Genius Low Dose 3 D Mammography Tomo HD

Genius™ Low Dose 3 D Mammography™ (Tomo. HD) Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 1

Terminology Genius™ 3 D Mammography™ • Acquired on the Hologic® 3 D Mammography™ system and consists of a 2 D and 3 D™ image set • The 2 D image can be either an acquired 2 D image or a 2 D image generated from the 3 D™ image set. Hologic® Low Dose 3 D Mammography™ • Low dose 2 -view exam acquired with the Hologic® 3 D Mammography™ system and C-View™ software option • also known as Tomo. HD mode Combo mode • An imaging mode that takes co-registered 2 D and 3 D™ images under one compression Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 2

Clinical Efficacy Tomosynthesis with 2 D is superior to 2 D alone 6 Combined with 2 D, tomosynthesis is a more accurate mammogram 3 Masses, distortions and asymmetric densities are better visualized with tomosynthesis 7 -8 Tomosynthesis significantly improves diagnostic accuracy of non-calcified lesions compared to supplemental 2 D diagnostic views 7 Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 3

Clinical Efficacy* Breast cancer screening with tomosynthesis significantly increases cancer detection with: 3 Compared to FFDM, sites report a significant reduction in recalls with tomosynthesis: 4 -5 • 40% increase in invasive cancer detection • 27% increase in cancer detection • Up to 40% reduction in recall rates compared to 2 D alone (based on site practices) Patients across all age groups and breast densities benefit from the addition of tomosynthesis screening 3 *Study utilized Hologic® Selenia® Dimensions® systems Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 4

Genius™ Low Dose 3 D Mammography™ (C-View™ Software Option) Less patient dose through fewer x-ray exposures Greater patient comfort via fast, <4 second scan time Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Heightened detail retained from tomosynthesis images Hologic Low Dose Mammography is superior than 2 D 11, 12 Genius™ Low Dose 3 D Mammography™ 5

Generating 2 D Images Perform a standard tomosynthesis scan Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 6

Generating 2 D Images Tomosynthesis Slices Perform a standard tomosynthesis scan Reconstruct tomosynthesis slices Reconstruction Algorithm 15 Projection Images Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 7

Generating 2 D Images Tomosynthesis Slices Perform a standard tomosynthesis scan Reconstruct tomosynthesis slices Software Algorithm Synthesize 2 D image Available in any tomosynthesis view Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Generated 2 D Images Genius™ Low Dose 3 D Mammography™ 8

Generated 2 D Images Facilitates current to prior exam review Maintains important details from tomosynthesis slices Interpreted in combination with tomosynthesis images Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 Genius™ Low Dose 3 D Mammography™ 9

Image Comparison: Case 1 2 D Tomosynthesis Slice Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 Generated 2 D Genius™ Low Dose 3 D Mammography™ 10

Image Comparison: Case 1 2 D Tomosynthesis Slice Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 Generated 2 D Genius™ Low Dose 3 D Mammography™ 11

Image Comparison: Case 2 2 D Tomosynthesis Slice Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 Generated 2 D Genius™ Low Dose 3 D Mammography™ 12

Which is the Generated 2 D Image? Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 Genius™ Low Dose 3 D Mammography™ 13

Which is Which? Generated 2 D Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 2 D Genius™ Low Dose 3 D Mammography™ 14

U. S. Dose Comparison Combo Mode • Tomo + FFDM • 10 second scan time • ACR Dose = 2. 65 m. Gy Tomo. HD Mode • Tomo + Generated 2 D • 4 second scan time • ACR Dose = 1. 45 m. Gy • • • Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Scan Time Reduction Lowers Risk of Patient Motion Patient Dose Reduction Genius™ Low Dose 3 D Mammography™ 15

Clinical Performance: Genius™ 3 D Mammography™ + Generated 2 D vs. 2 D alone Superior diagnostic accuracy for non-calcification cases 11 Increase in Cancer Detection Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Fewer non-cancer recalls 11 Recall Rate Reduction Genius™ Low Dose 3 D Mammography™ 16

Summary: Genius™ Low Dose 3 D Mammography™ Lower patient dose Shorter compression time Increased patient comfort Lowered risk of patient motion Superior performance compared to traditional 2 D alone 11 Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 17

# Additional publication information Reference 1 FDA submissions P 080003, P 080003/S 001 2 Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25; 311(24): 2499 -507. 3 Zuckerman SP, Conant EF, Keller BM, et al. Implementation of Synthesized Two-dimensional Mammography in a Population-based Digital Breast Tomosynthesis Screening Program. Radiology. 2016 Dec; 281(3): 730 -736. 4 Skaane P, Bandos A, Eben EB, et al. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology. 2014 Jun; 271(3): 655 -63. 5 Bernardi D, Macaskill P, Pellegrini M, et. al. Breast cancer screening with tomosynthesis (3 D mammography) with acquired or synthetic 2 D mammography compared with 2 D mammography alone (STORM-2): a population-based prospective study. Lancet Oncol. 2016 Aug; 17(8): 1105 -13. 6 Mc. Donald ES, Oustimov A, Weinstein SP, et al. Effectiveness of Digital Breast Tomosynthesis Compared With Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening. JAMA Oncol. 2016 Jun 1; 2(6): 737 -43. 7 Rafferty EA, Durand MA, Conant EF, et al. Breast Cancer Screening Using Tomosynthesis and Digital Mammography in Dense and Nondense Breasts. JAMA. 2016 Apr 26; 315(16): 1784 -6. 8 Data on file at Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 18

