Category Archives: Biotech Companies Medical Devices Medtech

Albus Health Device Detects Early Warning Signs of Child Asthma Attacks Up To Five Days Before Onset

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Albus Health Device Detects Early Warning Signs of Child Asthma Attacks Up To Five Days Before Onset

Research presented at British Thoracic Society Winter Meeting demonstrates potential for revolutionary shift in respiratory care

Technology set to transform respiratory clinical trials: single device delivers continuous endpoint data across multiple parameters with minimal patient burden

OXFORD, UK; November 29, 2024 — Albus Health, the healthcare technology company pioneering monitoring of nocturnal health parameters including cough and breathing patterns, announces results from a clinical study at the British Thoracic Society Winter Meeting 2024 this week. The data revealed that Albus Home, the company’s AI-powered, innovative non-contact monitoring device with advanced algorithms, can detect warning signs of asthma attacks in children up to five days before they occur, potentially transforming how respiratory conditions are managed globally.

The groundbreaking study, conducted at Birmingham Children’s Hospital and Royal Brompton Hospital, demonstrated that the Albus Home device successfully identified significant changes in children’s respiratory health days before they required emergency steroid treatment for asthma attacks. This early warning window could provide crucial time for medical intervention, potentially preventing emergency hospitalisations and improving patient outcomes.

“For the first time, we have technology that can reliably monitor children while they sleep, without any disruption to their normal routine,” said Dr. Prasad Nagakumar, Director for Research at Birmingham Children’s Hospital and lead researcher on the study. “The device’s ability to detect changes up to five days before an attack represents a potential paradigm shift in asthma management, offering a window of opportunity for early intervention that simply hasn’t existed before.”

Night-time symptoms are crucial early warning signs of respiratory disease deterioration, yet until now, healthcare providers have remained blind to at-home symptoms while patients and carers often identify deterioration too late. The Childhood Home Asthma Monitoring Project (CHAMP) study recruited 100 children with asthma. The researchers analysed 47 asthma attacks across 28 children, finding that nocturnal cough frequency and respiratory rate began increasing five days before attacks occurred. In earlier studies, the device achieved clinical-grade accuracy, with 98.3% accuracy in respiratory rate measurement and 99% correlation in cough detection against gold standards.

Following insights from the study and feedback from participants and carers, Albus has developed a next-generation device that also measures heart rate, sleep parameters and air quality metrics. The device’s unique set of sensors, along with Bluetooth, Wi-Fi, and cellular connectivity, unlocks unprecedented opportunities in remote patient monitoring.

“This study validates our mission to revolutionise respiratory care through passive monitoring and early detection,” said Mikesh Udani, CEO of Albus Health. “Our technology has the potential to transform both patient care and clinical trials for several chronic diseases. By providing objective, continuous monitoring data, we can help pharmaceutical companies demonstrate response to treatment more efficiently while generating valuable insights for future drug development.”

The ability to detect and measure these subtle respiratory changes with such precision represents a major advance for both patient care and drug development. While current clinical trials rely heavily on subjective symptom reporting and limited spot-checks of respiratory function, the Albus Home device provides continuous, real-world data throughout the night – exactly when respiratory symptoms typically worsen. This has significant implications for respiratory drug development, where poor quality data collection and unreliable symptom reporting often necessitate larger, longer, and more expensive clinical trials. The Albus Home device offers pharmaceutical companies the ability to capture objective respiratory and sleep endpoints continuously, which can be used to bring new classes of therapies to asthma patients, monitor patient outcomes for post approval studies, and expand indications and labels for existing drugs.

Albus Home has already been deployed commercially to collect real world evidence on treatment response in a US-based Phase IV trial by a major pharmaceutical company. Albus is in advanced negotiations with several additional partners, highlighting strong industry confidence in the technology’s potential to transform both patient care and clinical research. Albus is now focused on expanding its clinical evidence base and set of parameters monitored, while scaling its platform to address the growing global burden of respiratory disease.

For more information about Albus Health and its unique respiratory monitoring technology, visit www.albushealth.com.

This study was funded through The Artificial Intelligence in Health and Care Award, one of the NHS AI Lab programmes. The competitive award scheme is run by DHSC. The AI Award has made funding available to accelerate the testing and evaluation of artificial intelligence technologies which meet the aims set out in the NHS Long Term Plan. In addition to Birmingham Women’s and Children’s Hospital and the Royal Brompton Hospital, partners include Imperial College London, Asthma + Lung UK, and Health Innovation Oxford.

About Albus Health

Albus Health, a spin-off from the University of Oxford, is pioneering nocturnal respiratory insights through its advanced non-contact monitoring system. The company has developed a revolutionary technology that addresses significant unmet needs in both clinical trials and respiratory care, where the inability to reliably monitor patients whilst they are in bed leads to missed early warnings of severe attacks and compromised clinical development data. The company’s bedside device combines proprietary hardware with advanced AI algorithms to deliver automated, clinical-grade insights with unprecedented accuracy in real-world settings. With its first pharmaceutical contract secured and multiple trials underway at leading institutions, Albus Health is positioned to transform respiratory care from reactive to predictive, while significantly enhancing the efficiency of global respiratory clinical trials. The company’s initial focus on respiratory conditions provides a clear path to commercial success, with potential for expansion into other chronic conditions through its established hardware and software platforms.

