Volpara Health Technologies: Pioneering Personalized Breast Imaging Solutions Post-IPO

Globally, the incidence and mortality rates of breast cancer continue to rise, gradually becoming a significant health threat to humanity. In developed countries, 1 in every 8 women may be diagnosed with breast cancer. Worldwide, approximately 75 million women undergo mammography (abbreviated as: mammogram) annually, with this figure reaching 39 million in the United States.

Mammography is an effective method for breast cancer prevention and can be used for breast cancer screening. However, this method is not suitable for all women. For women with dense breasts, the accuracy of mammography decreases as breast density increases. According to VCBeat (WeChat ID: vcbeat), 40–50% of women in North America and 70–80% of women in parts of Asia have dense breasts.

Clinical studies spanning several decades have shown that women with dense breasts have a 4.7-fold higher risk of developing breast cancer compared to those with fatty breasts. Because both dense breast tissue and cancer cells appear white on mammograms, cancerous lesions hidden within dense tissue may be overlooked. Dense glandular tissue is more likely to obscure early signs of cancer.

To address the shortcomings of existing mammography techniques, Volpara Health Technologies Limited (hereinafter referred to as “Volpara”), a breast imaging analytics provider based in Wellington, New Zealand, is committed to resolving issues associated with dense breast tissue.

Volpara is dedicated to providing digital health solutions for the early detection of breast cancer, capable of comprehensively analyzing female breast density and performing analysis and screening based on objective measurements of breast density, compression, and radiation dose.

As the company’s sales and marketing department, Volpara Solutions has developed multiple software products. Among them, VolparaDensity provides clinicians with patient-specific X-ray radiation doses through mammographic diagnosis, converting mammography into volumetric data measurements to support clinical decision-making.

To date, more than 9 million women across 36 countries—including the United States, Europe, Asia, the Middle East, and Australia and New Zealand—have undergone breast density assessment using VolparaDensity, one of Volpara’s solutions. Volpara’s technology has been deployed in over 30 countries, with its geographic coverage continuing to expand.

In December 2014, Volpara Solutions secured $5.5 million in seed funding from undisclosed investors.

In 2016, Volpara announced its successful initial public offering (IPO) in Australia, issuing 20 million shares at a price of $0.50 per share, with an initial market capitalization of approximately $61 million. Following the IPO, Volpara was listed on the Australian Securities Exchange under the ticker symbol VHT. As of June 7, 2018, its stock price stood at $0.79, with an estimated market capitalization reaching $140 million.

Ralph Highnam, Executive Director and CEO of Volpara, reflects on his time at the University of Oxford. Since then, he has been engaged in breast cancer screening research, exploring pathways to reduce breast cancer mortality among women.

“As women undergo screening, we are also continuously improving patient care,” said Highnam. “This not only enhances the profitability and cost-effectiveness of breast screening programs but also reflects the tangible value Volpara delivers to its customers.” In the United States, more than 1 million women have subscribed to their products.

According to VCBeat, Ralph Highnam, as one of the founders of Volpara, has been exploring and developing state-of-the-art digital mammography imaging technologies for 25 years. From 1988 to 1999, he completed his Master’s degree in Computer Science, his DPhil in Engineering Science, and his postdoctoral research in Engineering at the University of Oxford.

1999In October, Ralph Highnam founded OXIVA Ltd., driven by continuous innovations in quantitative breast imaging technology. A year later, Highnam merged OXIVA with Professor Mike Brady’s OMIA to jointly establish Mirada Medical. The medical image analysis software developed by Mirada Medical has been installed and deployed in nearly 2,000 hospitals worldwide.

Under Highnam’s leadership, multimodal image imaging and fused-separated image technologies propelled Mirada Solutions to become the leading provider of image registration and fusion tools prior to its acquisition by CTI Molecular Imaging and Siemens Medical Systems.

2003In August, Highnam, as CEO of Highnam Associates Consulting, conducted in-depth consultations and studies on the technologies of the world’s leading medical imaging companies, including R2, Siemens, Hologic, and Dexela, as well as several top-tier breast cancer screening programs worldwide. During this period, he also engaged in business collaborations and academic discussions with imaging companies around the globe.

2009In February [Year], Volpara was officially established. Over the past nine years, Highnam has saved many women’s lives through breast screening technologies. Volpara Health Technologies is dedicated to providing patients with the most accurate measurements of breast composition (i.e., breast density), with the ultimate goal of improving the health outcomes of women worldwide.

In addition, Highnam has published numerous academic papers and co-authored the seminal work Mammographic Image Analysis with Professor Brady. In 2015, Highnam was named a Wellingtonian of the Year finalist in Wellington, New Zealand.

As another co-founder of Volpara, Professor Mike Brady currently serves as Professor of Oncological Imaging at the University of Oxford. He previously served for 20 years as a Non-Executive Director and Deputy Chairman of Oxford Instruments plc, an FTSE 250 company, and also held the position of Executive Chairman at AEA Technology plc for ten years.

Meanwhile, Professor Brady has published 750 papers in the fields of computer vision, robotics, medical image analysis, and artificial intelligence, and holds 35 related patents. He has contributed to the editing and authorship of 10 reference books.

2016In July, Volpara Solutions announced the launch of VolparaEnterprise software, which provides high-quality, personalized breast cancer screening for breast imaging providers. Their solution, built on the Microsoft Azure cloud platform, enables real-time monitoring of quality assurance and performance metrics for breast cancer screening through dynamic, interactive dashboards.

