Prepared for the SofPulse, Inc. Board & Shareholders · presented by Linda Difeliciantonio Rocca

The owner's lens.
More value, smarter dilution.

You've seen the thesis — a proven, FDA-cleared asset with no distribution. Here's the part that matters to owners: how a turnkey channel, paid mostly in wholesale margin and milestone-vested equity, becomes SofPulse's first scaling revenue line — and why the only dilution it asks for is the kind that makes every remaining share worth more.

Shareholder briefinglisten
57%
post-op pain reduction
Rhode 2010 breast-surgery RCT
>50%
narcotic use cut
post-surgical cohorts
800%
faster wound healing
pressure-ulcer studies
~0
side-effect signal
across millions of treatments
IWhat you own

The hard, expensive, multi-year part is already behind you.

Most medical-device companies die in the lab or at the FDA. SofPulse is past both. The regulatory clearance, the clinical proof, the patent wall, and a payer-coverage pathway already exist. That is the rarest and most valuable position a device company can hold — and it is the foundation everything below composes around.

FDA-cleared Class II tPEMF — 17 years of peer-reviewed evidence
18 granted patents — a defensible IP wall
CMS National Coverage for chronic wounds (G0329, since 2004)
Taiwan FDA approval (Oct 2023) — international expansion underway
IIThe one risk that matters

Your enterprise value isn't gated on the science. It's gated on distribution.

The only way a surgeon hears about SofPulse today is a rep visit; the only way a patient hears about it is through a rep-touched surgeon. Growth becomes a function of headcount — and headcount does not scale into the internet, where three large demand pools sit completely untouched.

Post-surgical recovery
47,000 opioid deaths a year. Patients actively searching for a drug-free way to recover.
Evidence →
Chronic MSK pain
OA and tendinopathy patients who have cycled through NSAIDs and cortisone and are still in pain.
Evidence →
Chronic wound care
Medicare-covered under G0329 since 2004 — and most eligible patients still don't know it exists.
Evidence →

The gate underneath the gate:the device is Class II — it requires a physician's prescription, and the HSA-unlocking Letter of Medical Necessity is a separate piece of paperwork almost no patient knows to ask for. So a $500 device that could be nearly free with pre-tax dollars reads as a $500 sticker plus a paperwork hurdle — and most patients defer. Solve the prescription path and the demand is already there.

IIIThe engine — live today

You don't build the channel. It already exists. You plug in.

Every layer SofPulse is missing has already been built, indexed, and put into operation by HealWithout. The work to connect SofPulse is configuration, not construction.

Three patient demand surfaces

healwithout.com (post-surgical), /chronic-pain (OA + MSK), /wounds (CMS-covered) — live, indexed, and converting today. Each is built around a distinct demand pool the rep model never reaches.

50-state async Rx + LMN

altru.care (Josh Emdur, DO — licensed in all 50 states) writes the Class II prescription and the matching Letter of Medical Necessity in 3–5 minutes. The patient pays with pre-tax HSA dollars and sees one number.

MD-signed surgeon outreach

21,000 LinkedIn connections cross-referenced against the NPI database produce 1,000–2,000 specialty-matched surgeons — each message landing with their procedure volume, the relevant trial, and the RTM revenue tPEMF unlocks under their own NPI.

VA federal beachhead

A direct VISN-level connection opens the VA — 1,300+ facilities, centralized formulary, a veteran population that maps cleanly to SofPulse indications, and a federal procurement path that bypasses the surgeon-by-surgeon ground game.

RTM auto-documentation

An SMS-based pain score (~98% open, ~45% reply — no app to install) feeds the care team's Remote Therapeutic Monitoring documentation automatically. $115.60 per patient per protocol cycle (98975 + 98977 + 98980) accrues to the monitoring provider — a co-managing PT/physiatrist post-surgically, or the prescriber directly for chronic-pain and wound patients (no global period) — the incentive that keeps patients on protocol.

RTM billing breakdown →

Hardened, portable data layer

FHIR-native, SMART-on-FHIR, SOC 2 Type II, 21 CFR Part 11 audit trail. SofPulse data becomes portable, billable, and trustworthy to every EHR and payer downstream — an asset that outlasts any single campaign.

IVWhat it does to your numbers

Your first scaling revenue line.

One fixed-fee engagement, AKS-clean: a $5K/month platform license plus a flat $50/unit administrative fee. SofPulse net revenue below is modeled at a $500 device — replace with your ASP for the exact figure; the structure is identical.

UnitsSofPulse net revenue
Year 11,200$478,800
Year 22,400$1,017,600
Year 34,800$2,095,200
3-yr cumulative8,400$3,591,600
$2.99M
SofPulse net position over 3 years — $3.59M net on $600K in fees
$2,500 → $30
cost to place one device: rep model → DTC slipstream
$971K
surgeon-side RTM revenue generated (3-yr) — the re-prescribing incentive
VWhy this is the shareholder-friendly path

The cheapest, lowest-risk way to put a revenue engine under the asset.

Dilution only on milestones that lift every share.

The partner takes equity — but it vests only as commercial milestones land: platform live, VA contract signed, units shipped. You dilute precisely when the company becomes more valuable, never before. It's the best dilution you take — a slice given to the one partner whose work makes the rest worth more.

Low fixed burn, ROI-positive.

The engagement is $60K/year fixed plus a flat $50/unit — a fraction of one rep's $255K loaded cost. Over three years SofPulse pays $600K in fees and nets $3.59M against it: a $2.99M net position, roughly 6× the fees.

AKS-clean by construction.

Every fee is flat, set in advance, FMV-justified, with no percentage-of-sale and no per-referral tie — structured to the Anti-Kickback Personal Services safe harbor (42 CFR 1001.952(d)). No regulatory tail risk attaches to your equity.

How the safe harbor works →

CAC collapses ~80×.

The rep model costs ~$2,500 to place one device. The DTC slipstream costs ~$30 — paid social, organic SEO, and slipstream auto-notify, fully digital. That is the difference between a structurally unprofitable sale and a 50×+ LTV/CAC engine.

VIThe value beyond the first sale

A channel today. A clinical-evidence platform tomorrow.

The first device sale is the floor, not the ceiling. The same engine that moves units builds the assets that re-rate the whole company.

01A longitudinal pain-outcome dataset that compounds with every patient — months, not journal cycles.
02A comparative-outcomes paper that writes itself from inside the data: tPEMF cohorts vs. opioid-only on pain trajectory and opioid use.
03Biomarker licensing — Quanterix, Olink, SomaLogic test their pain panels against real-world trajectories.
04A VA contract that creates a federal-procurement moat no consumer PEMF entrant can replicate.
05The repositioning that matters most: from a device company with a few citations to a clinical-evidence platform every biomarker partner wants on its reference list.
VIIThe ask

Endorse the engagement. Keep every share.

The recommendation to the board is to sign — one fixed-fee floor ($5K/mo + $50/unit), with the exclusive distribution rights and milestone-vested equity papered alongside. It is the lowest-risk, highest-leverage path to SofPulse's first scaling revenue line and a defensible commercial moat — paid mostly in wholesale margin and milestone-vested equity, not the cash you'd rather conserve. The full engagement structure, fee schedule, compliance posture, and risk register are documented in the partnership proposal.

Confidential. Prepared for the SofPulse, Inc. board and shareholders. Modeled at a $500 device retail; replace with SofPulse ASP for exact figures. Surgeon-side RTM revenue accrues to the monitoring provider, not to SofPulse or SolvingHealth — shown as a sales tailwind, not booked revenue. Not indexed. Not for distribution.