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Glaukos Corporation to Release Second Quarter 2021 Financial Results after Market Close on August 5

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SAN CLEMENTE, Calif.–(BUSINESS WIRE)– Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, plans to release second quarter 2021 financial results after the market close on Thursday, August 5, 2021. The company’s management will discuss the results during a conference call and simultaneous webcast at 1:30 p.m. PDT (4:30 p.m. EDT) on August 5, 2021.

A link to the live webcast will be available on the company’s website at http://investors.glaukos.com. To participate in the conference call, please dial 833-231-8262 (U.S.) or 647-689-4107 (International) and enter Conference ID 4248858. A replay will be archived on the company’s website following completion of the call.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its next-generation iStent inject® device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.

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Medical Devices

LumiThera Announces Valeda Treatments Improve Vision and Retinal Function in Top Line Data from the ELECTROLIGHT Pilot Study in Dry AMD patients

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SEATTLE, July 21, 2021 /PRNewswire/ — LumiThera Inc., a commercial stage medical device company offering a photobiomodulation (PBM) treatment for ocular damage and disease, today announced the final topline data from the ELECTROLIGHT pilot study in intermediate dry AMD patients.

A total of 23 eyes from 15 subjects with Dry AMD were enrolled into the prospective clinical study and treated with PBM using the Valeda® Light Delivery System (3 times per week for 3 weeks). Eight Caucasian males and seven females were enrolled with a mean age of 75.1 years (65-93 years). The mean time since AMD diagnosis was 5.0 years (0-14 years). Subjects were tested for safety and functional vision improvements using the Diopsys electroretinogram (ERG) device. ERG is a diagnostic test that measures the electrical activity of the retina of the eye in response to a light stimulus. All subjects were tested at weekly intervals for ERG function prior to the start of the next week of PBM treatments. The study followed the patients out to 6 months. The study was conducted by Dan Montzka, M.D. and Larry Perich, D.O. at the Perich Eye Center (New Port Richey, Florida).

Multi-luminance Electroretinogram (ERG) Magnitude AUC improved by 14.4% from baseline after completion of the Month 1 treatment and showed a 9% improvement at 6 months in the ITT population. A positive correlation between multi-luminance ERG and best corrected visual acuity (BCVA) was seen (p < 0.05) following initial PBM treatment. Positive correlations between multi-luminance ERG and fixed luminance (R = 0.870) and chromatic ERG outcomes (R = 0.676) were also reported in the Month 1 interim analysis.

Subjects showed approximately 12.8 ± 0.98 letter improvement in BCVA at Month 6 compared to BL scores. Mars Contrast Sensitivity (CS) also showed improvement from BL to Month 6 at 40 cm (0.202 log + 0.02), 80 cm (0.197 log + 0.02) and 120 cm (0.28 log + 0.03).

“Valeda provided statistically significant and sustained improvements in BCVA, CS and multi-luminance ERG function from baseline out to Month 6 time point following 9 PBM treatments,” stated Dan Montzka, M.D. “Diopsys multi-luminance ERG is an early, sensitive and quantitative measure of visual dysfunction in dry AMD patients.”

“The study further confirms previous LIGHTSITE I and II studies that the Valeda Light Delivery System improves visual function,” stated Larry Perich, D.O. “The subjects were very pleased with the results of their treatments and no safety issues were seen.”

Diopsys ERG testing is a powerful and quantitative diagnostic that can be coupled with LumiThera’s PBM treatments to characterize early patient benefits on visual function,” indicated Joe Fontanetta, CEO, Diopsys. “These results of this work will allow physicians to diagnose, treat and monitor patients and provides physicians a solution for a disease with limited treatment options.”

“We are strong supporters of treating degenerative disease early to slow the progression of vision-threatening disease.” stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. “The key in chronic ocular disease is early diagnosis, treatment and monitoring and we hope studies such as this pilot pave the way to a more preventative approach. The patients in the ELECTROLIGHT study are similar in demographics as the LIGHTSITE III US study in terms of time from dry AMD diagnosis, AREDs use and age. Previously, we reported the US LIGHTSITE III dry AMD trial fully enrolled 100 subjects in 1Q of 2021 and is continuing to move forward with the 13-month efficacy timepoint for all patients in 1Q of 2022.”

About AMD

AMD is a leading cause of vision loss for people age 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).

About Diopsys

Diopsys, Inc. is a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders. The company provides both Visual Evoked Potential (VEP) and Electroretinography (ERG) vision testing technology. It is this technology that powers Diopsys, Inc.’s medical devices – the Diopsys® NOVA, Diopsys® ARGOS, and Diopsys® RETINA PLUS ERG and VEP Vision Testing System product series and the Enfant® Pediatric VEP Vision Testing System.

