SpectraCure is a Swedish medtech company. Medical technology is a broad area that many, both healthcare professionals and patients, come into contact with daily. We have chosen to focus our clinical studies on one patient group – patients with recurrent prostate cancer who have previously received radiation therapy. This patient group currently lacks treatment options in today’s healthcare. This provides an opportunity for a more rapid market introduction for our treatment and the possibility to offer our treatment method to more patients with recurrent prostate cancer.

 

Our clinical studies continued throughout the year, and the patients so far treated in the studies have not suffered any major side effects. The evaluations we have received so far have shown good treatment effect.

“Our goal is to provide healthcare and patients a minimally invasive treatment when almost no other treatment options can be offered,” to quote one of the founders, professor Katarina Svanberg. We hope to offer patients better health with fewer side effects such as impotence and incontinence. Simply, a good quality of life after the treatment. I see great potential for SpectraCure’s method in the future. As we make progress and show good clinical efficacy, other opportunities emerge, such as introducing the treatment as the first choice in the treatment of primary prostate cancer.

 

Sweden and large parts of the western world face challenges such as an aging population and an increased need for care. SpectraCure’s treatment can allow shorter time for patients in hospitals, with the possibility to go home two to three hours after the treatment. This is not only good for the patient, but also reduces the burden, both in terms of resources and financially, for the healthcare system.

 

During the year, we have taken important steps towards our goal of getting the treatment approved within the European as well as the US market within two years.

 

In parallel with the clinical studies, the product has been fine-tuned and adapted to the needs of the market. The previous software in the system has been replaced with a new, more modern and more user-friendly interface that communicates with our dose planning platform (IDOSE®) and controls the hardware. For the doctors, the improved interface means higher resolution images and a more natural workflow.

 

The hardware has also been revised during the year to improve handling. The new, patent-pending, solution is more compact and easier to maintain. Manufacturing costs have been reduced by almost 80 percent. The treatment system now fits on a small medical cart and can easily be integrated with other equipment in the operating room. The first units are built and tested in SpectraCure’s own R&D department. The plan is to introduce the new system in the clinical trials in 2020.

We have also begun work on getting so-called accelerated approval, which, if approved by the FDA, could mean changing requirements for endpoints and a shorter path to product launch. We can then more quickly offer more patients with recurrent prostate cancer an effective treatment with hopefully few side effects, and healthcare a cost-effective treatment.

 

The coronavirus affects our entire society and the situation changes daily. Our procedures and directives are based on the decisions and recommendations of the Public Health Agency and we can adapt to new conditions at short notice. Our work is primarily aimed at protecting the staff so that we can continue our work without interruption. A crisis plan has been created to ensure work as well as development. At this time, I do not believe that covid-19 will affect the company’s financial position or that information from the FDA or other authorities will be postponed. SpectraCure has control over the things we can control, such as the development of the company’s software and hardware and the work is going according to plan. We continue to have continuous contact with the hospitals in our clinical study and the close contact and good cooperation will hopefully result in increased patient recruitment when the outbreak clears.

 

We will continue to work focused and dedicated to achieving the goal.

 

Lund, May 7th, 2020

 

Masoud Khayyami
CEO