Workflow
Regenerative Medicine
icon
Search documents
Hemostemix's Boots on the Ground in Florida October Update
Newsfile· 2025-10-30 15:29
Core Insights - Hemostemix Inc. is advancing its autologous stem cell therapy, VesCell™ (ACP-01), in Florida, focusing on patients with chronic limb-threatening ischemia (CLTI) and related conditions, leveraging the newly enacted Florida Senate Bill 1768 [1][2][4] Group 1: Legislative Framework - Florida Senate Bill 1768 establishes a progressive framework for regenerative medicine, allowing licensed physicians to administer unapproved stem-cell therapies for pain management and wound care, provided safety and ethical standards are met [2] - The statute offers a pathway for no-option CLTI patients to access potentially life-saving therapies like ACP-01 [2] Group 2: Company Initiatives - Hemostemix is implementing a "Boots on the Ground" initiative to enhance patient access to ACP-01, which includes educational webinars for vascular surgeons across Florida [1][4] - The company has deployed a dedicated sales and outreach team to engage with vascular surgeons and podiatrists in major Florida cities, focusing on education about SB 1768 and establishing clinic partnerships [6][7] Group 3: Physician Education and Training - A specialized curriculum is being developed to train physicians on ACP-01 protocols, patient consent standards, and monitoring practices, ensuring compliance with SB 1768 [8] - Hemostemix is conducting Grand Rounds presentations at the University of Florida to review clinical trial results and promote ethical integration of ACP-01 [5][4] Group 4: Patient Access and Community Engagement - The company is expanding compassionate-use access for CLTI patients under SB 1768, facilitating treatment for those with severe pain and non-healing wounds [9] - Educational materials are being created for patients to inform them about regenerative options and the benefits of ACP-01 in pain relief and wound healing [11] Group 5: Clinical Research and Results - Hemostemix has completed seven clinical studies involving 318 subjects, demonstrating the safety and efficacy of ACP-01 for various cardiovascular conditions [12] - The Phase II clinical trial for chronic limb-threatening ischemia reported a 0% mortality rate and an 83% wound healing rate among patients followed for up to 4.5 years, significantly better than the typical 50% mortality rate in this patient population [12]
Creative Medical Technology Holdings, Inc. Ignites Next-Gen Regenerative BioDefense Initiative for U.S. Veterans Exposed to Burn Pits
Globenewswire· 2025-10-30 13:15
Core Insights - Creative Medical Technology Holdings, Inc. has launched the BioDefense Inc. Veterans Initiative to address the long-term effects of toxic burn pit exposure among U.S. service members [1][2] - The initiative aims to position Creative Medical as a key player in America's biodefense infrastructure, utilizing proprietary iPSC and regenerative technologies alongside AI analytics [2][7] Group 1: Initiative Overview - The BioDefense Inc. initiative is believed to be a first-of-its-kind national program focused on combating the health impacts of toxic exposure for veterans [1] - The program will create a large molecular-level database of veteran toxic exposure, serving as a foundation for precision regenerative therapies [3][9] Group 2: Technological Collaboration - Greenstone Biosciences has been selected as the exclusive AI and iPSC development partner to enhance the initiative [4] - The partnership will leverage advanced molecular-sequencing and machine-learning algorithms to analyze data from service members exposed to burn pits [5][6] Group 3: Goals and Objectives - The initiative aims to develop predictive disease modeling systems for both military and civilian populations [6] - It seeks to decode the genomic and proteomic architecture of toxic-exposure-related injuries and engineer iPSC-based regenerative repair models [9]
Apollo Biowellness, Inc., Corporate Status and Merger Update
Newsfile· 2025-10-29 13:30
Core Insights - Apollo Biowellness, Inc. is updating shareholders on corporate developments and the merger with Revive Regenerative, Inc. [1] - The merger's original closing date was October 30, 2025, but an extension of approximately 30 days is needed to complete the process [1] - The company is negotiating to convert all debt to equity as a condition for closing the merger [1] Corporate Developments - The company has completed initial bridge financing of $500,000 for the merger and is seeking an additional $3,000,000 as per the Merger Agreement [1] - A definitive update on the debt conversion is expected within the next 7 to 10 days [1] - The company is also negotiating with a tele-med GPL-1 Peptide company to expand its product offerings [1] Product and Market Positioning - The merger aims to create a fully integrated company combining laser and energy devices with exosome-based biologic aesthetic products and GLP-1 weight loss products [3] - This integration is expected to significantly increase top-line revenues and enhance EBITDA [3] - Apollo Biowellness is positioning itself as a leader in Regenerative Medicine, focusing on biologic-based products [4]
United Therapeutics(UTHR) - 2025 Q3 - Earnings Call Presentation
2025-10-29 13:00
Financial Performance - Total revenue reached $800 million, representing a 7% year-over-year increase compared to Q3 2024[30] - Tyvaso DPI and nebulized Tyvaso combined revenue increased by 10% year-over-year to $478 million[30, 58] - Orenitram revenue increased by 16% year-over-year to $131 million[30, 58] - Remodulin revenue decreased slightly by 2% year-over-year to $126 million[30, 58] - Unituxin revenue decreased by 22% year-over-year to $48 million[30, 58] - The company's trailing twelve months (TTM) operating cash flow is $16 billion, and it holds $43 billion in cash, cash equivalents, and marketable investments[31] Pipeline Development - TETON-2 study of nebulized Tyvaso for Idiopathic Pulmonary Fibrosis (IPF) met its primary endpoint[37] - TETON-1 study data for Tyvaso in IPF in the U S and Canada is expected in the first half of 2026[37, 40, 42] - The ADVANCE OUTCOMES study of Ralinepag for Pulmonary Arterial Hypertension (PAH) is fully enrolled with 728 patients, and data is expected in the first half of 2026[47, 50]
