Amsterdam, 15 November 2022 – Teledyne DALSA, a Teledyne Technologies company and global leader in Digital X-Ray Image Sensing technology, is pleased to announce it has acquired the Sigmascreening B.V. patents and IP portfolio on pressure-sensitive breast compression for screening. With its purchase, Teledyne DALSA has exclusive access to the Sigmascreening IP portfolio and algorithms. Holland Capital was one of the early investors in Sigmascreening. Unique combination
The unique combination of detector and pressure-sensitive compression is expected to create new possibilities for immediate diagnostic information as well as biomarkers for breast screening. According to Thorsten Achterkirchen, Vice President and General Manager of Teledyne DALSA’s X-Ray Solutions business, “We intend to expand our CMOS X-Ray detector product line for mammography and digital breast tomosynthesis (DBT) with new subsystem products for optimizing breast imaging and improving patient comfort during mammographic screening.”
Ivo Aarninkhof, CEO of Sigmascreening, says that ‘’We are delighted with the purchase of the Sigmascreening patents and IP portfolio by Teledyne DALSA. Use of the pressure-based compression during digital breast tomosynthesis and mammography improves participant and technologist experience and reduces compression pressure variability, mean breast thickness, and glandular dose.”1
Expertise in radiology
Holland Capital joined the company in 2014 as an early investor. The investment has been used for product development and commercial growth in recent years. Holland Capital is experienced in supporting innovative radiology solutions. This is the investor’s second exit in the field of medical imaging, following the acquisition of Quantib, a leading radiology artificial intelligence (“AI”) company, by RadNet Inc earlier this year. Jan-Frens van Giessel, Partner Holland Capital : “We are proud that we have been able to assist Sigmascreening in the past 8 years. Sigmascreening’s pressure sensitive breast compression reduces extreme pain during mammography and improves detection of breast cancer. It is great to see that this important healthcare innovation will become available for women worldwide with the acquisition of Teledyne DALSA.”
About Teledyne DALSA
Teledyne DALSA provides state-of-the-art image sensing, capture and processing solutions to medical, dental, and scientific equipment manufacturers. Building on more than 30 years of proven capability and innovation, our highly skilled team of imaging specialists adds value with their continued focus on leading-edge product design. Our manufacturing processes are tailored to comply with the stringent quality, reliability, and traceability requirements of the medical and scientific X-ray community. About Sigmascreening
Sigmascreening B.V. is a medical device company focusing on the development of new innovative products in the area of digital mammography and breast cancer screening. Sigmascreening was established as a spin-off company from the Amsterdam UMC. About Holland Capital
Over the past 40 years, Holland Capital has responsibly and successfully invested in over more than 150 SME-companies. With a clear investment strategy Holland Capital is active in the attractive growth markets of Healthcare and Technology. Holland Capital’s experienced and committed investment team understand entrepreneurship. They aim to establish an open, sustainable, and professional relationship with the companies they invest in, with the common goal of achieving growth. Holland Capital is backed by a broad network of successful Healthcare and Technology entrepreneurs. 1 quote is based on this scientific article:  https://academic.oup.com/jbi/advance-article/doi/10.1093/jbi/wbaa070/5902745

