Integra LifeSciences to Acquire DuraSeal(TM) Product Lines From Covidien

PLAINSBORO, N.J., Oct. 28, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today it has entered into a definitive agreement with Covidien to acquire the Confluent Surgical product lines, including surgical sealants, adhesion barrier, and, most importantly, DuraSeal(TM). The companies expect to complete this transaction by the end of the first calendar quarter of 2014, subject to receipt of regulatory approvals.
Under the terms of the agreement, Covidien will receive an initial cash payment of $235 million from Integra upon the closing of the transaction. Additionally, Covidien may receive up to $30 million, contingent upon the achievement of certain performance measures related to the transition of the Confluent Surgical business to Integra.
"The addition of the DuraSeal(TM) product lines enables our sales force and distributor partners to provide their customers with a best-in-class dural sealant as they seek to support surgeon's efforts to minimize cerebrospinal fluid leaks upon completion of the surgical procedure," said Robert Davis, President of Integra's U.S. Neurosurgery division. "This acquisition perfectly complements our global Neurosurgery growth strategy aimed at providing a broader set of solutions for surgical procedures in the head. Together with our broad DuraGen(R) product line we are fortunate to have even more options to serve our customers and the individual needs of their patients."
"This transaction allows Covidien to better focus on its global strategic priorities," said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. "Based on Integra's presence in neurosurgery and spine surgery combined with a strong portfolio of clinical evidence, we believe these products will thrive under Integra's ownership. We express our sincere gratitude to our dedicated employees and the clinicians who have partnered with us throughout the years."
Confluent Surgical products include: DuraSeal(TM), DuraSeal(TM) Exact/Xact, VascuSeal(TM) and SprayShield(TM). These products generated approximately $65 million in revenue (unaudited) during 2012 and gross margin comparable to Integra's regenerative medicine product portfolio. Integra expects to provide detailed guidance regarding the financial impacts of this transaction upon closing. Preliminarily, Integra would expect the acquisition to add $57 million to $60 million in revenue in the first full year of the combination, and to then grow 3% to 5% longer term.
"This transaction adds scale to our business, leverages one of our strongest customer call points, and drives accretion to our gross margins," said Jack Henneman, Integra's Chief Financial Officer. "Upon completion of the transaction, we expect this deal to be accretive to both GAAP and adjusted earnings per share in the first year after considering the financing costs of the transaction."
Integra expects that revenues acquired through this transaction would be reported in its U.S. Neurosurgery and International divisions.

DuraSeal™ Sealants vs. Tisseel™ Fibrin Sealant

Dural repair with four spinal sealants: focused review of the manufacturers' inserts and the current literature.

Abstract

BACKGROUND CONTEXT:

Deliberate or traumatic dural fistulas are typically augmented by a "sealant" or "fibrin glue" to enhance the strength of dural closure.

PURPOSE:

Little is known about the risks and complications associated with two specific "sealants" and two specific "fibrin glues" used for dural closure.

STUDY DESIGN/SETTING:

Review of the manufacturers' inserts and a focused review of the literature concerning the pros and cons for two "sealants" (DuraSeal [Confluent Surgical Inc., Waltham, MA, USA] and BioGlue [Cryolife, Kennesaw, GA, USA]) and two "fibrin glues" (EVICEL [Johnson and Johnson Wound Management, Ethicon Inc., Somerville, NJ, USA] and Tisseel [fibrin sealant; Baxter International Inc., Westlake Village, CA, USA]) were assessed.

PATIENT SAMPLE:

A focused review of the literature using four different "sealants" or "fibrin glues" was performed.

OUTCOME MEASURES:

Documentation of persistent/recurrent postoperative cerebrospinal fluid fistulas was an end point for failure for the four different "sealants" and "fibrin glues."

METHODS:

Manufacturers' inserts and a focused review of the literature concerning the relative safety and efficacy of two "sealants" (DuraSeal and BioGlue) and two "fibrin glues" (EVICEL and Tisseel) used to augment dural closure were assessed.

RESULTS:

Although DuraSeal is approved by the Federal Drug Administration (FDA) for intracranial and spinal application, two instances of paralysis are described in the literature. BioGlue is classified by the manufacturer as neurotoxic. EVICEL, one of the "fibrin glues," appeared in just two animal studies, whereas Tisseel, the other "fibrin glue," has been used in many large clinical series without adverse events.

CONCLUSION:

Despite the lack of FDA approval, Tisseel (fibrin glue) has seen wide adoption in "off-label" use. DuraSeal, which is FDA approved, was associated with two instances of paralysis. Alternatively, BioGlue was described as neurotoxic even by the manufacturer.

Covidien Introduces First FDA-Approved Spine Sealant

NORTH HAVEN, Conn.--(BUSINESS WIRE)-- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of DuraSeal(TM) spine sealant, the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane during spine procedures. Nearly 1.5 million spine surgeries are performed in the U.S. every year, with an estimated 10% of these surgeries requiring dural repair and sealing. Tears in the dura the outermost membrane covering the brain and the spinal cord can result in cerebral spinal fluid (CSF) leaks after surgery, leading to possible medical complications and extended hospital stays. One recent study found that CSF leaks after spinal surgery are estimated to cost an average of $6,479 in additional expense, mainly due to longer hospital and intensive care unit stays.(1)
In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100% of the time, compared with 64% of the time by the control group. The safety results between the two groups were similar, given the patients' medical conditions and the nature of the complex spinal procedures performed.(2)
The new sealant is a 100% synthetic hydrogel that provides excellent tissue adherence, is absorbed by the body and is easy to apply. Stored at room temperature, DuraSeal spine sealant takes only two minutes to prepare and three seconds to set, which enables surgeons to achieve an intra-operative dural seal quickly.
"DuraSeal is a great example of how we develop solutions at Covidien," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien. "We observe the challenges that surgeons face in the operating room and work with the medical community to come up with innovative products that may optimize patient outcomes, can improve healthcare economics and are intuitive for surgeons and their teams to use."
The DuraSeal spine sealant system was introduced today at the North American Spine SocietyAnnual Meeting in San Francisco and last month at the Congress of Neurological Surgeons in New Orleans. For further information, please visit www.durasealspine.com.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of$10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.