Integra LifeSciences Obtains FDA Approval for Cardiac Application of CUSA Clarity System
FDA Clearance: Integra LifeSciences received U.S. FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System, expanding its use to cardiac surgery for debridement during valve replacement and repair procedures.
Existing Approvals: The CUSA Clarity system is already approved for various surgical fields, including neurosurgery and orthopedic surgery, where it aids in the fragmentation and aspiration of soft and hard tissues.
Significance of Clearance: This new clearance is a significant milestone, allowing for the application of ultrasonic aspiration in delicate cardiovascular surgeries, supported by sufficient safety and performance data.
Upcoming Showcase: Integra will present the CUSA Clarity system at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11-12, 2025, emphasizing its expanded role in cardiac care.
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Integra LifeSciences Faces Recall Due to Packaging Defects Linked to 11 Serious Injuries
- FDA Alert: The FDA has issued an early alert regarding potentially high-risk issues with Integra LifeSciences' MediHoney wound and burn care products, citing packaging and production failures that could lead to infection and compromise patient safety.
- Product Recall: Integra has notified customers to immediately cease the use of all MediHoney wound and burn products and specific lots of CVS Wound Gel, ensuring these products are removed from clinical settings to prevent further harm.
- Injury Reports: As of December 19, 2025, Integra reported 11 serious injuries linked to MediHoney products and three serious injuries associated with CVS Wound Gel, highlighting the severity of safety concerns despite no reported fatalities.
- Distributor Instructions: Integra instructed distributors to halt further distribution of affected products and manage customer communications directly, ensuring that impacted products are properly handled, reflecting the company's commitment to customer safety.
Integra LifeSciences CEO to Present at 44th Annual J.P. Morgan Healthcare Conference
- Conference Participation: Integra LifeSciences CEO Mojdeh Poul and CFO Lea Knight will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, showcasing the company's latest advancements in medical technology, which is expected to attract investor interest.
- Live Webcast: The presentation will be available via live webcast on Integra LifeSciences' investor relations website, enabling global investors to access real-time updates on the company, thereby enhancing transparency and investor confidence.
- Company Mission: Integra LifeSciences is committed to restoring patients' lives through innovative treatment pathways, demonstrating its leadership in surgical, neurologic, and regenerative care, which further solidifies its competitive position in the market.
- Brand Portfolio: The company offers a comprehensive portfolio of high-quality leadership brands aimed at meeting the evolving market demands through continuous innovation and high standards of medical solutions, driving long-term growth.
Integra LifeSciences Obtains FDA Approval for Cardiac Application of CUSA Clarity System
FDA Clearance: Integra LifeSciences received U.S. FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System, expanding its use to cardiac surgery for debridement during valve replacement and repair procedures.
Existing Approvals: The CUSA Clarity system is already approved for various surgical fields, including neurosurgery and orthopedic surgery, where it aids in the fragmentation and aspiration of soft and hard tissues.
Significance of Clearance: This new clearance is a significant milestone, allowing for the application of ultrasonic aspiration in delicate cardiovascular surgeries, supported by sufficient safety and performance data.
Upcoming Showcase: Integra will present the CUSA Clarity system at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11-12, 2025, emphasizing its expanded role in cardiac care.
JP Morgan Keeps Underweight Rating on Integra Lifesciences, Increases Price Target to $13
Real-time Intelligence: Benzinga Pro offers fast and accurate stock market intelligence to help traders make informed decisions.
Exclusive Stories: The platform provides exclusive news stories generated by Benzinga reporters, enhancing the trading experience for its users.
Community of Traders: Over 10,000 serious traders are part of the Benzinga Pro community, sharing insights and strategies.
Trade Alerts: Users can receive the fastest news alerts to ensure they never miss a trading opportunity.
Integra LifeSciences Reports Reduced Q3 Loss; Lowers FY25 Revenue Forecast; Shares Rise
Quarterly Performance: Integra LifeSciences reported a narrower loss of $5.40 million for Q3, improving from a $10.69 million loss last year, with revenues rising to $402.06 million.
Earnings Exceed Expectations: The company posted earnings of $41.6 million or $0.54 per share, surpassing analyst expectations of $0.43 per share.
Revised Revenue Guidance: Integra lowered its fiscal 2025 revenue guidance to a range of $1.620 billion to $1.640 billion, reflecting a growth adjustment from previous estimates.
Stock Market Reaction: Following the earnings report, Integra's stock was trading down 7.84% at $14.22 in premarket activity.
Integra LifeSciences Reports Q3 Adjusted EPS Exceeds Expectations, While Revenues Fall Short
Quarterly Financial Performance: Integra LifeSciences reported a net loss of $5.40 million for Q3, an improvement from a loss of $10.70 million in the same quarter last year.
