Medical Device Daily

VisualSonics (Toronto) may be looking at an unlimited market for its Vevo high-resolution, ultrasound-based in vivo micro-imaging systems, having recently sold its 200th system since the product's launch.

The company has gone from a few hundred thousand dollars in sales in 2003 to its current $24 million on an annualized basis.

VisualSonics said it reached the milestone in just over three years, although the technology has been in development for more than 10 years by the company's chief science officer and founder, Dr. Stuart Foster. The micro-ultrasound device, called the Vevo 770T, is used for preclinical research in animals by pharmaceutical companies and biotechnology companies, among others.

“Most people have some familiarity with ultrasound on the clinical side because of its really prevalent installation,“ CEO Tom Little told Medical Device Daily. “You can't find a hospital or center without an ultrasound. What we did was take that ultrasound and scale it so that it would be appropriate to look at small animals.“

Little obliged in a slight tutorial of the basic physics of ultrasound, explaining that when the frequency of the sound goes up, the resolution of the image goes up, as a function of wavelength. When frequency goes up, penetration goes down.

“Stuart experimented, developed and pioneered the transducers and the electronics to operate it at very high frequencies to get very high resolutions,“ Little said of the technology.

He said the Vevo 770T consists of a “rolling cart that houses all the microelectronics,“ allowing easy mobility, “small scanheads that emit and receive ultrasound signals“ and a “handling apparatus“ designed not only for the animal's comfort during the imaging procedures, but also to gather physiologic data.

The first prototype was developed in 1999 and 2000, and the product was launched in 2003. The in vivo micro-imaging relies on frequencies up to 85 megahertz vs. a traditional or clinical ultrasound, as would be used in obstetrics, for example. Little said the resolution for the in vivo micro-imaging can be accomplished “down to 30 microns vs. a traditional clinical system down to about 300 microns.“

What has coincided with the development of the micro-imaging ultrasound is the mapping of the human genome, as well as various animal genomes, and an increase in the analysis of phenotypes by scientists working with small animals, he said.

“You have the ultrasound scaled to a very high resolution, perfect for a very small animal target,“ Little told MDD. “Rather than a 100 kilogram man, [it is scaled for] a 40-gram mouse or a 200-gram rat. And life science researchers who are desperate for in vivo analysis and non-invasive analysis of the various anatomy and disease progression in the animal models take up the technology very quickly.“

Since the launch of the system in 2003, VisualSonics by last year had 145% compound annual growth, having sold more than 200 systems. Of that number, 75% are in North America, 15% in Europe, and the remainder in countries including Japan, Korea, Taiwan, Australia and China.

Little assessed the global micro-ultrasound pre-clinical market at $2.9 billion, so for the future there is “significant room for growth,“ he said.

It doesn't involve a difficult sale, he said, because “the demand is absolutely there for research needs.“ Usually, the only difficulty lies in an area that many life scientist researchers face – finding the funds to pay for it.

Priced at about $175,000 per unit, Little calls it a “value proposition“ when compared to competitors such as computed tomography (CT) or MRI for such imaging uses. Those systems can cost from $1 million to $2 million, he said, not to mention the costs of housing such large devices.

To explain the rapid adoption of this new product, however, he refers to its capability to show “a beating embryonic heart, a beating adult heart or a pulsing vessel“ that is non-invasive and “real-time.“ The Vevo also offers the advantage of longitudinal studies, which, for example, would allow a researcher to view a tumor over a long period of time and watch how it changes over time.

Also, contrast agents can be used that “target ex-pressed molecules,“ Little said.

“The versatility, the diversity and the combination of anatomical function and molecular data coming off one easy-to-use, relativly inexpensive platform is pretty compelling,“ he said.

While there are no immediate competitors on the horizon, VirtualSonics still faces competition from big players offering CT and MRI. Likewise, the company faces competition from the “old way“ of analyzing small animals, i.e., histology and sacrificing of animals.

VisualSonics said last week that it has expanded its international sales efforts with the opening of an office and in vivo demonstration facility in Amsterdam, the Netherlands. The company also said that it signed an agreement with Lavi-Industrial of Israel (Kefar-Saba, Israel) and Medical Agencies Ltd. (Tel Aviv, Israel) to add to its existing network of seven distributors across Asia and the Pan Pacific.

In late January, the company reported that it had in-licensed a contrast agent for the quantification of myocardial perfusion in preclinical studies from the University of Virginia (Charlottesville, Virginia). It will be sold under the name DepoT, the company said.

“From a product perspective, by adding contrast-enhanced and molecular imaging capabilities to its micro-ultrasound technology, VisualSonics is creating an even more powerful tool that responds to the current and future needs of preclinical researchers,“ Little said in an e-mail to MDD.

In the meantime, the company will be content to watch market demand grow, hoping to attack that virtually unlimited market.