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BioStem Technologies to Present at the 46th Annual TD Cowen Healthcare Conference
Prism Media Wire· 2026-02-20 12:01
Core Insights - BioStem Technologies, Inc. will present at the 46th Annual TD Cowen Healthcare Conference in Boston, MA, highlighting its focus on perinatal tissue-derived products for advanced wound care [1]. Company Overview - BioStem Technologies is a leading innovator in the MedTech sector, specializing in the development, manufacturing, and commercialization of allografts for regenerative therapies derived from perinatal tissue [3]. - The company utilizes its proprietary BioRetain® processing method, which is designed to maintain growth factors and preserve tissue structure, leveraging the latest research in regenerative medicine [3]. - BioStem's quality management system and standard operating procedures are accredited by the American Association of Tissue Banks (AATB) and comply with current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP) [3]. - The company's product portfolio includes brands such as VENDAJE®, VENDAJE AC®, American Amnion™, American Amnion AC™, and Neox® and Clarix® product lines [3].
X @Bloomberg
Bloomberg· 2026-02-19 01:06
A Japanese health ministry panel is set to review two regenerative therapies facing regulatory approval, a pivotal test of the country’s long-running push to build a domestic industry around advanced cell-based treatments https://t.co/d2b7d7Lng3 ...
Adia Nutrition Announces Subsidiary Adia Med's Submission of Second Clinical Study for IRB Review Targeting Lower Back Pain with AdiaVita
TMX Newsfile· 2026-02-16 14:00
Core Viewpoint - Adia Nutrition Inc. is advancing its clinical research by submitting a second study for its product AdiaVita, aimed at alleviating lower back pain through non-invasive intravenous administration, which could transform pain management practices [1][4][7]. Clinical Study Details - The new clinical study will be a single-blind, placebo-controlled trial involving approximately 100 participants, assessing the efficacy of AdiaVita in reducing inflammation and promoting tissue repair in the lower back [3][4]. - The study will utilize a crossover design, allowing participants in the placebo group to receive AdiaVita after an initial three-month treatment period, facilitating within-subject comparisons [3]. Treatment Methodology - Unlike traditional treatments that require localized injections, this study focuses on systemic delivery via IV infusion, potentially offering a less invasive and more accessible treatment option for patients [4]. Financial Aspects - Participation in the study is structured as a patient-pay model, costing $5,000 per patient, with no additional fees for the crossover phase [5]. Ongoing Research Initiatives - This submission follows Adia Med's ongoing clinical research in Autism Spectrum Disorder (ASD), which is actively recruiting participants and aims to evaluate the combined effects of AdiaVita and glutathione therapy [6][8]. Company Vision and Growth - The CEO of Adia Nutrition expressed enthusiasm about the progress of the lower back pain study, highlighting the company's commitment to advancing patient-centered regenerative therapies that prioritize safety and accessibility [7]. - Adia Nutrition Inc. is expanding its services through Adia Med clinics, which specialize in various regenerative treatments, including stem cell therapies and advanced wound care solutions [10][11].
BioTissue Holdings, Inc Strengthens Strategic Focus on Ocular Innovation with Sale of Surgical and Wound Care Business to BioStem Technologies
Prnewswire· 2026-01-21 23:00
Core Insights - BioTissue Holdings, Inc. has completed the sale of its non-ocular Surgical and Wound Care business to BioStem Technologies, Inc., allowing BioTissue to focus on ocular market leadership and innovation in eye care solutions [1][2][3] Company Overview - BioTissue specializes in utilizing human birth tissue for regenerative healing, particularly in treating acute and chronic ocular surface conditions [4] - The company has developed a portfolio of cryopreserved amniotic membrane products using proprietary CryoTek® technology, which preserves the tissue's structural and functional integrity [4] - BioTissue has conducted over 1 million human procedures with its products and has over 420 peer-reviewed publications supporting its technology [4] Strategic Focus - Following the divestiture, BioTissue will concentrate on advancing interventional therapies for ocular conditions, including products like Prokera, CAM360 AmnioGraft, and AmnioGuard [2][3] - The company aims to prioritize product innovation, professional education, and comprehensive customer support within the eye care market [2] Partnership with BioStem - BioStem Technologies will acquire exclusive rights to BioTissue's Neox and Clarix product lines, integrating BioTissue's surgical sales team into its commercial organization [2][3] - BioStem's CEO highlighted the complementary strengths of BioTissue's portfolio to their existing business, indicating a strong potential for growth and improved patient outcomes [3]
