[2023. 11. 28.][OTC:LBRG]Ladybug-Growhouse Surpasses Last Year’s Revenue of $2M

[2023. 11. 28.][OTC:LBRG]Ladybug-Growhouse Surpasses Last Year’s Revenue of $2M

Ladybug Resource Group, Inc. (OTC PINK: LBRG) has reported impressive financial results following its acquisition of Growhouse Nutraceuticals Ltd. For the nine months ending September 30, 2023, Growhouse achieved revenues of $2.3 million, marking a significant increase of approximately $300,000 compared to its total revenues in 2022.

The revenue breakdown for 2023 reveals a steady upward trajectory, with Q1-Q2 and Q3 revenues of $727,000, $788,000, and $826,000, respectively. This consistent 9% quarterly growth demonstrates the company's commitment to expansion and success in the nutraceutical industry.

Growhouse Nutraceuticals has strategically expanded its product offerings and customer base while focusing on enhancing its eCommerce platform. The company's primary focus now lies in online retailing, offering nutraceutical products that combine elements of nutrition and pharmaceuticals, providing consumers with health benefits beyond basic nutrition. The nutraceutical industry has witnessed substantial growth due to heightened consumer awareness of health and wellness, an aging population, and a growing demand for natural and preventive health solutions. Consequently, nutraceutical products have gained popularity in the eCommerce market, providing consumers with easy access to a wide range of options from the comfort of their homes.

To stay updated with the latest developments, investors and interested parties can visit Ladybug Resource Group, Inc.'s official websites at https://ladybuglbrg.com and https://growhousenutraceuticals.com, or follow the company on its social media channels.

In the realm of stocks, these positive financial results and strategic moves by Ladybug Resource Group, Inc. and Growhouse Nutraceuticals Ltd. are sure to capture the attention of investors and analysts alike. As the nutraceutical industry continues to flourish, the companies' focus on eCommerce and product expansion positions them well for future growth and success.

Safe Harbor for Forward-Looking Statements: This news release contains forward-looking statements that involve inherent risks and uncertainties. While the Company believes that the assumptions and factors used in preparing the forward-looking information are reasonable, actual results may differ from management's expectations due to various factors, including changes in economic and financial market conditions. The Company disclaims any intention or obligation to update or revise any forward-looking information.

Company Contact: Alan K. Fetzer, Chairman and CEO Ladybug Resource Group Inc. 1408 S. Denver Avenue, Tulsa, OK 74119 www.ladybuglbrg.com +1 918-727-7137 info@ladybuglbrg.com

[2023. 11. 28.][NYSE:SHOP]Shopify Merchants Drive Record-High $9.3 Billion in Black Friday-Cyber Monday Sales

[2023. 11. 28.][NYSE:SHOP]Shopify Merchants Drive Record-High $9.3 Billion in Black Friday-Cyber Monday Sales

Shopify Merchants Smash Sales Records with $9.3 Billion in Black Friday Cyber Monday Bonanza

Internet, Everywhere - November 28, 2023 - Shopify Inc. (NYSE, TSX: SHOP), the backbone of online commerce, has just unveiled jaw-dropping figures from this year's Black Friday Cyber Monday (BFCM) weekend, leaving financial analysts and e-commerce enthusiasts astounded. In a remarkable display of resilience and growth, Shopify merchants raked in a staggering $9.3 billion in sales, marking a remarkable 24% increase compared to the previous year.

From the moment Black Friday dawned in New Zealand to the late hours of Cyber Monday in California, over 61 million shoppers worldwide flocked to brands powered by Shopify, making this one of the most lucrative weekends in the company's history.

The shopping frenzy reached its zenith when the collective sales tally skyrocketed to an astonishing $4.2 million per minute, precisely at 12:01 p.m. EST on Black Friday.

Shopify's President, Harley Finkelstein, couldn't contain his excitement, stating, "Watching entrepreneurs achieve their first sale and witnessing established brands reach unprecedented heights during Black Friday-Cyber Monday was nothing short of incredible. Our dedicated merchants spend the entire year building relationships with customers and earning their trust. This weekend was a testament to how they consistently deliver outstanding experiences and products that global consumers crave."

