Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that Thierry Piéton has been appointed Chief Financial Officer for the company, effective March 3, 2025 . He will report to Medtronic Chairman and Chief Executive Officer Geoff Martha and will join the Medtronic Executive Committee. Piéton joins Medtronic from Renault Group, where he has served as Chief Financial Officer since March 2022 . Gary Corona who has been serving as interim CFO, will continue in this role until Piéton joins Medtronic, after which Corona will become Senior Vice President, Corporate Finance and will remain on the Medtronic Executive Committee.
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Peer-Review Further Supports CLEO’s Ovarian Cancer Detection Technology
Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce the publication of further data on its triage test for ovarian cancer.
Highlights
- CLEO’s second peer-reviewed dataset has now been published in medical journal “Diagnostics”
- The study concluded that CLEO’s test:
- Correctly identified most cancer cases that were missed by the standard marker CA125;
- Eliminated the majority of "false positive" results caused by CA125 use; and
- Correctly identified the majority of patients with early-stage ovarian cancers.
- Peer review validates CLEO’s technology and commercial strategy targeting the surgical triage market where accurate and early cancer identification is critical.
A copy of the publication is available here: https://www.mdpi.com/2075-4418/14/7/671
The article concluded:
a) CLEO’s test correctly identified most cancer cases missed by CA125, including a majority of patients with early stage cancers;
b) The test provided superior identification of benign disease to eliminate the majority of "false positive" results obtained using CA125; and
c) The test efficiently discriminated malignant from benign samples.
Commenting on the outcomes published, CLEO Chief Executive, Richard Allman, said:
“These results demonstrate that the CLEO ovarian cancer triage test is far superior to the current standard of care using the CA125 benchmark. Our test will improve the initial clinical investigation process, helping clinicians to triage patients far more effectively than current methods.
The ability to identify early-stage cancers also supports our ultimate goal of an ovarian cancer screening program using CLEO technology.
Our cancer detection technology is supported by a foundation of gold-standard scientific evidence. These publications will underpin regulatory approvals with the Food and Drug Administration (FDA) and will form a crucial part of CLEO’s market entry activities. They provide the required evidence for doctors to prescribe CLEO’s blood test and for reimbursement by health insurers.”
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.
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Cleo Diagnostics
Overview
A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer-reviewed international journal Cancers. The article concluded that Cleo’s ovarian cancer test was highly accurate with 95 percent sensitivity and 95 percent specificity, correctly discriminated malignant from benign samples, and has outperformed and was superior to current clinical methods. The second peer-reviewed dataset has also been published in the medical journal Diagnostics, which concluded that CLEO’s test has correctly identified most cancer cases that were missed by the standard marker CA125. It also eliminated the majority of “false positive” results caused by CA125 use, and it correctly identified the majority of patients with early-stage ovarian cancers.CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to support the commencement of its US market access program. HcFocus will provide specialised and strategic expertise to assist CLEO in navigating the complexities of the US health system and regulatory environment.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Throughout his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and lead medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
Company Highlights
- Backed by medical professionals and cancer specialists with decades of experience, Cleo Diagnostics has developed a disruptive, accurate and early-stage ovarian cancer detection blood test.
- Cleo targets the CXCL10 novel biomarker, which is now known to be overexpressed in all stages of ovarian cancer.
- Cleo is the result of more than a decade of research at the Hudson Institute of Medical Research, where chief scientist Dr. Andrew Stephens received more than $5 million OCRF & NHMRC funding for development and clinical studies.
- The test is also supported by Professor Tom Jobling, founder of the Ovarian Cancer Foundation and Lucinda Nolan, the foundation's former CEO.
- Cleo has developed a staged execution strategy focused on an achievable path to market. This ensures the project, which is currently in its advanced R&D stage, can maximise commercial value for all stakeholders.
Key Projects
Cleo Diagnostics
Developed over a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
Highlights:
- Readily Accessible: Cleo requires no additional or specialised equipment and can be conducted in any standard pathology lab either on its own or as part of a standard panel of tests ordered by a physician.
- AI-based Risk Assessment: Once the sample has been collected and tested, Cleo leverages a proprietary algorithm to perform a risk evaluation on the patient, determining the likelihood of a cancer diagnosis.
- Intuitive Results: Cleo generates an easy-to-understand post-assessment report which can then be sent to the patient's primary care provider or surgeon for triage.
