Medical Device Daily
Each year untold millions are spent by med-tech companies to develop screening devices for tumor detection. Neophyte med-tech company Seno Medical Instruments (San Antonio) has grabbed onto that technology wave with its Imagio system.
As of now the system is being used solely for research purposes, but Seno says that its differentiating feature in the clinic will be the ability to give physicians far greater insight into how to differentiate between malignant and benign tumors.
Seno describes Imagio as an opto-acoustic technology that produces real-time color images of the tumors and is being used to capture images of laboratory animals such as nude mice. The company says it holds core patents for the opto-acoustic technology, covering the fusion of light and ultrasound to create contrast between normal and cancerous tissues. It says the system has a multitude of possible applications, including the diagnosis of ovarian, prostate, colorectal, bladder, and melanoma cancers, plus cardiovascular applications.
“We look at two hallmarks of malignant tumors,” Janet Campbell, CEO of Seno, told Medical Device Daily. Those two hallmarks are: looking at the angiogenesis, the physiological process involving the growth of new blood vessels, from pre-existing vessels that develop into the tumor; and looking at whether or not the tumor is oxygenated. If oxygenated, then the tumor is said to be malignant.
Initially, the device is geared toward the detection of breast cancer.
“This is a whole new platform,” Campbell said. “Through Imagio we will be able to assist physicians in looking at the state of the diseased tissue. We’re looking at pursuing FDA approval at the end of next year.”
“This is essentially our technology,” Campbell said, in further explanation of the importance of the opto-acoustic technology for building the company. “This is a huge deal for us.”
Seno unveiled Imagio and its potential uses to researchers at the Joint Molecular Imaging Conference, sponsored by the Academy of Molecular Imaging (Los Angeles) last weekend in Providence, Rhode Island.
The conference annually offers a look at the developing work in several in vivo and in vitro imaging methods. Presentations include the discussion of optical imaging, ultrasound, CT, PET, SPECT, MRI, multi-modality imaging, new molecular imaging agents and probes and the application of imaging to drug development.
Barbara Lind, VP of business and marketing for Seno, told MDD that the device was well received at the conference.
With only two years under its belt, Seno says that, given its early-stage of existence and technical progress, it has developed significant funding, thus boding well for future R&D possibilities to build this technology.
Last month the company received a $2 million investment by the State of Texas’ Emerging Technology Fund (TEFT) that will go toward further work on Imagio (Medical Device Daily, Aug. 23, 2007). TEFT is a $200 million program created by the Texas Legislature in 2005 and to date it has given out $94.1 million in grant funds to the state’s companies and universities.
“This is the largest amount a private company has received from [T]EFT,” Campbell said regarding the grant.
The August funding however, was only the tip of the iceberg following more substantial grants and finances for fledgling company.
Last year, Seno reported receiving more than $3 million in new funding to launch commercial operations (MDD, July 20, 2006). And before that it had received $12 million in grant monies from the National Institutes of Health, the Department of Defense and the National Cancer Institute.
At the time the company said those funds would enable it to further develop what has become its initial effort in breast imaging via opto-acoustic technology.
Seno is just one company that has recently thrown its hat into the ring for new development in breast cancer detection, all essentially targeting the development of improved alternatives to mammography.
In July, Lifeline Biotechnologies (Reno, Nevada) finalized an agreement for a First Warning System, a device designed to assist in the early detection of breast cancer (MDD, July 10, 2007).
According to Lifeline, the underlying technology for the First Warning System offers the possibility of eliminating more than 90% of unnecessary breast biopsies performed each year and thus providing potential savings of up to $2.8 billion annually. The company says the system could conceivably eliminate the need for suggested MRI’s, a savings of another $1.3 billion.
And in August GE Healthcare (Waukesha, Wisconsin) released a traveling version of its Senographe Essential, a mobile platform to scan women for breast cancer (MDD, August 27, 2007).