A Medical Device Daily
Cardima (Fremont, California), which is focused on the treatment of atrial fibrillation (AF), has received approval from the FDA in Thailand to market its three main lines of products in that country.
Those lines include the company's diagnostic catheters, the EP Revelation line of therapeutic catheters and the Cardima Surgical Ablation System.
"The market approval for Thailand is ... another significant stride in achieving our ongoing regulatory strategy," said CEO Robert Cheney. "Thailand is an excellent market for Cardima because of its advanced medical infrastructure and highly trained physicians."
He noted that Cardima is working closely with Dr. Li Poa of Columbia University Medical School (New York) and MEDS Global Healthcare USA (Los Angeles) in conjunction with Mahidol University and the Thailand Ministry of Health to position its products to "play a key role in establishing centers of excellence in Thailand for the treatment of atrial fibrillation."
Training on the Cardima Surgical Ablation System is expected to commence shortly under the direction of Poa, in conjunction with Dr. Suchart Chaiyaroj, chief of cardiothoracic surgery at Ramathibodi Hospital. The initiative to establish AF centers of excellence in Thailand was strongly backed by the cardiology faculty at Ramathibodi Hospital, a teaching hospital associated with Mahidol University, which is one of the oldest medical schools in Thailand and a recognized center for medical training and research.
Cardima said Thailand has a "leading position globally" in the rapidly expanding "Tourist Medicine" market. Dr. Rome Jutabha, an associate professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles, said, "Leading Thai medical centers now treat over 1 million 'tourist' patients every year. Thailand wants to leverage [its] success in this market by focusing on key disease sectors."
He added that AF "represents a huge global market with millions of untreated patients. Atrial fibrillation [is] a problem requiring treatment resources that cannot currently be provided at adequate levels or at a reasonable cost in most, if not all, developed countries."
Jutabha said the establishment of centers of excellence in Thailand, using Cardima's minimally invasive surgical system and its other diagnostic and EP ablation therapeutic treatment catheters, will offer patients new treatment options, and at a more reasonable cost.
Poa said, "We have had great results working with the minimally invasive Surgical Ablation System. I am excited to introduce this new treatment option to Thailand as part of the program developing AF centers of excellence working with MEDS Global Healthcare, Ramathibodi Hospital, leading Thai physicians and the Thai Ministry of Public Health.
Chief of cardiothoracic surgery and cardiac surgery program director at Stamford Hospital in Connecticut, a teaching affiliate of the Columbia University College of Physicians and Surgeons, where he is a faculty member, Poa specializes in endoscopic cardiac access and the surgical treatment of AF and other minimally invasive techniques.
Japanese agreement for cancer drug
Celsion (Columbia, Maryland) and Yakult Honsha Co. Ltd. (Tokyo) reported that Yakult will undertake pre-clinical and clinical studies of the U.S. firm's ThermoDox product to support requirements for drug registration in Japan. ThermoDox a heat-sensitive liposomal encapsulation of doxorubicin, an often-used drug in the treatment of various cancers.
The two companies have executed a letter of intent relating to the commercialization of ThermoDox for the Japanese markets, which is subject to the execution of definitive agreements.
Michael Tardugno, Celsion president/CEO, said, "[Yakult's]interest in working with Celsion to develop ThermoDox's potential to treat primary liver cancer further confirms our confidence in the promise that we've seen in our early-phase studies and adds significant bench strength to our clinical program."
Dr. Kiyoshi Terada, head of Yakult's pharmaceutical division and senior managing director, said, "We are highly encouraged with Celsion's interest in the Japanese market. ThermoDox's ... unique therapeutic approach to treating difficult cancers such as HCC provides a solid basis for our collaborative development decision."
Celsion is a developer of oncology drugs, including tumor-targeting treatments using focused heat energy in combination with heat-activated drug-delivery systems. Yakult is focused on the development and marketing of pharmaceuticals, foods, beverages, and cosmetics, with an emerging presence in oncology and liposome drugs for the Japan market.
Zecotek in laser distribution deal
Zecotek Photonics (Vancouver, British Columbia) has signed a broad distribution agreement with T.E.M. (Tokyo), a distributor of laser and electro-optical products, for Zecotek's fiber and solid-state lasers, MAPD photo detectors, RFO vanadate crystals and LFS scintillation material in Japan.
T.E.M. will work within Zecotek's existing manufacturing agreement with Fujikura, the Canadian firm said.
Under the laser distribution agreement, T.E.M. has committed to pre-purchase products, including Green Fiber Lasers for immediate marketing to its major OEM customers.