Hospitals

CleveX thinks it can bring biopsies to the primary-care office

Biopsy device company CleveX got a slow start to its product launch. But it since hired a new chief executive officer to, in his words, “turbo-charge existing management.” Sam Finkelstein discusses the challenges and opportunities of the ExiClip.

COLUMBUS, Ohio — The biopsy device company CleveX got a slow start on its product launch — delaying the launch of its hand-held biopsy tool, ExiClip, by several months and into 2009.

But since then, it hired a new chief executive officer to, in his words, “turbo-charge existing management.” Now the device is on the market, and the company, a Cleveland Clinic spin-off, is trying to build the CleveX name and expand sales beyond dermatologists to OB/GYNs and primary-care physicians.

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New Chief Executive Officer Sam Finkelstein says this will be a brand-building year for the ExiClip, which with the help of a hook to raise the skin quickly snips off a lesion for a biopsy and then automatically seals the wound shut with a metal clip. The clip is removed in about two weeks, and there’s minimal scarring, according to the company.

Below are excerpts from an interview in which Finkelstein discusses the changes and challenges in selling CleveX’s new product, why the delays were a good thing, and why the company can expand interest in ExiClip.

Q. What’s one of the challenges in the first year?
A. What we will do is establish our identity in the marketplace. There are certainly other companies — Henry Schein and Miltex. We’re in the process of building the ExiClip brand and are looking to create strong brand awareness after 12 months.

We want to establish ourselves as a new solution to an old problem, which is basically to be able to expand this procedure to everyone in the U.S. population — particularly in under-served rural markets, where a dermatologist may not be available easily. We also are a cosmetic solution. The skin-closure technique and approach we use is virtually consistent. At the same time we really create no scar.

Q. So dermatologists aren’t your core market?
A. They’re the cornerstone of this, historically, because they receive the majority of referrals. But we see primary-care physicians as a key customer. We’ve also found OB/GYNs do a disproportionate amount of skin-cancer detection. And they’re embracing the product because it doesn’t require suturing and accommodates their office work flow. We also think we make sense in the under-served and rural markets where you may not have the specialist care you have in larger cities.

Q. But won’t pricing be a problem — particularly when you’re talking about under-served areas? You can buy 50 biopsy punches for $125 or less. The ExiClip — not to mention accompanying hooks and removal tools – is much more expensive: a $55 list price for a single ExiClip and skin hook.
A. When you combine the total cost of the procedure — removal, suturing, and so on –  when you add all that up it makes for a compelling case, and the cost is very marginally above a standard biopsy punch and suturing.

You have to ask: What is the value for the physician? We try to be very efficient for all types of physicians and dermatologists.

Q. How did the delay effect the company?
A. CleveX was smart in what [it] did. There were additional features that needed to be added. That spread our timeline out, but it meant a dramatic difference in how the ExiClip will be used and how it will be accepted in the market.

Q. What’s different in the product that’s on the market?
A. The product had to come with its own technique. And we had to make sure we taught that technique. What we found is that its’ optimal to teach that technique — and it takes 15 minutes, 30 minutes tops — up front. And there’s changes in the product, too. There’s a more tactile feel to the pieces. It works with the technique.