Medical Device Daily

NEW YORK — What you expect isn’t always what you get.

That appeared to be the case on the opening day of this year’s Healthcare Conference by Piper Jaffray (New York), held as usual in Manhattan’s Pierre Hotel. Continuing through tomorrow, the conference is replete with 180 companies making their pitches and hosting hundreds of interested investors.

Consider what we expected from the conference’s introductory session, “Spotlight on the Future: the Piper Jaffray Health Care Team.” What we thought we’d get was a spotlight on the future from that team, some sort of hard-hitting overview of the key trends and market shifts in 2007 for medical technology and the companies most media-worthy for us and our readers in the coming year.

Silly us.

What we got was mostly Piper Jaffray — a promotional overview, introduction of the company’s main analysts and a boosting of its expanding presence in Europe and, in the near future, the Asia/Pacific region.

In other words, an advertisement. Oh, well.

This slight disappointment was more than made up for by the unexpectedly robust presentations from two companies focused on eye care technologies — Advanced Medical Optics (AMO; Santa Ana, California) and IntraLase (Irvine, California) — from which we hadn’t foreseen that much grist for our laptop.

Most interesting was the presentation of AMO’s president Jim Mazzo, who delayed the company’s standard proffering of products and market targets, to discuss what he called “most pressing,” the recently unveiled recall of the company’s lens solution product (Medical Device Daily, Nov. 22, 2006).

Addressing an audience obviously well aware of the recent recalls of lens solutions that have seriously damaged Bausch & Lomb (B&L; Rochester, New York), Mazzo noted that the solution problems were relatively slight. With 2.9 million units of the product distributed in the Asia Pacific, Japan and the U.S. there had been “point-zero-three percent complications,” he said, and “none reported in the United States.”

He noted that some had questioned whether pulling the product with such a low rate of complication wasn’t “going overboard.” And he agreed.

“Yes, we did” go overboard, Mazzo said, but noted good reason for doing so.

“It’s prudent to take a product back if you don’t meet 100% of quality,” he said. “It’s prudent in light of market position.”

Besides issuing the recall the company had hired four “external consultants” and was focused on ensuring “that we manage this situation at the highest level.”

As company press statements on the recall had emphasized, Mazzo said that the problem was “not a formula issue,” but related to production problems at facilities producing the products for the Asia Pacific and Japan — though not detailing how production issues had impacted the product as the source of the problem.

Mazzo said that the recall would reduce AMO sales by $40 million to $45 million through the rest of 2006 and into 2007, but he predicted return to the Asian markets in “the first part of February.”

He said that “everybody appreciated our efforts” in the quick recall and that it would not hurt other phases of IntraLase’s business.

Looking at what he called “positive aspects,” Mazzo said AMO was being “realistic about expectations” and maintaining a strategy “to stay disciplined in products and categories where we’re at today.”

Mazzo predicted increasing the adoption of its new IOLs which pull in higher government reimbursement and its overall prospects for that technology driving the bulk of company growth.

And he noted the company’s roll-out next year of a new platform for phacoemulsification — “machinery that explants [a cataract] out of the eye,” he explained — that would be highly differentiated from competing products. The company also plans unveiling products in the presbyopia sector next year.

In the IOL sector, he emphasized a key aspect of the company’s business/marketing model: not targeting every practitioner but making its current practitioner customers more productive.

AMO also makes microkeratomes, the blades used in Lasik surgery, and Mazzo emphasized the company’s offering of customized treatment via its Wavefront technology.

Robert Palmisano, president/CEO of IntraLase, also stressed the need for better customization of Lasik, a procedure that was dubbed as “flap and zap” when first introduced.

Palmisano argued that the “flap” created by the standard microkeratome blade fails to match the curve of the cornea, hence causing the aberrations and dry eye frequently associated with the Lasik.

IntraLase’s answer is the use of a laser rather than a blade, the laser able to follow the curve of the cornea to avoid the side effects associated with Lasik. The IntraLase FS laser “goes through corneal tissue at a pre-determined depth, cuts a precise flap,” Palmisano said — “the ideal kind of flap.” The laser, he added, “can literally go around corners.”

Improved outcomes are the basis of attracting “voluntary” selection of the procedure, Palmisano said, IntraLase targeting those centers that do 50 or more procedures monthly.

Needing to expand on this benefit, IntraLase last year won appeal of its laser system for IntraLase-Enabled Keratoplasty (IEK), the first blade-free system for incising corneal tissue, a use that matches the laser’s ability to cut puzzle-piece tissue shapes.

In the standard procedure, a corneal “plug” is taken from a cadaver and then placed in the patient’s cornea by suturing it into place. This works, but the sutures delay healing and the recovery of sight up to 18 months.

In comparison, the IntraLase laser is able to remove a specific shape of plug from the donor, Palmisano said, and then fit exactly the corneal hole to be filled.

“The pressure of the cornea seals these things together so you don’t need all this suturing currently used in manual method,” Palmisano said. “That greatly reduces astigmatism and sealing time, outcomes are significantly better.”

With a charge of $350 per laser use, the extraction and then placement produces $700 per procedure.

This IEK laser for this application was FDA-approved last year and market-launched this past September.

Palmisano summarized the IntraLase story as: “compelling: better outcomes, better business, we’re growing rapidly. We’re still gaining market share, placing lasers worldwide.”