For Media enquires:

Sukaina Virji, Kate Hall

Albus@icrhealthcare.com

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More info for healthcare startups : Healthcare Investors Database and Healthcare Investors Matchmaking .

Vaxxas Expands Global Intellectual Property Portfolio for Exclusive Manufacture and Sale of Needle-Free Vaccination Technology

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BRISBANE, Australia & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vaxxas, a clinical-stage biotechnology company, has expanded its global intellectual property portfolio to 42 patents, supporting its exclusive claim to manufacture and sell its proprietary vaccination technology, the high-density microarray patch (HD-MAP), in the United States, Europe, Asia and Australia.

Vaxxas’ patent portfolio covers all significant proprietary aspects of the company’s vaccine delivery platform and products, including the manufacture and use of the HD-MAP technology and novel applicator device; vaccine formulations; and methods for formulating, loading and coating vaccines on HD-MAP technology.

The latest patent issued to Vaxxas in November 2024 covers the specific design and use of the HD-MAP and applicator technology for vaccine delivery to the skin in the United States.

Following issuance of the company’s latest US patent, Vaxxas CEO and President David Hoey said, “Vaxxas is aiming to transform the vaccine market by improving the performance of vaccines and reducing the economic and logistical challenges typically associated with needle-and-syringe vaccination.

“The growing breadth of our patent portfolio protects our exclusive use of the technologies necessary to achieve this goal, as well as freely manufacture and sell our products at commercial scale and in a safe and regulatory compliant manner.”

Vaxxas Chief Technology Officer Dr Angus Forster said the company has been very intentional in building its global intellectual property portfolio.

“The coverage of Vaxxas’ issued patents, both geographically and technologically, sets us apart as we continue to mature our vaccination platform and expand our range of products,” said Dr Forster.

“In the past 24 months alone, we have filed seven new patent applications covering new aspects of our technology platform, including HD-MAP delivery of mRNA vaccines, the fastest growing segment of the vaccine market. These patent applications, if granted, would extend our cover through to 2045.”

Vaxxas is scaling up to manufacture and distribute the world’s first commercially available vaccine patches from its global headquarters and state of the art biomedical facility in Brisbane.

Vaxxas Chief Operating Officer Scott Fry added, “Because we’re developing a combination product that includes a vaccine or medicine component with a medical device, we have broad patenting opportunities.

“We not only file patents around the vaccines we formulate and deliver, but also the systems and processes to manufacture the HD-MAPs and applicators at scale. This latest US patent is further evidence of the value our team of engineers brings to technology that could transform the vaccine industry.”

Vaxxas’ HD-MAP technology has completed five successful Phase I clinical trials involving over 500 participants with vaccines that address some of the world’s biggest health challenges including COVID-19, flu, and measles and rubella.

Vaxxas is currently conducting its first US IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine involving 258 participants, with funding from the United States Biomedical Advanced Research and Development Authority (BARDA).

About Vaxxas

Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious diseases and oncology.

With success in several completed human clinical trials, Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialisation. The company has completed Phase I clinical trials for COVID-19, seasonal influenza, and measles and rubella vaccine patches involving more than 500 participants; and conducted other vaccine studies targeting pandemic influenza with funding from the Biomedical Advanced Research and Development Authority (BARDA) – part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialisation group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners and US-based HealthCare Ventures, followed by further financing led by OneVentures, joined by UQ.

OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at OneVentures and Brandon Capital.

About HD-MAP needle-free vaccines

The Vaxxas high-density microarray patch (HD-MAP) is comprised of thousands of microscopic projections moulded into a small patch. Each microprojection is ‘printed’ with a small dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface.

HD-MAP vaccine delivery has the potential to overcome challenges faced by traditional needle and syringe delivery of vaccines. For example, the dried form of the vaccine has been shown in early clinical studies to be more stable at higher temperatures than vaccines in liquid formulations, potentially reducing the need for cold-chain storage and distribution.1

Previous studies have also shown the safety and tolerability of Vaxxas’ HD-MAP for use in vaccine delivery and inducing equal or greater immune responses to injected vaccines at lower doses.1 Compared with needle and syringe systems, HD-MAP vaccines are designed to be easier to administer and have potential use in future pandemic responses.1

Caution

The Vaxxas HD-MAP delivered vaccines are under investigation and available only for investigational uses. They are not available anywhere in the world for sale or purchase. As such, Vaxxas makes no claim that the vaccines are reliable, durable, dependable, safe, or effective, and makes no claim that it is superior to any other vaccine or vaccine delivery technology.

