Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported the launch of its Taxus Liberté paclitaxel-eluting coronary stent system in Japan. The drug-eluting stent (DES) was approved by the Ministry of Health, Labor and Welfare on Jan. 28, and reimbursement was granted by the National Health Insurance System earlier this week.

The company said Taxus Liberté is the only second-generation DES available in Japan.

It said design improvements over the first-generation Taxus Express2 stent include thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution.

"We are ... pleased to launch Taxus Liberté as the only second-generation drug-eluting stent in Japan," said Maulik Nanavaty, president of Boston Scientific Japan. "Boston Scientific has already established a diversified product portfolio in the coronary intervention field, and we are committed to building on these ... treatment options for Japanese patients with coronary artery disease."

Roughly 1,300 medical centers perform cardiac catheterization in Japan. The number of coronary stents implanted annually in the country is estimated at 200,000.

TissueGene to start South Korean trial

TissueGene (Rockville, Maryland) said that its South Korean licensing partner, Kolon Life Science (KLS; Seoul), has received regulatory allowance from the Korea Food and Drug Administration (KFDA) to initiate a Phase IIa clinical trial of TissueGene-C (TG-C) in patients with severe osteoarthritis of the knee.

TG-C has been developed for the localized delivery of allogeneic human cells expressing TGF-beta1 in order to induce the regeneration of cartilage.

In Asia, TissueGene has licensed intellectual property rights to KLS, a subsidiary of Kolon, for the clinical development and commercialization of its lead product candidates TG-C and TG-B, developed for the regeneration of cartilage and bone, respectively.

Under the terms of the agreement, TissueGene has received an undisclosed up-front payment and will receive ongoing royalty payments based upon future sales. TissueGene is currently completing Phase I clinical trials in the U.S. and continues to work closely with KLS in order to coordinate their regulatory efforts and efficiently conduct parallel clinical trials for TG-C in the U.S. and South Korea.

The Phase IIa clinical trial is designed as a randomized, multi-center study in order to evaluate the safety and efficacy of TG-C in patients with Grade IV degenerative joint disease of the knee who have been unresponsive to existing therapies. The patients will receive an intra-articular injection to the damaged joint area at one of two dose levels of TG-C.

The primary endpoint of the trial will be evidence of symptomatic improvement and the secondary endpoint will be evidence of cartilage regeneration through MRI evaluation.

"The launch of this Phase II study represents a critical step in the development of a commercially and clinically viable mechanism to initiate regeneration of cartilage for patients suffering from osteoarthritis," said Dr. Kwan Hee Lee, president/CEO of TissueGene. "And I believe our success thus far can be attributed primarily to the strategic alliance between TissueGene, Kolon and KLS. By bridging our domestic and international resources, this business model has not only enabled for rapid pre-clinical and clinical development, but has allowed for innovative cost control mechanisms and significant long-term growth opportunities."

Kolon established KLS in 2006 by merging TissueGene Asia Co. with its existing active pharmaceutical ingredients and specialty chemicals business.

Canadian distribution accord for Ceragenix

Ceragenix Pharmaceuticals (Denver), a device company focused on infectious disease and dermatology, said it has entered into an exclusive distribution and supply agreement with Pediapharm (Montreal) to commercialize EpiCeram, a by-prescription topical cream for treating atopic dermatitis and other dry skin conditions, in Canada.

The agreement grants Pediapharm exclusivity for the distribution and marketing of EpiCeram in Canada, while Ceragenix will be responsible for the manufacturing and supply of the product.

Pediapharm also is responsible for obtaining regulatory clearance for Canadian marketing of the product. Financial terms were not disclosed.

Steven Porter, chairman/CEO of Ceragenix said, "We are delighted to enter the Canadian market with Pediapharm. We believe that their focus on the pediatric market is a very good strategic fit for EpiCeram."

Pediapharm President/CEO Sylvain Chrétien said, "EpiCeram fits perfectly with our company's mission, which is to bring the best, novel innovative treatment to all Canadian pediatric stakeholders. With an exceptional safety profile, EpiCeram's demonstrated efficacy in helping the skin repair its moisture barrier will benefit patients suffering from atopic dermatitis and related illnesses. This market segment of dermatology has a lot of unmet needs and is substantial in size."

Chrétien said his company is that in the process of preparing for a regulatory filing with Health Canada and that it hopes to launch the product later this year.

Ceragenix has two base technology platforms; Ceragenin for treatment of infectious disease and Barrier Repair for the treatment of dermatological disorders, including atopic dermatitis, neonatal skin disorders and others.

MRG looks at hernia repair market

In its new Latin American Markets for Hernia Repair Devices 2009 report, Millennium Research Group (MRG; Waltham, Massachusetts) says growing demand for premium-priced ventral hernia repair meshes will generate notable revenues over the next five years.

The reduced recovery times, lower risk of infection, and lower recurrence rates that these products facilitate will cause revenues in this segment alone to surpass $20 million by 2013, according to the report.

MRG said these specialized meshes are sold at a "significant premium" to other mesh alternatives because they are more technologically advanced, allowing them to promote faster tissue regeneration and to prevent side effects such as bowel adhesion.

"Because the adoption of laparoscopy, which can only be carried out using nonadhesive mesh, has historically been limited in the region, uptake of these specialized meshes has been slow," Millennium said. However, physician training and marketing efforts are having a positive effect on laparoscopic procedure volumes.

"These trends will contribute to the increasing number of laparoscopic ventral hernia repairs performed in Latin America, providing a much greater opportunity for uptake of premium-priced nonadhesive meshes than has been the case in the past," says Lexie Code, Manager of the Endoscopy division at MRG.

The report provides coverage of key industry competitors, including Atrium Medical, B. Braun Aesculap, Cook Medical, Covidien, Davol (a subsidiary of C. R. Bard), and Ethicon (a Johnson & Johnson company).

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