Here are some remarkable highlights from Shopify's network of merchants during BFCM:

• Global Reach: Over 61 million consumers worldwide made purchases from Shopify-powered brands, underscoring the platform's global appeal.

• Record-Breaking Sales: Shopify's merchants collectively shattered previous records, amassing a jaw-dropping $9.3 billion in sales.

• Peak Shopping Moment: Sales peaked at an astonishing $4.2 million per minute at 12:01 p.m. EST on Black Friday, a testament to the platform's robust infrastructure and merchant success.

Shopify, the world's leading commerce company, empowers businesses of all sizes with essential internet tools for commerce. With a focus on speed, customization, reliability, and security, Shopify is committed to enhancing the online shopping experience for consumers worldwide. Trusted by renowned brands like Mattel, Gymshark, Netflix, and SKIMS, Shopify powers millions of businesses across 175 countries.

For further information, please visit www.shopify.com.

*Shopify's 2023 Black Friday-Cyber Monday data is based on gross merchandise volume (GMV) by Shopify merchants around the world from November 23 11:00 UTC to November 28 8:00 UTC. GMV represents the total dollar value of orders facilitated through the Shopify platform, net of refunds, and inclusive of shipping and handling, duty, and value-added taxes. Please note that all data presented here is approximate, unaudited, and subject to adjustment. Year-on-year variations may affect data methodology. All financial figures are in USD. Data includes both online and offline sales by Shopify's global merchants.

For media inquiries, please contact: Stephanie Ross Lead, External Communications press@shopify.com

For investor relations, please contact: Carrie Gillard Director, Investor Relations ir@shopify.com

[2023. 11. 28.][NASDAQ:MGRM]Monogram Orthopaedics Delivers First Surgical Robot

[2023. 11. 28.][NASDAQ:MGRM]Monogram Orthopaedics Delivers First Surgical Robot

Monogram Orthopaedics Achieves Major Milestone with First Surgical Robot Delivery

AUSTIN, TX / ACCESSWIRE / November 28, 2023 / Monogram Orthopaedics Inc. (NASDAQ:MGRM), a trailblazing medical technology company specializing in reconstructive joint procedures and surgical robotics, has reached a significant turning point in its journey. The company recently completed the delivery of its inaugural surgical robot to one of the world's leading global robotics distributors.

This milestone marks a monumental achievement for Monogram Orthopaedics and serves as a pivotal moment in their strategic roadmap. CEO Ben Sexson expressed his excitement, stating, "Delivering our first robot and realizing our first commercial revenues validates our technology and represents a pivotal milestone for our strategic roadmap. Our system is performing at an extremely high level. We now look forward to seeing how our robot competes and scales in the real world. We hope to see the mBôs robot contribute to advancing the standard of care for orthopedic patients worldwide."

Monogram's mission is to elevate the standard of care in orthopedic joint replacement surgery through cutting-edge, next-generation active surgical robotics. Remarkably, despite advances in technology, approximately 88% of knee replacement surgeries (the Company's initial target market) are still conducted manually. The mBôs robot aims to revolutionize the field by combining safety, user-friendliness, cost-efficiency, innovative implant design, extensive clinical capabilities, and speed to drive the next wave of robotic adoption in orthopedics.

About Monogram Orthopaedics

Monogram Orthopaedics (NASDAQ: MGRM) is at the forefront of developing a product solution architecture with the ultimate goal of enabling patient-optimized orthopedic implants on a large scale by integrating 3D printing and robotics with advanced pre-operative imaging. The Company has a robot prototype capable of autonomously executing optimized paths for the precise insertion of implants in synthetic bone specimens. Monogram intends to manufacture and market robotic surgical equipment, related software, orthopedic implants, tissue ablation tools, navigation consumables, and other essential instrumentation required for reconstructive joint replacement procedures. It's important to note that the Company has not yet submitted 510(k) premarket notifications or obtained 510(k) clearances for its robotic products, as FDA approval is required for marketing such products.

