The Problem: Breast cancer is a problem that will not go away. Every 30 seconds, somewhere in the world, a woman is told she has breast cancer, which is the number one killer of women between the ages of 40 and 55. Yet, when caught early, breast cancer is about 98% curable. The reason for this apparent paradox is that early stage cancer is hard to detect. Mammography, the current gold standard for breast cancer screening, fails to detect many early stage cancers. It also yields high rates of false alarms and generates over two million unnecessary biopsies per year. These biopsies can be painful and psychologically traumatic for the patient and represent annual worldwide health care expenditures of over $2 billion. Furthermore, mammography is painful for many women who undergo the exam and uses ionizing radiation (X-Rays) that can actually lead to the development of additional cancers. Mammography does not work well in dense breasts and is unsuitable for repeated imaging that is necessary for treatment monitoring.Alternative screening technologies also have serious drawbacks. Traditional ultrasound imaging is too time consuming and too dependent on the skills of the user. Dedicated breast Magnetic Resonance (MR) scanners indicated for breast cancer screening in high risk women, are extremely expensive with a total price of over two million dollars. The exams can be time consuming (up to 45 minutes) and require the injection of contrast agents. Next generation advances in treatment monitoring and the use of breast density measurements to predict breast cancer risk will require new imaging technologies.
The Solution: Delphinus Medical Technologies is currently in late-stage development of a revolutionary imaging device called SoftVue which eliminates many of these drawbacks and can serve as a valuable tool to address the entire lifecycle of breast cancer. Utilizing multi-parametric ultrasound and sophisticated computer algorithms, SoftVue is able to safely and comfortably scan women. The system is independent on the skills of the operator and is fast. Furthermore, SoftVue does not require expensive room preparations making it a cost effective and easy to install a system in any clinical setting.
Market: The worldwide market for breast cancer imaging equipment is greater than $1.7 billion and expanding rapidly. It is dominated by two industry leaders (GE and Hologic) that are focused on incremental improvements of existing products, rather than the introduction of breakthrough technologies. Delphinus’ product, the SoftVue system, is initially targeted at the rapidly growing diagnostic portion of the market. The company plans to follow up with the introduction of a biopsy capable product. Our ultimate goal is to introduce a product that will serve the entire spectrum of breast imaging needs from risk assessment through treatment follow-up.
Business Model: Delphinus' business model is based on the sales and service contracts of the SoftVue system to hospitals and imaging clinics throughout the United States and the rest of the world. The company plans to use dealer sales organizations in the U.S. for the distribution of the product. In the rest of the world the company will partner with large distributors, or imaging Original Equipment Manufacturers (OEM) looking for an entry into the breast cancer screening market. Delphinus plans to produce the devices through subcontracted manufacturing. Final assembly, testing, and quality assurance of the product will be contracted to a FDA and ISO 13485 certified manufacturer close to our facility in Michigan.
The Product: SoftVue is a tomographic ultrasound imaging device that scans women’s breasts for the presence of masses as an adjunct to mammography. The system provides the operator with B-mode images with tomographic corrections for superior image quality. SoftVue is capable of simultaneously collecting and reconstructing multiple sound properties resulting in important new information that is not available from existing screening and diagnostic modalities.
Intellectual Property Position: Delphinus holds or has exclusive license to ten patents covering broad aspects of its technology. In addition the company has filed eight patent applications on additional technologies and our systems reduction to practice. As a result, Delphinus has broad coverage of the field of use while also covering specific implementations of core technology. Patents, awarded and filed, protect the key competitive advantages of the technology.
Competition: There are a number of competitors in the company's primary market area. Most notable of these U-Systems Inc., which is working on improved ultrasound technologies. Delphinus’ current technology is faster than and provides more information than U-Systems. The company believes that these advantages are critical to success in the marketplace. There are other companies pursuing technologies to replace mammography; however Delphinus believes these competing technologies also have significant shortcomings and are well behind our development cycle.
"SoftVue is currently under development and has not received clearance from the FDA at this time"