FDA’S INITIATIVE CAN PROVIDE FASTER MARKET ACCESS FOR SPECTRACURE

29 Oct, 2019

During SpectraCure’s ongoing clinical study, the US FDA (Food and Drug Administration) has created an opening for a faster product launch by changing the requirements for endpoints in clinical trials for cancer treatment. The changed requirements provide new opportunities that may in the long term mean faster market access.

The FDA’s initiative to allow shorter follow-up times and accelerated approval by the authority is supplemented with requirements for reporting follow-up studies after approval. SpectraCure may launch its treatment system as early as 2020/2021 after FDA approval, with the requirement to conduct follow-up studies in parallel provided the results are good at the time.

“It is my hope that SpectraCure’s application for accelerated approval is approved by the FDA. More patients with recurrence of prostate cancer can then be offered our treatment,” says Masoud Khayyami, CEO of SpectraCure.

Great market potential – from $ 2 to $ 63 billion
The market for recurrent prostate cancer is worth approximately $ 2.2 billion at a price for SpectraCure’s treatment of $ 36,000. In two years, the global prostate cancer treatment and prevention market is estimated to be worth approximately $ 63 billion. For example, treating primary prostate cancer means that the potential total market for SpectraCure’s portion will increase from 60,000 relapse patients to 580,000 patients with prostate cancer per year in the United States and Europe. A market worth approximately USD 21 billion.

SpectraCure is already considering expanding its target group and including new indications that complement the existing market.

The company may broaden the target group for the treatment system to include patients with other cancer diagnoses such as primary prostate cancer, pancreatic cancer, liver and head and neck regions. The market potential will then be even greater.

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