Icecure Medical (NASDAQ: ICCM) stock is up 54%. ICCM stock rose on the back of an encouraging test report out of Spain. One way of reading this is that the cryotherapy treatment does in fact work in certain early stage breast cancers. But this testing also needs to be taken with a pinch of salt, as it doesn’t, particularly, meet the problems the FDA has identified with the testing process.
This is a certain problem with the base idea here of course. For it’s not possible to do double blind testing with a physical intervention. Therefore data collection and statistical inference are more difficult. Not impossible, but more difficult. There’s also a slight problem in that the intended treatment rather straddles two different things.
As to what’s done at Icecure: “IceCure Medical Ltd, a commercial stage medical device company, engages in the research, development, and commercialization of medical devices for cryoablation (freezing) of tumors in the human body. It offers ProSense system, a single probe system for the treatment of breast tumors; and IceSense3 system for ablation indications to urology, oncology, dermatology, gynecology, general surgery, thoracic surgery, and proctology.”
Icecure Medical stock price from Google Finance
If it’s simply a new surgical technique then that’s something that is picked up surgeon by surgeon. If it’s a new machine or drug then it needs the FDA. But if you can’t do double blind tests then the FDA might be difficult to convince. Which is exactly what has happened: “"We, along with our regulatory consultants, believe the FDA's response to the De Novo Classification request is largely due to the FDA's need for additional scientific literature as a comparator rate of recurrence in patients treated with lumpectomy.” As you can’t do double blinds then the new treatment has to be compared to the survival rates of those treated in some other manner. Which is what the FDA is insisting upon. That’s what caused the halving of the ICCM stock price a couple of weeks back.
And now there’s the new result: “All patients were diagnosed with biopsy-proven early breast cancer (cT1-2cN0-1cM0) with a median tumor size of 24 mm, ranging between 6 to 45 mm. Patients were followed by mammography and ultrasound every 6 months for 2 years and annually thereafter. The median follow-up was 10 months, with a range of 0 to 40 months. Cancer progression was observed in 1 patient (1/31, 3.2%). No major complications were seen and the procedure was well tolerated by all patients.” OK, that’s good. But as the FDA is insisting upon asking - how good is it compared to the lumpectomy alternative?
Until that’s known and proven we’ll not have stability in the Icecure medical stock price.
