Therapeutic and diagnostic devices maker AngioDynamics (ANGO) reported that it has completed the patient enrollment for the European clinical trial of its popular tumor-zapping NanoKnife system for the treatment of hepatocellular carcinoma (“HCC”), the most common type of liver cancer.
The European trial has been designed to assess the safety and efficacy of the NanoKnife System in treating early-stage HCC. The multi-center, company-sponsored trial includes 26 patients from 5 European sites.
Patients with one-to-three tumors with sizes not more than 3 centimeters (or roughly 1.18 inches) have been considered eligible for the study. These patients are allowed one re-treatment with the NanoKnife System.
Hepatocellular carcinoma affects more than 500,000 people globally every year. Major risk factors for the condition includes infection with hepatitis B (“HBV”) and hepatitis C (“HCV”). Despite advancements in therapy, one-year survival rates remain below 50%.
AngioDynamics is a leader in therapeutic and diagnostic devices for treating peripheral vascular and other non-coronary diseases. It has market leading positions in several of its operating segments including angiographic products and thrombolytic catheters.
The company’s focus on interventional peripheral products has allowed it to expand its share as the market continues to shift from open surgery to less invasive interventional procedures.
NanoKnife remains the life blood for AngioDynamics and it is seeking to expand the label to broaden its commercial opportunity. The company is ramping up R&D investments to support the ongoing clinical studies of NanoKnife and vascular product development programs.
However, AngioDynamics is exposed to pricing headwinds, stemming from lower selling prices of some access and peripheral vascular products. Moreover, its product lines face strong challenges from the competitive offerings of its larger rivals such as Boston Scientific (BSX) and C.R. Bard (BCR). We are also cognizant about the dilutive impact of higher R&D spending on the company’s bottom line. We are currently Neutral on the stock.
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