Ankündigung • May 16
BioStem Technologies, Inc. Provides Earnings Guidance for 2026 BioStem provided earnings guidance for 2026. The company expects its revenue for full year 2026 to be in the range of $25 million to $29 million. Ankündigung • May 02
BioStem Technologies, Inc. Appoints Katherine Gorrell as Chief Legal & Compliance Officer, Effective April 27, 2026 BioStem Technologies, Inc. announced the appointment of Katherine Gorrell as Chief Legal & Compliance Officer, effective April 27, 2026. Ms. Gorrell has an extensive career advising hospital systems and health technology companies, with deep experience in health law, regulatory, transactional, compliance, governance, and risk management, as well as other business-oriented legal functions that facilitate strategic expansion and ensure operational excellence. In her role, she will oversee BioStem’s legal and compliance functions and play a central role in enterprise governance, including the integration and oversight of Medical Affairs through BioStem’s compliance framework. Most recently Ms. Gorrell served as Vice President and General Counsel at Holy Cross Health in Fort Lauderdale, Florida, where she was as a member of the Executive Team and led legal strategy across a complex healthcare enterprise. She previously served as General Counsel and Compliance Officer for AdvancedMD, a national healthcare IT company, and held in-house roles at Intermountain Healthcare and Providence Health & Services/Swedish Health Services, advising across the full spectrum of operational, regulatory, and strategic matters. Ms. Gorrell holds a JD with Honors, with a concentration in Health Law, from the University of Washington School of Law, and a Bachelor of Arts with Honors in Political Science from the University of Utah. Ankündigung • May 01
BioStem Technologies, Inc. to Report Q1, 2026 Results on May 14, 2026 BioStem Technologies, Inc. announced that they will report Q1, 2026 results on May 14, 2026 Ankündigung • Mar 26
BioStem Technologies, Inc. Provides Earnings Guidance for First Quarter of 2026 BioStem Technologies, Inc. provided earnings guidance for first quarter of 2026. For the period, the Company anticipates first quarter revenue to be in the range of $5 million to $6 million. Ankündigung • Mar 23
BioStem Technologies Announces Board and Committee Changes BioStem Technologies announced the appointment of Jodi Ungrodt to its Board of Directors, where she will also serve as Chair of the Audit Committee, effective March 18, 2026. Ungrodt brings nearly three decades of financial leadership to the role, having spent her career as a senior partner at Ernst & Young advising life sciences companies on initial and secondary public offerings, business combinations, risk assessment and regulatory compliance. She is qualified to serve as a financial expert under SEC, NYSE, and NASDAQ rules. As Audit Committee Chair, Ungrodt will oversee the company’s financial reporting, internal controls and risk management practices. Her prior experience includes serving as Chair of the Audit Committee for Feeding San Diego, where she provided accounting, budgeting and risk assessment guidance for over a decade. She is also an Advisory Board Member for Life Science Cares. During her tenure at EY, Ungrodt served more than 70 companies across the Life Sciences sector. Ungrodt holds a BS in Accounting from San Diego State University and is a Certified Public Accountant and member of the American Institute of Public Accountants and the California Society of CPAs. Ungrodt replaces former board member Brandon Poe, who accepted the role of BioStem’s chief financial officer in August 2025. Poe brings more than 25 years of finance leadership experience across the healthcare and life sciences sectors. He served on BioStem’s Board of Directors for three years before joining the organization. Ankündigung • Mar 12
BioStem Technologies, Inc. to Report Q4, 2025 Results on Mar 24, 2026 BioStem Technologies, Inc. announced that they will report Q4, 2025 results on Mar 24, 2026 Ankündigung • Feb 04
BioStem Technologies Highlights Alignment with FDA's Openness to Bayesian Statistical Approaches in Clinical Research BioStem Technologies, Inc. underscored the significance of recent remarks from U.S. Food and Drug Administration (FDA) leadership signaling openness to expanded use of Bayesian statistical methodologies in clinical trial design and analysis. FDA Commissioner, Dr. Martin Makary recently described the agency's evolving stance on Bayesian approaches as a "leap forward" for clinical science, noting their potential to improve trial design, dose optimization, pediatric extrapolation, and integration of early-phase data into later-stage studies -- a shift aligned with emerging regulatory guidance on Bayesian methods from the agency. In BioStem's published DFU analysis, Bayesian regression and hurdle modeling were used to move beyond traditional binary endpoints, enabling the company to quantify probability of wound closure, magnitude of response, and treatment effect across heterogeneous patient populations. Similar statistics are expected to be included in the analysis of the Company's ongoing VLU and DFU studies to enhance the understanding of the clinical benefits of the BioRetain technology. That recently published study demonstrated that BioRetain-processed allografts achieved superior clinical outcomes in the treatment of patients with DFUs. Importantly, utilizing complete closure instead of initial incidence of closure, the BR-AC arm was almost twice as likely to achieve lasting wound closure than patients treated with standard of care alone. This trial was conducted with a degree of rigor not typically seen in the published literature. The patient selection criteria ensured that only those patients with the hardest-to-heal wound were enrolled, and the definition of closure followed the 2006 FDA guidance for cutaneous ulcers, the most rigorous standards established. Ankündigung • Jan 23
BioStem Technologies, Inc. (OTCPK:BSEM) acquired Surgical and Wound Care Business of BioTissue Holdings Inc. for $40 million. BioStem Technologies, Inc. (OTCPK:BSEM) acquired Surgical and Wound Care Business of BioTissue Holdings Inc. for $40 million on January 21, 2026. A cash consideration of $15 million will be paid by BioStem Technologies, Inc. BioStem Technologies, Inc. will pay an additional regulatory milestone payment of up to $10 million for achieving 510(k) clearance for a new product, and potential commercial royalty milestone payments of up to $15 million.