References

1 Baker, B., Hacker, E., Siller, G., Lee, M., Mursaliyev, N., & Forster, A. (2023). Evaluation of the self-administration potential of high-density microarray patches to human skin: A preliminary study. Human Vaccines & Immunotherapeutics, 19(1). https://doi.org/10.1080/21645515.2023.2189409

Contacts

Australia
Amy Miller

WE Communications

+61 431 072 422

amymi@we-worldwide.com

United States
Kathryn Morris

The Yates Network

+1 914 204 6412

kathryn@theyatesnetwork.com

Loci Orthopaedics Closes €12.8 Million Series A Financing

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  • Company developing its innovative InDx Implant System for thumb base joint arthritis
  • Focused on a painful and disabling condition with increasing prevalence in patient population
  • Funds to support clinical programs, regulatory submissions and future commercialisation

GALWAY, Ireland–(BUSINESS WIRE)–Loci Orthopaedics Ltd, an orthopaedic medical device company, today announced the successful closing of an oversubscribed €12.8 million Series A financing. The financing round was led by new investors Seroba, Johnson & Johnson Innovation, JJDC, Inc., (JJDC) and the European Innovation Council (EIC) Fund.

Loci Orthopaedics develops novel technologies that target major unmet clinical needs in orthopaedics extremities. The company’s primary device, its patented InDx Implant System, is an innovative, evidence-based implant for thumb base joint arthritis. Thumb base joint arthritis is a highly and increasingly prevalent condition which is estimated to actively affect up to 5% of the US and EU population and 100 million people worldwide1. The InDx implant replicates the functional biomechanics of the thumb base joint, with the aim of restoring natural motion for those affected by this painful and disabling condition. InDx’s novel design could address the limitations of current thumb implants which are often unsuccessful and are prone to both dislocation and movement post implantation.

The Series A financing will enable the company to augment the initial clinical investigation, which indicates positive preliminary results, and develop additional clinical data to support regulatory approval applications and future commercialisation in different geographies.

In October 2023, Loci Orthopaedics successfully completed enrolment of a 15-patient clinical study for its InDx Implant System. The Thumb Hemi-Arthroplasty with Natural Kinematics study is designed to evaluate the surgical implantation of the device as well as improvements in pain, grip, and quality of life for those affected by thumb base joint arthritis. Results from the clinical study are expected to be published later this year.

Dr Brendan Boland, Co-Founder and Executive Chairperson, commented: “Thumb base joint arthritis is a painful and disabling condition with a significant unmet clinical need for an effective, evidence-based, surgical solution. With a growing patient population, our InDx Implant System has the potential to provide surgeons and patients with a less invasive and more effective treatment for this condition. This funding will enable us to expand our clinical programs, submit regulatory approval applications in the US and EU and accelerate our efforts towards future commercialisation.”

Barry Russell, CEO, added: “The company is excited to work with three very experienced and well-respected investment groups to help the company bring a promising new solution to market to help the many currently underserved patients and their surgeons with a joint sparing treatment option.”

Maud Lazare, Head of Investor Relations at Seroba, commented: “Orthopaedics extremities is one of the fastest growing areas in orthopaedics, so it is great to work with a company whose innovative solutions may positively disrupt the future treatment landscape for one of the most frequently performed surgeries in this space.”

Svetoslava Georgieva, Chair of the EIC Fund Board, commented: “We are very happy to participate in this funding round. Loci Orthopaedics is disrupting the treatment landscape for one of the most frequently performed surgeries in orthopaedics extremities. The EIC’s unique financing approach, combining grants and equity, provides Europe’s most promising companies with means to develop and scale up their businesses in Europe.”

1

Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framingham Study. Am J Epidemiol. 2002 Dec 1;156(11):1021-7. doi: 10.1093/aje/kwf141. PMID: 12446258.Y

About Thumb Base Joint Arthritis

Most activities that involve grasping or pinching are possible because of the thumb’s remarkable range of motion. Dexterity, however, comes at a price – an increased risk of osteoarthritis (OA) in the first carpometacarpal (CMC) joint, where the thumb meets the trapezium bone in the wrist. Thumb arthritis is common with aging and occurs when cartilage wears away from the ends of the bones that form the joint at the base of the thumb.

Thumb arthritis can cause severe pain, swelling, and decreased strength and range of motion, making it difficult to do simple tasks, such as turning doorknobs and opening jars. Treatment generally involves a combination of medication and splints. Severe thumb arthritis might require surgery. It is estimated that 5% of the population have symptomatic thumb base joint arthritis which causes significant hand pain and has a major negative impact on quality of life1.

About Loci Orthopaedics

Loci Orthopaedics was founded by Mr Gerry Clarke and Dr Brendan Boland as a concurrent spin-out from the University of Galway (Ireland), University College Cork (Ireland) and KU Leuven (Belgium). The company develops orthopaedic technologies to meet major unmet clinical needs with a primary focus on the orthopaedics extremities market. The company focuses on evidence-based design to ensure that its technologies are physiologically optimal to restore natural movement for superior clinical outcomes. Following the Series A financing, to date the company has raised over €22 million in grant and equity financing. See more information at www.lociorthopaedics.com.

