Kymanox Acquires Agilis Consulting Group, A Trusted Human Factors Provider

Integrating the well-respected and trusted Agilis brand and team extends Kymanox’s capabilities in human factors (HF) by adding incredible talent, the ability to conduct HF studies globally, and unparalleled regulatory strategy and support.

Morrisville, North Carolina USA, and Cincinnati, Ohio USA, — Kymanox Corporation (“Kymanox”), a professional services company exclusively serving the life science industry, announced today the acquisition of Agilis Consulting Group. Agilis is a trusted human factors partner for the global medical market. They specialize in helping new and established companies achieve successful HF submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical products being brought to market.

The acquisition of Agilis by Kymanox helps both companies realize their shared corporate goal of helping bring modern medicines to patients, while also bolstering service capabilities by providing a broader array of highly specialized services to clients. Extensive usability engineering and HF study support will help ensure successful FDA, EMA, and other regulatory submissions. The strength of the combined companies’ service offerings and expertise will benefit customers who bring important biologics, including biosimilars and cell and gene therapies (C>s), pharmaceuticals, drug/device combinations products, and medical devices, to markets worldwide.

Based in Cincinnati, Ohio, Agilis has successfully navigated the human factors engineering (HFE) process for drug delivery devices, medical devices, SaMD products, and complex medical technologies for over two decades. Agilis offers early-stage design evaluation and product concept consultation on a wide range of products across a variety of therapeutic areas in order to improve use-related safety, effectiveness, and overall usability. Their proprietary HFE strategies seek to cost-effectively optimize device design in a way that aligns with regulatory requirements.

“For more than 20 years, Agilis Consulting Group has distinguished itself in its ability to provide ‘first time’ regulatory success in medical human factors delivered with integrity, agility, and professionalism,” stated Pat Patterson, Founder and CEO of Agilis. “As our growing team and highly valued global clients began seeking more opportunities and more services delivered to the same high standards, it became clear that Kymanox would be the ideal partner. Combined with Kymanox's diverse team of experts and broader service offerings, the synergy of our two companies will meet the demands of the rapidly growing medical device, pharmaceutical, and biologics industries.”

“The addition of Agilis to Kymanox provides our customers a world-class human factors, regulatory, and usability engineering team to support their programs from start through regulatory submissions and commercialization,” noted Evan Edwards, Chief Innovation Officer at Kymanox. “I have known the Agilis team and their leadership for many years, and the shared values of right-first-time submissions, uncompromising quality, and always a focus on the end user and patient, is what makes this a perfect partnership. I am very proud of our Human Factors and Regulatory Strategy team, led by Quynh Nguyen, for laying the foundation to allow this opportunity to occur, consistent with our long-term goal for providing end-to-end solutions to the life sciences industry.”

Shannon Hoste, President of Agilis commented further, “Our proven human factors processes and regulatory expertise has helped make medical devices safer and easier to use. Joined with Kymanox’s expansive resources, we will continue to provide strategic advice, guidance and deliverables that ensure right-first-time submissions. Together, Agilis by Kymanox will be the clear global human factors and usability engineering leader for comprehensive program support across the product lifecycle, including design, quality, and regulatory support.”

The terms of the transaction were not disclosed.

About Kymanox:
Kymanox has proven, collaborative, end-to-end solutions that help bring Life Science products to the market – and keep them there. We are a professional services organization that offers engineering, scientific, project management, quality, regulatory, human factors, testing/QC, and CQV support to companies exclusively in the biotechnology, pharmaceutical, medical device, and combination product industries. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. we strive to advance Life Science Innovation Through Insightful Solutions & Collaboration. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.

About Agilis Consulting Group:
Agilis Consulting Group is your trusted human factors partner for the global medical market. We enable product realization through successful human factors submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical devices and combination products. Agilis' proven human factors strategies, process and expertise drive regulatory success and speed to market - the first time. To learn how Agilis can support your medical device or combination product human factors success, contact inquiries@agilisconsulting.com, or visit https://www.agilisconsulting.com/.