Youth is Wasted
on the Young.
So we borrowed it. Introducing the first standardized, lyophilized neonatal secretome—delivering the signaling power your patient's own blood lost decades ago.
The Market Problem
Regenerative Medicine is Here,
But it Falls Short.
Together, platelet-rich-plasma (PRP), exosome, and stem cell therapies represent a ~$16B+ global market—built on source material that ages, doses that drift, and a supply chain that cannot scale.
01
No Standardization
PRP and exosome therapies vary clinic to clinic, batch to batch, with no consistent composition.
02
Depleted Source Material
Adult blood has lost decades of regenerative potency, with declining signaling.
03
Not Scalable
Treatments rely on per-patient or donor material, with no ability to manufacture, store, or distribute.
Sources: Grand View Research (Platelet Rich Plasma Market, Stem Cell Market, Exosome Market).
LYOS-001
The Signal in the Dust.
Standardized Lyophilized Neonatal Platelet Secretome
Neonatal Source
Minimal protein aging with higher signaling integrity and consistency.
Lyophilized
Shelf-stable format preserving bioactivity, enabling storage and distribution — the “Botox” Model.
Defined Dose
Standardized composition with consistent, reproducible dosing across treatments.
Youth is Wasted
on the Young.
So We Borrowed It.
Peak signaling potency
Neonatal platelets are in active developmental mode.
Low inflammatory profile
Reduced inflammatory cytokines.
No immune risk
Cell-free composition eliminates immune risk.
Relative Signaling Potency
Standardized Growth Factor Potency by Age
Illustrative, based on published growth factor decline data (Stem Cells Dev. 2011–2020).
Preclinical Validation
A Compelling Source: Cord Blood vs. Adult PRP.
+24%
PDGF-BB
More growth factors.
Primary driver of cell chemotaxis & proliferation versus adult PRP.
12H
Faster full wound closure
Better tissue regeneration.
Versus adult PRP in scratch assay.
M2
Macrophage polarization
Less inflammation.
Shifted to an anti-inflammatory phenotype.
Growth-factor differences between cord-blood and adult platelet preparations are reported inconsistently and are preparation-dependent; LYOS will confirm its own product's growth-factor and potency profile by qualified paired assays. Cf. Mani et al. 2024 and others.
Mani, R., Roopmani, P., Rajendran, J., Maharana, S., & Giri, J. (2024). Cord blood platelet rich plasma (PRP) as a potential alternative to autologous PRP for allogenic preparation and regenerative applications. International Journal of Biological Macromolecules.
Standard Regenerative Signaling
Activating Core
Regenerative Pathways
LYOS-001 delivers a defined neonatal secretome that activates core regenerative pathways across tissues.
Dormant cells, switched back on.
Activates dormant progenitor and stem cells via growth factor signaling (Wnt, IGF-1 pathways).
New blood vessels, new supply.
Induces new blood vessel formation to support tissue repair (VEGF, PDGF signaling).
Inflammation down, matrix rebuilt.
Reduces inflammation and promotes extracellular matrix (TGF-β modulation, cytokine balance).
Strategic Access
You Can't Spin Up
a Cord Blood Network.
LYOS is built on unique access to Americord's cord blood platform—the supply and the lab that competitors can't replicate on a whiteboard.
Neonatal Cord Blood Supply
Access to one of the largest U.S. cord blood banking donor networks, enabling consistent, high-quality sourcing.
Americord Laboratory, Somerset NJ
Our in-house lab is equipped with cutting-edge technology and staffed by trained professionals who follow rigorous protocols and uphold the highest quality standards.
Operating Within a Regulated Framework
The Mechanism of Action
One Injection.
A Dual Pathway.
LYOS-001 wakes hair follicles two ways at once—triggering new blood vessel formation while directly switching the regrowth pathway back on.
Native Stimulus
New blood vessel formation.
Angiogenesis
Triggers the hair follicle activation cascade through Wnt protein signals.
Anagen Phase Extension
Prolongs the active hair growth phase.
LYOS-001
Standardized neonatal growth factors.
Dormant Stem Cell Activation
Reactivates quiescent hair follicle stem cells.
RAS/ERK Pathway
Neonatal secretome directly activates the regrowth pathway.
Standardized growth factors, delivered.
LYOS-001 delivers a standardized neonatal secretome (PDGF-BB, VEGF, FGF-2) directly into the scalp dermis.
Wnt and RAS/ERK pathways re-awaken.
Growth factors activate Wnt and RAS/ERK pathways, reawakening dormant follicle stem cells.
Density and shaft diameter increase.
Follicular stimulation drives increased hair density and shaft diameter, with no scalp inflammation.
The Botox Model
Simple. Elegant. Done.
From a 60-minute procedure to a 60-second reconstitution.
1Vial Arrives
Room-temp stable. No drama. Ships in a box, not a cooler.
2Reconstitute
Add sterile saline. 60 seconds. Done.
3Inject
Inject. Done. The patient is out before their parking meter expires.