Adjusted Earnings: The company's adjusted earnings for the quarter were $0.54 per share, up from $0.41 per share in the previous year.
Revenue Growth: Total revenues increased by 5.6% to $402.06 million, with organic revenue growth at 5.0%.
Analyst Expectations: Analysts had anticipated earnings of $0.43 per share and revenues of $414.31 million, indicating that actual results fell short of expectations.
Integra LifeSciences Faces Recall Due to Packaging Defects Linked to 11 Serious Injuries
- FDA Alert: The FDA has issued an early alert regarding potentially high-risk issues with Integra LifeSciences' MediHoney wound and burn care products, citing packaging and production failures that could lead to infection and compromise patient safety.
- Product Recall: Integra has notified customers to immediately cease the use of all MediHoney wound and burn products and specific lots of CVS Wound Gel, ensuring these products are removed from clinical settings to prevent further harm.
- Injury Reports: As of December 19, 2025, Integra reported 11 serious injuries linked to MediHoney products and three serious injuries associated with CVS Wound Gel, highlighting the severity of safety concerns despite no reported fatalities.
- Distributor Instructions: Integra instructed distributors to halt further distribution of affected products and manage customer communications directly, ensuring that impacted products are properly handled, reflecting the company's commitment to customer safety.
Integra LifeSciences CEO to Present at 44th Annual J.P. Morgan Healthcare Conference
- Conference Participation: Integra LifeSciences CEO Mojdeh Poul and CFO Lea Knight will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, showcasing the company's latest advancements in medical technology, which is expected to attract investor interest.
- Live Webcast: The presentation will be available via live webcast on Integra LifeSciences' investor relations website, enabling global investors to access real-time updates on the company, thereby enhancing transparency and investor confidence.
- Company Mission: Integra LifeSciences is committed to restoring patients' lives through innovative treatment pathways, demonstrating its leadership in surgical, neurologic, and regenerative care, which further solidifies its competitive position in the market.
- Brand Portfolio: The company offers a comprehensive portfolio of high-quality leadership brands aimed at meeting the evolving market demands through continuous innovation and high standards of medical solutions, driving long-term growth.
Integra LifeSciences Obtains FDA Approval for Cardiac Application of CUSA Clarity System
FDA Clearance: Integra LifeSciences received U.S. FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System, expanding its use to cardiac surgery for debridement during valve replacement and repair procedures.
Existing Approvals: The CUSA Clarity system is already approved for various surgical fields, including neurosurgery and orthopedic surgery, where it aids in the fragmentation and aspiration of soft and hard tissues.
Significance of Clearance: This new clearance is a significant milestone, allowing for the application of ultrasonic aspiration in delicate cardiovascular surgeries, supported by sufficient safety and performance data.
Upcoming Showcase: Integra will present the CUSA Clarity system at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11-12, 2025, emphasizing its expanded role in cardiac care.
JP Morgan Keeps Underweight Rating on Integra Lifesciences, Increases Price Target to $13
Real-time Intelligence: Benzinga Pro offers fast and accurate stock market intelligence to help traders make informed decisions.
Exclusive Stories: The platform provides exclusive news stories generated by Benzinga reporters, enhancing the trading experience for its users.
Community of Traders: Over 10,000 serious traders are part of the Benzinga Pro community, sharing insights and strategies.
Trade Alerts: Users can receive the fastest news alerts to ensure they never miss a trading opportunity.
Integra LifeSciences Reports Reduced Q3 Loss; Lowers FY25 Revenue Forecast; Shares Rise
Quarterly Performance: Integra LifeSciences reported a narrower loss of $5.40 million for Q3, improving from a $10.69 million loss last year, with revenues rising to $402.06 million.
Earnings Exceed Expectations: The company posted earnings of $41.6 million or $0.54 per share, surpassing analyst expectations of $0.43 per share.
Revised Revenue Guidance: Integra lowered its fiscal 2025 revenue guidance to a range of $1.620 billion to $1.640 billion, reflecting a growth adjustment from previous estimates.
Stock Market Reaction: Following the earnings report, Integra's stock was trading down 7.84% at $14.22 in premarket activity.
Integra LifeSciences Reports Q3 Adjusted EPS Exceeds Expectations, While Revenues Fall Short
Quarterly Financial Performance: Integra LifeSciences reported a net loss of $5.40 million for Q3, an improvement from a loss of $10.70 million in the same quarter last year.
Adjusted Earnings: The company's adjusted earnings for the quarter were $0.54 per share, up from $0.41 per share in the previous year.
Revenue Growth: Total revenues increased by 5.6% to $402.06 million, with organic revenue growth at 5.0%.
Analyst Expectations: Analysts had anticipated earnings of $0.43 per share and revenues of $414.31 million, indicating that actual results fell short of expectations.
