Core Insights - BioStem Technologies, Inc. is expanding its operations by purchasing land for a new headquarters in the Research Park at Florida Atlantic University, which will create up to 100 new jobs over the next five years with the support of up to $300,000 in economic incentives from the city [1][2][3] Company Overview - BioStem Technologies specializes in the development, manufacturing, and commercialization of placental-derived products for advanced wound care, utilizing its proprietary BioRetain processing method to maintain growth factors and preserve tissue structure [5] - The company’s quality management system is accredited by the American Association of Tissue Banks and adheres to current Good Tissue Practices and Good Manufacturing Processes [5] Economic Impact - The new headquarters will centralize administrative offices, manufacturing, and distribution, enhancing operational efficiency and supporting the growing demand for advanced wound care products [2][3] - The Research Park serves as a hub for technology companies and research organizations, fostering collaboration and innovation in South Florida's life sciences sector [3][4] Strategic Location - The choice of the Research Park location is strategic, providing access to a talented workforce and proximity to a university with strong science and healthcare programs [3] - The Research Park has been established as a center for entrepreneurial ideas and technologies since 1985, promoting economic growth in the region [3][4]

Core Insights - BioStem Technologies, Inc. announced positive top-line results from its clinical trial evaluating BioRetain® - Processed Amnion Chorion (BR-AC) for treating non-healing diabetic foot ulcers (DFUs) [1][2] - The trial demonstrated that patients treated with BR-AC were almost twice as likely to achieve lasting wound closure compared to those receiving standard care alone [2][6] Clinical Trial Details - The BR-AC-DFU-101 study was a multicenter, randomized, controlled trial initiated in Q4 2024, involving 71 patients with Wagner 1 or 2 DFUs across 11 U.S. sites [2][3] - The primary objective was to assess the probability of complete wound closure over a 12-week period for patients treated with standard care plus BR-AC versus standard care alone [2][5] Patient Selection and Methodology - A rigorous patient selection process ensured only those with hard-to-heal wounds were enrolled, following FDA guidelines for cutaneous ulcers [2][3] - A 2-week run-in period was implemented to evaluate patient response to standard care, excluding those with significant initial improvement [3] Results and Efficacy - The probability of healing in the BR-AC group was 53%, compared to 31% in the standard care group, indicating superior clinical outcomes for BR-AC [6] - Future publications will address secondary outcome measures related to treatment efficacy and application frequency [5][7] Industry Context - Diabetic foot ulcers affect approximately 15% of individuals with diabetes, with significant hospitalization risks and complications [8] - In 2023, an estimated 2.2 million patients received treatment for DFUs, with treatment costs in the U.S. ranging from $9 billion to $13 billion annually [9] Company Overview - BioStem Technologies focuses on developing placental-derived products for advanced wound care, utilizing its proprietary BioRetain processing method to maintain tissue integrity [12][10] - The company is committed to expanding its clinical research and product offerings, including ongoing studies targeting venous leg ulcers [4]

Core Insights - MiMedx Group, Inc. has launched EPIXPRESS®, a new lyophilized human placental allograft aimed at enhancing its Advanced Wound Care (AWC) product portfolio [1][2] Product Overview - EPIXPRESS is designed to treat acute and chronic hard-to-heal wounds, featuring a tri-layer configuration and fenestrations for improved fluid movement [2][3] - The product is suitable for various conditions, including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), and is effective for deep or tunneling wounds [2][3] Company Background - MiMedx is a leader in the wound care sector, focusing on innovative solutions for chronic and hard-to-heal wounds, with a vision to be the global provider of healing solutions [4]

Company Overview - BioStem Technologies is a profitable med tech company focused on advanced wound care [2] - The company's core technology is BioREtain, which processes placental-based tissue allografts [2] Market Potential - The target patient population includes approximately 7 million Medicare beneficiaries [3] - The total market for advanced wound care is estimated to be around $11.3 billion [3]

Group 1 - MiMedx Group, Inc. will present six posters showcasing its latest product innovations at the Symposium on Advanced Wound Care (SAWC) Fall meeting from September 3-6, 2025, in Las Vegas, NV [1][3] - The company aims to highlight its advanced wound care portfolio at booth 511 during the SAWC event, which is a key platform for clinicians and industry professionals [1] - The company has a vision to be the leading global provider of healing solutions through relentless innovation, focusing on chronic and hard-to-heal wounds [4] Group 2 - A sponsored lunch symposium titled "Change is Inevitable: Mastering the Art of Wound Healing in an Evolving Landscape" will take place on September 4, 2025, featuring discussions on advanced treatment approaches for diverse patient populations [2] - The symposium will include presentations by notable faculty members, addressing the complexities and challenges in wound care [2]

