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MONTECH Debuts the Heritage: A New Era of Leather Craft & High-End PC

TAIPEI, Jan. 18, 2025 /PRNewswire/ — As a leading brand in PC case innovation, MONTECH introduces the Heritage, a luxurious blend of leather and metal. Featuring a suitcase-style handle, this compact yet spacious PC case redefines portability with elegance and practicality.

Heritage:  A New Era of Leather Craft & High-End PC
Heritage: A New Era of Leather Craft & High-End PC

Where Luxury Meets Practicality

The Heritage redefines sophistication with its timeless blend of premium leather and durable metal. Signature triangular accents showcase the brand’s identity, while the suitcase-style leather handle combines elegance with portability. Designed for those who value style and functionality, the Heritage offers both striking aesthetics and convenience.

Compact Design, Powerful Performance

Heritage proves that great things come in small packages. Designed to maximize internal capacity and deliver exceptional performance, it supports a wide range of cooling solutions, making it ideal for high-performance build in a compact form factor.

  • Top Radiator: 280mm/360mm
  • Air Cooler: 170mm
  • Fans Support: Up to 9 fans.

With its space-saving design and advanced cooling potential, the Heritage is engineered for users who demand efficiency and power in one elegant package.

Stability Meets Modern Elegance

Breaking away from traditional four-corner designs, the Heritage features sleek, elongated feet that enhance stability and elevate its modern aesthetic, blending functional support with refined style.

Elegance with Practical Utility

The Heritage PRO includes 4 premium GF 120 fans pre-installed and a replaceable handle connection point, enabling users to attach an accessory bracket for hanging headphones or other essentials. This thoughtful feature enhances functionality without compromising the case’s sleek and sophisticated design.

Click here for more information

Release Date & Pricing

The Heritage will be available for purchase on January 18, 2025, 9AM ET.

About MONTECH

Established by Telon Co. Ltd. in 2016, MONTECH is a powerhouse in the PC gaming industry, committed to delivering excellence in every product. With a focus on simplicity in design, unparalleled quality and safety, and user-friendly experiences, MONTECH has earned the trust of PC builders worldwide. Known for providing top-performance products at competitive prices, MONTECH has rapidly ascended to become a market leader in the USA and Asia.

Driven by innovation and a relentless pursuit of perfection, MONTECH is on an aggressive expansion path, bringing its cutting-edge solutions to a global audience. Join the revolution in PC gaming and experience the MONTECH difference.

For more information, visit www.montechpc.com or connect with us on Facebook, Instagram, LinkedIn, YouTube, and X.

2025 Yili Elite Summit Celebrates Employee Contributions with a Focus on Respect and Well-being

HOHHOT, China, Jan. 18, 2025 /PRNewswire/ — Recently, the Yili Elite Summit took place in Hohhot, Inner Mongolia. A total of 400 participants, including 200 employees and their families, gathered at Yili’s headquarters to celebrate this annual event.


During the event, Mr. Pan Gang, Chairman and President of Yili Group, highlighted the crucial role employees play in the company’s success, affirming that the benefits of Yili’s growth should be shared by everyone.

 

In his address at the opening dinner, Mr. Pan stated, “Family members are the strongest support system for our employees. We appreciate the unwavering support that allows our employees to fully focus on their work and face challenges with resilience. At Yili, we are dedicated to delivering our best at work; we are building a mission centered on health. Our development reflects the career aspirations of our 60,000 employees, the dreams of over 100,000 family members for a better life, the mutual success envisioned by millions of partners within our win-win collaborative ecosystem, and the pursuit of healthy lifestyles by billions of consumers worldwide.” Considering the low temperatures and chilly weather in Hohhot, Mr. Pan also prepared cashmere scarves and gloves for all attendees.


