BN000068504 – Medical Device Designer, Developer, and Manufacturer

The Company is a full-service, ISO 13485:2016 certified designer, developer, and manufacturer of Class II and Class III medical devices, including active implantable medical devices (AIMD), with a specialty in cardiovascular, wound care, and neuromodulation related devices and components. The Company partners with domestic and international customers to take medical device concepts from early-stage prototyping through design, development, and into clinical and manufacturing.

Key Aspects
· The Company achieved an impressive average adjusted EBITDA margin of 23.2% from 2023 through 2025.
· Maintaining comprehensive equipment that includes computer numerical control mills, lathes, high-resolution 3D printers, laser markers/cutters, thermal form, cable assembly equipment, ESD-safe electronic assembly area and ISO 7 cleanroom allows the Company to produce complex medical devices in-house.
· The Company operates an end-to-end Good Manufacturing Practices (GMP) framework, encompassing rigorous testing protocols such as human factors, battery life validation, electrical leakage testing, and pull strength analysis, ensuring consistent compliance with stringent quality and regulatory standards.
· An ISO 13485-certified facility supports a robust design and development infrastructure including industrial design, Printed Circuit Board (PCB) design and testing, clinical/regulatory support, QA/QC, Institute for Printed Circuits (IPC) soldering and cable testing, supply chain management and GMP manufacturing.

Opportunities
· Conduct a targeted marketing campaign to identify and secure new customers and opportunities to further diversify the Company's customer base.
· Leverage existing connections with customers and industry associations to expand market exposure and brand awareness.
· Grow the in-house research and development department to further utilize design, develop, and manufacture operations for proprietary medical devices owned by the Company.
· Prioritize manufacturing and becoming the manufacturer of record for medical devices that have already received regulatory clearance to grow different revenue streams and predictability.

Headquartered
· Southwest, U.S.

Current Markets
· The Company serves businesses in the medical industry requiring design, development, and manufacturing of various medical devices and components.

Real Estate
· The Company operates from an approximate 11,600 sq. ft. office, cleanroom, and production facility in the Southwest, U.S. The facility is leased from an unrelated third party and the lease can be assumed by new ownership post-sale.

Shareholder Objectives
· The Company is solely owned by an individual through a holding entity. The owner is seeking a full exit to prepare for retirement. The owner is open to remaining with the Company for a negotiable transition period and would consider various deal structures to facilitate a transaction.