Integra LifeSciences Archives - Page 2 of 3

Integra LifeSciences to acquire Surgical Innovation Associates

Integra LifeSciences (Nasdaq:IART) announced today that it entered into a definitive agreement to acquire Surgical Innovation Associates (SIA).

SIA develops, markets and sells the DuraSorb resorbable synthetic matrix for plastic and reconstruction surgery.

Princeton, New Jersey-based Integra said in a news release that the acquisition advances its global strategy in breast reconstruction. The deal expands plans to access the U.S. market with FDA-approved devices for use in implant-based breast reconstruction (IBBR) procedures.

Integra expects the deal to close by the end of the year. It plans to purchase SIA for $50 million at closing. Integra could spend up to an additional $90 million upon the achievement of certain revenue and regulatory milestones.

The transaction is not expected to materially impact Integra’s 2022 financial results. Integra expects a dilutive impact to adjusted earnings per share of approximately 6¢ in year one. It then…

Integra Lifesciences rises on Street-beating Q3 results

Integra Lifesciences (NSDQ:IART) today posted third-quarter results that beat the overall consensus on Wall Street.

The company reported profits of $49.9 million, or 60¢ per share, on sales of $385.2 million for the three months ended Sept. 30, for a bottom-line gain of 15.5% on sales loss of 0.43%.

Adjusted to exclude one-time items, earnings per share were 86¢, 14¢ ahead of The Street, where analysts were looking for sales of $378.32 million.

“We are pleased with our sales performance in the third quarter. Our diverse portfolio continues to deliver solid, profitable growth for our shareholders,” President and CEO Jan De Witte said in a news release. “We continue to see strong demand for our products globally and are focused on our execution in achieving our short- and long-term targets.”

Integra Lifesciences reaffirmed its full-year revenue expectations with a tightened range of $1.551 billion to $1.563 billion. For the fourth quarter, the compa…

Integra’s CereLink ICP Monitor recall is Class I

[Image from Integra]The FDA has labeled the recall of the Integra LifeSciences (Nasdaq:IART) CereLink system as Class I, the most serious kind.

Integra designed its CereLink system for intracranial pressure (ICP) monitoring. Last week, the company announced an immediate, voluntary global product removal of the systems.

An FDA notice classified the U.S. recall, initiated by Integra on June 22, 2022, as the most serious kind yesterday. Integra recalled a total of 388 devices (product codes 826820 and 826820P) in the U.S. The company distributed affected devices between June 1, 2021, and May 31, 2022.

Integra reported 105 global complaints associated with the recall as of July 31, 2022. As of Aug. 24, the FDA received at least 68 reports associated with the issue. Reports include one patient injury and one patient death. The report of death described a malfunctioning CereLink monitor during use in a critically injured patient. Replacing the ICP sensor mitigate…

Integra Lifesciences voluntarily recalls CereLink intracranial pressure monitors

[Image from Integra]Integra LifeSciences (Nasdaq:IART) announced today that it initiated an immediate, voluntary global product removal of CereLink.

The company on Aug. 18, 2022, initiated the product removal of all CereLink intracranial pressure monitors as a result of customer reports about monitors whose pressure readings were out of range.

According to a news release, Integra believes that the out-of-range readings have been principally caused by electrical interference from the external environment and/or interference from a component on the circuit board of the monitor. The company said the out-of-range readings have occurred at “a low incidence rate” and at a limited number of sites.

Despite the low rates and site numbers, the company said its decision to remove all CereLink monitors from the field comes “out of an abundance of caution.”

Integra is investigating the matter to remedy the observed issue. It plans to resum…

Former Integra founder, CEO Richard Caruso has died

Integra LifeSciences (Nasdaq:IART) announced today that its former founder, chair and CEO, Richard Caruso, passed away.

Caruso founded Princeton, New Jersey-based Integra in 1989 with the aim of enabling the human body to regenerate its own damaged or diseased tissue.

According to a news release, Caruso paved the way for what was then a new discipline in regenerative medicine. Integra said that, under his leadership, it became the first company to develop and bring to market a tissue regeneration product with the Integra dermal regeneration template receiving FDA approval in 1996 as a skin replacement system with a claim for regeneration of dermal tissue for the treatment of life-threatening burns and repair of scar contractures.

The company would go on to develop the DuraGen dural graft matrix for repairing the dura mater after cranial and spine surgery, as well as the NeuraGen nerve guide for creating a conduit for axonal growth across a severed nerve.…

Integra dips despite Street-beating Q2, plans to divest traditional wound care business

Integra Lifesciences (NSDQ:IART) shares were down today despite second-quarter results that came in ahead of the consensus forecast.

The Princeton, N.J.-based surgical and medical instrument maker posted profits of $44.8 million, or 54¢ per share, on sales of $397.8 million for the three months ended June 30, 2022, for a 27.7% bottom-line gain on sales growth of 20.1%.

Adjusted to exclude one-time items, earnings per share were 82¢, 2¢ ahead of Wall Street, where analysts were looking for sales of $395.3 million.

