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October 29, 2023
Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to provide the market with an update on activities in the September 2023 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.
Highlights
- U.S.patent granted for key novel ovarian cancer biomarker supporting CLEO's commercialisation pathway into its primary U.S. target market
- Early progress delivered against development program with the selection of biomarkers panel for Cleo’s ovarian cancer test-kit finalised
- Antibody development advanced increasing confidence for commercial assay development and upscaling for commercial manufacturing
- Evaluation of four commercial antibody manufacturing partners progressed in late stage as part of a robust tender process
- Board capacity enhanced with Chief Scientific Officer and Executive Director, Dr Andrew Stephens, expanding responsibilities to full-time
- A$10.73M cash at bank at 30 September 2023
U.S. PATENT
The granted Patent (U.S. Patent No: US 11,725,048, "CXCL10 Binding Proteins and Compositions Thereof”) covers CLEO proprietary biomarkers and antibody formulations, which comprise the core technology of the Company’s ovarian cancer diagnostic blood test. This Patent family is directed towards C-X-C motif chemokine ligand 10 (CXCL10) binding proteins and methods of diagnosing a condition, such as a malignancy, comprising determining a level of CXCL10 in a subject. Determination of the level of CXCL10 may also be utilised to monitor tumour burden, malignancy progression or likelihood of tumour recurrence in a subject.
The U.S. Patent expands the Company’s Intellectual Property (IP) portfolio, adding to the patent granted in Australia earlier this year (patent number 2020404453). Additional patent applications are currently pending in Europe, China, India, Japan, Korea, Israel, New Zealand and Singapore.
U.S. MARKET OPPORTUNITY
The U.S. is the largest diagnostic market in the world, and represents the Company’s primary target market for its potentially lifesaving simple diagnostic blood test. Ovarian cancer survival rates are much lower than other cancers that affect women, largely due to the fact that existing testing is insufficient to identify early stage cancers or differentiate from benign disease. Diagnosis is only made following radical surgery to remove the ovaries. The 5 year survival rate for ovarian cancer is 49%, compared to 92% for breast cancer1 where early detection screening exists.
A significant unmet clinical need exists and CLEO plans to bring to market a suite of ovarian cancer diagnostic blood tests based on the novel patented CXCL10 biomarker, which is expressed early and at high levels by ovarian cancers, but not in non-malignant disease. The tests aim to distinguish benign from malignant growths in a standard format that will be readily compatible with existing equipment used by pathology laboratories worldwide.
The U.S. Patent complements CLEO’s regulatory approval strategy designed to access target markets and secure a path to reimbursement approvals in the future. The Company is also currently preparing for the submission of a 510(k) U.S. Food and Drug Administration (FDA) application.
CLEO is initially targeting the delivery of its blood test for the surgical triage market, however has a staged execution strategy that de-risks a pathway to all ovarian cancer diagnostic markets:
- Surgical Triage Distinguishes benign from malignant disease to allow appropriate design of treatment before surgical intervention is considered;
- Recurrence Identifies relapse for earlier intervention to control/manage disease progression
- High Risk Screening Testing women with known BRCA status or extensive family history; and
- Early Stage Screening Systematic national screening to identify early stage ovarian cancers in patients without symptoms, to allow medical intervention before cancer spreads.
Early detection is vital. When ovarian cancers are diagnosed at stage 1, patients have over a 90% 5 year survival rate. However, this rate reduces rapidly to <40% if diagnosed once the cancer has spread beyond the ovaries.
TEST-KIT BIOMARKERS PANEL FINALISED
Cleo has finalised the selection of biomarkers to be used in its ovarian cancer test-kit, along with completing the development for a prototype of the proprietary scoring algorithm. The performance metrics of the test were evaluated in a clinical study of 334 patients, the results of which are being prepared for publication in a peer-reviewed medical journal. The Company expects the publication outcome to be reported to the market by the end of CY2023. The data cannot be released prior to publication due to the nature of the peer-review process. Concurrently, Cleo is also preparing a further patent application based on the findings.
Click here for the full ASX Release
This article includes content from CLEO Diagnostics, 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.
COV:AU
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13 March
BlinkLab Completes First Patient Test for US Autism Diagnostic Study
Digital healthcare company BlinkLab (ASX:BB1) has tested the first patient in its US autism diagnostic study, which is geared at validating the company's Dx1 test as a diagnostic aid for clinicians.
