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TrivarX Limited (‘the Company’) (ASX: TRI) is pleased to announce positive top-line results from the Company’s recently completed Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study utilising its proprietary AI-backed algorithm, MEB-001. MEB-001 uses EEG and ECG signals recorded during sleep to identify current Major Depressive Episode (cMDE).
Highlights:
- Analysis of 400 patients in Phase 2 SAMDE study for current Major Depressive Episode (cMDE) study utilising MEB-001
- MEB-001 is TrivarX’s proprietary AI-driven algorithm which can assist with the effective screening of a cMDE
- MEB-001 performance results from Phase 2 SAMDE study reported high performance, marking a significant achievement in the Company:
- Sensitivity: 87% (95% CI 73-95%)
- Specificity: 72% (95% CI 66-77%)
- Positive Predictive Value: 35% (95% CI 27-45%)
- Negative Predictive Value: 97% (95% CI 93-99%)
- Results provide strong validation of MEB-001’s ability to assist in the screening and diagnosis of a cMDE – a condition which is commonly misdiagnosed
- There is currently no screening undertaken for cMDE in sleep centres in the US or globally, representing a major commercial opportunity for TrivarX
- Results advance TRI’s aim to become the first depression screening tool used in clinical practice in sleep centres
There is a well-established connection between mental health conditions, such as depression, and sleep disturbances. People with insomnia may have a tenfold higher risk of developing cMDE and among people with depression, 75% of sufferers have trouble falling or staying asleepi. Furthermore, misdiagnosis of major depressive disorder is estimated at upwards of 65% in the USii. Despite this, depression screening is not routinely included in sleep studies, even though up to 21% of people undergoing a sleep study have depressioniii.
Positive results from SAMDE study highlight MEB-001’s significant potential:
The objective of the study (ClinicalTrials.gov ID NCT05708222) was to use MEB-001 to detect the likelihood of a cMDE using Clinician Reporting Outcomes (CRO) assessment in individuals referred to a sleep clinic. A total of 400 patients were recruited across 15 sleep centres in the US. Out of these, 73 patients were excluded due to incomplete data or a split night/titration sleep study. MEB-001 also automatically identified 32 patients with significant anomalies in their sleep data. Notably, the MEB-001 algorithm was locked prior to the analysis ensuring no data from Phase 2 was used in its training.
Analysis of the results showed that MEB-001 reported promising performance across key parameters including sensitivity of 87% (95% CI 73-96%), specificity of 72% (95% CI 66-77%), positive predictive value (PPV) of 35% (95% CI 27-45%) and negative predictive value (NPV) of 97% (95% CI 93-99%) (refer table below).
These results provide considerable validation of MEB-001 and its ability in the screening and diagnosis of a current Major Depressive Episode (cMDE) in test subjects.
Management commentary:
Non-executive Chairman, David Trimboli said: “We are very excited to share the results from our Phase2 study, which highlight the effectiveness of MEB-001 in screening for cMDE. This is underscored by the significant increase in sensitivity coming from recent improvements to the underlying algorithm, which was increased from 71% in Phase 1, to 87% in Phase 2 – demonstrating that the algorithm can successfully identify more people with cMDE. Our very high NPV validates MEB-001’s potential as a screening test, with the likelihood of having depression when testing negative to be less than 3%.
“There is currently no screening undertaken for cMDE in sleep centres in the US or globally. Our most recent results reaffirm the potential of MEB-001 to become the first depression screening tool used in clinical practice in sleep centres and marks a significant achievement in the Company’s history.”
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This article includes content from TrivarX, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
HITIQ Announces Exclusive Global Agreement with Shock Doctor for PROTEQT Instrumented Mouthguard
- Global Breakthrough: In a world-first exclusive, HITIQ secures an exclusive global agreement with Shock Doctor, the #1 global mouthguard brand, to provide a self-fit “boil and bite” mouthguard design incorporating PROTEQT instrumented technology revolutionizing the ease of use of cutting edge PROTEQT concussion management technology.
- Unmatched Partnership: Shock Doctor’s world-class mouthguard design expertise unites with HITIQ’s advanced sensor technology to deliver a game-changing safety solution. This agreement enables HITIQ to scale PROTEQT’s commercialisation globally, with plans to manufacture 20,000 units in 2025 and 100,000 units in 2026.
- Ready for Athletes: The co-branded mouthguard with the PROTEQT system, now in production, rolls out to community sports through partnerships with VAFA, AFL Barwon, and Westfield Sports High, with more to come.
Shock Doctor: The Ultimate Mouthguard Partner
Shock Doctor is the only company with the expertise, infrastructure and scale to provide a self-fit mouthguard that can integrate HITIQ technology thus enabling reliable worldwide distribution. The co- branded PROTEQT mouthguard, featuring HITIQ’s PROTEQT logo and Shock Doctor’s “SHOCK” branding, integrates advanced impact sensors into a high-performance design, setting a new global standard for athlete safety.
Left image: The PROTEQT HITIQ/SHOCK co branded instrumented mouthguard. Right image: Market ready PROTEQT concussion management system
PROTEQT: Redefining Safety, PROTEQT’s concussion management system detects head impacts, assesses risks, and guides recovery with precision, backed by a 7-day telehealth service using the Sports Concussion Assessment Tool (SCAT). Built on HITIQ’s proven Nexus iMG technology, validated by elite partners like the AFL and NRL, PROTEQT is ready to protect community athletes worldwide. Strategic partnerships with VAFA (HITIQ’s Official Concussion Technology Partner), AFL Barwon, and Westfield Sports High ensure rapid adoption, with more collaborations in development.
