Company overview

Myomo Inc. serves people who have limited arm and hand movement. Its MyoPro brace detects weak muscle signals and uses motors to assist movement, including reaching and grasping. The user initiates the movement; the brace does not electrically stimulate muscles. Motion G, the version with powered grasp, accounts for nearly all product revenue.

Most sales come from supplying patients directly. Myomo evaluates eligibility, gathers medical records and a physician’s prescription, arranges insurance authorization where required, and makes the brace to the patient’s measurements. It then delivers the device and bills the insurer. It also sells devices wholesale to orthotics and prosthetics providers, which add clinical services.

The business depends almost entirely on insurance reimbursement, usually approved patient by patient rather than through broad coverage policies. Medicare Part B patients generate most revenue, making Medicare coverage and payment rules especially important. Medicare pays for MyoPro as a brace in a lump sum; Medicare Advantage and commercial insurers generally require prior authorization, which does not always prevent later claim denials.

Myomo relies on Cogmedix as its sole contract manufacturer for MyoPro subassemblies. MyoPro also requires a prescription. Myomo considers the device exempt from FDA premarket clearance, but functionality or marketing claims beyond the exemption’s limits could require clearance or approval before continued U.S. clinical sales.