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Posted On: 08/28/2023 9:06:22 AM
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Innovation Pharmaceuticals Announces New Milestone at BeaMed; On Track to File 510(k) Submission to FDA in Q2 2024
WAKEFIELD, MA / August 28, 2023 Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company and minority stakeholder in BT BeaMed Technologies (“BeaMed”), is pleased to provide shareholders with an update on recent progress in the development of BeaMed’s groundbreaking StingRay Laser System (the “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 (KOLs) 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.
“The market need for new laser-based surgical technologies is significant. We fully expect BeaMed to capitalize on this opportunity as it positions itself for FDA submission by the middle of 2024,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.
“BeaMed remains steadfast in its commitment to help patients suffering from current gaps in care,” said Gil Shapira, Co-Founder of BeaMed. “Our goal with the StingRay system is to commercialize a novel technology to treat previous inoperable cases of epilepsy and improve outcomes in other surgical-based oncology procedures. It’s exciting to think that in approximately one year this may be a reality.”
WAKEFIELD, MA / August 28, 2023 Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company and minority stakeholder in BT BeaMed Technologies (“BeaMed”), is pleased to provide shareholders with an update on recent progress in the development of BeaMed’s groundbreaking StingRay Laser System (the “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 (KOLs) 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.
“The market need for new laser-based surgical technologies is significant. We fully expect BeaMed to capitalize on this opportunity as it positions itself for FDA submission by the middle of 2024,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.
“BeaMed remains steadfast in its commitment to help patients suffering from current gaps in care,” said Gil Shapira, Co-Founder of BeaMed. “Our goal with the StingRay system is to commercialize a novel technology to treat previous inoperable cases of epilepsy and improve outcomes in other surgical-based oncology procedures. It’s exciting to think that in approximately one year this may be a reality.”
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