Teledyne Dalsa has acquired the Sigmascreening B.V. patents

Enabling personalized compression for better quality mammograms without unnecessary discomfort for patients, Sigmascreening announced that more than 100,000 women received optimum mammographic compression with the Sensitive Sigma™ Paddle. Sigmascreening will showcase the technology at the upcoming 104th Annual Radiological Society of North America (RSNA) meeting, November 25-30, 2018. (South Hall #4129). Sigmascreening also announced that a study accepted for presentation at RSNA demonstrates the impact of a real-time pressure indicator during mammographic exam acquisition . The study, “Mammographic Compression Variability Increased after Removing Real-Time Pressure Indicator,” (SSE23-05; Monday 3:00-4:00 PM), will be presented by Monique van Lier, Clinical Application Scientist, during the Physics Breast X-Ray Imaging Session. The Sensitive Sigma Paddle attempts to standardize the compression procedure by introducing pressure-based compression using a paddle equipped with a real-time pressure indicator. In the study, researchers evaluated the impact on compression practice when replacing the pressure-based paddle with a conventional paddle without pressure indication in a group experienced technologists. Results showed that after removal of the pressure indicator the average compression pressure and variance significantly increased, leading to more unfavorable over- and under-compression. The proportion of compressions in the pressure range 5-15 kPa decreased from 87.4% to 77.9%. The proportion of high pressures (>15kPa) nearly doubled (11.0% to 18.8%) and low pressures (<5kPa) more than doubled (1.6% to 3.3%). The results suggest that when removing the pressure indicator, compression variability increased rapidly, indicating that an indicator is needed to maintain compression reproducibility. To get the best image quality during a mammogram with the least amount of radiation, the breast needs to be flattened or compressed with a reasonable and repeatable amount of pressure. However, lack of standardization can lead to variability in compression. Under-compression can lead to blurred images, more retakes and a higher average glandular dose (AGD), while over-compression causes discomfort and unnecessary pain for the patient
Based on breast-size and tissue-stiffness, the Sensitive Sigma Paddle calculates the pressure to achieve an optimal compression range and allows for a highly reproducible procedure. A real-time pressure indicator provides women more control over the compression of their breasts and enhances interaction between the technologist and the patient about the progress of the compression procedure. This makes communication easier because of the fact that the patient is more involved, making the examination less stressful, with overall better image quality, lower radiation dose and a faster workflow. “We are pleased that research continues to demonstrate that pressure-based compression driven by real-time indicators, deliver optimum mammographic compression for better exam quality and patient experience,” said Ivo Aarninkhof, CEO, Sigmascreening. “Since the Sensitive Sigma Paddle entered clinical practice, more than 100,000 women have received the benefits – a number that increases by more than 5,000 every month.”
About Sigmascreening
Sigmascreening is a medical device company focusing on the development of new innovative products in the area of digital mammography and breast cancer screening. The Sensitive Sigma™ Paddle is our CE-certified product, based on our patented technology preventing over- and under-compression. We aim to introduce new products that will improve mammography and contribute to the early detection of cancer which ultimately can save lives. Media Contact:

Sigmascreening Passes Milestone as More than 100000 Women Have Received Optimum Mammographic Compression with the Sensitive Sigma Paddle

Friday, 01 September 2017 14:45 (UTC + 2)
Amsterdam, The Netherlands, September 01, 2017 / B3C newswire / -- Sigmascreening , a Dutch MedTech developer and world leader in the field of pressure based digital mammography and breast cancer screening, announces that a study of in total 15,898 in digital mammograms from 3,772 Asian women(1), underlines the need for compression guidelines. The study confirms a number of other studies indicating that a force-standardized protocol leads to large variations in compression practices. This has serious negative effects on patient experience and the efficacy of mammography, one of the most commonly used diagnostic screening tools throughout the world. Therefore pressure guided mammography with the Sigma™ Paddle, which is taking breast size into account, may lead to improved test results and less unnecessary discomfort and pain especially for Asian women. In a mammographic examination, the breast is compressed four times. The importance of this study is that it clarifies that Asian women, who generally have smaller breasts, are subject to force standardized protocols originally intended for Caucasian women. For that reason the researchers retrospectively analyzed the digital mammograms from Asian women. The mean ± standard deviation compression pressure for all mammograms was 17.77±10.51 kPa, which indicates a very unpredictable outcome of the compression procedure in these women. This study showed that in particular a force-standardized mammographic compression practice led to these widely variable compression parameters with a substantial amount of excessively high pressures without the use of the Sensitive Sigma paddle. These results are in line with compression practice in other Asian countries(2). Monique van Lier, Clinical Application Scientist at Sigmascreening comments: “If the Sensitive Sigma™ Paddle would be used in Asia, we expect better breast compression, which could improve specificity (true positives) of tumor detection and at the same time preventing unnecessary discomfort and pain, which may contribute to a higher breast cancer screening compliance of women as well. In other words, the use of our technology protects especially women with smaller breasts against excessive high compression pressures while potentially improving the results of the test ”. This study underpins the importance of taking breast size into account and is in accordance with Sigmascreening’s concept of the Sensitive Sigma™ Paddle, which applies pressure guidance during mammography. The Sensitive Sigma™ Paddle is the first pressure based compression paddle providing real-time pressure information of the whole mammographic breast compression course, which can considerably improve compression reproducibility aiming at an evidence based pressure target; similar for all women . As a result of this, extremely high or low pressures, as observed in this study, will disappear almost entirely by the use of the Sensitive Sigma™ paddle. It optimizes compression for every individual breast, by taking breast size and stiffness into account, for the most optimal screening result while reducing unnecessary and often extreme pain. Rapid market acceptance in Europe
Sigmascreening’s pressure-standardized breast compression is expanding rapidly in screening centers and hospitals throughout Europe. In Europe, over 10,000 patients already experienced the more woman-friendly way of making mammograms while clinicians are starting to recognize the improved sensitivity and specificity of our technology. The Sensitive Sigma™ Paddle with CE marking is already being used in the United Kingdom, Norway, France, Germany, Sweden, The Netherlands, Belgium and Switzerland.

