Creo Medical Regulatory News (CREO)

Creo Medical Group plc

("Creo" the "Company" or the "Group")

Trading update

Strong regulatory and commercial progress achieved despite worldwide COVID-19 restrictions

Creo Medical Group plc (AIM: CREO), a medical device company focused on the emerging field of surgical endoscopy, announces that trading for the year ended 31 December 2020 was marginally ahead of management expectations, with revenue for the year ended 31 December 2020 increasing to over £9m (2019: £0.01m). The Company had a net cash position at 31 December 2020 in excess of £45m.

During 2020, the Company demonstrated commercial progress with the transformational acquisitions of Albyn Medical S.L. and Boucart Medical SRL. The acquisitions provide the Company with a direct sales presence in Europe to facilitate the roll-out of its CE marked advanced energy devices, and strengthen Creo's EU and UK commercial teams. The integration of these businesses have performed in line with management's expectations.

In addition, the Company has grown its commercial team organically. David Woods, previously a non-executive director of Creo and former President and CEO of Pentax Americas, joined Creo full time as Chief Commercial Officer. Following his appointment, David has built an experienced team in the US and APAC providing the Company with greater access to these important markets. This additional strength, together with the European acquisitions, allows Creo to move from a distributor model to a direct and/or directly managed sales approach worldwide.

At the beginning of 2020, Creo had a team of 91 people based almost exclusively in the UK, and by the end of the year the Company had more than doubled the size of its team, with a 10-fold increase in its commercial, marketing and distribution resource and a presence across five European countries, four regions of the US and a centralised hub in APAC. This additional headcount and global presence provide resilience and global capability to develop sales across a wide range of products primarily in GI but with business also in pulmonary and urology markets.

The Company made good progress ahead of plan on the regulatory front. During 2020, Creo successfully CE marked an additional five devices, achieved FDA 510k clearance for its tissue ablation device, MicroBlate™ Fine, and, in December 2020, reported the first clinical use of MicroBlate Fine in a successful pancreatic tumour ablation. In January 2021, FDA 510k clearance was achieved for a fourth product, MicroBlate™ Flex.

Despite COVID-19 continuing to create uncertainty worldwide, the Company has delivered exceptional results across many fronts including building a global commercial team, finding innovative ways to train clinicians and delivering revenue ahead of management's expectation. In 2021, the Company expects to build on its current momentum and commercial infrastructure to generate increasing revenues, develop wider commercial opportunities and take further steps along the pathway to commercialisation. The immediate focus for the Company is to deliver clinical outcomes for all devices. Creo also intends to explore possible applications for its Kamaptive™ technology in the adjacent fields of laparoscopic and robotic assisted surgery together with third party partners.

Craig Gulliford, Chief Executive Officer of Creo, commented: "Despite COVID-19 having a short-term impact on the business, the last 12 months has been a period of transformational change for the Company. At the start of the pandemic, we asked the Creo team to focus on what they can achieve not what they can't achieve; I believe that they have done just that.

"In addition to stepping up to provide our own COVID response in local communities, we have gained further CE marks and FDA regulatory approvals for our devices, organically grown talent and completed the acquisitions of Albyn Medical S.L. and Boucart Medical SRL. The regionalised nature of the Group's business hedges against pandemic related travel restrictions. With the roll out of COVID-19 vaccines underway, we look forward to realising our goals this year and beyond."

About Creo Medical 

Creo Medical, founded in 2003, is a medical device company focused on the development and commercialisation of minimally invasive surgical devices, by bringing advanced energy to endoscopy. The Company's mission is to improve patient outcomes by applying microwave and RF energy to surgical endoscopy. Creo has developed the CROMA Advanced Energy Platform powered by Kamaptive full-spectrum adaptive technology to optimise surgical capability and patient outcomes. Kamaptive is a seamless, intuitive integration of multi-modal energy sources, optimised to dynamically adapt to patient tissue during procedures such as resection, dissection, coagulation and ablation of tissue. Kamaptive technology provides clinicians with increased flexibility, precision and controlled surgical solutions.  

The Company's strategy is to bring its CROMA Advanced Energy Platform powered by Kamaptive technology to market, enabling a wide range of medical devices which the Company has designed, initially for the emerging field of GI therapeutic endoscopy, an area with high unmet needs. The CROMA Advanced Energy Platform will be developed further for bronchoscopy and laparoscopy procedures. The Company believes its technology can impact the landscape of surgery and endoscopy by providing a safer, less-invasive and more cost-efficient option of treatment.  

For more information about Creo Medical please see our website: investors.creomedical.com