About Seroba

Seroba is a European life sciences venture capital firm based in Dublin, Paris and Milan, investing from its fourth Fund. We focus on value creation through backing cutting-edge Biotech and MedTech innovation that will transform the treatment of unmet medical needs. Our team has deep industry and operational experience and an extensive global network. We like to work with entrepreneurs who share our passion for success and for investors who share the same goal of improving human health while driving financial returns. Follow our story at www.serobavc.com.

About EIC Fund

The European Innovation Council Fund from the European Commission is an agnostic Fund: it invests across all technologies and verticals, and all EU countries and countries associated to Horizon Europe. It provides the investment component of the EIC Accelerator blended finance. The European Investment Bank acts as investment adviser to the EIC Fund. The EIC Fund aims to fill a critical financing gap and its main purpose is to support companies in the development and commercialisation of disruptive technologies, bridging with and crowding in market players, and further sharing risk by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The Fund pays particular attention to the empowerment and support of female founders as well as the ambition to reduce the innovation divide among EU countries.

Contacts

For additional information, please contact Dr Brendan Boland.

T: +353 91 863 775

E: brendan@lociorthopaedics.com

Media Contacts

FTI Consulting

Paddy Berkery / Rugile Nenortaite

T: +353 86 602 5988 / +353 86 277 9905

E: LociOrthopaedics@fticonsulting.com

XyloCor and SmartCella enter into license agreement for use of the Extroducer to administer novel gene therapy XC001 to the heart

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  • The Extroducer® Infusion Catheter System® enables local delivery of XC001 to the heart without the need for surgery.
  • XC001 has achieved positive Phase 1/2 results in the EXACT Trial validating its transformative potential for treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality-of-life.

XyloCor Therapeutics, Inc. (“XyloCor”), a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, and SmartWise, a unit of SmartCella Holding AB (“SmartCella”), have entered into a licensing agreement under which XyloCor has rights to the Extroducer® Infusion Catheter System ®, a first-in-class endovascular device designed to deliver advanced therapies directly into the heart [and hard-to-reach tissues] .  XyloCor plans to deploy the Extroducer to support catheter-based endocardial delivery of its lead gene therapy candidate, XC001 (encoberminogene rezmadenovec), in future clinical studies and commercial use.  

XyloCor and SmartCella enter into license agreement for use of the Extroducer to administer novel gene therapy XC001 to the heart

“This agreement with SmartCella will enable XyloCor to build upon its robust foundation of efficacy and safety data for XC001 by offering the potential for improved safety and ease of delivery without surgery via this novel catheter,” said Al Gianchetti, President and CEO of XyloCor. “Teaming up with SmartCella will help in our effort to optimize patient safety and tolerability while maintaining accurate delivery of XC001 to target areas in the heart for patients with refractory angina. It also opens up the potential to develop XC001 earlier in the coronary artery disease progression for even larger patient groups.”

XC001 is designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple isoforms of vascular endothelial growth factor (VEGF). With the use of the Extroducer catheter, XyloCor can offer patients a better delivery option for local administration of XC001 directly to the heart, that is less invasive and eliminates potential risks associated with surgical administration.

“We welcome the Extroducer delivery of XC001 as it offers a more efficient method for gene therapy administration for patients with refractory angina,” said Timothy D. Henry MD, Interventional Cardiologist and Director of the Lindner Center, The Christ Hospital, Cincinnati, Ohio. “Preclinical models provide strong evidence that this approach will maintain, or even improve the efficacy when compared to surgical delivery and it should lower the risk of complications that may arise from surgical administration. I am looking forward to initiating the Phase 2b trial of XC001 in patients with refractory angina using this innovative administration approach.”

The recently published EXACT Phase 1/2 trial assessed the use of one-time gene therapy with XC001 as a new therapeutic approach in refractory angina – a debilitating and chronic condition that impacts over one million people in the United States and is growing in prevalence. In the EXACT trial, 42 patients with class II-IV angina were treated with XC001 directly administered to the heart following minimally invasive surgical access. The results demonstrated that treatment with XC001 can be safely administered and achieve durable clinical improvements of exercise duration, and angina frequency, due to a decrease in ischemic burden, as measured by Positron Emission Tomography (PET) imaging. Notably, six months after treatment 43% of patients had no chest pain with ordinary activities and 58% reported no angina episodes at 12-month clinical follow up. XC001 was well tolerated in the patient population and there were no serious adverse events related to the drug.  The Phase 2b trial will be a randomized double-blinded study assessing the safety and efficacy of XC001 administered via the Extroducer® Delivery Catheter in coronary artery disease patients with refractory angina.

“The collaboration underscores the transformative potential of the Extroducer in delivering XC001 therapy for patients with refractory angina. A great example of a powerful combination of delivery system and drug therapy representing a substantial advancement in treatment options. The collaboration with such a distinguished partner as XyloCor marks a significant milestone for our global expansion efforts and will also enable us to further explore and harness the future capabilities of the Extroducer, ultimately expanding the benefits to a greater number of patients in need,” said Niklas Prager, CEO of SmartCella.