Yili invited employees and their families to tour the Yili Modern Intelligent Health Valley, the corporate headquarters, and the National Center of Technology Innovation for Dairy, providing them with a firsthand look at Yili’s technological advancements and corporate culture. Complementing the tour, Yili organized a series of engaging activities, including health management lectures, a perfume workshop, and DIY cloisonné enamel crafting experience, ensuring a memorable and enriching day for all participants. Guests were also invited to attend the 2024 Annual Meeting and Networking Party, celebrating joyful moments with all Yili members.

The 2025 Yili Elite Summit embodies Yili’s dedication to its people-oriented philosophy and its commitment to creating value for employees. Over the years, Yili has adhered to a talent strategy focused on respect, unity, and bringing success to its employees, fostering mutual progress between the company and all Yili members. The company has upgraded its “Spring Rain Program,” a comprehensive talent well-being initiative, to support employees in housing, healthcare, education and other areas.

Globally, Yili has built an expansive network across Asia, Europe, America, and Oceania. With 15 R&D and innovation centers and 81 production bases, its products are sold in over 60 countries and regions.

Looking forward, Yili remains committed to empowering its employees through innovation, digital intelligence, and employee care programs. By fostering creativity and vitality, Yili aims to drive high-quality, sustainable growth, deliver superior products and services, and realize its vision of “World Integrally Sharing Health”.

VinFast officially enters the Indian market with the launch of the VF 6 and VF 7

NEW DELHI, INDIA – Media OutReach Newswire – 18 January 2025 – VinFast officially announces its first electric vehicles for the Indian market at the Bharat Mobility Global Expo 2025. The Vietnamese Nasdaq-listed automaker introduced two all-electric B-segment and C-segment SUVs, the VF 6 and VF 7, demonstrating its commitment to the market with high-quality, smart, and modern products.

VinFast India officially launched at the Bharat Mobility Global Expo 2025.
VinFast India officially launched at the Bharat Mobility Global Expo 2025.

The launch event marks a significant milestone for VinFast in the promising Indian electric vehicle market. VinFast chose the VF 6 and VF 7 as its first models for the market. India is also the first market where VinFast has developed a right-hand drive version of the VF 6 and VF 7. These two models are expected to meet the electrification needs of consumers and set a new benchmark in the green transportation industry in India.

Mr. Pham Sanh Chau, CEO of VinFast Asia, said: “Our presence at the Bharat Mobility Show 2025 represents a significant milestone as we showcase our India-bound products here for the first time. We believe our premium SUVs VF 6 and VF 7 are the game changers that will accelerate the adoption of EVs in India. We are thrilled to exhibit our broader portfolio of electric mobility solutions at the Expo. Our presence here not only underlines our commitment to the Indian market, but also showcases our vision for sustainable mobility solutions and advanced technology.”

Mr. Ashwin Ashok Patil, Deputy CEO of Sales – Marketing at VinFast India, shared: “Our India-centric premium SUVs VF 6 and VF 7 are expected to go for sales from early second half of CY 2025. VinFast is appointing dealers across all major towns in India with omni channel presence.”

VinFast will introduce the VF 6 and VF 7 to the Indian market.
VinFast will introduce the VF 6 and VF 7 to the Indian market.

The VF 6 and VF 7, designed to offer seamless, enjoyable, and safe electric mobility, embody a harmonious blend of comfort and modernity.

The VF 6, a B-segment SUV, delivers exceptional performance and features, inspired by the “The Duality In Nature” philosophy. This philosophy seeks to balance opposing elements, resulting in a vehicle that is both fun and sophisticated, technological and human-centric.

Meanwhile, the C-segment SUV, VF 7, delivers an exhilarating driving experience. Embracing the “Asymmetric Aerospace” philosophy, the VF 7 boasts a bold and robust exterior. Its driver-focused interior, complemented by intelligent technologies, creates a spacious and enjoyable experience.

At the Bharat Mobility Global Expo 2025, alongside the VF 6 and VF 7, VinFast showcased its VF 3, VF e34, VF 8, VF 9 SUVs; the Evo200, Klara S, Feliz S, Vento S, Theon S electric scooters; the VF DrgnFly electric bike and the VF Wild pickup truck concept.

