Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"BT BeaMedical Technologies (“BeaMed”), a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals (OTC: IPIX) (the “Company”) that it has received U.S. Food and Drug Administration (FDA) clearance (K222701) for its MANTA surgical laser family."

They got a substantial equivalence determination.
What is a "clearance"? Is a substantial equivalence determination the same thing as a "clearance"?

"A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements."

It sounds as if the 90 day point was reached in February. Do you think that they have sold any Manta lasers since then or is that not even BeaMed's intent? Will this IPIX investment go without revenue until "The next approval (is) for the fiber optic delivery system and integration with MRI imaging" is achieved and those things can be manufactured and incorporated into a system with the me-too Manta?
"My guess is that approval could come within months."
And your guess as to when the first sale might occur?
Did Shina get a piece of BeaMed for their help with "immediate access to decades of experience and knowledge regarding design and implementation of high end medical imaging platforms" and "acceleration of our development timeline to get through FDA clearance and market launch quickly"?
The terms of the BeaMed/Shina deal haven't been provided (despite the IPIX public company ownership) but as the saying goes "You don't get something for nothing". IPIX investors should be asking that question given that BeaMed is being hailed as the Company's savior.

The "clearance" of Manta was very much a non-event, wasn't it? The laser with which it was deemed substantially equivalent received the same clearance in 2010.

https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222701.pdf
https://fda.report/PMN/K100558