Evidence
Evidence & development status
We believe a medical device should describe its evidence honestly. This page sets out what has been done, how strong it is, and what remains to be shown.
How to read this page
Distinguishing tiers of evidence
Not all evidence carries equal weight. We label each item so you can judge it for what it is — from early internal work to independently published research.
Early work carried out by the company or its collaborators. Useful for direction; not confirmatory.
Findings from a clinical study that are early or not yet independently published.
Peer-reviewed, independently published evidence. We will list items here only when they genuinely qualify.
What has been done
The AIIMS clinical study
SwaKnee was assessed in a controlled clinical study conducted with the Department of Physical Medicine & Rehabilitation (PMR), AIIMS Bhubaneswar, in adults with knee osteoarthritis.
Study design
A comparative study of two groups followed over 45 days:
- Device group (n=40) — using the SwaKnee device.
- Comparison group (n=42) — using conventional care such as pain medication and injections.
Outcomes were measured with standard tools: a Visual Analogue Scale (VAS) for pain, knee range of motion, the Knee injury and Osteoarthritis Outcome Score (KOOS), and a quality-of-life score.
Clinical study sessions. Participants' identities are obscured.
| Measure | Device group (n=40) | Comparison group (n=42) |
|---|---|---|
| Pain — VAS (lower is better) | ~32% reduction | ~14% reduction |
| Knee range of motion | ~14% increase | ~7% increase |
| KOOS (higher is better) | ~127% increase | ~78% increase |
| Quality-of-life score | ~29% improvement | ~13% improvement |
The wider picture
Other evidence and its status
Design & parameter development
Iterative design, prototyping and testing established the PEMF parameters used. This supports the design rationale but is not clinical evidence of benefit.
Proposed mechanism
The mechanism described on the how-it-works page is drawn from the PEMF literature and presented as a hypothesis — not proven for any individual.
Peer-reviewed publications
None are listed here yet. When peer-reviewed evidence specific to SwaKnee is available, it will be cited with its full reference so it can be checked.
Intellectual property
Protected technology
SwaKnee is backed by granted Indian design registrations and registered trademarks.
Granted design registrations
Four granted Indian design registrations covering the electromagnetic knee brace, an adjustable brace, a portable/retrofit PEMF therapy device, and a thin-film sensing arrangement.
Registered trademarks
Two registered trademarks associated with the company and the SwaKnee product.
Want the underlying details?
Clinicians and evaluators can request available study information and documentation directly.