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
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
Click here to connect with Cloud DX (TSXV:CDX) (OTC:CDXFF) to receive an Investor Presentation
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) (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.
News Provided by ACCESSWIRE via QuoteMedia
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.
News Provided by ACCESSWIRE via QuoteMedia
Continued growth in US RPM as partner Maxwell Telecare signs two additional clinics in Illinois
News in Summary
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.
News Provided by ACCESSWIRE via QuoteMedia
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 (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.
News Provided by ACCESSWIRE via QuoteMedia
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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StickIt Technologies Inc.(the" Company "or "StickIt") (CSE: STKT), an Israeli Canadian technology company, announces a ground-breaking new development of a medical straw for delivering vitamins to children and adults and start the research in 2025 once fund raising will be completed.
Stickit Technologies has developed a straw plus cartridge for delivering vitamins and/or medications for children and/or adults who have difficulty swallowing pills or for children who regularly miss medications and/or vitamins. The company, which filed a patent for a straw plus cartridge for transporting cannabinoids and/or medications, decided to develop a model of a medical straw for transporting vitamins and medications for children and adults.
The company intends to raise 1.5 million Canadian dollars for the new medical straw project during Q1 and Q2 2025. StickIt Technologies will establish a new subsidiary named "Stickit Pharma Ltd". and will be owned by the public company and the new investors who will join.
The company intends to seek partnerships with generic pharmaceutical companies globally that are interested in being part of the research and submission for FDA approval.
"This is a significant breakthrough for our company and the investors." says Eli Ben Haroosh, CEO of StickIt Technologies Inc. "We are looking for every opportunity to develop our technology and lead the global market. I believe that if we will raise the necessary fund and also succeed in raising partnerships with generic pharmaceutical companies, making Stickit a pharma leader very soon." concluded Ben Haroosh.
About StickIt Technologies Inc
StickIt is a technology company that invented and manufactures innovative products ("devices") that can contain varying quantities of Catabolites or Vitamins for recreational and medical users. Its operating model is to establish joint ventures/licensees ("partners") in countries around the world that will establish a production facility in which they will add the cannabinoid content to the "sticks" and "straws" produced and supplied by StickIt. The Company's precise dosing options cater to a wide range of effects, including painkilling, energizing, focus, sleep improvement, etc., and can be tailored to meet local preferences and regulations. StickIt Technologies serves customers worldwide.
For more information, please contact:
StickIt Technologies Inc.
Eli Ben Haroosh, CEO
E: info@stickit-labs.com
Sophie Galper , CFO
E: sophie@stickit-labs.com
Website: www.stickit-labs.com
Facebook: @Stickit
Twitter "X": @STICKIT74776509
LinkedIn: @Stickit-labs
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward-Looking Statements
This news release includes certain statements and information that constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, are forward-looking statements. The Company provides no assurance that forward-looking statements and information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements or information. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company does not undertake to update any forward-looking statements, other than as required by law. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by StickIt Technologies Inc. Readers are cautioned not to place undue reliance on forward-looking statements.
Invion Limited (ASX: IVX) (“Invion” or the “Company”) is pleased to announce the dosing of the first patient in its Phase I/II non- melanoma skin cancer (NMSC) trial conducted at Veracity Clinical Research (Veracity) in Brisbane.
Highlights:
The trial marks a significant milestone for Invion and is designed to evaluate the safety and efficacy of its lead drug candidate INV043, a novel photosensitiser developed in Australia for use in Photodynamic Therapy (PDT) for the treatment of multiple cancers.
Trial Design and Objectives
This open-label, adaptive trial provides flexibility to go beyond the testing and collection of human safety data of the topical formulation of INV043.
The initial part of the study aims to assess the safety profile of the topically applied INV043 in non-metastatic cutaneous Squamous Cell Carcinoma (cSCC). Subsequent parts aim to address dose optimisation (dose-light interval and light intensity) and the identification of efficacy signals. Part 3 will expand testing to include superficial Basal Cell Carcinoma (sBCC)
The adaptive design allows for modifications to the trial procedures based on interim results, enhancing the efficiency and effectiveness of the study. As such, the trial will enrol a minimum of 18 patients, which can be increased depending on the results.
Veracity will select male and female patients over the age of 18 with non-metastatic cSCC and sBCC, although other NMSCs may be approved on a case-by-case basis. Other screening criteria include size and location of the lesion.
Significance of NMSC
Skin cancer is one of the world’s most common cancers and NMSC makes up over 98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322. The prevalence of the disease highlights the urgent need for effective and affordable treatments with minimal side effects.
Currently, the mainstream treatment for SCC and BCC is surgery, which can lead to permanent scarring. Preclinical studies undertaken at the Hudson Institute of Medical Research showed the potential for INV043 to regress cancers without scarring and with minimal pain.
Next Steps
The NMSC trial follows the release of promising results from a Phase II prostate cancer trial using the same active pharmaceutical ingredient, INV043. Once the trial results have been analysed, in addition to progressing the NMSC program, Invion plans to leverage this data into a planned Phase II anogenital cancer trial using topical INV043, and potentially including the use of immune checkpoint inhibitors (ICIs) on the back of solid in vivo data from the Peter MacCallum Cancer Centre.
This study showed 80% complete pathological control of anal squamous skin cancers versus a 12% response rate on ICI treatments on a standalone basis.
