VIENNA – A California company secured its expansion into Europe with the release of a multi-center European study highlighted in the opening plenary session as United European Gastroenterology Week 2009 (UEGW) got under way here.
With 11,700 participants from 126 countries attending the meeting, Barrx Medical (Sunnyvale, California) reported it has launched a follow-on to the three-center EURO I trial it presented that will involve 10 reference medical centers, which "reads like a Who's Who for endoscopy in Europe," according to Darin Wilson, who heads up the nascent international marketing effort.
Roos Pouw, MD, from the Academic Medical Center (AMC; Amsterdam) presented the results from EURO I, a validation trial conducted at the AMC, Evangelisches Krankenhaus (D sseldorf, Germany), and Erasme University Hospital (Brussels, Belgium).
Pouw described a "stepwise" study based on a series of procedures where patients with the most advanced stages of Barrett's esophagus, including dysplasia and early cancer, underwent endoscopic mucosal resection (ER) and then were treated with the endoscopic radiofrequency (RF) ablation using the HALO Ablation System.
The study is similar to validation trials Barrx has conducted in the U.S. with similar results.
In Europe, among the 24 patients in this first trial, all but one were cured of all diseased tissue after a one-year follow-up, or 96%.
Because the patients are well advanced in the development of cancerous tissue, the first stage of endoscopic resection both confirms absence of a more invasive cancer and clears the field for the HALO radio frequency therapy that radiates down to a 1,000-micron depth.
The two-step HALO process is described by the Barrx product names, the HALO 360 and HALO 90 indicating the scope of the ablation.
Six weeks after the resection, the patient undergoes the first Barrx procedure where a balloon-based ablation device applies a controlled heat over the entire surface of the targeted segment, or 360-degrees.
At two-month intervals following this procedure the patient receives, where necessary, a more focused ablation using the HALO 90 device mounted on the endoscope to treat smaller, residual areas of Barrett's esophagus.
While the procedure seems protracted, it is as close to a magic bullet as a cancer patient is likely to receive. The treatment is non-surgical, so after shaking off the sedatives, the patient can go home rather than spending the five days in the hospital required by other remedies to Barrett's esophagus.
"Preliminary data of this European study suggests this treatment modality effectively removes dysplasia without serious adverse events and therefore compares favorably with radical ER or photodynamic therapy," Pouw said in her presentation.
AMC will lead the second European multi-center cohort study, EURO-II that targets ten patients at each of the 10 tertiary referral centers for endoscopic treatment.
Barrx's entry into Europe was boosted in part by a $27.8 million financing in 2006 that also underwrote the development of the HALO 90 (Medical Device Daily, July 21, 2006).
The international strategy for Barrx is twofold, according to CEO Gregg Barrett: "To win the support of key opinion leaders, and then to get reimbursement."
"We have now demonstrated in Europe that we can tightly control ablation, reverse Barrett's disease and that new, healthy tissue grows back," he said.
On the ground, Wilson, who runs the Barrx European operations from Switzerland, said the two primary markets in Europe for Barrett's disease are the UK and France, especially the UK, which is the top market.
His goal is to continue winning more procedures in countries where Barrx has inroads, and then to win reimbursement.
"In Europe the health technology assessment authorities demand evidence, and we have the evidence," he said.
In the UK, he said Barrx has submitted necessary documentation to the National Institute for Clinical Excellence, which allows the device to be used under research conditions while awaiting guidelines for clinical practice and reimbursement.
In France he said a study is planned for 2009 with the Société Française d'Endoscopie Digestive, a necessary step for winning reimbursement.
In Germany, another important European market, he said the company has filed procedures for 2009 that should lead to reimbursement approval in 2010.
Wilson said the international groups expects to double sales year-to-year before winning reimbursement and after that sales targets "are much more aggressive."
More than 250 centers use Barrx technology worldwide for an accumulated total of 20,000 procedures to date, he said.
The company has established operations in 10 European countries as well as Australia and Canada, he said.
The complete Barrx HALO assembly sells for about €45,000 ($60,000) according to the Dutch team at the UEGW event, which includes the two generators and the endoscope-mounted RF applicators that can be mounted on the gastro endoscope of any manufacturer.