Terms of the agreement include a global license to XyloCor for use of the Extroducer for the administration of XC001 and provide for SmartCella to supply catheters to XyloCor in clinical trials and commercial use in exchange for an upfront payment, clinical, regulatory and commercial milestones and a royalty on sales. Total deal value amounts to approximately USD 130 million and mid-single digit royalties.

About XC001

XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one-time, local administration. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About Extroducer® Infusion Catheter System

The Extroducer® Infusion Catheter System is a first-in-class endovascular delivery device which enables direct-to-tissue drug delivery. The Extroducer® addresses a significant unmet need in the field of novel therapies, enabling targeted delivery of a wide range of modalities for solid tumor treatment, genetic disorders and tissue repair, to name but a few. Using standard equipment and routine interventional radiology approaches, the Extroducer provides access to hard-to-reach tissues by safely penetrating the vessel wall and delivering payload directly to the target location. Smartwise received U.S. Food and Drug Administration (FDA) clearance under 510(k) for the Extroducer® delivery catheter in June 2022.

About XyloCor

XyloCor Therapeutics, Inc. is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

About SmartCella

SmartCella, founded in 2014, is an innovative biotechnology company based in Stockholm, Sweden. SmartCella’s vision is to combine first-in-class delivery platforms with cutting-edge cell and mRNA therapies to unleash the full potential of targeted therapies. The company has three main business units, Smartwise, SmartCella Solutions and ProCella. For more information, visit www.smartcella.com.

NanoVibronix Announces Distribution Agreement with VA Supplier CB Medical for the Distribution of UroShield

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TYLER, Texas–(BUSINESS WIRE)–NanoVibronix, Inc. (Nasdaq: NAOV) (“NanoVibronix,” or the “Company”), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that it has entered into a distribution agreement with CB Medical, LLC (“CB Medical”) for the sale and distribution of the Company’s UroShield.

UroShield is an ultrasound-based product designed to prevent bacterial colonization and biofilm on indwelling urinary catheters and increase antibiotic efficacy, ultimately reducing the incidence of catheter-associated urinary tract infections (CAUTI). UroShield is also intended to decrease pain and discomfort associated with urinary catheter use.

CB Medical is a U.S. Department of Veteran Affairs (“VA”) certified and Service-Disabled Veteran-Owned Small Business (“SDVOSB”) with two decades of experience serving veterans. Founded by an Iraq War veteran, CB Medical is committed to helping veterans and active-duty members live pain free. Under the terms of the multi-year agreement, CB Medical has the right to sell and distribute UroShield to its customers throughout the VA system in the United States.

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., commented, “This new agreement provides us with another distribution channel for UroShield within the VA system of providers. CB Medical has a national presence and is committed to helping veterans and active-duty members gain access to beneficial treatments. With millions of urinary catheters used both in and outside of hospitals every year, the risk of infection can be high. UroShield not only prevents infection but can also reduce the pain associated with urinary catheters. We are pleased to be able to add UroShield to CB Medical’s catalog for the benefit of veterans and to advance our efforts towards achieving broader distribution.”

Shawn Pinkston, President and Chief Executive Officer of CB Medical, commented, “We are committed to bringing world-class medical supplies and treatments to beneficiaries of the VA system. There are many veterans, particularly those with spinal injuries, who live with indwelling catheters and are therefore at constant risk of infection. We are pleased to now offer UroShield as both a preventative device for infection and to help reduce the discomfort of living with a urinary catheter.”

About NanoVibronix

NanoVibronix, Inc. (Nasdaq: NAOV) is a medical device company headquartered in Tyler, Texas, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety to medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The Company’s PainShield® product is a portable device suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: www.nanovibronix.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with: (i) market acceptance of our existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results; (iii) inability to secure regulatory approvals for the sale of our products; (iv) intense competition in the medical device industry from much larger, multinational companies; (v) product liability claims; (vi) product malfunctions; (vii) our limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xi) our reliance on single suppliers for certain product components, (xii) the need to raise additional capital to meet our future business requirements and obligations, given the fact that such capital may not be available, or may be costly, dilutive or difficult to obtain; (xiii) our conducting business in foreign jurisdictions exposing us to additional challenges, such as foreign currency exchange rate fluctuations, logistical and communications challenges, the burden and cost of compliance with foreign laws, and political and/or economic instabilities in specific jurisdictions; and (xiv) market and other conditions. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at: http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

Contacts

Investor Contacts:
Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com
(646) 536-7331

Cagent Vascular appoints Chairman Brian Walsh to expanded role as Chief Executive Officer

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WAYNE, Pa.–(BUSINESS WIRE)–#CLI–Cagent Vascular announced today that Brian Walsh has been named Chief Executive Officer by the Cagent Vascular Board of Directors. He has served as Chairman of the Board since March 2018 and will continue in this capacity. Mr. Walsh will succeed Carol Burns as CEO.