Asian Study of Over 15,000 Mammograms Underlines the Potential Value of Sigmascreening’s Sensitive Sigma™ Paddle Solution for Pressure Guided Mammography

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May 26, 2017
Sigmascreening, a Dutch MedTech developer and world leader in the field of pressure based digital mammography and breast cancer screening , announces that a large independent Norwegian study further confirms Sigma’s hypothesis that pressure has a clear relation with the most optimal results in mammography. The study confirms the importance of pressure in accordance with Sigmascreening’s concept of the Sensitive Sigma Paddle , which applies pressure guidance during mammography. The combination of results of an earlier Dutch and this new Norwegian study shows an optimal pressure in the range of 10 kPa. This pressure clearly correlates very well with the proposed pressure by Sigmascreening. The data show that high breast volume and low compression pressure are associated with positive performance measures such as lower recall rate and higher specificity (true positive) of tumor detection. Procedures with too low pressures result in unnecessary recalls due to false positives. Flattening of the breast on the basis of pressure, also prevents unnecessary discomfort and pain, which may contribute to a higher breast cancer screening compliance of women. The Sigma pressure technology aims to optimize these three elements. Sigmascreening’s Sensitive Sigma Paddle is the first pressure based compression paddle providing real-time and reproducible information on mammographic pressure, which can considerably reduce frequently experienced pain for women during screening. It optimizes compression for every individual breast, taking into account breast size and tissue stiffness, which leads to an optimal mean contact pressure per woman thereby optimizing both specificity (true negative) and sensitivity (true positive) for the most optimal screening result. Ivo Aarninkhof, Sigmascreening’s CEO, said:
The data from this Norwegian study clearly show the huge potential of our pressure based paddle for women’s health. We strongly believe that our less painful solution will increase the compliance of breast cancer screening programs, while at the same time significantly improves the diagnostic performance. Our Sensitive Sigma Paddle can measure and visualize a – previously not available – parameter, PRESSURE, which allows hospitals and breast screening centers to take breast size and tissue stiffness into account. This avoids the currently experienced negative consequences of under- or over compression of the breast and enables a highly reproducible procedure, year after year. But foremost leads to a more precise tumor detection. Related Stories

Norwegian study shows huge potential of Sigmascreening’s pressure based paddle for women’s health

