Creo and Intuitive amend collaboration agreement

Intuitive's Ion Endoluminal System and Creo's MicroBlate™ Flex ablation device used in pioneering lung cancer treatment

Creo Medical Group plc (AIM: CREO), a medical device company focused on the emerging field of minimally invasive surgical endoscopy for pre-cancer and cancer patients, provides an update in relation to the multi-year collaboration agreement with Intuitive Surgical Inc. ("Intuitive"), which will now expand the number of sites in the UK and Europe undertaking combined lung cancer diagnostic and microwave ablation procedures.

Intuitive (Nasdaq: ISRG) is a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery. Under the collaboration agreement, certain Creo products will be tested for compatibility with Intuitive's Ion Endoluminal System, and it provides a framework for undertaking joint clinical studies ahead of commercial launch of the MicroBlate Flex device.

Accelerated timescale for further Lung Tissue ablation cases across UK and Europe

As announced in May 2023, the first in-human use of the Company's MicroBlate Flex device for the microwave ablation of soft tissue lung lesions was successfully completed by Professor Shah at Royal Brompton Hospital, part of Guy's and St Thomas' NHS Foundation Trust. The initial MicroBlate Flex procedure was undertaken in a clinical study1 which is ongoing. In March 2024, Professor Shah and his team announced that they had performed the first ever robotic-guided microwave ablation of lung tissue in the same sitting as a diagnostic procedure2.

The collaboration agreement amendment will support the collection of post-market clinical evidence as part of a controlled market release ahead of the next stage in commercialisation of the MicroBlate Flex device. To achieve this, Intuitive and Creo have agreed to extend the number of sites in the UK and Europe undertaking robotic-guided microwave ablation procedures for lung cancer.

Over the next 12 months, Creo and Intuitive will carefully roll out a controlled clinical pioneer programme across multiple sites in the UK and Europe under which a number of trained Ion users will learn how to simultaneously use Creo's MicroBlate Flex device for microwave ablation of cancerous tissue. The first cases from these additional sites are expected to begin before the end of the calendar year, alongside the continuation of the work being undertaken at the Royal Brompton.

As is typical in such a controlled market release, the CROMA system will be loaned at no cost along with the MicroBlate Flex devices to cover the initial cases during the proctoring/mentoring phase before each site enters a commercial phase. A member of the Intuitive or Creo clinical team will be present during procedures as part of an oversight program, to carefully monitor cases during this initial phase.

Craig Gulliford, Chief Executive Officer of Creo, said: "This is an exciting step for all involved as we are already seeing patients for whom this product is ideally suited. The ability to diagnose and treat an early lesion as part of a singular anaesthetic event is what we are aiming for and the potential is clear.

"Our mission is to help drive improvements in the survivability of lung cancer through a combination of precise, accurate diagnosis aligned with precise and accurately targeted therapy through our Kamaptive partnership programme.

"This is an exciting time for the programme for all involved and we look forward to carefully introducing this to the treatment of an increasing number of patients in the near future."

1 Bronchoscopic Microwave Ablation of Lung Tissue - Full Text View - ClinicalTrials.gov

2 https://guysandstthomasspecialistcare.co.uk/news/ion-robot-lung-tumour/