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Developing the Clinic of the Future, Cloud DX work to be supported by Sheridan College through federal grant
News in Summary
Cloud DX (TSXV:CDX) (OTC:CDXFF), a leading Virtual Care platform, announces the issuance of a new patent for its upcoming Pulsewave 2.0 Vital Sign Monitor. The wrist-worn device stands to be the first at home clinical-grade vital signs monitor to capture diagnostic-quality blood pressure, heart rate, heartbeat irregularities, and respiration status simultaneously. This is the second patent for the Pulsewave 2.0 platform and this award arrives during the company's record-breaking quarter.
US patent 11,272,859 entitled ‘System and Method of Determining Respiratory Status From Oscillometric Data', strengthens the protection of Cloud DX's innovative and novel methods used to determine respiratory status. Building upon the device's initial US patent 11,006,843,which depicts the concept of using oscillometric data to determine respiration rate. This patent protects the methods developed to analyze data in determining respiratory status, beyond just respiratory rate. The company congratulates inventors Vesal Badee, Sara Ross-Howe, Josh Haid, Lamiaa Amzil, Cezar Morun, and Bonghun Shin, all members of the Research and Development team at Cloud DX.
Lead inventor and Cloud DX Biomedical Data Scientist, Vesal Badaee, states "There are plenty of digital health wearables in the market. Most, however, are limited in the quality of data they provide. This can frustrate doctors and healthcare professionals when users want to rely on them. In medicine, clinical-grade vitals are required for diagnostics or medical direction; Cloud DX is driving the transition in bringing clinical-grade wearables into the consumer space, from hospitals and clinics to our homes. This second patent on our next-generation Pulsewave underlines the innovation we're producing at Cloud DX. The team and I are proud to be a part of this Virtual Care transition."
"With the Medical Metaverse and the Virtual Care movements growing the need for home-based diagnostics grows ever more prominent," added Robert Kaul, CEO and Founder of Cloud DX. He continued, "Together these technologies create an all-encompassing model of care improves access to healthcare and can expedite accurate clinician decision making. The ability to accurately capture patient vitals anywhere in the world, even in most remote locations, and transfer that data directly to their doctor or care team means primary care teams can make better clinical decisions, potentially remove the need for an in-person doctor visit, or even circumvent an emergent care visit. To put it simply, the connected ecosystem means better patient outcomes, closer circles of care, and more economical for providers and payers."
How Pulsewave 2.0 breathing rate technology works
- Cloud DX's Pulsewave vital signs monitor is worn on a patient's wrist, and oscillometric pulse waveforms are obtained as the cuff deflates, obtaining pulse wave signals and artifact signals over multiple patient breaths.
- Pulsewave software analyzes these signals producing an envelope of pulse waveforms as well as a frequency modulated sequence of pulses at various time intervals containing breathing rate data.
- Pulsewave 2.0 operates autonomously but can also be connected to the internet. When connected, clinicians receiving the data can derive additional biological metrics via the Cloud Diagnostics® online platform.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
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Cloud DX partners with Sheridan College on Medical Metaverse Research and Development
- Funding awarded for mobile and machine learning healthcare innovation projects
- Supports commercialization of patented Cloud DX technology for the Medical Metaverse
- Research partnership between Sheridan's CMI and Cloud DX's eXtended Reality division, Cloud XR
Cloud DX (TSXV:CDX) (OTCQB:CDXFF), leading Virtual Care platform provider, will partner with Sheridan College (the grant recipient) on a project with Cloud XR, the company's eXtended Reality division, to further develop the Clinic of the Future, an augmented reality (AR) platform. This is made possible through the support of a Natural Sciences and Engineering Research Council (NSERC) Applied Research and Technology Partnership (ARTP) non-dilutive funding grant. As a key industry partner, Cloud DX will work with Sheridan College who will conduct a portfolio of applied research projects in Mobile Health and Health and Machine Learning
Cloud XR's Clinic of the Future demonstrates how its patented Vitaliti™ continuous monitoring device displays real-time patient information in the form of 3-D holographic images. The Clinic of the Future is the Medical Metaverse in action, a fully remote, touchless, seamless method enabling healthcare professionals to interact with patients.
