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BioStem Technologies Products Placed on “12-Month Status Quo Period” List in Update to CMS CY 2026 Final Medicare Reimbursement Rule for Skin Substitutes
Prism Media Wire· 2025-12-18 12:02
Core Viewpoint - BioStem Technologies' products, VENDAJE® and VENDAJE AC®, have been granted a 12-month status quo period for reimbursement eligibility under the CMS CY 2026 Final Medicare Reimbursement Rule, ensuring continued access for patients with diabetic foot ulcers (DFU) and venous leg ulcers (VLU) [3][4]. Group 1: Reimbursement Status - The 12-month status quo designation allows BioStem's products to remain eligible for reimbursement in 2026, provided their use meets the "reasonable and necessary" standard [4]. - The Medicare Administrative Contractors (MACs) will review additional evidence by December 31, 2026, with updated determinations expected in early 2027 [4]. Group 2: Impact on Other Products - The final policy from CMS specifically applies to DFU and VLU indications, leaving reimbursement for other wound types, such as pressure ulcers, unaffected [5]. - Pressure ulcers represent the largest segment of the chronic wound market at 41%, which is crucial for BioStem's sales volume and Medicare-related revenue [5]. Group 3: Company Statements and Future Plans - The CEO of BioStem expressed appreciation for CMS's evidence-driven approach and anticipates uninterrupted payment for their products in DFU and VLU applications throughout 2026 [6]. - BioStem plans to engage with CMS and MACs to discuss clinical trial findings and aims to achieve reclassification of their products from Status Quo to Covered status during the 2027 reconsideration cycle [6].
BioStem Technologies Announces Filing of Restated Financial Statements
Prism Media Wire· 2025-11-13 21:01
Core Insights - BioStem Technologies, Inc. has filed restated interim financial statements for Q1 2024 through Q2 2025 and annual financial statements for 2023 and 2024, aligning with US GAAP revenue recognition standards [3][12]. Financial Restatement - The restatement is a significant milestone for the company, resulting from a comprehensive review of US GAAP revenue recognition guidance, particularly regarding the distribution agreement with Venture Medical [4][12]. - Bona fide services fees previously recorded as Sales and Marketing expenses will now be classified as contra revenue, reducing gross revenue but not impacting EBITDA, net income, or cash flow [5][12]. - The restated financials will affect percentage-based metrics such as gross margin and EBITDA margin due to the change in revenue reporting [5]. Balance Sheet Adjustments - Amounts owed to Venture Medical related to bona fide services fees will now be netted against Accounts Receivable, effectively offsetting the liabilities between the two companies [6]. Business Outlook - The company maintains that the underlying strength of its business remains unchanged, continuing to deliver clinically validated wound care products [7]. - The independent audit led by KPMG is expected to be completed by the end of Q1 2026, which will support the company's plans to uplist and enhance investor transparency [8][12].
