Hologic : New Research Shows Hologic’s BioZorb® Marker is a Safe Adjunct to Breast-Conserving Surgery that May Benefit Radiation Oncologists, Surgeons and PatientsPDF Format

February 2, 2021

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--Large, long-term study published in peer-reviewed journal finds tissue marker can benefit radiation therapy planning and surgical cosmesis--

MARLBOROUGH, Mass. February 2, 2021 - A newly published study has demonstrated the safety and clinical efficacy of Hologic, Inc.'s (Nasdaq: HOLX) BioZorb^®3D bioabsorbable marker when used as an adjunct to breast-conserving surgery.[i]Published online in the Annals of Surgical Oncology, the BioZorb^®Registry is the first large, multi-center study to report 24-month outcomes following implantation of the marker as part of breast-conserving surgery.

The BioZorb marker is a 3D implantable marker consisting of a spiral, bioabsorbable framework embedded with six permanent, titanium clips designed to precisely mark the surgical excision site. Designed to absorb into the body over a year or more, the BioZorb marker is used in breast-conserving surgery and provides 3-dimensional targeting for radiation therapy.

'This study reinforces the existing body of research supporting the BioZorb marker on a national scale, strengthening the case that it is a helpful adjunct for breast-conserving surgeries, particularly those requiring post-procedure radiation therapy,' said Jennifer Meade, Hologic's Division President, Breast and Skeletal Health Solutions.

Radiation oncologists participating in the study reported the BioZorb device often aided in targeting for tumor bed boost and accelerated partial breast irradiation (APBI).ⁱ

'Radiation oncologists are trained to target seromas, but newer oncoplastic surgical techniques can rearrange tissues, making traditional methods of defining the tumor bed challenging,' said William H. Hall III, MD, co-author and radiation oncologist with Bellingham Radiation Oncology in Bellingham, WA. 'In my experience, the BioZorb marker allows for more accurate delineation of the lumpectomy cavity and can contribute to smaller planning target volumes, reducing irradiation of normal tissue.'

Surgeons reported their primary motives for using the BioZorb marker were as a communications tool for radiation targeting, as well as enhancing the cosmetic outcome.ⁱ

Patients and surgeons indicated the BioZorb marker yielded a significant cosmetic benefit, with 90% or more of patients reporting good-to-excellent long-term cosmetic outcomes with low adverse effects.ⁱ

'As more patients enjoy long-term survival following breast-conserving surgery, cosmetic results gain increasing clinical importance, particularly given the correlation to quality of life,' said Cary S. Kaufman, MD, FACS, lead author and surgeon at Bellingham Regional Breast Center in Bellingham, WA. 'I've seen in my own patients that the BioZorb marker has a major cosmetic benefit, and this registry study replicates those results on a national scale. It is my belief that the BioZorb marker is clearly a valuable addition to a surgeon's toolkit to provide comprehensive, patient-focused care.'

For more information about the BioZorb marker, clickhere. To access the complete study results, clickhere.

About Hologic, Inc.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic, BioZorb 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 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 disclaim 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 [e-mail].

Media Contact:

Jane Mazur

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585.355.5978 (mobile)

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[i]Kaufman CS, Cross MJ, Barone JL, Dekhne NS, Devisetty K, Dilworth JT, Edmonson DA, Eladoumikdachi FG, Gass JS, Hall WH 3rd, Hong RL, Kuske RR, Patton BJ, Perelson C, Phillips RF, Smith AB, Smith LA, Tafra L, Lebovic GS. A Three-Dimensional Bioabsorbable Tissue Marker for Volume Replacement and Radiation Planning: A Multicenter Study of Surgical and Patient-Reported Outcomes for 818 Patients with Breast Cancer. Ann Surg Oncol. 2020 Nov 21. doi: 10.1245/s10434-020-09271-2. Epub ahead of print. PMID: 33221977.

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