Florida Medicaid Adds BioStem’s VENDAJE® and VENDAJE AC® to Covered Skin Substitutes ListPOMPANO BEACH, Fla., Nov. 25, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company specializing in placental-derived biologics for advanced wound care, today announced expanded reimbursement with the inclusion of VENDAJE® and VENDAJE AC® in Florida Medicaid’s list of covered skin substitutes. This expansion marks a significant milestone in BioStem’s national reimbursement strategy, ...

Core Insights - BioStem Technologies, Inc. supports the CMS's final rule on the Physician Fee Schedule for 2026, which aims to create a more transparent and sustainable reimbursement system for skin substitutes [2][4] - The new reimbursement model is expected to restore market balance and reward clinical performance, aligning with BioStem's goals for its BioREtain-processed placental allografts [2][3] Company Positioning - BioStem's BioREtain manufacturing process offers lower cost of goods sold (COGS) and scalable production, which is expected to maintain robust product margins under the new reimbursement model [3] - The company is well-positioned to thrive in the evolving reimbursement environment due to its clinically validated products and efficient cost structure [4] Clinical Validation - BioStem's commitment to scientific validation is highlighted by a Level 1 randomized controlled trial demonstrating superior patient outcomes with its products compared to standard care [2] - The company collaborates with clinical partners and policymakers to ensure that the reimbursement framework supports innovation and optimal patient care [4]

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. will release its third quarter 2025 financial results on November 13, 2025, and will host a conference call and webcast at 4:30 PM ET [1][2] Company Overview - BioStem Technologies is a MedTech company focused on developing, manufacturing, and commercializing placental-derived products for advanced wound care [1][3] - The company utilizes its proprietary BioREtain processing method, which is designed to maintain growth factors and preserve tissue structure [3] - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and complies with current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP) [3] Product Portfolio - The company's product brands include AmnioWrap2™, VENDAJE, VENDAJE AC, and VENDAJE OPTIC, all processed at its FDA registered and AATB accredited site in Pompano Beach, Florida [3]

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]

Core Points - BioStem Technologies, Inc. has partnered with the Florida Panthers to sponsor the "Heroes Among Us" program, which honors military veterans during NHL home games [1][2] - The program has recognized over 500 military members since its inception in 2013, including veterans from various wars [2] - BioStem is also continuing its support for the "Seats for Service" initiative, providing game-day experiences for veterans and their families [4] Company Overview - BioStem Technologies is a MedTech company focused on developing and commercializing placental-derived products for advanced wound care [1][8] - The company utilizes its proprietary BioREtain processing method to maintain growth factors and preserve tissue structure in its allografts [8] - BioStem's quality management systems are accredited by the American Association of Tissue Banks, adhering to current Good Tissue Practices and Good Manufacturing Processes [8] Community Engagement - The "Heroes Among Us" program features a military hero at each home game, with a national anthem dedication and a video highlighting their story [2][3] - The Florida Panthers Foundation emphasizes veterans' affairs as one of its core pillars, supporting organizations that provide resources to military members [5] - The community can nominate veterans for the "Heroes Among Us" program through the Florida Panthers' website [3]

Core Insights - BioStem Technologies Inc. is a leading MedTech company specializing in placental-derived biologics for advanced wound care [1][4] - The company will present at the Morgan Stanley Global Healthcare Conference and the H.C. Wainwright 27th Annual Global Investment Conference in New York [2][5] - BioStem's proprietary BioREtain processing method is designed to maintain growth factors and preserve tissue structure, enhancing the efficacy of its products [4] Company Overview - BioStem Technologies focuses on the development, manufacture, and commercialization of allografts for regenerative therapies [4] - The company’s quality management system is accredited by the American Association of Tissue Banks (AATB) and adheres to current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP) [4] - BioStem's product portfolio includes brands such as AmnioWrap2™, VENDAJE, VENDAJE AC, and VENDAJE OPTIC, all processed at its FDA registered and AATB accredited facility in Pompano Beach, Florida [4]