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 focuses on the development, manufacturing, and commercialization of 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 products [8] - BioStem's quality management system is 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 (OTCPK:BSEM) FY Conference Transcript
2025-09-09 16:02
Summary of BioStem Technologies FY Conference Call Company Overview - **Company**: BioStem Technologies (OTCPK:BSEM) - **Industry**: Advanced Wound Care - **Market Size**: The advanced wound care market is valued at **$11.3 billion**, with a significant portion in the wound biologic segment at **$8.5 billion** [2][6] Core Business and Technology - **Proprietary Technology**: BioStem has developed **BioREtain®**, a technology that enhances wound healing by retaining key growth factors [3][7] - **Patent Portfolio**: The company holds **55 issued patents** and **53 pending patents** related to its technologies [3] - **Product Offerings**: Currently, BioStem has **five products** targeting diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and pressure ulcers (PUs) [3] Financial Performance - **Revenue**: In 2024, BioStem reported over **$300 million** in top-line revenue and over **$39 million** in adjusted EBITDA [4] - **Cash Position**: As of June 30, 2025, the company had over **$30 million** in cash on hand [4][21] - **Growth Trajectory**: Revenue growth from under **$16 million** in 2023 to over **$300 million** in 2024, indicating a significant upward trend [19] Market Dynamics - **Patient Demographics**: There are over **7 million Medicare patients** with chronic non-healing wounds, with projections indicating a **20% increase** by 2030 [4][5] - **Wound Types**: Pressure ulcers account for **41%**, diabetic foot ulcers for **30%**, and venous leg ulcers for **11%** of the chronic wound market [4] Clinical Trials and Research - **Ongoing Studies**: BioStem is conducting clinical trials for DFUs and VLUs, with results expected by the end of 2025 [8][9] - **Real-World Data**: The BioREtain® technology has shown a **25% reduction** in the number of applications needed compared to competitor products [6] Reimbursement Landscape - **Current Reimbursement**: Products are currently reimbursed at approximately **$1,780** in hospital outpatient settings and **$860** in ambulatory surgery centers [13] - **Future Changes**: Anticipated changes in 2026 may lead to a flat-rate reimbursement model across all service sites, which could stabilize pricing and improve margins [13][14] Strategic Initiatives - **Expansion Plans**: BioStem aims to expand its commercial team and increase penetration in various healthcare settings, including the VA segment [16][22] - **Product Development**: The company is looking to innovate its BioREtain® process and explore strategic acquisitions to enhance its product portfolio [17] Management and Team - **Leadership Changes**: Recently appointed CFO Brandon Poe and marketing head Barry Hassett are expected to drive future growth [21][22] Conclusion - **Market Outlook**: The chronic wound care market is expected to grow, and BioStem is well-positioned to capitalize on this growth through innovative products and strategic partnerships [22][23]
BioStem Technologies Appoints Brandon Poe as Chief Financial Officer
GlobeNewswire News Room· 2025-08-14 20:01
Core Insights - BioStem Technologies, Inc. has appointed Brandon Poe as Chief Financial Officer, marking a significant leadership change during a period of growth and innovation for the company [1][2] - The company is recognized for its innovative wound care technologies and aims to leverage its BioREtain® platform to accelerate growth and expand market presence [3] Company Overview - BioStem Technologies focuses on the development, manufacturing, and commercialization of placental-derived products for advanced wound care [1] - 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 and adheres to current Good Tissue Practices and Good Manufacturing Processes [3] Leadership Background - Brandon Poe brings over 25 years of experience in finance within the healthcare and life sciences sectors, having previously served as CFO at Midi Health, Inc. and Jumpcode Genomics, Inc. [2] - His experience at Illumina, Inc. included multiple senior finance roles, enhancing his capability to contribute to BioStem's strategic goals [2] Strategic Goals - The company aims to expand into new markets and advance its plans for a Nasdaq uplisting, indicating a focus on long-term growth ambitions [2] - Brandon Poe expressed enthusiasm about driving value for shareholders and executing the company's strategy during this pivotal stage [3]
BioStem Technologies to Host Second Quarter 2025 Financial Results Conference Call on August 14, 2025
Prism Media Wire· 2025-07-30 11:00
Core Points - BioStem Technologies Inc. will release its second quarter 2025 financial results on August 14, 2025, and will host a conference call and webcast at 4:30 PM ET [3][4] - The conference call will include a review of the financial results and updates on the Company's Form 10 filing and Nasdaq uplisting, led by CEO Jason Matuszewski and CFO Michael Fortunato [4] - BioStem Technologies focuses on the development, manufacture, and commercialization of placental-derived products for advanced wound care, utilizing its proprietary BioREtain® processing method [6][7] Company Overview - BioStem Technologies is recognized as a leading innovator in the MedTech sector, specializing in allografts for advanced wound care [6] - The Company’s quality management systems are accredited by the American Association of Tissue Banks (AATB) and comply with Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [7] - BioStem's product portfolio includes brands such as AmnioWrap2™, VENDAJE®, and American Amnion™, all processed at its FDA registered and AATB accredited facility in Pompano Beach, Florida [7]