BRENTWOOD, Tenn., Feb. 25, 2008 (PRIME NEWSWIRE) -- Imagine a life-saving heart test from a non-invasive device that uses no catheters, no needles, and no blood. A Brentwood, Tenn., company not only imagined it -- they created it and industry analysts now say it could become the future standard of care.
The FloWave 1000, one of a mere handful of medical devices created in this Nashville-TN region so rich in healthcare, is actually a medical miracle in its own right after securing clinical trials in three of the country's most respected heart institutes just two years after its inventor died.
"We've turned the corner, the future is very promising," said Kin Clinton, CEO of Woolsthorpe Technologies, the Tennessee company that maintains the rights to the patient-friendly device.
The novel, non-invasive device monitors Cardiac Output, a key indicator of cardiovascular health. Once available in the market, the FloWave 1000 -- which uses ECG and Pulse Oximetry sensors -- will provide a unique window into cardiovascular health, without the cost and risk associated with current invasive procedures.
Corporate Resuscitation
Two years ago, the company was struggling to implement the clever inventions of its Founder, Dr. Alex Mills. Mills had developed a method to measure Cardiac Output without actually catheterizing the heart. The clinical trials on the device were producing mixed results when, ironically, Dr. Mills died of a pulmonary embolism.
"It was an extraordinarily challenging time for the company," says Clinton, a member of the Board at that time. "Dr. Mills was not only the founder, but the inventor and Chief Science Officer." When the Board learned that Mills' two chief scientific advisors met for the first time at his funeral, Clinton said "we knew the challenge of moving forward would be great."
Clinton and other officers bound together through months of discovery and charted an improved course. Their success, according to Clinton, was in attracting an "extraordinarily talented" group of scientists and engineers. "Dr. Mills got the ball to the red zone. These folks have put it in the end zone," Clinton said.
Next Healthy Steps:
Today, the company is receiving "enthusiastic support for our technology" in clinical trials at three outstanding heart centers - Vanderbilt University Medical Center and Saint Thomas Research Institute, both in Nashville, and the Texas Heart Institute in Houston, Clinton said. The studies are comparing the company's FloWave 1000 to the invasive Swan-Ganz Pulmonary Artery Catheter procedure. A snapshot from these ongoing studies indicates "exceptional agreement" between the two methods.
Meanwhile, the company anticipates growing inquiries by capital and partnering interests. "Our efforts now are in raising $14 million to fund the clinical, regulatory and manufacturing run into our fourth quarter launch. Phase I of that financing process is underway and we're overwhelmed by the interest."
The current device employs improvements to Mill's original design as developed by Clinton's new team. Encouraged by the performance in these preliminary trials, the Company expects to apply for FDA approval of the device this spring. Marketing and sales of the device will begin immediately following FDA approval, which by federal requirement on "non-significant risk" devices will take 90 days or less.
About Woolsthorpe Technologies: Woolsthorpe Technologies is a privately held medical device company headquartered in Brentwood, Tennessee. For additional information, contact Rankin A. Clinton III, 615-376-9779 or kclinton@woolsthorpe.com. More information is available at www.woolsthorpe.com.
Additional contacts:
John Howser, (615) 322-4747 Paul Lindsley, (615) 222-6859
Vanderbilt University St. Thomas Heart Institute
Medical Center plindsley@stthomas.org
John.howser@vanderbilt.edu