Cagent Vascular

Mr. Walsh previously served as Head of Carl Zeiss Meditech Cataract Technology from 2018 until 2024. Prior to that, he was President and CEO of IanTECH Medical, Inc. (acquired by Carl Zeiss Meditech AG) and Transcend Medical, Inc which was acquired by Alcon, a division of Novartis Co (NYSE: NVS) at the time. Brian Walsh brings over 25 years of medical device and health care industry experience in Marketing, Sales, and Executive Leadership which positions him as the ideal candidate to drive the market adoption of Cagent Vascular’ s flagship product, Serranator.

“Cagent Vascular is an exceptional company with a disruptive technology platform and a highly talented team,” Mr. Walsh said. “It is a privilege to lead this company through the next phase of growth. Our focus in the weeks, months, and years ahead will be on driving superior execution as we scale up and realize further market adoption.

Marc-Andre Marcotte, a Cagent Vascular board member and Partner at Sectoral Asset Management, said, “Brian Walsh’s tenure as Chairman of the Board and previous executive leadership positions give him the perfect vantage point from which to take the company forward. The board is dedicated to working with Brian and team to accelerate market adoption of Serranator and help elevate the patient care journey. On behalf of the board, I thank Carol for her significant contributions both as co-founder and as CEO over the past 10 years.”

About Cagent Vascular

Cagent Vascular, founded and led by serial medical technology entrepreneurs, is the leader in Serration Technology to treat peripheral artery disease. The company has developed a transformative improvement to conventional angioplasty, which is the most commonly performed procedure to restore blood flow. Although angioplasty has been used clinically for over 50 years, there remain significant opportunities to optimize the therapy and to improve the treatment outcomes of cardiovascular disease. To learn more about Cagent Vascular’s mission to fight PAD, visit www.cagentvascular.com.

The information contained herein obtained from Cagent Vascular management is believed to be reliable. This does not constitute the solicitation of the purchase or sale of securities. Except for historical information contained herein, matters discussed in this document are forward-looking statements, the accuracy of which is subject to risks and uncertainties.

This project is supported by the Ben Franklin Technology Partners of Southeastern PA, an initiative of the Pennsylvania Department of Community and Economic Development funded by the Ben Franklin Technology Development Authority.

Contacts

Cagent Communications and Media Contact:

Lauren Pfeiffer

+1 610 668-2006

LPfeiffer@cagentvascular.com

Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

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AACHEN, Germany–(BUSINESS WIRE)–#CerebralProtection–Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The funding round was structured in two separate capital increases which have both been completed. It was co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund. Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.

“We are delighted to announce the completion of the round and would like to thank our existing investors as well as the new investors for their trust and confidence,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis. “It reflects the fact that the field of cerebral embolic protection is buoyant, and that future growth will be driven by younger and lower risk patients who have zero tolerance for brain injury risk when selecting to undergo transcatheter aortic valve replacement.”

Additionally, Protembis is proud to announce the addition of Keith D. Dawkins, MD, to the Board of Directors. Dr Dawkins has more than 35 years’ experience in the cardiovascular environment. With over 20 years as a practicing interventional cardiologist in the UK he has held research roles as a Fulbright Scholar at Stanford University, served as President of the British Cardiovascular Intervention Society, and authored more than 750 academic publications and presentations. Dr Dawkins has been the Chief Medical Officer (CMO) of Shockwave (NASDAQ:SWAV) since 2019, and this was preceded by his role as Global CMO at Boston Scientific where he held senior positions since 2008. He also serves as a member of the boards of Ventric Health LLC and JenaValve Technology Inc., as well as Chairman of InnovHeart s.r.l. Dr Dawkins will contribute his significant expertise to the clinical strategies of Protembis and the pre-commercial programs as the IDE study reaches its conclusion.

“To have such a visionary leader as Dr Dawkins join our Board of Directors is an exciting indication of the opportunities that cerebral embolic protection holds for future transcatheter therapies. We look forward to close collaboration as the field develops and our superiority trial gains momentum,” said Azin Parhizgar, PhD, Chairwoman of the Board of Directors.

“As a long-term believer in the need to protect the brain from all new lesions during transcatheter aortic valve replacement, I am very pleased to join Protembis,” said Dr Dawkins. “The ProtEmbo System and the clinical trial design are both novel and I am confident that they will be highly disruptive to the field of cerebral embolic protection, removing or mitigating many of the current issues that concern the physician community.”

About ProtEmbo® and Protembis

The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.

Protembis is a privately held emerging medical device company that has developed the ProtEmbo® Cerebral Protection System. The company strives to provide a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury during such procedures. The ProtEmbo System is currently undergoing clinical investigations.

Contacts

Protembis GmbH

Conrad Rasmus & Karl von Mangoldt

+49(0)241 9903 3622

management@protembis.com
www.protembis.com

Mainstay Medical Announces US$125 Million Equity Financing Transaction

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Funding to accelerate commercial growth and expand clinical and health economic evidence for ReActiv8® Restorative Neuromodulation™ System

DUBLIN–(BUSINESS WIRE)–Mainstay Medical Holdings plc today announced an equity financing in which it will receive gross proceeds of US$125 million. Mainstay intends to use the funds to support the company’s continued commercial growth of ReActiv8® Restorative Neurostimulation in the U.S., Europe and Australia, additional post-market clinical studies and research, and general operations.


