Regenerative Medicine
Search documents
Apollo Biowellness, Inc., Launches New Product Brand
Newsfile· 2025-08-21 13:30
Core Insights - Apollo Biowellness, Inc. has announced the launch of a new self-stable biologic cosmetic line named Cielo Skin Care, which utilizes self-stabilized exosome and placental-based products derived from human tissue to enhance skin cell regeneration and anti-aging effects [1][3][4] Product Launch Details - The Cielo Skin Care line is set to launch in late Q3 and will be available in Q4 through major retail, e-commerce, direct-to-consumer marketing, social media influencers, and TV shopping outlets [4] - The company claims this is the first shelf-stable biologic skin care cosmetic, which is expected to significantly contribute to the growth of its business model alongside its existing Doctor and Med Spa brand, Evolutionary Biologics [4] Company Overview - Apollo Biowellness, Inc. and its subsidiary, Evolutionary Biologics, focus on the discovery, development, and marketing of products aimed at improving human health, positioning themselves as leaders in the field of Regenerative Medicine [5] - The company is currently working on marketing licensed patent-pending natural stem cell mobilizing agents and a dual acting all-natural diet aid designed to help control hunger [5]
NurExone Biologic Announces Preclinical Evidence of Structural Repair in Injured Spinal Cord Tissue following ExoPTEN Treatment
Globenewswire· 2025-08-20 20:03
Core Viewpoint - NurExone Biologic Inc. has successfully closed a private placement and announced promising preclinical imaging results for its lead product ExoPTEN, which shows potential for spinal cord repair following injury [1][10][14]. Company Developments - The company closed a non-brokered private placement of 1,258,072 units at C$0.62 per unit, raising gross proceeds of C$780,004.64, intended for working capital [10][11]. - NurExone is preparing for its first-in-human clinical trial of ExoPTEN, pending regulatory approval [4][14]. Product and Research Insights - Preclinical imaging analysis indicates that ExoPTEN-treated animals exhibited more organized spinal cord tissue compared to untreated controls, with 100% of higher-dose group animals regaining motor function [2][3]. - MRI-Diffusion Tensor Imaging (MRI-DTI) results show that treated spinal cords had greater structural integrity, with higher Fractional Anisotropy (FA) values and lower Mean Diffusivity (MD) values near the injury site, suggesting healthier tissue architecture [5][6][8][9]. - The imaging results support the neuroprotective and regeneration-promoting activity of ExoPTEN in spinal cord injury [3][15]. Market Context - Spinal cord injuries present significant healthcare and economic challenges, with current treatments primarily focusing on stabilization rather than tissue repair. ExoPTEN aims to address this unmet need by supporting nerve repair and restoring function [4][14]. - The market for spinal cord injury treatments is substantial, with NurExone's lead product positioned in a multi-billion-dollar market [14].
Longeveron® to Present at the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-08-20 13:15
Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs [2] - The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [2] - Laromestrocel has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [2] Pipeline and FDA Designations - Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [2] - The HLHS program has received three important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [2] - The Alzheimer's disease program has received two FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [2] Upcoming Events - Longeveron will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City [1] - The company's presentation is scheduled for September 8, 2025, from 4:00 to 4:30 p.m. ET, with a webcast available on the company's website [1]
Apollo Biowellness, Inc., Corporate Update
Newsfile· 2025-08-18 13:30
Core Viewpoint - Apollo Biowellness, Inc. has received approval to file on OTCIQ and is actively pursuing multiple strategic initiatives to enhance its product offerings and market presence [1][6]. Group 1: Product Development - The company is in final negotiations with a NASDAQ-listed Israeli Bio-Tech manufacturer for the co-development of a shelf-stable biologic cosmetic named Ceilo Skin Care, set to launch in Q4 2025 [3]. - Apollo plans to introduce a unique Pet and Veterinarian Biologic product utilizing exosomes and placental products, targeting issues like arthritis and inflammation in pets, with a launch before the end of Q3 2025 [5]. Group 2: Strategic Partnerships - The company is negotiating with a large aesthetic company specializing in Laser Energy Devices for a potential merger or business combination to create a combined therapy company [4]. Group 3: Financial Strategy - Apollo is working with its debt holders and convertible note holders to restructure, refinance, or convert most positions to a preferred class of equity, aligning with management's growth financing plans for the next 12 months [6]. Group 4: Company Overview - Apollo Biowellness, Inc. and its subsidiary, Evolutionary Biologics, Inc., focus on discovering, developing, and marketing biologic-based products aimed at improving human health, positioning itself as a leader in Regenerative Medicine [7][8].
