Core Insights - Kneat.com, inc. has signed a Master Services Agreement with a leading multinational manufacturer to implement its Kneat Gx platform for critical validation processes [1][2][3] Company Overview - The multinational manufacturer employs over 30,000 people and operates in more than 30 countries [2] - Kneat Solutions specializes in digitizing and automating validation and quality processes for highly regulated industries [4] Agreement Details - The agreement will focus on two use cases: Computer Systems Validation for enterprise applications and Commissioning, Qualification, and Validation at 18 manufacturing sites within the medical and healthcare sector [2][3] - This strategic win emphasizes Kneat's capability to digitize validation processes across various sectors, enhancing compliance, efficiency, and scalability [3] Platform Capabilities - Kneat Gx is recognized for its ability to manage validation disciplines from end-to-end, achieving significant reductions in labor hours and accelerating review cycles [4] - The platform is fully certified under ISO 9001 and ISO 27001, and compliant with 21 CFR Part 11/Annex 11, ensuring high standards of regulatory compliance [4]

Core Insights - Kneat.com, inc. has been recognized as a leader in the G2 Software Review's Fall 2025 reports for the Pharma and Biotech Software categories, achieving a total G2 Satisfaction Score of 98 out of 100, significantly surpassing the second-ranked company's score of 78 [1][4]. Company Performance - Kneat received three G2 leader badges, indicating strong customer satisfaction and market presence in a demanding industry [3]. - The company's top rating in the G2 Pharma and Biotech Relationship Index is based on customer feedback in categories such as "Ease of Doing Business," "Likely to Recommend," and "Quality of Support" [4]. - Kneat was rated second overall in the G2 Pharma and Biotech Usability Index, which measures customer feedback on "Ease of Admin," "Ease of Use," and "Meets Requirements" [4]. Product Offering - Kneat Solutions provides a digital validation platform, Kneat Gx, which enhances efficiency in validation and compliance for highly regulated industries [5]. - Kneat Gx is fully ISO 9001 and ISO 27001 certified, validated, and compliant with 21 CFR Part 11/Annex 11 standards [5]. - Independent studies indicate that Kneat Gx can reduce labor hours associated with validation documentation by over 50% and accelerate review and approval cycles by up to 50% [5].

Kneat to Present at The Emerging Growth Conference on September 24, 2025Kneat invites investors to real-time, interactive engagement with CEO Eddie RyanSeptember 16, 2025 5:12 PM EDT | Source: kneat.com, incLimerick, Ireland--(Newsfile Corp. - September 16, 2025) - kneat.com, inc. (TSX: KSI) (OTCQX: KSIOF), a leader in digitizing and automating validation and quality processes, is pleased to announce that it will be presenting at the Emerging Growth Conference on September 24, 2025.This live, ...

Core Insights - Kneat.com, inc. has signed a three-year Master Services Agreement with a leading equipment manufacturer to implement the Kneat Gx platform for digitizing equipment testing processes [1][2][3] - The agreement marks Kneat's seventh strategic customer win in 2025, following a record-setting quarter for new customer additions in the life sciences and other industries [3] Company Overview - Kneat Solutions specializes in providing digital validation and compliance solutions for highly regulated industries, enhancing efficiency in validation processes [4] - The Kneat Gx platform is fully ISO 9001 and ISO 27001 certified, validated, and compliant with 21 CFR Part 11/Annex 11 standards [4] - Independent studies indicate that Kneat Gx can reduce labor hours for validation documentation by over 50% and accelerate review and approval cycles by up to 50% [4] Industry Context - The agreement with the equipment manufacturer is part of a broader trend where industries are expanding their digital capabilities to improve quality, compliance, and speed to market [3] - The company employs over 15,000 people and markets products in over 120 countries, indicating a significant global presence [2]

Core Insights - Kneat.com, inc. has signed a three-year Master Services Agreement with a global medical technology company, indicating strong demand for its services in the life sciences sector [1][3] - The global medical technology company is part of a larger manufacturer based in Asia, employing over 30,000 people and providing medical devices in over 160 countries [2] - Kneat's Gx platform will be utilized for equipment validation, showcasing its technical fit for various validation use cases [2][3] Company Overview - Kneat Solutions specializes in digital validation and compliance for highly regulated industries, offering the Kneat Gx platform which enhances efficiency in validation processes [4] - The platform is fully certified under ISO 9001 and ISO 27001, and compliant with 21 CFR Part 11/Annex 11, ensuring high standards of quality and security [4] - Customer studies indicate that Kneat Gx can reduce documentation cycle times by up to 40% and speed up time to market by up to 20% [4]