VolparaEnterpriseThe software is designed for both large and small enterprises. Regardless of whether a company operates from a single site or multiple sites, users can access the dashboard from any browser or mobile device via a central database to obtain necessary information. Additionally, users can compare performance across multiple facilities and conduct comprehensive reviews and assessments of quality and performance metrics.

VolparaEnterpriseThe software provides hundreds of key performance indicators (KPIs). Based on Volpara’s scientific understanding of breast anatomy and imaging technology, the ConstantQuality metric in VolparaEnterprise is continuously updated with every mammography or digital breast tomosynthesis examination. This software enables breast imaging providers to rapidly perform quality control checks to optimize image quality.Resource Productivity, with the aim of reducing redundant imaging to help lower technological costs, improve staff efficiency, and provide higher-quality nursing care for patients.

The following are the product features of VolparaEnterprise software:

1.  Fully Prepare for the U.S. Food and Drug Administration (FDA) EQUIT Program

FDARecently announced projects related to Enhancing Quality Using Inspection Plans (EQUIP). This program requires medical imaging companies to implement regular image quality inspection plans for their equipment.

EQUIPLeveraging FDA Annual Inspections to Drive Image Quality Improvements in Mammography. Inspectors primarily focus on quality assurance for medical devices (corrective actions for clinical images), quality control, and a range of issues pertaining to clinical image quality.

Using Volpara Enterprise software helps customers complete the EQUIP inspection plan more smoothly. By conducting relevant learning and research, medical imaging companies can quickly identify and resolve image quality issues, thereby improving patient care services.

2.  Better Understand Patients' Conditions and Needs

VolparaEnterpriseThe software advocates for medical imaging companies to maintain contact and engage in mutual communication with patients.

The software’s in-depth understanding of breast anatomy and imaging techniques ensures that every female patient receives standardized, personalized screening, reduces discomfort during the examination process, and performs specific X-ray dose analysis based on each patient’s breast density prior to image acquisition. During use, VolparaEnterprise categorizes female patients and arranges additional breast cancer screening when necessary.

3.  Ensure that healthcare professionals can work efficiently

Research has found that Volpara Enterprise software can monitor the workflow, quality, and efficiency of healthcare staff, including the time required to obtain images, the speed at which patient screening data is acquired, and the average efficiency of machine positioning for patients. Meanwhile, this software helps healthcare professionals gain a clearer understanding of patients' needs and disease characteristics, and forwards relevant patient cases to medical staff specializing in those areas for diagnosis and treatment.

VolparaEnterpriseThe software will more accurately assess equipment utilization, workflow steps, and related requirements for other systems.

4.  Objective Quality Metrics for Professionals

VolparaEnterpriseThe software enables healthcare professionals to measure quality in a correct and objective manner. Fully automated machine metrics help medical imaging companies save time and costs, ensuring that hundreds of data points are tracked for each imaging study, with the aim of reducing human error.

“Volpara Enterprise software provides a fresh perspective on clinical analytics, quality assurance, and business data—factors that virtually impact every aspect of breast imaging practice, efficiency, and quality. As physicians, we have never had such convenient access to vast amounts of data,” said Dr. Bruce Schroeder, a breast imaging specialist from the Carolinas in the United States. “Hundreds of quality metrics empower us to optimize patient care while reducing the effort required for healthcare-related quality assurance.”

Volpara Solutionsstated that VolparaEnterprise software is currently the only solution available for breast imaging that can comprehensively assess the image quality of each mammogram and implement procedures such as positioning and compression. VolparaEnterprise software has received FDA clearance in the United States.

The female breast is composed of skin, fibrous tissue, glandular tissue, and adipose tissue. Breast cancer is a malignant tumor arising from the epithelial tissue of the mammary glands. Ninety-nine percent of breast cancer cases occur in women, while men account for only 1%.

The breast is not a vital organ for sustaining human life, and carcinoma in situ of the breast is not fatal. However, breast cancer cells lose the characteristics of normal cells; they exhibit loose intercellular connections and are prone to detachment. Once detached, these free-floating cancer cells can disseminate throughout the body via the bloodstream or lymphatic system, leading to metastasis and posing a life-threatening risk. Currently, breast cancer has become a common malignancy that threatens women's physical and mental health.

Global breast cancer incidence has been on the rise since the late 1970s. Although China is not a country with a high prevalence of breast cancer, the situation is far from optimistic; in recent years, the growth rate of breast cancer incidence in China has been 1 to 2 percentage points higher than that in countries with high prevalence. According to the 2009 breast cancer incidence data released in 2012 by the National Cancer Center and the Bureau of Disease Prevention and Control under the Ministry of Health: among tumor registry areas nationwide, breast cancer ranked first among malignant tumors in women. The overall national crude incidence rate of female breast cancer was 42.55 per 100,000, with rates of 51.91 per 100,000 in urban areas and 23.12 per 100,000 in rural areas.

Breast cancer has become a major public health issue in contemporary society. Since the 1990s, global breast cancer mortality rates have shown a downward trend. This decline is attributable to two main factors: first, the implementation of breast cancer screening programs has increased the proportion of cases detected at an early stage; second, the adoption of comprehensive treatment strategies has improved therapeutic efficacy. Breast cancer is now among the solid tumors with the most favorable treatment outcomes.