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Biostem (OTCPK:BSEM) FY Conference Transcript
2025-09-10 20:22
Summary of Biostem Technologies FY Conference Call Company Overview - **Company**: Biostem Technologies (OTCPK:BSEM) - **Industry**: Advanced Wound Care - **Core Technology**: BioREtain®, a proprietary process for processing placental-based tissue allografts aimed at treating diabetic foot ulcers, pressure ulcers, and venous leg ulcers - **Market Size**: Approximately $11.3 billion in the advanced wound care space, with a patient population of around 7 million Medicare beneficiaries [2][4] Key Points and Arguments - **BioREtain® Process**: - Retains natural elements of tissue, including extracellular matrix and growth factors - Demonstrated in real-world data to require fewer applications and less time to close wounds compared to alternatives [3][20] - **Clinical Trials**: - Currently running three randomized controlled trials (RCTs) focused on diabetic foot ulcers and venous leg ulcers, with data expected later this year and into mid-next year [6][15] - **Partnership with Venture Medical**: - Significant growth driver, with revenue increasing from approximately $16.9 million in 2023 to over $300 million projected for 2024 - Partnership enhances cash flow management and compliance for providers through Venture Medical's software platform, OneView [7][8] - **Commercial Strategy**: - Plans to internalize some commercial teams while continuing to leverage the partnership with Venture Medical - Focus on mobile wound care and physician office segments, with potential shifts in strategy as reimbursement structures evolve [10][26] - **Reimbursement Landscape**: - Proposed changes to CMS fee schedules for skin substitutes could impact pricing and market dynamics - Concerns about low initial pricing of $125, which may challenge mobile wound care providers in underserved areas [11][14] - **Financial Performance**: - Reported $121.8 million in revenue for the first half of 2025, a 5% year-on-year increase - Strong gross margins at 95%, attributed to efficient manufacturing processes [16][31] - **Market Share and Growth Potential**: - Current market share is small relative to the total addressable market of $10.3 billion - Opportunities for growth through M&A and expansion into hospital outpatient and acute wound care segments [29][30][35] Additional Important Insights - **Clinical Data Importance**: - Upcoming clinical data is expected to validate the efficacy of BioREtain® and support market differentiation [15][39] - **M&A Opportunities**: - Potential to acquire smaller organizations or products that complement existing offerings, particularly in areas lacking hospital access [35][36] - **Industry Dynamics**: - Ongoing discussions about the need for normalization in pricing and reimbursement structures to address issues of overutilization and ensure fair access to wound care products [12][44] - **Provider Adoption**: - Positive testimonials from providers highlight the effectiveness of BioREtain® in treating hard-to-heal wounds, which could drive further adoption [20][23] This summary encapsulates the key insights from the Biostem Technologies FY Conference Call, focusing on the company's strategic direction, market opportunities, and challenges within the advanced wound care industry.
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 Showcasing its Leading BioREtain® Technology at the Symposium for Advanced Wound Care (SAWC) Fall Meeting
Globenewswire· 2025-09-05 16:19
Core Viewpoint - BioStem Technologies, Inc. is showcasing its innovative placental-derived products for chronic wound care at the Symposium for Advanced Wound Care (SAWC) Fall meeting, emphasizing collaboration with Venture Medical, LLC to enhance patient care and streamline treatment processes [1][2]. Company Overview - BioStem Technologies focuses on the development, manufacturing, and commercialization of placental-derived products aimed at advanced wound care [1][11]. - The company utilizes its proprietary BioREtain processing method, which preserves the natural properties of perinatal tissue, ensuring the integrity of amniotic tissue components critical for wound treatment [8][11]. Product Highlights - Key products include AmnioWrap2® and Vendaje AC®, which are exclusively available through Venture Medical [3]. - The BioStem-Venture collaboration aims to provide a superior allograft platform that meets the needs of both patients and healthcare providers [3]. Event Details - The SAWC Fall meeting is taking place from September 3-6 in Las Vegas, NV, serving as a significant educational forum for healthcare professionals focused on chronic wound care [1]. - A sponsored breakfast symposium titled "Navigating the Future of Wound Care" will feature discussions on clinical evidence and best practices in wound care management [4]. Research Contributions - BioStem has three clinical and scientific posters accepted for display at the symposium, contributing to the discourse on chronic wound care [5][10]. - Research topics include comparisons of processing methods for placental tissue allografts and sterilization methods for dehydrated birth tissue [6][10]. Strategic Partnership - The collaboration with Venture Medical enhances the logistics of managing patients requiring skin substitutes for chronic wound treatment, showcasing a combined value proposition [2][3][13].
