LeSquish — Fiomet Ventures | Adaptive Pressure-Injury Prevention

The Hidden Epidemic

Hospital-acquired pressure injuries are a problem the system can't see.

Tissue injury begins deep at the bone–muscle interface and surfaces late — often after the damage is done. Most early-stage injuries are never captured by administrative coding or visual skin checks.

~2 hr

Sustained pressure to tissue ischemia in an at-risk area

2.5M

Cases officially reported each year (CMS administrative data)

~50M

Estimated true annual incidence per active-surveillance research*

$535B

Estimated total U.S. economic burden when hidden cases are counted*

Officially reported (CMS data)2.5M

Estimated actual incidence~50M

A widely cited Health Affairs surveillance analysis (Smith, Meddings et al., 2018) found pressure-injury incidence roughly 20× higher than administrative discharge data captures — the gap LeSquish and the Fiomet platform are built to close.

The Iceberg Effect

Why visual checks fail.

Pressure concentrates where no one is looking — at the bone–muscle interface. By the time redness appears on the surface, deeper tissue may already be compromised.

The iceberg effect: the skin surface can look normal while pressure peaks against bone and hidden tissue necrosis forms below

↑

Bottom-up destruction

The injury starts deep and spreads upward. Pressure peaks against bone first, where it can't be inspected.

⃠

The visual blind spot

Surface redness (Stage 1) can appear hours after underlying tissue has already begun to break down.

SettingCheck frequencyRisk window

ICU / acute~4-hour checks2+ hrs

Home / SNFDaily–weekly visitsDays

Casts & splintsNo visual accessWeeks

Conventional padding pressed against a patient's face during a prolonged procedure, marked to show the failure point

Fixed padding compresses, shifts, and concentrates load on delicate facial tissue — exactly what LeSquish is designed to prevent.

Ⓢ The gap today

Conventional padding isn’t enough.

Foam blocks, rolls, and gel pads are made in fixed shapes. Pressed against real anatomy for hours, they compress, shift, and leave unsupported voids exactly where pressure concentrates — over the bony prominences most at risk.

✕Fixed shapes can’t conform. Gaps form against curved or delicate anatomy, concentrating load instead of spreading it.

✕Padding collapses under sustained load. Foam loses thickness and protective value within hours.

✕It slips out of position. Once it moves, the area it was meant to protect is exposed.

Comparison: manually stacked foam leaves unsupported voids and a peak interface pressure point, versus LeSquish which shares the load evenly across the surface

One product. Infinite fits.

Instant-molds to any body part for a zero-gap fit — eliminating the pressure points that stacked foam leaves behind.

An elbow resting in custom-molded LeSquish foam

ZERO-GAP FIT

Meet LeSquish®

One product. Infinite fits.

LeSquish is poured at the point of care and hardens beneath the body in about four minutes, delivering full-contact, gap-free pressure support. Where stacked foam leaves unsupported voids that concentrate pressure, LeSquish shares load evenly across the entire surface — and holds its custom contour instead of collapsing.

ConformanceLiquid → solid, custom-molded

Cure time~4 minutes on-site

Wet-field behaviorMaintains structure when saturated*

UseSingle patient · disposable

Forms on demand

A two-part silicone foam expands and sets into a firm, supportive cushion.

Open-cell silicone

Soft interface with durable structure — the densest foam tested, yet low stiffness.

Anatomical shapes

Universal and horseshoe configurations, plus pediatric sizing, for head-to-heel support.

Liquid in. A custom fit, set in minutes.

The same component is poured as a liquid, then cures in place into a solid foam shaped to the patient — no sizing, no stacking, no gaps.

Bench demo · Liquid → foam → conform

The liquid component rises into a solid foam, then conforms and compresses around the anatomic contour pressed into it — supporting every curve without gaps.

LeSquish horseshoe foam pre-fill in its sealed pouch, with the component pack inset, before activation

Before · Pre-fill

Sealed foam pre-fill and component pack, before curing.

→

LeSquish after curing into a solid custom-molded foam pad

After · Cured foam

Expanded and set to a custom contour.

How It Works

Prepared in four simple steps.

No sizing guesswork, no stacking. LeSquish is mixed and placed in minutes, then sets to the exact contour it's supporting.

Open the kit

Each single-use kit contains the two-part foaming system and connector.

Burst the seal

Roll Part A into Part B to combine the components.

Connect & mix

Click the male and female connectors together and mix thoroughly.

Transfer & shape

Pour into position and shape to the anatomy — it cures in ~4 minutes.

Why It's Different

Built to support every body, in every position.

Instant conformance

Liquid-to-foam fills gaps and evens out pressure support across the contact surface.

Position-proof

Adapts to supine, lateral, and prone positioning — and to complex anatomy.

Adaptable fit

Custom-forms to each patient's unique pressure points rather than one fixed shape.

Fast curing

Fully set in about four minutes — ready to support without long preparation.

Wet-field durability

In bench testing, structure held when saturated — where polyurethane foams weakened.*

Sensor-ready

Designed to pair with the Fiomet sensing platform for continuous monitoring in future versions.

LeSquish vs. Legacy Foam

Foams collapse. Orthotics gap. LeSquish molds and holds.

Metric

LeSquish

Conventional foam

Structural hold

Retains form under sustained load

Compresses and loses efficacy within ~2 hours

When wet

Maintains structure when saturated*

Weakens in irrigation & body fluids

Fit

Custom-molds to each patient's anatomy

Fixed shape — unsupported voids & gaps

Position adaptability

Any position, head to heel

Limited; poor fit in head/neck areas

Recovery after load

Returns toward original form*

Eggcrate & gels stay compressed

Clinical & Bench Evidence

Proof, not promises.