For the period ending December 31, 2025, BioTissue Holdings' Surgical and Wound Care Bu reported total revenue of $29 million. the transaction is expected to be accretive to BioStem's growth, EBITDA and profitability in 2026.
Bass, Berry & Sims PLC acted as legal counsel for BioTissue Holdings Inc.
BioStem Technologies, Inc. (OTCPK:BSEM) completed the acquisition of Surgical and Wound Care Business of BioTissue Holdings Inc. on January 21, 2026. Ankündigung • Jan 22
BioStem Technologies, Inc. Announces Promotion of Barry Hassett as Chief Commercial Officer BioStem has promoted industry veteran Barry Hassett, previously the Senior Vice President of Commercial Strategy, into the role of Chief Commercial Officer to lead the newly combined commercial team. Barry has over 25 years of industry experience, including five years with BioTissue where he held the role of Vice President of Marketing, leading the initial development of its surgical and wound care business as well as its ophthalmic portfolio. Ankündigung • Dec 19
Biostem Technologies, Inc. Announces Its Products, Vendaje®? and Vendaje Ac®? BioStem Technologies, Inc. announced that its products, VENDAJE®? and VENDAJE AC®?, have been granted a 12-month status quo period in an update to Centers for Medicare & Medicaid Services' ("CMS") Local Coverage determinations ("LCD") for skin substitute grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers ("DFU") and venous leg ulcers ("VLU") that will be effective on January 1, 2026. Under the final policy, CMS and the Medicare Administrative Contractors (MACs) categorized products into three groups: Covered, Non-Covered, and 12-month Status Quo. This provides patient access, provider choice, customer continuity, and revenue stability for BioStem. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. Ankündigung • Dec 13
BioStem Technologies, Inc. to Debut American Amnion at the 2025 Desert Foot Multi-Disciplinary Limb Salvage and Wound Care Conference BioStem Technologies, Inc. announced the launch of a new product line, American Amnion, at the Desert Foot Multi-Disciplinary Limb Salvage and Wound Care Conference held in Phoenix, Arizona, on December 10-13, 2025. American Amnion AC is a human connective tissue allograft comprised of full thickness dehydrated human amnion and chorion membrane (DHACM) including the intermediate layer, while American Amnion is comprised of dehydrated human amnion membrane (DHAM) also including the intermediate layer. Both are intended for homologous use as a protective covering for acute or chronic wounds and are produced using BioStem’s proprietary BioRetain technology, which optimizes the preservation of the native tissue’s innate structural and molecular composition. Allografts produced with this technology have demonstrated superior clinical performance as documented in several recently published studies. In a multi-center randomized controlled clinical trial published in the International Journal of Tissue Repair (2025), McCoy et al. reported that patients treated with the BioRetain-preserved full thickness amniochorion product (referenced in the published manuscript as BR-AC) demonstrated a probability of wound closure (53%) that was almost twice that observed in patients treated with the standard of care (31%). Similarly, in a comparative retrospective study published in Health Science Reports (2024), Frykberg et al. documented that the BioRetain-preserved DHACM outperformed a leading competitor in both clinical and cost effectiveness, by demonstrating a 14% reduction in time to closure and requiring 27% fewer applications to achieve closure. Ankündigung • Nov 26
BioStem Technologies, Inc. Expands Product Access in Medicaid BioStem Technologies, Inc. announced expanded reimbursement with the inclusion of VENDAJE and VENDAJE AC in Florida Medicaid's list of covered skin Substitutes. This expansion marks a significant milestone in BioStem's national reimbursement strategy, extending access to the company's advanced wound care products to thirteen Medicaid programs, including California (Medi-Cal), Texas, Michigan, and now Florida. This progress builds on early traction in other states, including initial success with Medi-Cal and Texas Medicaid. BioREtain has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks ("AATB"). These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). The portfolio of quality brands includes AmnioWrap2™?, VENDAJE AC®?, V ENDAJE OPTIC®?, American Amnion, and American AC. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. Ankündigung • Nov 01
BioStem Technologies Reports Positive Top-Line Clinical Results Demonstrating Superior Outcomes with BioRetain®? Allograft in Diabetic Foot Ulcers BioStem Technologies, Inc. announced top-line results of the Company's clinical trial evaluating BioRetain®? - Processed Amnion Chorion (BR-AC) versus standard of care for patients with non-healing diabetic foot ulcers (DFUs), as published in the International Journal of Tissue Repair. BR-AC achieved superior clinical outcomes in this patient population. The probability of healing in the BR-AC arm was 53% while the probability of healing in the standard of care arm was 31%, utilizing complete closure instead of initial incidence of closure as the endpoint. Future Publications: The primary outcome of the study published in this report was to determine whether DFUs treated with standard care plus BR-AC resulted in a higher probability of achieving complete wound closure compared to standard care alone over a 12-week period. Future publications will address secondary outcome measures, including, but not limited to: Comparing treatment group differences in proportions of wounds achieving complete wound closure based on time in days. portfolio of quality brands includes AmnioWrap2™?, VENDAJE®?, V ENDAJE AC®?, VENDA JE OPTIC®?, American Amnion and American Amnion AC™?. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. Ankündigung • Oct 31
