MARLBOROUGH, Mass. November 14, 2016 -- Hologic, Inc. (Nasdaq: HOLX) today announced the launch of its next-generation NovaSure® 6mm global endometrial ablation (GEA) system, the NovaSure® ADVANCED system. The system has been CE-marked and is being launched in Europe, Canada and Australia.
The NovaSure system reduces abnormal uterine bleeding by applying radiofrequency energy to the endometrium and gently removing the lining of the uterus in two minutes or less.1 The enhancements in the NovaSure ADVANCED product are designed with the patient and physician in mind, offering a 6mm diameter to improve patient comfort and physician ease-of-use while maintaining the clinical efficacy of the trusted NovaSure system.
As an alternative to the 8mm NovaSure device, the current standard of care, the 6mm device requires less dilation based on a smaller sheath size. This can improve patient comfort, especially for patients who have difficulty dilating. In addition, the new NovaSure device is designed with an acorn-like shaped cervical seal with 13% more “working length” than the previous product. The new device is also equipped with rounded Smooth Access™ tips that simplify insertion, and a blue handle that serves as a useful reminder for how the device should be inserted.
“In addition to the new system providing a high level of patient and physician satisfaction, it’s important to note that the slender diameter will allow physicians to perform more procedures in-office,” said Dr. Henrik Skensved, a Consultant Gynecologist from Denmark who was one of the first clinicians to use the new NovaSure ADVANCED system. “The introduction of the 6mm device gives physicians the ability to treat patients in a more comfortable setting, while maintaining the efficacy we have trusted from the NovaSure system for more than 10 years.”
The NovaSure system is used to treat women with abnormal uterine bleeding, a condition that affects one in five women2 and can be lifestyle-restricting. Endometrial ablation with NovaSure is a one-time procedure that can be performed in the doctor's office. The procedure is safe and effective, dramatically reducing or stopping menstrual bleeding in 90% of women. More than two million women have chosen the NovaSure procedure to treat abnormal uterine bleeding.3
"Our next-generation NovaSure ADVANCED system is the same safe and efficacious NovaSure device that physicians and patients have relied on for years, now thoughtfully designed with the enhancements our customers have been requesting,” said Tom O'Neill, Hologic's Division President, GYN Surgical Solutions. “The evolution of the NovaSure system signals our ongoing commitment to addressing our customers’ needs and improving the overall patient experience by offering quick and effective solutions to treat excessive bleeding.”
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.
Hologic, NovaSure, The Science of Sure, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.
NovaSure ADVANCED has been CE-marked and is being launched in Europe, Canada and Australia. NovaSure ADVANCED is not approved for marketing in the United States. This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to firstname.lastname@example.org.
1 Gimpelson, R. Ten-year Literature Review of Global Endometrial Ablation with NovaSure Device. International Journal of Women's Health 2014:6 269-80.
2 Centers for Disease Control and Prevention. Blood disorders in women: heavy menstrual bleeding. http://www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html. Accessed September 24, 2015.
3 Hologic Inc., Data on file, 2014.