Global Impact, Unmatched Scale Shock Doctor’s design and production partner prowess enable PROTEQT’s rapid production at affordable price points, with production trials confirming a robust supply chain. This exclusive global agreement, built on World Rugby’s approval and a U.S. patent for HITIQ’s Nexus technology, positions PROTEQT as a global leader in athlete safety.
Leadership Vision
Earl Eddings, Executive Chair, HITIQ: “This world-first global agreement with Shock Doctor, the global mouthguard leader, is a defining moment. PROTEQT, now market-ready, combines our cutting-edge technology with their mouthguard excellence to transform concussion management worldwide.”
Jay Turkbas, SVP Product Development: Shock Doctor, Inc. It was a welcome challenge developing and producing the physical structure to house HITIQ’s sensor technology. Paired with Shock Doctor’s world-class design and development expertise we are proud of this groundbreaking mouthguard solution allowing HITIQ to provide PROTEQT technology that can redefine athlete safety globally.”
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This article includes content from HITIQ Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here
Binding Commitments Received for A$1.0 Million under Convertible Note Placement
HIGHLIGHTS
- NGS has secured commitments of A$1.0 million under a placement of convertible notes.
- Under the placement, 1,000,000 convertible notes will be issued at A$1.00 each, with the conversion of the convertible notes into ordinary shares in NGS at a price of between A$0.03 and A$0.025 per ordinary share to occur within 10 business days of NGS shareholders approving their conversion including for the purposes of ASX Listing Rule 7.1.
- Each investor who is issued with ordinary shares on conversion of the convertible notes will be issued with one option for each fully paid ordinary share that is issued on conversion of the convertible notes, with that issuance of options to take place on the same date as the ordinary share issuance date. This is expected to be within 10 business days of NGS shareholders approving that issuance of options including for the purposes of ASX Listing Rule 7.1. These options will be exercisable on a 1:1 basis into fully paid ordinary shares in NGS at an exercise price of $0.04 per option, and will expire 3 years following their issue date if they have not been exercised during that 3 year period.
- The placement of convertible notes was supported by Australian sophisticated and professional investors.
- Funds raised from the placement of convertible notes will be used to purchase inventory for retail expansion in CVS and Wakefern, as well as working capital and corporate expenses.
The offer of the Placement CNs was made to sophisticated and professional investors in Australia and successfully closed, achieving binding commitments of A$1.0 million.
Stephen Turner, NGS CEO and Managing Director, commented on the CN Placement:
“We are very pleased with the strong support shown by investors in this placement, which provides important growth capital to support our retail expansion into leading U.S. retailers, including CVS and Wakefern. We would like to thank our shareholders for their ongoing support as we execute our growth strategy and build on the momentum from our recent distribution achievements.”
The conversion of the convertible notes into fully paid ordinary shares in NGS will take place at a price of between A$0.03 and A$0.025 per ordinary share within 10 business days of NGS shareholders approving their conversion including for the purposes of ASX Listing Rule 7.1. NGS expects to convene a general meeting of its shareholders to consider whether to approve the conversion of the convertible notes into fully paid ordinary shares in NGS and whether to approve the issuance of options within the next few weeks.
Until the convertible notes are converted into ordinary shares or redeemed, they bear interest which is payable quarterly in arrear at either 10% per annum (if the holder of the convertible notes elects not to receive ordinary shares in NGS in lieu of cash interest), or 15% per annum (if the holder of the convertible notes elects to receive ordinary shares in NGS in lieu of cash interest). Issuance of ordinary shares in NGS in lieu of cash interest is subject to NGS being in compliance with the ASX Listing Rules. If the convertible notes have not been converted by the date that is 2 years after their issue date, they will be redeemed by NGS at their issue price.
Each investor who is issued with ordinary shares on conversion of the convertible notes will be issued with one option for each fully paid ordinary share that is issued on conversion of the convertible notes, with that issuance of options to take place on the same date as the ordinary share issuance date. This is expected to be within 10 business days of NGS shareholders approving that issuance of options including for the purposes of ASX Listing Rule 7.1. These options will be exercisable on a 1:1 basis into fully paid ordinary shares in NGS at an exercise price of $0.04 per option, and will expire 3 years following their issue date if they have not been exercised during that 3 year period (the CN Holder Options). Quotation of the CN Holder Options on the ASX will be sought.
USE OF PROCEEDS
The net proceeds from the issue of the convertible notes are planned to be used in the following areas:
LEAD MANAGER OPTIONS
The Company engaged GBA Capital Pty Ltd (AFSL 544680) to act as lead manager for the CN Placement (Lead Manager).
Under the terms of the mandate with the Lead Manager, the Lead Manager will be issued with 30% of the number of CN Holder Options (the Lead Manager Options). The Lead Manager Options will be exercisable on a 1:1 basis into fully paid ordinary shares in NGS at an exercise price of $0.04 per Lead Manager Option. The Lead Manager Options will expire 3 years following their issue date if they have not been exercised during that 3 year period.
The Lead Manager Options will be issued within 10 business days of NGS shareholders approving that issuance including for the purposes of ASX Listing Rule 7.1. NGS expects the Lead Manager Options to be issued at the same time as the issuance of the CN Holder Options. Quotation of the Lead Manager Options on the ASX will be sought.
Click here for the full ASX Release
This article includes content from Nutritional Growth Solutions Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.