#Australia #Melbourne #4DMedical #CT:VQ™ #Cardiothoracic Imaging

4DMedical’s CT:VQ™ Receives CE Mark Certification

4DMedical Limited (ASX:4DX), a frontrunner in cardiothoracic imaging technology, has recently announced the approval of its imaging solution, CT:VQ™, with the CE Mark. This notable certification allows the company to commence commercial operations within the vast European Union (EU) market, recognized as one of the most significant regions for respiratory medical imaging.

CT:VQ™ represents a groundbreaking approach in lung imaging, combining the anatomical resolution of computed tomography (CT) with functional insights into ventilation and perfusion derived from standard non-contrast CT scans. This innovative imaging modality empowers healthcare professionals with quantitative analyses of lung function, eliminating the need for radiotracers traditionally employed in nuclear scans.

Significance of CE Mark and European Expansion

The CE Mark certification is crucial for 4DMedical as it not only signifies compliance with European health and safety regulations but also opens doors to a highly sophisticated healthcare environment comprising over 450 million residents. In addition, the supported clinical imaging infrastructure and a large installed base of CT scanners in Europe create a substantial opportunity for adopting CT-based functional lung imaging technologies.

In conjunction with the CE Mark announcement, 4DMedical disclosed a significant funding accomplishment, securing approximately AU$83 million through a private placement. The capital obtained will bolster the company's expansion strategy across Europe, focusing on deploying CT:VQ™ and conducting research initiatives in collaboration with leading European healthcare institutions.

CT:VQ™: A Leap in Lung Imaging

CT:VQ™ distinguishes itself as the first and sole non-contrast ventilation-perfusion imaging technology currently available. It enables the mapping of lung function without employing radiotracers, which are often hard to acquire and can complicate imaging processes. The core innovation lies in its ability to seamlessly integrate into existing CT workflows within large medical facilities, alleviating persistent challenges associated with traditional nuclear imaging methods.

According to current estimates, around 400,000 nuclear ventilation-perfusion (VQ) scans are conducted annually across Europe, highlighting an unmet need that CT:VQ™ is poised to address. By generating both ventilation and perfusion maps, this technology allows clinicians to visualize and better understand regional lung function in a manner that is both intuitive and informative.

Global Context and Future Prospects

Andreas Fouras, CEO and Founder of 4DMedical, expressed that obtaining the CE Mark is a monumental achievement that paves the way for rapid commercialization in one of the world's most sophisticated healthcare markets. With regulatory clearances now secured not only in Europe but also in the U.S., 4DMedical is strategically positioned for swift market entry.

The U.S. market has already begun experiencing the benefits associated with CTVQ™ technology, as it is currently in operation at major academic medical centers including Stanford University and Mayo Clinic. Early adoption patterns in prominent institutions have generated significant interest among radiology and pulmonary medicine teams in the U.S., setting a promising precedent as they gear up for the upcoming launch in Europe.

Conclusion

As 4DMedical embarks on its next chapter, the focus will be on enhancing partnerships within the European landscape, engaging with top-tier hospitals, and facilitating research initiatives centered on CT:VQ™. The clinical requirements faced globally indicate that the demand for advanced functional lung imaging technologies like CT:VQ™ will continue to grow, thus setting the stage for the technology to make a solid impact in the speedily evolving medical imaging field. For more information on 4DMedical and its technologies, visit 4dmedical.com.