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Celularity Inc. (NASDAQ: CELU), headquartered in Florham Park, N.J., is a trailblazer in the field of cellular medicine. As a clinical-stage biotechnology company, Celularity is at the forefront of developing off-the-shelf, placental-derived allogeneic cell therapies. Its innovative products include unmodified natural killer (NK) cells, genetically-modified NK cells, T-cells engineered with a chimeric antigen receptor (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs). These therapies target a diverse range of conditions such as cancer, infectious diseases, and degenerative disorders.
Celularity is also a pioneer in the development and manufacture of advanced biomaterials derived from the postpartum placenta. The unique biology and availability of the placenta allow Celularity to create accessible, effective, and affordable therapeutic solutions that address significant global health challenges.
Recent Achievements and Current Projects:
- The company has received IND clearance from the FDA and is set to begin a Phase 1/2 study in 2024 with its placental-derived cell therapy.
- The Healthcare Common Procedure Coding System (HCPCS) Q code approval for Biovance® 3L has been granted by the Centers for Medicare and Medicaid Services (CMS). This code enhances the use of Biovance® 3L for wound care in office settings, enabling broader adoption and growth.
- Celularity has presented promising data from in vivo studies of its PT-CD16VS, a genetically modified allogeneic cell therapy, in combination with various monoclonal antibodies. This data highlights the therapy’s potential in treating HER2-positive cancers and other conditions.
Financial Condition and Partnerships:
The company’s financial health is under scrutiny as it works to regain compliance with Nasdaq listing requirements. Celularity is actively developing a plan to submit to Nasdaq by June 17, 2024, to address its delinquent reports. Meanwhile, the company anticipates continued growth through its advanced cell therapies and biomaterials.
Celularity’s partnerships, particularly in the field of regenerative medicine, exemplify its commitment to innovation and excellence. The company’s state-of-the-art manufacturing facility further supports its ability to produce advanced cell therapies at scale, aiming to meet the unmet needs of patients worldwide.
For more detailed information and the latest updates, visit the official website www.celularity.com.
Celularity Inc. (Nasdaq: CELU) announced that the FDA has conducted a preliminary classification of its investigational FUSE Bone Void Filler, recommending that it be classified as a device under its Center for Devices and Radiological Health (CDRH). This follows Celularity's Pre-Request for Designation (Pre-RFD) from October 2022. The company plans to submit its 510(k) pre-market notification to the FDA in early 2024. The global bone void filler market is expected to grow from $3.2 billion in 2021 to $7.3 billion by 2031, driven by factors such as an increase in orthopedic diseases and an aging population.
Celularity Inc. has entered into an exclusive distribution agreement with AD Ports Logistics to distribute Halal-Certified regenerative medicines and wellness products across the Middle East, including UAE, Qatar, Bahrain, Oman, Kuwait, and Egypt. This partnership follows a prior agreement for Saudi Arabia and aims to enhance access to innovative healthcare solutions in the region. Celularity's commercial biomaterial products include various types derived from human placental tissue. The regenerative medicine market is expected to grow significantly, reaching $37.10 billion by 2030, highlighting the importance of this distribution deal for both companies.
Celularity Inc. (NASDAQ: CELU) has entered an exclusive distribution agreement with AD Ports Logistics for the distribution of its Halal-Certified regenerative medicine products across the United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, and Egypt. This follows a similar agreement for Saudi Arabia. The global regenerative medicine market, valued at approximately $9.80 billion in 2021, is projected to grow at a CAGR of 15.9%, reaching $37.10 billion by 2030. Celularity aims to expand its presence in the Middle East and North Africa, leveraging AD Ports’ logistics capabilities to enhance healthcare access in the region.
Celularity Inc. (Nasdaq: CELU) has announced intentions to submit a 510(k) pre-market notification to the FDA for its investigational Celularity Tendon Wrap (CTW). The FDA has agreed to regulate CTW as a device, based on the company's recommendation. The CTW is designed for tendon injuries without substantial tissue loss, serving as a surgical mesh. The global tendon repair market was valued at $2.1 billion in 2021, with a projected CAGR of 7.5% through 2030. Celularity also has exclusive agreements for distributing its biomaterial products in over 100 countries. The submission is expected by year-end with planned product launch in 2024.
Celularity Inc. (Nasdaq: CELU) announced progress in its strategic review, focusing on its commercial biomaterials and cell therapy programs. Key highlights include a new distribution agreement covering over 100 countries for Halal-certified products and ongoing advancements in its osteoarthritis programs. Promising preclinical results show significant improvements in cartilage formation and reduced inflammation using its placental-derived products. The company aims to align its operating priorities through targeted expense reductions while preparing for a biomaterials production ramp-up in 2023. Additionally, workforce notifications were made as part of its strategic realignment.
Celularity Inc. has partnered with Tamer Group as the exclusive distributor of its Halal-Certified regenerative biomaterial products in Saudi Arabia. This strategic collaboration aims to enhance public health and support Saudi Arabia's Vision 2030 healthcare objectives. With the global regenerative medicine market projected to reach $37.10 billion by 2030, this distribution agreement is positioned to capitalize on significant market growth. Products are expected to be available in Saudi Arabia in 2023, pending regulatory approval.
Celularity Inc. (NASDAQ: CELU) has partnered with CH Trading Group to distribute its Halal-Certified regenerative biomaterial products in over 100 countries. The agreement includes a minimum purchase commitment of
Celularity Inc. (Nasdaq: CELU) announced positive findings from its legacy studies on placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy for Crohn’s disease. The re-analysis revealed a clinical remission rate of 50% at two years and an overall response rate of 83% among a limited patient group. The optimal treatment schedule involved two infusions a week apart. The safety profile was favorable with no dose-limiting toxicities. Celularity is moving forward with its genetically modified allogeneic therapy, APPL-001, in hopes of addressing unmet medical needs in Crohn's disease.
Celularity Inc. (Nasdaq: CELU) has appointed Paul Graves as Senior Vice President and Chief Communications Officer, effective January 2, 2023. Bringing over 30 years of experience in biopharmaceutical public relations, Graves will lead strategic communications as the company progresses towards FDA submissions for its clinical pipeline. Graves previously held senior communication roles at Janssen and Takeda Pharmaceuticals, focusing on R&D communication across various therapeutic areas. His role aims to enhance the visibility of Celularity's placental-derived therapies, which target cancer and other diseases.
Celularity Inc. (Nasdaq: CELU) has achieved Halal Certification for its cellular therapy candidates and biomaterial products, allowing access to Islamic markets globally. This certification, issued by Circle H International, validates compliance with Islamic law, facilitating Celularity's expansion strategy, particularly in the Middle East North Africa (MENA) region, focusing on Saudi Arabia. The MENA healthcare market is projected to reach
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