Core Viewpoint - BioStem Technologies Inc. is set to present at the 25th Annual Needham Virtual Healthcare Conference, highlighting its focus on regenerative medicine and perinatal tissue allograft products [1][2]. Company Overview - BioStem Technologies is a publicly traded biomedical innovator specializing in the development, manufacturing, and commercialization of advanced allograft solutions derived from perinatal tissue [3]. - The company utilizes proprietary technologies such as BioRetain®, CryoTek®, and SteriTek® to optimize the preservation of natural tissue properties for clinical use [3]. - BioStem's allografts are utilized by clinicians across various specialties, indicating a broad application of its products [3]. Quality Assurance - The company's quality management system and standard operating procedures have been accredited by the American Association of Tissue Banks (AATB), ensuring compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP) [4]. - BioStem's product portfolio includes well-known brands such as Neox®, Clarix®, VENDAJE®, and American Amnion™, reflecting its commitment to quality [4].

Core Insights - The divestiture of Coflex and Paradigm Spine assets to Companion Spine for $21.4 million signifies a strategic shift towards focusing exclusively on high-margin core biologics [1] - Management has successfully achieved a multi-year goal of self-sustainability, reporting positive net income, adjusted EBITDA, and cash flow through disciplined operational execution [1] - Q4 performance was affected by the early closing of the Companion Spine deal, resulting in a loss of approximately $2 million in anticipated revenue for the period [1] Strategic Focus - The company is transitioning from a phase of internal consolidation and manufacturing optimization to one of aggressive top-line growth pursuit [1] - Strategic differentiation is now centered on being a comprehensive partner in regenerative medicine, providing solutions across all five major orthobiologic categories [1] Commercial Expansion - The company is expanding its commercial reach by doubling the regional sales force and increasing investments in the national accounts team to drive institutional adoption [1]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $32.4 million, a 3% increase from $31.5 million in Q4 2024, despite a $2 million revenue loss due to the early closure of the Companion Spine transaction [4][12] - Full year 2025 revenue reached $133.9 million, representing a 14% growth from $117.3 million in 2024 [6][16] - Adjusted EBITDA for Q4 2025 was $1.9 million, compared to approximately $0.4 million in Q4 2024, while full year adjusted EBITDA was $16.3 million, a significant improvement from a loss of $2.3 million in 2024 [19][16] - Net income for Q4 2025 was $57,000, compared to a net loss of $3.2 million in Q4 2024, and full year net income was $5 million, compared to a net loss of $16.5 million in 2024 [16][19] Business Line Data and Key Metrics Changes - The biologics product family was essentially flat in Q4 2025, but is expected to grow due to new product launches and increased sales force [6][8] - The sale of non-core assets to Companion Spine was transformational, allowing the company to focus on high-margin biologics [5][11] - Gross margin for Q4 2025 was 54.9%, up from 50.8% in Q4 2024, driven by a favorable sales mix [14] Market Data and Key Metrics Changes - The company anticipates organic growth in its core biologics business, despite headwinds from the divestiture and loss of license revenue [11][12] - The hardware business is expected to decline at a steady rate, approaching high teens percentage in 2026 [30] Company Strategy and Development Direction - The company is focused on self-sustainability, positive cash flows, and tighter operating discipline, with a strategic emphasis on in-house manufacturing [7][11] - Plans to double the number of regional sales representatives and expand the national accounts team to drive institutional adoption [8][11] - Continued investment in R&D and new product introductions is central to the company's growth strategy [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategy and foundation for growth, with a revenue outlook for 2026 projected between $95 million and $99 million [11][12] - The company expects to maintain positive free cash flow and does not anticipate the need for additional outside capital [5][11] Other Important Information - The company completed the sale of its Coflex assets for approximately $21.4 million, which has strengthened its cash position [5][6] - Cash equivalents and restricted cash as of December 31, 2025, were $17.3 million, up from $6.2 million in 2024 [20] Q&A Session Summary Question: Outlook for 2026 and organic growth in core biologics business - Management expects sequential quarter-over-quarter growth in 2026, driven by new product offerings and an expanded commercial organization [24] Question: Headwinds from loss of license revenue related to Q-Codes - The Q-Code revenue will cease, but management anticipates ramping up sales under the Xtant brand as distributors shift to using their contracts [26] Question: Decline in hardware business throughout 2026 - A slow decline in the hardware business is expected, with a steady rate approaching high teens percentage [30] Question: Specific products expected to support biologics growth - Key products include OsteoVive Plus, OsteoFactor Pro, and CollagenX, with significant growth opportunities identified [34] Question: Growth channels for biologics business - The majority of growth is expected to come from Xtant branded products through independent agent networks, with OEM channels contributing around 20% [38][42] Question: Strategic thoughts on the hardware business - The hardware business is still beneficial for the biologics segment, but management is evaluating its long-term strategic value [45]

