During the quarter, we have placed great emphasis on our relations with the hospitals in our clinical trial. The aim is to get the trial moving quickly when travel restrictions are eased. We have set up a plan to have the clinical trial activated in hospitals in the United Kingdom, Canada and the United States before the end of the year, provided that no additional travel restrictions are imposed. I have personally participated in all of these dialogues, and I sense a strong drive and eagerness to get going again. This stems from a genuine interest of the hospitals to advance the trial, with ambitions of ensuring a better care for patients.

We are awaiting approval in Canada and the United Kingdom of the new generation of our treatment system, P18-4, and our plan is to deliver the new system to hospitals as approvals are obtained. To start the trial, it is, however, not necessary to wait for them, as the trial can be conducted with the existing system in the meanwhile.

An approval of P18-4 will provide us with new possibilities to include additional hospitals in the trial, which will be very valuable in view of an upcoming Phase 3 clinical trial.

Our discussions with UCLH and the other hospitals have centred on the restart of the trial, but also on how the patient recruitment can be accelerated beyond the pre-pandemic level. Part of the plan involves recruiting staff that can spend a lot of time on location in the various hospitals to support the trial effort. In October, we finally got word from UCLH that the treatment of a patient with recurring prostate cancer is planned to commence shortly.

The Company’s hope and ambition is that the recruitment and treatment of patients for the Phase 2 trial will be completed in 2022. Based on conversations with a number of expert advisors in the late summer and fall, we have made the assessment that the probability of having an application for accelerated approval accepted has declined. This entails that there is a high probability that we will not receive market authorization for a product until a Phase 3 trial has been carried out.

During the fall, our development effort has continued intensively. As planned, we believe that we will be able to complete all development projects that were undertaken this year before the end of the year.

The focus on clinical issues and business developed was strengthened across the organization, and SpectraCure’s executive management was expanded with the additions of Johan Glindre, Head of Clinical Affairs, and Johan Ingemansson, Head of Business Development. Both Johan Glindre and Johan Ingemansson were already employed by the Company.

Quality management is becoming ever more important, and in order to ensure our compliance with the European Medical Device Regulation (MDR), the organization was strengthened with a Quality Assurance Manager, who will develop and advance our effort to ensure the best quality and patient safety.

We have a strong organization in place, and a persistently strong financial position which allows us to step up the pace of the clinical trial. In due course, I look forward to communicate the trial’s resumption in both Canada and the United States.

Lund, November 2021
Johan Folkunger, CEO of SpectraCure AB (publ)