Monogram Orthopaedics is on a mission to transform the landscape of orthopedic surgery. Their system aims to combine personalized knee implants with precision robotic surgical assistants to provide patients with better-fitting knee replacements through minimally invasive surgery. With a market of $19.4 billion and approximately 100,000 knee replacements failing each year, this presents a tremendous opportunity for the company.

For more information, please visit www.monogramorthopedics.com.

Forward-Looking Statements

This press release may contain "forward-looking statements." These statements pertain to Monogram Orthopaedics Inc.'s financial projections, business plans, product expectations, or other forecasts about future events. Such statements are identified by words such as "should," "may," "intends," "anticipates," "believes," "estimates," "projects," "forecasts," "expects," "plans," and "proposes."

While Monogram Orthopaedics Inc. believes that these forward-looking statements are based on reasonable assumptions, there are inherent risks and uncertainties that could cause actual results to differ materially. It is advisable to carefully review and consider any cautionary statements and other disclosures, including those under the "Risk Factors" section and elsewhere in the SEC filing. Forward-looking statements are only valid as of the document's date, and Monogram Orthopaedics Inc. does not commit to updating them except as required by law.

Investor Relations

Chris Tyson Executive Vice President MZ North America Direct: 949-491-8235 MGRM@mzgroup.us

SOURCE: MONOGRAM ORTHOPAEDICS INC

[2023. 11. 29.][NASDAQ:CHRS]Coherus and Junshi Biosciences Announce Publication of Positive Final Overall Survival Results of JUPITER-02, a Phase 3 Trial Evaluating LOQTORZI™ (toripalimab-tpzi) as Treatment for Nasopharyngeal Carcinoma, in the Journal of the American Medical Association

[2023. 11. 29.][NASDAQ:CHRS]Coherus and Junshi Biosciences Announce Publication of Positive Final Overall Survival Results of JUPITER-02, a Phase 3 Trial Evaluating LOQTORZI™ (toripalimab-tpzi) as Treatment for Nasopharyngeal Carcinoma, in the Journal of the American Medical Association

Coherus BioSciences and Junshi Biosciences Announce Breakthrough in Cancer Treatment

REDWOOD CITY, Calif. and SHANGHAI, China, Nov. 28, 2023 (GLOBE NEWSWIRE) -- In a groundbreaking development, Coherus BioSciences, Inc. (Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd (HKEX: 1877; SSE: 688180) have revealed the final results of the JUPITER-02 trial (NCT03581786) in a recent publication in the Journal of the American Medical Association (JAMA). The study evaluated the combination of LOQTORZI™ (toripalimab-tpzi), an immune checkpoint inhibitor, with gemcitabine and cisplatin chemotherapy as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC).

The JUPITER-02 trial demonstrated a remarkable 37% reduction in the risk of death for NPC patients treated with toripalimab plus chemotherapy compared to chemotherapy alone. This groundbreaking discovery is a significant milestone in the treatment of this aggressive form of head and neck cancer.

Dr. Robert Ferris, Director of UPMC Hillman Cancer Center, emphasized the urgent need for new treatment options for patients with rare cancers like NPC. He stated, "As these data demonstrate, toripalimab clearly has the potential to significantly extend both progression-free and overall survival for patients living with NPC, and I believe this approach will offer a new standard of care for patients."

LOQTORZI is the first and only FDA-approved treatment for recurrent or metastatic NPC, irrespective of PDL-1 status, and is set to become available in the United States in January 2024. The addition of LOQTORZI to gemcitabine-cisplatin chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone, with a median OS that was not reached in the LOQTORZI arm versus 33.7 months in the placebo arm.

Moreover, LOQTORZI exhibited a consistent positive effect on OS across various subgroups, including PD-L1 expression and EBV copy number high and low subgroups. The combination therapy also demonstrated superior progression-free survival (PFS), with a median PFS of 21.4 months compared to 8.2 months with chemotherapy alone.

