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Tandem Diabetes Care to Announce Second Quarter 2021 Financial Results on August 4, 2021

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SAN DIEGO–(BUSINESS WIRE)– Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, plans to release its second quarter 2021 results after the financial markets close on Wednesday, August 4, 2021. The Company will hold a conference call and simultaneous webcast on the same day at 4:30 pm Eastern Time (1:30 pm Pacific Time), to discuss its second quarter 2021 financial and operating results.

Conference Call/Webcast Details:
Date:
August 4, 2021
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Toll Free Dial-In Number: (855) 427-4396
International Dial-In Number: (484) 756-4261
Conference ID: 6897987
Webcast Link: https://edge.media-server.com/mmc/p/ttkpgjat

An archive of the webcast will be available for 30 days following the event on Tandem Diabetes Care’s Investor Center website located at http://investor.tandemdiabetes.com in the “Events & Presentations” section.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The Company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem’s flagship product, the t:slim X2™ insulin pump, is capable of remote software updates using a personal computer and features integrated continuous glucose monitoring, and optional automated insulin delivery technology. Tandem is based in San Diego, California.

Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslimX2 and $TNDM.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at www.linkedin.com/company/TandemDiabetes.

Tandem Diabetes Care is a registered trademark and t:slim X2 is a trademark of Tandem Diabetes Care, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210712005658/en/

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Source: https://www.biospace.com/article/releases/tandem-diabetes-care-to-announce-second-quarter-2021-financial-results-on-august-4-2021/?s=93

Medical Devices

Sight Sciences Announces Multiple Presentations at the 2021 American Society of Cataract and Refractive Surgery Annual Meeting

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New safety and efficacy data from both retrospective and prospective studies of the OMNI Surgical System and a prospective study of the TearCare System to be presented

MENLO PARK, Calif., July 22, 2021 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), a growth-stage medical device company focused on addressing the underlying causes of the world’s most prevalent eye diseases, today announced that data from multiple retrospective and prospective clinical studies of the OMNI® Surgical System and TearCare® System will be presented at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The in-person conference will take place July 23-27 in Las Vegas.

A total of five papers have been accepted for presentation. Details of the presentations are as follows (all times are Pacific Daylight Time (PDT)):

Saturday, July 24

Session Title: “Efficacy of Ab Interno Canaloplasty Followed by Trabeculotomy in Pseudophakic Eyes with Open-Angle Glaucoma”
Session: Minimally Invasive Glaucoma Surgery (MIGS)
Presenter: Adam Bleeker, O.D.
Location: MBCR – Level 2, Surf CD
Time: 1:30 PM

Session Title: “Ab Interno Canaloplasty and Trabeculotomy in Pseudophakic Eyes with Mild-Moderate Open Angle Glaucoma: Prospective Multicenter Trial (ORION)”
Session: Minimally Invasive Glaucoma Surgery (MIGS)
Presenter: Mark J. Gallardo, M.D.
Location: MBCR – Level 2, Surf CD
Time: 2:00 PM

Session Title: “Novel Blink-Assisted Meibomian Gland Procedure for Safe and Effective Treatment of Dry Eye: A Prospective, Masked, Multicenter Trial (CHEETAH)”
Session: Ocular Surface
Presenter: David Wirta, M.D.
Location: MBCR – Level 2, Surf EF
Time: 2:11 PM

Session Title: “Effect of Canaloplasty and Trabeculotomy on Intraocular Pressure in Eyes with Open Angle Glaucoma Undergoing Phacoemulsification”
Session: Minimally Invasive Glaucoma Surgery (MIGS)
Presenter: Arkadiy Yadgarov, M.D.
Location: MBCR – Level 2, Surf CD
Time: 2:30 PM

Sunday, July 25

Session Title: “Canaloplasty Plus Trabeculotomy with Cataract Surgery for Mild-Moderate Open Angle Glaucoma: Prospective Clinical Trial Results (GEMINI)”
Session: Minimally Invasive Glaucoma Surgery (MIGS) II
Presenter: Mark F. Pyfer, M.D., F.A.C.S.
Location: MBCR – Level 2, Surf EF
Time: 10:10 AM

About Sight Sciences
Founded in 2011, Sight Sciences develops and commercializes intelligently designed and engineered products that target the underlying causes of the world’s most prevalent eye diseases. The company currently markets two products, the OMNI® Surgical System and the TearCare® System. For more information, visit www.sightsciences.com.

OMNI® and TearCare® are registered trademarks of Sight Sciences.
© 2021 Sight Sciences. All rights reserved.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Sight Sciences’ current expectations and various assumptions. Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward-looking statements. While the Company believes that its assumptions are reasonable, Sight Sciences may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including the factors discussed under the caption “Risk Factors” in its registration statements on Form S-1, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Sight Sciences may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Sight Sciences’ views as of any date subsequent to the date of this press release

Media contact:
Shay Smith
Health+Commerce
707.971.9779
[email protected]

Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
[email protected]

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Source: https://www.biospace.com/article/releases/sight-sciences-announces-multiple-presentations-at-the-2021-american-society-of-cataract-and-refractive-surgery-annual-meeting/?s=93

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BioSpace’s Business Report Highlights Sustained Growth and New Blood

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Industry_Business

The life sciences is always a frenetic sector when it comes to mergers & acquisitions, initial public offerings (IPOs) and Series A announcements (not to mention B and C rounds). But during the second quarter of 2021, these companies were especially busy bees – all positive signs that the industry is still booming coming out of the COVID-19 pandemic. 