BioStem Technologies, Inc. to Report Q3, 2025 Results on Nov 13, 2025 BioStem Technologies, Inc. announced that they will report Q3, 2025 results on Nov 13, 2025 Ankündigung • Jul 30
BioStem Technologies, Inc. to Report Q2, 2025 Results on Aug 14, 2025 BioStem Technologies, Inc. announced that they will report Q2, 2025 results on Aug 14, 2025 Ankündigung • Jun 24
BioStem Technologies Completes Enrollment in Clinical Trial Evaluating BioREtain ®? Amnion Chorion for Treatment of Diabetic Foot Ulcers BioStem Technologies, Inc. announced that patient enrollment has been completed in the Company's clinical trial evaluating BioREtain Amnion Chorion (BR-AC) versus standard of care for patients with non-healing diabetic foot ulcers (DFUs). The BR-AC-DFU-101 study is a multicenter, randomized, controlled trial that was initiated in Fourth Quarter 2024 at 11 sites across the U.S. to evaluate at least 60 patients with non-healing DFUs. The primary objective is to determine whether DFUs treated with standard care plus BR-AC achieve a higher probability of complete wound closure over a 12-week period when compared to standard care alone. BioStem recently completed enrollment of 71 patients in the study, with topline data expected to be reported during the fourth quarter of 2025. Trial Primary & Secondary Outcome Objectives: The primary outcome of the study is to determine whether DFUs treatment plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone over a 12-week period. Secondary outcome measures include: Comparing treatment group differences in proportions of wounds achieving complete wound closure based on time in days. Comparing treatment group differences in wound area and volume. Assessing total number of applications of BR-AC required to achieve complete wound closure. Ankündigung • May 29
BioStem Technologies, Inc. Announces Notice of Allowance for Three New U.S. Patent Applications BioStem Technologies, Inc. announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for two design patents and one utility patent covering the Company's novel fenestrated human placental allograft designs and compositions manufactured using the BioREtain®? process. The United States Patent and Trademark office (USPTO) has issuing a Notice of Allowance for BioStem's Design Patent Application No. 29/860,417 for FENESTRATED HUMAN PLACENTAL ALLOGRAFT and for Design Patent Application No. This patent pertains to novel and inventive fenestrated human placementental allograft compositions manufactured using the BioRE obtain process with a unique fenestration that allows wound exudate to pass through the graft and away from the wound without sacrificing allograft area. The method of preparation preserves the structural and molecular integrity of the amnion and chorion tissues, thereby facilitating and enhancing wound treatment compared to conventional human placental allografts, particularly in the treatment of diabetic foot ulcers, dental wounds, and other topical wounds. These newly granted patents play a pivotal role in the advancement of next-generation placental allograft technologies and underscore the proprietary nature of BioREtain process - designed to preserve the structural and molecular integrity Of the placental tissue. By optimizing the retention and preservation of the amnion, intermediate, and chorion layers, are able to offer clinicians solutions that support better outcomes and improve patient care. This continued innovation further solidifies BioStem's leadership in advanced wound care. These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). portfolio of quality brands includes AmnioWrap2™?, VENDAJE®?, VENDAJ E AC®?, and VENDAJE OPTIC®?. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. Ankündigung • Apr 30
BioStem Technologies, Inc. to Report Q1, 2025 Results on May 12, 2025 BioStem Technologies, Inc. announced that they will report Q1, 2025 results on May 12, 2025 Ankündigung • Apr 08
BioStem Technologies, Inc. to Report Q4, 2024 Results on Apr 14, 2025 BioStem Technologies, Inc. announced that they will report Q4, 2024 results at 4:00 PM, US Eastern Standard Time on Apr 14, 2025 Ankündigung • Mar 31
BioStem Technologies, Inc. Announces Notice of Allowance for Two U.S. Patent Applications BioStem Technologies, Inc. announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for two of BioStem's patent applications. The patent is directed to novel and inventive micronized human placental compositions for wound care. The unique method of preparing BioStem's compositions results in optimal retention of the structural and molecular profile of the amnion and chorion tissue. These compositions can be used to develop products for wound packing, treatment of wounds having irregular surfaces/boundaries, emotional wounds, and dental/oral wounds. Thesemicronized compositions could even be integrated into a therapeutic bandage to support healing of a topical wound. No. These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). portfolio of quality brands includes AmnioWrap2™?, VENDAJE®?, VENDAJ E AC®?, and VENDAJE OPTIC®?. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. Ankündigung • Feb 24