The financing was co-led by new investors Gilde Healthcare and Viking Global Investors. Key existing investors who participated in the financing include Ally Bridge Group, Sofinnova Partners (Crossover Fund), Fountain Healthcare Partners, and Perceptive Advisors.

“A financing of this magnitude will allow us to accelerate our efforts to revolutionize the treatment of mechanical low back pain through ReActiv8 Restorative Neurostimulation, including by continuing our rapid commercial growth and building on our insurance coverage for ReActiv8,” said Jason Hannon, CEO of Mainstay Medical. “We are now strongly capitalized to execute on our corporate objectives. In addition to commercial expansion in our target markets, these objectives include the generation of additional clinical and health economic data to further demonstrate that ReActiv8’s purpose-built, restorative approach to the treatment of mechanical chronic low back pain is superior to competitive therapies originally designed for other indications, as well as the continued development and enforcement of our dominant intellectual property portfolio.”

“We are excited to lead this financing and to work with Mainstay to continue to unlock the potential of ReActiv8 therapy,” said Geoff Pardo, Partner at Gilde Healthcare, who also joins the Mainstay Medical Board of Directors. “Patients with mechanical chronic low back pain have had very limited treatment options, and the restorative mechanism of action offered by ReActiv8 is both unique and very promising.”

Two extraordinary general meetings of Mainstay shareholders were held on 23 February 2024 to approve the financing and related matters. At the EGMs, all resolutions were duly passed. The results of the voting on each of the resolutions is available on the Company’s website.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

Mainstay Forward-Looking Statements

All statements in this announcement other than statements of historical fact are, or may be deemed to be, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the company’s intentions, beliefs or current expectations concerning, among other things, the company’s funding needs, strategies, alternatives and transactions, ability to fund its objectives moving forward, commercial efforts and performance, research studies and results, financial position, product design and development, intellectual property portfolio and its scope, regulatory applications and approvals, and reimbursement arrangements.

Forward-looking statements involve risk and uncertainty and are not guarantees of future performance. Actual results may differ materially from those described in, or suggested by, the forward-looking statements. A number of factors could cause results and developments to differ materially from those expressed or implied by the forward-looking statements herein, including, without limitation, the risks and uncertainties included in the company’s Annual Report for the year ended 31 December 2022, which should be read in conjunction with the company’s public disclosures (available on the company’s website (www.mainstaymedical.com)). The forward-looking statements herein speak only as of the date of this announcement.

Contacts

Mainstay PR and IR Enquiries:

LifeSci Advisors, LLC
Brian Ritchie

Tel: + 1 (212) 915-2578

Email: britchie@lifesciadvisors.com

FTI Consulting (for Ireland)

Jonathan Neilan or Patrick Berkery

Tel. : +353 86 602 5988

Email: mainstay@fticonsulting.com

Mainstay Medical
Corporate Communications

Email: Media@mainstaymedical.com

A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

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A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

CASTEL SAN PIETRO, 14 December 2023 – Medacta Group SA (“Medacta”, SIX:MOVE), a Swiss company specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgeries, announces the publication of a new study in the European Spine Journal which demonstrates that NextAR Spine seamlessly integrates into the OR workflow, enabling the surgeon to enhance efficiency, accuracy, and versatility in spine surgery.

“Precision and accuracy in spine surgery is critical. As stated in our recent study, NextAR, the new AR-assisted navigation system, greatly simplifies pedicle screw placement, ensuring effectiveness and accuracy. It’s a reliable tool, straightforward to use, and it elevates our ability to provide safe and precise navigation for various spinal conditions,” says Professor Dr. med. Bernhard Meyer, Director of the Neurosurgical Clinic and Policlinic at the University Hospital Rechts der Isar, Munich.

The study “Evaluating a cutting‑edge augmented reality‑supported navigation system for spinal instrumentation”1 led by Prof. Dr. med. Bernhard Meyer, evaluates the efficiency, accuracy, and versatility of NextAR Spine, a navigation system that incorporates augmented reality to provide unique real-time surgical guidance, superimposed onto the operative field, enhancing precision and enabling data-driven decision-making in the placement of pedicle screws, and addressing different types of spine indications, such as trauma, degeneration, infection, and tumor.

The placement of pedicle screws has been achieved with precision using both open and percutaneous approaches in both long and short constructs, indicating a lower intraoperative revision rate (1.7%)1 compared to the rate documented in the scientific literature with other navigation systems (3.4% by Ille at al2; 4.7% by Ryang at al3). This further highlights that NextAR Spine proves to be a reliable and safe tool for 3D imaging-based pedicle screw placement while requiring minimal setup during surgery, in line with Medacta’s philosophy of healthcare sustainability. The setup is reduced to a minimum by integrating the cameras into the surgical instruments and establishing a flexible platform which includes the preoperative planning.

