Ethicon Introduces ETHIZIATM Hemostatic Sealing Patch, Clinically Proven to Stop Disruptive Bleeding
Addition of hemostatic patch complements Ethicon’s comprehensive Biosurgery portfolio and ability to address critical unmet needs in controlling bleeding.
RARITAN, NJ – November 15, 2023 – Ethicon*, a Johnson & Johnson MedTech company**, today announced the approval of ETHIZIATM, an adjunctive hemostat solution which has been clinically proven to achieve sustained hemostasis in difficult to control bleeding situations.1 Comprised of unique synthetic polymer technology, ETHIZIA™ Hemostatic Sealing Patch is the first and only hemostatic matrix designed to be equally active and efficacious on both sides***.2 Designed for maximum adaptability, it can be stuffed, rolled, pulled apart, trimmed and tailored,3,4 making it easy to handle in both open and minimally invasive surgeries.5 In 80% of clinical trial patients studied****, ETHIZIA™ Hemostatic Sealing Patch stopped bleeding in 30 seconds, an average of six times faster than the leading Fibrin Sealant Patch*****. 6,7
ETHIZIA™ Hemostatic Sealing Patch has received CE Mark approval as an adjunctive hemostat for disruptive bleeding on internal organs, except cardiovascular and neurological, and is expected to launch in EMEA in Q1 2024, and other key markets in North America, APAC and LATAM following regulatory approvals.
“As a global leader in surgery, we are committed to empowering healthcare providers to safeguard patients from surgical complications by continuously delivering breakthrough solutions,” said Vladimir Makatsaria, Company Group Chairman, Ethicon. “Disruptive bleeding can contribute to serious complications, and with the addition of ETHIZIA™ to our portfolio, we are well positioned to deliver critical hemostasis solutions for patients.”
In May 2022, Ethicon acquired GATT Technologies B.V., a Netherlands-based company using differentiated synthetic polymer to create hemostatic and sealant products to address complex surgical bleeding and leak challenges. The acquisition of GATT and the addition of its synthetic technology complements Ethicon’s current capabilities, enabling the development of innovative solutions that address critical unmet needs, such as ETHIZIA™ Hemostatic Sealing Patch which can offer sustained hemostasis in difficult to control bleeding situations.
As a global leader in surgery, Ethicon harnesses deep expertise to design surgical solutions that are smarter, less invasive, and more personalized. The introduction of ETHIZIA™ provides a unique design that surgeons can trust to work equally effective on both sides***8 , giving surgeons the confidence they need in any surgical situation.
At Ethicon, a Johnson & Johnson MedTech company, putting humanity at the core of care is our passion and our purpose. In collaboration with clinicians and health care experts around the world, we develop clinically-differentiated surgical technologies and solutions to help address some of the most pressing health challenges of our time such as metabolic disease, cardiovascular disease and cancer. Through our efforts and ingenuity, we aspire to elevate standards of care and create a healthier future for the patients of today and tomorrow. Visit www.ethicon.com to learn more about us.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more, visit https://thenext.jnjmedtech.com.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the ETHIZIATM adjunctive hemostat solution. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Johnson & Johnson Enterprise Innovation Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Johnson & Johnson Enterprise Innovation Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
1 GATT Technologies BV, DHF-01-QR-021 Clinical Investigation Report, Feb 2022, Data on file.
2 Roozen EA, Lomme RM, Calon NU, ten Broek RP, van Goor H. Efficacy of a novel polyoxazoline-based hemostatic patch in liver and spleen surgery. World Journal of Emergency Surgery. 2023;18(1). doi:10.1186/s13017-023-00483-x
3 GATT Technologies BV, DHF-SR-120 Partly heparinized in vivo porcine model ORSI, Nov 2021, Data on file.
4 GATT Technologies BV, DHF-SR-142 Partly heparinized in vivo porcine model Radboudumc, Jan 2023, Data on file.
5GATT Technologies BV, DHF-01-SFT-200 GATT-Patch Summative Usability Report, Jan 2023, Data on file.
6 Orsi Academy, DHF-01-SR-154 GATT-Patch vs Suturing in a robotic porcine partial nephrectomy model, Feb 22, Data on file.
7 Genyk Y, Kato T, Pomposelli JJ, et al. Fibrin sealant patch (tachosil) vs oxidized regenerated cellulose patch (surgicel original) for the secondary treatment of local bleeding in patients undergoing hepatic resection: A randomized controlled trial. Journal of the American College of Surgeons. 2016;222(3):261-268. doi:10.1016/j.jamcollsurg.2015.12.007
8 Roozen EA, Lomme RM, Calon NU, ten Broek RP, van Goor H. Efficacy of a novel polyoxazoline-based hemostatic patch in liver and spleen surgery. World Journal of Emergency Surgery. 2023;18(1). doi:10.1186/s13017-023-00483-x
*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners.
**Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
***Pre-clinical test data are not necessarily indicative of clinical performance.
****Based on clinical trial data. The Full Analysis Set showed 32/39 patients (82%) achieved hemostasis in 30 seconds.
*****Tachosil Fibrin Sealant Patch is leading in EMEA region based on market share data. Tachosil time to hemostasis is 3 min per IFU.