Innovotech

Innovotech Inc. is a Canadian life sciences contract research organization and testing laboratory headquartered in Edmonton, Alberta, with scientific roots tracing back to the University of Calgary Biofilm Research Group, where the company was founded in 2001 by expert biofilm scientists. Now publicly traded on the TSX Venture Exchange (ticker: IOT.V), Innovotech operates as a GMP- and ISO/IEC 17025-accredited laboratory providing analytical, microbiological, and contract testing services to pharmaceutical manufacturers, biotechnology companies, medical device developers, compounding pharmacies, nutraceutical producers, and related regulated industries across Canada and internationally. In 2024, Innovotech expanded its capabilities through the acquisition of Keystone Labs, adding a 20-year legacy of client-focused boutique contract research expertise to its portfolio.

The laboratory's most distinctive specialty is biofilm science and antimicrobial testing, a discipline in which Innovotech holds recognized global leadership. Its Biofilm Contract Research Department supports clients across the full product development lifecycle—from early-stage screening of candidate compounds for anti-biofilm activity, through regulatory-grade efficacy studies suitable for product claim validation, to post-market comparisons for marketing support. Innovotech's proprietary MBEC Assay® platform (Minimum Biofilm Eradication Concentration, standardized under ASTM E2799) enables high-throughput testing of antimicrobial and antibiotic efficacy against biofilm-forming organisms. The BEST Assay™ (Biofilm Eradication Surface Testing) extends this capability to coated medical device surfaces, while the BESTplus Assay® offers additional refinement for specialized testing scenarios. These proprietary platforms complement validated standard industry methods and allow Innovotech to address biofilm-related challenges across diverse product types including medical devices, textiles, pharmaceutical formulations, agricultural products, and industrial solutions.

Innovotech's medical device testing services evaluate a wide range of implantable and single-use devices for antimicrobial efficacy, anti-adherence performance, and anti-encrustation properties. Device categories tested include central venous catheters (CVCs), peripherally inserted central catheters (PICCs), urinary stents, endotracheal tubes, guide wires, vascular stents, implantable ports, wound dressings, filters, textiles, masks, and antiseptic solutions. Testing is performed under aerobic, anaerobic, and microaerophilic conditions using clinically isolated microbial strains and physiologically relevant solutions that closely mimic in-vivo environments. The laboratory maintains a library of approximately 3,000 microbial strains and draws on more than 20 years of regulatory expertise to support clients pursuing FDA 510(k) clearance and other regulatory submissions. Key standards applied include ISO 22196 (antibacterial activity on non-porous surfaces), CLSI M07 (MIC testing guidelines), and AATCC TM100 (textile antimicrobial performance evaluation).

Innovotech Labs Corporation, the regulated laboratory subsidiary, holds a Drug Establishment License (DEL) issued by Health Canada, authorizing pharmaceutical testing under Good Manufacturing Practices (GMP) as defined in Canada's Food and Drug Regulations. Compendial microbiology testing is performed in compliance with USP and Ph. Eur. (European Pharmacopoeia) monographs and encompasses Antimicrobial Effectiveness Testing (USP <51>), sterility testing, environmental bioburden monitoring, and facility water testing. The lab also conducts probiotic testing per USP <64> for nutraceutical and natural health product manufacturers. Minimum Inhibitory Concentration (MIC), Minimum Bactericidal Concentration (MBC), and Minimum Fungicidal Concentration (MFC) determinations are offered alongside GMP analytical chemistry to support finished product release testing and development-stage programs for pharmaceutical clients.

Beyond endpoint efficacy assays, Innovotech supports pharmaceutical and biologic programs through stability testing and comprehensive method development and validation services. These capabilities allow clients to characterize the shelf-life and performance degradation of antimicrobial formulations, drug products, and medical device coatings under controlled storage conditions. Method development services include customization of antimicrobial, anti-adherence, or anti-encrustation protocols using the BEST Assay™ and MBEC Assay® frameworks, as well as full validation packages designed to meet regulatory submission requirements. This end-to-end support model—from early feasibility screening through validated, regulatory-ready study reports—positions Innovotech as a scientific partner across the complete product development continuum.

Innovotech operates under robust quality management systems designed to meet the highest regulatory and scientific benchmarks. The laboratory holds ISO/IEC 17025 accreditation through CALA (accreditation number A4146) for the enumeration of bacteria in solid and liquid matrices, demonstrating technical competence and producing defensible data accepted by regulators internationally. The GMP Drug Establishment License from Health Canada covers pharmaceutical testing activities conducted in the dedicated GMP laboratory at 9407 20 Avenue NW, Edmonton. These dual credentials—ISO/IEC 17025 technical accreditation and a Health Canada DEL for GMP compliance—enable Innovotech to service clients requiring data for both regulatory submissions and commercial product release across North American and international markets.

Innovotech operates from two Edmonton, Alberta locations: its head office at Suite C203, 2011–94 Street (T6N 1H1) and its GMP laboratory at 9407 20 Avenue NW (T6N 1E5). The GMP lab is equipped as a Containment Level 2 facility capable of handling a broad range of routine clinical and environmental microorganisms. In addition to contract testing, Innovotech develops and commercializes proprietary laboratory products including the MBEC Assay® Biofilm Inoculator (available in 96-well and trough-base configurations, as well as silicone-coated variants) widely used in academic and industrial biofilm research globally, and InnovoSIL™, a silver periodate antimicrobial compound engineered with multiple killing mechanisms effective against bacteria in both planktonic and biofilm states. The company's ongoing R&D is supported by funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP), which has provided up to CAD $234,000 to develop new antimicrobial testing services specifically for medical devices such as catheters, implants, and wound dressings, underscoring Innovotech's position as an active innovator at the intersection of biofilm science and regulated contract testing.