Occlutech Holding AG is an innovative pioneer in the medical device industry, providing minimally invasive structural heart implants to 85 countries around the world. By tapping into the tremendous global potential of the congenital and structural heart devices sector, the company is set on a path of accelerated growth and progress.
We are thrilled to share that Q1 2023 brought great success for us, with significant growth in our direct markets and successful transformation initiatives that have further bolstered our organization’s strength. We look forward to continuing on this positive trajectory!
Growth momentum and good conditions
I am pleased to announce that Occlutech ended the first quarter of 2023 on a very strong note, with revenue rising by 10.3 percent year-over-year to EUR 8,949 thousand. Our key European market saw a surge of 10.9 percent, while our direct sales experienced a remarkable 20.9 percent increase compared to last year.
March, in particular, was a record breaker for us, with the highest sales numbers to date. Despite trade restrictions due to the conflict in Ukraine, our distributor network remained resilient, showing positive results.
We achieved an incredible victory at the end of the quarter: a long-term financing agreement with a bond subscription commitment of EUR 40 million from a total framework of EUR 75 million. This groundbreaking victory will equip us with the necessary resources to make leaps in our current studies, launch into the vast US market, and propel growth in our prime markets.
Clinical studies moving forward
Occlutech has been investing heavily into clinical studies and R&D, while developing and implementing regulatory and clinical strategies for all its products. This quarter also marked a very special moment for the company when Dr. Morwan Choli joined the Executive Management Team as the VP of Regulatory Affairs & Quality.
With his expertise in device testing, certification processes, and working with Notified Bodies, he will be a valuable asset to the product and marketing strategies for Occlutech as we move forward. In addition, we have bolstered our clinical team with additional resources to support the clinical studies.
March marked a momentous occasion for Occlutech – the enrollment of the very first patient in the groundbreaking FROST-HF (heart failure) study of the Atrial Flow Regulator (AFR) device. With this major milestone, our work around the clinical strategy and optimal progression of the AFR has intensified and we look forward to the incredible potential of this innovative device.
In the second quarter of 2022, we achieved a major milestone with the enrollment of our first patient in OCCLUFLEX, an international study into the safety and effectiveness of the Patent Foramen Ovale (PFO) Occluder.
Launching both in the United States and Canada, the study is comprised of participants from all across the globe, giving us a unique opportunity to explore the potential of PFO Occluders in different settings. We are excited to share the results of this unparalleled endeavor.
We eagerly look forward to the launch of our Atrial Septal Defect (ASD) Occluder in the US, our priority market, as soon as the Premarket Approval (PMA) is granted. Our partner, B. Braun Interventional Systems Inc., is ready to bring the device to the US market. However, due to processes that need to be adapted to FDA standards, we may experience a slight delay in the PMA application. Nevertheless, we remain excited to expand our US presence.
We are firmly on track for Medical Device Regulation (MDR) preparation, despite some minor challenges. We have seen a slight delay in Notified Bodies response times, which has made it harder to achieve certification for some of our accessories. In the background, our teams are integrating SAP into our operations and continuously improving our process to ensure maximum efficiency.
Sales, marketing and innovation
We are actively ramping up our sales and marketing efforts as we continue to witness signs of market recovery. To ensure our long-term success, we have established advisory boards within our three primary market segments to stimulate growth and foster creativity in the development of our products. Our aim is to maximize opportunities and capitalize on the current uptick in demand.
At our annual kick-off meeting in Barcelona this past January, we looked to the future, both for 2022 and beyond. We’re now feeling the positive impacts of increased salesforce engagement as our sales and marketing teams come together to ensure clear responsibilities and deliverables. We plan to take full advantage of this aligned approach in the months and years to come.
Future outlook
As we make our way into 2023, Occlutech is primed and ready to seize the multitude of opportunities that await. Our mission remains clear – to provide people all over the world with innovative solutions that enhance their wellbeing.
To that end, we are excited to contemplate broadening our portfolio with more products and forging strategic partnerships that can benefit everyone involved. It’s a journey that we can’t wait to embark on, and one that promises to be truly rewarding for all.
With the dedication of our team and adoption of cutting-edge technology, I am certain that Occlutech will reach heights that will make it a leading name in the global medical technology sphere and help improve countless lives. By taking such bold steps, we are confident that we can achieve a lasting and positive impact.