BioStem Technologies Appoints KPMG as its Independent Registered Public Accountant
Globenewswire· 2025-10-27 20:15
Core Insights - BioStem Technologies, Inc. has appointed KPMG LLP as its new independent registered public accounting firm, replacing Marcum LLP, effective October 22, 2025 [1][2] - The transition to KPMG is part of the company's strategy to support long-term growth and its planned uplisting to the Nasdaq Capital Market [2][3][4] Company Strategy - The company aims to proceed with its uplisting to the Nasdaq following the completion of audits for the fiscal years 2024 and 2025 [3] - Uplisting is considered a key priority for the company, expected to enhance visibility, improve stock liquidity, provide accurate market valuation, and attract top talent [4] Company Overview - BioStem Technologies focuses on developing, manufacturing, and commercializing placental-derived products for advanced wound care, leveraging its proprietary BioREtain processing method [4] - The company’s quality management system is accredited by the American Association of Tissue Banks and complies with current Good Tissue Practices and Good Manufacturing Processes [4]
Creative Medical Technology Holdings Issues Letter to Shareholders
Globenewswire· 2025-10-27 12:15
Core Insights - Creative Medical Technology Holdings, Inc. has made significant advancements in 2025, transitioning from proof-of-concept to clinical trials for regenerative stem cell therapies across multiple indications [1][2] - The company is leveraging proprietary cellular platforms, including AlloStem™, ImmCelz™, and iPScelz™, to position itself as a leader in regenerative medicine, capitalizing on breakthroughs in biology and AI [2][3] - Creative Medical's diversified platform strategy allows for multiple therapeutic approaches, enhancing market reach and reducing development risks [3][4] Clinical Trials - The company is advancing two pivotal FDA-cleared clinical programs targeting multi-billion-dollar markets, which are expected to serve as major near-term catalysts [5][6] - The trials utilize the AlloStem foundation, maximizing cost efficiency and scalability [6] Intellectual Property - Creative Medical boasts a strong intellectual property portfolio with over 60 patents and pending applications, including two cornerstone U.S. patents secured in Q3 2025 for ImmCelz, covering Type 1 Diabetes and Heart Failure [7] - These patents validate the company's core science and provide long-term exclusivity in high-value healthcare markets [7] AI Integration - The integration of AI into the iPScelz platform represents a significant advancement in regenerative medicine, aimed at accelerating target discovery and optimizing donor cell selection [8] - By utilizing AI to decode cellular behavior, the company is pioneering personalized regenerative medicine, enhancing treatment precision [9] Financial Strategy - The company operates with financial discipline, focusing investments on high-return milestones while maintaining a lean operational structure [9] - Multiple potential value-driving events are anticipated in the next 12 months, with a commitment to sustainable growth without excessive dilution [9] Future Focus - Creative Medical is dedicated to redefining possibilities in regenerative medicine, with validated science, scalable platforms, and a clear vision for long-term shareholder value [10]
CollPlant Expands its rhCollagen Distribution Capabilities in the United States and Canada
Prnewswire· 2025-10-27 11:01
Core Insights - CollPlant Biotechnologies is expanding its distribution capabilities in North America by establishing a new logistics center in the U.S. to support its rhCollagen and BioInk product lines [1][3][4] Group 1: Expansion and Infrastructure - The new logistics center will provide cGMP-compliant storage and distribution services, enhancing logistical efficiencies for CollPlant's operations in the U.S. and Canada [1][2] - The facility features advanced infrastructure, including a cloud-based temperature monitoring system, AI-powered security, and remote inventory management, ensuring reliable and secure distribution [2] Group 2: Strategic Commitment - The establishment of the U.S. logistics center reflects CollPlant's long-term commitment to the North American market and is seen as a significant milestone in advancing its regenerative medicine products [3] - By maintaining local inventory, the company aims to improve efficiency and reduce shipping times, thereby enhancing customer access to its products [3] Group 3: Company Overview - CollPlant focuses on regenerative and aesthetic medicine, utilizing its proprietary recombinant human collagen technology for various applications, including tissue repair and organ manufacturing [4] - The company has previously entered into a global commercialization agreement for dermal and soft tissue fillers with Allergan, a leader in the dermal filler market [5]
REGENTIS BIOMATERIALS LTD.(RGNT) - Prospectus(update)
2025-10-24 12:00
As filed with the Securities and Exchange Commission on October 24, 2025. Registration No. 333-285692 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 AMENDMENT NO. 6 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REGENTIS BIOMATERIALS LTD. (Exact name of registrant as specified in its charter) | State of Israel | 2834 | Not Applicable | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organ ...
