A Grand Junction-based company is developing a product that company officials say could be a major advancement in the prevention of blood clots in the legs, which affect as many as 600,000 patients after surgery.
Leap Frogg LLC has successfully tested its prototype product, a device contained in the sole of a shoe that squeezes the veins in the arch of the foot. The squeezing action pushes blood up through the leg, reducing the possibility of clot formation. Matt Mayer, president and chief executive officer of the company, says the device – called a Frogg – could reduce the cost of blood clot preventative treatments and improve the mobility of patients.
According to research cited by Leap Frogg, blood clots (or “venous thromboemboli”) kill 200,000 to 300,000 people annually in the United States, more than AIDS, breast cancer, and highway accidents combined. Many blood clots occur in the hospital due to post-surgical immobility.
Typically, Mayer says, blood-clot prevention is accomplished in two ways: blood-thinning drugs and air-driven compression devices which squeeze limbs to increase blood flow. He says pharmaceuticals can be expensive, and compression devices require patients to remain tethered to an air compressor and are uncomfortable.
In contrast, Frogg devices don’t require drugs and are small and light enough to let patients move around.
“Our device is self-contained and portable,” Mayer says.
Froggs are thick-soled, lightweight sandals that attach securely to each foot. Each shoe’s sole contains an electronic device that pushes a small platform up into the arch of the foot every 30 seconds, putting pressure on a series of veins called the “plantar venous plexus.” Mayer says this compression forces blood up through the deep veins of the leg, encouraging better circulation and reducing the chance for clots to form.
The idea for Froggs originated with Mayer’s father, Dr. David M. Mayer, M.D., an orthopedic surgeon who has worked in private practice for three decades, served as chairman of Rocky Mountain Orthopaedic Associates in Grand Junction, and also was chief of surgery for St. Mary’s Hospital in Grand Junction. Dr. Mayer is co-founder and chief medical officer of Leap Frogg LLC.
Matt Mayer says his father believed for years that the methods for preventing blood clots needed improvement, and he eventually developed the concept that became Froggs. The company was formed in 2007.
A small, 60-patient trial of the devices was conducted in Grand Junction, and the study found that Froggs significantly improve blood flow in patients’ legs, Mayer says. Results of the initial trial are scheduled for publication in Clinical Orthopaedics and Related Research the first quarter of 2011, he says.
The company plans to conduct a much larger clinical trial at 10 to 15 locations across the United States, and Mayer says the U.S. Food and Drug Administration’s approval of Froggs is expected in six to nine months.
Mayer says the company has spent about $1.5 million on product development and initial testing, and it has embarked on an effort to raise approximately $5 million more in two tranches. The first $2.5 million would fund the completion of product development, undertake a larger clinical trial, and introduce Froggs to the market. The additional $2 million to $3 million would serve as working capital to improve sales capabilities, build inventory, and shift into full production mode.
The market for blood-clot prevention totals about $3 billion but could grow significantly as new guidelines expand the use of preventative treatments to more at-risk patients, Mayer says. Froggs could serve the growing medical demand inexpensively and effectively, especially if final agreement is reached with a “large medical device company” to sell the shoes under the company’s name, he says. He would not disclose the company’s name, but he said it is well-known in the medical industry and would give Froggs considerable market access.
Leap Frogg LLC is headquartered at the Business Incubator Center, 2591 B 3/4 Road in Grand Junction. The company can be reached at 970-245-0124.
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