Biostem Receives Institutional Review Board Approval to Advance Clinical Trial Demonstrating the Therapeutic Benefits of Bioretain®? Technology in Treating Venous Leg Ulcers BioStem Technologies, Inc. announced Institutional Review Board (IRB) approval for a clinical study to evaluate its proprietary BioREtain®? Amnion Chorion (BR-AC) for the treatment of venous leg ulcers (VLU). This study aims to assess the efficacy of BR-AC compared to standard of care in patients with non-healing VLUs, providing critical data to support continued market adoption of its proprietary technology. BioStem's allografts are processed utilizing the Company's proprietary BioREtain®? method, which retains the tissue's native properties while maintaining the structure and matrix found in fresh perinatal tissue. It contains collagen, extracellular matrix, and a wide array of protein components including growth factors, cytokines, and chemokines. BR-AC is a minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds. BR-AC-VLU Clinical Trial Overview and Design: Title: Non-healing Venous Leg Ulcers Treated with Standard Care, With or Without BR-AC; Primary Outcome Measures: The primary objective of this study is to assess whether the addition of BR-AC increases the likelihood of achieving complete wound closure in venous leg ulcers (VLUs) compared to standard of care alone. The study will evaluate the proportion of subjects who achieve full wound closure, defined as 100% re-epithelialization, over a 12-week treatment period. The portfolio of quality brands includes AmnioWrap2™?, VENDAJE®?, VENDA JE AC®?, and VENDAJE OPTIC®?. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. Ankündigung • Jan 08
BioStem Technologies, Inc. Launches Clinical Trial to Demonstrate Therapeutic Benefits of its BioREtain Technology in Treating Diabetic Foot Ulcers Using Vendaje BioStem Technologies, Inc. announced the initiation of the BR-AM-DFU (BioREtain Amniotic Membrane - Diabetic Foot Ulcers) clinical trial to evaluate Vendaje versus standard of care for patients suffering with non-healing diabetic foot ulcers. BR-AM-DFU Clinical Trial Overview and Design: Title: Non-healing Diabetic Foot Ulcers Treated with Standard Care, With or Without BR-AM Primary Outcome Measures: The primary objective of this study is to assess whether the addition of Vendaje to standard care increases the likelihood of achieving complete wound closure in diabetic foot ulcers (DFUs) compared to standard care alone. The study will evaluate the proportion of subjects who achieve full wound closure, defined as 100% reepithelialization, over a 12-week treatment period. The BR-AM-DFU trial is a multicenter, randomized, controlled study that will enroll 60 patients with non-healing DFUs at approximately twelve sites across the United States. The study will focus on a patient population with diabetic foot ulcers (DFUs) that have adequate perfusion and no clinical signs or symptoms of infection. Weekly visits will be conducted to monitor compliance with wound care protocols and off-loading, as well as to document when wound closure is achieved. A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up will consist of a four-week period with two visits at each two-week interval. Supporting Ongoing Clinical Trials: This is the second clinical trial launched by BioStem that is actively enrolling patients. The first trial, BR-AC-DFU-101 (BioREtain – Amnion Chorion – Diabetic Foot Ulcers), was initiated in October 2024 and is evaluating the effectiveness of the company’s AmnioWrap2 placental tissue in treating patients with DFUs. Ankündigung • Nov 26
BioStem Announces Notice of Allowance for U.S. Patent Application for Sterile Human Placental Allografts BioStem Technologies, Inc. announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for BioStem’s patent application No. 18/591,883 for STERILE HUMAN PLACENTAL ALLOGRAFTS HAVING A PLURALITY OF SLITS, OPENINGS, AND/OR FENESTRATIONS FORMED THEREON. The patent application will grant as U.S. Patent No. 12,144,831 on November 19, 2024. This patent will be used in the development of novel placental allografts designed for advanced wound care using BioStem’s BioREtain® process, which preserves essential natural factors. The allografts using this technology will feature flaps that open to allow exudate to escape without sacrificing surface area, making them suitable for both acute and chronic wound settings. This technology is unique, as there are no other fenestrated allografts on the market that offer the same benefits. A product using this technology is under development and is currently not commercially available and will be introduced using the HCT/P regulatory pathway. Once developed, the new allografts could be used as a protective covering for exudating wounds across the acute or chronic setting. Ankündigung • Oct 29
BioStem Technologies, Inc. to Report Q3, 2024 Results on Nov 12, 2024 BioStem Technologies, Inc. announced that they will report Q3, 2024 results on Nov 12, 2024 Ankündigung • Oct 17