Core Viewpoint - BioStem Technologies, Inc. is progressing towards a Nasdaq uplisting by filing its audited consolidated financial statements for the fiscal years ended December 31, 2024, and 2025, marking a significant milestone for the company [1][2]. Financial Progress - The company has published its audited financial statements for 2024 and 2025, which is a crucial step in establishing robust financial reporting processes [2]. - The appointment of a new CFO, auditor, and audit committee chair further emphasizes the company's commitment to improving its financial governance [2]. Corporate Strategy - Listing on Nasdaq is a top priority for BioStem, as it would enhance visibility, improve stock liquidity, provide a more accurate market valuation, and attract top talent [2]. - The company is focused on advancing its corporate initiatives, including the development and commercialization of perinatal tissue allograft products [1][2]. Quality Assurance - BioStem's quality management system and standard operating procedures have been accredited by the American Association of Tissue Banks (AATB), ensuring compliance with current Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [3]. - The company offers a portfolio of quality brands, including Neox, Clarix, VENDAJE, and American Amnion™ [3]. Company Overview - BioStem Technologies is a publicly traded biomedical innovator specializing in advanced allograft solutions derived from perinatal tissue, utilizing proprietary technologies like BioRetain, CryoTek, and SteriTek [2]. - The company is committed to advancing innovation in regenerative medicine with a growing portfolio of products and expanding clinical research initiatives [2].

Core Insights - Matricelf Ltd. has entered a strategic collaboration with the CiRA Foundation to advance next-generation regenerative manufacturing for engineered neural tissue therapies [1][2][7] - The collaboration aims to evaluate the integration of induced pluripotent stem cells (iPSCs) into Matricelf's proprietary neural tissue engineering platform, potentially leading to automated large-scale manufacturing processes [3][6] Company Overview - Matricelf is a biotechnology company focused on developing personalized regenerative therapies for spinal cord injury patients using autologous engineered neural tissue [8] - The CiRA Foundation, established in 2019, is a global leader in iPSC research and manufacturing, dedicated to advancing regenerative medicine [4][8] Collaboration Details - Under the agreement, CiRA Foundation will supply iPSCs derived from three healthy donors for Matricelf to evaluate the feasibility of generating engineered neural tissues [5] - The resulting tissues will be assessed based on neural marker expression and functional electrical activity, which may indicate compatibility between the platforms [5][6] Strategic Importance - The collaboration is seen as a significant step towards scalable, efficient, and cost-effective production of regenerative therapies, aligning with Matricelf's long-term strategy to broaden access to these therapies [2][6] - The partnership with a recognized leader like CiRA strengthens Matricelf's international positioning and enhances the potential of its technology in the regenerative medicine field [7]

Core Insights - Cellgenic, a subsidiary of Regenerative Medical Technologies Group (RMTG), has commenced full-scale manufacturing at its biologics facility in Cancún, Mexico, producing six product lines for international markets [2][3]. Manufacturing Operations - The Cancún facility is the first in the region specifically designed for external manufacturing and international distribution of biologics, actively shipping products to authorized medical professionals across compliant markets [3]. - The facility's operational launch follows a soft opening during the ISSCA Global Regenerative Medicine Summit in September 2025, which saw participation from physicians and scientists from over 30 countries [3]. Financial Performance - The full-scale launch is expected to add a significant revenue stream to RMTG's integrated business model, building on recent financial momentum with Q1 2025 sales of $1.35 million, reflecting a 67% year-over-year growth, and operational profits of $134,000 [4]. Product Lines - The Cancún facility is producing and distributing the following biologic products: - Exosome Flow Series - Lyophilized Exosomes - Umbilical Cord-Derived Mesenchymal Stem Cells (MSCs) - Natural Killer (NK) Cells - Allogeneic Fibroblasts - Sterile Diluents [6]. Manufacturing Standards - All biologics are produced under xeno-free conditions, ensuring no animal-derived components are used, which aligns with evolving regulatory expectations and supports broader international acceptance [7]. Integrated Model - The facility operates in coordination with the Cellular Hope Institute and ISSCA, providing educational opportunities for physicians and researchers, enhancing transparency and professional dialogue in regenerative medicine [8][9]. Future Growth Initiatives - Cellgenic has outlined a 2026 pipeline that includes: - Exosome-peptide combination formulations - Multi-peptide blended delivery formats - Cell-free conditioned media (secretome) - Cryopreserved cell banking services - Private-label and white-label manufacturing programs - An Authorized Distributor Program to support long-term collaboration and international growth [9][10]. Company Overview - RMTG, through its Global Stem Cells Group subsidiary, operates in over 30 countries, focusing on regenerative medicine solutions and physician education via its ISSCA platform [11][12].