BlinkLab states in its Wednesday (March 12) release that the study is the largest digital diagnostic trial for autism in the US, with its aim being to support the early detection of developmental conditions like autism.
The first patient test took place at PriMED Clinical Research in Dayton, Ohio. PriMED, a division of PriMED Physicians, is one of two clinical sites selected for the study’s initial phase, which is targeting 100 patients.
"Launching our US trial marks a very special and important moment for BlinkLab. Our mission has always been to connect fundamental neuroscience with clinical practice through accessible technology, thereby enhancing autism diagnostic evaluations and enabling early intervention for children,” said CEO and Co-founder Dr. Henk-Jan Boele.
According to BlinkLab, the American Academy of Pediatrics advises that all children be screened for autism at 18 to 24 months. This is to refrain from delays in diagnosis, as many children miss critical windows for early intervention.
Dx1’s goal is to address these delays by helping healthcare providers deliver faster and more reliable assessments. The smartphone-based platform uses artificial intelligence to measure sensory sensitivity.
“After extensive app and portal development, stimulus refinement, and testing in hundreds of children, we are very confident in our (Food and Drug Administration) study's potential," Boele added.
Results from the targeted 100 participant study are scheduled for release in the third quarter of 2025. The trial will proceed to the main study thereafter, which aims to test 750 to 900 children.
BlinkLab’s submission for FDA 510(k) clearance is anticipated in 2026.
In 2023, privately held EarliTec Diagnostics came up with a similar innovation for autism detection. The company's creation focuses more on social-visual engagement, evaluating a child’s looking behaviour.
Currently, BlinkLab is the only ASX-listed company focusing on providing autism detection services or applications.
Don’t forget to follow us @INN_Australia for real-time news updates!
Securities Disclosure: I, Gabrielle de la Cruz, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: BlinkLab is a client of the Investing News Network. This article is not paid-for content.
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25 February
HeraMED Signs Strategic Collaboration Agreement with Garmin Health
HeraMED Limited (ASX: HMD), a medical data and technology company leading the digital transformation of maternity care, is delighted to announce it has entered into a collaboration agreement with Garmin (NYSE: GRMN), a leading global provider of smartwatches and GPS-enabled products, aimed at enhancing remote pregnancy monitoring and expanding the range of health data available to expectant mothers and their healthcare providers.
- HeraMED has executed a collaboration agreement with Garmin;
- Agreement enables integration of Garmin smartwatch data through the Garmin Health API into HeraMED’s clinical grade remote monitoring pregnancy platform, HeraCARE;
- Expansion of the range of health data available to expectant mothers and their healthcare providers;
- HeraMED and Garmin will jointly collaborate on marketing efforts to promote their integrated solutions;
- Collaboration includes exploration of women's health research opportunities
Driven by Garmin Health, a leading provider of digital health solutions that leverage the data and insights of the Garmin product ecosystem, the collaboration will focus on data integration, joint marketing initiatives and exploration of women’s health research. Using the Garmin Health API, pregnant women who consent to sharing their health and fitness activity data through the Garmin Health API can wear Garmin smartwatches and have their health data collected and integrated into the HeraCARE platform, including:
- Expanded health metrics including heart rate, sleep patterns, and fitness activity levels
- Improved continuous monitoring capabilities for pregnant women
- Enhanced data quality and quantity for more informed decision-making
The collaboration will allow HeraCARE users to seamlessly connect their Garmin devices, providing a more comprehensive view of maternal health. This integration is expected to significantly augment the platform's existing capabilities, which include fetal and maternal heart rate monitoring, blood pressure tracking, and mood assessment. This collaboration will have an initial 3-year term with either group having the ability to withdraw by providing 3 months notice.
HeraMED Managing Director and CEO, Anoushka Gungadin, commented: “This is an incredibly exciting collaboration for HeraMED. Garmin is a globally recognised brand that has developed a specific smartwatch technology strategy for women. It is a significant step forward in our mission to revolutionise maternity care. By incorporating Garmin's high-quality sensor data into HeraCARE, we're expanding and enhancing our ability to provide continuous, real-time health insights to expectant mothers and their healthcare providers.
We are delighted to bring health and wellness data into our clinical grade platform for the purpose of transforming the model of care for maternity. The additional data points will contribute to HeraMED’s ‘data- as-an-asset’ approach with the possibility to monitor activities such as steps for pregnant mothers with hypertensive or diabetic conditions or sleep quality for our mental health care plans will only enrich the capability of HeraCARE.”