BioStem Technologies Reports Results in A Diabetic Foot Ulcer Wound Closure Study Comparing BioREtain® to Standard of Care Treatment BioStem Technologies, Inc. announced breakthrough results published in the peer-reviewed journal, International Wound Journal. The study validates the clinical efficacy of BioREtain®-processed placental membranes (RE-AC) compared to the standard of care (SOC). Utilizing a real-world population with large, hard-to-heal, complex chronic diabetic foot ulcers (DFUs), the study demonstrates a clear advantage in 12-week wound healing rates for the RE-AC-treated group compared to the SOC group. In this study, researchers conducted a retrospective analysis to evaluate the effectiveness of a sterile, dehydrated amnion/chorion membrane processed using a proprietary method (RE-AC) compared to a cohort of patients treated with standard of care (SOC) measures in healing hard-to-heal diabetic foot ulcers (DFUs) in a real-world environment. A total of 21 subjects met the study's inclusion criteria, which included factors such as wound type (DFU), medical history, and previous treatment involving the RE-AC placental membrane product. The DFU wounds in the study were considerably larger than those typically included in randomized controlled trials (RCTs), averaging nearly 14 cm², compared to an average wound size of about 5 cm² in most RCTs. The study demonstrated that patients treated with RE-AC experienced an 8.53% higher probability of achieving full wound closure compared to the standard of care (SOC) group after 12 weeks. Notably, the study included large, complex DFUs with significant co-morbidities and other exacerbating factors, often excluded from typical studies due to their unfavorable outcomes, regardless of intervention. For those wounds that did not achieve complete closure, the RE-AC group still showed a 93.6% improvement in expected area reduction, were as the SOC group stalled or grew larger, confirming RE-AC's superior performance over SOC in managing difficult DFUs. The relative risk for wound closure in the RE-AC group was 52% higher than in the SOC group, underscoring the product’s effectiveness even under challenging conditions. Despite the complexity of the wounds, which averaged nearly 14 cm² and often persisted for extended durations, the RE-AC group achieved a statistically significant advantage in healing rates over SOC. Ankündigung • Oct 03
BioStem Technologies, Inc. Initiates BR-AC-DFU-101 Clinical Trial to Study BioREtain® in Diabetic Foot Ulcers BioStem Technologies, Inc. announced the initiation of the BR-AC-DFU-101 (BioREtain - Amnion Chorion - Diabetic Foot Ulcers) clinical trial to evaluate BR-AC (BioREtain - AmNion Chorion) against the standard of care for patients suffering from non-healing diabetic foot ulcers (DFUs). Study Overview and Design: The BR-AC-DFU -DFU-101 study will examine a patient population with a DFU (diabetic foot ulcer) that has adequateusion without clinical signs and symptoms of infection. The trial will enroll 60 patients with non-healing diabetic foot Ulcers at ten sites across the United States, with an expected completion date by the end of 2025. weekly subject visits will be conducted to monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. It is hypothesized that weekly applications of the human placental allograft BR-AC applied to a non-healing DFU will result in a higher rate of complete wound healing within 12 weeks of initiating therapy compared to standard care alone. The primary outcome of the study is to determine whether DFUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone over a 12-week period. Secondary outcome measures include comparing the differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure over a 12-week period. Secondary outcomes also include the differences between treatment groups in percent change in wound area (cm2) and (cm3), as well as the total number of applications of BR-AC needed to achieve complete wound closure. Diabetic foot ulcers (DFUs) are a serious and chronic condition affecting millions of individuals within the diabetic population. According to the American Podiatric Medical Association (APMA), a leading authority on foot and ankle health, approximately 15% of people with diabetes will develop foot ulcers. Alarmingly, 6% of these individuals may require hospitalization due to infections or other complications related to their ulcers. The risks for diabetic patients are substantial, as DFUs are the leading cause of lower extremity amputations in the U.S. Studies indicate that between 14% and 24% of individuals with diabetes who develop foot ulcers will ultimately need an amputation. Recent data analysis from GlobalData Plc., a prominent global data provider, revealed that 2.2 million patients received treatment for DFUs in 2023, with numbers projected to rise in the coming years. The economic burden of these ulcers on healthcare systems is significant, with annual treatment costs estimated between $9 billion and $13 billion in the United States alone. Ankündigung • Aug 21
