Stereotaxis and Osypka Enter Strategic Collaboration to Advance Robotic Catheter Technology

Stereotaxis, a global developer of robotic technologies for the treatment of cardiac arrhythmias, and Osypka AG, a pioneer in electrophysiology and manufacturer of interventional products, have announced a broad strategic collaboration. Stereotaxis and Osypka are designing and developing a next-generation magnetic ablation catheter to be navigated using Stereotaxis’ robotic technology. Stereotaxis is funding the development and will be the sole owner of the catheter. In addition, Stereotaxis and Osypka have entered into additional business agreements to support a long-term broad collaboration in electrophysiology.
 
“The precision, safety, and efficacy of existing magnetic ablation catheters have been extensively demonstrated in clinical literature and commercial use. We are highly excited to be advancing significant innovation in ablation catheter technology. We are confident we can take already great technology and make it that much better,” said David Fischel, chairman and CEO of Stereotaxis.
 
The next-generation magnetic ablation catheter is being developed with three primary design considerations: improving the capabilities and performance of the radiofrequency ablation tip, improving the quantity and placement of magnetic material in the catheter to improve navigation efficiency, and ensuring an open ecosystem design that can accommodate use within various mapping environments. Initial early prototypes of the catheter have been developed, and clinical use and commercial launch in select geographies is possible in 2020.

Osypka is a pioneer in the field of interventional electrophysiology with the first arrhythmia patient treated by radiofrequency ablation in 1986 benefiting from Osypka’s early ablation catheter and generator technology. Osypka has significant expertise and robust facilities dedicated to electrophysiology catheter design and manufacturing. Osypka has a proprietary electrophysiology product portfolio that includes diagnostic catheters, manual ablation catheters, and an advanced radiofrequency generator. Additional terms of the business agreement were not disclosed.
 
“Stereotaxis is delighted to be partnered with Osypka. We have been impressed with Osypka’s expertise and capabilities, as well as with their commitment to high quality products that improve patient care,” said Fischel. “Stereotaxis remains committed to advancing robotic technology in electrophysiology. This collaboration leverages the highly complementary strengths of both firms. It promises to dramatically improve our clinical impact in electrophysiology and opens attractive potential options as we advance our strategic vision. We look forward to working with Osypka to advance patient care and the physician experience in electrophysiology.”
 
“Osypka is excited to collaborate with Stereotaxis. This collaboration leverages our extensive experience and capabilities in catheter technology and electrophysiology. It allows Osypka technology to have an expanded impact on the treatment of arrhythmias,” said Nicola Osypka and Achim Kitschmann, co-CEOs of Osypka. “We have observed the clinical benefits of Stereotaxis’ robotic technology and the committed physician community that supports Stereotaxis’ success. We understand Stereotaxis’ strategy and vision for the future. We are excited to join hands to advance that vision for the betterment of patients, physicians and the electrophysiology field.”
 
Osypka AG designs, develops, and manufactures medical devices for interventional cardiology, cardiac surgery, and neurostimulation. Founded in 1977, Osypka AG is headquartered in Rheinfelden, Germany, and has subsidiaries near Denver, Colo., and in the Czech Republic. Among Osypka’s pioneering innovations are the introduction of the non-breakable screw-tip pacing lead in the 1970s, the HAT100 RF generator used in the world’s first radiofrequency ablation of a cardiac tachycardia performed in 1986, and a broad range of specialty interventional solutions for pediatric cardiac applications. Osypka’s HAT500 is the only RF generator designed for bipolar tip-to-tip ablation, enabling simultaneous epicardial and endocardial ablation. Osypka continues to offer high quality brand name medical devices and is an established design and manufacturing partner for many of the largest medical device firms globally.
 
Stereotaxis is a global developer of robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development, and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Over 100 issued patents support the Stereotaxis platform. Stereotaxis’ robotic technology has received various regulatory clearances in the United States, European Union, Japan, Canada, China, and elsewhere. The Stereotaxis Genesis RMN System is CE marked and will become available in other global geographies subject to regulatory approvals. Stereotaxis Imaging Model S is CE marked and U.S. Food and Drug Administration-cleared.