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KOLON TISSUEGENE COMPLETES PATIENT DOSING IN TWO PIVOTAL US PHASE III CLINICAL TRIALS FOR TG-C

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Completed patient dosing in US Phase 3 clinical trials.There will be a two-year follow-up period, followed by submission of the Biologics License Application (BLA) to permit marketing of TG-C once approved.

ROCKVILLE, Md., July 11, 2024 /PRNewswire/ — Kolon TissueGene, Inc. (‘the Company”) announced today that patient dosing has been completed on the US Phase 3 clinical trials for Knee Osteoarthritis. Since resuming patient recruitment in November 2021, the Company has completed 2 large clinical trials involving 1,066 patients in about 30 months.

Completion of patient dosing is a big milestone which enabled the Company to complete the pivotal Phase 3 clinical trials. The Company worked diligently with the US Food and Drug Administration (FDA) to get the clinical hold lifted in April 2020, which allowed resumption of the Phase 3 clinical trials in the US. The clinical hold was successfully lifted through extensive research based on scientific data on TG-C and an intensive regulatory review process.

Even though there were difficulties in the Phase 3 clinical trial process such as significant delays of the clinical studies in the US due to the global pandemic, the Company was able to complete patient dosing in the Phase 3 clinical trials with the determination and conviction to succeed in developing the world’s first and only cell and gene therapy for osteoarthritis of the knee.

During the patient recruitment process, approximately 6,700 patients signed up to participate in the Phase 3 clinical trials. Among them, more than 1,000 patients met eligibility criteria and were enrolled in the Phase 3 clinical trials.

In accordance with the protocol, the Company will continue a two-year follow-up on all dosed patients to assess the safety and efficacy after TG-C administration. The results of the Phase 3 clinical trials will be published at the end of the two-year follow-up period.

During the follow-up period, the Company will prepare the BLA submission package for the US FDA in order to obtain marketing authorization of TG-C in the US. The Company has already begun preparations related to commercial production (manufacturing) and is collaborating with Lonza, the world’s largest pharmaceutical CDMO.

“We expect the Phase 3 clinical trials to provide positive results, similar to the successfully completed Phase 2 clinical trial in the US” said Moon Jong Noh, PhD, CEO of the Company, adding, “When the Phase 3 clinical trials are successfully completed, we will start discussions with potential partners for commercial sales and marketing along with completion and submission of the BLA for product approval.” In addition, he said, “All executives and employees will do their best to repay all customers, shareholders, and others who have trusted and waited for the Company for a long time with meaningful results.”

About Kolon TissueGene, Inc. 
Kolon TissueGene, Inc., is an advanced cell therapies company that has developed a first-in-class cell and gene therapy targeting OA of the knee. The Company’s lead product, TG-C, is an allogeneic cell and gene therapy. The Company is conducting Phase 3 clinical trials in the US under a Special Protocol Assessment (SPA) agreement reached with the US FDA. Information about the trials can be found at the National Institutes of Health registry, www.clinicaltrials.gov.  For additional information about Kolon TissueGene, Inc., please visit www.tissuegene.com.

About TG-C
TG-C is a first-in-class cell and gene therapy targeting OA of the knee through a single intra-articular injection. Clinical trials held in the US and abroad have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. The allogeneic (off-the-shelf) drug could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions. In a concluded US Phase 2 clinical trial, Kolon TissueGene demonstrated a two-year improvement of pain and function. The Company seeks to continue to support these results through its Phase 3 clinical trials. In addition, the Company has designed the trials to seek a disease-modifying osteoarthritis drug (DMOAD) designation for TG-C from the US FDA—potentially making TG-C the first therapy to receive such a DMOAD label.

View original content:https://www.prnewswire.com/news-releases/kolon-tissuegene-completes-patient-dosing-in-two-pivotal-us-phase-iii-clinical-trials-for-tg-c-302195060.html

SOURCE Kolon TissueGene, Inc.

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Siemon Appoints Trey Somers as Vice President of Product Management

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The Siemon Company, a global leader in network infrastructure solutions, announces the appointment of Trey Somers as Vice President of Product Management, effective Monday, July 15th, 2024.