These results have positioned LOQTORZI as a promising treatment option for NPC patients, filling a critical unmet need. The safety profile of LOQTORZI was consistent with other toripalimab clinical trials and the PD-1 inhibitor class.

Professor Ruihua Xu, principal investigator from Sun Yat-sen University Cancer Centre, noted, "The latest 3-year follow-up data showed that the combination of toripalimab with GP chemotherapy significantly reduced the risk of death by 37% and the risk of disease progression by 48%, and the 3-year OS rate reached 64.5%, an encouraging result for the first-line treatment of advanced NPC."

Dr. Jianjun Zou, Global Research and Development President of Junshi Biosciences, highlighted the global impact of this innovative treatment, which has received approval in both China and the U.S. He stated, "At present, this innovative treatment has been approved in China and the U.S. And through extensive cooperation, we strive for toripalimab to reach other parts of the world to provide more patients with better treatment options."

This groundbreaking research opens up new possibilities for NPC patients and underscores the importance of ongoing advancements in cancer treatment.

About NPC: Nasopharyngeal carcinoma (NPC) is a rare and aggressive cancer that originates in the upper part of the throat behind the nose, near the base of the skull. It has a low incidence rate in the United States, with limited treatment options. The five-year survival rate for advanced NPC is approximately 49%, highlighting the urgent need for effective therapies.

About LOQTORZI™ (toripalimab-tpzi): LOQTORZI is a next-generation anti-PD-1 monoclonal antibody that has demonstrated significant improvement in overall survival in several tumor types. It is the first and only FDA-approved treatment for recurrent or metastatic NPC, marking a new standard of care for this rare and aggressive cancer.

[2023. 11. 29.][OTC:CSBTF]Kuros Biosciences Receives FDA Clearance for Use of MagnetOs in Interbody Spinal Cages

[2023. 11. 29.][OTC:CSBTF]Kuros Biosciences Receives FDA Clearance for Use of MagnetOs in Interbody Spinal Cages

ZURICH, SWITZERLAND / ACCESSWIRE / November 28, 2023 / Kuros Biosciences ("Kuros"), a pioneer in cutting-edge bone graft technologies, has received the green light from the U.S. Food and Drug Administration (FDA) to utilize MagnetOs Flex Matrix in interbody spaces, marking a significant development in the field of spinal fusion procedures.

With interbody cages playing a pivotal role in almost half of the approximately 1.5 million instrumented spinal fusion procedures carried out annually in the United States, this announcement bears great importance for surgeons and patients alike. MagnetOs Flex Matrix stands out as an ideal choice for interbody applications due to its remarkable granule retention, maintaining strength and flexibility even when wet. This versatility enables easy placement through a funnel or direct packing into cages of various sizes, approved for use with a bone void filler.

MagnetOs Flex Matrix, the latest product from Kuros to receive FDA clearance, had previously gained approval for use in posterolateral fusions. Its unique fibrillar and flexible structure complements Kuros' established NeedleGrip™ surface technology, optimizing bone growth even in soft tissues.

Chris Fair, CEO of Kuros, expressed the significance of this milestone, stating, "This clearance opens up substantial commercial opportunities for our MagnetOs Flex Matrix product, enabling us to re-engage with surgeons who were previously unable to use it for interbody procedures. Kuros remains committed to advancing our research and technology to benefit patients and investors alike."

For more information, please contact:

About MagnetOs MagnetOs is a revolutionary bone graft that boasts NeedleGrip™ surface technology, promoting bone growth even in soft tissues. This surface technology provides traction for essential 'pro-healing' immune cells (M2 macrophages), unlocking the potential to stimulate stem cells and facilitate new bone formation throughout the graft. This emerging field of science, known as osteoimmunology, ultimately translates into more predictable fusion outcomes for surgeons and patients.

