Cleo commences FDA process
Cleo Diagnostics (ASX:COV) has announced significant progress in advancing its regulatory strategy for its pre-surgical triage test designed to detect ovarian cancer.
Recently, Cleo conducted an initial pre-submission meeting with the US FDA.
During this meeting, Cleo presented its comprehensive submission framework and outlined its clinical plan for the ovarian cancer detection blood test.
The interaction with the FDA was highly constructive, Cleo said, with the regulator providing positive feedback on Cleo’s approach.
This feedback not only validates Cleo’s strategy but also enhances confidence in its clinical trial designs aligning with FDA expectations.
Cleo believes such early engagements are pivotal in shaping its pathway towards gaining regulatory approval in the US, particularly through the 510(k) application pathway aimed at achieving “substantial equivalence” to existing predicate devices.
Cleo has also successfully obtained Institutional Review Board (IRB) approvals in both the US and Australia, which are essential for ensuring compliance of clinical trials.
With these approvals in place, Cleo is now moving forward with formalising trial site contracts and preparing for patient recruitment.
The international arm of the clinical trial will be overseen by Lindus Health, a respected Contract Research Organization (CRO) based in the US.
Cleo says it is now strategically placed to potentially expedite the timeline towards FDA application submission.
Imricor expands into Hungary
Imricor Medical Systems (ASX: IMR) continues to expand its global footprint with a milestone in Hungary.
Semmelweis University in Budapest has chosen Imricor to supply and install its iCMR electrophysiology system, becoming the first hospital in Hungary to adopt this technology for MRI-guided ablation procedures.
The procurement included Imricor’s Advantage-MR EP Recorder/Stimulator and complementary capital devices like the Osypka HAT-500 RF Ablation Generator, and NordicNeuroLab in-room monitors.
Additionally, the purchase covers consumables essential for the initial 15 procedures.
The hospital anticipates commencing procedures in early Q4 under the guidance of Imricor’s specialised medical team.
“The tender process is sometimes required at new sites, but we know that only Imricor can bid on an ‘iCMR electrophysiology system’ because we are the only company in the world that makes one,” said Steve Wedan, Chair and CEO of Imricor.
“With the tender process now behind us, we look forward to installing our iCMR lab equipment and commencing procedures with the world-class medical team at Semmelweis.”
Race Oncology confirms RC220 ‘s safety
Meanwhile, Race Oncology (ASX:RAC) reported the successful completion of the Good Laboratory Practice (GLP) toxicology and safety pharmacology studies for RC220 bisantrene, a key formulation designed for peripheral intravenous (IV) infusion in oncology treatment.
Conducted by Attentive Science and Agilex Biolabs, these studies confirmed RC220 bisantrene’s excellent safety profile, essential for progressing to human clinical trials slated for the second half of 2024.
Results showed no unexpected toxicities, with all observed effects reversible after a recovery period.
Importantly, RC220 bisantrene exhibited no adverse reactions at infusion sites, distinguishing it from previous formulations requiring central line administration.
These findings are pivotal as Race Oncology prepares to advance RC220 bisantrene into Phase 1 clinical trials in multiple countries, including an Investigational New Drug (IND) application with the US FDA in 2025.
“Receiving clear confirmation of the safety of RC220 bisantrene in these studies and identifying a suitable starting dose for our upcoming trial is another major milestone in bringing our new drug product to cancer patients,” said Race Chief Executive Officer, Dr Daniel Tillett.
At Stockhead we tell it like it is. While Race Oncology and Imricor Medical Systems are Stockhead advertisers, they did not sponsor this article.
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