Lysahealالعربية

Pre-clinical · Riyadh, Saudi Arabia

Lysaheal

From the blood bank, back to the patient.

Lysaheal turns the platelets that blood banks throw away into a standardised wound-healing gel for chronic ulcers.

Expired unitPoolingLysatePotency checkGel on wound

The problem

Two problems that are actually one.

The waste

19.44%
average blood-component waste rate at a Saudi tertiary hospital (King Fahad Armed Forces Hospital), 2021–2023 — expiration was the leading cause, at 28.4% of discards
13%
average platelet disposal rate across 17 European countries, ranging 6.7–25% between institutions
5–7 days
the transfusion shelf life of a platelet unit — the shortest of any blood component, and why platelets are the most-discarded component in almost every blood bank

The wound

23.1%
adult diabetes prevalence in Saudi Arabia — one of the highest rates in the world (IDF Diabetes Atlas, 2024)
8.5%
diabetic foot ulcer prevalence in Saudi Arabia — the highest of five Arab countries in a systematic review
33%
of diabetic foot ulcer patients undergo amputation across the Middle East, with Saudi rates significantly higher than regional peers

Sickle cell disease is also concentrated in Saudi Arabia's Eastern Province (134 per 1,000 population). 8% of Saudi sickle cell patients report a history of leg ulcers — 16.7% among those over 50 — and there is currently no approved therapy for them.

The same hospital incinerates in one department the biological material that another department's patients need.

The solution

An off-the-shelf allogeneic platelet gel, produced inside existing hospital blood banks from platelet units that have already expired.

How it is made

01

Collect

Expired platelet units are collected within a defined post-expiry window (day 6–10). Units suspended in 100% plasma are preferred for higher fibrinogen and roughly double the gel yield.

02

Pool and lyse

Four units — at least 16 donors per batch — are pooled to average out donor variability. Four freeze–thaw cycles (−80 °C / +37 °C) are followed by centrifugation at 4,000 × g for 10 minutes. Pathogen reduction is applied at the unit stage using the blood bank's existing system.

03

Release on potency

Every batch is tested by ELISA for PDGF-BB, VEGF, TGF-β1, EGF and bFGF, plus a fibroblast scratch (migration) bioassay. A batch fails release if PDGF-BB or TGF-β1 falls below specification. Dose is expressed as nanograms of growth factor per cm² of wound, not millilitres of gel.

04

Activate and apply

10 mL lysate is combined with 3.3 mL 10% calcium gluconate and 0.4 mL tranexamic acid, forming a fibrin gel in 30 minutes. Reagent cost is under €3 per dose. No bovine thrombin, no batroxobin, no capital equipment, no patient blood draw.

Three design innovations

Waste as feedstock

Lysaheal uses expired units rather than the patient's own blood or in-date transfusable units. Input cost is near zero because the material is already collected, screened, and paid for. Supply grows with the blood system instead of competing with it.

Potency on the label

Every batch is released on measured growth-factor content. No existing platelet product states a measured dose.

Built for the wound and the climate

A fibrin matrix uses heparin-binding retention to protect growth factors from the proteases (MMP-9, elastase) that degrade them within hours in chronic wounds. A lyophilised, single-use sachet with trehalose stabilisation targets stability at 45 °C for Saudi conditions and eventual home application.

Why Lysaheal

How existing platelet and growth-factor therapies compare
SolutionSourceCost per doseAvailable in KSA
Aurix (USA)Patient's own blood, drawn each visitSeveral hundred USDNo
Amnion allografts (EpiFix, Grafix)Donated placenta, importedUSD 1,000–3,000Imported, costly
Italian blood-service platelet gelIn-date donor unitsVery lowItaly only
Cord blood platelet gelCord bank surplusLowNeeds a cord bank
LysahealExpired units — freeBlood-component costEvery blood bank in KSA

Every existing platelet therapy either takes blood from the sick patient, consumes transfusable units, or needs infrastructure most countries don't have.

Evidence

The approach is built on published outcomes for allogeneic platelet products. Our specific product has not yet been tested.

RR 2.72

95% CI 1.77–4.19

relative risk of wound healing with allogeneic platelet-rich plasma vs. standard care

Li et al., Scientific Reports, 2024 — meta-analysis of 12 RCTs, 717 patients

RR 1.53

relative risk of healing with PRP vs. standard care, specifically in diabetic foot ulcers

Acta Diabetologica, 2025 — meta-analysis of 15 RCTs, 1,010 patients

79% vs 46%

ulcer area reduction with cord blood platelet gel after revascularisation, vs. standard care

Piccin et al., 2018

Caveats

  • Most allogeneic platelet trials are single-centre.
  • One diabetic foot PRP meta-analysis was retracted in 2025.
  • The International Working Group on the Diabetic Foot has historically not recommended platelet gels.

What we have not yet shown

These are our hypotheses. They are the subject of our pre-clinical programme, not established facts.

  • That day 6–10 post-expiry is the right collection window
  • That potency-based ng/cm² dosing improves outcomes over volume-based dosing
  • That the protease-protected formulation extends growth-factor activity in a real wound
  • That the product is stable at 45 °C for field conditions
  • That the product is safe and effective in sickle cell leg ulcers, an indication with no prior platelet-therapy data

Clinical status: pre-clinical (in vitro). No clinical data exists yet on this specific product. This is a pilot programme, not an efficacy claim.

Roadmap

  1. Bench feasibility at KAIMRC

    Current stage

    An expired-vs-in-date potency panel, gel formation, fibroblast bioassay, protease challenge, and heat-stability pilot — each with a pre-registered go/no-go threshold.

  2. IP filing

    Patent filing completed before any public disclosure of technical detail.

  3. IRB approval

    MNGHA/KAIMRC institutional review board approval for a study using discarded material.

  4. SFDA classification

    Saudi Food and Drug Authority classification and scientific-advice meeting.

  5. Diabetic foot ulcer pilot

    20–40 patients. Primary endpoint: complete wound closure at 12 weeks.

  6. Sickle cell leg ulcer safety pilot

    Initiated once diabetic foot ulcer safety data is clean.

Team & affiliations

[FOUNDER NAME]

Founder & Project Lead

Sixth-year medical student, KSAU-HS

[CO-FOUNDER NAME]

[CO-FOUNDER ROLE]

[ADVISOR NAME]

Clinical & Scientific Advisor

Transfusion Medicine

[SUPERVISOR NAME]

Academic Supervisor

Affiliations

Lysaheal was founded at King Saud bin Abdulaziz University for Health Sciences (KSAU-HS), Riyadh, with research access through the Ministry of National Guard Health Affairs (MNGHA) and the King Abdullah International Medical Research Center (KAIMRC).

Contact

Lysaheal welcomes conversations with blood banks, transfusion medicine specialists, and wound-care centres.

Or write to us directly
[EMAIL]
LinkedIn
[LINKEDIN]
Riyadh, Saudi Arabia