Blood- and bone marrow-based efficient growth factors extraction system demonstrates substantial equivalence and high cell viability

SEOUL, South Korea, April 10, 2026 /PRNewswire/ — Miracell, a leading stem cell technology company, announced that it has obtained U.S. FDA 510(k) clearance for its stem cell extraction system, SMART M-CELL, along with its dedicated kits, the BSC Blood Kit and BMSC Bone Marrow Kit.

The clearance was granted based on demonstrated substantial equivalence to SmartPReP, a globally recognized standard system originally developed by the Institute for Immunological Research (IDI) at Harvard Medical School. This milestone underscores the international credibility of Miracell’s technology in terms of cell quality and performance.

The cell concentration technology utilizing SmartPrep has been continuously validated through a wide range of studies and comparative analyses, with approximately 100 related publications and review articles reported to date.

Notably, in patients with knee osteoarthritis, BMAC injections have demonstrated reductions in pain and improvements in function. In cases of rotator cuff tears, the application of BMAC and BSC has been associated with increased cell proliferation, as well as pain relief and functional recovery. Additionally, studies in cartilage defects and bone injury sites have reported tissue regeneration and histological improvements following the use of BMAC or BSC.^[1,2]

Beyond musculoskeletal indications, the biological efficacy and broader applicability of cell concentration technologies have been explored across multiple therapeutic areas, including skin regeneration and aesthetics, diabetic ulcers, chronic wound healing, vascular and cardiovascular regeneration, and immune-related conditions.

While SmartPReP has been widely recognized as a high-performance concentration system, SMART M-CELL represents a significant advancement.

Miracell’s technology maximizes cellular activity during the extraction process, maintaining cell viability.

This breakthrough is the result of hundreds of experimental iterations

SMART M-CELL is an automated system that selectively separates and concentrates Efficient Growth Factors from blood and bone marrow. Beyond Efficient Growth Factors, it produces a multi-cell composition that includes growth factors, white blood cells, and SDF-1α, supporting tissue regeneration and functional recovery. The system is designed to maximize clinical applicability with high recovery rates and operational stability.

Notably, this FDA clearance validates not only individual components but the entire integrated system—combining both centrifuge and kit—demonstrating its performance and effectiveness as a unified solution. This distinguishes Miracell from conventional centrifuge devices, which have typically been classified as lower-risk, notification-only products.

Efficient Growth Factors extraction technology requires more than simple physical concentration; it demands the preservation of cellular sensitivity and biological characteristics. Achieving higher purity levels requires exponentially greater engineering precision. Through its unique system and kit design, SMART M-CELL delivers world-class cell recovery rates and purity. Miracell previously secured a U.S. patent in February 2024 for its centrifuge container (kit) used in SMART M-CELL.

SMART M-CELL is currently the only FDA-cleared Efficient Growth Factors extraction system from Korea. The FDA clearance, along with U.S. patent recognition, validates Miracell’s differentiated approach from Harvard-based systems and confirms its superior extraction performance and product stability.

Miracell emphasized that as cell purity increases, performance improves exponentially, noting that this FDA clearance reflects the culmination of its intensive R&D efforts to enhance purity—even by just 1%. With both U.S. patent protection and FDA 510(k) clearance, SMART M-CELL is positioned to become one of the most trusted regenerative medicine solutions in the clinical field.

While treatment has traditionally focused on symptom relief through pharmacological approaches, there is a growing shift toward biologic therapies based on the body’s intrinsic healing capabilities. Advances in regenerative medicine—particularly those leveraging autologous cells and growth factors—are driving new treatment paradigms aimed at fundamental tissue repair and functional restoration, rather than simple symptom management.

Miracell also noted that it has already obtained regulatory approvals in multiple countries and is currently supplying SMART M-CELL and related kits to approximately 40 countries worldwide, including across Europe. The company added that regulatory approvals are underway in markets such as Brazil and Taiwan, and that, following the recent FDA clearance, it plans to aggressively expand into the global market, including the United States.