U.S. Indications Statement MagnetOs Flex Matrix is designed to fill bony voids or gaps in the skeletal system, including the intervertebral disc space and posterolateral spine. These osseous defects can be surgically created or result from traumatic bone injuries but are not intrinsic to the stability of the bony structure. In intervertebral disc space and posterolateral spine applications, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When employed in intervertebral body fusion procedures, it must be used with an intervertebral body fusion device cleared by the FDA for use with a bone void filler. MagnetOs Flex Matrix is gradually resorbed and replaced with bone during the healing process.

About Kuros Biosciences Kuros Biosciences is a rapidly growing leader in the development of spinal fusion biologics, alleviating the burden of back pain. With presence in the United States, Switzerland, and the Netherlands, the company is listed on the SIX Swiss Exchange. MagnetOs, the company's debut commercial product, is a unique synthetic bone graft that has demonstrated success in over 15,000 spinal fusion surgeries across three continents. The next candidate in Kuros' pipeline is Fibrin-PTH, a groundbreaking drug-biologic combination for interbody spinal fusions, currently undergoing a Phase 2 clinical trial in the U.S.

Forward-Looking Statements This press release contains forward-looking statements that involve inherent risks and uncertainties, which could lead to materially different outcomes compared to historical or future results implied by these statements. Words such as "will" or "expect" or their negatives are used in uncertain and forward-looking contexts. Scientific, business, economic, and financial factors can contribute to actual results differing from those predicted in forward-looking statements. Given these uncertainties, reliance on forward-looking statements is discouraged. The company does not assume responsibility for updating or adjusting forward-looking statements to reflect future events or developments.

1. iData Research, How Many Spinal Fusions are Performed Each Year in the United States? https://idataresearch.com/how-many-instrumented-spinal-fusions-are-performed-each-year-in-the-united-states/, accessed November 2023

2. AcuityMD, procedure numbers estimated by CPT code Q4 2022-Q3 2023

3. Duan, et al. eCM. 2019;37:60-73

4. Van Dijk, et al. eCM. 2021;41:756-73

5. Van Dijk, et al. JOR Spine. 2018;e1039

6. Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater. 2019;107(6):2080-2090

7. Van Dijk, et al. Clin Spine Surg. 2020;33(6):E276-E287

8. Data on file

*In large animal models

†Results from in vivo laboratory testing may not be predictive of clinical experience in humans.

§MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft

¶MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion.

[2023. 11. 17.][NASDAQ:ANL]Adlai Nortye Announces Completion of Patient Enrollment in Global Phase III Clinical Trial of Buparlisib （AN2025） in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC

[2023. 11. 17.][NASDAQ:ANL]Adlai Nortye Announces Completion of Patient Enrollment in Global Phase III Clinical Trial of Buparlisib （AN2025） in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) is making waves in the biotechnology world with the announcement of a major milestone in their quest to revolutionize cancer treatment. The company has just completed patient enrollment for the Global Phase III Clinical Trial (BURAN) of their groundbreaking drug, Buparlisib (AN2025), in combination with Paclitaxel for the treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). This groundbreaking study spans over 180 sites worldwide, covering 18 markets across North America, Europe, Asia, and South America.

The BURAN study is breaking new ground as the first global multicenter Phase III trial for HNSCC involving pan-PI3K inhibitors. Buparlisib (AN2025), an oral pan-PI3K inhibitor, is being evaluated alongside paclitaxel to combat recurrent or metastatic HNSCC.

Lars Birgerson, President and Chief Medical Officer of Adlai Nortye Ltd., highlighted the pressing need for innovative treatments in the field: "There is a high unmet medical need for patients with recurrent or metastatic HNSCC after anti-PD-1/anti-PD-L1 therapy. As the trial is now fully enrolled, we eagerly look forward to the results which may change the paradigm of second-line treatment for HNSCC and provide a new treatment option for patients worldwide."

The BURAN study is a randomized, open-label, multicenter phase III study designed to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel, compared to weekly paclitaxel alone. It targets patients with recurrent or metastatic head and neck squamous cell carcinoma who have progressed after prior anti–PD–1/anti–PD–L1 monotherapy, prior anti–PD–1/anti–PD–L1 therapy in combination with platinum-based therapy, or after sequential treatment of anti–PD–1/anti–PD–L1 therapy, either prior to or post-platinum-based therapy.

