Regenerative Therapies

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Regen BioPharma Prepares Response For FDA Regarding Its Orphan Drug Application for HemaXellerate
Globenewswire· 2025-09-16 12:00
Core Viewpoint - Regen BioPharma is addressing comments from the FDA regarding its Orphan Drug Application for HemaXellerate, aimed at treating aplastic anemia, a rare and serious bone marrow disorder [1][3]. Company Overview - Regen BioPharma, Inc. is a publicly traded biotechnology company focused on immunology and immunotherapy, advancing novel technologies through pre-clinical and Phase I/II clinical trials [8]. Product Details - HemaXellerate is a novel, cell-based therapeutic designed to stimulate bone marrow activity and restore hematopoietic function, representing a significant milestone in the company's mission to develop innovative therapies for patients with limited options [2][5]. - The product is an autologous mesenchymal stem cell product expected to reverse the effects of aplastic anemia-induced bone marrow suppression [5]. Regulatory Aspects - The Orphan Drug Application is a major step for the company, as receiving orphan drug designation from the FDA would provide regulatory and commercial advantages, including seven years of market exclusivity, tax credits for clinical testing, and exemption from certain FDA application fees [3][4]. Market Context - Aplastic anemia is characterized by insufficient blood cell production, leading to severe health issues such as fatigue and infections, with current treatment options being limited and often ineffective [4].
BioStem Technologies to Present at Two Upcoming Investor Conferences
Globenewswire· 2025-09-02 12:34
Core Insights - BioStem Technologies Inc. is a leading MedTech company specializing in placental-derived biologics for advanced wound care [1][4] - The company will present at the Morgan Stanley Global Healthcare Conference and the H.C. Wainwright 27th Annual Global Investment Conference in New York [2][5] - BioStem's proprietary BioREtain processing method is designed to maintain growth factors and preserve tissue structure, enhancing the efficacy of its products [4] Company Overview - BioStem Technologies focuses on the development, manufacture, and commercialization of allografts for regenerative therapies [4] - The company’s quality management system is accredited by the American Association of Tissue Banks (AATB) and adheres to current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP) [4] - BioStem's product portfolio includes brands such as AmnioWrap2™, VENDAJE, VENDAJE AC, and VENDAJE OPTIC, all processed at its FDA registered and AATB accredited facility in Pompano Beach, Florida [4]
BioStem Technologies Announces Insider Share Purchase by Chairman and Chief Executive Officer
Globenewswire· 2025-08-21 11:00
Core Insights - BioStem Technologies, Inc. disclosed an insider purchase of common stock by Jason Matuszewski, the Chairman and CEO, indicating confidence in the company's future prospects [1][2] Group 1: Insider Transactions - Jason Matuszewski purchased a total of 15,500 shares on August 19, 2025, for approximately $100,000, with transactions executed at average prices of $6.28 for 2,500 shares and $6.51 for 13,000 shares [2] - Following these transactions, Mr. Matuszewski's total ownership in BioStem Technologies increased to 1,145,362 shares [2] Group 2: Company Overview - BioStem Technologies is a MedTech company focused on developing, manufacturing, and commercializing placental-derived products for advanced wound care [1][3] - The company utilizes its proprietary BioREtain processing method, which is designed to maintain growth factors and preserve tissue structure, enhancing the effectiveness of its allografts for regenerative therapies [3] - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and adheres to current Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [3] - The company's product portfolio includes brands such as AmnioWrap2™, VENDAJE, VENDAJE AC, and VENDAJE OPTIC, all processed at its FDA registered and AATB accredited facility in Pompano Beach, Florida [3]
BioStem Technologies Reports Preliminary Second Quarter 2025 Financial Results
Globenewswire· 2025-08-14 20:06
Core Insights - BioStem Technologies, Inc. reported preliminary financial results for Q2 2025, highlighting a sixth consecutive quarter of positive adjusted EBITDA despite facing revenue challenges due to increased competition and reimbursement uncertainties [4][9][11]. Recent Business Highlights - The company appointed Brandon Poe as the new Chief Financial Officer, bringing over 25 years of healthcare finance experience [4][8]. - BioStem completed enrollment in a clinical trial for BioREtain® Amnion Chorion aimed at treating diabetic foot ulcers, with data expected in Q4 2025 [8]. - The commercial organization is expanding with new direct representatives to access additional care sites [8]. - The intellectual property portfolio has been expanded with three new U.S. patent applications, totaling 58 issued and 68 pending patents [8]. Preliminary Financial Highlights - Net revenue for Q2 2025 was $49.3 million, a 34% decrease from Q2 2024, primarily due to lower volumes in the wound care portfolio [9][27]. - Gross profit was $48.6 million, representing 98.6% of net revenue, compared to $70.7 million or 95.0% of net revenue in Q2 2024 [10]. - Operating expenses decreased to $48.5 million from $61.9 million in Q2 2024, driven by lower revenue and reduced sales and marketing costs [10]. - Adjusted EBITDA for Q2 2025 was $2.5 million, down from $10.1 million in Q2 2024, reflecting lower gross profit but offset by reduced operating expenses [11]. - The company reported a GAAP net loss of $0.6 million or ($0.03) per share, compared to net income of $6.3 million or $0.39 per share in Q2 2024 [12][27]. - Cash and cash equivalents increased to $30.8 million as of June 30, 2025, up from $26.7 million as of March 31, 2025 [12][27]. Uplisting and Audit Update - BioStem is pursuing an uplisting to Nasdaq and is currently working through the audit of its historical financial statements [5][6]. - The company has clarified the accounting treatment for its distribution agreement with Venture Medical and is preparing to file an amended Form 10 to address SEC comments [5][6].