- High Performance: The Cleo prototype outperforms FDA-cleared predicates and clinical guideline tests in terms of accuracy and specificity.
- Current Roadmap: Cleo plans for the test to be ready for clinical use in a surgical triage setting by 2025, where it will be available initially to one million patients. Target launch dates for recurrence, high-risk screening and mass screening are still to be determined. Additionally, the company has numerous inflection points planned over the next two years:
- Kit Development:
- Internal trial antibody optimisation
- Finalisation of antibody selection for the Cleo test-kit
- Complete re-agent development
- Pre-IDE strategic development
- Manufacturing:
- Establishment and accreditation of ISO13485 quality system
- Manufacturing establishment of Cleo key biomarker
- Manufacturing establishment of Cleo Ovarian Cancer Kit
- Clinical Studies:
- Sign key opinion leaders and trial sites
- Perform and finalise verification of the Cleo kit through clinical studies
- Regulatory Approval:
- FDA Pre-IDE submission
- CE regulatory submissions and approval
- TGA regulatory submission and approval
- FDA submission and approval
- Kit Development:
Cleo is bringing to market three testsfor ovarian cancer diagnosis, monitoring and screening.
Management Team
Dr. Richard Allman — Chief Executive Officer and Executive Director
Dr. Richard Allman has over 30 years of scientific research leadership and innovation with a clear focus on commercialisation. He has wide experience in research leadership, innovation management, and intellectual property strategy, covering oncology, diagnostics, and product development.
Previously, Allman was chief scientific officer at Genetic Technologies (ASX:GTG). Recent successes include the strategic design and management of a second-generation breast cancer risk assessment test from concept to commercial launch and a similar test for colorectal cancer. These tests have now been NATA-accredited and comprise the first commercially available polygenic risk tests in Australia.
More recently, Allman supervised the underlying R&D, translation, regulatory approval, patent filing and commercial launch of a COVID-19 disease severity test within 12 months. This strategy has been utilised to expedite a product development pipeline covering six major cancers, cardiovascular disease and type-2 diabetes which were commercially launched in March 2022.
Dr. Andrew Stephens — Chief Scientific Officer and Executive Director
Dr. Andrew Stephens is a career research scientist with 20 years of experience in molecular and cellular biology research. He has broad experience in academic and pre-clinical research and a strong focus on translation and the commercialisation of research findings. He established and leads an independent academic research group at the Hudson Institute of Medical Research, investigating mechanisms that contribute to the formation, progression and dissemination of high-grade, serous epithelial ovarian cancers. Since 2010, his research has focused on biomarker identification and development in ovarian cancer and the development of therapeutic strategies to improve patient outcomes. He is also actively involved across the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has more than 60 academic publications and numerous patents (pending and provisional) in the cancer therapeutic and diagnostic space.
Professor Tom Jobling — Lead Medical Advisor and Non-executive Director
Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical Centre. He graduated from Monash University in 1980 and did his postgraduate sub-specialist training in gynaecologic oncology in London at the Royal Marsden and St Bartholomew's hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and is also founder of the Ovarian Cancer Research Foundation (1999). He was the chairman of the Ovarian Cancer Research Foundation Board. His major interests are in radical surgery for ovarian cancer and the application of robotic surgery for gynaecological malignancy.
Jobling is an active member of a research team in biomarker detection and proteomics in ovarian cancer. He is involved as a collaborative investigator on a number of international clinical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the International Society of Gynaecological Cancer.
Lucinda Nolan — Non-executive Director
Lucinda Nolan is a non-executive director and was most recently the CEO of the Ovarian Cancer Research Foundation. She has a wealth of knowledge and experience across the public sector and not-for-profit environments. Before joining the Ovarian Cancer Research Foundation, she was selected as the first female CEO of the Country Fire Authority, one of the world’s largest volunteer-based emergency services organisations. She also spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan is also the chair of BankVic and a director on the boards of Alkira Box Hill and the Melbourne Archdiocese of Catholic Schools. She has a Master of Arts and a Bachelor of Arts (Honours) from Melbourne University and is an alum of the Advanced Management Programme at Harvard University.