Peer-Reviewed · PRS Global Open 2025

A biomechanical comparison of current padding materials vs. open-cell silicone foam.

In a controlled bench study, the open-cell silicone foam used in LeSquish retained roughly 20% of its structure under maximal load, while polyurethane foams and gels collapsed. It showed no significant change in force-to-deform when saturated (P = 0.081) — unlike PU foams, which required significantly less force when wet. Electron microscopy showed PU fibers fracturing while the silicone lattice stayed largely intact.

Rapp SJ, Pierzchajlo N, Gordon CB, Anderson SR. Prevention of Pressure-induced Soft Tissue Injuries… A Biomechanical Comparison. Plast Reconstr Surg Glob Open 2025;13:e7291. doi.org/10.1097/GOX.0000000000007291
An in vitro bench comparison; the study authors note in vitro and sample-size limitations.

IRB-approved cases with zero reported adverse events

84 hr

Longest reported single-use duration with no events

Pressure injuries reported across the company's clinical cases

35°C

Peak cure temperature — 8°C below the 43°C injury threshold

LeSquish has been used in reported compassionate-use craniopagus twin-separation procedures (84-hour and 51-hour) with no reported pressure injuries to facial soft tissues. Reflects the manufacturer's clinical experience to date, not a controlled clinical trial.

Safety & Regulatory

A clean profile, clearly scoped.

LeSquish is classified as a Class I, 510(k)-exempt device under FDA product code FMP (21 CFR 880.6450, skin pressure protector). Intended use and excluded settings are defined below.

Safety profile

Materials & biocompatibility

✓Peak curing temperature 35°C — below the 43°C tissue-injury threshold

✓Biocompatible — cytotoxicity PASS (ISO 10993-5, Nelson Labs)

✓No natural rubber latex · no DEHP plasticizer

✓Single patient use — no cross-contamination risk

✓Wet-field durable — structure maintained when saturated*

Intended & excluded settings

Per manufacturer's compliance reference

✓Hospitals & postsurgical floors; PICU (non-neonatal)

✓SNFs, outpatient clinics, wound care, home care

✓All patient ages in supervised, non-NICU settings

✕Not for NICU / neonates, or infant sleep positioning

✕Not for intraoperative use on anesthetized patients, or MR environments

Device class

Class I · 510(k) Exempt

Product code

FMP · 21 CFR 880.6450

FDA establishment

FEI 3043668222

Documentation

Technical File · IFU on request

How to Order

Order LeSquish.

Submit a purchase order or request a quote below. For qualified facilities we invoice on net terms; payment is accepted by ACH, wire, or card.

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Products & quantities

UniversalLS01-AX · Single

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HorseshoeLS02-HS · Single

HorseshoeLS02-HS-5 · 5-Pack

Pediatric HorseshoeLS03-HS-P · Single

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Email sales@fiomet.com or call our team for contract pricing, samples, and value-analysis packets.

The Fiomet Platform

LeSquish is the entry point to a four-product system.

Prevention, monitoring, and recovery across the care continuum — each device addresses a clinical "black box" where pressure and tissue stress go unseen.

LeSquish®

Universal Positioning

Liquid-to-solid orthotic positioning that molds to any body part and holds.In clinical use

DermaLiner™

Continuous Monitoring

Wireless skin-pressure sensing, cuttable to fit, for surgery, ICU, NICU and wound care.In development

CastLiner™

Orthopedics

Under-cast sensor strip that monitors swelling and pressure inside the orthopedic "black box."In development

SmartRAP™

Vascular Therapy

Graded therapeutic compression with real-time pressure sensing for vascular care.In development

"Under anesthesia, patients lose their natural protection against pressure. We needed a solution that wouldn't fail after a few hours."

Scott J. Rapp, MD, FACS

Founder & CEO, Fiomet Ventures · Plastic & Craniofacial Surgery, Cincinnati Children's

Reconstructs severe pressure injuries in practice — and built LeSquish after seeing standard prevention fail.
Lead surgeon on first-of-their-kind craniopagus twin-separation procedures.
Surgeon-inventor and clinical investigator on the published bench study behind LeSquish.

Hospital-acquired pressure injuries are a problem the system can't see.

Why visual checks fail.

Bottom-up destruction

The visual blind spot

Conventional padding isn’t enough.

One product. Infinite fits.

One product. Infinite fits.

Forms on demand

Open-cell silicone

Anatomical shapes

Liquid in. A custom fit, set in minutes.

Prepared in four simple steps.

Open the kit

Burst the seal

Connect & mix

Transfer & shape

Built to support every body, in every position.

Instant conformance

Position-proof

Adaptable fit

Fast curing

Wet-field durability

Sensor-ready

Foams collapse. Orthotics gap. LeSquish molds and holds.

Proof, not promises.

A biomechanical comparison of current padding materials vs. open-cell silicone foam.

A clean profile, clearly scoped.

Safety profile

Intended & excluded settings

Seven SKUs, head to heel.

Order LeSquish.

Choose configurations

Submit your PO

We confirm & invoice

Pay & ship

Purchase order / quote request

Order online

Payment methods

Wire / ACH details

Questions?

LeSquish is the entry point to a four-product system.

See how LeSquish fits your patients.