FluoGuide develops surgical solutions that are expected to reduce suffering for the patient and increase the likelihood of cure as well as reducing costs for the health care system. The first product is the compound FG001, which lights up the cancer and its invasive growth into the surrounding tissue. Local cancer cells are left behind in approx. 50% of patients undergoing surgery with the intention to completely remove the cancer. Intelligent surgical targeting, in fact, has a potential to help surgeon to reduce costs and time for any kind of surgery. 5% of the gross National Product (GNP) is spent on surgery – over EUR 1,000 billion annually. This is the market FluoGuide enters with intelligent surgical targeting.
What have been the milestones so far in your company development?
– Initiated partnering discussions to understand their interest and integrate their feedback into our development activities.
– Decided on manufacturing partners to do the manufacturing of FG001 to support the first clinical study
Establish the manufacturing process for FG001.
– Develop a formulation for FG001 to support first clinical trials.
– Prepare toxicity testing on FG001.
– Define FG002.
– Upscaled and transfer the synthesis process and the formulation to vendors fulfilling the GMP quality needed to support manufacturing of FG001 for use in the first clinical study
What are your most important markets, segments and customers?
Initially we develop our uPAR target product – FG001 – to guide surgical removal of glioblastoma (aggressive brain cancer). Hence the neurosurgeries become the key stakeholders in short term, in particularly those involved in clinical testing of new technologies and products. Our geographic focus is initially Europe and USA.
Where do you see the company five years from now?
We anticipate our first regulatory approval in 2023/24 assuming we obtain orphan drug designation for guide surgical removal of glioblastoma. An orphan drug designation is granted by a regulatory authority such as e.g. FDA, against developing a product for a rare disease and allow the product to become approve faster by delaying some of the development work.
In five years (2024), FluoGuide is a commercial company which change the company dramatically.
What are your priorities within 2020/21?
– Our key news the next 15 months are:
– Establish a commercial supply chain
– Obtain the result of first regulatory meeting
– Submission of clinical trial application
– Obtain a clinical proof-of-concept in glioblastoma
– Submit additional patent applications and have those pending granted in additional geographies
– Conduct the planned warrant issue (part of the IPO)
– Realize our first compassionate use sales
– Realize a commercial partnership
Why should one consider adding your company into their portfolio?
FluoGuide is an early stage life science company reflected in the market cap, however, FluoGuide targets a huge market and with a very steep curve for value generation due to a low risk approach and a short time to market. There should be at least a few shares of FluoGuide in any life science portfolio.