A Medical Device Daily

AngioScore (Fremont, California), a developer of angioplasty catheters for use in the treatment of cardiovascular disease, reported that its flagship product, the AngioSculpt Scoring Balloon Catheter, has received approval for the interventional treatment of peripheral artery disease from Japan's Ministry of Health, Labor and Welfare (MHLW/PMDA).

AngioScore said it has collaborated with USCI Japan, a distributor of medical devices in Japan, for several years to achieve this milestone. "Japan, which is second only to the U.S. in the number of cardiovascular procedures performed globally on an annual basis, represents a major market opportunity for AngioScore," the company said.

"Very few small medical device companies ever gain access to the Japanese market, given that nation's high performance standards and stringent quality control requirements," said AngioScore President/CEO Thomas Trotter.

He added, "This approval is the second in Japan for an AngioSculpt catheter and follows the approval of our coronary catheter in 2008."

Michael Van Zandt, president/CEO of USCI Japan, said, "The AngioSculpt PAD approval highlights our two companies' combined efforts to bring innovative therapies to Japanese physicians and patients, well-aligned with USCI's future focus on peripheral vascular disease."

The AngioSculpt Scoring Balloon Catheter represents what AngioScore termed "the next generation in angioplasty catheters. Its innovative nitinol element provides unique anti-slipping properties while circumferentially dilating plaque, providing a precise and predictable dilatation across a wide range of lesion types. The AngioSculpt provides the versatility and effectiveness of a new technology together with the simplicity and deliverability of a high-performance balloon catheter."

MDS producing PET agent for Bracco

MDS Nordion (Ottawa, Ontario), a major provider of medical isotopes and radiopharmaceuticals, said that it has begun the manufacture of CardioGen-82 (Rubidium-82 generators), for Bracco Diagnostics (Princeton, New Jersey), part of Bracco Group, one of the world's leading companies in the production of imaging agents.

MDS Nordion said it has designed and built a dedicated manufacturing suite within its FDA-approved, Good Manufacturing Practices-compliant production facility in Ottawa.

CardioGen-82, the only generator-based, cardiac PET perfusion imaging agent approved by the FDA, produces Rubidium-82 using a specialized generator technology. Once administered to the patient, Rubidium-82 is used as a PET imaging tracer for perfusion studies of the heart to examine blood flow through heart vessels.

PET is a medical imaging technique that produces a 3-D image of the functioning heart, allowing the cardiologist to identify regions of the heart muscle receiving poor blood flow.

"This is an important milestone in the development of Bracco's ... cardiac imaging technology, and the new MDS facility provides Bracco with a world-class manufacturing capability with significant capacity for future expansion to meet anticipated market growth," said Carlo Medici, president/CEO of Bracco Diagnostics. "MDS Nordion's unique expertise in the development and manufacture of radiopharmaceuticals, along with its highly specialized facilities, made them an obvious choice when Bracco looked to expand its CardioGen-82 production capacity."

Israel boosts grants by 50%

Between November 2008 and May 2009 the Chief Scientist's Office (CSO) in Israel approved NIS 480 million ($121.74 million) in grants to life science projects. The CSO awarded NIS 235.8 million to biotech projects, NIS 155.7 million to medical device projects and NIS 88.5 to pharmaceutical projects.

These figures represent an increase of 50% in comparison to the same time period of last year. The CSO committee responsible for the allocation of the grants examined 140 projects submitted by 87 companies.

"The combination of our wonderful academic system, entrepreneurial spirit and technological capabilities continue to position Israel as a significant player in the global life sciences world," said Dr. Eli Opper, Chief Scientist of Israel. "We are committed to continuing our support of the local life sciences industry and believe that in order to fulfill its true potential there is a need to allocate a tremendous amount of resources over the long run."

Over the last two years, the CSO has allocated roughly 27% of its funds to life science projects, a major increase from 2000, when it distributed only 14% of its available funds to life science projects.

The Chief Scientist also reported that in 2008 the CSO distributed NIS 329 million in R&D research grants, with NIS 147.3 million going toward medical device projects, NIS 140 million to biotechnology initiatives and NIS 84.7 million to pharmaceutical projects.

"The 50% increase in the Chief Scientist grants is very significant in any period, [especially] in this very difficult financial time," said Ruti Alon, general partner at Pitango Venture Capital. "The world venture capital community in general, and the Israeli one in particular, have tightened their purses due to the fact that they need to reserve funds for their existing portfolios. As such, funds provided by the CSO are critical to the Israeli start-up companies and even more so in the life sciences, where the number of investors are small from the start."

New distributors signed by Accumetrics

Accumetrics (San Diego) said it has signed new distribution agreements for its VerifyNow System in both Israel and Cyprus. Medtechnica Ltd. will oversee distribution of all VerifyNow products in Israel, while Z.S. Curemed Ltd. will be the sole distribution channel in Cyprus.

These distribution agreements expand Accumetrics' reach in both scope and geography, and add to the growing numbers of countries outside of the U.S. and Europe where physicians have access to the VerifyNow System.

The system assesses response to antiplatelet therapies, such as aspirin, Plavix and GP IIb/IIIa inhibitors. As response to these drugs varies, the tests help physicians ensure their patients on antiplatelet medications are receiving the optimal benefit.

"We have chosen these partners based on their demonstrated expertise and knowledge of our markets in their respective territories," said Accumetrics President/CEO Timothy Still. "These partnerships continue to emphasize our focus on expanding our global distribution channels, and support our vision of providing physicians worldwide access to critical information for managing their cardiovascular patients on antiplatelet therapies."