Medical Device Daily

While the role for doctors and surgeons has remained mostly unchanged over the years – treating patient's illnesses – what has changed over time is the method in which they treat patients. A panel at the RBC Capital Markets (New York) Healthcare Conference at the Westin New York in Times Square last week took an in-depth look on just how new technologies have changed the practice of medicine.

iCAD (Nashua, New Hampshire), Novadaq (Mississauga, Ontario), EndoGastric Solutions (Redmond, Washington) and superDimension (Minneapolis) were the companies participating in the panel.

Representing a myriad of devices that range from MRIs to treatments for acid reflux, panelists spent the better part of an hour talking about their technologies and how to get better outcomes for patients. Each company gave brief presentations before discussing the issue at hand: "How Technologies Are Changing Medical Practice."

"In the big picture I'd say it's good old-fashioned capitalism," Daniel Sullivan, president/CEO of superDimension, said. "Technology meets market need market need meets technology ... they both drive each other. It's the proverbial chicken and egg."

Sullivan went on to describe the difference in methodology of thinking today and added that investors have very different ideas from what they had years ago.

"If you were a young analyst or a young investor in 1978 and you happened to be reading the July issue of Time magazine about the first angioplasty, then you would have that 'Gee, I'm not really interested in that because interventional cardiology is zero" response, he said.

Since that time, Sullivan's company has developed an FDA-approved catheter that is billed as a "disruptive" technology and turns conventional practice on its ears.

"If you're going to get knee surgery and you go and get a CT scan done and there's a spot on your lungs," Sullivan said. "It might be cancer, it might not. The only way you can diagnose that is with open-chest surgery where they take out a section of your lung or put a needle through your chest that collapses the lung 30% to 50% of the time. superDimension has developed a catheter that goes down your throat and acts as a GPS tracker."

iCad is currently working on data that has the ability to revolutionize the way radiologists are able to read through data sets and save valuable time while doing so.

"When you think about radiology, the data sets that are being upgraded, particularly from a CT scan or an MRI machine, for example, are just getting greater and greater," Kenneth Ferry, president/CEO of iCad, said during the panel discussion.

"The ability for the radiologist to assimilate with a highly trained eye, all of that data and to make an extraordinary accurate diagnosis relative to cancer ... to do this in a (reasonable amount) of time is becoming more and more challenging," he said. "So what we're able to do is deliver computerated detection."

EndoGastric Solutions is working on a plan to supersede proton pump inhibitors, which have some negative side affects such as draining minerals such as calcium from the body.

"People with acid reflux disease are miserable. They can't eat late at night; they can't eat Mexican food; they are not drinking beer and not drinking wine and in some cases they are sleeping in an easy chair because they don't dare lie down for a night," Tom Foster of EndoGastric Solutions said. " What we're doing is changing the way people with this disease, so prevalent diseases are being treated."

To do this the company has two devices.

The EndoGastric Solutions (EGS) EsophyX System with Serofuse Fastener is indicated for use in endoluminal, transoral tissue approximation, full-thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy.

The StomaphyX is a pioneering device for natural orifice surgery (NOS). Without incisions and with minimal patient downtime, StomaphyX can be used to create durable large tissue folds in the gastrointestinal tract. Performed under endoscopic visualization, StomaphyX is introduced into the body transorally (through the mouth).

In all, the companies have been in the process of releasing and commercializing these technologies which have seemed to find footing in a highly FDA-regulated environment.

iCAD is a provider of computer-aided detection (CAD) solutions, and most recently reported completing agreement to purchase the principal assets of CAD Sciences (White Plains, New York), a private med-tech company (Medical Device Daily, July 22, 2008). The purchase price was $5 million, comprised of $2 million in cash and 1,086,957 shares of iCAD common stock.

Earlier this year, Novadaq's SPY imaging system received FDA 510(k) clearance for organ transplant surgery, allowing surgeons to visualize blood flow to the new organ while the patient still is on the operating table (MDD, Jan. 22, 2008).

This past summer, EndoGastric Solutions said that its EsophyX device was used to complete the first ever incisionless transoral natural orifice surgery on a child.

And in October, BlueCrest Capital Finance (Chicago) provided $15 million in new debt financing to superDimension, which used the funding to help commercialize what it says is the first minimally invasive system to access distant areas of the lungs (MDD, Oct. 16, 2008).