About LumiThera Inc.

LumiThera is a commercial-stage medical device company focused on treating people affected by ocular damage and disease including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of visual disorders. The company is commercializing the office based Valeda Light Delivery System to be used by eye care specialists as medical treatments.

The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Union only. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.

Visit the Company’s website at www.lumithera.com.

2021 LumiThera, Inc., All rights reserved.

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Medical Devices

Quibim Teams Up With Molecular Imaging Partners And GE Healthcare To Advance Total-Body PET Scanning

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VALENCIA, Spain, July 20, 2021 /PRNewswire/ — Quibim, a global leader in artificial intelligence (AI) and medical image processing, is participating in a €7.5M (US$8.9M) High Sensitivity Molecular Imaging project IMAS (Imagen Molecular de Alta Sensibilidad) to build an innovative total-body PET/CT scanner for simultaneous whole-body imaging in a Temporary Business Association (TBA) backed by world-class experts in diagnostic imaging equipment GE Healthcare.

The TBA between Quibim, and Full Body Insight and Oncovision, is subcontracted by the Regional Minister of Health of the Government of Valencia in a public procurement of innovation project. The initiative is co-financed (50%) by the European Regional Development Fund (ERDF) through the Spanish Ministry of Science and Innovation.

PET imaging, a safe medical examination, allows visualization of extremely low amounts of radioactive compounds administered to patients and provides functional information of processes occurring within the body. The High Sensitivity Molecular Imaging project goes a step beyond current PET technology with the goal of developing new applications of PET in biomedical research. The project aims to notably increase the sensitivity of such devices by increasing the axial coverage of the system. This increase in sensitivity can be used to reduce the radiation dose or acquisition time keeping the same image quality. A direct benefit will be obtained by pediatric patients and patients that need various diagnostic tests to evaluate the efficiency of treatments. In addition, the axial coverage of the system will enable dynamic acquisitions of the main organs of the body simultaneously, paving the way for new medical applications. Efforts will be invested to provide excellent spatial and time resolution in this complex system to generate images with very finite details in the highest contrast.

Quibim, with a long track record of building whole-body imaging solutions for systems biology problems, will provide the whole-body segmentation to perform automatic quantification of the PET images.  “We will create automatic pipelines to obtain a virtual in vivo dissection of key organs using AI and characterize radiotracer and radiomics features,” said Angel Alberich-Bayarri, Quibim CEO and co-founder. “The output of this innovative  collaboration will help clinicians reading a PET exam decide on which regions they must focus on to support patient diagnosis and prognosis evaluations.”

In addition to Quibim, the TBA was formed with Full Body Insight, a company dedicated to the exploitation of continuous scintillator technologies for the application of total-body PET equipment, and Oncovision, a specialist in molecular imaging equipment. The governance of the project is managed by the Technical Office led by the consulting firm Ayming.

In parallel to the newly developed prototype system, slated to be ready in 2023, the initiative also supports the creation of post-processing tools to advance PET/CT image analysis. Software developers will deliver image reconstruction algorithms and identify pertinent biomarkers to build the image processing platform.

The TBA has included collaboration of public institutions including the Institute of Instrumentation for Molecular Imaging, a joint research center created by the Spanish National Research Council and the Polytechnic University of Valencia that focuses on research into new imaging techniques in the biomedical field. Other partners include the Institute of Corpuscular Physics, a joint center of the Spanish National Research Council and the Valencia University dedicated to research in nuclear and high energy physics, and the Donostia International Physics Center, a foundation specializing in physical chemistry, photonics and computational chemistry.

About Quibim
Quibim, a company based in Valencia, Madrid and Palo Alto, California (USA), builds whole-body imaging solutions for systems biology problems. A prominent medical imaging analysis provider, Quibim plans to become the global leader in virtual biopsies, using quantitative imaging biomarkers to unlock complex diseases signals in medical images.