This launch event further solidifies VinFast’s commitment to the Indian market. Last year, the Company broke ground on an electric vehicle manufacturing plant in Thoothukudi, Tamil Nadu, aiming to strengthen its global manufacturing capabilities, meet growing demand, and drive the adoption of sustainable mobility in India and beyond.

Hashtag: #VinFast #VF6 #VF7

The issuer is solely responsible for the content of this announcement.

About VinFast

VinFast (NASDAQ: VFS), a subsidiary of Vingroup JSC, one of Vietnam’s largest conglomerates, is a pure-play electric vehicle (“EV”) manufacturer with the mission of making EVs accessible to everyone. VinFast’s product lineup today includes a wide range of electric SUVs, e-scooters, and e-buses. VinFast is currently embarking on its next growth phase through rapid expansion of its distribution and dealership network globally and increasing its manufacturing capacities with a focus on key markets across North America, Europe and Asia. Learn more at:

Laos-China Railway Expands Services for Chinese New Year Travelers

Laos-China Railway Expands Services for Chinese New Year Travelers
Travelers gather at the bustling the Laos-China Railway Station

With the Chinese New Year approaching, the Laos-China Railway has rolled out special measures at the Bohan Railway Border, including expanded counter services and a lane for travelers, to manage the surge in passenger flow.

Hong Kong Airlines Takes Off to Australia’s Gold Coast Bringing Popular Travel Option for the Chinese New Year

HONG KONG, Jan. 18, 2025 /PRNewswire/ — Hong Kong Airlines celebrated the first flight between Hong Kong and Australia’s Gold Coast, marking the airline’s return to become the first local carrier to reinstate this highly anticipated route after several years.

Hong Kong Airlines held a ceremony event at Hong Kong Airport to mark the relaunch
Hong Kong Airlines held a ceremony event at Hong Kong Airport to mark the relaunch

Operating seasonally from 17 January to 15 February 2025, the service covers four flights per week for a four-week period encompassing the Chinese Lunar New Year holiday. The route is operated by an A330 wide-body aircraft, offering both business and economy-class seating.

To commemorate the relaunch, a ceremony was held at the boarding gate before the inaugural flight took off. Hong Kong Airlines President Mr Jeff Sun, representatives of Gold Coast and Queensland Airports, as well as senior representatives of the Airport Authority Hong Kong attended the event, interacted with passengers, and presented bespoke gifts to share the joy.

First flight HX015 to Gold Coast arriving at the Gold Coast Airport at 8:55 am local time. Passengers are welcomed by a lively traditional lion dance performance arranged by the Gold Coast Airport.

OOL airport welcomes HKA with lion dance
OOL airport welcomes HKA with lion dance

Hong Kong Airlines Chairman Mr Yan Bo stated, “We are delighted to have a full flight of passengers on our first voyage, with around 300 travellers coming to experience Queensland’s warm climate and exciting tourist activities. We also look forward to welcoming visitors from the Gold Coast and the Queensland region to Hong Kong during our operation period, inviting them to immerse in the vibrant atmosphere of the Chinese Lunar New Year celebrations and enjoy authentic Hong Kong cuisine.”

Hong Kong Airlines President and Captain Mr Sun joined the cockpit crew to pilot the first flight, he stated, “As one of Hong Kong’s leading full-service airlines, Hong Kong Airlines is committed to providing high-quality, comprehensive services, including flexible baggage allowance options, complimentary inflight meals, and comfortable seats, to ensure that every passenger can enjoy a pleasant journey.”

A welcoming ceremony was held at the Gold Coast Airport
A welcoming ceremony was held at the Gold Coast Airport

Queensland Airports Limited CEO Ms Amelia Evans said, “We’re delighted to welcome Hong Kong Airlines’ guests to our beautiful city of Gold Coast and can’t wait for them to experience the best of an Australian summer across the whole region. We hope this connection with Hong Kong will pave the way for longer-term services across our key markets in Hong Kong, the Greater Bay Area, and Mainland China.”

