French medtech start-up Theraclion is poised to commercially launch what is being billed as the first device capable of performing ultrasound non-invasive surgery on the neck. The device, which uses high intensity focused ultrasound to zap diseased tissue, promises to allow tens of thousands of patients suffering from a common disease of the parathyroid glands to avoid going under the knife.
Dr. James Norman, an American surgeon who has performed over 11,000 parathyroid operations, says the French company’s technology is unique. He says he plans to be among the first doctors to adopt it.”I am tremendously excited about getting this technology going,” Norman said in an interview with Informilo. “Patients will be lining up the door for this kind of thing.”
Created in 2004 as a spin-off from French medical equipment company Edap-Technomed, Theraclion, which is based in an incubator at Paris’ Cochin University Hospital, specializes in non-invasive treatment of head and neck diseases using high-intensity focused ultrasound (HIFU). Its team and board includes surgeons, interventional radiologists, endocrinologists and nephrologists.
François Lacoste, the company’s co-founder, chairman and chief scientific officer, has 25 years of experience as an engineer in R&D for projects in the field of non-invasive therapies. At French medical equipment maker Edap Technomed, where he headed R&D for 15 years, Lacoste launched HIFU projects, including one focused on thyroid problems.
Theraclion’s device uses diagnostic ultrasound to identify the target and then uses high-intensity focused ultrasound to heat and rapidly destroy diseased tissue, enabling patients to avoid drug treatment and the risks of surgery.
Theraclion is among the first to attempt to use HIFU on the neck, which requires particularly high precision. On December 16 the French company announced conclusive clinical results validating its technology. A female patient suffering from a non-malignant tumor on a parathyroid gland resulting in over secretion of parathyroid hormone received Theraclion’s HIFU treatment instead of undergoing surgery. Her parathyroid hormone level returned to normal and the size of the tumor was halved, with no observed side effects, according to results presented in November to the American Society of Nephrology’s 42nd annual meeting and Scientific Expositions, in San Diego.
“For the first time a company can offer a non-invasive, cost-effective alternative to surgery for patients suffering from hyperparathyroidism,” says Dr. Ismael Nujurally, a medical doctor who serves as Theraclion’s chief executive. Theraclion’s procedure takes between 10 to 20 minutes.
The U.S.’s Dr. Norman estimates that one-half to one percent of the population suffers from hyperparathyroidism. The parathyroid glands are four pea-sized glands located on the thyroid gland in the neck. The parathyroid glands secrete PTH, a substance that helps maintain the correct balance of calcium and phosphorus in the body.
PTH regulates the level of calcium in the blood, release of calcium from bone, absorption of calcium in the intestine, and excretion of calcium in the urine.When the level of calcium in the blood drops, the parathyroid glands secretes just enough PTH to restore the blood calcium level. If the parathyroid glands secrete too much hormone, the balance is disrupted and too much calcium is released into the bloodstream, causing a condition known as primary hyperparathyroidism .
Patients with hyperparathyroidism may have severe symptoms, subtle ones, or none at all. Symptoms include fatigue and depression and thinning of the bones.In the U.S. alone about 100,000 people are diagnosed each year with the disease and an even higher number remain undiagnosed.
To date, Theraclion has raised €6.1 million from Truffle Capital, a Paris-based venture capital firm. It has also raised more than €8.5 million from OSEO, the French government agency for innovation.
The company first plans to market its products in Europe. It plans to sell ten devices in Britain, Germany and Italy in 2010. It has also initiated procedures for gaining market approval from the United States Food and Drug Administration (FDA).
Norman, who limits his surgical practice to parathyroid operations and averages 1,800 parathyroid operations annually, says he sees Theraclion’s technology as complimentary. Norman holds nine US and foreign patents (with another three patents pending), including the patent for the techniques and tools used in radio guided parathyroid surgery. He has perfected a minimally invasive form of parathyroid surgery which requires only a one inch incision.
A certain percentage of patients will still need surgery, says Norman. But in as high as 60% of cases Theraclion’s technology might be substituited, he says.”Whenever a patient has to have to have an operation there is a chance of infection,” says Norman, And even his minimally invasive surgey leaves a small scar “so fixing the problem without an operation is always better,” he says. A physian skilled in the art will need to administer either treatment, he says. His center in Tampa, Florida plans to add the technology as soon as the FDA gives approval. “We are just waiting for the FDA to let us use it,” says Norman. “I can’t wait to get going.”