Ann: Positive CE Mark Status Report, page-63

It would have been helpful to all SH, and more transparent, if “closed out” could have been better explained, because we’ve seen that term has been used before.
Your earlier point about the tech being at risk of being quickly superseded is valid, though to be superseded you kinda need to have established some sort of market acceptance. A while back the company sent me a couple of papers for the original studies done with the device, published around 2007/8 I think. Assuming no research since then until now with panco, that’s a hell of a period of development inactivity. In that time, radiation techniques (and chemo) have leapt ahead. The new data for high dose mri guided sabr look good - team in US just reported mOS 20 months with > 70Gy to pancreas, with nothing like the tox problems of older radiotherapy. Genesis care in uk just got themselves MRIdian to treat pancreatic. And now ASTRO expert group just put out guidelines for radiotherapy in pancreatic cancer with quite strong endorsement for SABR.

So how will the OSL device be positioned in a market with more established alternative? Without rapid uplift in further data generation, their sales and marketing efforts post CE will have to rely just on panco for a lengthy period, a safety study of modest size where the efficacy issue isn’t really confirmed. Despite what the company puts in its slides to the market about “superior to comparators”, that’s spin and misleading as there’s no evidence at this stage to show device is superior to any meaningful comparator in a controlled study. My take on this is that if I had this cancer and had to make a choice between something like mri guided sabr or osl device, and assuming cost isn’t a consideration, I’d go for the former. Much more practical experience in health systems with external radiation use and greater evidence base- and no evidence osl device offers better outcomes anyway.