Meanwhile, Miracell is a regenerative medicine company that has successfully awarded four stem cell-based new medical technologies in Korea, including treatments for cartilage defects, acute myocardial infarction, critical limb ischemia, and knee osteoarthritis. The company is also advancing efforts to expand its treatment portfolio, including the registration of a new medical technology involving concentrated autologous bone marrow stem cell injections for intervertebral disc pain.

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HONG KONG, April 10, 2026 /PRNewswire/ — Now TV’s on-demand service, Now True, is dedicated to curating high-quality programmes from around the world and presenting original works under its Now True Original label, specifically crafted for Hong Kong audiences. Aside from creating Cantonese dubbing scripts, the brand also invites well-known artists and industry professionals to serve as voice narrators. The Cantonese dubbing script for the documentary Shades of Indigo, written by scriptwriter Yip Ka Man, has recently been nominated for the 2026 EGA’s Hermes Awards in the category of “Best Script Adaptation for a Dubbed Audio”, bringing the production onto the international stage. The film will compete alongside leading titles such as Stranger Things and Squid Game Season 3, with results to be announced on 16 April 2026.

Directed by Shigeru Yoshida, Shades of Indigo marks his first feature-length documentary, chronicling the stories of artisans devoted to the art of indigo dyeing. After the Industrial Revolution, “synthetic blue” dyes became the mainstream in textile production, yet the film’s protagonists have remained steadfast in their use of traditional indigo dyeing techniques. The documentary’s unique theme vividly showcases the spirit of Japanese craftsmanship. Now True has specially invited Hong Kong film director Adam Wong to serve as voice narrator. During the recording session, Wong praised the thoughtful scripts production, and now, with industry recognition through the EGA Hermes Awards nomination, this achievement holds even greater significance.

Now True Original features a diverse range of content—ranging from sports, food, art, music to gang culture and indigo-dyeing techniques—each widely appreciated by audiences. Its voice-narration lineup is equally star-studded, featuring Stanley@MIRROR, Serrini Leung, Sumling@COLLAR, Michelle Loo, Adam Wong, Joey Leung, Justin Cheung, Alton Diwei Yu, Peter Cheung, and Lau Shun-man.

More Now True Original Titles:

• The Hidden World of Yakuzas – Cantonese Narrator: Justin Cheung
• Come Back Anytime – Cantonese Narrator: Michelle Loo
• Fuzjko Hemming: A Soulful Pianist in Love – Cantonese Narrator: Serrini Leung
• The Making Of A Japanese – Cantonese Narrator: Stanley@MIRROR
• Virgilio – Cantonese Narrator: Joey Leung
• Boris Becker: The Rise And Fall – Cantonese Narrator: Alton Diwei Yu
• In The Mood For Art – Cantonese Narrator: Sumling@COLLAR
• FC Bayern: Generation Wembley – Cantonese Narrator: Lau Shun-man
• The Grizzlie Truth – Cantonese Narrator: Peter Cheung

Watch Shades of Indigo online: https://nowplayer.now.com/

Learn more about Now TV: https://www.nowtv.now.com/blog

About Now True

Now True brings together quality programmes from around the world, offering customers award-winning films, inspiring true stories, and a wide variety of premium content. Its library also includes concerts, arts and cultural programmes, and stories that touch your heart.

*Now True on-demand service lets you watch what you want anytime, at your convenience.
*Selected programmes are available in 4K UHD for an enhanced visual experience.
*Multi-language programmes include English or Chinese subtitles.
*Selected titles also feature Cantonese dubbing for a more convenient viewing experience.

Website: https://www.nowtv.now.com/nowtrue/
Facebook: Now TV
Instagram: nowtv.hk

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BEIJING, April 10, 2026 /PRNewswire/ — On March 28, iQIYI, China’s leading online entertainment platform, announced plans to develop iQIYI LAND in Wuhan, Central China’s Hubei province. Set within the Hanyangzao Cultural and Creative Industry Park, the park is the company’s first project integrated into an urban renewal initiative, which positions iQIYI LAND as a new cultural and tourism landmark for the city, combining homegrown IP with technology-driven immersive experiences.

