Been hearing similar stuff on the grapevine. Hope the upswing continues this week, along with substantial news coming soon. I wouldn't bother about the fungus among us. Brilacidin shows promise eradicating fungal infections.
Bump " A successful Squalus 510k could result in our shares appreciating substantially."
I got this from a BIG ipix investor a while ago
Looks like 2 years is almost up!!!!! Tic Toc Tic Toc
Leo Ehrlich From:leo@ipharminc.com To:xxxxxxxxx Thu, Jun 16, 2022 at 11:25 AM Hi xxxx,
The 510k route of the approvals we are seeking should take about 2 to 3 years. Along the way and possibly within 1 year other regulatory approvals may be granted. Because of market conditions and lack of liquidity we were able to acquire this equity position for what we believe is a fraction of the cost had this been available a year ago. A successful Squalus 510k could result in our shares appreciating substantially. Leo
And now we have the following approval on December 6, 2023 - U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 6 . 0 6 Silver Spring, MD 20993 www.fda.gov December 6, 2023 BT BeaMedical Tachnoogies Ltd. (BeaMed) Gil Shapira CEO 7 HaEshel Street Caesarea, 3088900 Israel Re: K232769 Trade/Device Name: BeaMed Laser Surgery Fibers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 10, 2023 Received: September 11, 2023 Dear Gil Shapira: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions.