Biosensors International (Singapore) said last month that its European subsidiary, Occam International (Eindhoven, the Netherlands), has received CE mark approval for the company's first drug-eluting stent (DES), Axxion, allowing its sale in the European Union. The Axxion DES is a polymer-free system that incorporates Biosensors' Calix stent delivery system and the drug paclitaxel, which is directly coated on the stent over a layer of glycocalix, a substrate designed to improve biocompatibility of the metal stent surface after the drug is released.
This technology is licensed exclusively by Occam from a privately held company in Germany that is a manufacturer of ultra-thin coatings that according to Biosensors, "set unsurpassed standards of efficiency, hemocompatibility and biocompatibility."
Yoh-Chie Lu, chairman and CEO of Biosensors, said, "The polymer-free' approach potentially can reduce concerns about the long-term effects of polymer coatings used in competitors' products." Lu added: "We had expected to receive the CE approval for Axxion in the second half of 2005, [so] we are elated to receive this approval now, barely one month into our expected time period."
Chief Operating Officer Steve Thomson said, "In anticipation of CE mark approval, we have already ramped up our manufacturing and marketing preparedness. We are operationally ready to launch Axxion in selected markets, which is an essential part of our long-term strategy to have the commercialization of our own DES products drive the group's future revenues."
Biosensors said it expects European sales of Axxion to contribute to the company's revenues for the current financial year ending March 31, 2006, prior to receiving regulatory approval of its flagship DES system, BioMatrix, for which a CE mark filing was made in April. The BioMatrix DES system incorporates the company's proprietary anti-restenotic drug, Biolimus A9, bioresorbable polymer, S-Stent and stent delivery catheter, all of which have been developed in-house. Biosensors said it expects to receive CE mark approval for the BioMatrix in the first half of calendar 2006.
CE mark for laser algorithm
Nidek (Gamagori, Japan) said it has received CE mark approval for its Optical Path Difference Customized Aspheric Treatment (OPDCAT) algorithm and software for the Nidek EC-5000 Excimer Laser System.
The company said the approval clears the way for marketing of its laser and OPDCAT algorithm throughout the world, especially in Europe and the Middle East. They are used for the correction of myopia and myopia with astigmatism with aberrations of the entire optical system.
"This is a major milestone for Nidek and our refractive surgery business in Asia, Europe, the Middle East and South America," said Hideo Ozawa, president and founder of the company. "With this approval, Nidek takes a step forward in providing our customers around the world and their patients with the best possible clinical outcomes in the market for laser vision correction."
He said Nidek "can now provide an innovative system designed to improve refractive outcomes for patients and treat aberrations of the entire optical system, with wide ranges of myopia and astigmatism."
OPDCAT uses a proprietary ablation algorithm based on topography and wavefront data generated by the Nidek OPD-Scan. The company said that with a combination of slit scan and multi-point ablation, OPDCAT is intended to correct refractive errors as well as optical aberrations of the entire eye.
"We expect an unsurpassed level of patient and physician satisfaction with this improvement in refractive surgery," Ozawa said.
"Aberrations based on corneal and entire eye irregularities can result in visual blur and other undesired visual phenomena are reduced with this new ablation algorithm," the company said. "This results in a shorter visual recovery period and better post-operative visual acuity."
The company said clinical data submitted to gain CE mark approval showed "excellent clinical outcomes," with 97% of patients having an uncorrected visual acuity of 20/20 or better. In addition, 86% of patients gained at least one line of best-corrected visual acuity and a similar percentage of patients were within 0.50 diopters of the targeted refractive correction. Average contrast sensitivity was maintained three months post-operatively, indicating the potential of excellent quality of vision after the procedure.
"The use of the OPDCAT software algorithm with [our] excimer laser technology potentially increases the visual acuity and quality of vision while addressing two major issues in refractive surgery: treatment of aberrations of the entire optical system and reducing higher order aberrations that can occur post-ablation," Ozawa said.
The company said its excimer platform now offers "a full suite of treatment algorithms that use wavefront and topography data from the Nidek OPD-Scan to treat a patient's refraction needs."
GE, Roche team on Alzheimer's care project
Roche (Basel, Switzerland) and GE Healthcare (Chalfont St. Giles, UK) said in June that they have joined in a drug-and-imaging agent collaboration focused on developing personalized care for patients with Alzheimer's disease. Financial terms were not disclosed.
In clinical trials, patients taking a Roche anti-amyloid drug candidate for Alzheimer's disease will be monitored clinically for drug response using GE's positron emission tomography (PET) diagnostic imaging agent. The PET technology measures and tracks levels of beta-amyloid, a form of brain plaque believed to cause memory loss in Alzheimer's patients.
Previously, the presence of plaque could only be confirmed during autopsy.
GE Healthcare licensed a broad class of imaging compounds from the University of Pittsburgh in 2003. Those compounds attach to beta-amyloid plaque in the brain, allowing the plaque to be imaged with PET. By using these compounds to measure the levels of beta-amyloid during clinical trials, the company said it should be possible to measure the effectiveness of drug therapies being developed by Roche to combat Alzheimer's disease.