Beam Therapeutics Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to BEAM-101 for the Treatment of Sickle Cell Disease
Globenewswire· 2025-08-14 11:00
Core Insights - Beam Therapeutics has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for BEAM-101, a genetically modified cell therapy aimed at treating sickle cell disease (SCD) [1][2] - The RMAT designation follows an earlier orphan drug designation and is expected to facilitate collaboration with the FDA as the company progresses towards a Biologics License Application (BLA) filing [2][4] - The BEACON Phase 1/2 trial has dosed 30 patients, with promising clinical data indicating robust increases in fetal hemoglobin and reductions in sickle hemoglobin [3][5] Company Overview - Beam Therapeutics is focused on developing precision genetic medicines using its proprietary base editing technology, which allows for precise genetic modifications without double-stranded breaks in DNA [7][8] - The company aims to create a fully integrated platform for gene editing, delivery, and manufacturing to provide long-term cures for serious diseases [7][8] Product Details - BEAM-101 is an investigational therapy that utilizes autologous CD34+ hematopoietic stem and progenitor cells, which are base-edited to enhance fetal hemoglobin production [5] - The therapy is designed to mimic naturally occurring variants that lead to increased fetal hemoglobin, potentially alleviating symptoms of SCD [5][6] Clinical Trial Insights - Updated clinical data from the BEACON trial presented at the EHA 2025 Congress showed durable increases in fetal hemoglobin and no vaso-occlusive crises reported post-engraftment [3][4] - The trial is ongoing, with additional data expected by the end of 2025, further supporting the potential of BEAM-101 as a transformative treatment for SCD [2][4]
Longeveron Announces Closing Of Up To $17.5 Million Public Offering
Globenewswire· 2025-08-11 20:15
Core Points - Longeveron Inc. has closed a public offering of 5,882,354 shares of Class A common stock at a price of $0.85 per share, with potential additional gross proceeds of up to $12.5 million from short-term warrants [1][3] - The company intends to use the net proceeds for ongoing clinical and regulatory development of laromestrocel, targeting conditions such as HLHS, Alzheimer's disease, and pediatric DCM, as well as for general corporate purposes [3][6] - H.C. Wainwright & Co. acted as the exclusive placement agent for this offering [2] Financial Details - The gross proceeds from the offering were approximately $5.0 million before deducting fees and expenses [3] - The short-term warrants have an exercise price of $0.85 per share and are immediately exercisable for a period of twenty-four months [1][3] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines, with its lead product being laromestrocel, an allogeneic mesenchymal stem cell therapy [6] - The company is pursuing four pipeline indications: HLHS, Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [6] - Laromestrocel has received multiple FDA designations, including Orphan Drug and Fast Track designations for HLHS, and Regenerative Medicine Advanced Therapy designation for Alzheimer's disease [6]
Longeveron Announces Up To $17.5 Million Public Offering
Globenewswire· 2025-08-08 17:28
Group 1 - Longeveron Inc. announced a public offering of 5,882,354 shares of Class A common stock at a price of $0.85 per share, with potential additional gross proceeds of up to $12.5 million from short-term warrants [1][3] - The offering is expected to close on or about August 11, 2025, subject to customary closing conditions [1] - The company intends to use the net proceeds for ongoing clinical and regulatory development of laromestrocel, including funding for various disease states such as HLHS, Alzheimer's disease, and pediatric DCM [3][6] Group 2 - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The securities are being offered under a registration statement filed with the SEC, which became effective on August 8, 2025 [4] Group 3 - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines, with its lead product being laromestrocel, an allogeneic mesenchymal stem cell therapy [6] - The company is pursuing four pipeline indications: HLHS, Alzheimer's disease, Pediatric DCM, and Aging-related Frailty, and has received multiple FDA designations for its development programs [6]
Adia Med Enters $1.9 Billion Glutathione Industry with Innovative IV and Transdermal Therapies, Expanding High-Demand Offerings
Newsfile· 2025-08-06 13:00
