Cardima, Inc. (OTCBB:CADM), a medical device company focused on the diagnosis and treatment of atrial fibrillation (“AF”), is providing the following update on its progress, recent activities and upcoming milestones:
JAPANESE DIAGNOSTIC MARKET
Cardima expects to receive regulatory approval in the near term to re-enter the Japanese market with its family of guidewire-based, PATHFINDER® diagnostic micro-mapping catheters. Upon approval, Cardima’s PATHFINDER catheters, which are designed for accessing and mapping the smallest and most tortuous vasculature of the heart wall to facilitate treatment of arrhythmias, will be marketed in Japan though an exclusive agreement with medical device distributor Japan Lifeline Co. Ltd., a sub-distributor of Robert Reid Inc., Cardima’s logistics and regulatory partner in that country. The Japanese market for diagnostic catheters is robust and Cardima has been building inventory to meet anticipated demand. Japan Lifeline is an ideal marketing partner for Cardima’s diagnostic line of products as it has a significant presence in Japan’s electrophysiology market and sales representatives with established relationships with key physicians and clinical centers nationwide. Cardima notes that entering the Japanese diagnostic market is entirely dependent upon receipt of regulatory approval and in the event marketing approval is significantly delayed or denied, marketing efforts will be materially affected.
Cardima’s PATHFINDER diagnostic mapping catheters are currently approved for marketing in the U.S., Europe, Canada and Thailand.
SURGICAL ABLATION SYSTEM – U.S.
Cardima is training a number of cardiothoracic surgeons at leading U.S. medical centers on the use of the Cardima Surgical Ablation System (“SAS”). Cardima’s training program focuses on establishing commercial centers with some designated as regional training centers to facilitate additional surgeons training. Certain centers also will collect registry data to track product performance and safety. Dr. Li Poa, a pioneer in minimally invasive thoracoscopic atrial ablation and long-time user of the Cardima SAS, recently performed his first case at Kaiser Permanente Hospital – Sunset in Los Angeles. The SAS performed well and the probe was well received by other surgeons and electrophysiologists (“EPs”) in attendance. Additionally, several leading U.S. surgeons are planning clinical studies using the Cardima Surgical Ablation System.
SURGICAL ABLATION SYSTEM – Europe
Cardima will be launching surgical programs during the current quarter at hospitals affiliated with select leading European cardiac surgeons who have extensive experience in the surgical treatment of AF. These programs will highlight the benefits and advantages of the Cardima Surgical Ablation System over competing products for European physicians, patients and hospitals. A European surgical study using the Cardima Surgical Ablation System also is planned.
SURGICAL ABLATION SYSTEM – Thailand
Cardima has completed the first stage of surgeon training on the Cardima Surgical Ablation System at Ramathibodhi Hospital, a large public and teaching hospital in Bangkok. Ramathibodhi Hospital is preparing to launch its AF Center of Excellence utilizing the Cardima Surgical Ablation System. This Center of Excellence will be promoted in Thailand, as well as more broadly throughout Asia. Cardima also expects to begin training surgeons at one of Thailand’s leading private and tourist medicine cardiac centers, Bangkok Heart Hospital. Thailand is known as a significant “tourist medicine” market and Cardima’s move into the private market in Thailand is expected to commence in the current quarter.
SURGICAL ABLATION SYSTEM – China
Cardima expects to receive marketing approval for its Surgical Ablation System in China within the next two quarters, acknowledging the approval is outside of its control. The Company has established relationships with leading physicians at cardiac centers involved in the treatment of AF to facilitate market entry, subject to marketing approval. Some of these physicians also are attached to academic teaching hospitals, and clinical studies with the Cardima Surgical Ablation System are being actively considered in the Chinese market.
SURGICAL ABLATION SYSTEM – Regulatory and Clinical
Cardima is actively considering entering additional markets with the Cardima Surgical Ablation System, including Australia, India, Russia and several European markets. A decision to enter these markets is dependent on regulatory approvals, and an assessment of the individual market’s potential and the resources available to the Company.
EP ABLATION SYSTEM