Clinicians, researchers and pharmaceutical companies use Quibim Precision®, an ecosystem of radiological medical image analysis applications, to assess every part of the body and in different clinical scenarios, from disease detection to monitoring the efficacy of new treatments.

www.quibim.com 
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Medical Devices

Mercy St. Louis Begins Installation of Mevion Proton Therapy System

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LITTLETON, Mass.–(BUSINESS WIRE)– Mevion Medical Systems announced today that it has delivered the 15-ton compact accelerator to Mercy Hospital St. Louis in Missouri. The accelerator, the world’s smallest, is the core of the MEVION S250i Proton Therapy System® which precisely delivers therapeutic doses of radiation to tumors while preserving healthy tissue and critical organs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210720005195/en/

The 15-ton compact accelerator is lifted into the David C. Pratt Cancer Center at Mercy St. Louis. (Photo: Business Wire)

The 15-ton compact accelerator is lifted into the David C. Pratt Cancer Center at Mercy St. Louis. (Photo: Business Wire)

The arrival of the accelerator commences the installation of the proton system at the David C. Pratt Cancer Center at Mercy St. Louis. The nationally accredited center provides outpatient treatment, radiation oncology and infusion services for patients throughout the Mercy network. Mevion’s unique and compact design enabled the new proton center to be embedded directly into the existing radiation oncology department. This efficient approach allows the hospital to share existing resources and offer patients all its cancer-fighting tools under one roof.

“This major milestone in construction puts us one step closer to making the Mercy Proton Therapy Center a reality for our patients,” said Steve Mackin, Mercy executive vice president and Mercy’s East Communities president. “Seeing the equipment before it’s enclosed in the concrete vault shows just how massive an undertaking this project has been. It’s remarkable to think of the many people who will survive – and thrive – because of this technology.”

The MEVION S250i features the industry-leading HYPERSCAN® pencil beam scanning technology and Adaptive Aperture® pMLC, a powerful duo that provides faster and more precise dose delivery, Mevion’s natively integrated CBCT imaging, and surface-guided tracking from C-RAD for high precision patient positioning and intra-fraction motion management.

“We are proud to partner with Mercy to provide this leading-edge technology,” said Tina Yu, Ph.D., CEO of Mevion Medical Systems. “Mevion’s mission is to make proton therapy accessible and the quality and value of the MEVION S250i has enabled more centers, like Mercy, to provide this powerful treatment modality to their patients.”

Reducing the size and complexity of a proton therapy system has allowed more hospitals to adopt proton therapy without the enormous expenditures and space requirements of other proton systems. Today, new proton therapy centers in the United States are almost exclusively compact single-room systems, and Mevion is the preferred compact room provider of NCI-Designated Cancer Centers. To date, over 6,000 patients have been treated on Mevion proton therapy systems, more than on any other compact system.

About Mevion Medical Systems

Since 2004, Mevion Medical Systems has been the leading provider of compact proton therapy systems for cancer care. Dedicated to advancing the design and accessibility of proton therapy worldwide, Mevion was the first company to innovate this new single-room platform and continues to further the science and application of proton therapy. Mevion’s flagship product, the MEVION S250i Proton Therapy System with HYPERSCAN pencil beam scanning, is the world’s smallest proton therapy system that eliminates the obstacles of size, complexity, and cost that exists with other proton therapy systems. Mevion is headquartered in Littleton, Massachusetts, with a presence in Europe and Asia. For more information, please visit www.mevion.com.

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Source: https://www.biospace.com/article/releases/mercy-st-louis-begins-installation-of-mevion-proton-therapy-system/?s=93

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Medical Devices

BD Seeks to Transform Patient Experience through Vision of ‘One-Stick Hospital Stay’

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Acquisition of Velano Vascular Adds Innovative Needle-Free Blood Draw Technology to Reduce Pain and Discomfort of Multiple Needlesticks

FRANKLIN LAKES, N.J., July 20, 2021 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has taken a large step forward in transforming the patient experience through a vision of a “One-Stick Hospital Stay,” building on its history of innovation and leadership in blood collection and vascular access solutions.

For more than 70 years, BD has advanced the science of specimen collection helping to transform the blood collection process, making it safer and more comfortable1 for patients and clinicians, through the BD Vacutainer® family of products. At the same time, the company’s comprehensive vascular access management solutions help clinicians choose the right device for the right patient to achieve “first-stick success” for starting IV lines while also reducing IV complications and extending catheter dwell times through proper IV care and maintenance, which may result in improved clinical outcomes and better patient experiences through fewer needlesticks.

With the recent acquisition of San Francisco-based Velano Vascular and its innovative, needle-free technology that enables high-quality blood draws from existing peripheral intravenous catheter (PIVC) lines, BD can now enable health care providers to help eliminate multiple needlesticks for blood sample collection, reducing the pain and discomfort from the process while delivering quality outcomes and increased patient satisfaction. The addition of Velano Vascular’s FDA-cleared PIVO™ device allows BD to help health care providers move closer to the aspirational vision of the “One-Stick Hospital Stay,” where certain low-acuity patients will only have one “stick” for their entire hospital stay.