AN2025 (buparlisib) is a game-changing oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In a global randomized Phase II clinical trial for the treatment of recurrent or metastatic HNSCC with buparlisib in combination with paclitaxel, the median overall survival reached an impressive 10.4 months, compared to 6.5 months in the paclitaxel-only group. The FDA has granted Fast-Track designation for buparlisib in this indication, underscoring its potential to transform cancer treatment. This ongoing study marks Adlai Nortye's inaugural global Phase III clinical trial.

Adlai Nortye (NASDAQ: ANL) is rapidly gaining recognition as a global clinical-stage biotechnology company with a laser focus on pioneering cancer therapies. The company's research and development centers in New Jersey and Hangzhou are at the forefront of innovative oncology solutions. With a robust pipeline of six drug candidates, Adlai Nortye boasts a management team and scientific advisory board comprised of industry leaders and influential scientists, providing international and strategic guidance. The company actively seeks partnerships with leading multinational pharmaceutical companies like Eisai and Novartis to fully unlock the potential of its pipeline programs. Adlai Nortye aims to lead the charge in the next era of immuno-oncology therapies through combination therapy strategies, with the ultimate goal of turning deadly cancers into manageable and curable diseases.

Forward-Looking and Cautionary Statements: This announcement contains forward-looking statements, made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are characterized by terms like "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "potential," "continue," "ongoing," and "targets." They encompass the Company's beliefs and expectations, business outlook, and management's quotes. Forward-looking statements come with inherent risks and uncertainties, including factors like the progress and results of preclinical studies and clinical trials, regulatory approvals, commercialization, and market acceptance. Adlai Nortye remains committed to transforming the landscape of cancer treatment and will continue to provide updates on its progress.

Contacts: Investor Relations: Charles Zhou Amanda Kong

Adlai Nortye Ltd. ir@adlainortye.com

[2023. 11. 17.][NASDAQ:SANA]Uppsala University Hospital and Sana Biotechnology Announce Authorization of the First-in-Human Clinical Trial Application for a Primary Islet Cell Treatment for Patients with Type 1 Diabetes

[2023. 11. 17.][NASDAQ:SANA]Uppsala University Hospital and Sana Biotechnology Announce Authorization of the First-in-Human Clinical Trial Application for a Primary Islet Cell Treatment for Patients with Type 1 Diabetes

Sana Biotechnology, Inc. and Uppsala University Hospital in Sweden are set to revolutionize the field of medical transplantation with their groundbreaking UP421 islet cell therapy. This innovative treatment, engineered using Sana's hypoimmune (HIP) technology, aims to provide proof of concept for transplanting functional islet cells without the need for immunosuppression, offering hope to patients with type 1 diabetes.

In a historic move, the Swedish Medical Products Agency has granted authorization for Uppsala University's Clinical Trial Application (CTA) to commence an investigator-sponsored, first-in-human study of UP421. This therapy has been designed to evade both allogeneic and autoimmune rejection, a major breakthrough in the world of transplantation.

The primary objectives of this study include assessing the safety of UP421, monitoring cell survival, evaluating immune evasion capabilities, and measuring C-peptide production. Success in these areas could pave the way for Sana's SC451, a hypoimmune-modified stem-cell derived islet cell therapy that holds immense promise for individuals with type 1 diabetes.

Traditional islet cell transplantation has long been a beacon of hope for type 1 diabetes patients, but the requirement for concurrent immunosuppression has been a limiting factor, leading to side effects and reduced effectiveness. Sana's hypoimmune technology, with its unique modifications, has demonstrated the potential to circumvent both allogeneic and autoimmune rejection in preclinical models, offering a glimpse of hope for a future where cell transplantation can occur without the need for immunosuppression.