The company’s Codman Specialty Surgery segment saw a 0.4% growth in revenues year-over-year, thanks to strength in both instruments and neurosurgery. That comprised 65% of the company’s sales, while the remainder was brought in by its Tissue Technologies business, which saw 5.1% growth from 2021. That growth was driven by private label customer orders and growth in wound reconstruction and care thanks to the Integra Dermal Matrices a…

Integra Lifesciences beats The Street in Q1 results

Integra Lifesciences (NSDQ:IART) posted first-quarter results that beat the overall consensus on Wall Street.

The Princeton, N.J.-based surgical and medical instrument company reported profits of $32.9 million, or 39¢ per share, on sales of $376.6 million for the three months ended March 31, for a bottom-line loss of 27.5% on sales growth of 4.6% compared with Q1 2021.

Adjusted to exclude one-time items, earnings per share were 74¢, 6¢ ahead of The Street, where analysts were looking for sales of $362 million.

“I am pleased with the resilience shown by Integra colleagues as we navigated the COVID-19 Omicron wave early in the quarter,” CEO Jan De Witte said in a news release. “With global procedure volumes improving in March, our strong execution enabled us to deliver better-than-expected first-quarter revenue with organic growth exceeding 5%.”

Integra Lifescience expects reported revenues for Q2 2022 to be in the range of $392 million to $400 mill…

Integra Lifesciences beats The Street in Q4 results

Integra Lifesciences (NSDQ:IART) today posted fourth-quarter results that beat the overall consensus on Wall Street.

The Princeton, N.J.-based surgical and medical instrument company reported profits of $45.4 billion, or 53¢ per share, on sales of $405.5 million for the three months ended Dec. 31, 2021, for a sales growth of 4.34% compared with Q4 2020.

Adjusted to exclude one-time items, earnings per share were 84¢, 1¢ ahead of The Street, where analysts were looking for sales of $403.4 million.

“Our 2021 financial performance and business achievements are a testament to our broad and differentiated product portfolio, and the resilience and commitment of our team members around the world, despite the ongoing effects of the global pandemic,” president and CEO Jan De Witte said in a news release. “I look forward to working with my Integra colleagues to continue to execute our growth priorities and accelerate our product pipeline and global opportunities i…

12 of medtech’s biggest personnel changes in 2021

As medtech companies continued to drive innovation throughout the past 12 months, a number of high-level executives led the way.

Some of those companies and those executives opted for major changes over the course of 2021, though, with some high-profile moves from medtech giant to medtech giant.

Here are some of the biggest personnel moves in the medtech space in 2021:

Get the full story at our sister site, Medical Design & Outsourcing.

Integra rises on Street-beating Q3, raised EPS guidance

Integra LifeSciences (NSDQ:IART) shares got a boost this morning on third-quarter results that topped the consensus forecast.

IART shares were up 5.6% at $70.95 per share in early-morning trading. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.2%.

The Princeton, N.J.-based surgical and medical instrument company posted profits of $43.2 million, or 51¢ per share, on sales of $386.9 million for the three months ended Sept. 30, 2021, for a 33.7% bottom-line gain on sales growth of 4.5%.

Adjusted to exclude one-time items, earnings per share were 86¢, 14¢ ahead of Wall Street, where analysts were looking for sales of $384.6 million.

“Strength across most of our product portfolio, driven by commercial and operational execution and a contribution from our recently launched CereLink ICP monitor, led to third-quarter results near the high end of our guidance range, despite ongo…

Integra Lifesciences announces new CEO

Incoming Integra LifeSciences CEO Jan D. De Witte [Image courtesy of Integra]Integra LifeSciences (NSDQ:IART) announced today that former Barco CEO Jan D. De Witte will take over the corner office at Integra by the end of the year.

De Witte left Barco effective September 1. He will succeed Peter J. Arduini, who is leaving Integra Lifesciences to lead GE Healthcare.

The top spot at Integra will transition by the end of the year.

Barco’s healthcare portfolio includes a host of medical displays and imaging systems. During his five years at the Kortrijk, Belgium–based company, De Witte led a turnaround that included streamlining the portfolio and strengthening the digital capabilities.

Princeton, N.J.–based Integra has a focus on regenerative tissue technologies and neurosurgical technology.

“The company has a rich history of global leadership in neurosurgery with some of the most recognized brands in plastic and reconstructive surgery…

Integra Lifesciences raises guidance on Street-beating Q2 results

Integra LifeSciences (NSDQ:IART) today posted second-quarter results that beat the overall consensus on Wall Street.

The Princeton, N.J.-based company reported profits of $35.1 million, to 41¢ per share, on sales of $389.9 million, for the three months ended June 30, for a sales growth of 50.8% compared with Q2 2020.

Earnings per share were 79¢, 13¢ ahead of The Street, where analysts were looking for sales of $376 million.

“We are pleased with second-quarter results that exceeded our forecasts. Our business segments were well-positioned to capitalize on the improving demand driven by the ongoing global market recovery,” president and CEO Peter Arduini said in a news release.

“We saw particularly healthy order activity in products used in neurosurgery, instruments, burn, trauma and surgical reconstruction as markets gradually recovered. Areas such as capital equipment and our international indirect markets are still early in their recovery but are…