BioStem Technologies Inc. Receives Institutional Review Board Approval to Advance Clinical Study Evaluating Value of Vendaje Compared to Standard of Care for Non-Healing Diabetic Foot Ulcers BioStem Technologies Inc. announced that the Institutional Review Board (IRB) has approved a clinical study to evaluate Vendaje® for diabetic foot ulcers (DFU), a key product in the company’s placental-derived allograft portfolio. This study aims to assess the efficacy of Vendaje compared to standard of care in diabetic patients with non-healing DFU’s, providing critical data to support both patient outcomes and payer decisions. Vendaje is a placental-derived, minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds. Composed of the amnion layer of the placenta, the product naturally possesses extracellular matrix scaffolding that provides mechanical protection and functional support for cell attachment, growth factors that help modulate proliferation and angiogenesis, and anti-inflammatory cytokines that inhibit inflammatory effects, all critical in aiding the body’s natural healing cascade. The product is used in private office and hospital/surgical settings, and which is currently reimbursed through Medicare. Vendaje Trial Overview: This trial is a multi-center, randomized, controlled study of non-healing DFUs treated with standard of care with or without Vendaje. The primary endpoint of the study is the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks. Secondary endpoints comparing differences between treatment groups include the time to closure, percent change in wound area and volume at 12-weeks, total number of applications used to achieve complete wound closure, and time to closure for subjects that crossover. The safety endpoint will evaluate spontaneously reported and elicited adverse events, and the exploratory endpoint will assess the differences between treatment groups in clinical signs and symptoms of infection. Ankündigung • Aug 05
BioStem Technologies, Inc. to Report Q2, 2024 Results on Aug 12, 2024 BioStem Technologies, Inc. announced that they will report Q2, 2024 results After-Market on Aug 12, 2024 Ankündigung • Jul 10
BioStem Technologies, Inc. Receives Institutional Review Board Approval to Advance a Clinical Study Evaluating AmnioWrap2 in Diabetic Foot Ulcers BioStem Technologies Inc. announced that the IRB has approved a clinical study to evaluate AmnioWrap2 (AW2) in diabetic foot ulcers (DFU), one of the company's placental-derived allograft commercial products. BioStem has received IRB approval to proceed with the clinical study evaluating AW2 in patients with diabetic foot ulcers. The primary endpoint of the study is the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks. Secondary endpoints comparing differences between treatment groups include the time to closure, percent change in wound area and volume at 12-we weeks, total number of applications used to achieve complete wound closure, and time to closure for subjects that crossover. The safety endpoint will evaluate spontaneously reported and elicited adverse events, and the exploratory endpoint will assess the differences between treatment groups in clinical signs and symptoms of infection. AW2 consists of unseparated amnion and chorion membranes, including the intact intermediate layer. These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). portfolio of quality brands includes AmnioWrap2, VENDAJE, VENDA JE AC, and VENDAJE OPTIC. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. Ankündigung • Jun 26
Biostem Technologies Reports Breakthrough Results with Amniowrap2® in Retrospective Wound Care Study BioStem Technologies Inc. announced that an article validating its proprietary processing method and its placental allograft products has been published in the international, peer-reviewed journal, Health Science Reports. The article, titled Assessing placental membrane treatment efficiency in diabetic foot ulcers: Processing for retention versus lamination provides a retrospective analysis of wound care in 41 subjects. The study’s primary objective was to evaluate and compare the effectiveness of two wound care products for managing diabetic foot ulcers, including BioStem’s AmnioWrap2® (RE-AC), processed using the BioREtain® method, and (L-AC) processed through a more ablative method used by a leading competitor in the industry. The study found that RE-AC products required fewer applications, suggesting greater efficiency in managing wounds, and that they offered overall better efficiency. The research found that RE-AC achieved a significantly higher expected Percent Area Reduction (xPAR) in DFUs compared to L-AC at 12 weeks (67.3% vs. 52.6%). Additionally, RE-AC required fewer applications, suggesting greater efficiency in general wound management. The probability of full wound closure was similar in both groups (0.738 vs. 0.740 in RE-AC and L-AC, respectively), further emphasizing the effectiveness of the treatment. Ankündigung • May 09
BioStem Technologies, Inc. to Report Q1, 2024 Results on May 14, 2024 BioStem Technologies, Inc. announced that they will report Q1, 2024 results on May 14, 2024 Ankündigung • Mar 22
BioStem Technologies, Inc. to Report Q4, 2023 Results on Apr 01, 2024 BioStem Technologies, Inc. announced that they will report Q4, 2023 results at 4:00 PM, US Eastern Standard Time on Apr 01, 2024 Ankündigung • Jan 11
BioStem Technologies, Inc. Appoints Shawn Mccarrey as Chief Commercial Officer BioStem Technologies Inc. announced it has appointed a proven life science sales leader, Mr. Shawn McCarrey, as Chief Commercial Officer. Before joining, Mr. McCarrey held the position of Chief Commercial Officer at BLUEWAVE, successfully leading the commercialization of their proprietary system in Orthotics & Prosthetics (O&P), Wound Care, and Podiatry markets. Prior to this, he served as the Vice President of Sales at Glytec, and held the role of Senior Vice President of Sales in the regenerative medicine sector at the medical device company, AxoGen. During his tenure at AxoGen, Mr. McCarrey was instrumental in boosting the company's annual growth rate from 39% to an impressive 60%. Additionally, he brings valuable leadership experience from his time at Bayer, where he significantly expanded the company's install base by 910% and grew its sales force by 250%. At Possis Medical, Mr. McCarrey was pivotal in launching 16 new products over a decade, contributing to a substantial 1,158% increase in the company's sales. Ankündigung • Dec 19