Garmin Health Senior Director of Global B2B Sales Joern Watzke said: “We are excited to collaborate with HeraMED to leverage Garmin smartwatch technology in support of women’s healthcare. This strategic relationship will highlight how Garmin wearable data can extend beyond informing daily healthy habits to supporting pregnancy monitoring by providing healthcare providers with valuable patient insights. By making smartwatch technology and advanced health data available for a variety of applications in the fields of healthcare, insurance and research, we believe Garmin is truly helping change the future of women’s healthcare for the better.”
In addition to the HeraCARE platform integration, HeraMED and Garmin will explore potential research collaborations and data integrations through the Garmin Health API focused on women’s health, including maternity care. This collaboration is dedicated to research and data rather than commercial and it is intended will develop specific research projects to be supported by targeted granting bodies in key target markets.
This collaboration agreement does not involve any direct financial consideration between the companies. However, HMD anticipates the collaboration is beneficial as it will enhance the HeraCARE platform by providing a more holistic view of maternal health by bringing health and wellness data together, and the additional data points will contribute to HMD's ‘data-as-an-asset’ strategy.
Click here for the full ASX Release
This article includes content from HeraMED 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.
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17 February
2 Biggest Medical Device ETFs in 2025
Exchange-traded funds (ETFs) are a popular investment strategy, and generally contain a variety of publicly traded companies under one stock symbol, often with a focus on a specific sector.
Depending on the ETF, investors may be able to track up-and-coming companies, get exposure to top firms or a mix of both. Aside from stocks, some ETFs also track commodities or bonds.
In the healthcare industry, medical device ETFs bring together companies that go to great lengths to develop pharmaceutical-based technology that can improve the lives of patients.
To help investors make decisions when it comes to medical device ETFs, here the Investing News Network provides a brief breakdown of what ETFs are and a look at the medical device ETFs you can invest in.
What is an exchange-traded fund?
Exchange-traded funds, or ETFs, hold a basket of equities, often focused on a theme or niche. ETFs are appealing because they give investors the ability to hone in on a specific market area without investing in individual companies. While they are similar to mutual funds, ETFs trade on stock exchanges in the same way stocks do.
Put simply, ETFs reduce the risk of investing by providing access to a larger pool of companies — they let investors pick an area that interests them and suffer less financially if one company under the ETF’s umbrella underperforms. In this way, ETFs allow investors to enter the market confidently and hopefully enjoy long-term capital gains.
Like many areas of the life science space, the medical device sector can be volatile, making ETFs particularly appealing. For example, if a company in a medical device ETF fails a clinical trial or receives negative feedback from the US Food and Drug Administration, ETF investors will largely be protected from any share price drop the stock might have.
On the other hand, if a company in a medical device ETF sees a major gain, that increase will also be muted for ETF investors. That's why some investors prefer to take their chances by adding individual stocks to their portfolios.
Medical device ETFs to consider
Investors keen on medical device ETFs only have three choices, according to ETFdb.com.
Here’s a brief look at the two biggest medical device ETFs available. The third ETF, the First Trust Indxx Medical Devices ETF (BATS:MDEV), is much smaller, with total assets of only US$2.16 million.
1. iShares US Medical Devices ETF (ARCA:IHI)
Total assets: US$5.1 billion
The iShares US Medical Devices ETF was launched in 2006 and tracked 50 holdings as of February 11, 2025. This iShares ETF has more than US$5.1 billion in assets under management and its top three constituents by weight are:
- Abbott Laboratories (NYSE:ABT): Abbott Laboratories’ medical devices are geared towards vascular disease, diabetes and vision care.
- Intuitive Surgical (NASDAQ:ISRG): This medical device firm is the maker of the da Vinci surgical and Ion endoluminal systems. These robotic products are designed to improve clinical outcomes for patients through minimally invasive surgery.
- Boston Scientific (NYSE:BSX): Boston Scientific's device portfolio is extensive. Its areas of focus include gastroenterology, cardiac and vascular surgery, neurological and orthopedic surgeries, and urology.
2. SPDR S&P Health Care Equipment ETF (ARCA:XHE)
Total assets: US$208.99 million
Formed on January 26, 2011, the SPDR S&P Health Care Equipment ETF tracked 66 holdings as of February 11, 2025. This SPDR ETF has more than US$208 million in assets under management and some of its top holdings are:
- Inari Medical (NASDAQ:NARI): Headquartered in California, Inari Medical developed the first mechanical thrombectomy system to receive FDA 510(k) clearance for the treatment of pulmonary embolism.