Adrien Wing — Non-executive Chair
Adrien Wing began his professional career practising in the audit and corporate advisory divisions of a chartered accounting firm. He has over 25 years of experience in the corporate sector with a large portion of this experience in ASX small caps, lead in IPO transactions and post listing reverse takeovers and acquisitions across a range of industry sectors and jurisdictions. He also has a strong pedigree in the life sciences industry being the founder of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing currently serves as an officer/director on the following company boards: New Age Exploration (ASX: NAE), director and joint company secretary; Red Sky Energy (ASX:ROG), director and joint company secretary; Sparc Technologies (ASX:SPN), company secretary; and Osmond Resources (ASX:OSM), company secretary.
CLEO Further Expands Ovarian Cancer Trial with Siles Health
The Royal Women's Hospital Joins CLEO Ovarian Cancer Trial
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.
Medtronic appoints Thierry Piéton as Chief Financial Officer
News Provided by PR Newswire via QuoteMedia
Medtronic appoints Thierry Piéton as Chief Financial Officer
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that Thierry Piéton has been appointed Chief Financial Officer for the company, effective March 3, 2025 . He will report to Medtronic Chairman and Chief Executive Officer Geoff Martha and will join the Medtronic Executive Committee. Piéton joins Medtronic from Renault Group, where he has served as Chief Financial Officer since March 2022 . Gary Corona who has been serving as interim CFO, will continue in this role until Piéton joins Medtronic, after which Corona will become Senior Vice President, Corporate Finance and will remain on the Medtronic Executive Committee.
"Thierry is a strategic, creative, operationally focused, experienced CFO with a proven track record of delivering innovation-driven growth, margin improvement, and earnings power through strong financial leadership, which is directly aligned with our financial objectives," said Geoff Martha , Medtronic chairman and chief executive officer. "We are confident he is the right choice at this important time for Medtronic and can't wait to benefit from his expertise and leadership."
Under Piéton's leadership, Renault achieved its highest ever operating margins and improved free cash flow, while also executing portfolio management, including tuck-in acquisitions, divestitures, and funding development through innovative partnerships. This led to significant value creation for its shareholders. Piéton brings experience in both healthcare and other highly regulated, operationally focused manufacturing companies, including Nissan Motor Co. Ltd, General Electric, GE Healthcare and PricewaterhouseCoopers. His career path to CFO demonstrates intentional development through accretive experiences across several industries, geographies, companies, and all facets of a global finance function.
As CFO, Piéton will be responsible for leading the Medtronic global finance organization and key supporting functions, including Treasury, Controller, Tax, Internal Audit, Investor Relations, Corporate Strategy, and Business Development.
"I also want to recognize Gary Corona , who has served as interim CFO. Gary helped us deliver revenue growth and EPS that exceeded expectations in our first and second quarters and has provided strong leadership of our Finance function over the last six months. He will help ensure a smooth and successful transition, and I look forward to continuing to work with him in his new role leading several key Corporate finance functions," said Martha.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .
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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 Candidain order to help investors learn more about the company. Zero Candidais 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.
Top 5 Small-cap Medical Device Stocks (Updated January 2025)
The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device technology. In 2024 alone,30 new devices were approved by the US Food and Drug Administration (FDA).
Wearable medical devices and the use of artificial intelligence in medical technology are two key trends in this sector. Moving forward, BCC Research projects that the global medical device industry will increase from US$810.4 billion in 2024 to US$1.3 trillion by 2029, expanding at a CAGR of 9.8 percent.
Investors who want exposure to this wave of growth may want to consider NASDAQ small-cap medical device stocks. Below, the Investing News Network has compiled a list of the top NASDAQ medical device companies based on yearly gains.
All data was compiled on January 14, 2025, using TradingView’s stock screener, and the medical device makers listed below had market caps between US$50 million and US$500 million at that time.
1. Delcath Systems (NASDAQ:DCTH)
Year-over-year gain: 202.86 percent
Market cap: US$405.43 million
Share price: US$12.69
Delcath Systems is a pharmaceutical and medical device company focused on “interventional oncology,” specifically in the treatment of primary and metastatic liver cancers. Delcath's commercial product portfolio is focused on combining its Hepactic Delivery System (HDS) with the chemotherapeutic drug melphalan for "high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects."
The HDS is approved in the US and Europe under different commercial names and categories. In the US, it is marketed in combination with melphalan as the FDA-approved Hepzato Kit, which is considered a combination drug and device product. In Europe, the HDS is marketed as device-only under the name Chemostat Hepatic Delivery System for Melphalan and is regulated as a Class III medical device.