Core Insights - BioStem Technologies, Inc. disclosed an insider purchase of common stock by Jason Matuszewski, the Chairman and CEO, indicating confidence in the company's future prospects [1][2] Group 1: Insider Transactions - Jason Matuszewski purchased a total of 15,500 shares on August 19, 2025, for approximately $100,000, with transactions executed at average prices of $6.28 for 2,500 shares and $6.51 for 13,000 shares [2] - Following these transactions, Mr. Matuszewski's total ownership in BioStem Technologies increased to 1,145,362 shares [2] Group 2: Company Overview - BioStem Technologies is a MedTech company focused on developing, manufacturing, and commercializing placental-derived products for advanced wound care [1][3] - The company utilizes its proprietary BioREtain processing method, which is designed to maintain growth factors and preserve tissue structure, enhancing the effectiveness of its allografts for regenerative therapies [3] - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and adheres to current Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [3] - The company's product portfolio includes brands such as AmnioWrap2™, VENDAJE, VENDAJE AC, and VENDAJE OPTIC, all processed at its FDA registered and AATB accredited facility in Pompano Beach, Florida [3]

Core Insights - BioStem Technologies, Inc. reported preliminary financial results for Q2 2025, highlighting a sixth consecutive quarter of positive adjusted EBITDA despite facing revenue challenges due to increased competition and reimbursement uncertainties [4][9][11]. Recent Business Highlights - The company appointed Brandon Poe as the new Chief Financial Officer, bringing over 25 years of healthcare finance experience [4][8]. - BioStem completed enrollment in a clinical trial for BioREtain® Amnion Chorion aimed at treating diabetic foot ulcers, with data expected in Q4 2025 [8]. - The commercial organization is expanding with new direct representatives to access additional care sites [8]. - The intellectual property portfolio has been expanded with three new U.S. patent applications, totaling 58 issued and 68 pending patents [8]. Preliminary Financial Highlights - Net revenue for Q2 2025 was $49.3 million, a 34% decrease from Q2 2024, primarily due to lower volumes in the wound care portfolio [9][27]. - Gross profit was $48.6 million, representing 98.6% of net revenue, compared to $70.7 million or 95.0% of net revenue in Q2 2024 [10]. - Operating expenses decreased to $48.5 million from $61.9 million in Q2 2024, driven by lower revenue and reduced sales and marketing costs [10]. - Adjusted EBITDA for Q2 2025 was $2.5 million, down from $10.1 million in Q2 2024, reflecting lower gross profit but offset by reduced operating expenses [11]. - The company reported a GAAP net loss of $0.6 million or ($0.03) per share, compared to net income of $6.3 million or $0.39 per share in Q2 2024 [12][27]. - Cash and cash equivalents increased to $30.8 million as of June 30, 2025, up from $26.7 million as of March 31, 2025 [12][27]. Uplisting and Audit Update - BioStem is pursuing an uplisting to Nasdaq and is currently working through the audit of its historical financial statements [5][6]. - The company has clarified the accounting treatment for its distribution agreement with Venture Medical and is preparing to file an amended Form 10 to address SEC comments [5][6].

Core Insights - BioStem Technologies, Inc. supports the reform of the reimbursement framework for skin substitutes, aiming to address rising Medicare spending in this category [2] - The company is engaged in randomized controlled trials to demonstrate the clinical superiority of its BioREtain technology, which is central to its commercial products [2] - BioStem is in the process of filing Form 10 and plans to provide updates on its Nasdaq uplisting during its second quarter 2025 earnings call [2] Company Overview - BioStem Technologies is focused on developing, manufacturing, and commercializing placental-derived products for advanced wound care [1][3] - The company utilizes its proprietary BioREtain processing method, which preserves growth factors and tissue structure [3] - BioStem's quality management system has been accredited by the American Association of Tissue Banks, adhering to current Good Tissue Practices and Good Manufacturing Processes [3] Industry Context - The Centers for Medicare and Medicaid Services (CMS) has released proposals for the Calendar Year 2026 Physician Fee Schedule and Outpatient Prospective Payment System regarding skin substitute reimbursement [1] - The proposed changes are expected to promote investment in innovation and improve outcomes for patients with chronic wounds [2]