Queensland Tourism Minister Andrew Powell stated, “This influx from Hong Kong over the Lunar New Year period is an exciting opportunity for Gold Coast, supporting local jobs and the economy.”

Tourism and Events Queensland’s (TEQ) Ollie Philpot helped mark the milestone arrival. He commented, “TEQ has worked closely with Hong Kong Airlines and partners including Experience Gold Coast to put the Gold Coast up in lights in Hong Kong and Mainland China to drive demand for these flights and the destination.”

Acting Gold Coast Mayor Donna Gates celebrated the return of this important service after six years and its positive contribution to the region.

Experience Gold Coast CEO John Warn said the resumption of Hong Kong Airlines’ services marks a significant step forward for the Gold Coast’s tourism industry.

“China is a hugely important source market for the Gold Coast, so we are thrilled to see Hong Kong Airlines’ services lift off again,” 

The resumption of the Gold Coast route marks Hong Kong Airlines’ first step back into the long-haul market. The company is progressively expanding its fleet to support a phased expansion of its network, including potential new routes within Australia and a return to the North American market. Additionally, beyond Vancouver, the airline is also actively exploring the possibility of expanding services to Los Angeles, Seattle, and Toronto to offer passengers a wider range of international travel options.

Hong Kong Airlines flight schedule* between Hong Kong and Gold Coast is as follows (All times local): 

Route

Flight Number

Departure

Arrival

Frequency

HKG – OOL

HX015

22:00

08:55+1

Mon, Wed. Fri, Sun

OOL – HKG

HX016

10:25

17:20

Mon, Tue, Thurs, Sat

* Flight number and schedule may change without prior notice

For high-resolution photos, please download here: https://bitly.cx/xLwl

About Hong Kong Airlines

Established in 2006, Hong Kong Airlines is a full-service airline firmly rooted in Hong Kong. The airline flies to 30 destinations across the Asia Pacific, and currently maintains interline and codeshares with multiple airline partners and ferry service providers. Hong Kong Airlines operates an all-Airbus fleet. It has been awarded the internationally acclaimed four-star rating from Skytrax since 2011. For more information, please visit hongkongairlines.com or our social media channels on LinkedIn, Twitter, Instagram and Facebook.

Galaxy Macau Collaborates with “Luzhou Laojiao · Guojiao 1573” Spring Festival Tasting Pop-Up Store Debuts

Experience Exclusive 2025 Yisi Snake Year Baijiu at Galaxy Macau Until March 31, 2025


MACAU SAR – Media OutReach Newswire – 18 January 2025 – In the spirit of the Lunar New Year, the world-class integrated resort, Galaxy Macau™ has partnered with the renowned Guojiao 1573, one of China’s most prestigious baijiu brands, to present the first-ever “Auspicious Snake · Guojiao 1573 Tasting Festival” pop-up store in Macau.

Galaxy Macau joins hands with Guojiao 1573, a leading strong-aroma baijiu brand, to present Macau's first Guojiao 1573 pop-up store.
Galaxy Macau joins hands with Guojiao 1573, a leading strong-aroma baijiu brand, to present Macau’s first Guojiao 1573 pop-up store.

The Guojiao 1573 Tasting Festival pop-up store officially opened on January 17 with a ceremony attended by distinguished guests and senior management, including senior management from Mr. Nelson Chan, Executive Vice President of Customer Development of Galaxy Entertainment Group and Mr. Xiang Ye, the General Manager of the Comprehensive Management Department at Luzhou Laojiao International Development (Hong Kong) Co., Ltd., along with Ms. Lucy Siu, Senior Regional Sales Manager and Ms. Shirley Ieong, General Manager of Wai Ming Hong, who gathered to witness this precious moment.

The Guojiao 1573 tasting festival pop-up store at Galaxy Macau officially opened, marking its grand debut with a ceremony attended by distinguished guests and senior executives.
The Guojiao 1573 tasting festival pop-up store at Galaxy Macau officially opened, marking its grand debut with a ceremony attended by distinguished guests and senior executives.