Biostem Technologies Appoints Patrick Daly to Board of Directors BioStem Technologies Inc. announces it has appointed Mr. Patrick Daly to its Board of Directors. Mr. Daly is an award-winning executive leader with a strong track record of success in operations, strategy, sales, marketing, fundraising, and partnership-building. Mr. Daly is an Advisor at Pappas Capital, a private equity firm focused on the life sciences industry. Most recently, he served as Global VP Commercial Solutions and subsequently, Global VP MedTech Data Delivery, at IQVIA Holdings and was responsible for leading a global strategic MedTech Commercial Solutions business unit. Previously, he held the position of President and CEO at Cohera Medical, an early-stage commercial-stage life sciences company developing biomaterials for surgical adhesives, sealants, and drug delivery products that was acquired by global investment firm, KKR. At Cohera, Mr. Daly spearheaded the development of a novel delivery device for synthetic surgicaladhesive that maintained a two-year shelf life and received the Businesswire 2012 Medical Design Excellence Award. Ankündigung • Dec 13
BioStem Technologies Inc. Appoints Thomas J. Dugan as Chairman of Board BioStem Technologies Inc. announced the appointment of Mr. Thomas J. Dugan to the position of Chairman of the Board. Mr. Dugan brings a wealth of experience to BioStem, with proven, hands-on expertise as a senior executive who has transformed businesses, established new market opportunities, and driven growth in the face of strong competition. He has extensive experience in the wound care and surgical fields. Mr. Dugan co-founded 360 Life Sciences Advisors. Most recently, Mr. Dugan was the President of Integrum, Inc. Previously, he served as Chief Executive Officer and board member at Amniox Medical. Mr. Dugan was President at Surgiquest, Inc., President of the Americas for Smith and Nephew Wound Management, and served in senior roles at SonoSite, Datascope, and Tyco Healthcare. Mr. Dugan served on the board of directors of Rita Medical Systems, which was acquired by AngioDynamics, and various venture-backed medical device companies. He chaired the Wound Healing and Tissue Regeneration sector of AdvaMed and also served on the board of MITA. Ankündigung • Nov 09
BioStem Technologies Inc. Receives Q Code for VENDAJE AC Line from Centers for Medicare and Medicaid Services BioStem Technologies Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has published a new Q code, Q4279 for VENDAJE AC pursuant to its application for Healthcare Common Procedure Coding System (HCPCS) Q codes. The HCPCS code assigned for VENDAJE AC will be effective January 1, 2024. VENDAJE AC is a human connective tissue matrix comprised of dehydrated amniotic/chorionic tissue processed using BioStem’s proprietary BioREtain process. It is an easy to handle, thicker structural tissue allograft, intended for use as a protective covering for soft tissue wounds. Q codes are established to identify drugs, biologicals and medical equipment or services not identified by national HCPCS Level II codes and are needed for Medicare claims processing. CMS assigns codes based on HCPCS Committee review and they are maintained by the HCPCS national panel, comprised of representatives from the Health Insurance Association of America, Blue Cross/Blue Shield and CMS. Ankündigung • Nov 08
BioStem Technologies, Inc. to Report Q3, 2023 Results on Nov 14, 2023 BioStem Technologies, Inc. announced that they will report Q3, 2023 results Pre-Market on Nov 14, 2023 Ankündigung • Nov 05
BioStem Technologies, Inc. announced that it has received $2.0055 million in funding BioStem Technologies, Inc. announced a private placement of 1,337,000 units at a price of $1.50 per unit for the gross proceeds of $2.0055 million on November 3, 2023. Each unit consists of one common share in the capital of the company and one common share purchase warrant at an exercise price of $2 per warrant. The transaction was oversubscribed. Ankündigung • Sep 27
BioStem Technologies, Inc. Receives IRB Approval for Clinical Study to Evaluate Vendaje(R) in Diabetic Foot Ulcers BioStem Technologies Inc. announced the approval of an Investigational Review Board (IRB) sanctioned clinical study. This study aims to investigate the utilization and effects of Vendaje in diabetic patients suffering from foot ulcers. Diabetic Foot Ulcers are a significant risk for people with diabetes. According to the American Podiatric Medical Association (APMA), a leading resource for foot and ankle health, approximately 15% of people with diabetes develop foot ulcers. Diabetic Foot Ulcers are a significant risk for people with diabetes. According to the American Podiatric Medical Association (APMA), a leading resource for foot and ankle health, approximately 15 % of people with diabetes develop foot ulcers. Of those 15 %, 6 % go on to be hospitalized due to infection or other ulcer-related complications. The risk to patients with diabetes is significant, as it is the leading cause of lower extremity amputations in the U.S. Approximately 14 to 24 % of people with diabetes that develop foot ulcers will require an amputation. Vendaje is a placental-derived, minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds. Composed of the amnion layer of the placenta, Vendaje naturally possesses extracellular matrix scaffolding that provides mechanical protection and functional support for cell attachment, growth factors that help modulate proliferation and angiogenesis, and anti-inflammatory cytokines that inhibit inflammatory effects, all critical in aiding the body's natural healing cascade. Ankündigung • Feb 15