Dr. Sonny Kohli, Chief Medical Officer and Co-Founder at Cloud DX states: "Improving healthcare is important to everyone, we all use it throughout our lives, and advancement in healthcare and medicine is only possible through innovation. Working with partners such as Sheridan's Center for Mobile Innovation is essential to push the industry into the future. At Cloud DX working with leaders such Dr. Edward Sykes helps bring our inventions to life and supports our commercialization of new healthcare devices, such as our patented Vitaliti™. This NSERC funding not only recognizes Canadian technology leadership like our partnership, more importantly it advances the MedTech industry - one where virtual and remote care, AI, and Augmented Reality are embedded throughout; the Medical Metaverse. Think about it, a leading specialist can now examine a patient on the other side of the world, its limitless. The Medical Metaverse will improve access to healthcare, create more efficiencies, lead to better patient outcomes, and much more."
About the Sheridan Centre for Mobile Innovation
The Sheridan Centre for Mobile Innovation (CMI) creates innovative solutions to industry-relevant challenges, in close collaboration with industry, community, and academic partners. CMI uses leading technologies in its research including: mobile, Artificial Intelligent/Machine Learning/Deep Learning, wearable computing, augmented/virtual reality/mixed reality and Internet of Things. Please visit: cmi.sheridancollege.ca. For more information on research and innovation at Sheridan, please visit research.sheridancollege.ca.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and was named a "New Innovator 2022" by Canadian Business magazine. Cloud DX is an exclusive virtual care partner to Medtronic Canada and Equitable Life.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
# # #
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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Cloud DX Signs Contract with Paramedical Service Provider for Remote Patient Monitoring
Cloud DX chosen as Virtual Care Platform for the Ontario Paramedical Service provider, replacing existing hardware and services
Cloud DX (TSXV:CDX)(OTCQX:CDXFF) is pleased to announce a new 24-month contract with an Ontario Paramedic Service Provider enabling the client to provide Remote Patient Monitoring (RPM) across its serviceable area. Cloud DX will provide its award-winning Connected Health™ platform and support the client as it transitions from its previous remote care tools to Cloud DX's Virtual Care Platform. The client showcases how beneficial ‘Remote Care Monitoring' is for Paramedical Service providers, enabling providers to establish deeper community roots and maintain funding levels, while community members benefit from greater access to much-needed care. The client has purchased 223 Connected Health™ kits totalling ~$145,000 CAD with additional recurring fees for subscription software services. Funding for the program comes from the $82.5M Community Paramedicine for Long-Term Care program announced by the Ontario government on October 22, 2021
The Paramedical client will provide Cloud DX's biometric monitoring equipment to clients in their homes to monitor vital signs including weight, blood pressure, heart rate, oxygen level, temperature, and blood glucose. Daily monitoring allows the client and health care providers to make informed decisions and enables the Paramedic to connect with the client if a metric is out of range. The paramedical care provider seeks to keep individuals on the long-term care bed waitlist and individuals who are medically complex or isolated comfortable and safe in their homes. In turn, Remote Care Monitoring is expected to reduce 911 calls, emergency room visits, and hospital admissions.
Cloud DX COO and co-founder, Anthony Kaul, states "At-home remote monitoring is critical to improving the health of vulnerable populations, such as community members with chronic conditions or seniors who wish to live independently for as long as possible. By bringing Remote Care Monitoring directly to the community our client is forging a new path in paramedicine. This modern approach improves community health and enables significantly earlier intervention for those with deteriorating health, in turn reducing hospitalizations. Cloud DX is well known for our high user satisfaction ratings, so we are confident this initiative will be well received by the community. Of course, with our Headquarters in Ontario, we're always extremely happy to support our neighbouring communities."
