ZEO ScientifiX Announces First AABB QMS-Certified Manufacturing Facility
ZEO ScientifiX has announced that its manufacturing facility became the first recipient of AABB's newly established Quality Management Systems Certification after an independent assessment.
ZEO ScientifiX, Inc. (OTCQB:ZEOX) has announced that its manufacturing facility became the first facility to receive Quality Management Systems (QMS) Certification under the newly established programme of the Association for the Advancement of Blood & Biotherapies (AABB). The company said AABB confirmed its status as the inaugural recipient.
ZEO received formal notification on October 23, 2026, after an independent assessment conducted under the new certification programme. The company announced the development on November 3, 2026.
The certification covers quality management systems within the scope of the applicable AABB programme. ZEO said the assessment does not extend to cellular products without an approved biologics licence application.
The company also stressed that the certification is not FDA approval, a finding of regulatory compliance, or an AABB assessment or endorsement of the safety, efficacy, clinical outcomes, or intended uses of any individual product or therapy made or distributed by ZEO. It does not independently permit the marketing, distribution, or administration of any product or therapy. Those activities remain subject to applicable federal and state laws, including applicable statutory requirements and limitations.
ZEO said the presence of an AABB credential does not automatically mean that every manufacturing activity at a facility has been independently reviewed. Existing AABB accreditation applies to a defined category of products, processes, or services, and does not necessarily cover other cellular manufacturing work carried out at the same site.
The company described the new QMS Certification as focused on quality management rather than on the evaluation of cellular products. It said physicians, hospitals, and clinics should consider which services and systems a particular credential covers and whether that scope relates to the manufacturing activities supporting the products supplied.
ZEO operates an approximately 6,000-square-foot laboratory and manufacturing facility at Nova Southeastern University's Center for Collaborative Research in South Florida. The company is based in Davie, Florida.
ZEO identified documented procedures, trained personnel, process controls, product traceability, equipment oversight, deviation management, corrective and preventive actions, and continuous improvement as elements of cellular-product manufacturing. The company said its certification followed investment in personnel, systems, processes, and infrastructure.
ZEO said Florida legislation effective July 1, 2025 established a framework under which licensed physicians may administer certain non-FDA-approved stem cell therapies for orthopedic conditions, wound care, and pain management, subject to specified conditions and limitations.
According to the company, the framework requires cells used in qualifying therapies to be retrieved, manufactured, and stored at a facility registered with and regulated by the FDA and certified or accredited by one of several designated organisations, including AABB. ZEO noted that AABB QMS Certification alone does not establish compliance with all applicable federal or state requirements. The relevance of any credential must be considered alongside its scope, the statutory requirements, and other applicable laws.
Dr. George Shapiro, ZEO ScientifiX's Chief Medical Officer, described the certification as recognition of the company's investment in a quality-focused manufacturing organisation. He said healthcare providers should examine the quality systems covered by an independent assessment rather than rely only on the existence of an accreditation.
Ian T. Bothwell, ZEO's Chief Executive Officer, said the company's approach includes regenerative biologics research, manufacturing infrastructure, quality management, and independent oversight. He said ZEO intends to continue investing in innovation and in its biotechnology platform.
ZEO describes itself as a U.S. biopharmaceutical company involved in regenerative biologics research, development, and manufacturing, alongside commercial operations. It combines those activities with a physician network, sales and marketing resources, physician education infrastructure, internal development, and strategic partnerships.
ZEO ScientifiX said its manufacturing facility was the first to receive AABB's newly established QMS Certification.
The company received formal certification notification on October 23, 2026, following an independent assessment.
The certification concerns quality management systems and does not constitute FDA approval or approval of any individual product or therapy.
ZEO operates an approximately 6,000-square-foot facility at Nova Southeastern University's Center for Collaborative Research in South Florida.
Florida's framework for certain stem cell therapies includes specified facility requirements, and QMS Certification alone does not establish compliance with all applicable rules.
ZEO ScientifiX announced that its manufacturing facility had become the first facility to achieve Quality Management Systems (QMS) Certification under the newly established programme of the Association for the Advancement of Blood & Biotherapies (AABB). AABB confirmed to the Company that ZEO was the inaugural recipient.
ZEO ScientifiX received formal notification of its certification on October 23, 2026. The notification followed an independent assessment under AABB's newly established QMS Certification programme.
The certification assesses ZEO ScientifiX's quality management systems within the scope of the applicable AABB certification programme. The Company says this includes independent assessment of quality management, but not evaluation of cellular products without an approved biologics licence application.
No, ZEO ScientifiX's AABB QMS Certification does not constitute FDA approval, a determination of regulatory compliance, or an assessment of the safety, efficacy, clinical outcomes or intended uses of any individual product or therapy. It also does not independently authorise the marketing, distribution or administration of any product or therapy, which remain subject to applicable federal and state laws and regulatory requirements.
ZEO ScientifiX says an AABB credential does not by itself establish that every manufacturing activity at a facility has been independently assessed. Existing AABB accreditation is limited to a defined scope, while the new QMS Certification focuses solely on quality management and does not automatically cover other cellular manufacturing activities or products.
ZEO ScientifiX identifies documented procedures, trained personnel, process controls, product traceability, equipment oversight, deviation management, corrective and preventive actions, and continuous improvement as components of cellular-product manufacturing. The Company says its certification reflects investment in personnel, systems, processes and infrastructure.
ZEO ScientifiX operates from an approximately 6,000-square-foot laboratory and manufacturing facility at Nova Southeastern University's Center for Collaborative Research in South Florida. The facility is in Davie, Florida, according to the Company's description.
ZEO ScientifiX describes itself as a U.S. biopharmaceutical company focused on regenerative biologics research, development and manufacturing alongside established commercial operations. It combines scientific and manufacturing expertise with a substantial physician network, sales and marketing resources, physician education infrastructure, internal development and strategic partnerships.
Dr George Shapiro, Chief Medical Officer of ZEO ScientifiX, said the certification validates the Company's investments in building a disciplined, quality-focused manufacturing organisation. He also said physicians and healthcare institutions should assess the quality management systems covered by an independent assessment rather than rely only on the existence of an accreditation.
Ian T. Bothwell, Chief Executive Officer of ZEO ScientifiX, said the Company aims to build a biotechnology platform based on scientific innovation, manufacturing excellence, independent oversight and quality. He said ZEO intends to continue investing in innovation and building a company capable of contributing to regenerative medicine.
ZEO ScientifiX says Florida legislation effective July 1, 2025 established a framework allowing licensed physicians, under specified conditions, to administer certain non-FDA-approved stem-cell therapies for orthopaedic conditions, wound care and pain management. The Company says qualifying stem cells must be retrieved, manufactured and stored in a facility registered with and regulated by the FDA and certified or accredited by one of several designated organisations, including AABB.
No, ZEO ScientifiX states that AABB QMS Certification does not, standing alone, establish compliance with all applicable statutory, federal or state requirements. The relevance of any certification or accreditation must be assessed in light of the credential's scope and other applicable laws and regulations.
ZEO ScientifiX shares trade on the OTCQB under the ticker symbol OTCQB:ZEOX.