A nice excerpt from earnings call transcript! It’s a good read!
$Icecure Medical(ICCM.US$ Last month, we submitted the full and final data set to the FDA and requested marketing authorization for ProSense for the indication of treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. We are in continued discussions with the FDA as they review our file.
Since the U.S. is one of our largest market in the world, if the FDA cleared ProSense for marketing, we believe delivering alternative surgery-free options to women in the U.S. This will have a significant impact on treating patients with breast cancer. We believe that this will also lead to a substantial growth in product sales, especially as we intend to continue to work on more reimbursement coverage and our commercial team in the U.S. is ready for rollout.
We see a demand building ahead of a potential approval in the U.S. At the American Society of Breast Surgeons' annual meeting, a lot of positive talks and interest were created following two data presentations centered around breast cryoablation. We had many surgeons come to our booth to learn more, and we continue to engage with them as they consider incorporating cryoablation into their practice.
Further validation, the finding of our ICE3 data and the progress in the U.S., recent independent study in Italy and Japan published similar results. The Italian study found 100% tumor reduction in early-stage breast cancer at the six to 12 months following cryoablation. In Japan, where our distributor Terumo, plans to file the regulatory approval of ProSense for the breast cancer in the second half of 2024, a study reported zero local recurrence following treatment with ProSense.
Since the U.S. is one of our largest market in the world, if the FDA cleared ProSense for marketing, we believe delivering alternative surgery-free options to women in the U.S. This will have a significant impact on treating patients with breast cancer. We believe that this will also lead to a substantial growth in product sales, especially as we intend to continue to work on more reimbursement coverage and our commercial team in the U.S. is ready for rollout.
We see a demand building ahead of a potential approval in the U.S. At the American Society of Breast Surgeons' annual meeting, a lot of positive talks and interest were created following two data presentations centered around breast cryoablation. We had many surgeons come to our booth to learn more, and we continue to engage with them as they consider incorporating cryoablation into their practice.
Further validation, the finding of our ICE3 data and the progress in the U.S., recent independent study in Italy and Japan published similar results. The Italian study found 100% tumor reduction in early-stage breast cancer at the six to 12 months following cryoablation. In Japan, where our distributor Terumo, plans to file the regulatory approval of ProSense for the breast cancer in the second half of 2024, a study reported zero local recurrence following treatment with ProSense.
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Jaguar8 : This is the stock when its study showed 100% tumor reduction didn’t gain traction compared to just a pre-clinical trial on obesity and it soared. I wish they will solve their obesity and won’t get afflicted with cancer
Trytosaveabit OP Jaguar8 : Yup! I knew without a doubt you would remember that day a couple months ago quite well! So much so, I knew you would be my first comment! This has the chance to not just help but save countless lives of women a year
Jaguar8 Trytosaveabit OP : Agreed!
Mod Tanyatorn : Read their pipline and Er , looks to be decently poise for big profits in future after FDA Marketing approval and ER. Whats your take?
Trytosaveabit OP Mod Tanyatorn : I have to agree with your assessment 100%! I have actually been scaling in a bit at a time to accumulate for the marketing approval! They get that approval? With the sales team they have built over the last 6 months or so to prepare for it is impressive!
T-24Century : $Vocodia Holdings (VHAI.US)$
T-24Century : I hope is a big pum
after few months being really low
Trytosaveabit OP T-24Century : As do I? I actually think that if they get the marketing approval? That will be a major step towards getting that pump! NFA
T-24Century : let's
how it goes
Trytosaveabit OP T-24Century : Right