Macao’s First National Liquor Launch

From January 17 to March 31, 2025, two Chinese New Year gift liquors – “Guojiao 1573 · Auspicious Spirit Snake” and “Luzhou Laojiao · 2025 Year of the Yi Si Lunar New Year Gift Baijiu,” will debut at the pop-up store for the first time in Macau.

The design of both exclusive offerings features fine porcelain bottles crafted by Yongfengyuan Guoci. The Guojiao 1573 · Auspicious Spirit Snake, limited to 2025 bottles, is adorned with golden yellow glaze and a spirit snake symbolizing wealth and blessings, with a tail embracing a copper coin. The Luzhou Laojiao · 2025 Year of the Yi Si Lunar New Year Gift Baijiu, features a gold-ingot-topped lid symbolizing fortune. Both baijiu deliver a rich and layered aroma, smooth and soft palate, leaving a lasting impression. They are of great collection value with limited edition for sales. Guests can enjoy tastings of Luzhou Laojiao · Antique Edition and Guojiao 1573 · Classic in the pop-up store, alongside exclusive privileges and limited-time pairing menus.

The pop-up store offers a range of exclusive experiences, including special offers and premium tasting sessions.
The pop-up store offers a range of exclusive experiences, including special offers and premium tasting sessions.

Exquisite Pairings of Fine Baijiu and Cuisine

From now until March 31, five Chinese restaurants at Galaxy Macau and StarWorld Hotel are collaborating with Guojiao 1573 to present a limited-time baijiu pairing menu. Notable restaurants include Michelin two-star restaurant Feng Wei Ju, Shang Pin Seafood Hotpot Restaurant, Pang’s Kitchen, Putien, and Bei Shan Lou, featuring signature dishes such as Signature Roost Goose, Pan-fried Dalian Abalone, Simmered Softshell Turtle, Crystal Duck with Ginseng Herbal Soup, Braised Soft-Shelled Turtle with Goose. Guests can savor the perfect harmony of Luzhou Laojiao · Antique Edition with various gourmet delicacies. These dishes are paired with specially crafted Guojiao 1573 liquors and Luzhou Laojiao · Zisha Daqu, welcoming the spring with rich flavors and festive spirit, allowing guests to savor the harmonious beauty of strong-aroma baijiu and exquisite Cantonese and Fujian delicacies.

The “Guojiao 1573 · Auspicious Spirit Snake” and “Luzhou Laojiao · 2025 Year of the Yi Si Lunar New Year Gift Baijiu,” will debut at the pop-up store for the first time in Macau.
The “Guojiao 1573 · Auspicious Spirit Snake” and “Luzhou Laojiao · 2025 Year of the Yi Si Lunar New Year Gift Baijiu,” will debut at the pop-up store for the first time in Macau.

There are five Chinese restaurants at Galaxy Macau and StarWorld Hotel collaborating with Guojiao 1573 to present a limited-time baijiu pairing menu.
There are five Chinese restaurants at Galaxy Macau and StarWorld Hotel collaborating with Guojiao 1573 to present a limited-time baijiu pairing menu.

Hashtag: #GalaxyMacau

The issuer is solely responsible for the content of this announcement.

ABOUT GALAXY MACAU INTEGRATED RESORT

Galaxy Macau™, The World-class Luxury Integrated Resort delivers the “Most Spectacular Entertainment and Leisure Destination in the World”. Developed at an investment of HK$43 billion, the property covers 1.1 million-square-meter of unique entertainment and leisure attractions that are unlike anything else in Macau. Eight award-winning world-class luxury hotels provide close to 5,000 rooms, suites and villas. They include Banyan Tree Macau, Galaxy Hotel™, Hotel Okura Macau, JW Marriott Hotel Macau, The Ritz-Carlton, Macau, Broadway Hotel, Raffles at Galaxy Macau, Andaz Macau. Unique to Galaxy Macau, the 75,000-square-meter Grand Resort Deck features the world’s longest Skytop Adventure Rapids at 575-meters, the largest Skytop Wave Pool with waves up to 1.5-meters high and 150-meters pristine white sand beach. Two five-star spas from Banyan Tree Spa Macau and The Ritz- Carlton Spa, Macau help guests relax and rejuvenate.

