Integra LifeSciences

Integra LifeSciences today announced it launched its MicroMatrix Flex dual-syringe system for urinary bladder matrix (UBM) access.

The Princeton, N.J.-based company designed MicroMatrix Flex to enable the convenient mixing and precise delivery of MicroMatrix paste to provide more convenient access to hard-to-reach spaces in wound management.

“MicroMatrix Flex has allowed me to expand how I use UBM technology in complex wound reconstruction procedures,” said Dr. Aaron Moore, an acute care surgeon at Mercy Health St. Vincent Medical Center. “In addition to the benefits of UBM technology, the flexible delivery tip addresses the need to access hard-to-reach geometries in complex wounds.”

MicroMatrix Flex is intended to manage wounds, including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds and draining wounds.

The device has a flexi…

Integra Lifesciences (NASDAQ: IART) + is closing its ACell plant in Lafayette, Indiana, letting go of almost all of the workers.

Princeton, New Jersey–based Integra informed the Indiana Department of Workforce Development in a Feb. 13 WARN notice that the closure will result in a layoff of 60 workers — 52 on April 26 and eight on May 31. The number is less than 2% of the 3,722 employees that the company listed in its most recent annual report.

The Lafayette Journal & Courier and other local media broke the news last week. Integra said that it is moving Urinary Bladder Matrix manufacturing to its Columbia, Maryland location. UBM is an extracellular matrix scaffold derived from porcine urinary bladder. Integra Lifesciences uses it in its Cytal wound and Cytal burn matrix, Micromatrix UBM particulate, and Gentrix surgical matrix products.

The company acquired the Urinary Bladder Matrix tech through its more tha…

The FDA says Integra Lifesciences (Nasdaq: IART) +  has inadequately responded to violations that it found at the company’s TEI Biosciences plant in Boston.

Integra Lifesciences’ Boston facility makes extracellular bovine matrix products for tissue repair and regeneration, wound care and more. In May, the company voluntarily recalled all tissue-related products made in Boston and distributed between March 1, 2018 and May 22, 2023. The recalled products included SurgiMend, PriMatrix, Revize and TissueMend. According to the company, an internal investigation found deviations with endotoxin testing. The result was a release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, including a postoperative fever.

The facility previously received an FDA warning letter in 2019. A new FDA warning letter — dated July 17 and …

Integra LifeSciences (NASDAQ: IART) recently announced that it plans to resume manufacturing in its Boston facility by the end of the fourth quarter.

Just two months before, Integra voluntarily recalled all tissue-related products made in Boston and distributed between March 1, 2018 and May 22, 2023. The recalled products included SurgiMend, PriMatrix, Revize and TissueMend. According to the company, an internal investigation found deviations with endotoxin testing. The result was a release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, including a postoperative fever.

During a July 27 earnings call with analysts, CEO Jan De Witte said the company, over the past months, has strengthened its leadership and project management in Boston, made investments and brought in outside subject matter experts. A third-party auditor is assessing progress and key milestones …

Integra LifeSciences (Nasdaq: IART) + announced that it completed enrollment ints U.S. DuraSorb trial.

The FDA investigational device exemption (IDE) clinical study evaluates DuraSorb in two-stage breast reconstruction. The bioabsorbable matrix-based monofilament mesh currently has FDA clearance to reinforce soft tissue where weakness exists.

Princeton, New Jersey-based Integra said its study marks the first and only active, multi-center IDE study evaluating the use of a surgical matrix in two-stage breast reconstruction. It enrolled several hundred patients across seven major academic hospitals around the U.S. Integra noted in a news release that it completed enrollment “sooner than anticipated.”

The company aims to evaluate the safety and effectiveness of DuraSorb to obtain premarket approval for use in two-stage breast reconstruction. Its primary follow-up period comes one year after device implan…

Integra LifeSciences (Nasdaq:IART) + shares dipped today despite first-quarter results that beat the consensus revenue forecast.

Shares of IART slid 8.5% to $53.84 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 1.4%.

BTIG analyst Ryan Zimmerman said an implied set-up for the remainder of the year may be viewed as “challenging” by investors. Any reservations over Integra’s ability to hit its goals this year could be responsible for the stock dip.

The Princeton, New Jersey-based surgical and medical instrument maker posted profits of $24.2 million. That amounts to 29¢ per share on sales of $380.8 million for the three months ended March 31, 2023.

Integra posted a 26.4% bottom-line slide on sales growth of 1.1%. Codman specialty surgical segment sales grew by 0.3% while tissue techn…

Integra LifeSciences (Nasdaq:IART) shares fell slightly today despite fourth-quarter results that topped the consensus forecast.

Shares of IART dipped 1.25% to $56 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 8.7%.

The Princeton, New Jersey-based surgical and medical instrument maker posted profits of $52.9 million. That amounts to 63¢ per share on sales of $398.022 million for the three months ended Dec. 31, 2022.

Integra recorded a 16.7% bottom-line gain on a sales decline of 1.8%.

Adjusted to exclude one-time items, earnings per share totaled 94¢. That landed 4¢ ahead of Wall Street. Revenues narrowly topped expectations as analysts projected sales of $397.95 million.

“We made key advances in strengthening our strategic path. We met our organic growth and exceeded our adjusted EPS guidance for the year. I am proud of our coll…