WATERTOWN, Conn., July 20, 2024 /PRNewswire-PRWeb/ — The Siemon Company, a global leader in network infrastructure solutions, announces the appointment of Trey Somers as Vice President of Product Management, effective Monday, July 15th, 2024. In this role, Somers will lead Siemon’s global product management team and drive the development of innovative solutions that meet the evolving needs of the market. With a distinguished career spanning over two decades in the industry, Somers brings a wealth of experience in enterprise product management, OEM product management, and consulting services. Most recently, he served as Managing Director at Align Communications where he successfully led a team delivering smart building solutions to major financial institutions across the globe. “We are thrilled to welcome Trey to the Siemon team,” said Henry Siemon, President and CEO. “His deep industry knowledge and proven track record in product management make him an invaluable asset to our organization. We are confident that under Trey’s leadership, Siemon will continue to deliver cutting-edge solutions that drive customer success.” In his new role, Somers will oversee both the OEM and Enterprise Product Management teams, combining them into a unified global product management organization. He will also collaborate closely with the marketing team to align product development with current market needs and developing industry trends. “I am excited to join the Siemon team and contribute to the company’s continued growth and success,” said Trey Somers, Vice President of Product Management. “Siemon has CONNECTING THE WORLD TO A HIGHER STANDARD www.siemon.com a strong reputation for innovation and customer focus. I look forward to working with the team to develop groundbreaking solutions that address the challenges and opportunities of today’s dynamic market.” Learn more about Siemon at www.siemon.com.

“We are thrilled to welcome Trey to the Siemon team,” said Henry Siemon, President and CEO. “His deep industry knowledge and proven track record in product management make him an invaluable asset to our organization.”

About Siemon – Established in 1903, Siemon is an industry leader specializing in the design and manufacture of high-quality, high-performance IT infrastructure solutions and services for Data Centers, LANs, and Intelligent Buildings. Headquartered in Connecticut, USA, with global sales, technical, and logistics expertise spanning 150 countries, Siemon offers the most comprehensive suites of copper and optical fiber cabling systems, racks, cable management, and Intelligent Infrastructure Management solutions. With more than 400 patents specific to structured cabling, Siemon Labs invests heavily in R&D and the development of Industry Standards, underlining the company’s long-standing commitment to its customers and the industry. Through an ongoing commitment to waste and energy reduction, Siemon’s environmental sustainability benchmarks are unparalleled in the industry.

Contact Information: Brian Baum, brian_baum@siemon.com

Media Contact

Brian Baum, Siemon, 1 860 945-4213, brian_baum@siemon.com

View original content:https://www.prweb.com/releases/siemon-appoints-trey-somers-as-vice-president-of-product-management-302201236.html

SOURCE Siemon

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Online Generator Seller Announces Cummins 7-Day Inflation Fighter Discount For Homeowners

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Cordova, Tennessee based Buckeye Power Systems, LLC announced its partnership with Cummins Power Generation and a 7-day inflation fighting 5% discount on the popular Cummins 20kW RS20A air-cooled home standby generator. The discount applies for purchases between July 25th and August 1st, 2024.

CORDOVA, Tenn., July 20, 2024 /PRNewswire-PRWeb/ — Cordova, Tennessee based Buckeye Power Systems, LLC announced its participation with Cummins Power Generation and its 7-day 5% discount for homeowners on the popular RS20A 20kW HSB air-cooled home standby generator. The discount also applies to the RS20AC kit which includes a 200-Amp Automatic Transfer Switch. The discount applies for purchases between July 25th and August 1st, 2024.

“The 7-day special discount applies to Cummins 20kW air-cooled home standby generator which is also its most popular model.”

David Richey, president of Buckeye Power Systems, said today, “The 7-day special discount applies to Cummins 20kW air-cooled home standby generator which is also its most popular model. The 20kW generator provides whole house coverage for homes up to 2000 square feet. The same generator also provides managed whole house coverage for homes up to 3000 square feet.”

Richey said the Cummins 20kW includes a built-in load management feature which manages the operation of high-power consumers like air conditioners, kitchen ovens, and clothes dryers. “The load management feature prevents certain loads from operating when the generator is already operating at or near peak performance,” Richey continued. “So, the RS20A offers managed whole house coverage for homes up to 3000 square feet.”

When fueled by natural gas, homeowners enjoy an unlimited supply of fuel from their utility supplier, thus eliminating the need for fuel storage. The same generator can also be fueled by liquid-propane (LP). A 5-year manufacturer’s warranty is standard and extended warranty coverage up to 10 years is available as an option.