Hemostemix Granted Trademark "KNOW YOUR HEALTH" in Japan, International Registration No. 1744775 Covers Stem Cell Preparations and Research in Classes 1, 5, 42
Newsfile· 2025-10-22 14:04
Core Viewpoint - Hemostemix Inc. has been granted the trademark "KNOW YOUR HEALTH" in Japan, enhancing its intellectual property and global branding strategy in regenerative medicine and personalized health innovation [2][3]. Trademark Grant Details - The trademark registration covers Classes 1, 5, and 42, which include chemicals for scientific research, pharmaceutical preparations, and technological services in regenerative medicine [6]. - The registration number is International Registration No. 1744775, issued by the Japanese Patent Office [6]. Strategic Significance - The trademark aligns with Hemostemix's clinical programs, particularly the ACP-01 treatment for various ischemic and cardiopulmonary diseases, reinforcing the synergy between brand identity and product pipeline [5]. - The registration strengthens Hemostemix's global intellectual property portfolio, particularly in Japan, a leading market for medical research [10]. - The trademark allows for expanded therapeutic coverage, reflecting Hemostemix's leadership in developing autologous cell-based treatments for vascular and degenerative disorders [10]. - It provides a platform for global collaboration, enabling licensing and commercialization of innovations within Japan's regulatory framework for regenerative medicine [10]. CEO Commentary - The CEO expressed honor at the trademark grant, highlighting its importance for the company's commitment to improving patient health through autologous stem-cell therapy and enhancing partnerships with institutions in Asia [7]. Company Overview - Hemostemix is an autologous stem cell therapy platform company founded in 2003, known for its VesCell™ (ACP-01) treatment, which has shown significant clinical results in various studies [8]. - The company has completed seven clinical studies involving 318 subjects, demonstrating the safety and efficacy of ACP-01 for treating multiple ischemic conditions [8].
Visionary Holdings Launches Toronto-Based Joint Venture to Drive Global Commercialization of Innovative Stem Cell Therapy for Diabetes Remission, Targeting a $150 Billion Market Opportunity
Prnewswire· 2025-10-22 13:30
Core Viewpoint - Visionary Holdings Inc. has signed a strategic cooperation agreement with Jiangsu Yike Regenerative Medical Technology Co., Ltd. to establish a joint venture, Visionary Yike Stemcell Technologies Inc., aimed at advancing stem cell research and commercialization globally [1][5]. Group 1: Joint Venture Details - The joint venture will focus on stem cell therapy, immune cell engineering, and AI-supported anti-aging diagnostics, leveraging Yike's proprietary platform and GV's global market infrastructure [3]. - GV will hold an 85% equity stake in the joint venture, while Yike will hold 15% [3]. - The joint venture aims to create a vertically integrated regenerative medicine enterprise encompassing R&D, trials, manufacturing, and global sales [3]. Group 2: Location and Infrastructure - The headquarters for the joint venture is proposed to be located at GV's property in Toronto, which spans over 40,000 square meters [2]. - The parties are evaluating the feasibility of developing cleanrooms, low-temperature biostorage, and related infrastructures to support future operations [2]. Group 3: Strategic Importance - The establishment of the joint venture is seen as a transformative milestone for GV's global health strategy, with potential for long-term value creation [4]. - This collaboration is expected to enhance GV's positioning in the North American stem cell sector and reflects a commitment to global innovation and shareholder value [5]. Group 4: Company Background - Visionary Holdings Inc. is a technology-driven multinational enterprise focused on innovative education, AI applications, and high-tech healthcare solutions, operating across North America and Asia [6]. - Jiangsu Yike Regenerative Medicine specializes in regenerative medicine and precision anti-aging technologies, holding numerous international patents and certifications [7].