The FDA process for approving medical devices can be much less stringent than pharmaceuticals.
BeaMedical Technologies {IPIX' has about a 40% position} has received clearance fro the Manta family of surgical lasers
11/2022
"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. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022."
"he MANTA surgical laser family was cleared by the FDA including five different wavelengths (810nm, 980nm, 1064nm, 1470nm and 1940nm) and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery."
The next approval is for the fiber optic delivery system and integration with MRI imaging.
2/2023
"Having already obtained FDA clearance for the laser component of the StingRay
System, BeaMed expects soon to make additional requisite submissions to the
FDA for clearance of its fiber optics and its software integration package
with Siemens and GE imaging systems."
ttps://www.bloomberg.com/press-releases/2023-02-23/innovation-pharmaceuticals-visits-beamed-new-stingray-laser-system-for-epilepsy-and-brain-tumors-moving-toward-fda-submission
In addition Beamed has signed an agreement with Shina Systems to facilitate development and regulatory approval:
1/2023
"BT BeaMedical Technologies (“BeaMed”), a private company minority-owned by Innovation Pharmaceuticals (OTC: IPIX) (the “Company”) developing a next-generation laser based platform for epilepsy and cancer surgery, has notified the Company that it has entered into a definitive strategic agreement with Shina Systems Ltd. (“Shina”), a company specializing in medical imaging software platforms, in order to build on unique capabilities of Shina and accelerate the development, regulatory clearance, and commercial deployment of BeaMed’s StingRay Laser System for brain surgery."
“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.”
"Shina Systems Ltd. develops and markets clinical image management, PACS and medical imaging analysis application software for almost 3 decades. Shina is recognized for its unique tools and intuitive, clinician-friendly application workflow. Clinically effective and technologically distinguished, Shina’s software is installed in thousands of clinical sites worldwide, including OEM partners from the top 10 global medical imaging and equipment companies."
My guess is that approval could come within months.
GLTA, Farrell