Core Insights - Kneat.com, inc. is on a trajectory towards profitability, achieving record new customer wins and welcoming new leadership in key areas [2][10] - The company reported significant financial growth in Q2 2025, with total revenue reaching $15.4 million, a 32% increase year over year [7][8] Financial Highlights - Q2 2025 total revenue was $15.4 million, up from $11.7 million in Q2 2024, marking a 32% increase [8] - SaaS revenue for Q2 2025 grew 31% to $14.1 million compared to $10.8 million in Q2 2024 [8] - Gross profit for Q2 2025 was $11.6 million, a 34% increase from $8.7 million in Q2 2024, with a gross margin of 75% [8] - Annual Recurring Revenue (ARR) as of June 30, 2025, was $64.8 million, reflecting a 43% year-over-year growth from $45.4 million [7][8] Business Developments - In April 2025, Kneat signed a Services Agreement with a multinational generic pharmaceuticals producer to digitize its drawing management process [13] - The company launched Kneat Gx 9.5 in July 2025, enhancing data management capabilities and supporting risk-based validation processes [13] - Kneat expanded its executive leadership team, appointing a new Chief Innovation Officer and a new Chief Product Officer [13] Operational Performance - For the first half of 2025, total revenue increased 34% to $30.2 million compared to $22.4 million in the same period of 2024 [9] - Net income for the first half of 2025 was $1.8 million, a significant improvement from a net loss of $6.4 million in the first half of 2024 [9]

Core Viewpoint - Kneat.com, Inc. is set to release its financial results for the quarter ended June 30, 2025, on August 5, 2025, after the TSX market close [1] Financial Results Announcement - The financial results will be available on the Investors page of the Kneat Solutions website [3] - A conference call and Q&A session for sell-side analysts will be hosted by the CEO and CFO on August 6, 2025, at 09:00 ET [2] Company Overview - Kneat Solutions specializes in digitizing and automating validation and quality processes for highly regulated industries [3] - The company’s digital validation platform, Kneat Gx, is fully certified and compliant with ISO 9001, ISO 27001, and 21 CFR Part 11/Annex 11 [3] - Kneat Gx has demonstrated significant efficiency improvements, including up to a 40% reduction in validation cycle times and up to a 20% faster speed to market [3]

Leadership Change - Kneat.com, inc. announces a change in its senior leadership team with the retirement of CFO Hugh Kavanagh, who contributed significantly to the company's growth and success [2][4] - Dave O'Reilly will join as the new CFO on July 7, bringing experience from his previous role at Ekco, where he helped scale the company to $200 million in annual revenue [3][4] Company Overview - Kneat Solutions specializes in digitizing and automating validation and quality processes for highly regulated industries, offering a digital validation platform known as Kneat Gx [5] - Kneat Gx is fully ISO 9001 and ISO 27001 certified, and compliant with 21 CFR Part 11/Annex 11, demonstrating its commitment to high compliance standards [5] - The platform has shown to reduce documentation cycle times by up to 40% and increase speed to market by up to 20% through independent customer studies [5]

Core Insights - Kneat.com, inc. has signed a multi-year Master Services Agreement with a leading healthcare technology and diagnostics company to digitize and automate validation and quality processes [1][2] - The healthcare technology company employs over 50,000 people and operates manufacturing facilities in more than a dozen countries [2] - The agreement will initially focus on digitizing Commissioning, Qualification, and Validation workflows at several key manufacturing sites [2][3] Industry Trends - The trend towards digital validation in the life sciences sector is accelerating, with 93% of organizations either using or planning to use digital validation, up from 86% in 2024 [3] - Digital validation is recognized for delivering speed to market, scalable compliance, and a foundation for future automation and AI innovations [3] Company Performance - Kneat Solutions is noted for its efficiency in validation and compliance through its digital validation platform, Kneat Gx, which is fully certified and compliant with industry standards [4] - Customer studies indicate that Kneat Gx can reduce documentation cycle times by up to 40% and speed to market by up to 20% [4]

Core Insights - Kneat.com, inc. has signed a three-year Master Services Agreement with a US-based manufacturer of clinical diagnostics, indicating a strategic partnership aimed at digitizing and automating validation processes in the healthcare sector [1][2]. Company Overview - The Company operates in over 40 countries and employs more than 14,000 people, providing a wide range of clinical diagnostics and biomedical testing services [2]. - As part of a larger life sciences organization with over 60,000 employees, the Company will initially utilize Kneat Gx to digitize its equipment validation process [2]. Industry Trends - There is a growing trend in the life sciences sector towards digitalization, with companies moving from manual, paper-based validation processes to streamlined digital solutions to enhance quality, compliance, and speed to market [3]. Product and Service Details - Kneat Solutions offers a digital validation platform, Kneat Gx, which is designed for highly regulated industries, providing efficiency in validation and compliance [4]. - Kneat Gx is fully certified (ISO 9001 and ISO 27001) and compliant with 21 CFR Part 11/Annex 11, demonstrating its reliability and adherence to industry standards [4]. - Independent studies indicate that Kneat Gx can reduce documentation cycle times by up to 40% and accelerate speed to market by up to 20% while improving compliance standards [4].