ZIEN Medical Technologies Achieves CE Mark

SALT LAKE CITY, Aug. 6, 2025 /PRNewswire/ -- ZIEN Medical Technologies ("ZIEN"), a portfolio company of Banner Capital, is pleased to announce achievement of its first CE Mark under the EU MDR (EU 2017/745) on behalf of its customer SAM Medical Products (www.sammedical.com).

Founded in 2009 and based in Salt Lake City, ZIEN is a vertically integrated medical device contract design & manufacturing organization ("CDMO") providing product design & development, manufacturing, cost-down, packaging, sterilization, and quality & regulatory services to medical device companies. As part of ZIEN's capabilities, the ability to act as the "Legal Manufacturer (LM)" or "Manufacturer of Record (MoR)" allows ZIEN to serve as an accelerator to speed innovative technologies to the global market.  With ZIEN's EU MDR and MDSAP certifications and ability to serve as LM/MoR technologies that would otherwise take a Medical Device company over 2+ years to reach certification can be brought to market in likely under a year. Combined with ZIEN's other innovative offerings such as packaging and sterilization services the overall combined cost and time savings to reach the market can be significant.

SAM Medical Products is an innovator in devices targeted to serve patients undergoing emergency medical procedures. Having provided devices for fracture management, hemorrhage control, and respiratory management SAM Medical entered the Intraosseous Access Market to improve its ability to serve patients in these emergency situations. Having served patients in the USA, Canada, and other global regions SAM desired to reach patients in Europe. Through the existing relationship with ZIEN as a contract manufacturer of the IO products SAM Medical found in ZIEN an opportunity to help expand their capacity and market reach by using ZIEN to provide regulatory support as MoR for the IO product. This allows SAM Medical to focus on expanding other product introductions, and place attention on the market distribution of the IO products while ZIEN manages the ongoing regulatory and engineering support and maintenance of the IO.

Kyle Sims, Director of Product Development for SAM Medical stated, "ZIEN's role as Manufacturer of Record allows us to expand our engineering and product support capacity by transitioning the regulatory and technical oversight of this strong IO product line to their team. This partnership enables our internal teams to focus on building out the broader SAM Medical portfolio and gives us a scalable path to deliver more patient solutions as we grow our market presence."

Tim Nieman, CEO of ZIEN, remarked "ZIEN has for over 16 years been serving our customers as an integrator of services allowing speed to market for medical devices. The EU MDR has resulted in increased barriers to the introduction of innovative technologies, stifling technology and causing supply bottlenecks. We have seen products that can help patients either be retracted from the EU market or fail to reach the EU due to the expense and complexities of achieving CE mark. ZIEN is pleased to once again be able to help our customers break through these barriers to provide care solutions that might otherwise not reach patients. With the EU MDR and MDSAP certificates and the experienced team here at ZIEN, we are poised to be able to develop, manufacture, and distribute, products that can bring care to patients worldwide while simultaneously reducing the time and expense of doing so. We believe that this service offering reduces the time to global market for a product by up to 2 years and by more than $100,000. Our partnership with SAM Medical allows us to bring the benefits of the SAM Medical IO products to patients in the EU that have to date been unable to have access to this product."

Media Contact: Tim Nieman, [email protected]

SOURCE ZIEN Medical Technologies LLC