Shaping the future of
mask-free sleep apnea care.
HYPNARA™ is a single in-office procedure — a palatal implant placed in under 20 minutes — that effectively treats snoring and mild-to-moderate OSA. One procedure. No mask. No device. No nightly routine.
CPAP works in trials.
Patients abandon it in practice.
CPAP is still prescribed to 80% of OSA patients — yet up to 50% abandon it within three years, and up to 83% fail to meet the minimum 4-hour nightly threshold. The alternatives (surgery, hypoglossal nerve stimulation) are invasive, expensive, or require continuous nightly compliance.
Of the ~80.6M US adults with OSA (2024) and ~37M regular primary snorers, approximately 68 million fall into the mild-to-moderate and snoring-only camp — patients for whom CPAP is inappropriate and HGNS is overkill. That is the gap HYPNARA™ fills.
HYPNARA™ Palatal Implant System
HYPNARA™ is placed by Otolaryngology–Head & Neck (ENT) surgeons, Oral and Maxillofacial surgeons (OMFS), and dental sleep medicine physicians in a single in-office procedure. The implant — manufactured from biocompatible UHMWPE or PLLA — stiffens the soft palate to reduce airway collapse during sleep.
- Under 20-minute outpatient procedure
- Biocompatible implant — UHMWPE or PLLA material
- 510(k) Class II pathway — no clinical study required
- FDA pre-submission meeting on calendar (May 2026)
- Manufacturing partnership in place (Voltas CDMO)
- 510(k) submission planned Q1 2027; clearance Q2–Q3 2027
Progress investors can verify today.
Regulatory Path Confirmed
510(k) Class II — no clinical study required. Q-Submissions complete. FDA pre-sub meeting scheduled May 2026 with King & Spalding regulatory counsel.
Manufacturing Contracted
$2M manufacturing agreement in place with Voltas CDMO. Design-for-manufacture in progress. Tooling and pilot builds scheduled Q3–Q4 2026.
IP Strategy in Motion
HYPNARA™ trademark in filing. Freedom-to-operate analysis underway. Clean cap table with no institutional encumbrances.
Clinical Network Building
Clinical advisory board recruitment underway. Target: 25 KOL ENT/sleep medicine physicians for pilot launch. Direct ENT channel validated at conferences.
Founder-Led Traction
Active conference presence (LSI, LSA 2026). SAFE note round closing April 1, 2026. Seed round targeted Q2 2026 at $16M pre-money / $20M post-money.
Series A Runway Visible
$4M takes company to 510(k) clearance + 2,000 commercial procedures. Cash-flow positive Q3–Q4 2027. Series A positioned at $50M+ post-money following commercial proof.
Built by a founder who understands both sides of the OR.
Founder and operator with deep domain expertise spanning medical device regulatory pathways (FDA 510(k), Q-submissions), implant design, clinical trial strategy, OEM manufacturing partnerships, and investor relations. Built Somnus Technologies from concept through active seed fundraising across HYPNARA™, MORPHEX™AI, and NOXERA™ product lines.
Clinical advisory board, regulatory counsel (King & Spalding), and full team bios available in the investor data room. Request access below.
- Company overview & problem framing
- HYPNARA™ product summary
- Regulatory pathway milestone map
- Key traction indicators
- Founder background
- Full pitch deck (22 slides)
- Financial model & 5-year projections
- Regulatory dossier (Q-Sub, pre-sub strategy)
- Voltas manufacturing agreement summary
- IP, patent landscape & FTO analysis
- Corporate & cap table documents
$16M pre-money.
Path to 510(k) clearance
and 2,000 commercial cases.
SAFE note funding closes April 1, 2026. Seed round targeted Q2 2026. 20% dilution. Structured for a clean cap table and Series A optionality at $50M+ post-money following regulatory clearance.