Delcath Systems’ share price got its first big boost in the second quarter of 2024, rising nearly 45 percent from US$5.56 on May 5 to US$8.04 on May 21, 2024, a period that included the publication of encouraging results from its FOCUS Study in metastatic uveal melanoma patients treated with the Hepzato Kit and its first quarter financials highlighting total revenues of US$3.1 million, up more than 416 percent over the same quarter in the previous year.
A series of positive study results released in late August sent shares in Delcath rising another 37 percent. This included an independent study conducted by the University Hospital of Leipzig, Germany, which shows the efficacy and safety of repeated chemosaturation treatments using Delcath’s Chemostat system for the treatment of patients with primary or secondary liver tumors.
On December 2, Delcath announced that it received FDA clearance for its investigational new Drug application for a Phase 2 clinical trial evaluating Hepzato in combination with standard of care for liver-dominant metastatic colorectal cancer. The clearance gives Delcath the authorization to initiate patient enrollment, which the company expects to begin in the second half of 2025. The news sent Delcath’s stock up to US$12.64 per share.
Shares in Delcath reached their highest yearly peak of US$12.79 on January 13, 2025, after the company shared outstanding preliminary fourth quarter and full-year total revenues of about US$15.1 million and US$37.2 million, respectively.
2. Sensus Healthcare (NASDAQ:SRTS)
Year-over-year gain: 147.76 percent
Market cap: US$108.01 million
Share price: US$6.59
Sensus Healthcare is a medical device company that delivers and develops non-invasive treatments for skin cancer and keloids. The company has developed a patient-centric treatment platform based on its superficial radiotherapy (SRT and IG-SRT) technology.
In early May 2024, Sensus Healthcare posted product sales milestones and robust first quarter financials that gave its share price a nearly 70 percent boost to US$6.42 on May 16. The company announced the sale of the first SRT-100 Vision (IG-SRT) system in Asia, followed by the commercial sale of the SRT-100 to a veterinary specialist in Israel, its first for veterinary use outside the United States. Lastly, Sensus reported Q1 2024 revenues of US$10.7 million, up from US$3.4 million in the prior-year quarter.
Sensus' share price received its next big bump up in November after the company reported its Q3 financials, including revenues of US$8.8 million compared to US$3.9 million in the prior-year quarter. On November 20, the company’s stock reached its highest point of the past year at US$8.94 per share.
3. Pro-Dex (NASDAQ:PDEX)
Year-over-year gain: 118.55 percent
Market cap: US$146.02 million
Share price: US$44.80
Pro-Dex develops and manufactures battery-powered and electrical surgical instruments used in the orthopedic, spine, maxocranial facial and dental markets. Some of its customers include Smith & Nephew, the Lawrence Livermore National Laboratory, Medtronic (NYSE:MDT) and Arthrex.
Shares of Pro-Dex traded relatively sideways for much of the past year, with its biggest gains coming in the last four months. After the company announced its fiscal 2024 fourth quarter and full-year financial results in early September, its stock climbed nearly 42 percent to US$31.34 by October 1. Net sales for its Q4 ended June 30 increased by 41 percent year-over-year to US$15 million, while net sales for the fiscal year grew by 17 percent to US$53.8 million over the prior year.
Pro-Dex saw its stock price rally yet again in November, surging nearly 60 percent to US$49.55 per share on November 12. This latest upward momentum followed the company’s October 31 release of its fiscal 2025 first quarter financials. Net sales for the quarter ended September 30, 2024, increased 25 percent from the same quarter in the previous year to US$14.9 million.
4. AngioDynamics (NASDAQ:ANGO)
Year-over-year gain: 92.18 percent
Market cap: US$477.29 million
Share price: US$11.80
AngioDynamics is a global medical technology company that design, manufacturers and sells high-quality, minimally invasive medical devices. Its focus is on vascular access, surgery, peripheral vascular disease and oncology.
In mid-July, shares of AngioDynamics jumped 25 percent to US$7.51 following the release of its fiscal 2024 fourth quarter and full-year financials.
“Within our Mechanical Thrombectomy segment, we achieved key milestones by receiving both FDA 510(k) clearance and CE Marking for AlphaVac in the treatment of pulmonary embolism,” Jim Clemmer, President and CEO of AngioDynamics, stated. “These indications open up multiple large, fast-growing markets, and helped to drive a more than 68% sequential increase in AlphaVac revenue during the fourth quarter.”
