New team takes over Intacs technology

Addition Technology Inc. will continue where KeraVision left off. The first order of business will be reassuring the marketplace they are here for the long run.

Issue: August 15, 2001

FREMONT, Calif. — Intacs corneal ring segments are here to stay, according to Addition Technology, the startup company that acquired the refractive technology from bankrupt KeraVision in May.

The new company leadership said it is committed to its physician users and to seeing all current American and international application studies through to conclusion.

Potential new indications and technologies may evolve, such as the treatment of myopic astigmatism and use of a new laser channeling method, but the company envisions success through careful expansion and working closely with its existing users.

For Addition Technology, based here, regaining the full confidence of the refractive surgery marketplace is the first order of business, said company president and chief executive officer William Flynn. Clearly, the bankruptcy and failure of KeraVision, the original company that developed Intacs, may have created doubts about the technology in existing users and scared off new prospects.

The bankrupt KeraVision sold substantially all its assets to Addition for a little more than $1 million.

“Certainly some of the surgeons, as they heard news of the bankruptcy, or even heard rumors prior to it, they may have gone into a wait-and-see mode. We heard some of that from physicians in telephone calls,” Mr. Flynn said.

The good news, he continued, “is the reception we’re getting. We’ve told them that we’re behind this, and that we believe in the technology and are going to take it forward. The reception has been very positive,” he said.

Focus on core supporters

The new owners see the best engine for growth as marketing Intacs not to consumers but to surgeons already using the technology. For the time being at least, costly consumer marketing plans have been shelved. That is not to say that consumer awareness is not important, but for now that is best accomplished by going directly to clinicians, said Brian Regan, vice president of Addition Technology.

“Intacs are a relevant segment of refractive surgery and they need to reflect that within the refractive surgery practices that have decided to use the Intacs procedure today,” Mr. Regan said.

He and the other Addition leaders believe Intacs can compete with other methods of vision correction.

“We feel there are opportunities, and Intacs needs to be one of the options communicated to patients. … We are going to stay with our core supporters. We are going to work with them, help them expand their practices, and then we are going to expand our core,” Mr. Flynn added.

Indications to date

Currently in the United States, Intacs are approved by the Food and Drug Administration (FDA) to treat myopia of up to –3 D. Clinical trials for FDA approval of a greater myopic range and for the treatment of hyperopia are “reaching maturity,” company officials reported.

In Europe, Intacs corneal ring segments are used to treat up to 4.12 D of myopia and up to 2.75 D of hyperopia. The devices have not been given the CE mark.

In future developments, correction of astigmatism of more than 1 D may be possible with modified segment lengths. A small study in Europe is currently underway to assess the feasibility of using Intacs to treat compound myopia and astigmatism, said Thomas A. Silvestrini of Addition Technology, a co-inventor of the Intacs technology.

Another development in the offing is the expected approval of a specialized laser that could perform the channeling portion of the Intacs surgery. This could help automate the procedure for large refractive centers that want to increase their Intacs surgery volume with better efficiency, Mr. Silvestrini said.

“I think (the laser) will make the surgery easier, though when you have a doctor who is well-trained, the mechanical instrumentation procedure is not a difficult one,” Mr. Silvestrini said.

For now, Mr. Silvestrini and other company leaders are content with a maximum correction of –4.12 D, noting that this still represents a large potential market, “the lowest hanging fruit of the refractive surgery market to go after,” as Mr. Silvestrini said.

An eventual goal is achievement of higher myopia correction, out to approximately 7 D, which was obtainable with the original design of full 360° rings.

“We might revisit some of that,” Mr. Silvestrini said. “There were some problems with wound healing (with the full ring) and segments were a quick way to get out of that. We always envisioned the product and the market as being low myopia. So even with 4 D and below there is still a very significant market there if you can get to it.”

One concern is that refractive lasers are increasingly being used to treat low myopia, the market segment in which Intacs must compete, Mr. Silvestrini said.

More on Addition Technology

Addition Technology is a brand-new, privately held ophthalmic corporate entity that merges personnel from KeraVision, an executive team of former executives from Wessley Jessen and an investor group. The company has acquired all former KeraVision manufacturing and research facilities.

It is a leaner organization now, said Mr. Silvestrini.

“At one time KeraVision had 140 employees. We have become a smaller, more nimble, new corporation,” he said.

Their focus is clear: building from their core users outward and expanding the new business carefully, he added.

“The new investor group wants to keep all the core Intacs technology, to build around the base of Intacs consumers who have emerged from KeraVision and to build that support brick by brick,” he said.

The response from supporters and interested physicians has been encouraging, he continued.

“The base of doctors that KeraVision developed who were enthusiastic still seems to be there and are increasing in numbers,” he said. “In addition, there seems to be a lot of new interest in therapeutic applications, and generally when they get involved with that they will try some in myopia. If they like the results they will continue on from there.”

For Your Information:

William Flynn, Brian Regan and Thomas A. Silvestrini of Addition Technology Inc., manufacturers of Intacs intrastromal corneal rings, can be reached at 48630 Milmont Dr., Fremont, CA 94538; (510) 353-3000; fax: (510) 353-3030.