The NextAR platform is offered as a hardware system with limited capital investment and single-use instrumentation at a low cost per case and offers the ability to host software for multiple applications (NextAR Knee, NextAR Shoulder, NextAR Spine, and Hip applications). The platform represents an optimal solution worldwide, particularly for US Ambulatory Surgery Centers (ASCs).

The NextAR surgical platform is part of Medacta’s MySolutions Personalized Ecosystem, a network of advanced digital solutions designed to improve patient outcomes and healthcare efficiency. MySolutions embodies Medacta’s holistic approach to personalized medicine, aiming at bringing value to every step of the patient’s journey, from preoperative through postoperative care.

NextAR is also supported by the comprehensive, tailored educational offerings provided by the M.O.R.E. Institute. With an international network of expert surgeons, the M.O.R.E. Institute is at the forefront of education on spine procedures and products with personalized high-level educational pathways. With Medacta, the surgeon is never alone.

REFERENCES
[1] Schwendner M, Ille S, Wostrack M, Meyer B. Evaluating a cutting-edge augmented reality-supported navigation system for spinal instrumentation. Eur Spine J. 2023 Nov 14. doi: 10.1007/s00586-023-08011-w. Epub ahead of print. PMID: 37962688.
[2] Ille S, Baumgart L, Obermueller T, Meyer B, Krieg SM (2021) Clinical efficiency of operating room-based sliding gantry CT as compared to mobile cone-beam CT-based navigated pedicle screw placement in 853 patients and 6733 screws. Eur Spine J 30(12):3720–3730. https:// doi. org/ 10. 1007/ s00586- 021- 06981-3
[3] Ryang YM, Villard J, Obermuller T et al (2015) Learning curve of 3D fluoroscopy image-guided pedicle screw placement in the thoracolumbar spine. Spine J 15(3):467–476. https:// doi. org/ 10. 1016/j. spinee. 2014. 10. 003    
 

Contact

Medacta International SA
Gianluca Olgiati     
Senior Director Global Marketing  
Phone: +41 91 696 60 60
media@medacta.ch

 

About Medacta

Medacta is an international company specializing in the design, production, and distribution of innovative orthopaedic products, as well as in the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta is active in joint replacement, spine surgery, and sports medicine. Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Medacta’s innovation, forged by close collaboration with surgeon experts globally, began with minimally invasive surgical techniques and has evolved into personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 50 countries. Follow us on Medacta TV, YouTube, LinkedIn, and X.

 

 

 

Additional features:

File: MEDIA RELEASE – A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

End of Media Release

Language: English
Company: Medacta Group SA
Strada Regina
6874 Castel San Pietro
Switzerland
Phone: +41 91 696 6060
E-mail: info@medacta.ch
Internet: www.medacta.com
ISIN: CH0468525222
Listed: SIX Swiss Exchange
EQS News ID: 1796547

 
End of News EQS News Service

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Nanostics – micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

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Nanostics is focused on development and commercialization of novel, non-invasive diagnostic tests for cancer. Its core technology is an advanced liquid biopsy platform that can accurately diagnose cancer from a single drop of blood. Its lead product, ClarityDx Prostate, is the most accurate diagnostic test to diagnose aggressive prostate cancer, and is positioned to emerge as the world’s leading diagnostic tool for prostate cancer.

Nanostics - micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

EVs carrying disease-specific biomarkers like nucleic acid and proteins are continuously released from cells and can be found in biological fluids including blood, urine, semen, and cerebrospinal fluid.  The levels of disease-specific EVs are closely related to disease progression making EVs promising targets for minimally invasive diagnostic assays.

Technology designed to accurately detect and measure EVs has the potential to greatly improve liquid biopsy diagnostics. At Nanostics, we use micro-flow cytometry (µFCM) to quantify EV size, concentration, and marker abundance for millions of EVs in minutes. We then use advanced machine learning to analyze the vast amount of data generated using µFCM to provide rapid and precise results that continuously improve with every test.

The EV and machine learning platform ClarityDX® is set to transform the diagnostic landscape and make easy-to-use, minimally invasive predictive tests a reality in the near future.

At Nanostics, we use micro-flow cytometry (µFCM) to quantify EV size, concentration, and marker abundance for millions of EVs in minutes. We then use advanced machine learning to analyze the vast amount of data generated using µFCM to provide rapid and precise results that continuously improve with every test.

The EV and machine learning platform ClarityDX® is set to transform the diagnostic landscape and make easy-to-use, minimally invasive predictive tests a reality in the near future.

The ability to detect and measure EVs is transforming the diagnostic landscape in immunology, neurology, cardiology, and oncology. The ClarityDX® platform technology is well-positioned for future pipeline products including tests for screening, early diagnosis, complementary diagnosis, monitoring, and management for many diseases and medically-related events. Nanostics’ R&D team continues to expand the product pipeline through in-house and partnered projects to include additional liquid biopsy diagnostic tests to improve patient care.

Nanostics – micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

More info : http://www.nanosticsdx.com

Keywords : machine learning, exosomes, extracellular vesicles, diagnostics, oncology, cancer, prostate cancer, cardiovascular, neuroscience, biofluids , liquid biopsy , micro-flow cytometry