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]
Ernst & Young LLP (EY US) Announces Jason Matuszewski, CEO of BioStem Technologies, as an Entrepreneur Of The Year® 2025 Florida Award Winner
Globenewswire· 2025-06-17 12:59
Company Overview - BioStem Technologies is a leading MedTech company focused on improving the lives of patients with chronic, non-healing wounds through innovative solutions [3][14] - The company develops and manufactures placental-derived allografts using proprietary BioREtain® technology, which preserves tissue's native properties and optimizes clinical outcomes [3][15] - BioStem's products are used by clinicians nationwide to address the growing demand for advanced wound care solutions [3][14] Leadership Recognition - Jason Matuszewski, CEO and Chairman of BioStem Technologies, was awarded the Entrepreneur Of The Year 2025 Florida Award by Ernst & Young LLP [1][4] - The award recognizes leaders who demonstrate long-term value creation, entrepreneurial spirit, and significant growth and impact [2][5] - Matuszewski emphasized the collective effort of the BioStem team in achieving this recognition, highlighting their commitment to innovation and patient care [3][4] Future Aspirations - As a Florida award winner, Matuszewski is eligible for the Entrepreneur Of The Year 2025 National Awards, with winners announced in November [4] - The National Award winner will compete for the EY World Entrepreneur Of The Year™ Award in June 2026 [4][8] - BioStem aims to expand its impact and continue advancing its platform in the healthcare system [3][14]
BioStem Technologies Provides Update on the Company’s Form 10 Submission and SEC Review Process
Globenewswire· 2025-06-03 11:00
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].
BioStem Technologies to Participate in the Goldman Sachs 46th Annual Global Healthcare Conference
Globenewswire· 2025-05-29 11:00
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 [4] - The company utilizes its proprietary BioREtain® processing method to maintain growth factors and preserve tissue structure in its products [4] - 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 current Good Manufacturing Processes (cGMP) [4] Recent Developments - BioStem Technologies will participate in the Goldman Sachs 46th Annual Global Healthcare Conference in Miami [1] - Jason Matuszewski, the CEO, will engage in a fireside chat and is available for one-on-one meetings with conference attendees [2] 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 [4]
BioStem Announces Notice of Allowance for Three New U.S. Patent Applications
Globenewswire· 2025-05-28 11:00
Core Insights - BioStem Technologies, Inc. has expanded its patent portfolio with 55 issued patents and 52 pending applications, emphasizing its commitment to innovation in wound care [1] - The United States Patent and Trademark Office (USPTO) has granted a Notice of Allowance for two design patents and one utility patent related to BioStem's fenestrated human placental allograft designs [2][3] - The unique design of the allografts allows for effective drainage of wound exudate while maintaining allograft area, enhancing the healing environment [2][3] Patent Details - The newly allowed patents include Design Patent Application No. 29/860,417 and No. 29/860,420, which focus on fenestrated human placental allograft designs using the BioREtain process [2] - Patent Application No. 18/926,867 covers sterile human placental allografts with multiple slits and openings, improving wound treatment efficacy, particularly for diabetic foot ulcers and dental wounds [3] Company Strategy - The CEO of BioStem Technologies highlighted the importance of these patents in advancing next-generation placental allograft technologies and reinforcing the proprietary nature of the BioREtain process [4] - The BioREtain process is designed to preserve the structural and molecular integrity of placental tissue, which is crucial for better clinical outcomes [4] Company Overview - BioStem Technologies specializes in the development, manufacturing, and commercialization of placental-derived products for advanced wound care [6] - 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 [6]