As the dining destination in Asia, Galaxy Macau offers a wide variety of gastronomic delights, exquisite experiences and ingredients of the finest quality with over 120 dining options from Michelin dining to authentic delicacies.

Embark on a delightful and rewarding journey at Galaxy Promenade, the one-stop shopping destination boasting some of the world’s most iconic luxury brands. Be the first to get the latest limited-edition items; explore fascinating pop-ups by coveted labels and revel in fabulous shopping rewards and privileges. Our VIPs are entitled to a highly-curated experience with dedicated personal shoppers at guests’ service, and be invited to exclusive luxury brand events. A different caliber of privileges and rewards also await. Discover the joys of fashion and stand at the forefront of style and sophistication—Galaxy Promenade has everything guests need to stay ahead of the style game.

Galaxy Cinemas, immersive thrills and luxurious comfort go hand in hand at Galaxy Cinemas. All 10 theaters are equipped with the latest audio-visual technology; CHINA ROUGE, one-of-a-kind deluxe lounge that evokes the glitz and glamor of Shanghai’s golden era with entertainment in luxury and style; and Foot Hub presents the traditional art of reflexology to make you feel more relaxed and revitalized. For Authentic Macau Flavours & Vibrant Asian Experiences, Broadway Macau – just a 90-second walk via a bridge from Galaxy Macau, has over 35 Authentic Macau & Asian Flavours at its Broadway Food Street. The 2,500-seat Broadway Theatre plays host to world-class entertainers and a diverse array of cultural events.

Meeting, incentive and banquet groups are also well looked after with a portfolio of unique venues in Galaxy Macau and a professional service staff. Galaxy International Convention Center (GICC) is the latest addition to the Group’s ever-expanding integrated resort precinct and will usher in a new era for the MICE industry in Macau. GICC is a world- class event venue featuring 40,000-square-meter of total flexible MICE, and a 16,000-seat Galaxy Arena – the largest indoor arena in Macau.

For more details, please visit www.galaxymacau.com, and

The Moskowitz Law Firm, PLLC Announces Preliminary Approval of a Proposed Class Action Settlement on Behalf of Purchasers of Astrals Non-Fungible Tokens and Galaxy Tokens

MIAMI, Jan. 18, 2025 /PRNewswire/ — The Moskowitz Law Firm, PLLC announces the preliminary approval of a proposed class action settlement that would benefit purchasers and legal title holders of Astrals Non-Fungible Tokens or Galaxy Tokens:

On January 14, 2025, the United States District Court for the Southern District of Florida preliminarily approved a proposed settlement of a class action captioned Harper v. O’Neal, Case No. 23-CV-21912-MORENO. The settlement class includes persons and entities who, from May 24, 2022 to January 14, 2025, purchased Astrals NFTS and/or who, before January 14, 2025, purchased GLXY tokens.

Claims for settlement benefits must be submitted by April 17, 2025. Objections to the settlement and requests for exclusion from the settlement must be received by March 3, 2025 in accordance with the instructions in the Class Notice, which is posted on the settlement website www.astralsnftsettlement.com. The Court will hold a Final Approval Hearing on April 1, 2025, at 9:30 a.m. For more information about the settlement and its terms please visit www.astralsnftsettlement.com.

If you have questions about any matter in this Class Notice, please contact the following representative of Class Counsel, who can answer questions:

Adam M. Moskowitz
The Moskowitz Law Firm, PLLC
P.O. Box 653409
Miami, FL 33175
(305) 740-1423
adam@moskowitz-law.com
service@moskowitz-law.com 

MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function

  • Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired renal function.
  • The transdermal GFR (tGFR) methodology has been designed to be effective across the adult population without input of age, weight, sex, gender, race, or ethnicity.
  • More than 800 million people have Chronic Kidney Disease (CKD), one of the world’s leading causes of mortality worldwide, with associated deaths increasing over the past two decades.1

ST. LOUIS, Jan. 18, 2025 /PRNewswire/ — MediBeacon Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the MediBeacon® TGFR for the assessment of kidney function in patients with normal or impaired renal function.