Additional slides Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 19

International Dose Comparison Combo Mode • Tomo + FFDM • 10 second scan time • PMMA Dose = 3. 42 m. Gy Tomo. HD Mode • Tomo + Generated 2 D • 4 second scan time • PMMA Dose = 2. 00 m. Gy • • • Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Scan Time Reduction Lowers Risk of Patient Motion Patient Dose Reduction Genius™ Low Dose 3 D Mammography™ 20

Additional publication information 1. Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fantò C, Valentini M, Montemezzi S, Macaskill P. Integration of 3 D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol. 2013 Jun; 14(7): 583 -9. doi: 10. 1016/S 1470 -2045(13)70134 -7. Epub 2013 Apr 25. 2. Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr; 267(1): 47 -56. doi: 10. 1148/radiol. 12121373. Epub 2013 Jan 7. 3. Rose SL, Tidwell AL, Bujnoch LJ, Kushwaha AC, Nordmann AS, Sexton R Jr. Implementation of breast tomosynthesis in a routine screening practice: an observational study. AJR Am J Roentgenol. 2013 Jun; 200(6): 1401 -8. doi: 10. 2214/AJR. 12. 9672. 4. Friedewald SM, Rafferty EA, Rose SL, Durand MA, Plecha DM, Greenberg JS, Hayes MK, Copit DS, Carlson KL, Cink TM, Barke LD, Greer LN, Miller DP, Conant EF. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25; 311(24): 2499 -507. doi: 10. 1001/jama. 2014. 6095. 5. Philpotts L, Raghu M, Durand M, Hooley R, Vashi R, Horvath L, Geisel J, Butler R. Initial Experience With Digital Breast Tomosynthesis in Screening Mammography. Presented at the ARRS 2012, Scientific Session 22 - Breast Imaging: Screening/Emerging Technologies. 6. Haas B, Kalra V, Raghu M, Philpotts L. Performance of digital breast tomosynthesis compared to conventional mammography for breast screening. Radiological society of North America annual meeting. Chicago, Il, 2012. 7. Destounis S, Murphy P, Seifert P, Somerville P, Paulis L, Cavanaugh D, Arieno A, Morgan R. “Experience with Combination 2 D/3 D Breast Tomosynthesis vs FFDM in the Screening Environment. ” (paper presented at the Radiological Society of North America. Chicago, Il, November 2012. ) 8. Bernardi D, Ciatto S, Pellegrini M, Tuttobene P, Fanto' C, Valentini M, Michele SD, Peterlongo P, Houssami N. Prospective study of breast tomosynthesis as a triage to assessment in screening. Breast Cancer Res Treat. 2012 May; 133(1): 267 -71. doi: 10. 1007/s 10549 -0121959 -y. Epub 2012 Jan 22. 9. Zuley ML, Bandos AI, Ganott MA, Sumkin JH, Kelly AE, Catullo VJ, Rathfon GY, Lu AH, Gur D. Digital breast tomosynthesis versus supplemental diagnostic mammographic views for evaluation of noncalcified breast lesions. Radiology. 2013 Jan; 266(1): 89 -95. doi: 10. 1148/radiol. 12120552. Epub 2012 Nov 9. 10. Dang P, Humphrey K, Freer P, Halpern E, Saksena M, Rafferty E. “Comparison of Lesion Detection and Characterization in Invasive Cancers Using Breast Tomosynthesis versus Conventional Mammography” (paper presented at the annual meeting of the Radiological Society of North America, Chicago, Il, December 2013). 11. FDA PMA submission P 080003/S 001. 12. Skaane P, Bandos AI, Eben EB, Jebsen IN, Krager M, Haakenaasen U, Ekseth U, Izadi M, Hofvind S, Gullien R. Two-View Digital Breast Tomosynthesis Screening with Synthetically Reconstructed Projection Images: Comparison with Digital Breast Tomosynthesis with Full -Field Digital Mammographic Images. Radiology. 2014 Jan 24: 131391. 13. Zuley ML, Guo B, Catullo VJ, Chough DM, Kelly AE, Lu AH, Rathfon GY, Lee Spangler M, Sumkin JH, Wallace LP, Bandos AI. Comparison of Two-dimensional Synthesized Mammograms versus Original Digital Mammograms Alone and in Combination with Tomosynthesis Images. Radiology. 2014 Jan 21: 131530. Hologic Proprietary – For Educational Use Only – PRE-00380 – rev 006 – July 2017 style Genius™ Low Dose 3 D Mammography™ 21