frenchbroad
2 days ago
Q2 2024 is over and the middle of 2024 is here.
This is super correct.
Three months for last USA FDA approval on the BeaMed system: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232769
BeaMed has distributors and will be ready to sell with approval day. They maybe allready sell some system contingent for approval.
For sales in USA they have ForTec:
"BeaMed has in place a U.S. distribution partnership with ForTec Medical, a mobilizer of surgical laser technology with access to over 2,200 hospitals in the U.S. This means BeaMed is in the enviable position for an immediate market launch upon FDA clearance, which we are optimistic is attainable in 2024."
https://www.ipharminc.com/press-release/2023/2/23/innovation-pharmaceuticals-visits-beamed-new-stingray-laser-system-for-epilepsy-and-brain-tumors-moving-toward-fda-submission
For other sales they have Shina:
“This agreement provides us with two key strategic advantages,” said Gil Shapira, Chief Executive Officer of BeaMed. “The first is immediate access to decades of experience and knowledge regarding design and implementation of high end medical imaging platforms including MRI access, 3D image processing and visualization, and superlative usability. The second is acceleration of our development timeline to get through FDA clearance and market launch quickly. This path underscores the execution-focused strategy of BeaMed to successfully bring its innovation to the market efficiently and expeditiously.”
https://www.ipharminc.com/press-release/2023/1/9/innovation-pharmaceuticals-announces-bt-beamedical-technologies-and-shina-systems-ltd-enter-into-a-definitive-strategic-development-agreement
I expect a Ipix wake up and filing and re-trading before November.
While Ipix sleeps the Brilacidin research and potential value goes on and on. It is a remarkable new drug.
loanranger
3 days ago
From the last press release on the IPIX website...issued on August 28, 2023.
BeaMed is on track to submit, in Q2 2024, the System for potential FDA approval via the 510(k) regulatory pathway. BeaMed’s other shareholders are the controlling shareholders of neoLaser, now the industry leader in their class of lasers in some European and Asian markets.
“The market need for new laser-based surgical technologies is significant. We fully expect BeaMed to capitalize on this opportunity as it positions itself for FDA submission by the middle of 2024,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.
Q2 2024 is over and the middle of 2024 is here.
MackG
5 days ago
A BeaMed/IPIX scenario I read that makes sense:
A Payor Analysis began in May of 2022 regarding the use of Brilacidin in treating oral mucositis.
On June 15,2022 Leo announced the investment in Squalus/BeaMed.
On July 22 or so Leo announced the results of the Payor Analysis in a PR and the results were very good. We haven’t heard a word since then about OM. Why?
It is unlikely that this investment/reverse merger deal with BeaMed wasn’t just about the $4,000,000 and IPIX 35% cut, but the value of OM going forward and how much that could be worth to the merged company.
Leo proved the value of Brilacidin for OM to BeaMed, and a deal was signed. IPIX will go it alone with OM using BeaMed money or the SP will be high enough after the merger or the 510 FDA approval (which ever comes 1st) to invoke the Aspire deal or they do another financial deal. Considering the war in Israel, progress may have been slower than had been anticipated.
frenchbroad
6 days ago
New report on Brilacidin anti-fungus capacity and potential. The Brilacidin work continues in Brazil and the world. The contributor list is impressive.
https://journals.asm.org/doi/10.1128/mbio.01031-24
"The global incidence of cryptococcal meningitis is estimated at more than 400,000 new cases annually, with 181,100 annual deaths (13, 14). This number corresponds to approximately 19% of AIDS-related deaths globally (14, 15). Despite the significant impact of these infections, treatment options for cryptococcosis remain limited (16, 17). In vivo experiments show BRI significantly reduces C. neoformans survival inside macrophages and partially clears C. neoformans lung infection in an immunocompetent murine model of invasive pulmonary cryptococcosis. We also observed that BRI interacts with caspofungin (CAS) and amphotericin (AmB), potentiating their mechanism of action against C. neoformans. BRI + CAS affects endocytic movement, calcineurin, and mitogen-activated protein kinases. Our results indicate that BRI is a novel antifungal drug against cryptococcosis."
TheHound
2 weeks ago
IPIX is dead.
Leo’s last words….
“On August 29, 2023, the trial for this case commenced, and on January 18, 2024, the Court ruled in favor of Cummings, finding that Cummings is entitled to recover liquidated damages in the amount of $810,251.36, minus the Company’s $77,600 security deposit, plus eighteen percent per annum interest owing since January 17, 2020.”