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and was named a "New Innovator 2022" by Canadian Business magazine. Cloud DX is an exclusive virtual care partner to Medtronic Canada and Equitable Life.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Social Links
Twitter https://twitter.com/CloudDX
Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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Cloud DX Signs Two Contracts with US Primary Care Clinics
Continued growth in US RPM as partner Maxwell Telecare signs two additional clinics in Illinois
News in Summary
- These RPM contracts bring the total Maxwell Telecare clinics in 2022 to five
- Addition of these two contracts brings this quarter's total number of contracts to twelve
- Reimbursed RPM programs have the potential to impact 33% of American adults1
Cloud DX (TSXV:CDX) (OTCQB:CDXFF), Cloud DX, a leading Virtual Care platform in North America, and partner Maxwell Telecare announce two additional new contracts with US based Primary Care practices in Illinois. Under the company's Patient First™ program, the clinics will deploy Connected Health™ to control exacerbations, improve quality of life, and avoid hospital admissions, and ER visits. The participating Maxwell clinics will prescribe the kits under US codes for reimbursed Remote Patient Monitoring and Chronic Care Management, paid for by public and private health insurance. This announcement contributes to a record-setting quarter for Cloud DX bringing the total signed contracts this quarter to 12
Rajani Nair, Deployment Manager at Cloud DX, states "Maxwell Telecare understands the value of RPM and how it improves not only a clinic's return on investment but more importantly improves patient care and patient outcomes. As deployments across their network scale, the Maxwell team seamlessly integrates our Connected Health™ kit as part of their patient offerings, reimbursable in the US for RPM or Chronic Care Management. Given their ease of integration, this partnership has transitioned from establishment to scaling. We look forward to continuing to work with them"
Footnotes:
1. Hajat, C., & Stein, E. (2018). The global burden of multiple chronic conditions: A narrative review. Preventive medicine reports, 12, 284-293. https://doi.org/10.1016/j.pmedr.2018.10.008
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner of Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
# # #
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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https://www.accesswire.com/694570/Cloud-DX-Signs-Two-Contracts-with-US-Primary-Care-Clinics
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Cloud DX Signs New Palliative Contract with Ontario Healthcare Team
Cloud DX Signs New Palliative Contract with Ontario Healthcare Team
Healthcare team to use Connected Health™ kits to provide dignity in care for up to 85 patients
News in Summary
- Cloud DX to provide Connected Heath™ kits and supporting software services
- Program will support up to 85 patients in palliative care
- This is the 10th contract this quarter for the Virtual Care platform
Cloud DX (TSXV:CDX)(OTCQB:CDXFF), a leading Virtual Care platform, signs a contract with a healthcare team in Niagara, Ontario, Canada. The team will use Cloud DX's Connected Health™ kits and software services for up to 85 palliative patients. The 12-month contract will commence deployment this month, adding to Cloud DX's successful quarter and recently announced, industry first patent in vital-sign analysis. Connected Health™ has been deployed for palliative patients by other provinces and territories, including Yukon Health and Social Services, since 2019
"While we're known for our post-surgical and chronic care programs, it is refreshing to work with clinics who are passionate about the extended benefits and applications of RPM. This healthcare team understands RPM and recognizes its many use cases," says Head of Operations, Cara MacDonald. "Making healthcare better means encompassing all stages of life, all stages of illness or conditions. We look forward to paving the palliative healthcare delivery pathway with a clinical leader in Ontario."
Palliative Care Management is the third focus area for Cloud DX, building upon its growing Post-Surgical and Chronic Care Management programs. As the digital healthcare sector grows globally, the company continues to work with care providers to pursue new use cases for virtual care and remote patient monitoring while innovating new care pathways alongside industry-leading partners such as Medtronic Canada and Equitable Life.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Social Links
Twitter https://twitter.com/CloudDX
Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
View source version on accesswire.com:
https://www.accesswire.com/694157/Cloud-DX-Signs-New-Palliative-Contract-with-Ontario-Healthcare-Team
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Cloud DX Announces Closing of Private Placement
Cloud DX (TSXV:CDX)(OTCQB:CDXFF), a leading North American provider of virtual care and Remote Patient Monitoring (RPM) solutions, is pleased to announce that it has closed a non-brokered private placement (the "Private Placement") of 260 units (the "Units") of the Corporation at a price of $1,000 per Unit, for gross proceeds of $260,000 (the "Offering"). Each Unit is comprised of (i) a C$1,000 principal amount unsecured convertible debenture (each, a "Debenture") and (ii) 1,430 common share purchase warrants of the Corporation (each, a "Warrant"). The Debentures will mature on January 27, 2025 (the "Maturity Date") and shall bear interest at a simple rate of 10% per annum. The principal amount of the Debentures may be converted at the election of the holder thereof into common shares in the capital of the Company ("Common Shares") at a conversion price of C$0.35 per Common Share (the "Conversion Price") at any time prior to the Maturity Date. Each Warrant entitles the holder thereof to acquire one common share of the Corporation (each, a "Common Share") at a price of C$0.50 per Common Share at any time prior to 4:30 p.m. (Toronto Time) on January 27, 2024
As consideration for services rendered in connection with the Offering, the Corporation paid to certain registered brokers a cash commission in the amount equal to $13,000 (5% of the gross proceeds of the Offering); and (ii) issued to certain registered brokers 37,142 non-transferable common share purchase warrants (the "Broker Warrants"). Each Broker Warrant entitles the holder thereof to acquire one Common Share at an exercise price of $0.35 per Common Share for a period of 24 months from the date of closing of the Private Placement.
