PARIS — Dyn'R Sarl (Muret), a small company in the south of France, is taking a deep breath before plunging into world markets with a breathing device that allows radiotherapy patients to actively participate in their treatment to reduce collateral damage to healthy tissue adjacent to a targeted tumor.
"For 20 years we have stayed a small company focused exclusively on research and development with little focus on sales," the company's chief executive, Patrick Le Correm, told Medical Device Daily.
"We are reversing all of that for 2009," he said, with approval expected from the FDA in September, preliminary results from a four-year clinical study, and what he called a "very, very strong interest in the device, because it is the most advanced on the market."
The world premier for the SpiroDyn'rX (SDX), a spirometer that displays breathing patterns on a pair of glasses worn by a patient to help control the rhythm, will take place in Boston in September at the annual meeting of the American Society for Therapeutic Radiology and Oncology (Fairfax, Virginia).
Originally aimed at assisting radiotherapists deliver measured and more accurate dosages of radiation to tumors in the chest and lungs, Le Corre said the clinical study conducted by the French government at 18 reference hospitals in France show the breathing apparatus helps stabilize patient movement for improved treatment of liver tumors and organs near the heart.
The national medical economic study STIC (Supports with Expensive Innovating Technologies) was led by the Institute Curie (Paris) and involved 20 centers over four years, of which 18 are reference hospitals within the national health system.
"We have patients treated in 2004 who are still alive today, so there is strong evidence, excellent results for controlling the treatment," Le Corre said.
Radiotherapy can be complicated by any movement, such as respiration, that first impacts the quality of the imaging used to diagnose and plan treatment, and then during treatment itself, irregular breathing or movement can expose healthy nearby tissue to tangential beams.
Normal breathing generates significant movements of targeted organs such as the lungs, the breasts or the liver and the tumoral mass attached to these organs moves with every inspiration or exhalation, sometimes as much as four centimeters.
Under the best conditions breathing is never perfectly reproducible and can be affected during radiotherapy by the position required for the patient and that patient's physical condition, including factor such as fatigue, stress, or effects induced by image-enhancing agents injected in the blood.
The SDX monitors in real time patient breathing through a mouthpiece, displaying a visual representation of an "optimal inspiration zone" for the patient to achieve.
The pattern seen by the patient wearing the video glasses is simultaneously viewed by the radiotherapist who can determine the optimal moment for delivering the radiation.
Control of reproducible respiratory movements is essential in radiotherapy and the deep-inspiration breath hold method (DIBH) reduces post-radiotherapy side effects by more accurately positioning the tumor mass during the imaging step and then, critically, guide a reliable repositioning for treatment.
SDX includes software to identify patient breathing variations and patterns during a preparation phase, calculating the maximum and minimum levels as well as how long breath for the maximum pulmonary expansion.
The radiotherapist then determines the optimal moment to trigger the radiation, or the operator can use the software in an automated mode where the SDX will trigger the imaging or treatment.
The SDX spirometer is calibrated for plus or minus 1% on volume measure, a precision that aids the patient in reproducing and sustaining a given volume of breathing.
"When we started, most clinicians told us that most of their patients would not be able to use the mouthpiece to control their breathing, but over the eight years of development we have shown 95% of patients can do it," said Le Corre, who added that mentally or physically impaired patients account for the 5% unable to comply.
"The patient becomes an actor in his own treatment, which is an original approach to the market, and one that is welcomed by patients," he said, adding that it also is the "least expensive technique."
Located outside of Toulouse, Dyn'R is privately held and has plateaued at 11.2 million ($1.9 million) in annual revenues for the past four years from on-line and catalog sales of a line of products both for medical offices and individuals.
The company offers paramedical devices, anti-mite covers and a range or spirometers for clinics, as well as devices for at-home follow up care.
"We are well-known in France, but outside of the country no one has heard of us," said LeCorre.
He said he is currently negotiating with distributors for the SDX device in North America, Europe and Asia.
With product development complete, the CE mark obtained and a government-sponsored study to demonstrate the clinical efficacy and economic benefits of the SDX, Le Corre said he is not seeking investors to support the ramp-up to a global distribution.
He said global growth can be sustained through distributor sales, as well as collaborations with original equipment manufacturers, such as Philips Medical Systems (Amsterdam, the Netherlands) and GE Healthcare (Waukesha, Wisconsin).