DEERFIELD, Ill., Oct 23, 2013 (BUSINESS WIRE) -- Baxter International Inc. BAX -0.04% today announced the launch of HEMOPATCH Sealing Hemostat, a novel collagen-based hemostatic device, following CE mark approval in Europe. HEMOPATCH is a resorbable hemostatic device used for surgical procedures when control of bleeding by pressure, ligature or conventional procedures is either ineffective or impractical. The development of HEMOPATCH combined Baxter's expertise in collagen, internal coagulation processes, and PEG (polyethylene glycol) technology platforms.
''HEMOPATCH is a valuable addition to the tools in the surgical suite, as it provides fast hemostasis and strong tissue adherence. Surgeons will appreciate that the product works quickly and effectively, does not require preparation time, and can be used in a range of surgical settings,'' said Frank Ulrich, M.D., head of surgical oncology at Goethe University in Frankfurt, Germany.
HEMOPATCH is a soft, thin and flexible collagen pad that is designed to allow surgeons control during application to gain hemostasis and firm adherence of the hemostatic pad to the bleeding tissue surface. In preclinical tests, HEMOPATCH achieved fast and effective hemostasis, reaching 97.5 percent success by fully controlling bleeding at two minutes.
The pad consists of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG). This gives the pad a dual-method mechanism of action, in which two components interact to achieve hemostasis by sealing off the bleeding surface and initiating the body's own clotting mechanisms. Significant preclinical testing was conducted to confirm its hemostatic performance, biocompatibility, and safety profile.
''HEMOPATCH is a significant innovation in the field of surgical hemostasis and is a valuable enhancement to the portfolio of biosurgical products offered by Baxter,'' said Russell Holscher, vice president of research and development in Baxter's BioSurgery business. ''Importantly, the robust development process, including evaluation of more than 400 prototypes with feedback from more than 200 surgeons, exemplifies the company's commitment to customer-centric innovation. This hemostat will offer surgeons a valuable new tool. We plan to support the registration and launch of HEMOPATCH in additional countries in the coming years.''
About HEMOPATCH
HEMOPATCH Sealing Hemostat is intended as a hemostatic device for surgical procedures when control of bleeding by pressure, ligature, or conventional procedures is either ineffective or impractical.
Important Risk Information
HEMOPATCH Sealing Hemostat is not intended to be used in pulsatile, severe bleedings. The use of HEMOPATCH Sealing Hemostat is not recommended in the presence of an active infection. When used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm, care should be exercised to avoid overpacking (collagens do expand upon absorption of liquid, and may create the potential of nerve damage). HEMOPATCH Sealing Hemostat is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
Do not compress HEMOPATCH Sealing Hemostat into blood vessels or use intravascularly. The device must not be used in patients with known hypersensitivity to bovine proteins or brilliant blue (FD&C #1, blue dye).
Monday, October 28, 2013
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.
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.
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