Tissue ablation involves targeted destruction of tumors or benign tissues with pathologic impact using one of a variety of ablation devices based on a specific energy source, such as radiofrequency, microwave, laser, ultrasound, and cryoablation. With the exception of cryoablation, all these devices act through a common pathway of cellular hyperthermia. The overall tissue ablation market targeting numerous anatomic sites is estimated to generate $4-5 billion in annual revenue. One target which has not been successfully treated with ablation is fistula tracts. The renal nerves have also been identified as a therapeutic target for ablation in patients with poorly controlled hypertension. Endovenous ablation of varicose veins is a common and well established procedure. The estimated annual addressable markets for fistula ablation, renal denervation, and varicose veins are $300 million, $1 billion, and $240 million respectively.
All commercially available devices rely on some form of console to generate the ablation energy. These consoles, whether sold or leased as capital equipment or incorporated to the disposable cost, represent a significant proportion of the cost of the technology and the procedure, dramatically impacting procedural margins. These consoles require ongoing maintenance and monitoring by the manufacturer and local facility technical staff to assure they remain safe for use in patients. This can be particularly burdensome when commercializing such devices in emerging markets where access to qualified biomedical personnel may be limited.
We are developing completely disposable tissue ablation devices based on direct thermal ablation using heated fluid. We take advantage of the fact that all currently available energy sources, except cryoablation, act through the same common pathway of cellular hyperthermia. Caldus uses a proprietary disposable infusion device to continuously deliver heated fluid to a specially designed balloon catheter, which heats the target tissue above its cytotoxic threshold according to a specific pattern. Although, we believe this technology is applicable to over a dozen ablation targets, we have decided to initially focus on developing devices to treat fistula tracts, perform renal denervation and endovenous ablation of varicose veins. Once these products are commercialized, we believe that our completely disposable system will have lower procedural costs and higher margins than existing technologies. We anticipate applying the technology to other target tissues as resources permit.