The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient’s bedside or in the outpatient setting.

The TGFR is validated for use in the assessment of Glomerular Filtration Rate (GFR) in patients with stable kidney function at the point of care. The TGFR utilizes an intravenous Lumitrace injection but does not require blood draws or urine analysis, unlike current methodologies requiring multiple blood draws or urine samples. In addition, current clinical practice measured GFR (mGFR) assessment requires sophisticated clinical laboratory analysis away from the patient’s point of care.

“The development of a system such as the TGFR that assesses a patient’s kidney function without the need to use estimating equations is an important milestone for the nephrology community,” said Dr. Mitchell Rosner, chair of the Department of Medicine at University of Virginia and a highly regarded expert who has authored numerous articles on the challenges of assessing kidney function. “We are excited to explore applications of the transdermal GFR methodology in patients where current clinical practice is understood to be suboptimal.”

Dr. Pierre Galichon, an active kidney researcher at the Sorbonne Université and an attending physician in kidney transplantation at Pitié-Salpêtrière Hospital in Paris, said: “It has long been a challenge to understand kidney function in the context of its interaction with other vital organs, such as the heart and lungs. My experience with MediBeacon products in preclinical use, as relayed in Scientific Reports,2 has been exciting, and I look forward to evaluating how transdermal GFR can be applied in clinical practice.”

“The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function,” said Steve Hanley, CEO of MediBeacon. “According to the National Kidney Foundation, CKD causes more deaths each year than breast cancer or prostate cancer. It is the under-recognized public health crisis.3 The potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings.”

The timing of FDA approval aligns well with the Q4 2024 publication by MediBeacon’s Chief Scientific Officer, Dr. Richard Dorshow, et al. in Kidney International4 with data that supports the utility of MediBeacon’s patented agent Lumitrace®.

The TGFR met its primary efficacy endpoint as per agreement with the FDA by demonstrating a P30 value of 94% while recruiting patients with a range of GFR values and skin tones. P30 is defined as the percentage of GFR estimation falling within +/- 30% of measured GFR (mGFR) values. 

P30 Value

Upper 95% Confidence Bounds

Lower 95% Confidence Bounds

94.0 %

96.9 %

89.4 %

 

In clinical studies no serious or severe adverse events have been observed. For more information, including the FDA Summary of Safety and Effectiveness Data, please refer to www.fda.gov.

About MediBeacon Inc.
MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon’s use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 55 granted U.S. patents and over 215 granted patents worldwide that provide extensive coverage of the MediBeacon® TGFR, including Lumitrace® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: www.medibeacon.com.

About Lumitrace® (relmapirazin) injection
Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al.

IMPORTANT SAFETY INFORMATION FOR TGFR 

Indication for Use:
The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function.

The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI).

The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR.

The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient’s skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor.

Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment.

Contraindications:
There are no known contraindications.

Warnings and Precautions:

  • See ifu.medibeacon.com for full instructions, warnings, and cautions.
  • In clinical studies no serious or severe adverse events have been observed.
  • Lumitrace® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace.
  • Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally-impaired patients). The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing.
  • Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established.
  • During a TGFR session, the patient should be as still as possible, especially during the “Establishing Baseline” stage. The current system is designed to compensate for light activity such as reading or eating after the Baseline stage.

1 Epidemiology of chronic kidney disease: an update 2022, Kidney International Supplement, 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003., Csaba P Kovesdy
2 Pulmonary hypertension without heart failure causes cardiorenal syndrome in a porcine model, Scientific Reports (2023) 13:9130, Orieux et al, doi.org/10.1038/s41598-023-36124-1
3 National Kidney Foundation, Fast Facts (2024 Update), Updated as of 8/6/2024
4 Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012