Core Insights - BioStem Technologies, Inc. reported a significant decline in revenue for Q4 2025, with net revenue of $10.1 million, a 55% decrease compared to Q4 2024, primarily due to reimbursement uncertainty and competitive pressures [5][6] - The company completed the acquisition of BioTissue Holdings Inc. in January 2026, which is expected to enhance its product portfolio and commercial reach [9][10] - BioStem anticipates first quarter 2026 revenue to be between $5 million and $6 million, with expectations for growth in the hospital business in the second half of the year [12] Recent Financial and Business Highlights - CEO Jason Matuszewski emphasized the company's strengthened position and diversification following the BioTissue acquisition, which expands its market presence [3] - The gross profit margin for Q4 2025 was 97%, up from 84% in Q4 2024, attributed to a shift in product mix [5] - Operating expenses increased to $17.3 million in Q4 2025 from $10.7 million in Q4 2024, largely due to charges for potentially uncollectible accounts receivable [6] Financial Results Overview - For the full year 2025, net revenue was $47.5 million, down from $69.7 million in 2024, driven by lower wound care volume [8] - Gross profit for 2025 was $44.4 million, or 94% of net revenue, compared to $55.9 million or 80% in 2024 [10] - The company reported a GAAP net loss of $6.6 million for 2025, a significant decline from a net income of $31 million in 2024 [11] Cash Position and Future Outlook - As of December 31, 2025, cash equivalents totaled $29.5 million, which decreased to approximately $16 million post-BioTissue acquisition [7] - The company expects to drive sequential and year-over-year growth in the hospital business after integrating the BioTissue assets and expanding its salesforce [12]

Company Presentation MARCH 2026 Forward Looking Statements Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions. The Company's actual results and financial condition may differ materially from those indicated in the forward-looking statements. The following is a list of risks, among others, that could cause actual results to differ materially from those contemplated by the forward-looki ...

Core Insights - Matricelf Ltd. has entered a strategic collaboration with Sheba Medical Center to advance its first human clinical trial for spinal cord injury treatments [1][2] - This partnership marks a significant transition for Matricelf from preclinical development to clinical stage, aiming for human proof of concept [2][4] Collaboration Details - The collaboration will involve GMP compliant manufacturing of autologous neural tissue implants at Sheba's Advanced Biotherapy Center [2][3] - The clinical trial will leverage Sheba's integrated environment, combining advanced manufacturing, surgical expertise, and rehabilitation capabilities [3][4] Operational Efficiency - Centralizing manufacturing and clinical execution at a leading institution is expected to streamline operations, reduce execution risk, and accelerate clinical timelines [4] - This approach is designed to establish a scalable model for future expansion [4] Preclinical Progress - The milestone builds on positive preliminary safety data from preclinical studies, which demonstrated the safety profile of Matricelf's engineered neural tissue platform in animal models [5] - Additional data is anticipated to support regulatory progression into human clinical studies [5] Leadership Statements - Dr. Alon Sinai, Founder and President of Matricelf, emphasized that advancing into clinical development is a defining milestone for the company [6] - CEO Gil Hakim highlighted that the collaboration enhances efficiency and supports de-risking of early-stage clinical development [6]

Core Insights - Sernova Biotherapeutics has successfully closed a non-brokered private placement financing, securing total gross proceeds of $2.1 million by issuing 13,762,659 units at a price of $0.15 per unit [1] - Each unit consists of one common share and one common share purchase warrant exercisable at $0.25 per share for 36 months, with a four-month hold period applicable [1] - The financing, along with an additional $5.5 million committed by a board member and the anticipated retirement of approximately $17 million in debt, significantly enhances the company's balance sheet and supports the advancement of its Cell Pouch Bio-hybrid Organ clinical program aimed at treating type 1 diabetes [2] Company Overview - Sernova Biotherapeutics is a clinical-stage company focused on developing regenerative medicine therapeutics, specifically the Cell Pouch integrated with human donor cells or stem-cell derived islet-like clusters, in collaboration with Evotec [4] - The goal is to create bio-hybrid organs that restore or enhance the function of compromised organs, particularly for the treatment of type 1 diabetes [4]