Adia Nutrition Inc. Receives Notification from SEC: Form 10 to Become Effective on February 3, 2026
TMX Newsfile· 2026-01-20 14:30
Core Viewpoint - Adia Nutrition Inc. has received notification from the SEC that its Form 10 registration statement will automatically become effective on February 3, 2026, marking a significant milestone in its transition to full SEC reporting status [1][2][4]. Group 1: SEC Registration and Reporting - The Form 10 was originally filed on December 5, 2025, and its effectiveness will enhance transparency for investors through regular audited financial disclosures, including annual reports on Form 10-K and quarterly reports on Form 10-Q [2][4]. - The notification from the SEC is seen as a major step forward for Adia Nutrition, as it will provide investors with increased confidence and transparency starting February 3 [3][4]. Group 2: Business Operations and Growth Strategy - Adia Nutrition focuses on delivering innovative healthcare solutions through its divisions, including Adia Med clinics that specialize in advanced stem cell therapies and Adia Labs that provide biologic products to healthcare providers [5][7]. - The company generates revenue through service fees, product sales, equity stakes, and billing insurance for healthcare treatments, while also investing in aligned businesses like Cement Factory LLC [8]. Group 3: Future Prospects and Strategic Partnerships - The effectiveness of the Form 10 will trigger standard SEC reporting obligations, aligning Adia with best practices in public company disclosure and positioning it to meet eligibility requirements for potential listing on a national exchange [4]. - The company encourages clinic owners and healthcare practitioners to explore licensing the Adia Med name or integrating its regenerative therapies into their practices, indicating a focus on strategic partnerships to expand access to advanced stem cell solutions [6].
Adia Med Kicks Off Recruitment Today for Innovative Autism Stem Cell Study
TMX Newsfile· 2026-01-13 15:16
Core Insights - ADIA Nutrition Inc. has initiated a clinical study to evaluate the effects of stem cell therapy on children with Autism Spectrum Disorder (ASD) [1][2] - The study aims to enroll around 100 children aged 3-12 diagnosed with ASD, comparing the effects of a proprietary stem cell product combined with glutathione therapy against glutathione therapy alone [3][4] Study Details - The clinical trial, titled "Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study," is a 24-month randomized interventional study [2] - The study is registered on ClinicalTrials.gov with ID NCT07304440 and is currently in the recruitment phase [2] - The primary outcome will be assessed using the Autism Treatment Evaluation Checklist (ATEC) at six months, focusing on safety, tolerability, and overall well-being [3][4] Participation and Costs - Participation is voluntary with a one-time fee of $12,000 covering all treatments and assessments during the study [5][11] - Families can withdraw at any time without penalty, although fees for completed procedures are non-refundable [6] Company Overview - ADIA Nutrition Inc. specializes in stem cell and regenerative products, operating clinics that offer various advanced treatments [8][9] - The company generates revenue through service fees, product sales, and insurance billing for healthcare treatments [9] - ADIA Nutrition is expanding its operations and partnerships to enhance access to regenerative therapies [7][9]
BioStem Technologies Comments on Withdrawal of CMS CY 2026 Final Medicare Reimbursement Rule for Skin Substitutes
Globenewswire· 2026-01-07 21:05
Core Viewpoint - BioStem Technologies, Inc. has commented on the withdrawal of all seven Local Coverage Determinations (LCDs) by the Centers for Medicare & Medicaid Services (CMS) for skin substitute grafts and cellular products for treating diabetic foot ulcers and venous leg ulcers, effective January 1, 2026, indicating that this will not impact patient access to their technology [1][2]. Company Overview - BioStem Technologies is a MedTech company focused on developing, manufacturing, and commercializing 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 [2]. - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and complies with current Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [2]. Market and Innovation - The company emphasizes the importance of high-quality clinical evidence for long-term adoption and value creation, committing to an evidence-based strategy [2]. - BioStem plans to continue investing in expanding its clinical data foundation to demonstrate the differentiated performance of its proprietary technology compared to alternatives [2]. Product Portfolio - BioStem's product portfolio includes brands such as AmnioWrap2™, VENDAJE, and American Amnion™, all processed at their FDA registered and AATB accredited site in Pompano Beach, Florida [2].
