Medical Device Daily National Editor

If at first you don't succeed ... re-launch.

That could be the motto of Scivanta Medical (Spring Lake, New Jersey), formerly Medi-Hut, a company that ran aground, first as a distributor of drugs and other medical products, then moving to manufacturing and distribution of a safety syringe.

Medi-Hut was beset by accounting irregularities and the inevitable subsequent shareholder lawsuits, and three years ago it withdrew from the markets in which it was working.

It now is focused on the device sector, licensing from Donald Hickey, MD, of the University of Buffalo, the Hickey Cardiac Monitoring System (HCMS) — agreeing to pay Hickey royalties and various milestones. And then, distancing itself from previous unhappy operational results, the company changed its name to Scivanta Medical in January 2007, with the HCMS device being the product it will use in its re-launch.

Repositioning of the company will ride on some of the current hot concepts in the device sector: ease of use, minimally invasive, less-invasive, the terms likely to be most plentiful in the sales pitches of its reps selling the HCMS — that is, if it succeeds in winning FDA clearance for the device, a two-balloon catheter inserted through the nose and down the esophagus, to sense the pumping action by its closeness to the aortic arch.

The procedure will be "as simple as inserting a feeding tube," said Tom Gifford, executive VP/CFO of Scivanta.

He and David LaVance, president/CEO/chairman of the company, told Medical Device Daily that the person being monitored might have to be treated with a mild spray at the back of the throat to suppress a gag reflex, but a small inconvenience given the information the HCMS device is intended to give and the broader use outside the cardiac cath lab.

Once positioned, the catheter's balloons are inflated, with the wall motion in the left atrium and the aorta generating pressure changes in the balloons. These signals, along with signals from an ECG, phonocardiogram, and automated blood pressure cuff, are transmitted to the monitoring system, which converts the data into clinical measurements via proprietary software algorithm.

LaVance said that the information derived is "very similar in content to information from a Swan-Ganz catheter. Most important, it measures main left atrial pressure — in laymen's terms, how well the pumping action of the heart is working. It's not a perfusion catheter — like an angiogram or angioplasty catheter — it measures blood getting to muscles of the heart, how much volume and with what pressure can the heart pump. The heart is a pump and we're trying to measure pump effectiveness."

While the Swan-Ganz catheter or comparable devices require invasive arterial insertion in a cath lab or intensive-care setting, the HCMS is designed for much faster ease-of use outside an intensive care setting and perhaps ultimately in office setting — and not inconsequentially, at much lower cost.

The company has launched enrollment of patients for its initial clinical trials of the HCMS at Kaleida Health/Millard Fillmore Hospital (Buffalo, New York). LaVance said that the approach is to use the HCMS in a cath lab setting, comparing it to a Millar catheter, a device placed during angioplasty procedures to measure aortic pressure directly.

Up to 10 patients will be enrolled in the initial study. After completion, the company will then move on to enrollment of another 40 patients at Kaleida and three other institutions.

LaVance said that the clinical trial program builds on work done by Hickey with a predecessor device used at the University of Buffalo to validate its effectiveness in dogs and baboons.

Scivanta hopes for clinical trial completion as early as December of this year, and will then be on track for submission to the FDA for 510(k) clearance. It estimates 510(k) clearance as early as the beginning of the second quarter 2009, with U.S. sales commenced shortly thereafter.
LaVance told MDD that the approach for developing and rolling out the device will be "step-by-step," first selling to hospitals — with the reimbursement boost of payment codes already in place and covering this type of monitoring — and then hope that the device can be shown as being just as useful, and easily usable, in an office setting.

That is an ultimate goal. Another downstream target is to move from measuring simple heart function to more specific assessment, LaVAnce said, such as such as cardiac contractility.

Early this month, Rivertek Medical Systems (St. Paul, Minnesota), a medical device development firm and consultant to Scivanta, assumed the development of the hardware component of the HCMS, and at the same time Scivanta terminated its development agreement with Sparton Medical Systems (Strongsville, Ohio), a business of Sparton Electronics Florida (De Leon Springs, Florida).

Scivanta says it is in discussions with other partners regarding the sales and distribution of the HCMS in the U.S., as well as manufacturing of the device's hardware component. The company says it anticipates that one of its current development partners, Ethox International (Buffalo), will manufacture the catheter component of the HCMS.

LaVance said, "Our product development efforts, which have been done in concert with Ethox International and under the guidance of Rivertek Medical Systems, will continue through the clinical trials, with the expectation that a commercial product will be manufactured and available at the same time as FDA clearance is received."

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