Hologic Obtains CE Mark for Affirm ® Contrast Biopsy Software

Global women’s health leader Hologic, Inc. (Nasdaq: HOLX) today announced that its Affirm^® Contrast Biopsy Software, which combines contrast-enhanced diagnostic capabilities with accurate lesion targeting to help streamline workflow and accelerate biopsy procedures,^1-2 is now CE-marked. The technology received clearance from the U.S. Food and Drug Administration in October 2020.

Designed from the ground up to integrate with the Selenia^® Dimensions^® and 3Dimensions™ systems, Hologic’s Affirm Contrast Biopsy Software enables clinicians to target and acquire tissue samples in lesions identified through contrast-enhanced mammography (CEM).

“At Hologic, we are committed to helping women live healthier lives everywhere, every day, including through innovative technologies that support the detection and diagnosis of breast cancer,” said Tanja Brycker, Vice President of International Strategic Development for Breast & Skeletal Health and Gynecological Surgical Solutions at Hologic. “We understand the pressures that radiologists work under and the impact that the breast screening and diagnosis process can have on women. Our new Affirm Contrast Biopsy solution is designed to support radiologists by maximizing workflow efficiencies while helping them to continue to deliver compassionate patient care.”

The software allows the targeting and acquisition of tissue samples in lesions identified on CEM where a correlation may not be found using tomosynthesis or ultrasound, offering an alternative to MRI-guided biopsy. In addition, for those patients who cannot tolerate MRI-guided biopsies, contrast-enhanced biopsy provides a smooth examination experience due to reduced noise and shorter examination time compared with MRI.³ Ultimately, contrast-enhanced biopsy has the potential to help save time, reduce costs and improve patient experience.¹

With Hologic’s powerful contrast mammography and biopsy portfolio — including the Affirm Upright Biopsy System, I-View^® 2.0 Contrast-Enhanced Mammography Software and Affirm Contrast Biopsy Software — the company provides solutions to confidently guide the clinical pathway from screening to diagnosis and biopsy.

For more information, please visit Hologic UK Screening & Diagnosis Solution.

About Hologic, Inc.

Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X,Instagram and YouTube.

Forward-Looking Statements

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.

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 womenshealth@hologic.com.

Hologic, The Science of Sure, 3Dimensions, Affirm, Dimensions, I-View and Selenia are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

References

¹ Hologic Data on File. Affirm Contrast Biopsy Instructions for Use. MAN-07748 Rev 002.
² Schrading S, Distelmaier M, Dirrichs T, et al. Digital breast tomosynthesis-guided vacuum-assisted breast biopsy: initial experiences and comparison with prone stereotactic vacuum-assisted biopsy. Radiology. 2015;274(3):654-62.
³ Compared to MRI procedures.

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