The Executive Chair and Chief Executive Officer of Invion, Thian Chew, said:
“Having the first patient dosed in our NMSC trial is a significant milestone for Invion in demonstrating the potential for the Photosoft technology to address limitations and undesirable side effects of current standard of care for NMSCs, including scarring and pain.”
“On the back of the recently announced prostate cancer results, this trial can also provide clinical evidence that INV043 can be safely used in more than one formulation to treat multiple cancers. This can then open up the potential for our next-generation PDT to become an important alternative modality for treating cancers.”
The NMSC trial will be conducted under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) and ISO 14155 standards.
Click here for the full ASX Release
This article includes content from Invion 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.
Resonance Health Ltd (ASX: RHT) (Resonance or the Company) advises that it has been contracted by Sun Pharmaceutical Industries Limited, an international, publicly listed pharmaceutical company with global operations (Customer) to be the local Australian sponsor, and to provide clinical research organisation (CRO) services, trial site services, and imaging analysis services (collectively, Services), for their clinical trial in Australia of a new drug compound (Clinical Trial).
New Clinical Trial
The newly executed clinical trial agreement (Agreement) is worth an estimated AUD $13.775 million in revenue to the Resonance group over the next ~24 months, with the first payment of AUD $2.066 million due within 30 days of Agreement execution. Resonance, through its wholly owned subsidiary, CRO Services Pty Ltd (CRO Services), will serve as CRO and Local (Australian) Sponsor for the Customer and will engage and make payment to the institutions, trial sites, and the vendors needed to conduct the Clinical Trial.
Whilst the Company will receive the first payment within 30 days of Agreement execution, provision of the Services under the Agreement (and the remaining payments) are subject to (among other things) receipt of regulatory approvals to commence the Clinical Trial including human research ethics committee approval (Regulatory Approvals).
Resonance will provide its imaging analysis services at various timepoints throughout the Clinical Trial along with clinical trial site services through its recently acquired TrialsWest business. It is notable that trial sites are among the largest vendors for clinical trials of this nature, so a benefit of the TrialsWest acquisition is that a significant portion of the revenues payable to trial sites will now stay within the Resonance group.
The Company expects patient recruitment for the Clinical Trial could commence in early 2025, subject to receipt of Regulatory Approvals, with both TrialsWest sites expected to play a key role in the recruitment of subjects and the conduct of the Clinical Trial.
This contract win highlights Resonance’s strategy of providing its technology and services to the burgeoning and highly technical global pharma and clinical trials markets.
The material commercial terms of the Agreement are set out at Annex A.
Resonance Health CEO, Mr Andrew Harrison commented:
“The Agreement is a direct result of the incredible work the team have done in executing the existing clinical trial with the customer and more broadly the Company’s focus on winning more work in the global clinical trials ecosystem. This illustrates our ability to win repeat work from customers, and our capacity to scale the size of contract wins.”
This announcement has been authorised for release in accordance with the delegated authority of the Board of Directors of Resonance Health Ltd.
Click here for the full ASX Release
This article includes content from Resonance Health Ltd, 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.
Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to announce progress on its ISLA-101 Phase 2a/b clinical trial in dengue fever.
Following the announcement (ASX: 3 October 2024) that all subjects in the Phase 2a cohort of the trial had been dosed, Island confirms it has now collected the required samples to analyse how the viremia (viral load) levels in the blood of trial subjects have changed through the study. Other samples are being analysed for pharmacokinetic data as well as other blood analyses.
This data is currently being consolidated for review by the Safety Review Committee (SRC), who will meet in the coming weeks. The SRC will evaluate the safety of ISLA-101 in dengue infected individuals and consider if there is evidence of anti-dengue activity. They will then make a recommendation regarding advancing the trial to the Phase 2b cohort before the end of the calendar year.
Island’s CEO and Managing Director, Dr David Foster commented, “We are very pleased to be able to report that 46 days into the trial, we’ve collected the key data required for evaluation by the Safety Review Committee. From here, while we will continue to check in with patients up to 90 days post dosing, we look forward to providing all the data to the SRC for evaluation in the coming weeks. Importantly, this means we remain on track to report data before the end of the year from our Phase 2a component, and next steps for the Phase 2b cohort before the end of the year.”
Phase 2b will include 10 subjects randomised 8:2 (active: placebo) and will examine if ISLA-101 has activity as a treatment against dengue infection. This is the first time a potential countermeasure to combat the dengue virus, which afflicts more than 400 million individuals a year and for which there is no therapeutic option, is being investigated as both a preventative and therapeutic measure.
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Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to report the interim data analysis from the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial). The trial is investigating the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the standard-of-care chemotherapy regimen of gemcitabine and Abraxane®. Data cut-off for the interim analysis is 27 September 2024.
HIGHLIGHTS
As previously reported by the Company, narmafotinib continues to be generally well tolerated by patients with no dose reductions. In addition, six (6) patients recorded confirmed partial responses (PRs), meaning in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained for two or more months.
Further details regarding the responses observed by trial participants are summarised below and presented in the attached slides:
A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs obtained, recruitment of the remaining 24 patients has begun. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025 and three patients have already been enrolled as of 24 October 2024.
Amplia CEO and MD Dr Chris Burns commented: “We continue to be excited by the data coming from the clinical study of narmafotinib in this challenging disease. We thank the patients and their loved ones for their involvement in the study. Further trial updates will be provided to the market in due course."
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This article includes content from Amplia Therapeutics, 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.
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