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BioStem Technologies Completes Enrollment in Clinical Trial Evaluating BioREtain® Amnion Chorion for Treatment of Diabetic Foot Ulcers
Globenewswire· 2025-06-23 12:17
Head-to-head study comparing BioREtain®- processed Amnion Chorion (BR-AC) allograft to standard of care initiated in Q4 2024 to demonstrate healing superiority Topline results and full data analysis expected in Q4 2025 POMPANO BEACH, Fla., June 23, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (“BioStem” or the “Company”) (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today announced that pa ...
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
Award celebrates bold leaders shaping the future through the world’s most ground-breaking companiesPOMPANO BEACH, Fla., June 17, 2025 (GLOBE NEWSWIRE) -- Ernst & Young LLP (EY US) announced that Jason Matuszewski, CEO and Chairman of the Board of BioStem Technologies (OTC: BSEM), was named an Entrepreneur Of The Year 2025 Florida Award winner. Entrepreneur Of The Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. For 40 years, EY US has celebrated ambit ...
ImmuCell (ICCC) 2025 Conference Transcript
2025-05-29 14:30
Summary of ImmuCell Corporation Conference Call Company Overview - **Company**: ImmuCell Corporation (Ticker: ICCC) - **Industry**: Animal Health, specifically focusing on products that reduce antibiotic use in livestock [1][2] Core Products and Market Position - **First Defense**: A USDA licensed product aimed at providing immediate immunity to newborn calves, reducing the need for traditional antibiotics [3][5][17] - **Retain**: A novel alternative to traditional antibiotics for treating mastitis, currently in the investigational phase due to FDA approval delays [6][38] - **Market Dynamics**: The company positions itself against competitors by emphasizing immediate immunity rather than delayed responses typical of vaccines [17][19] Sales and Financial Performance - **Historical Growth**: From 2011 to 2018, the company experienced an 11.6% CAGR, which accelerated to 15.8% CAGR from 2018 to 2024 following the launch of Tri Shield [12][14] - **Recent Sales Data**: Q1 2024 revenue was $8.1 million, with trailing twelve-month growth reaching $27.3 million, indicating strong recovery from previous production issues [14][15] - **Production Capacity**: The company has successfully doubled its production capacity to over $30 million annually and has been operating without contamination issues since April 2024 [16][15] Operational Challenges and Strategies - **Contamination Issues**: The company faced contamination problems during capacity expansion in late 2022 and throughout 2023, which limited supply [15][16] - **Backlog Management**: The backlog of orders was reduced from over $4 million to just over $3 million, with expectations to clear it in the upcoming quarters [27][28] - **Capital Expenditures**: Plans to increase production capacity from 30 million to 40 million annually, requiring approximately $3 million in capital expenditures [29][30] Product Development and Future Outlook - **First Defense Product Suite**: The product line has evolved since its initial approval in 1991, with the introduction of new formulations to enhance efficacy [34][35] - **Retain Investigational Use**: The company is initiating investigational use of Retain to gather field data, which is crucial for future strategic decisions [39][40] - **Gross Margin Improvement**: Gross margins improved from 22% during contamination issues to 42% in Q1 2025, with a target of reaching 45% [42][45] Strategic Financial Tools - **At-the-Market (ATM) Offering**: The company has utilized the ATM offering judiciously, with significant activity in 2024 but minimal in 2025, allowing for flexibility in financing [31][33] Conclusion - **Optimistic Outlook**: The management expresses optimism for the latter half of 2025, focusing on growth in First Defense and resolving strategic options for Retain [45]
BioStem Technologies to Participate in the Goldman Sachs 46th Annual Global Healthcare Conference
Globenewswire· 2025-05-29 11:00
POMPANO BEACH, Fla., May 29, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, announces that the company will participate in the Goldman Sachs 46th Annual Global Healthcare Conference, which is taking place in Miami. Jason Matuszewski, the Company’s CEO, will participate in a fireside chat and will be available for one-on-one meetings. For conferen ...
BioStem Announces Notice of Allowance for Three New U.S. Patent Applications
Globenewswire· 2025-05-28 11:00
Expanding patent portfolio reinforces the Company's commitment to wound care innovation, with 55 issued patents and 52 pending applications Join BioStem's Distribution List & Social Media: To follow the latest developments at BioStem, sign-up to the Company's email distribution list HERE, and follow us on X and LinkedIn. About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, a ...
BioStem Technologies Reports Preliminary First Quarter 2025 Operating and Financial Results
Globenewswire· 2025-05-12 20:00
Core Insights - BioStem Technologies, Inc. reported a record first quarter in 2025, with revenue increasing by 73% year-over-year to $72.5 million, driven by strong performance in its wound care portfolio, particularly the Vendaje AC product [2][7][13] - The company is focused on transitioning more customers to Vendaje AC to enhance brand consistency and is also working on reducing selling, general, and administrative expenses by phasing out licensing fees associated with AmnioWrap2 [2][3] - BioStem has received IRB approval for a new clinical trial for its BioREtain Amnion Chorion product aimed at treating venous leg ulcers, marking its third prospective clinical trial [3][4] Financial Performance - Preliminary net revenue for Q1 2025 was $72.5 million, a 73% increase from $41.9 million in Q1 2024 [7][13] - Gross profit reached $71.7 million, representing a gross margin of 99%, compared to 95% in the same quarter of the previous year [7][13] - Operating expenses increased to $66.4 million from $35.1 million in Q1 2024, primarily due to higher sales and marketing costs [7][13] Clinical Trials and Product Development - BioStem launched the BR-AM-DFU clinical trial to evaluate Vendaje for non-healing diabetic foot ulcers, aiming to validate the clinical efficacy of its BioREtain technology [4] - The company has expanded its intellectual property portfolio, holding 55 issued patents and 52 pending patents, reinforcing its innovation leadership in regenerative medicine [5] Market Position and Strategic Focus - The company is actively pursuing an uplisting to Nasdaq and is currently under SEC review regarding its Form 10 registration [2][7] - BioStem aims to strengthen its position in the chronic wound care market while maintaining a focus on clinical evidence to support product adoption [2][3]
BioStem to Showcase its Leading BioREtain® Technology at the Symposium for Advanced Wound Care (SAWC) Spring Meeting
Globenewswire· 2025-05-01 11:00
Company to co-exhibit with strategic partner Venture Medical, LLC, highlighting collaborative innovation in chronic wound care managementThree accepted scientific posters will feature BioStem’s advanced allograft portfolio POMPANO BEACH, Fla., May 01, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today announced its agenda for the Symposium for ...