Steve Harr, Sana's President and CEO, expressed excitement about the collaboration with Uppsala University and the potential to transform the landscape of type 1 diabetes treatment. He highlighted the extensive experience of the Uppsala team in islet cell transplantation and clinical care, emphasizing the importance of this clinical study's results in advancing the development of SC451.

Per-Ola Carlsson, Study Principal Investigator and Senior Physician at Uppsala University Hospital, underlined the significance of this groundbreaking research, stating that their long-term goal is to cure type 1 diabetes by replacing damaged insulin-producing cells with new ones, ultimately eliminating the need for immunosuppression.

The core challenge in islet cell transplantation has been immune rejection, primarily due to human leukocyte antigen (HLA) class I and class II expression, which UP421 aims to disrupt. Furthermore, overexpression of CD47 allows these cells to evade the innate immune cell system, including macrophages and natural killer (NK) cells. If UP421 can successfully overcome immunologic rejection, it may open the door to engraftment, survival, and C-peptide production without the burden of immune suppression.

Sana's hypoimmune platform is at the heart of this groundbreaking research, offering the potential to create cells ex vivo that can be transplanted without the need for immunosuppression. This technology is being applied to various cell types, including donor-derived allogeneic T cells and pluripotent stem cells, with promising results in evading both innate and adaptive immune responses while retaining their functionality.

Sana Biotechnology, Inc. is dedicated to changing the landscape of medicine by delivering engineered cells as therapies to patients. Their vision encompasses repairing and controlling genes, replacing damaged cells, and making these groundbreaking therapies accessible to all. With operations spanning Seattle, Cambridge, South San Francisco, and Rochester, Sana is at the forefront of innovation in the field of biotechnology.

As we eagerly await the results of the UP421 clinical trial, the world watches with bated breath, hoping that this pioneering approach will usher in a new era of transplantation and treatment for patients with type 1 diabetes.

[2023. 11. 17.][NYSE:MAIA]MAIA Biotechnology （NYSE： MAIA） Has Received FDA Orphan Drug Designation For THIO As A Treatment For Most Aggressive Brain Cancer

 [2023. 11. 17.][NYSE:MAIA]MAIA Biotechnology （NYSE： MAIA） Has Received FDA Orphan Drug Designation For THIO As A Treatment For Most Aggressive Brain Cancer

CHICAGO, IL / ACCESSWIRE / November 17, 2023 / In a groundbreaking development, MAIA Biotechnology Inc. (NYSE: MAIA) has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for their pioneering cancer telomere-targeting agent, THIO, aimed at transforming the treatment landscape for glioblastoma, one of the most aggressive and prevalent forms of brain cancer.

Glioblastoma, a devastating disease that affects over 15,000 individuals annually in the United States alone, has limited treatment options and a grim prognosis, with only 7% of patients surviving beyond five years after diagnosis.

What sets THIO apart is its unique ability to breach the formidable blood-brain barrier (BBB) in both syngeneic and humanized mouse models of telomerase-expressing brain cancers. This breakthrough enables THIO to directly target brain tumors in vivo, offering hope to glioblastoma patients.

Sergei Gryaznov, Ph.D., MAIA's Chief Scientific Officer, expressed enthusiasm about the data presented to the FDA, which showcased THIO's remarkable mechanism of action and BBB-penetrating property. In preclinical studies, treatment with THIO demonstrated potent anticancer activity and significantly extended the lifespan of animal models, particularly in cases that are traditionally challenging to treat.

The FDA's Orphan Drug Act of 1983 aims to incentivize the development of therapies for rare diseases, affecting fewer than 200,000 people in the U.S. annually. With glioblastoma falling into this category, MAIA's orphan drug designation for THIO brings substantial financial incentives, including up to seven years of market exclusivity if approved.

The glioblastoma market is expected to grow from $2.2 billion to $3.2 billion globally in the next three years, and MAIA Biotechnology is poised to make a significant impact with its groundbreaking therapy.

THIO is not limited to glioblastoma; it has previously received orphan drug designations for hepatocellular carcinoma (HCC) and small-cell lung cancer (SCLC) in 2022, highlighting its potential to treat various cancer types, including rare ones.