- AtriCure (NASDAQ:ATRC): Another venous-focused medical device company, AtriCure developed the first medical device to receive FDA approval for the treatment of persistent atrial fibrillation.
- iRhythm Technologies (NASDAQ:IRTC): Medical device firm iRhythym Technologies combines wearable biosensors and cloud-based data analytics with its proprietary algorithms to produce clinical actionable information.
This is an updated version of an article originally published by the Investing News Network in 2016.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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23 January
Cyclopharm Signs US Agreement with HCA Healthcare for Technegas®
Cyclopharm Limited (ASX: CYC) is pleased to announce the signing of a major contract with Hospital Corporation of America Healthcare (HCA), one of the largest single healthcare providers in the United States. This agreement marks a significant milestone for the company which will allow the deployment of Technegas® in up to 169 nuclear medicine departments across HCA’s extensive network.1
HCA Healthcare operates one of the most comprehensive hospital networks in the US, encompassing over 180 hospitals and approximately 2,400 sites of care in 20 states.
The national contract covering the deployment of Technegas in nuclear medicine departments across the entire HCA network was instigated by HCA after multiple of its sites entered into independent discussions with Cyclopharm regarding Technegas. This prompted HCA head office to initiate the creation of a broad-based contract which will bypass the need for individual site contract negotiations and most efficiently streamline the deployment of Technegas technology.
The agreement further underscores the commercial demand for Technegas which is already the preferred agent of choice in 65 countries outside the US for diagnosing lung conditions, including pulmonary embolism, hypertension, chronic obstructive pulmonary disease (COPD), and other respiratory diseases.
Cyclopharm CEO James McBrayer said, “We are thrilled to partner with HCA Healthcare, a leader in delivering quality care to millions of patients annually. This 3-year agreement will allow for the accelerated availability of Technegas across the US and reinforces our commitment to improving outcomes for patients with respiratory conditions.”
As well as streamlining implentation across up to 169 HCA nuclear medicine departments, today’s agreement opens discussions with the HealthTrust Purchasing Group (HealthTrust)2, HCA’s affiliated group purchasing organisation (GPO) that serves as the contracting and purchasing arm to a further network of over 1,800 hospitals in the USA.
Cyclopharm will now engage directly with individual HCA locations, clinical leaders and Divisional Directors to implement Technegas, prioritising those sites which had already entered preliminary discussions with Cyclopharm.
Technegas has been recognized globally for its ability to provide precise and reliable functional lung imaging. With this contract, HCA facilities will be at the forefront of adopting advanced nuclear medicine technology, ensuring better diagnostic and therapeutic options for their patients.
Mr. McBrayer concluded, “This agreement not only extends the footprint of Technegas in the US market but also sets the stage for its broader adoption within HealthTrust’s extensive network. We are proud to support HCA in its mission to provide exceptional care and are eager to see the positive impact of our technology on patients and clinicians alike.”
Click here for the full ASX Release
This article includes content from Cyclopharm 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.
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23 January
CONNEQT App Launches in USA as Pulse Deliveries Commence
16 January
Revolutionizing Women's Health: Antifungal Innovation Brings New Investment Opportunities
The intersection of women's health and antifungal innovation represents a pivotal moment in healthcare, offering both transformative medical advancements and compelling investment opportunities.
The groundbreaking developments in antifungal treatments specifically targeting women's health issues present a substantial market potential, resulting in rising investor interest in this rapidly evolving sector.
Despite comprising half the global population, women face unique health challenges that have historically received insufficient attention and investment. Among these health challenges, vaginal candidiasis stands out as a persistent and widespread issue affecting millions of women worldwide.
Recent statistics paint a stark picture of the prevalence and burden of these infections. Approximately 75 percent of women experience vulvovaginal candidiasis (VVC) — commonly known as vaginal yeast infection — at some point in their lives, with the annual global prevalence reaching a staggering 134 million cases. The impact is particularly pronounced in developing countries, where the associated morbidity leads to increased healthcare costs and a significant compromise in quality of life for affected women.
