A Medical Device Daily

Staar Surgical (Monrovia, California), a developer of minimally invasive ophthalmic products, reported on the status of its application to obtain approval to market the company's Visian ICL products in Japan.

As anticipated, the Ministry of Health, Labor and Welfare's Expert Meeting II was held at the end of July in Japan, at which time the company said the products were considered for approval in the Japanese market. The company has received formal written feedback within the anticipated timeline. This feedback includes formal requests for additional information regarding potential labeling and long-term clinical data. Staar said it will respond to those requests very quickly and anticipates significant dialogue with the Japanese Pharmaceutical and Medical Devices Agency's (PMDA) officials during the month of August.

"We are very encouraged and pleased with the feedback and guidance we have received from the PMDA on the outcome of the Expert Meeting regarding the Visian ICL products," said Barry Caldwell, president/CEO of Staar. "Our team in Japan will be focused on working with PMDA in the coming weeks as we move to the final phase of approval to market the Visian ICL products. Obtaining the ability to market the Visian ICL products in Japan should create a significant opportunity for the company in what we believe has emerged as the world's third largest myopic market."

"Estimates are that over 400,000 refractive procedures will be performed in Japan during 2009," said Caldwell. "The Japanese population is believed to have one of the highest prevalence rates of myopia in the world as well as a much higher percentage of the population in the high myopic range. Market Scope, the industry leading ophthalmic research firm, reports that the worldwide average rate of myopia is 23% of the population, while the rate in Japan is 45%. This compares to an estimated 27% prevalence rate of myopia in the U.S." he added.

Vicor in distribution accord with Glotecx

Vicor Technologies (Boca Raton, Florida) reported that it has entered into an exclusive international distributorship agreement with Glotecx (Coral Springs, Florida), a global provider of medical equipment, for the distribution of its PD2i Cardiac Analyzer.

Vicor is a biotechnology company focused on the commercialization of non-invasive medical devices and diagnostics using its patented PD2i algorithm and software to stratify patients at risk of sudden cardiac death (SCD) and trauma victims in need of life saving intervention.

The agreement grants Glotecx the exclusive right to purchase, inventory, promote, and resell the private label Vicor PD2i Cardiac Analyzer, and accompanying computer hardware and test analyses in India, Kenya, Uganda, Tanzania, and Nigeria. According to the terms of the agreement, Glotecx guarantees to pre-pay Vicor for a pre-determined minimum amount of equipment and test analyses, with payment for equipment and test analyses in excess of the minimum guaranteed amount payable monthly. The initial term of the agreement will commence on Oct. 1, 2009.

"Glotecx is a leading provider of cutting-edge medical equipment to nations worldwide and is extremely well positioned in the countries covered by this agreement. Consequently, we are confident that our PD2i Cardiac Analyzer will be well-represented and distributed widely in the countries covered by this agreement," said David Fater, CEO of Vicor Technologies. "Most importantly, with pre-payment for a minimum amount of equipment and test analyses guaranteed, Vicor should achieve another milestone — commencement of revenue generation — during the fourth quarter of 2009," Fater added.

Anika receives Canadian approval for Monovisc

Anika Therapeutics (Bedford, Massachusetts), a developer of products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, reported that it has received Health Canada approval for Monovisc, its single injection viscosupplement approved for the treatment of osteoarthritis of the knee.

The company said it expects to launch the product this month through its long-term Orthovisc distribution partner in Canada, Rivex Pharma, the specialty drug distribution division of Helix BioPharma (both Aurora, Ontario). Monovisc has been broadly available in the European Union since 2Q08.

"Health Canada approval marks an important next step as we continue to expand the geographic reach of our novel osteoarthritis treatment therapy and establish Monovisc as the premier single-injection product on the market worldwide," said Charles Sherwood, PhD, Anika's president/CEO. "We are successfully moving forward on our goal of achieving FDA approval for Monovisc in the U.S. The initial PMA modules have been submitted to the FDA and are currently under review. We expect to submit the final module containing the clinical study data prior to year-end 2009."

The company previously reported that it has completed the clinical segment of the U.S. pivotal trial for Monovisc, and is now focused on completing the retreatment study for the product, which is designed to demonstrate the safety and benefit of repeat injections.