Market approval

The treatment system has the potential to be applied to different types of internal solid tumours, but the strategy is to first start with recurrent and primary prostate cancer. The focus is initially on obtaining market approval for the treatment system Q-PRO® in the North American and European markets. Product approval for market launch can only be obtained after a successfully completed clinical trial. SpectraCure is certified according to ISO 13485:2016, which means that the company strictly follows the regulations governing medical devices. The certification also facilitates the process of market approval for medical devices globally.

Establishing Q-PRO®

We aim to establish Q-PRO® as a preeminent treatment for localised prostate cancer. The strategy is based on connecting prominent doctors from leading key clinics to the clinical studies. Through these reference clinics and leading physicians, the intention is to build clinical evidence, increase awareness, and reach clinical acceptance of the treatment.

Business model

SpectraCure will offer a combination of fixed and variable pricing. The treatment system is planned to be sold to the customer/clinic at a relatively low price, with a limited margin to lower the entry barrier. Through a code, along with associated disposable items, the clinic utilises the system and pays per treatment. To penetrate the market in a cost-effective and scalable manner, SpectraCure will collaborate with one or more major global distributors, for example, through licensing agreements.