BioStem Technologies, Inc. (OTCPK:BSEM) entered into a share purchase agreement to acquire remaining 10% stake in Blue Tech Industries, Inc. from M.W. Jens Realty Investments, LLC for $1.9 million. BioStem Technologies, Inc. (OTCPK:BSEM) entered into a share purchase agreement to acquire remaining 10% stake in Blue Tech Industries, Inc. from M.W. Jens Realty Investments, LLC for $1.9 million on February 14, 2023. Pursuant to the Agreement, the Company agrees to acquire the shares of Blue Tech Common Stock held by M.W. Jens in exchange for the issuance to M.W. Jens of 500,000 shares of common stock, par value $0.001, of BioStem Common Stock. Ankündigung • Oct 27
Biostem Technologies, Inc. Promotes Michael Fortunato, CPA to Chief Financial Officer BioStem Technologies Inc. announced that Michael Fortunato, CPA has been promoted to the role of Chief Financial Officer from his prior position of Controller, effective immediately. Mr. Fortunato brings over 28 years of expert level financial accounting, SEC reporting, M&A and IPO experience to BioStem. Mr. Fortunato spent 11 years at “Big 4” accounting firms having served clients within the health and life sciences industries. He spent almost seven years with the SEC’s Enforcement Division, San Francisco Regional Office where he monitored SEC registrant compliance with SEC rules and regulations for companies located from Northern California to Washington State. Mr. Fortunato also held various technical accounting and SEC reporting roles with major technology companies located within the SF Bay Area. He has participated in six IPOs including Alibaba’s $22 billion initial public offering. Mr. Fortunato holds a B.S. in accounting from Rutgers University and holds an active CPA license in the State of Florida. Ankündigung • Sep 09
Biostem Technologies, Inc. Appoints Brandon Poe as Independent Board Member and Chair of the Audit Committee BioStem Technologies Inc. announced the appointment of Brandon Poe as Independent Board Member and Chair of the Audit Committee as of September 7, 2022. Mr. Poe is an experienced executive with more than 25 years of financial experience across various industries, including life sciences, medical devices and genomics services. He currently serves as Chief Financial Officer (CFO) of Jumpcode Genomics, a genomic tools company unlocking the power of next-generation sequencing using CRISPRclean technology in the fields of basic research, infectious disease, oncology and consumer genomics. Previously, he held the position of CFO at Genome Medical, a genomic telehealth provider, where he led all aspects of finance. Prior to Genome Medical, Mr. Poe was Vice President of Finance at Illumina; CFO at Sotera Wireless, a medical device start-up; and Vice President of Finance at Inverness Medical Innovations, a point-of-care diagnostics company acquired by Abbott. Mr. Poe received his bachelor's degree from Bucknell University and his MBA from the University of Chicago Booth School of Business. Ankündigung • May 26
BioStem Technologies, Inc. announced a financing transaction BioStem Technologies, Inc. (OTCPK:BSEM) announced that it will receive $3,000,000 in a round of funding on May 25, 2021. The company will issue common shares and option, warrant or other right to acquire another security in the transaction pursuant to exemption provided under Regulation D. Ankündigung • Oct 29
BioStem Technologies, Inc. Announces Launch of AEON BioStem Technologies, Inc. (BioStem or the Company) announced the launch of AEON, the 6th and newest addition to the Company’s perinatal tissue allograft platform. AEON is an all-natural amniotic fluid allograft, aseptically processed and then terminally sterilized using e-beam irradiation. The Company’s newly developed proprietary fluid processing technique has resulted in an allograft that does not require any preservative solutions to maintain the fundamental natural components which activate paracrine signaling. This lack of preservatives results in a pure natural fluid, free from dilution of the many growth factors, cytokines, proteins, and other naturally occurring nutrients present. The development process of AEON placed a paramount value on patient safety and product consistency. Extensive product characterization, cGMP and cGTP procedures and strict quality control measures have been put in place around AEON™ production to make this assurance. AEON is tested to meet United States Pharmacopeia (USP<71>) sterility requirements, as well as full growth factor characterization, to deliver a quality tissue transplant product. BioStem's comprehensive portfolio of high-quality flowable and membrane-based perinatal tissue allografts are all processed at BioStem Life Sciences, an FDA registered and AATB® accredited laboratory located in Pompano Beach, Florida. 