NORWELL, MASSACHUSETTS, USA, March 11, 2024 /EINPresswire.com/ — NED Medical™ (the “Company” or “NED”), a development stage, Interventional Oncology company, announced the successful completion of major technical and regulatory milestones as part of its development plan.
NED Medical is developing CombiSphere™, the next generation of radiation-emitting microspheres made with proprietary materials and designs that incorporate clinically desirable and novel features in various configurations for the treatment of Hepatocellular Carcinoma (HCC) and a Bioradioembolic™ particle with the ability to co-administer combination therapies locally at the tumor site.
KEY MILESTONES ACHIEVED
“The impetus behind CombiSphere stems from a general discontent with the lack of advancements in the selective internal radiation therapy space over the past 30+ years.” — Andrew Thoreson, MD
Product Development
– The Company is announcing data to show total gamma impurities, post-reactor activation, of 5 microcurie (uCi) per 50mg of one of its proprietary material compositions. These results are well below accepted levels and validate NED Medical’s material chemistry, manufacturing processes, and supply chain.
– The Company is announcing the successful manufacturing of microspheres incorporating key design features using its second proprietary material. This specific material represents a potential leap forward in embolic technology as it allows the delivery of elevated levels of radiation payloads while achieving a similar density profile as red blood cell.
– The Company is also announcing the completion of its preliminary benchtop evaluation of one of its drug-delivery polymers for the Bioradioembolic™ application. The results demonstrated a meaningful amount of drug uptake and delivery.
Regulatory
– Lastly, the Company has completed its first pre-submission with the FDA for the CombiSphere™ HCC indication and received confirmation on the regulatory pathway along with specific feedback on other topics that the Company plans to fully incorporate into its regulatory strategy. The Company’s regulatory team will now focus on engaging the FDA on the Bioradioembolic™ indication.
“I am excited to share with our investors and the broader community these major technical achievements,” said Richard Yazbeck, NED Medical’s Chief Executive Officer. “Our team, including our R&D and manufacturing partners, have been hard at work leveraging our decades of combined experience to develop the CombiSphere™ technology, with the goal to give clinicians and patients improved options in their fight against some of the most difficult diseases to treat.”
“The impetus behind CombiSphere stems from a general discontent with the lack of advancements in the selective internal radiation therapy space over the past 30+ years. I am energized by the progress that the NED Medical team has made in such a short period of time and the results continue to align with our mission to introduce meaningful innovation to embolization therapies,” said Andrew Thoreson, MD, NED Medical’s co-founder, Chief Medical Officer and board-certified Interventional Radiologist.
ABOUT NED MEDICAL
NED Medical is a development stage, life science company developing CombiSphere™, a proprietary technology that addresses many of the shortcomings of existing embolization monotherapies and is poised to transform Interventional Oncology embolization procedures from palliative to curative-intent treatments. The initial target market is liver cancer, the 3rd leading cause of global cancer deaths and one of only four cancers that have shown no improvements in death rates in the United States per the latest Annual Report to the Nation from the NIH. Liver cancer is often detected at later stages of disease progression when it is more difficult to treat.
Richard Yazbeck
NED Medical, Inc.
[email protected]
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