iRhythm Technologies 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 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 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…

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…

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…

iRhythm’s FDA warning letter details alleged violations and patient deaths

The iRhythm Zio AT [Image courtesy of iRhythm]An FDA warning letter made public today accused iRhythm Technologies (Nasdaq: IRTC) + of violations of the Federal Food, Drug, and Cosmetic Act’s rules for labeling, quality systems and medical device reporting.

In at least two cases, iRhythm did not report patient deaths in the required 30-day window, and instead reported them the following year, the FDA said.

The FDA issued the warning letter on May 25, 2023, following an inspection of the company’s facility in Cypress, California, in July and August 2022. The alleged violations concern iRhythm’s Zio AT electrocardiogram (ECG) monitoring system, which includes the Zeus software reporting system. The FDA cleared the system in 2017 under the 510(k) pathway.

Previously: iRhythm faces another subpoena from the DOJ

While the FDA said some of iRhythm’s responses and corrective actions have been…

iRhythm has an FDA warning letter over Zio AT quality systems

The Zio AT mobile cardiac telemetry device [Image courtesy of iRhythm]iRhythm (Nasdaq: IRTC) + stock is down today on news of an FDA warning letter involving its Zio AT mobile cardiac telemetry device.

In a Form 8-K filed with the SEC yesterday, iRhythm said it received the warning letter on May 25. The warning letter resulted from an FDA inspection at the company’s Cypress, California facility that concluded on August 2022.

The warning letter alleged that iRhythm was not conforming to medical device reporting requirements related to its Zio AT and medical device quality system requirements, according to the company’s SEC filing. (The actual letter is not yet available on the FDA’s website.)

Said iRhythm: “The company takes these matters very seriously. The company intends to respond within the specified time period and work diligently to address the FDA’s concerns.”

IRTC share…

New data from iRhythm back the use of long-term ambulatory cardiac monitoring

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]iRhythm (Nasdaq:IRTC) today announced the presentation of four studies reinforcing evidence behind its long-term cardiac monitoring.

San Francisco-based iRhythm presented the data at the Heart Rhythm Society’s annual meeting, Heart Rhythm 2023, in New Orleans. Data supports ambulatory cardiac monitoring of up to 14 days with the company’s Zio XT. It demonstrated increased diagnostic yield and improved diagnostic accuracy of ventricular arrhythmias across a variety of patient populations.

“These studies thematically showcase the value of iRhythm’s Zio products and services — in particular for identifying ventricular arrhythmias for risk stratification and disease management,” said Dr. Mintu Turakhia, iRhythm chief medical officer, chief scientific officer and EVP, product innovation. “The findings have important clinical and scientific implications, and they further demonstrate the strength of our technolo…

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…