SpectraCure takes the next step in the work with the new clinical study
SpectraCure AB (publ) continues in the process of initiating a clinical study, for primary localised prostate cancer. The study's protocol has been submitted to the U. S. Food and Drug Administration (FDA), which has not expressed any specific comments, and the work to initiate the clinical study can proceed. In November 2023, the board decided to […]
A well-accomplished annual audit in accordance with ISO 13485:2016
SpectraCure AB (publ) announces today that the company has successfully undergone the annual audit according to ISO 13485:2016. The audit, conducted by a notified body, confirms that SpectraCures's quality management system meets the stringent requirements of the international standard. SpectraCure’s quality management system has undergone the annual ISO 13485:2016 audit. The authorised auditor confirmed that […]
Expert group comments on results of ongoing study
SpectraCure AB (publ) is conducting a clinical study for patients with recurrence of prostate cancer after radiotherapy. The study's expert group, the Data Safety Monitoring Board ("DSMB"), has been able to state that the current treatment is safe with mild to moderate side effects. Magnetic resonance images indicate that treatment has positive effects as it […]
SpectraCure has decided to seek approval for a clinical study of primary prostate cancer
SpectraCure AB (publ) has decided to seek approval to start a clinical study for primary localised prostate cancer. During autumn, the board and management have evaluated the conditions for approval to start a clinical study from authorities in the USA, Great Britain, Canada and Sweden and assessed these as good. The goal is to start […]
SpectraCure strengthens presence among urologists
SpectraCure AB has for four days participated with a stand at Urologiveckan, the annual conference gathering Sweden's top urologists, urology nurses, and researchers. This presence enhances SpectraCure's relationship with leading urologists. At this year's Urologivecka in Sundsvall, SpectraCure demonstrated the system and highlighted the company's ongoing clinical study. The conference serves as a strategic platform […]
SpectraCure has been awarded an additional EU grant for industrialisation of the company’s treatment system Q-PRO®
SpectraCure has been awarded an additional EU grant of 125,000 euros for the ongoing industrialisation project regarding the company's system Q-PRO® for treatment of prostate cancer using interstitial photodynamic therapy (PDT). The funding is awarded as part of MedPhab, a so-called "pilot production line" financed by grant from the EU's Horizon 2020 program. SpectraCure has […]
Approval for clinical study at Skåne University Hospital
The regulatory authorities in Sweden have approved SpectraCure's clinical study of a new treatment for patients who suffer from prostate cancer recurrence. The recruitment of patients at Skåne University Hospital in Malmö is intended to start in March. SpectraCure has previously signed an agreement with Skåne University Hospital regarding participation in the company's clinical study. […]
Positive feedback from treatment with SpectraCure’s system Q-PRO® in New York
In the ongoing clinical study, the first treatment with the new generation of SpectraCure's system Q-PRO® with integrated image processing technology was performed in November. The treatment was performed at Memorial Sloan Kettering Cancer Center (MSKCC) in New York. The procedure went according to plan, and the system met the highly set expectations. Dr. James […]
Masoud Khayyami has been appointed as interim CEO of SpectraCure
The board of SpectraCure has decided to appoint Masoud Khayyami as interim CEO in connection with the current CEO Johan Folkunger leaving the company. On January 1, Masoud Khayyami will take over as interim CEO of SpectraCure AB. Masoud will stay in the role until the recruitment process for a new CEO has been completed. […]
SpectraCure signs Letter of Intent with Cheplapharm
SpectraCure aims at becoming the Market Authorization Holder of the photosensitizing drug used together with the Q-PRO system. SpectraCure has now signed a Letter of Intent with German pharma company Cheplapharm to secure global supply of the required active product ingredient (API). SpectraCure has taken the strategic decision to become the Market Authorization Holder of […]