The economic ramifications of recurrent VVC are substantial, encompassing both direct costs such as medical visits and medications, and indirect costs related to lost productivity. A study published in the Lancet estimates that in high-income countries, the economic burden attributed to RVVC could reach approximately US$14.39 billion annually. With nearly 500 million women worldwide impacted by VVC, including both initial and recurrent cases, the need for innovative solutions has never been more pressing.
The antifungal market: Gaps and opportunities
Despite the clear need, the current antifungal market faces significant challenges. The limited number of available drug classes — only three primary classes — restricts treatment options and increases the risk of drug resistance.
This situation is exacerbated by rising resistance rates among common fungal genera like Candida and Aspergillus, coupled with a lack of new antifungal classes in development.
The complexity of diagnosing fungal infections often leads to treatment delays, contributing to inappropriate drug use and further increasing the risk of resistance. Moreover, the emergence of drug-resistant fungal species from environmental sources poses additional challenges within clinical settings, underscoring the urgent need for innovative approaches in antifungal therapy development and resistance management.
Advancements in antifungal treatments
Amidst these challenges, recent research has highlighted significant advancements in antifungal treatments specifically addressing women's health concerns. The development of oral oteseconazole, for instance, has shown promising efficacy in clinical trials for recurrent vulvovaginal candidiasis, indicating a potential shift towards more effective management strategies.
Innovative approaches combining antifungal treatments with probiotics aim to restore the natural flora of the vaginal microbiome, offering a holistic solution to improve outcomes for women experiencing recurrent infections. Furthermore, research into new antifungal targets specific to fungal pathogens affecting women has surged, potentially leading to the development of therapies with fewer side effects and improved efficacy against resistant strains.
Zero Candida: Pioneering innovation in women's health
The femtech market, projected to reach nearly $117.37 billion by 2029, represents a golden opportunity for innovative solutions in women's healthcare. At the forefront of antifungal innovation is Zero Candida Technologies (TSXV:ZCT), a company poised to transform the landscape of women's health. Zero Candida is pioneering a SMART diagnostic and therapeutic device designed to provide a chemical-free treatment for candidiasis, aiming to reduce side effects commonly associated with traditional antifungal treatment.
Zero Candida’s groundbreaking approach to treating fungal infections is centred on its innovative device that treats infections without side effects. This aligns perfectly with the growing demand for non-chemical treatments to women's health issues, addressing a critical gap in the current market.
The company's innovative use of AI and blue light technology shines a new light on women's health. In a pre-clinical study, Zero Candida reported an impressive 99.99 percent success rate in treating Candida infections, a significant breakthrough considering that these infections affect 75 percent of women worldwide at some point in their lives.
Market potential and investor interest
The market for women's health and antifungal therapeutics is on a trajectory of significant growth. As of 2023, the global antifungal drugs market was valued at approximately US$15.8 billion, with projections indicating a compound annual growth rate (CAGR) of 3.8 percent from 2024 to 2030. Concurrently, the global women's health therapeutics market is expected to expand to US$61.6 billion by 2032, growing at a CAGR of 4.05 percent from 2024 to 2032.
This growth is driven by increasing awareness of women's health issues, particularly in areas such as reproductive health and menopause-related therapies. The untapped potential in this sector is attracting significant investor interest, with women's health companies reportedly drawing 25 percent of the overall funding market in recent years.
Zero Candida's position at the intersection of antifungal innovation and women's health places it squarely in one of the most dynamic and promising areas of healthcare investment. By addressing the unmet needs in women's health with cutting-edge technology and a focus on non-chemical treatments, Zero Candida is not just participating in the market — it's helping to shape its future.
Investor takeaway
As investor interest grows and market projections continue to climb, the stage is set for a new era in women's health. The potential impact extends far beyond the bottom line, promising improved quality of life for women globally, and a significant reduction in the economic and social burdens associated with these prevalent conditions.
It's clear that the transformative impact of antifungal innovation on women's health is not just a possibility — it's an unfolding reality with profound implications for healthcare, investment and most importantly, the wellbeing of women around the world.
This INNSpired article is sponsored by Zero Candida (TSXV:ZCT). This INNSpired article provides information which was sourced by the Investing News Network (INN) and approved by Zero Candida in order to help investors learn more about the company. Zero Candida is a client of INN. The company’s campaign fees pay for INN to create and update this INNSpired article.
This INNSpired article was written according to INN editorial standards to educate investors.
INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.
The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Zero Candida and seek advice from a qualified investment advisor.
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