Company Overview - BioStem Technologies, Inc. is a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care [5] - The company utilizes its proprietary BioREtain processing method to maintain growth factors and preserve tissue structure in its allografts [5] Market Position and Opportunities - Jason Matuszewski, Chairman and CEO, will present BioStem's current position in the chronic wound care market and key opportunities for growth at the Advanced Wound Care Summit on July 15, 2025 [1] - The company aims to drive continued growth in its core allograft business while pursuing opportunities to expand its portfolio across the continuum of care [8] Event Details - The Advanced Wound Care Summit will take place from July 15 to 17, 2025, bringing together global leaders in wound care innovation and clinical research [3] - The summit will feature keynote presentations, interactive panels, and strategic networking opportunities to address unmet needs in chronic wound management [3] Quality and Compliance - BioStem's quality management systems and standard operating procedures are accredited by the American Association of Tissue Banks (AATB) and adhere to Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [6] - The company's products are processed at an FDA registered and AATB accredited site in Pompano Beach, Florida [6]

Core Insights - BioStem Technologies, Inc. has completed patient enrollment for a clinical trial comparing BioREtain® Amnion Chorion (BR-AC) to standard care for non-healing diabetic foot ulcers (DFUs) [2][3] - The BR-AC-DFU-101 study aims to evaluate the effectiveness of BR-AC in achieving complete wound closure over a 12-week period [3][5] - Topline results from the study are expected in Q4 2025, with the trial initiated in Q4 2024 across 11 sites in the U.S. [3][4] Company Overview - BioStem Technologies focuses on developing, manufacturing, and commercializing placental-derived products for advanced wound care [2][10] - The company utilizes a proprietary BioREtain processing method that preserves the natural properties of perinatal tissue [8][10] - BioStem's quality management systems are accredited by the American Association of Tissue Banks and adhere to Good Tissue Practices and Good Manufacturing Processes [11] Clinical Trial Details - The primary objective of the BR-AC-DFU-101 study is to determine if the combination of standard care and BR-AC leads to a higher probability of complete wound closure compared to standard care alone [5] - Secondary outcome measures include comparing treatment group differences in wound closure rates, wound area, and volume [7] - The study has enrolled 71 patients, exceeding the initial target of 60 [3][4] Market Context - Diabetic foot ulcers affect approximately 15% of individuals with diabetes, with 6% requiring hospitalization due to complications [5] - The economic burden of DFUs in the U.S. is significant, with annual treatment costs estimated between $9 billion and $13 billion [6] - In 2023, 2.2 million patients received treatment for DFUs, with numbers projected to rise [6]

Core Viewpoint - BioStem Technologies, Inc. is progressing towards uplisting to the Nasdaq Capital Market following the anticipated approval of its amended Form 10 by the SEC, which includes audited financial statements for fiscal years 2023 and 2024, and unaudited results for Q1 2025 [2][4]. Group 1: SEC Review Process - BioStem has resolved outstanding SEC accounting comments and plans to file an amended Form 10 by the end of June 2025 [2]. - The company initially submitted its Form 10 in September 2024 and has been collaborating with auditors and the SEC to address accounting treatment questions related to revenue and service fees [3]. - The uplisting is contingent upon the effectiveness of the Form 10 and meeting other Nasdaq listing requirements [3]. Group 2: Company Overview - BioStem is a MedTech company focused on developing, manufacturing, and commercializing placental-derived products for advanced wound care, utilizing its proprietary BioREtain® processing method [6]. - The company’s quality management systems are accredited by the American Association of Tissue Banks and adhere to Good Tissue Practices and Good Manufacturing Processes [7]. Group 3: Leadership and Communication - Jason Matuszewski, BioStem's CEO, expressed optimism about the progress made in the SEC review process and thanked the team for their commitment [4]. - The company encourages stakeholders to stay informed through its distribution list and social media channels [5].

Core Viewpoint - BioStem Technologies, Inc. is showcasing its innovative placental-derived products for chronic wound care at the Symposium for Advanced Wound Care (SAWC) Spring meeting, emphasizing collaboration with Venture Medical, LLC to enhance patient management and treatment outcomes [1][2][3]. Company Overview - BioStem Technologies focuses on the development, manufacturing, and commercialization of placental-derived products aimed at advanced wound care [1][13]. - The company utilizes its proprietary BioREtain processing method to preserve the natural properties of perinatal tissue, ensuring the efficacy of its allografts [11][13]. Partnership Highlights - The collaboration with Venture Medical, LLC aims to streamline the logistics of managing patients requiring skin substitutes for chronic wound treatment [2][3]. - BioStem's leading products, AmnioWrap2 and Vendaje AC, are exclusively available through Venture Medical, which has effectively penetrated the physician office and mobile segments [3]. Event Participation - BioStem will co-exhibit with Venture Medical at the SAWC Spring meeting in Dallas, TX, from April 30 to May 4, 2025, featuring three accepted scientific posters on its advanced allograft portfolio [1][6]. - The booth schedule includes discussions on reimbursement landscapes, mobile wound care practices, and the benefits of BioStem's BioREtain technology [3][8]. Scientific Contributions - Three clinical and scientific posters accepted for presentation will demonstrate favorable outcomes with BioREtain technology and comparisons with competitive products [10]. - Ongoing randomized clinical trials are evaluating the treatment of diabetic foot ulcers and venous leg ulcers, with results expected later this year [10]. Educational Initiatives - A sponsored breakfast symposium titled "Healing Under Pressure: Advancements in Skin Substitutes for Pressure Ulcer Treatment" will address the importance of comprehensive care for patients with chronic wounds [5].