Both companies will independently analyze patient data gathered during the controlled trials to monitor the progression of the disease and then share information to validate the efficacy of both the therapeutic product and the diagnostic tool.
The data gathered will aid both companies in submitting comprehensive data to regulatory authorities for approvals.
Peter Hug, Roche's global head of pharma partnering, called the collaboration "an early step in experimental medicine," noting that use of GE's PET technology "allows Roche to test the efficacy of our product more accurately than was previously possible, which in the long term, will help us efficiently advance through clinical development, potentially helping patients sooner."
"This imaginative and groundbreaking agreement demonstrates how medical equipment and pharmaceutical companies are increasingly collaborating with the aim of developing innovative, more effective and safer treatments," said Bill Clarke, chief technology and medical officer at GE Healthcare.
He said the collaboration "should allow clinicians to identify effective treatments earlier for this debilitating disease."
When General Electric (Fairfield, Connecticut) announced its plans to acquired Amersham (Little Chalfont, UK) in the fall of 2003, a $9.5 billion deal that was completed in April 2004, it said its mission was to transform healthcare from a late-disease treatment orientation to an "early health" diagnostics orientation.
Clarke said the Roche-GE Healthcare deal, which will "[increase] clinical value at the intersection of diagnostics and therapeutics, is one way that GE is carrying out its mission."
The World Health Organization (Geneva, Switzerland) estimates that there are about 18 million people worldwide suffering with Alzheimer's disease, a figure projected to nearly double by 2025 to 34 million.
China okays Cardiac Science AEDs
Cardiac Science (Irvine, California) said it has received regulatory approval from China's State Food and Drug Administration (SFDA) to sell its latest line of automatic external defibrillators (AEDs), including its Powerheart brand public-access AEDs and the Powerheart CRM, a bedside monitor that automatically treats hospitalized cardiac patients who suffer life-threatening heart rhythms.
The approval provides clearance for Cardiac Science to begin shipments of its G3 series AEDs into China under the Powerheart and FirstSave brands, as well as under GE Healthcare's (Waukesha, Wisconsin) Responder brand name, which Cardiac Science manufactures on a private-label basis for GE. Cardiac Science-branded AEDs operate in the Chinese language and are sold through its local Chinese distribution partners. The GE Responder brand AEDs are marketed in China by GE Healthcare.
The AEDs are initially expected to be deployed primarily in medical and emergency rescue settings and used by hospitals, physicians and paramedics on fire vehicles and ambulances. More than 100 Powerheart CRMs are currently in use in Chinese hospitals.
Cardiac Science said that historically, as new markets for its products have developed, medical and first responder segments have been the first to deploy AEDs, followed by more widespread adoption for installation in government institutions, transportation, corporations and other public places where citizens congregate.
Chairman and CEO Raymond Cohen said Cardiac Science has gained what he termed "a solid market share position" in emerging AED markets around the world, with international sales now accounting for about 40% of the company's revenue.
"People all over the world are recognizing that AEDs offer an effective and inexpensive way to protect citizens against sudden cardiac arrest," Cohen said. "While the U.S. market continues to lead the way in the awareness and adoption of AEDs, we believe the international market now accounts for over 20% of worldwide AED sales."
He said that China, "which represents a large potential market for us," joins an extensive list of countries where the company's latest-generation Powerheart AED G3 line is approved for sale, including other Asia/Pacific countries such as South Korea, Thailand, New Zealand and Australia, as well as dozens of countries in Europe, South America and the Middle East. "We plan to pursue our business aggressively in these countries," Cohen said.
Morocco approves breast implants
Breast implant provider Heritage Worldwide (Le-Seyne-Sur-Mer, France) reported that its subsidiary, Poly Implant Protheses, has been awarded approval by Morocco's Ministry of Health to market its pre-filled, silicone-gel breast implants in that country.
"Marketing our products in Morocco is a natural progression for us," said Heritage Chairman Jean-Claude Mas. "We are already well established in North Africa and the Middle East, with a distribution network in Turkey, Iran, Egypt, Lebanon, Israel, Tunisia, Kuwait and United Arab Emirates."
He said the company has worked closely with Ikorpharm, its Moroccan distributor, for the past year to plan for the distribution of the breast implants in Morocco, whose population is more than 30 million. Ikorpharm is the largest distributor of aesthetics, plastic and reconstructive products in that country.
"Morocco is yet another excellent market for our products," Mas said. "They are popular with surgeons and patients in the region, and we estimate the annual Moroccan breast implant market to approximate 5,500 units, with double-digit increases."
He said that Heritage is "confident that the quality of our products, their leading aesthetics appearance and our alliance with this strong distributor will allow us to obtain at least 30% of this market within the next 12 months."
Alain Serreyjol-Garros, CEO of the French company, said its international expansion "continues at a torrid pace. This is the third country in which we gained market approval within one month, [following] Brazil and Argentina." He added: "We are committed to increasing our worldwide market share and we will do so country by country, surgeon by surgeon." Heritage describes itself as "a top three global breast implant company."
The company and its subsidiaries manufacture breast and other body implants and body support products worldwide. In addition to its headquarters and production facility in the Toulon metropolitan area in Southern France, it has a distribution facility in Spain.