The Corporation intends to use the net proceeds from the Offering for sales, marketing, research and development and working capital requirements.
In accordance with applicable Canadian securities laws, all securities issued pursuant to the Offering will be subject to a four (4) month hold period ending July 19, 2022. The Offering remains subject to final approval from the TSX Venture Exchange.
The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any State in which such offer, solicitation or sale would be unlawful.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Social Links
Twitter https://twitter.com/CloudDX
Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
Forward-Looking Information
This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Corporation to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. In particular, this news release includes certain forward-looking statements concerning the Offering, including the use of the net proceeds, as well as management's objectives, strategies, beliefs and intentions.
Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. In making the forward-looking statements in this news release, the Corporation has applied several material assumptions, including without limitation, information concerning the receipt of approval from the TSX Venture Exchange, the use of proceeds and the Corporation's marketing and research and development strategies and the expected benefits thereof.
Although management of the Corporation has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information.
The securities of the Corporation have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") or any U.S. state securities laws and may not be offered or sold in the United States absent registration or an available exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there by any sale of the securities referenced in this press release, in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE:Cloud DX Inc.
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Positive results from Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) Study
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.
Positive Phase 2a Fibromyalgia Results Deliver Pain Reduction in 100% of Patients, Strengthening IP Position and Clinical Trial Strategy
- Phase 2a fibromyalgia trial undertaken with University of Michigan (“UOM’) with results presented at the IASP 2024 World Congress on Pain 9 August 2024 in the Netherlands
- All patients dosed with TRP-8802 (TYP’s oral psilocybin formulation), and administered psychotherapy reported an improvement in fibromyalgia pain severity, sleep, pain interference and at least 3 other endpoints measured one month after dosing
- Fibromyalgia is a condition associated with widespread pain – 1m people in Australiai and ~10m people in the USii suffer from it and there are currently limited treatment options
- Results highlighted that there was a clinically meaningful reduction in pain, pain interference and fatigue
- Patients also reported a number of other improvements including clinically meaningful improvements in quality-of-life measures such as sleep, physical activity, and the ability to participate in daily social activities
- Clinically meaningful reduction in anxiety and improved cognitive abilities were also reported in 4 out of 5 patients dosed
- In addition, one patient reported during follow-up that their sense of smell had returned following a COVID- 19 diagnosis in 2021
- Results highlight the significant potential for psychedelic-assisted therapy as a compelling treatment pathway for fibromyalgia when compared to the inadequacies of incumbent treatments
- Results considerably strengthen Tryp’s IP position and lay a strong foundation for a future trial using TRP- 8803 (IV-infused psilocin) – Phase 2 trial planning now underway and expected to commence H1 2025
- Additional clinical trials progressing well at MGH for patients with IBS, and the beginning of Cohort 3 in the TRP-8803 Healthy Volunteer Study expected to begin soon – updates to be provided in due course
The trial was designed to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with fibromyalgia, a condition associated with widespread pain and comorbidities that significantly impact daily living and patient well-being. The trial was undertaken by the UOM, a top-ranked public university in the US in collaboration with Tryp.
Results highlighted that 100% of patients experienced reductions in fibromyalgia pain, sleep disturbance and pain interference (refer figures one and two below).
Whilst appreciating the limitations of the small number of patients and the open label nature of the ‘signal’ style study, the results are highly encouraging and considerably strengthen TYP’s intellectual property position. Further, the results validate Tryp’s clinical trial approach targeting nociplastic pain with an initial focus on fibromyalgia and will inform an additional clinical study utilising TRP-8803 (IV-infused psilocin), which is expected to commence H1 2025.
Figure one: Individual patient (001-005) and pooled results highlighting improvements in fibromyalgia domains as presented by University of Michigan 9 August 2024 (adapted)
Figure two: Individual patient and pooled results as presented by University of Michigan 9 August 2024 (adapted)
Trial background:
The study was an open-label clinical trial with psychotherapy, seeking to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with fibromyalgia. A total of five patients were recruited and were administered two doses of TRP-8802 in 15mg initial dose and 25mg second dose formats, two weeks apart. Patients were administered psychotherapy in concert with TRP-8802 and results were compared to baseline values one month following the completion of the second dose.
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This article includes content from Tryptamine Therapeutics 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.