BioStem Technologies Appoints Brandon Poe as Chief Financial Officer
GlobeNewswire News Room· 2025-08-14 20:01
Core Insights - BioStem Technologies, Inc. has appointed Brandon Poe as Chief Financial Officer, marking a significant leadership change during a period of growth and innovation for the company [1][2] - The company is recognized for its innovative wound care technologies and aims to leverage its BioREtain® platform to accelerate growth and expand market presence [3] Company Overview - BioStem Technologies focuses on the development, manufacturing, and commercialization of 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 [3] - BioStem's quality management system has been accredited by the American Association of Tissue Banks and adheres to current Good Tissue Practices and Good Manufacturing Processes [3] Leadership Background - Brandon Poe brings over 25 years of experience in finance within the healthcare and life sciences sectors, having previously served as CFO at Midi Health, Inc. and Jumpcode Genomics, Inc. [2] - His experience at Illumina, Inc. included multiple senior finance roles, enhancing his capability to contribute to BioStem's strategic goals [2] Strategic Goals - The company aims to expand into new markets and advance its plans for a Nasdaq uplisting, indicating a focus on long-term growth ambitions [2] - Brandon Poe expressed enthusiasm about driving value for shareholders and executing the company's strategy during this pivotal stage [3]
Adia Nutrition Inc. Celebrates Grand Opening of Adia Med of San Antonio, First Licensed Clinic, Led by Michele DeLeon MD
Newsfile· 2025-07-14 13:28
Core Insights - Adia Nutrition Inc. has opened its first licensed clinic, Adia Med of San Antonio, under a strategic license agreement, led by Dr. Michele DeLeon [1][2] - The clinic aims to expand access to innovative regenerative therapies in the U.S. and will offer FDA-registered products, including AdiaVita and AdiaLink [1][2] - A clinical study focusing on regenerative therapies for autism will be conducted in collaboration with Adia Med of Winter Park, highlighting the company's commitment to transformative healthcare solutions [2] Company Overview - Adia Nutrition Inc. is a publicly traded company (OTCQB: ADIA) focused on revolutionizing healthcare and supplementation through two main divisions: a supplement division and a medical division specializing in stem cell therapies [3] - The medical division emphasizes treatments involving Umbilical Cord Stem Cells (UCB-SC) and Autologous Hematopoietic Stem Cell Transplantation (aHSCT) [3] - The company is dedicated to empowering individuals by addressing nutritional needs and providing groundbreaking medical treatments [3]
BioStem Technologies to Host First Quarter 2025 Financial Results Conference Call on May 12, 2025
Globenewswire· 2025-04-30 11:00
Core Viewpoint - BioStem Technologies Inc. will release its first quarter 2025 financial results on May 12, 2025, and will host a conference call and webcast to discuss the results [1][2]. Company Overview - BioStem Technologies is a MedTech company focused on developing, manufacturing, and commercializing placental-derived biologics for advanced wound care [1][4]. - The company utilizes its proprietary BioREtain processing method to maintain growth factors and preserve tissue structure in its products [4]. - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and adheres to current Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [4]. Upcoming Events - The conference call and webcast will feature an overview of the quarter from CEO Jason Matuszewski and CFO Michael Fortunato [2]. - Interested parties can register for the event and follow the company on social media for updates [3]. Contact Information - BioStem Technologies can be contacted via phone at 954-380-8342 or through their website [7]. - Investor relations inquiries can be directed to Adam Holdsworth at adam@holdsworthco.com [7].