Ed Wood, former CEO of a major Colorado device firm, recently had been enjoying what he called a “blissful retirement” from med-tech and its numerous enjoyments — that is, until he received a tug at his entrepreneurial spirit that he couldn’t resist.

UltraLink (St. Petersburg, Florida), a small med-tech company with optical technology spawned out of Cornell University (New York), had developed the Artemis, an ultrasound system that UltraLink successfully promoted as offering a more comprehensive look at the structure of the human cornea than any other device on the market, and needed help promoting the device.

The company especially had marketed the device, the Artemis 2, as enabling much greater accuracy in the way the LASIK procedure is performed.

The problem was that UltraLink lacked the necessary capital to properly produce, market and service the device, though FDA-cleared a few years ago, on a broad commercial level.

“They raised about $2 million,” Wood told Medical Device Daily, “not enough to take the device to the level of sophistication that it needed to be.”

Nearly 2,000 of the devices were sold successfully, but given a bulky footprint and the backup sales and service infrastructure that the Artemis 2 required, Wood described the system as at best only a working prototype.

UltraLink subsequently approached Evergreen Research (Golden, Colorado) for help in raising money to promote the device, with Evergreen in turn contacting Wood.

The result of that contact has been the creation of ArcScan (Morrison, Colorado), a virtual company with Wood serving as president/CEO. And ArcScan has contracted with Evergreen to develop the third generation of the Artemis system.

Since ArcScan was founded last February, UltraLink has merged with it, and Wood has been instrumental in gathering together more than $900,000 in A-round financing, most of that initial funding coming from Wood and the founders of UltraLink. And Wood now is currently in the process of raising $5 million in round B financing which he hopes to complete in the near future.

“I think we have a wonderful story and investors are very understanding of it,” Wood said. “We’ve completely paid off [UltraLink’s debts].”

Perhaps the most compelling part of the story is the device itself, or rather the newest iteration – Artemis 3 – a more aesthetically pleasing upgrade of Artemis 2, according to Wood.

“This is the tool to know what the structure in the cornea is before they cut it [for Lasik procedures],” he said, specifically in its ability to identify the exact structure of the different corneal layers.

Here’s how this ultrasound system works.

The device can tell the surgeon how cutting a flap can affect the shape of the cornea biomechanically. It will give the surgeon the ability to predict how much tissue will be left under the flap, and thus avoid the occasional imperfections of Lasik post-op.

Artemis sweeps a 50-MHz transducer in several arcs over the cornea. Then, a computer digitizes the signal and 3-D software interprets it, displaying the information as overall pachymetry, stromal thickness and residual stromal thickness post-LASIK down to a resolution of 1 µm.

The inventors of the device say that neither wavefront nor topography-linked ablations or other eye monitoring technologies can work effectively for abnormal corneas unless the actual, physical, epithelial profile is taken into account. This is because the epithelium changes when the stromal surface is uneven. If the stroma is ablated incorrectly in LASIK, the epithelium compensates, but usually not adequately, leaving the patient with irregular astigmatism.

Even though the epithelium fixes half the bent surface, there’s still a bend off to the side. The company says that the device will show the epithelial changes that cause the bend while topography will miss them, due to the smoothing effect of the epithelium.

“The design is similar to many other diagnostic devices in an optometrist’s office,” Wood said. “On the patient’s end, the only difference would be that the patient would look into a rubber eyecup that was filled with a saline solution. This is because the ultrasound doesn’t travel through air. The only thing patients would need to do differently is use a paper towel to wipe the solution from their faces when the procedure is finished.”

In use, the patient leans forward placing his or her head onto an adjustable headrest. The headrest’s unique design permits the patient to pull away quickly from the scanner if desired. The eyecup filled with a saline-based interface fluid couples the ultrasound signal to the eye, while a precision mechanism moves the transducer past the front of the eye. During the accurately controlled arc motion of the transducer, which lasts less than one second, many thousands of ultrasound samples are digitized.

Wood said the company isn’t yet ready to reveal a detailed image of what the latest generation version of the device will look like or how it will differ from the earlier version, which received FDA clearance a few years back.

Artemis will be the sole device for ArcScan, and Wood said over the coming months the company will pour its resources in making sure the updated device makes a successful move out into the market next year.

“We expect to have no difficulties for regulatory approval since the device is very much like Artemis 2,” he told MDD. “Approval should come through sometime next year.”

So that blissful retirement that Wood was enjoying – well, let’s just say it’s being put on the back burner for the foreseeable future.