Welcome to our dedicated page for Biostem Tech news (Ticker: BSEM), a resource for investors and traders seeking the latest updates and insights on Biostem Tech stock.
BioStem Technologies, Inc. (OTC: BSEM) generates news that reflects its role as a MedTech company focused on placental-derived allografts for advanced wound care and regenerative therapies. Coverage of BSEM often centers on clinical trial milestones, reimbursement developments, financial reporting, and operational updates related to its BioRetain®-processed product portfolio, which includes brands such as AmnioWrap2™, VENDAJE®, VENDAJE AC®, VENDAJE OPTIC®, American Amnion™, and American Amnion AC™.
Investors and healthcare professionals following BSEM news can expect updates on randomized controlled trials and other clinical studies evaluating BioRetain-preserved placental allografts in chronic wound indications like diabetic foot ulcers and venous leg ulcers. The company has reported top-line clinical results from a multicenter randomized controlled trial in non-healing diabetic foot ulcers, as well as comparative studies versus standard of care and competitor products, and these types of announcements are key components of its news flow.
Another major theme in BioStem’s news is reimbursement and policy. The company regularly comments on Centers for Medicare & Medicaid Services (CMS) rules and Local Coverage Determinations affecting skin substitutes and cellular and tissue-based products. News items have addressed the placement of VENDAJE and VENDAJE AC in a “12-Month Status Quo” category under certain LCDs, the withdrawal of specific LCDs, and the inclusion of these products on Florida Medicaid’s list of covered skin substitutes, along with coverage in multiple state Medicaid programs.
Financial and corporate developments also feature prominently. BioStem has issued press releases on quarterly financial results, restated financial statements related to the treatment of bona fide services fees in a distribution agreement, and the appointment of a new independent registered public accounting firm. Operational news has included the purchase of land in the Research Park at Florida Atlantic University in Boca Raton, Florida, for a future headquarters, as well as partnerships to serve the U.S. Department of Veterans Affairs and community initiatives supporting veterans.
By monitoring this news page, readers can follow BioStem’s clinical evidence generation, reimbursement positioning, financial reporting, and strategic initiatives as they relate to its placental-derived advanced wound care products and BioRetain processing technology.
BioStem Technologies (OTC: BSEM) was featured on Benzinga's All Access show on June 17, 2022, at 10:20 AM EST. CEO Jason Matuszewski provided updates on the company's business growth and product portfolio. BioStem Technologies focuses on perinatal tissue's regenerative properties, utilizing the proprietary BioRetain® processing method to enhance growth factors and tissue structure. The company's manufacturing is FDA registered and AATB accredited, with products like VENDAJE® at its Pompano Beach, Florida site.
BioStem Technologies Inc. (OTC: BSEM) reported a 212% increase in net revenue for Q1 2022, totaling $2.749 million, compared to $0.882 million in Q1 2021. Despite this, the net loss rose to $0.879 million from $0.130 million year-over-year, marking a 578% increase in losses.
Adjusted EBITDA improved to $1.479 million (54% of revenue) from $0.225 million (25% of revenue) in the prior year. Gross profit was $2.345 million, or 85% of revenue, reflecting strong demand for the Vendaje® product. The company aims to expand its product offerings and salesforce in 2022.
BioStem Technologies Inc. (OTC: BSEM) reported a strong financial performance for the year ending December 31, 2021, achieving net revenue of $4.341 million, a remarkable 80% increase from $2.415 million in 2020. The net loss shrank to ($1.408 million), down 44% from ($2.518 million) the previous year. The gross profit rose by 121% to $2.824 million. CEO Jason Matuszewski highlighted ongoing growth driven by the commercialization of the Vendaje product and anticipates continued growth in 2022, bolstered by product launches and an expanding commercial team.
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BioStem Technologies (BSEM) reported impressive financial results for Q2 2021, with sales increasing by 306% to $970,511 compared to Q2 2020. Gross profit surged 1,348% to $455,723, representing 47% of sales. The net loss decreased by 47% year-over-year to $373,651. For the first half of 2021, sales rose 89% to $1,923,019 with a gross profit of $1,191,817, or 62% of sales. The company attributed this growth to an expanded sales force and increased adoption of its amniotic product portfolio.
BioStem Technologies (OTC PINK: BSEM) has partnered with Biologics Consulting to advance its investigational new drug (IND) candidates through the regulatory pipeline. With nearly 30 years of experience, Biologics Consulting has aided over 3,500 companies globally and contributed to more than 50 original INDs in the past four years. The collaboration aims to navigate the FDA’s Biologics License Application (BLA) process, enhancing BioStem's potential for product development in regenerative therapies.
BioStem Technologies, Inc. (OTC PINK: BSEM) announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new Healthcare Common Procedure Coding System (HCPCS) Q-code (Q4252) for its VENDAJE product. This decision, effective October 1, 2021, enables Medicare claims processing for the product, enhancing reimbursement strategies. CEO Jason Matuszewski emphasized that this Q-code is a crucial step for providing better billing options for healthcare providers and patients, potentially leading to significant growth opportunities.
BioStem Technologies, Inc. (BSEM) reported its first quarter 2021 results, showcasing a 22% increase in sales to $952,508 compared to $777,365 in Q1 2020. The cost of sales decreased to $216,414, significantly improving the gross margin to 77.23%, up from 45.5% year-over-year. Net losses also fell by 25% to $292,782. Recent highlights include receiving FDA TRIP response for their VENDAJE™ allograft and expanding their scientific advisory board.
BioStem Technologies (OTC PINK: BSEM) announced the appointment of three new members to its Scientific Advisory Board (SAB) to enhance its focus on perinatal tissue regenerative therapies. The new members are Jeffrey Harrison, Daniel Shelly, and Shaun Opie, joining Chairman Kenneth Warrington. Their combined expertise spans pharmacology, regulatory strategies, and advanced therapeutics, which will support BioStem's innovative product development and market expansion. This strategic move aligns with BioStem's vision to reinforce its scientific foundations and improve its product portfolio.
BioStem Technologies (OTC PINK: BSEM) is expanding its national sales force to boost sales of its perinatal tissue allografts. This strategic move comes as elective surgeries resume post-COVID-19 shutdowns, increasing demand for regenerative therapies. BioStem will add experienced sales representatives in key regions: Northeast, Midwest, and Mountain Region. The company specializes in utilizing perinatal tissue for regenerative medicine, leveraging proprietary technologies to enhance patient outcomes and shareholder value.