AngioDynamics received FDA 510(k) clearance for its NanoKnife System for prostate tissue ablation on December 9, sparking a 31 percent rally that brought the share price to US$9.33 on December 16.
Shares in AngioDynamics hit their highest yearly peak of US$12.94 on January 8 following the release of the company’s fiscal 2025 second quarter financials. Net sales for the quarter came in at US$73 million, up 9.2 percent compared to the prior-year quarter.
5. KORU Medical Systems (NASDAQ:KRMD)
Year-over-year gain: 85.84 percent
Market cap: US$186.56 million
Share price: US$4.07
KORU Medical Systems develops and manufactures medical devices and supplies in the United States and internationally, with a focus in mechanical infusion products. Its Freedom Syringe Infusion System first received FDA clearance in 1994. Based on this system, its primary products include the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets.
Shares in KORU Medical made their biggest price gains in the last few months of 2024, rising more than 67 percent from the end of October to a yearly peak of US$4.40 per share on December 12.
On October 31, KORU Medical released positive data that it had presented days prior at the Partnership Opportunities in Drug Delivery Conference in Boston, Massachusetts. The data demonstrates nursing preference for use of the KORU FreedomEdge Infusion System over manual syringe administration for subcutaneous oncology infusion.
In mid-November, the company shared its third quarter 2024 financial results, which included net revenues of US$8.2 million, up 17 percent over the prior year period.
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Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
Medtronic announces CMS national coverage analysis for Symplicity Spyral Renal Denervation System
- National coverage analysis is the first-of-its kind for a minimally invasive, interventional treatment for high blood pressure
- Milestone is supported by large public health need and robust, long-term data from the SPYRAL-HTN global clinical program
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic's request to support Medicare beneficiary access to the Symplicity™ Spyral renal denervation (RDN) system, used in the Symplicity blood pressure procedure.
"Hypertension is a global health epidemic that impacts a wide variety of patients," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral. We appreciate CMS' efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy."
CMS' action follows Medtronic's work with the agency to pilot the framework for the Transitional Coverage for Emerging Technologies (TCET) pathway to establish coverage for the Symplicity Spyral renal denervation system, a U.S. FDA-approved breakthrough device. As referenced in the CMS tracking sheet, the expected completion date for the national coverage analysis is October 11, 2025 . Until a national coverage determination is put into effect, Symplicity blood pressure procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients.
About the Symplicity Spyral renal denervation procedure
The Symplicity Spyral RDN system, approved by the U.S. Food and Drug Administration (FDA) in November 2023 , is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. Symplicity Spyral is the only commercially available RDN device with the breadth of durable, consistent, long-term data and single catheter design. The SPYRAL-HTN clinical program has demonstrated 18 mmHg office blood pressure reductions out to three years in a real-world setting, 1 has the longest and largest real-world registry 2 and the largest dataset showing long-term reductions without the need for additional medication. 2-3
The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN in over 4,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk. The Symplicity blood pressure procedure has demonstrated sustained and durable drops in blood pressure out to three years in randomized control and real-world registry trials. 5-8 The Symplicity RDN system is approved for commercial use in over 75 countries around the world.
About Hypertension
Hypertension, or high blood pressure, impacts more than1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death. 4 Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly 80% of adults with hypertension do not have it under control 1 and half of hypertension patients become non-adherent to medication within one year. 4-5
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomized, sham-controlled trial. The Lancet. 2022; 399:1401-1410.
2 Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug ;80(8):1759-177.
3 Kandzari DE et al. Long-term Safety and Efficacy of Radiofrequency Renal Denervation in the Presence of Antihypertensive Drugs: 24-Month Results from the SPYRAL HTN–ON MED Randomized Trial. TCT 2024
4 WHO. Hypertension fact sheet. September 13, 2019 . Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension . Accessed February 15, 2022 .
5 Bhatt, D. et al, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. The Lancet. September 18, 2022. DOI: https://doi.org/10.1016/S0140-6736 (22)01787-1.
6 Mahfoud, F. et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. August 2023; DOI: 10.1161/HYPERTENSIONAHA.123.21283.
7 Mahfoud, F. et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. April 2022. https://doi.org/10.1016/S0140-6736(22)00455-X(opens new window)
8 Mahfoud, F. et al. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. Journal of the American College of Cardiology. November 2022. https://doi.org/10.1016/j.jacc.2022.08.802
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