Core Insights - Adia Nutrition, Inc. is entering the $1.9 billion glutathione market with innovative IV and transdermal therapies, expanding its offerings in regenerative medicine [1][6] - The global glutathione market is projected to reach $3.9 billion by 2035, driven by increasing consumer awareness of antioxidants [6] Company Developments - Adia Med has integrated glutathione IV therapies into its treatment protocols, which include advanced stem cell and exosome therapies [3][4] - The newly introduced Glutaryl Transdermal Glutathione Spray utilizes sub-nanotechnology for enhanced skin absorption, providing a non-invasive alternative to IV therapies [5] - The addition of glutathione therapies reflects Adia Med's commitment to innovative, science-backed patient care solutions [4][7] Market Position - Adia's entry into the glutathione market strengthens its position as a leader in regenerative medicine, creating significant revenue potential for investors [6][7] - The glutathione therapies are expected to appeal to a broad audience, including athletes and wellness enthusiasts, enhancing Adia's clinic offerings [5][6] Strategic Vision - The CEO of Adia Nutrition expressed enthusiasm about entering the glutathione market, emphasizing the importance of delivering solutions requested by patients and doctors [7] - The company is open to strategic partnerships to expand access to its advanced stem cell solutions [7]
Cryoport Reports Second Quarter 2025 Financial Results
Prnewswire· 2025-08-05 20:19
Core Insights - Cryoport, Inc. reported strong financial results for Q2 and H1 2025, with total revenue from continuing operations increasing by 14% year-over-year to $45.5 million in Q2 and 12% to $86.5 million in H1 [10][19][20] - The company achieved double-digit growth across all revenue streams within Life Sciences Services, with a notable 21% increase year-over-year [2][4] - A strategic partnership with DHL Group was launched, enhancing Cryoport's global biologistics capabilities and providing a strong capital infusion [5][10] Financial Performance - Life Sciences Services revenue for Q2 2025 was $24.4 million, up 21% from $20.2 million in Q2 2024, and accounted for 54% of total revenue [19][10] - BioLogistics Solutions revenue increased by 20% year-over-year to $19.9 million, while BioStorage/BioServices revenue rose 28% to $4.5 million [19][10] - Life Sciences Products revenue grew 8% year-over-year to $21.1 million [19][10] Profitability Metrics - Gross margin from continuing operations improved to 47.0% in Q2 2025, compared to 44.5% in Q2 2024 [19][10] - Adjusted EBITDA was a negative $0.9 million for Q2 2025, an improvement from negative $5.6 million in Q2 2024 [21][10] Strategic Developments - The company supported 728 global clinical trials as of June 30, 2025, a net increase of 44 trials from the previous year [7][9] - Cryoport's customer, Abeona Therapeutics, received FDA approval for their cell therapy ZEVASKYNTM during the quarter [9][10] Guidance and Future Outlook - Cryoport reaffirmed its full-year 2025 revenue guidance, expecting total revenue from continuing operations to be in the range of $165 million to $172 million, representing 5% to 10% growth year-over-year [24][10] - The company anticipates additional application filings and therapy approvals in the remainder of 2025 [11][10]
Vericel Q2 Revenue Jumps 20%
The Motley Fool· 2025-08-05 19:14
Core Insights - Vericel reported a 20% year-over-year GAAP revenue growth in Q2 2025, reaching $63.2 million, driven by its MACI franchise, despite missing analyst expectations of $64.5 million [1][2] - The company achieved a gross margin of 74%, an increase of 4 percentage points from the previous year, and narrowed its net loss per share to $0.01, outperforming the estimated loss of $0.03 [1][2][8] Financial Performance - Revenue for Q2 2025 was $63.2 million, up from $52.7 million in Q2 2024, reflecting a 20% increase [2] - Adjusted EBITDA (Non-GAAP) reached $13.4 million, a 112% increase from $6.3 million in Q2 2024 [2] - Operating cash flow was reported at $8.2 million, with cash reserves of approximately $164 million and no long-term debt [2][8] Product Performance - MACI, the cartilage repair implant, generated $53.5 million in revenue, a 21% increase year-over-year, and saw a significant rise in biopsies, indicating future revenue potential [5][6] - In burn care, Epicel and NexoBrid generated revenues of $8.6 million and $1.2 million, respectively, with Epicel revenue increasing from $7.8 million and NexoBrid growing by 52% from $0.8 million [7] Business Strategy - The company is focused on expanding the usage of its products, training more physicians, and enhancing delivery methods, such as the new arthroscopic technique for MACI [4][6] - Management plans to expand the MACI sales force in the second half of 2025 to align with expected demand and surgeon training momentum [11] Market Outlook - Management expects full-year MACI revenue growth in the low 20% range and a stable run rate of approximately $10 million per quarter for burn care in the second half of 2025 [12] - Vericel received FDA clearance for a Phase 3 study of MACI for ankle cartilage repair, potentially opening a new market worth an estimated $1 billion annually [11]