Slated to open in 2027, the park is iQIYI’s fourth theme park development and the first in Central China, in partnership with Wuhan Urban Construction Group. It will bring iQIYI’s most beloved Chinese IPs to life through immersive theaters, immersive experiences, immersive stage performances, iconic film-and-TV scene photo spots, live character interactions, and social games, alongside cultural tourism experiences developed around Wuhan’s local heritage. The result is a destination designed not just to entertain, but to deepen the emotional connection audiences already have with iQIYI’s content.

The announcement reflects a broader shift underway in China’s cultural tourism industry, where content and emotional resonance, rather than just scenery and ticket sales, are becoming the primary draw. “IP and technology are the accelerators of this transition,” said Gong YU, founder and CEO of iQIYI. “Powered by technology, we will use IP as our core thread, delivering emotional value through dramas, animation, and variety shows online, and through theme parks and IP-based consumer products offline.”

Building on the Proven Results of iQIYI LAND Yangzhou

The new iQIYI LAND in Wuhan builds on a strong start at iQIYI LAND Yangzhou, which opened on February 8, 2026, and has since earned ratings above 4.9 out of 5 on Dianping, Meituan, and Ctrip, driven by its blend of drama IP experiences and technology-powered immersion. Recent programs include a costume exhibition featuring wardrobe pieces from iQIYI’s shows such as “Mysterious Lotus Casebook” and “FEUD,” as well as upcoming events including an offline promotional event for other upcoming dramas that turns the shows’ streaming momentum into a physical draw.

iQIYI LAND locations in Beijing, China’s Capital in the north, and Kaifeng, a city in eastern Henan Province in Central China, are currently under construction and expected to open later this year. As the network grows, so does iQIYI’s ability to bring the same stories audiences watch at home into spaces they can physically experience.

Contact: iQIYI Press, press@qiyi.com

Source: iQIYI Inc.

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SEOUL, South Korea, April 9, 2026 /PRNewswire/ — NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, announced today that it has entered into an exclusive distribution agreement in Japan with Asahi Intecc Co., Ltd., a global medical device company, for Nexsphere-F™, the company’s novel fast-resorbable microsphere for embolization.

Unlike many biotechnology companies that generate revenue through technology transfer and royalties, NEXTBIOMEDICAL differentiates itself by exporting finished medical devices directly. This agreement follows the same model, under which the Company will supply finished products to its Japanese partner.

Asahi Intecc specializes in medical microcatheters and guidewires and has established a strong global presence across Japan, the United States, Europe, China, and India. Guidewires are essential devices used in most vascular interventional procedures, while microcatheters play a critical role in various embolization procedures, including musculoskeletal embolization (MSKE) and transcatheter arterial chemo-embolization (TACE).

Asahi Intecc supplies its products to approximately 120 countries worldwide and continues to expand its business in the vascular intervention field, supported by a broad product portfolio aligned with the growing demand for minimally invasive treatments. In particular, Asahi Intecc has strengthened its market influence through its extensive physician network in Japan, including Dr. Yuji Okuno, a pioneer in genicular artery embolization for osteoarthritis, as well as its strong distribution capabilities. Its flagship products maintain a leading global market share and strong competitiveness.

As of the end of fiscal year 2025, Asahi Intecc reported revenue of approximately JPY 120 billion, representing a 12% year-over-year increase, with an operating profit margin of 25.1%. Approximately 90% of its revenue is generated from its medical device segment, and the company continues to expand beyond its domestic Japanese market into global regions, including the United States, Europe, and China. NEXTBIOMEDICAL expects that Asahi Intecc’s robust physician network and distribution capabilities will play a key role in facilitating Nexsphere-F’s entry into the Japanese market.