In the current inflationary economic environment, the price rollback should be warmly welcomed among homeowners looking for special deals on standby power. The Buckeye Power Systems website currently offers the Cummins RS20A for $5,069 with no sales tax in most states, less the $253.45 discount. The Cummins RS20AC kit includes a 200-Amp Automatic Transfer Switch and is offered for $5995 less a $299.75 discount during the 7-day special promotion.

Buckeye Power Systems is also offering a $500 VISA Gift Card for purchase of the two other Cummins air-cooled home standby generators including the 13kW Cummins RS13A and the 17kW Cummins RS17A.

Media Contact

Steve Baker, Buckeye Power Systems, LLC, 1 19013798097, steve@benchmarkelectric.us, https://buckeyepowersystems.com

David Richey, Buckeye Power Systems, LLC, 1 9013798097, david@buckeyepowersystems.com, https://buckeyepowersystems.com

View original content to download multimedia:https://www.prweb.com/releases/online-generator-seller-announces-cummins-7-day-inflation-fighter-discount-for-homeowners-302201860.html

SOURCE Buckeye Power Systems, LLC

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UBX Cloud Creates A Rapid Solution To The Crowdstrike Outage Affecting Millions Worldwide.

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Download the newest version of the “CrowdFix” update on UBX Cloud’s website.

DETROIT, July 20, 2024 /PRNewswire-PRWeb/ — UBX Cloud, a dedicated cloud hosting provider with experience in IT solutions on a global scale, has developed a safe automated repair for the CrowdStrike outage that has affected millions worldwide. The new update has been named “CrowdFix” by UBX Engineers. The solution has been tested on thousands of servers that UBX Engineers manage internally with results that work highly efficiently.

“Our engineers have developed a countermeasure within 2.5 hours after the first reported incident. I appreciate the team working to create a solution that makes it simple, effective, and secure.” – Steven Panovski, President and Founder of UBX Cloud.

“Our engineers have developed a countermeasure within 2.5 hours after the first reported incident. I appreciate the team working to create a solution that makes it simple, effective, and secure,” stated Steven Panovski, President and Founder of UBX Cloud.

CrowdFix Solution Developed by UBX Cloud

To implement the CrowdFix solution, Engineers can simply boot the CrowdFix ISO on the impacted system and it’ll automatically detect all attached disks on the system, while deleting the CrowdStrike related files that are preventing impacted Windows systems. Administrative access or restoration from the backups isn’t required.

For step-by-step instructions on implementing the CrowdFix, please view the documentation in or video to implement. Complete Disclaimer will be listed on our company blog.

Instructions are to boot the ISO file and run the batch file.
Primary LINK 1: http://ubx.link/csfix
Alternate LINK: TBA

Filename: WinPE_UBXCloud_CSFix103.iso
MD5 Hashes: 623c3e11895dda4015bd02f0f8b49313e1fdf2806c961f71d41fbdc96cdc03b5
Size: 380 MB

UBX Cloud Inc.

UBX Cloud is a global IT and Engineering company founded in Michigan in 2008. After steady growth, they opened a new satellite office in India. The company has a team of Engineers working to develop and manage cloud solutions for businesses around the world. This ensures business continuity and secure cloud solutions that give customers peace of mind. To learn more about partnering with UBX Cloud on secure cloud solutions and managed services, please visit the website and contact the team.

With the growing dependence on technology and software solutions, it’s even more important for cloud service providers to develop solutions that support the overall architecture and framework of interconnectivity.

“We’re happy to develop a solution that supports business continuity and operations worldwide. Our team is dedicated to helping customers and the industry at large with cybersecurity and IT solutions that bring value. I especially want to thank our Engineer Mohammed Ali, for developing the solution rapidly,” Steven Panovski said passionately.

In addition to the CrowdFix solution, UBX Cloud previously supported other large enterprises with cybersecurity and cloud solutions. They’re quickly becoming a resource for Engineers across the globe that collaborate on developing technology solutions.

For more information, please visit UBX Cloud’s website at https://www.ubxcloud.com.

UBX Cloud LinkedIn

Media Contact

Carrie Stapleford, UBX Cloud, 1 (586) 808-5000, oop@ubxcloud.com, https://www.ubxcloud.com/

View original content to download multimedia:https://www.prweb.com/releases/ubx-cloud-creates-a-rapid-solution-to-the-crowdstrike-outage-affecting-millions-worldwide-302201954.html

SOURCE UBX Cloud

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