OrthAlign Advances Global Strategy with New CE Mark for Surgical Devices

OrthAlign's CE Mark Announcement: A Step Toward Global Expansion

OrthAlign, Inc., recognized as a leader in handheld orthopedic enabling technology, has reached a significant milestone by securing the CE Mark under the European Union Medical Device Regulation (EU MDR). This certification allows OrthAlign to commercialize its innovative navigation solutions across various European markets, marking a pivotal advancement in its global growth strategy.

The CE mark is now applicable to both its Lantern® and OrthAlign Plus® platforms, which are set to transform the landscape of joint replacement surgeries in Europe. With an increasing focus on healthcare efficiency and cost control, these technological solutions are entering a region eager for effective surgical tools.

Meeting European Healthcare Needs

OrthAlign’s dedicated handheld systems are crafted to align seamlessly with the operational needs of European healthcare providers. One of the standout features of these technologies is the single-use format, accompanied by per-case pricing. This framework alleviates the necessity for upfront capital investment in equipment, service contracts, or intricate infrastructure, thereby enabling hospitals and ambulatory surgical centers to manage their costs more effectively.

Eric Timko, OrthAlign's CEO, emphasized the ease of accessibility and integration of their technology: “Our solutions were designed for straightforward implementation. Without the need for prior imaging or extensive training, we can empower surgeons to incorporate advanced technology into their existing workflows without disruption.”

Compatibility and Flexibility

The versatility of OrthAlign’s open-platform technology is another vital advantage. It is compatible with all major implant systems, allowing surgeons to maintain their preferred practices while also aiding in standardizing solutions across diverse care sites. This adaptability is crucial as it assures consistent outcomes in procedures for total knee replacements, revision knees, partial knees, and total hip operations.

Since their launch, OrthAlign has recorded over 450,000 procedures globally, establishing a robust reputation for enabling precise, real-time data delivery, all while enhancing procedural efficiency. The design of their systems ensures that they integrate effortlessly into operating rooms, providing performance that is time-neutral compared to traditional manual methods without the complexities associated with traditional navigation systems or robotics.

Underscoring the current gap in the market, Timko stated, “European healthcare systems are seeking technologies that ensure clinical effectiveness while balancing operational costs. We are confident that OrthAlign is poised to meet these emerging demands.”

Commercial Rollout and Future Prospects

With the CE Mark now secured, OrthAlign plans to initiate the commercial rollout of its platforms in key European markets without delay. This endeavor will be supported by a network of distribution partners along with dedicated clinical education programs aimed at facilitating the technology’s integration into European medical practices.

For any inquiries regarding distribution, interested parties can reach out via [email protected]

About OrthAlign

OrthAlign, Inc. is at the forefront of medical device innovation, focusing on delivering user-friendly, cost-effective handheld technologies for joint replacement surgeries. Their product lineup, including the well-regarded OrthAlign Plus and Lantern systems, not only enhances surgical accuracy but also promotes efficiency, eliminating the need for extensive capital investments in equipment. As the company expands into new markets, it continues to focus on improving patient outcomes and ensuring the best surgical practices across the globe.