Why LYOS Wins
LYOS Combines
What Others Cannot.
| Patient Benefit | Minoxidil / Finasteride | PRP | Hair Transplant | LYOS |
|---|---|---|---|---|
Quarterly Dosing vs. daily pills / topicals | ~monthly | one-time | ||
No Serious Side Effects no cardiac / sexual dysfunction | surgical risk | |||
Consistent Results Every Time standardized dose, not doctor dependent | skill-dependent | |||
No Surgery, No Blood Draw 60-second reconstitution + inject | ||||
Neonatal Growth Factors peak regenerative potency, not adult-derived |
De-Risking the Path
Regulatory, Clinical &
IP—Aligned.
Hair-first. US-only. One asset, one path to market.
FDA Pre-IND meeting
IND-enabling → IND open
Combined Phase 1/2 (~120–160 pts)
End-of-Phase-2 meeting
Phase 3 pivotal → BLA
52-wk safety follow-up
BLA submission
Topical (US + intl)
Ex-US aesthetic injectable
US injectable (post-approval)
Wound healing / chronic wounds
Orthopedic / MSK (tendon, osteoarthritis)
CMC/potency work starts now; the GLP local-tolerance study is a repeat-dose (3-dose) study and only if FDA requires it (waiver sought at Pre-IND). Phase 1/2 reads an 8-week signal then a 16-week proof-of-concept; the pivotal uses a 3-dose induction (Day 0/Wk4/Wk8) and registers on a 24-week target-area hair-count primary; maintenance is deferred to post-approval. Founder ~38% at IPO (no bridge). US injectable launches on approval and ramps OFF-CHART to a ~$0.8–1.0B US peak by ~2040 (5-treatment loading: Day 0/Wk4/8/12/16, then quarterly maintenance: ~$0.1B '33, ~$0.3B '35, ~$0.6B '37, ~$0.8B '40 (see financial model, Injectable_Peak).
Regulatory
- FDA Pre-IND meeting requested — Jun 2026.
- IND filing targeted H1 2027; IND opens ~30 days after filing. (Pre-IND filed; FDA written responses due Aug 8, 2026.)
- Single combined Phase 1/2 under one IND — no separate Phase 2 filing.
Clinical
- Hair-first, US-only: injectable secretome for androgenetic alopecia.
- Phase 1/2: dose-escalation into efficacy expansion under one seamless protocol.
- Proof-of-concept readout targeted mid-2029; 2030 decision point.
Capital & IP
- Seed $10M ($30M pre / $40M post); balance targeted by Dec 2026.
- Series A ~$50M targeted post-IND open + early clinical.
- QSBS-eligible: 2030 transaction sits inside the 5-year clock.
All dates are forward-looking targets gated by the science. Everything right of the tox gate assumes lots land mid-2026 and tox runs clean.
Our Team
Operators & Doctors,
Building Together.
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Martin Smithmyer
Founder / CEO
Founder & CEO of Americord. 15+ years building cord-blood platforms and biotech operations.
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Robert Dracker, MD
Interim Chief Medical Officer
Pediatric hematologist; Medical Director of Americord. Decades of clinical leadership in cellular therapy.
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Sophia Aburmeileh, DMH
Interim Chief Operating Officer
Leads donor operations & quality at Americord. GMP, regulatory, and process expertise.
Kendal Schoettlin
Interim Chief Financial Officer
Head of finance, operations and HR at Americord.
Starting
at the Top.
We are launching with Hair Restoration because the market is loud and the current solutions are quiet. But the platform is agnostic—one signaling system, four very large markets.
Beyond Hair: Skin, Joints, Wounds
- Hair Restoration$4.5B
- Skin Rejuvenation~$14B
- Orthopedics & Joint Care$6.8B
- Wound Care$24.9B
Market figures sourced from 2024/2025 industry reports (Market.us, Precedence Research, Grand View Research, Global Market Insights). Hair Restoration shown here as platform TAM.
We Turned a Procedure
into a SKU.
Regenerative medicine has a "time" problem. PRP is a service business capped by clinic hours and patient veins. We just uncapped it.
(Volatile)
(Scalable)
The Service Trap
The Old Way
"To sell PRP, you need a patient, a nurse, a phlebotomist, a centrifuge, and 45 minutes of room time."
The Lyos Way
"To sell Lyos, you need a shipping label. We don't sell hours; we sell units."
The Logistics of Biology
The Problem
"You can't ship a fresh platelet. It dies before it leaves the zip code."
The Solution
"We lyophilized the asset. Our product is shelf-stable, lightweight, and travels globally without a cold chain. We can stock a clinic in Dubai as easily as one in Dallas."
The "Ctrl+Z" Platform
The Vision
"Hair is just the proof of concept. The same signaling platform applies to joints, skin, and wounds."
The Wit
"We aren't building a hair loss company. We're building the 'Undo' button for biological aging."
Capitalize the Signal.
We are standardizing a ~$16B+ wild west market.