Adia Nutrition Inc. Announces Landmark Autism Spectrum Disorder Clinical Study Now Live on ClinicalTrials.gov
TMX Newsfile· 2026-01-05 15:21
Core Insights - Adia Nutrition Inc. has launched a clinical study targeting Autism Spectrum Disorder (ASD), which is now live on ClinicalTrials.gov, representing a significant advancement in the company's research pipeline [1][4]. Group 1: Clinical Study Details - The clinical trial, titled "Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study," aims to enroll approximately 100 children aged 3-12 with confirmed ASD [3]. - The study will evaluate the potential benefits of intravenous glutathione combined with umbilical cord blood-derived stem cells and exosomes (AdiaVita) compared to glutathione alone, focusing on changes in Autism Treatment Evaluation Checklist (ATEC) scores [3]. - The trial includes a 24-month follow-up period, with patient recruitment expected to begin in January 2026 [3]. Group 2: Company Overview - Adia Nutrition Inc. is based in Winter Park, Florida, and specializes in regenerative medicine, particularly through its subsidiary Adia Med [1][6]. - The company generates revenue through service fees, product sales, equity stakes, and billing insurance for healthcare treatments [7]. - Adia Nutrition is expanding its offerings to include insurance-billable wound care products and operates Adia Med clinics that specialize in various regenerative treatments [6][7]. Group 3: Strategic Vision - The CEO of Adia Nutrition emphasized the importance of rigorous and transparent research, indicating that this study will serve as a foundational model for additional clinical investigations planned for 2026 [5]. - The company is open to strategic partnerships to expand access to advanced stem cell solutions and encourages clinic owners and healthcare practitioners to integrate Adia's regenerative therapies into their practices [5].
BioStem Technologies® to Debut American Amnion™ at the 2025 Desert Foot Multi-Disciplinary Limb Salvage and Wound Care Conference
Prism Media Wire· 2025-12-10 12:01
Core Insights - BioStem Technologies has launched a new product line, American Amnion, aimed at enhancing wound care for veterans, showcasing its commitment to serving this underserved population [1][3][6] Product Overview - American Amnion and American Amnion AC are placental-derived allografts designed to improve chronic wound healing through enhanced structural integrity and cell preservation [2][4] - American Amnion AC consists of full thickness dehydrated human amnion and chorion membrane, while American Amnion is made from dehydrated human amnion membrane, both utilizing BioStem's proprietary BioRetain technology [4] Clinical Performance - Clinical studies indicate that allografts produced with BioRetain technology show superior performance, with a 53% probability of wound closure compared to 31% for standard care [5] - The BioRetain-preserved DHACM demonstrated a 14% reduction in time to closure and required 27% fewer applications than a leading competitor [5] Market Context - The use of placental-based products in the VA system has increased by 50% over the last five years, highlighting a growing demand for advanced wound care solutions [6] - The introduction of American Amnion is positioned as a significant advancement in the standard of care for veterans with chronic, non-healing wounds [6] Community Engagement - BioStem Technologies is actively involved in community support, exemplified by its sponsorship of the Florida Panthers' Heroes Among Us program, which honors military veterans [7] Company Background - BioStem Technologies specializes in placental-derived biologics for advanced wound care, focusing on innovative solutions that leverage the natural properties of perinatal tissue [8] - The company’s products are processed at an FDA registered and AATB accredited facility in Pompano Beach, Florida, ensuring compliance with industry standards [8]
BioStem Technologies Expands Product Access in Medicaid
Globenewswire· 2025-11-25 13:59
Core Insights - BioStem Technologies, Inc. has announced the inclusion of its products VENDAJE and VENDAJE AC in Florida Medicaid's list of covered skin substitutes, marking a significant milestone in its national reimbursement strategy [1][2][3] Group 1: Company Developments - The addition of Florida Medicaid coverage enhances BioStem's mission to provide high-quality wound care, significantly increasing its addressable patient base in one of the largest Medicaid markets in the U.S. [3] - BioStem's advanced wound care market is estimated to exceed $11 billion annually in the U.S., with over 70 million Americans enrolled in Medicaid, including approximately 7 million aged 65 and older [3] Group 2: Product Information - VENDAJE and VENDAJE AC are placental-derived, minimally manipulated dehydrated tissue allografts designed for soft tissue wound protection, utilizing the proprietary BioREtain technology to optimize the retention of extracellular matrix scaffolding [5][6] Group 3: Distribution Strategy - BioStem is actively seeking qualified regional distributors and wound care organizations to represent the VENDAJE portfolio in Florida and other covered states [4]