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BioStem Technologies Provides Comments on CMS CY 2026 Final Medicare Reimbursement Rule Changes for Skin Substitutes
Globenewswire· 2025-11-05 21:05
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]
BioStem Technologies Secures Land Purchase at the Research Park at Florida Atlantic University in Boca Raton for Future Headquarters
Globenewswire· 2025-11-05 12:00
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]
BioStem Technologies to Host Third Quarter 2025 Financial Results Conference Call on November 13, 2025
Globenewswire· 2025-10-30 20:05
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]
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]
BioStem Technologies Expands Partnership with the Florida Panthers as a Sponsor for the 13th Season of the “Heroes Among Us” Program
Globenewswire· 2025-10-02 16:00
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]
BioStem Technologies to Present at Two Upcoming Investor Conferences
Globenewswire· 2025-09-02 12:34
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]
BioStem Technologies Announces Insider Share Purchase by Chairman and Chief Executive Officer
Globenewswire· 2025-08-21 11:00
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]
BioStem Technologies Reports Preliminary Second Quarter 2025 Financial Results
Globenewswire· 2025-08-14 20:06
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].
BioStem Technologies Provides Comments on CMS CY 2026 Proposed Medicare Reimbursement Rule Changes for Skin Substitutes
Globenewswire· 2025-07-17 11:00
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]
BioStem Technologies to Present at the Advanced Wound Care Summit in Boston on July 15, 2025, at 2:00 PM ET
Globenewswire· 2025-07-10 12:54
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]