Innovation Pharmaceuticals Inc (IPIX)

[williamssc]

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:[e-mail]
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.