Nexsphere-F™, NEXTBIOMEDICAL’s flagship product, is a fast-resorbable microsphere designed for musculoskeletal pain embolization. The product has received regulatory approvals from the Ministry of Food and Drug Safety (MFDS) in Korea, CE-MDD certification in Europe, and approval from Health Canada. Post-market clinical studies are actively underway both domestically and internationally. In addition, clinical trial for U.S. FDA approval is currently in progress, with the Company targeting approval between 2027 and 2028.

Through this agreement, NEXTBIOMEDICAL aims to accelerate its entry into the Japanese market. The PMDA approval and reimbursement approval processes in Japan are expected to be pursued in collaboration with Asahi Intecc Co., Ltd.

A representative from NEXTBIOMEDICAL stated, “This agreement was made possible due to strong recognition of our product competitiveness and global market potential. We plan to accelerate our expansion into Japan by leveraging Asahi Intecc’s local sales network.”

The representative added, “This exclusive agreement in Japan will serve as a significant milestone in Nexsphere-F™’s global expansion strategy. We aim to achieve meaningful outcomes in the Japanese market through close collaboration with local physicians and partners.”

Source: NEXTBIOMEDICAL CO., LTD.

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ROCKVILLE, Md., April 9, 2026 /PRNewswire/ — OncoC4 Inc., a late clinical stage biopharmaceutical company, today announced first participant’s dosing following the clearance of the Investigational New Drug (IND) application for a Phase 1/2 clinical trial of ONC-841, the company’s investigational Alzheimer’s disease therapy by the National Medical Product Administration (NMPA). The clinical trial registration number is CTR20260866.

ONC-841 is the world’s first and only clinical stage anti-SIGLEC 10 antibody. The drug was initially developed, and is in a Phase 2 trial, for patients with solid tumors. New preclinical research by OncoC4 has revealed ONC-841’s novel activity in normalizing microglia’s function in clearance of pathogenic protein aggregates in the brain (1, 2). Benefitting from safety data from the oncology study, the new Phase 1/2 AD clinical trial received accelerated clearance to test the safety and clinical activity of the product for AD treatment.

The first study participant was successfully dosed at Xuanwu Hospital of Capital Medical University in China. The Principal Investigators for the clinical study are Professor Yi Tang and Professor Cuibai Wei at the Xuanwu Hospital.

“Extending our clinical study from cancer to AD showcases OncoC4’s research engine and Xuanwu Hospital’s infrastructure as the world’s eminent AD research center. We are extremely grateful to our colleagues at Xuanwu for the collaboration, ” said Dr. Yang Liu, CEO and Chief Scientific Officer. 

“We are extremely excited to collaborate with OncoC4 to explore the potential of targeting SIGLEC 10, the novel checkpoints of AD pathogenesis, to bring clinical benefit for patients with this devastating illness”, added Professor Yi Tang, Executive Vice President and Principal investigator. 

About OncoC4

Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for the treatment of cancer and immunological diseases. OncoC4’s pipeline features assets with first-in-class and best-in-class potential targeting both novel and well validated targets across oncology and immunological diseases. Among them, AI-081 is a fully owned bispecific antibody candidate targeting PD-1 and VEGF. ONC-841 is a first-in-class anti-SIGLEC 10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.

More information: www.oncoc4.com. 

CONTACTS

Media Relations
Pan Pan
media@oncoc4.com

Investor Relations
Ryan Cui
ir@oncoc4.com

1. Wang P, et al. Therapeutic activities of anti-human SIGLEC 10 mAb in multiple transgenic mouse AD models. Alzheimer’s Dement. 2025, 21 (Suppl. 5): e101818.
2. Wang P, et al. Mice carrying unmutated human SIGLEC 10 gene cluster transgene develop both amyloid plaques and Tau neurofilament tangles: a model for late onset Alzheimer’s disease. Alzheimer’s Dement. 2025, 21 (Suppl. 5): e101773.

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