Hologic Announces FDA Clearance and Commercial Availability of the Affirm™ Prone Biopsy System, the First 2D/3D™ Imaging-...

MARLBOROUGH, Mass., April 21, 2016 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) today announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of the Affirm™ prone biopsy system, the first dedicated prone biopsy system to offer both 2D and 3D™ imaging-guided breast biopsies.

"At Hologic, we challenge ourselves to advance medical technology so that healthcare professionals and patients can benefit from innovative solutions that significantly improve outcomes and patient experience, while also creating a powerful economic model for our customers," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "The launch of our Affirm™ prone biopsy system is the most significant advancement in prone biopsy technology since we introduced the first system more than 20 years ago. We identified a need for a minimally invasive, stereotactic breast biopsy technology that marries the advances in 3D MAMMOGRAPHY™ exams with the prone positioning many doctors prefer, and are excited to bring this new generation prone biopsy system to market."

With a larger field of view than existing dedicated prone biopsy systems, the new Affirm™ prone biopsy system allows radiologists to better target lesions found during 3D MAMMOGRAPHY™ exams, as well as other screening modalities. Furthermore, this new product features a streamlined workflow with increased automation designed to make using the system fast and easy.

With the patient lying prone, the biopsy system provides true 360-degree access to lesions using a fully integrated C-Arm. Approach angles can be varied with minimal movement on the patient's part, as the patient is supported stably throughout the procedure. In addition to these important benefits for clinicians, the system's design aims to increase patient satisfaction through faster procedure times than Hologic's market leading MultiCare® Platinum system, and comfortable prone positioning that eliminates a direct view of the biopsy needle.

"Until now, we've been struggling to handle complex biopsies for subtle lesions or faint calcifications that we are only able to identify using 3D MAMMOGRAPHY™ exams," said Dr. Alejandro Tejerina of the Centro Patologia de la Mama, Fundación Tejerina in Madrid, Spain. "As an early testing site for the Affirm™ prone biopsy system, we've had the opportunity to perform many biopsies using this technology, and are pleased to report that this new biopsy table has helped to solve our challenges. We are able to visualize more tissue and have access to challenging lesion locations, and the procedures are very fast."

The system is CE marked, and Hologic has begun installing Affirm™ prone systems at leading imaging sites in Europe.

The Affirm™ prone biopsy system expands Hologic's breast biopsy portfolio, complementing the Company's Genius™ 3D MAMMOGRAPHY™ exam and Affirm™ upright biopsy system. This portfolio equips hospitals and imaging centers with the options necessary to provide minimally invasive breast biopsies for their patients.

The system is now available for order in the U.S. For additional information on the Affirm™ prone biopsy system, please visit www.affirmpronebiopsy.com.

About Hologic

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, 3D, 3D Mammography, Affirm, Genius, MultiCare and the Science of Sure are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic mammography and breast biopsy systems. There can be no assurance the systems will achieve the benefits described here, or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that the systems will achieve any expected level of sales or market share. Hologic expressly disclaims any obligation to release publicly any updates to the data or statements presented here to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.

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SOURCE Hologic, Inc.

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