Onward Medical (ONWD) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Key achievements and milestones

• Received first FDA approval for ARC-EX, a non-invasive spinal cord stimulation device, in December, marking a major step for people with spinal cord injuries.

• ARC-EX pivotal trial published in Nature Medicine showed 90% of participants improved strength or function, with 87% reporting better quality of life.

• Raised $50 million in equity, anchored by Ottobock, and secured exclusive rights to a brain-computer interface (BCI) technology.

• Expanded board with experienced leadership, including a new chairman with Medtronic and MedTech Europe background.

• Commercialization underway, with initial focus on top 75 U.S. rehab clinics and rapid VA system access via a key distributor partnership.

Technology platforms and pipeline

• Three platforms: ARC-EX (external stimulator), ARC-IM (implantable), and ARC-BCI (brain-computer interface integration).

• ARC-IM targets blood pressure instability, with pivotal study to start mid-year; also being studied for mobility and bladder function.

• ARC-BCI enables thought-driven movement, with three patients implanted and more planned, supported by grant funding.

• Pipeline indications include Parkinson's, stroke, sexual function, and temperature regulation, with ongoing feasibility studies.

• Many pipeline activities are grant-funded, allowing capital focus on near-commercialization projects.

Market opportunity and competitive positioning

• Initial total addressable market (TAM) for first indications is $20 billion, expanding to over $100 billion with broader applications.

• Limited competition due to strong IP portfolio (280 patents), exclusive licenses, and first-mover advantage.

• High awareness in the spinal cord injury community and among clinicians reduces marketing spend needs.

• Favorable reimbursement pathways and streamlined sales model targeting a limited number of specialized clinics.

• Strategic partnership with Ottobock, a global leader in prosthetics, now largest shareholder.