BiologicsExtremitiesHospitals

Integra LifeSciences Announces Positive Clinical Results for Integra® Bilayer Wound Matrix (IBWM)

PRINCETON, N.J., May 15, 2020 (GLOBE NEWSWIRE) — Integra LifeSciences Holding Corporation (Nasdaq: IART), a leading global medical technology company, today announced positive clinical and economic data on Integra® Bilayer Wound Matrix (IBWM) in complex lower extremity reconstruction. This data from two retrospective studies was recently published by Stephen J. Kovach, M.D., FACS, and John P. Fischer, M.D., MPH, FACS, from the University of Pennsylvania Health System, in Plastic and Reconstructive Surgery, the official journal of the American Society of Plastic Surgeons.

IBWM provides an environment where the body can rebuild the layers of the skin supporting the healing process. In areas of the body where range of motion is important, IBWM helps patients get back to functioning and living as they did before the wound occurred.

This product is part of Integra’s broader regenerative technology portfolio of collagen and amniotic products for use by clinicians in the operating room to help address the epidemic of approximately 8.2 million wounds, with an estimated cost to U.S. Medicare of up to $98.6 billion annually.1 

“These studies demonstrate our ongoing commitment to investing in clinical data and providing innovative solutions to help surgeons effectively repair and close wounds, while restoring functionality for patients,” said Robert T. Davis, Jr., executive vice president and president, Orthopedics and Tissue Technologies.  “During this COVID-19 pandemic, IBWM can help address the efficiency needed in operating rooms by reducing both the operating time and costs to hospitals and patients. We have continued to provide educational opportunities to surgeons to improve the standard of care and quality of life for patients suffering from debilitating wounds.”

Yesterday, 200 surgeons from around the world attended an Integra LifeSciences webinar “Efficient & Effective Ways to Manage Lower Extremity Wounds.” During this webinar, Drs. Kovach and Fischer presented their recently published data and shared their insights and strategies to help address the efficiency of operating room time and prioritization of procedures as operating rooms start to reopen during the COVID-19 pandemic. 

“In complex lower extremity reconstruction, no approach is completely effective in all situations and contexts, and our recent publications highlight the key scenarios where skin substitutes can be optimally positioned for maximal clinical success,” said John P. Fischer, M.D, plastic surgeon and assistant professor of surgery and director of clinical research at University of Pennsylvania Health System. “Our findings identify key relative advantages with respect to operative efficiency and hospital utilization that align with current issues caused by the COVID-19 pandemic.”

“Lower extremity reconstruction can be challenging and costly for both the patient and health care system. Our goal is to choose an appropriate treatment algorithm, including dermal constructs, that restores function while providing economic benefits,” said Stephen J. Kovach, M.D., plastic surgeon and Herndon B. Lehr endowed associate professor of surgery at the University of Pennsylvania Health System.

Over the last 30 years, Integra Dermal Matrices have been studied in more than 300 clinical trials and studies. They have helped nearly one million patients recover and restore functionality so they can live their lives. For more information please visit our Integra Bilayer Wound Matrix Product Page on www.integralife.com.

1. Chandan K. Sen, Ph.D., Human Wounds and Its Burden: An Updated Compendium of Estimates, ADVANCES IN WOUND CARE, VOLUME 8, NUMBER 2

Summary of Study Results
The first clinical publication reviews the efficacy of the Integra Bilayer Wound Matrix for lower extremity soft tissue reconstruction.  With 70% of the wounds successfully salvaged at the 180-day timepoint, the authors were able to identify success factors across patient selection and wound types. 

The second publication reviewed cost and resource utilization comparing Integra Bilayer Wound Matrix, Local Tissue Rearrangement (LTR) and Free Flap (FF).  This study showed significantly longer surgery time at 85 and 408 minutes for LTR and FF respectively, compared with 50 minutes for Integra Bilayer Wound Matrix.  It also reported more than double the length of stay in the hospital for both LTR and FF versus Integra Bilayer Wound Matrix. Lastly, total cost of the surgery was $53,492 for FF, $35,220 for LTR and $34,877 for Integra Bilayer Wound Matrix.  Given the shorter operating time and the potential lower cost, Integra Bilayer Wound Matrix may represent an opportunity for patients, surgeons and hospitals during the current situation.

About Integra
Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™, Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors that may be discussed include, but are not limited to, future financial performance, new product development, governmental approvals, market potential as well as potential therapeutic applications. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the economic, competitive, governmental, technological and other factors identified under the heading “Risk Factors” included in item 1A of Integra’s Annual Report on Form 10-K for the year ended December 31, 2019 and information contained in subsequent filings with the Securities and Exchange Commission, including, without limitation, Integra’s Report on Form 10-Q filed on May 7, 2020, could affect actual results. These forward-looking statements are made only as the date thereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Michael Beaulieu
609-529-4812
michael.beaulieu@integralife.com  

Media
Laurene Isip
609-208-8121
laurene.isip@integralife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/babbb8c1-fcc8-4912-b85e-0c9a821d72e8

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Mike Adams

Mike Adams is a medical device sales leader with extensive clinical experience in spine and biologics and a nationwide distribution network built over the last 10+ years in the industry. He has held various leadership positions in healthcare and device including Distributor Partner, Hospital COO and Spine VP of Sales. He currently leads the commercialization strategy for OrthoSpine Partners and is a Distributor Principal at Novel Medical. Because of his unique career path, Mike has the ability to see the healthcare business from multiple perspectives making him passionate about building strategic partnerships that help reduce overall costs, drive innovation, and cultivate growth for new markets.

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