tiprankstipranks
Innovation Pharmaceuticals says BeaMed on track to file 510(k) submission
The Fly

Innovation Pharmaceuticals says BeaMed on track to file 510(k) submission

Innovation Pharmaceuticals provides shareholders with an update on recent progress in the development of BeaMed’s groundbreaking StingRay Laser System. BeaMed is a pioneering company dedicated to revolutionizing epilepsy and cancer surgery through laser-based innovations. BeaMed informed the Company that it is ready to submit its family of specially designed fiber optics for FDA clearance, a key step in the development of its novel laser System for uses initially targeting the brain. Earlier, BeaMed’s family of laser technologies was cleared by the FDA. The unique System is being developed to enable a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. These features differentiate the BeaMed System from other laser-based surgical technologies. BeaMed is targeting broad therapeutic applications of the System in numerous clinical indications, 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. In related news, BeaMed has initiated System MRI compatibility testing at the Technion-Israel Institute of Technology, and the Rambam Health Care Campus. Integration testing is being conducted with Siemens MRI equipment, with plans to extend the testing to GE MRI equipment – two of the most common MRI device manufacturers worldwide. Additionally, sessions with Key Opinion Leaders in the neurosurgery field generated excitement about the System’s potential to improve treatment of epilepsy and brain cancer. 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.

Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>

See Insiders’ Hot Stocks on TipRanks >>

Trending

Name
Price
Price Change
S&P 500
Dow Jones
Nasdaq 100
Bitcoin

Popular Articles