With all of the activity, it would be impossible to go over every single transaction and announcement in detail, so here’s a glimpse at some of the real newsmakers. The rest can be found right here in BioSpace’s Industry Update: Vol. 2 Business Edition.

Mergers & Acquisitions

This space has been particularly busy the past two months. In June, AbbVie made good on its option to acquire strategic partner, Teneobio Inc. and its BCMA-targeting immunotherapeutic for relapsed or refractory multiple myeloma (R/R MM). AbbVie made the call following positive interim data from a phase I study of the compound, TNB-383B, which saw the drug achieve an objective response rate (ORR) of 79%, and a very good partial response rate of 63% at doses of at least 40 mgs.

Also in June, Bayer boosted its portfolio of targeted alpha radionuclide therapies for prostate cancer, with the purchase of Noria Therapeutics Inc. and its subsidiary, PSMA Therapeutics Inc. The acquisition of the companies and their investigational compound could help to make up for declining sales of metastatic castration-resistant prostate cancer, Xofigo. 

Germany-based MorphoSys AG strengthened its position in the hematology-oncology space with the pick-up of clinical-stage biopharma company, Constellation pharmaceuticals. In the deal, which has a total value of $1.7 billion, MorphoSys added two mid-to-late stage assets, BET inhibitor, pelabresib (CPI-0610) and CPI-0209, a second-generation EZH2 inhibitor. Both have wide-ranging potential for patients with hematological and solid tumors. 

SPAC Mania

It’s a SPAC parade again this year – and 2021 is still a long way from over. Ginkgo Bioworks led the way, going public through a massive deal with Soaring Eagle Acquisition Corp. that saw “the organism company” valued at $15 billion. Ginko uses genetic engineering to produce bacteria that has potential in a wide range of areas, including food and agriculture, antibiotics, vaccines, and therapeutics.

Less than a year after its official debut, Boston-based Valo Health hit the Nasdaq in June through a SPAC merger with Khosla Ventures Acquisition Co. Valo, which was founded by Flagship Pioneering, claimed a valuation of approximately $2.8 billion. The company’s Opal Computational Platform is designed to speed up the rate of drug discovery for cancer, neurodegenerative and cardiovascular diseases.

Popular genetic testing company, 23andMe also decided to skip the traditional route, entering into a deal with Sir Richard Branson’s VG Acquisition Corp. 23andMe began trading on the Nasdaq on June 17th, valued at $3.6 billion and trading under the ticker symbol “ME”. The company’s stock rose 21% on the first day of trading.

New Beginnings (Series A Launches)

An impressive cadre of investors demonstrated their faith in ArriVent Biopharma, which launched in June with a whopping $150 million in Series A financing. The financing was led by Hillhouse Capital Group, and saw the Pennsylvania-based ArriVent receiving $90 million upfront to advance its potential best-in-class epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), furmonertinib. The lung cancer treatment, licensed from Allist Pharmaceuticals, was approved in March by China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC).

Mnemo Therapeutics now holds the record for France’s largest-ever Series A, raking in $90 million USD (€75 million) in a round led by Casdin Capital and Sofinnova Partners. The Paris-based biotech will use the funds to advance its proprietary EnfiniT platform which identifies a new class of antigens with greater tumor specificity. The broad group of technologies comprising the platform is collectively aimed at significantly improving persistence, sensitivity and T-cell memory.

It didn’t take long for Roger Perlmutter to emerge from stealth mode. After leaving his post as president of Merck Research Laboratories at the end of 2020, Perlmutter is back as the CEO of drug discovery startup Eikon Therapeutics, Inc., which officially debuted in May with $148 million in Series A financing. Eikon is using its super-resolution microscopy platform to track and measure the movement of individual proteins in living cells in order to gain a better understanding of disease biology. Perlmutter will be tasked with translating this novel technology into feasible therapeutics. 

Taking the Helm

Speaking of leadership – and Merck – Timothy (Tim) Noyes, the new CEO of Aerovate Therapeutics, began his career at the German multinational. He will now lead the charge to develop lead compound, AV-101, an investigational anti-proliferative therapy for pulmonary arterial hypertension (PAH).

 Bio North Texas Foundation (BioNTX), which represents the bioscience industry in 26 counties including Dallas and Fort Worth, has a new chief executive. Kathleen M. Otto, who brings experience from the north in New York and New Jersey, began her tenure on the first of June.

Peter Arduini has parted ways with Integra LifeSciences to become the new CEO of GE Healthcare. William L. Greene, M.D. will tackle age-related diseases as the new CEO at Fountain Therapeutics, and biopharma veteran, Yizhe Wang, Ph.D., is the new leader at rapidly rising licensing-based biotech, LianBio.

Job Creation Superstars

With all of this action, it might go without saying that this has been a promising quarter for job creation in the Life Sciences. With the 2019 and 2020 additions of cell and gene therapy companies, BlueRock Therapeutics and AskBio, Bayer is in growth mode. With the company’s ardent commitment to cornering this space and planned expansion at its Berkeley facility, Bayer expects to add 1000 new jobs. Meanwhile, the Bio Capital region continues to explode, with Australian diagnostic company, Ellume, establishing its first U.S.-based manufacturing site in Frederick County, Maryland. The new operation is expected to bring more than 1,500 new jobs to the state by the end of 2022.

For more in-depth insight on all of the action, click here to download a free copy of BioSpace’s Industry Update: Vol. 2 Business Edition

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Source: https://www.biospace.com/article/biospace-s-business-report-highlights-sustained-growth-and-new-blood/?s=93

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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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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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