From 17 years of research to SofPulse, Inc.
A device past the hard part — and now a direct-to-patient channel.
The research behind it
The tPEMF signal was developed and clinically validated over more than 17 years, with a portfolio of 18 granted patents. The long, expensive, failure-prone work of proving a medical device — the lab, the FDA, the trials — is largely behind it.
SofPulse, Inc. today
SofPulse, Inc. holds the SofPulse brand, the FDA clearance, and the intellectual property, and is bringing the device to patients directly — including through the HealWithout.com telehealth channel, where a licensed physician issues the prescription and Letter of Medical Necessity so the device can be paid for with pre-tax HSA/FSA dollars.
Why the hard part being done matters
Medical device development typically spans 10–15 years from first lab evidence to clinical clearance. The vast majority of devices that enter development never reach clearance. SofPulse carries the FDA clearance, the CE mark, the peer-reviewed clinical literature, and 18 granted patents — the compounding regulatory and evidentiary assets that are expensive and slow to build and cannot be replicated quickly by a competitor. The direct-to-patient channel HealWithout is building is layered on top of that foundation, not alongside the effort of building it.
Sources
- SofPulse, Inc. corporate record; patent portfolio
Ready to put SofPulse to work?
SofPulse is available by prescription. Patients can order online and pay with pre-tax HSA/FSA dollars; clinicians can start prescribing in minutes.
For education only — not medical advice, and not a substitute for a clinician's judgment. SofPulse is available by prescription only. Reimbursement figures reflect the 2026 CMS Physician Fee Schedule and vary by locality, payer, and documentation.