Furthermore, MAIA Biotechnology is actively conducting a phase 2 clinical trial of THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). Recent data from the THIO-101 trial revealed an unprecedented Disease Control Rate (DCR) of 100% in second-line treatment for NSCLC, surpassing the standard-of-care DCR by a significant margin.

This news positions MAIA Biotechnology as a frontrunner in the race to combat challenging cancers, offering new hope to patients and investors alike.

Investor Relations ir@maiabiotech.com

SOURCE: MAIA Biotechnology

[2023. 11. 18.][NYSE:MDT]Medtronic announces FDA approval of minimally invasive device to treat hypertension

[2023. 11. 18.][NYSE:MDT]Medtronic announces FDA approval of minimally invasive device to treat hypertension

Medtronic plc (NYSE: MDT), a global healthcare technology leader, has just received FDA approval for its groundbreaking Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure. This marks a significant milestone in the world of hypertension treatment. With the green light from the FDA, Medtronic is gearing up for immediate commercialization.

Hypertension, commonly referred to as high blood pressure, is a pervasive health issue that can lead to heart attacks, strokes, and even death. It particularly affects underserved populations in the United States. Despite the availability of medications and lifestyle interventions, many struggle to control their blood pressure effectively. This approval is a promising development as it offers patients a new approach to managing hypertension.

Medtronic's Symplicity blood pressure procedure is an innovative, minimally invasive technique that employs radiofrequency energy to target nerves near the kidneys that can become overactive and contribute to high blood pressure. The procedure involves the insertion of a thin tube (catheter) into the artery leading to the kidney under sedation. Once in place, the medical team administers energy to calm the overactive nerves. The tube is then removed, leaving no implant behind.

"The Symplicity blood pressure procedure is a safe and effective method that significantly reduces blood pressure levels for patients," noted Dr. David Kandzari, Chief of the Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. "This milestone approval comes after extensive scientific research and clinical trials, including long-term studies with and without medication, and the largest real-world study."

Patient preference and shared decision-making are key elements in developing a comprehensive hypertension care plan that includes the Symplicity blood pressure procedure. A patient preference study conducted by Medtronic showed that when presented with an interventional treatment option with similar blood pressure reduction potential and associated risks as the Symplicity blood pressure procedure, approximately one third of patients were inclined to choose the interventional treatment.

Dr. Raymond Townsend, from the Hypertension Section at the University of Pennsylvania School of Medicine and co-principal investigator of the SPYRAL clinical program, emphasized, "This approval opens the door to a transformation in hypertension treatment, offering a complementary solution to medication and lifestyle changes. The Symplicity blood pressure procedure holds promise for both clinicians and patients, addressing an unmet need in hypertension care, especially for those seeking additional approaches to lower their blood pressure."

Medtronic's SPYRAL HTN Global Clinical Program is the most extensive clinical program dedicated to studying RDN, with over 25,000 patients treated globally. It encompasses studies conducted with and without medication, involving patients with high cardiovascular risk. While currently limited for investigational use in Japan, China, and Canada, the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries worldwide.

This approval represents a significant advancement in the field of hypertension treatment, providing patients with a promising adjunctive therapy option to better manage their blood pressure and reduce the risk of serious cardiovascular complications.

About Medtronic

Medtronic plc, headquartered in Dublin, Ireland, is a global healthcare technology company at the forefront of addressing some of the most challenging health issues worldwide. With a mission to alleviate pain, restore health, and extend life, Medtronic's diverse team of over 95,000 professionals across 150 countries develops innovative technologies and therapies that treat 70 different health conditions. Their portfolio includes cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more, all designed to make a positive impact on people's lives. Expect more from Medtronic as they continue to empower insight-driven care, prioritize patient experiences, and drive better outcomes for the world. For further information on Medtronic (NYSE:MDT), please visit www.Medtronic.com, and follow @Medtronic on Twitter and LinkedIn.