“As a global leader in vascular access solutions and blood collection, BD has been on the forefront of innovations that improve the patient experience and reduce additional needlesticks,” said Rick Byrd, president of Medication Delivery Solutions for BD. “Now, with the addition of Velano and its groundbreaking technologies, we can envision a world where a ‘One-Stick Hospital Stay’ could be a reality for many by making the numerous inpatient blood draws better for everyone.”

Blood draws by venipuncture and inserting PIVCs are two of the most commonly performed procedures in hospitals.2,3 Needlesticks affect nearly every hospitalized patient daily and are typically associated with some level of pain and anxiety for patients, especially with successive sticks.3,4

“By potentially removing multiple, individual needlesticks from blood draws, we can change the decades-old practice and help transform it into a better experience for patients and providers,” said Anna Kiger, DNP, DSc., R.N., FAONL, chief nursing officer for Sutter Health, a Northern California-based integrated, not-for-profit health system that first implemented the needle-free technology in 2016. “What can be an unpleasant or anxiety-inducing procedure, with multiple pokes and prods throughout the day and night, is now a more compassionate one for those in our care.”

Approximately 90 percent of hospitalized patients require IV therapy and 95 percent of these devices are PIVCs.2,5 With best practice in vascular access, the PIVC blood draw experience can be reinvented through PIVO™ to help health care providers deliver higher quality care and improve patient satisfaction and outcomes.

“Since inception, we have long championed a more compassionate vision for quality vascular care for every patient in every hospital anywhere in the world,” said Eric M. Stone, co-founder of Velano Vascular. “By joining forces with BD, we can collectively accelerate the impact of our work to more rapidly make this shared vision of a ‘One-Stick Hospital Stay’ a reality.”

Velano Vascular was named one of the Fast Company’s Most Innovative Companies in the World and the fastest growing medical device company in 2020 according to Deloitte.6 Earlier this year, Real Leaders Magazine named Velano Vascular to its list of 100 leading Impact Companies, celebrating those organizations doing well by doing good,7 which complements BD’s decades of leadership in shared value creation and being named to Fortune’s Change the World list four times as one of the companies who tackle society’s unmet needs.

The Velano acquisition is consistent with BD’s growth strategy to enter new categories that address unmet needs and deliver higher impact to patients and health systems. Terms of the transaction were not disclosed.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to accurately detect disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at linkedin.com/company/bd1 and Twitter @BDandCo.

Forward-Looking Statements
This press release contains certain forward-looking statements regarding the use of the PIVO™ device. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many of these risks and uncertainties are beyond the company’s control, including without limitation, challenges inherent in market acceptance of products and other factors listed in our 2020 Annual Report on Form 10-K and other filings with the SEC. BD expressly disclaims any undertaking to update any forward-looking statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable laws or regulations.

References

  1. Mouser A, Uettwiller-Geiger D, Plokhoy E, Berube J, Ahuja AJ, Stankovic AK. Evaluation of pain and specimen quality by use of a novel 25-gauge blood collection set with ultra-thin wall cannula and 5-bevel tip design. J Appl Lab Med. 2017;2(2):201-210.
  2. Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs 2015; 38: 189–203.
  3. Cadacio C, Nachamkin I. A novel needle-free blood draw device for sample collection from short peripheral catheters. JIN. 2017;40(3):156-162
  4. Mulloy DF, Lee SM, Gregas M, Hoffman KE, Ashley SW. Effect of peripheral IV based blood collection on catheter dwell time, blood collection, and patient response. Applied Nursing Research. 2017;40:76-79. doi:10.1016/j.apnr.2017.12.006.
  5. iData Research Inc. US Market Report Suite for Vascular Access Devices and Accessories. 2016.
  6. Deloitte Unveils 2020 North America Technology Fast 500 Rankings. November 2020. https://www.prnewswire.com/news-releases/deloitte-unveils-2020-north-america-technology-fast-500-rankings-301175378.html. Accessed June 3, 2021.
  7. Velano Vascular Named Top Impact Company for 2021 by Real Leaders. January 2021. https://www.globenewswire.com/en/news-release/2021/01/13/2157985/0/en/Velano-Vascular-Named-Top-Impact-Company-for-2021-by-Real-Leaders.html. Accessed June 3, 2021.

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SOURCE BD (Becton, Dickinson and Company)

Company Codes: NYSE:BDX

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Source: https://www.biospace.com/article/releases/bd-seeks-to-transform-patient-experience-through-vision-of-one-stick-hospital-stay-/?s=93

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