Medical Device Daily European Editor ands
PARIS – A French company will announce next week it has secured €1.7 million ($2.2 million) funding from the state agency OSEO Innovation to accelerate development of a single-use flexible endoscope in what is shaping up as a three-way race with British and German companies to win the first-to-market advantage.
In October, Axess Vision Technology (Tours) received €2.5 million from two Paris-based venture capital funds giving the company €4.2 million to industrialize its current prototype and secure market approvals.
A video bronchoscope will be the first application of the Axess Vision Technology platform, according to CEO Olivier Fructus, who said procedures in the lungs are the most sensitive to the risk of infection, and that there is a sufficient volume worldwide to risk development of a novel device.
Back in September, Invendo Medical (Kissing, Germany) secured €4.5 million from two venture capital funds to complete development of the first single-use colonoscope to win regulatory approval earning a CE mark.
CEO Berthold Hackl said the fresh funding will enable the company to obtain regulatory approval for the U.S. market, and that he expected the product to be introduced in 2010.
The unique proposition of Invendo Medical is for a no-sedative, eyes-wide-open colonoscopy thanks to a joystick control of a motorized deflecting tip on a flexible endoscope, which allows a surgeon to navigate the colon rather than pushing and pulling against intestine walls.
A proof-of-principle study of 28 adults consenting to undergo sedation-free total colonoscopy at Charité Hospitals Berlin presented at Digestive Disease Week 2007 in Washington found that 92% of volunteers reported no pain. (Medical Device Daily, May 23, 2007).
The dark horse in the three-way race is Single Use Surgical Ltd. (SUSL; Barnsley, UK), which is transferring a proof of concept developed with innovation funding from the European Union for the Disposable Use Endoscopy Tool (DUET).
"We are probably in a race," said Mathew Tulley, CEO at SUSL, who said that while there is a small market for a high-priced, single-use endoscope, the greater opportunity is for a low-cost instrument that beats the cost of ownership for reusable endoscopes, including sterilization staff and facility costs.
A single-use endoscope is a sterile-packaged, ready-to-use instrument that is discarded after use, including the camera head.
The optics and lighting used by the three competing European designs are the same as the technology found in a cell phone – CMOS (Complementary Metal Oxide Semiconductor), which is a less-expensive, lower-powered alternative to the current generation of video chip endoscopes with charge-coupled device (CCD) sensors used in traditional reusable endoscopes.
Fructus said the Axess endoscope, "is in every way comparable to endoscopes from Olympus, Fujinon or any competitor," with working channels and navigation controls.
"We have the key advantage that our instruments are sterile from the start," he said, which eliminates a risk of cross-infection characteristic with endoscopes processed for reuse.
A second advantage, he said, is the CMOS output can be connected directly to a standard laptop running Axess software.
"This replaces the typical endoscopy video cart of image processors and lighting generators with a laptop PC," Fuctus said.
This new mobility brings the potential for endoscopic diagnostic exams in intensive care, emergency or at the bedside without a need to move patients to a separate endoscopy lab.
Axess's endoscope is based on a re-usable handle and the disposable sheath.
Tulley of Single-Use Surgical notes that Boston Scientific (Natick, Massachusetts) last year put on standby its program for developing a disposable endoscope.
"Some concern stopped them," he said, "which means they did not like either the costs or the probable market price."
Tulley said, "Right now we have a stage two prototype that is almost working," adding that since the DUET program ended Single-Use Surgical is auto-financing the product development and continuing to work with companies from the EU consortium as preferred contractors.
Yet he said he is not yet convinced there is a business case for a disposable endoscope. "We are gambling that we can make a market," he said.
Estonian hospital gets Varian machine
Cancer patients in Estonia now have access to advanced radiotherapy techniques such as intensity modulated radiotherapy (IMRT) for the first time, with the official unveiling of an advanced Varian Medical Systems (Palo Alto, California) treatment machine at the North Estonia Regional Hospital in the nation's capital, Tallinn.
North Estonia Regional Hospital, which serves two-thirds of Estonia's 1.4 million population, has doubled its linear accelerator capacity with the acquisition of a Varian Clinac DHX equipped with a Millennium 120-leaf collimator, enabling more conformal radiotherapy treatment.
"We have moved from conventional radiotherapy to conformal radiotherapy for the first time," said senior physicist Eduard Gerskevitch. "The collimator's finer leaves allow clinicians to conform the treatment beam tighter to the tumor and limit irradiation of normal healthy tissue."
He added that the new Varian equipment "has enabled us to improve the quality of our treatments while reducing waiting lists. Our waiting times have reduced from five weeks to three weeks," despite a vastly increased workload.
That workload increased shortly after the new machine arrived when an older device at the only other Estonian radiotherapy hospital broke down and all of that hospital's patients were transferred to the North Estonian Regional Hospital. "At present we are the only hospital in the country treating patients with a linear accelerator and we are extremely busy," said Maire Kuddu, chief radiation oncologist.
Despite a workload of more than 130 patients a day, the hospital staff has been able to introduce advanced IMRT for head and neck cancer patients, which enables clinicians to "sculpt" the dose to the shape of the tumor and avoid more surrounding healthy tissue.
The company said that for head and neck patients, "it means more precise treatments and less potential harm to nearby salivary and parotid glands."