Innovation Pharmaceuticals Announces New Milestone at BeaMed; On Track to File 510(k) Submission to FDA in Q2 2024
Innovation Pharmaceuticals provides update on BeaMed's StingRay Laser System development
Positive
BeaMed ready to submit fiber optics for FDA clearance for its novel laser System
BeaMed's family of laser technologies already cleared by FDA
System aims to enable precise energy delivery while protecting vital functional areas
Testing underway for MRI compatibility with Siemens and GE equipment
Excitement generated among Key Opinion Leaders in neurosurgery field
System expected to be submitted for FDA approval in Q2 2024
08/28/2023 - 08:00 AM
WAKEFIELD, MA, Aug. 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire
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.”
About BeaMed
BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay System are also supported by a special prestigious grant from the BIRD Foundation (https://www.birdf.com/ 43% CAGR on its way to more than 1500 global installations and performing 70,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser based medical device spin-off out of the Massachusetts Institute of Technology (MIT).
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future product development plans, including with respect to specific indications; statements regarding the therapeutic potential and capabilities of the StingRay System; future regulatory developments; and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals in the United States and other jurisdictions, including without limitation that compounds and devices may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company’s filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company’s ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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