79, $0.12 ahead of The Street, where analysts expected a loss of $0.92 per share on sales of $100.12 million.

“New account openings were up 22% quarter-over-quarter and revenue volumes increased 10% sequentially, underscoring our solid performance amidst a difficult market environment,” iRhythm CEO and President Quentin Blackford said in a news release. “With business highlights regarding reimbursement and our Zio Watch clearance al…