Hologic's Clarity HD & Intelligent 2D Systems Gain FDA Nod
Zacks Investment Research | Mar 28, 2018 04:51AM ET
Strengthening the Breast Health portfolio, Hologic, Inc. (NASDAQ:HOLX) recently announced the receipt of PMA approval from the FDA for the Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology. Following the approval, these products are now available on the 3Dimensions breast tomosynthesis system.
Notably, in conjunction with enhanced 3D image quality for radiologists, this system provides an improved workflow for technologists. Moreover, it aims to provide a more comfortable mammography experience with low-dose options. We encouragingly note that Hologic has already placed over 5000 3D Mammography systems across the United States. The company is optimistic about the recent addition to its suite of breast cancer screening, diagnostic and interventional solutions under the Breast Health business.
Clarity HD High-Resolution 3D Imaging and Intelligent 2D Imaging Technologies
Per the company, Clarity HD high-resolution 3D imaging technology has been developed and designed to articulately discover subtle lesions and fine calcifications to help diagnose cancers early. Moreover, Clarity HD technology's combination of innovative detector and advanced 3D imaging algorithm aid in producing superior 3D images, regardless of the breast density or size.
Furthermore, the Intelligent 2D imaging technology in combination with Clarity HD technology delivers exceptional overall image quality at a lower dose.
Breast Health Unit in Focus
We are upbeat about Hologic’s consistent efforts to gain traction in the Breast Health business that has contributed 36% to the company’s overall top-line growth in first-quarter fiscal 2018. This segment recorded 4.2% growth in constant currency in the quarter.
The company’s unique direct-to-consumer initiatives in the segment provided it with a competitive edge in the niche space.
In a bid to enhance the breast health portfolio, Hologic recently announced a worldwide collaboration deal with Royal Philips (PHG), a leading health-technology company. The global partnership agreement will provide integrated imaging solutions for women's health.
In November 2017, the company announced a development and distribution agreement with Clarius Mobile Health for its portable ultrasound scanner system. It also announced the receipt of the 510(k) clearances from the FDA for its Quantra 2.2 Breast Density Assessment Software later in the month. Notably, the software can be used with Hologic 3D Mammography systems.
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Within this segment, the company has redesigned its R&D strategy toward continued innovation around its leadership position in 3D Mammography. Also, in November, it announced plans to make all of its mammography systems available for the Dutch Breast Cancer Screening Program, in collaboration with Tromp Medical, Hologic’s distributor in the Netherlands.
In line with this, starting 2018, Hologic’s latest 3Dimensions mammography systems will be installed in mobile and stationary screening facilities in the Netherlands.
Market Trends Buoy Optimism
Per a report by DPI Research on Medium, the breast cancer screening market in the United States is expected to reach a value of roughly $5.8 billion by 2022.
Also, per a report by GBI Research, the global breast cancer treatment market will reach a value of $17.2 billion by 2021, at a CAGR of 7.3%.
Thus, the company clearly has solid prospects in this market.
Share Price Performance
Over the past three months, Hologic declined 11.9%, underperforming the industry ’s gain of 8.6%. We believe that the latest FDA nod will help the stock to rebound.
Zacks Rank & Key Picks
Hologic carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical sector are Bio-Rad Laboratories (NYSE:BIO) , athenahealth, Inc. (NASDAQ:ATHN) and Edwards Lifesciences Corporation (NYSE:EW) .
Bio-Rad Laboratories sports a Zacks Rank of 1 (Strong Buy). You can see It has long-term expected earnings growth rate of 20%.
athenahealth is a Zacks #1 Ranked player. It has long-term expected earnings growth rate of 21.5%.
Edwards Lifesciences has long-term expected earnings growth rate of 15.1%. The stock carries a Zacks Rank of 2 (Buy).
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