Norwegian Study Confirms the Potential Health Benefits of Pressure      Based Compression in Accordance with Sigmascreening’s Sensitive Paddle      Concept for Mammography Equipment
Fewer false positives, fewer false negatives and reduced unnecessary      pain
May 23, 2017 04:10 AM Eastern Daylight Time
AMSTERDAM--( BUSINESS WIRE )--Sigmascreening, a Dutch MedTech developer and world leader in the field      of pressure based digital mammography and breast cancer screening,      announces that a large independent Norwegian study1 further      confirms Sigma’s hypothesis that pressure has a clear relation with the      most optimal results in mammography. The study confirms the importance      of pressure in accordance with Sigmascreening’s concept of the Sensitive      Sigma Paddle , which applies pressure guidance during mammography. The      combination of results of an earlier Dutch and this new Norwegian study      shows an optimal pressure in the range of 10 kPa. This pressure clearly      correlates very well with the proposed pressure by Sigmascreening. The data show that high breast volume and low compression pressure are      associated with positive performance measures such as lower recall rate      and higher specificity (true positive) of tumor detection. Procedures      with too low pressures result in unnecessary recalls due to false      positives. Flattening of the breast on the basis of pressure, also      prevents unnecessary discomfort and pain, which may contribute to a      higher breast cancer screening compliance of women. The Sigma pressure      technology aims to optimize these three elements. Sigmascreening’s Sensitive Sigma Paddle is the first pressure based      compression paddle providing real-time and reproducible information on      mammographic pressure, which can considerably reduce frequently      experienced pain for women during screening. It optimizes compression      for every individual breast, taking into account breast size and tissue      stiffness, which leads to an optimal mean contact pressure per woman      thereby optimizing both specificity (true negative) and sensitivity      (true positive) for the most optimal screening result. “The data from this Norwegian study clearly show the huge potential of      our pressure based paddle for women’s health. We strongly believe that      our less painful solution will increase the compliance of breast cancer      screening programs, while at the same time significantly improves the      diagnostic performance,” says Ivo Aarninkhof, Sigmascreening CEO. “Our      Sensitive Sigma Paddle can measure and visualize a – previously not      available – parameter, PRESSURE, which allows hospitals and breast      screening centers to take breast size and tissue stiffness into account. This avoids the currently experienced negative consequences of under- or      over compression of the breast and enables a highly reproducible      procedure, year after year. But foremost leads to more precise tumor      detection.”
Norwegian study
The data of the Norwegian retrospective study of 261,000 mammography      exams, show that high breast volume and low compression pressure are      associated with positive performance measures such as lower recall rate      and higher specificity (true positive) of tumor detection. Especially      the findings on the applied pressure are in line with earlier data      generated in a Dutch study by the research group of Professor Nico      Karssemeijer et al2 in 54,137, showing that the performance      of breast cancer screening also depends on mammographic compression. These studies confirm the philosophy behind Sigmascreening’s Sensitive      Sigma Paddle for breast cancer screening devices. The Norwegian researchers, led by Dr. Nataliia Moshina, a doctoral      research fellow at the Cancer Registry of Norway in Oslo1 categorized compression force and pressure to determine performance      outcome measures such as recall rate, sensitivity, specificity, and      positive predictive value (PPV). "Based on our findings, low compression      pressure and high breast volume are associated with favorable early      performance measures, including lower recall rate, higher rate of      screen-detected cancer, and lower rate of interval breast cancer,      compared with high compression pressure and low breast volume," the      study authors wrote. But apart from the screened and diagnosed women, also radiographers and      radiologists benefit from pressure based compression. The real-time      visualization of the applied pressure gives more insights into the      compression practice, which leads to a faster more pleasant and much      more accurate procedure. Rapid market acceptance in Europe
Sigmascreening’s pressure-standardized breast compression is expanding      rapidly in screening centers and hospitals throughout Europe. In Europe,      over 10,000 patients already experienced the more woman-friendly way of      making mammograms while clinicians are starting to recognize the      improved sensitivity and specificity of our technology. The Sensitive      Sigma Paddle with CE marking is already being used in the United      Kingdom, Norway, France, Germany, Sweden, The Netherlands, Belgium and      Switzerland. About Sigmascreening
Sigmascreening, founded in 2009, is an Amsterdam based MedTech company      focusing on the development of new innovative products in the area of      digital mammography and breast cancer
screening. The Sensitive Sigma Paddle is the first product with CE      marking, based on patented technology. Sigmascreening aims to further      introduce new products that will improve mammography and contribute to      the early detection of cancer which ultimately can save lives. 1 Nataliia Moshina, Sofie Sebuødegård, Solveig      Hofvind; Is breast compression associated with breast cancer detection      and other early performance measures in a population-based breast cancer      screening program? - Breast Cancer Research and Treatment, 29 March 2017. 2 Katharina Holland, Ioannis Sechopoulos, Gerard den Heeten,      Ritse M. Mann, Nico Karssemeijer; Performance of Breast Cancer Screening      Depends on Mammographic Compression. – Breast Imaging, 17 June, 2016
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Norwegian Study Confirms the Potential Health Benefits of Pressure Based Compression in Accordance with Sigmascreening’s Sensitive Paddle Concept for Mammography Equipment

Claymount is a designer and manufacturer operating from three continents that adds value to X-ray systems through Technology Excellence and Cost Leadership. The company offers a product portfolio of components and subsystem devices for the global Medical and Industrial X-ray markets.

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Cambrios provides solutions using nanotechnology. Its silver nanowire-based transparent conductors simplify electronics manufacturing and improve end-product cost and performance for electronic devices. The company's ClearOhm product is a transparent conductor with significantly higher optical and electrical performance than traditional materials and methods. Applications of ClearOhm material include touch screens, EMI shielding, LCDs, ePaper, OLED lighting and thin film photovoltaics.

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`` Our partnership with Claymount and Cambrios Technologies has resulted in a product that has been subject to extensive scientific research and has already been put into practice at the Academic Medical Center in Amsterdam and women have responded very positively .

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SigmaScreening is a medical device company focusing on the development of new products in the area of breast cancer screening.

Name	Work History	Title	Status
Guido Maertens	Enzyre, Arcarios, and Radboud University Medical Center	Chief Financial Officer	Current
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