Demonstrated Safety & Airway Stabilization in FIH Trial

UCSF Medical Center trial cohort evaluating safety, tolerance, and event reduction.

50% Lower

Apnea-Hypopnea Index (AHI)

Measures apneas and hypopneas per hour during sleep. Lower is better.

35.6
Start AHI
18.0
End AHI
40% Lower

Epworth Sleepiness Scale (ESS)

Standard clinical measurement of daytime sleepiness. Lower is better.

9.9
Start ESS
5.9
End ESS
Safety & Tolerance: Zero Severe Adverse Events (SAEs) reported during the study cohort. Implant design, manufacturing, and packaging systems are fully finalized.
X-ray showing hyoid alignment with and without brace

Fluoroscopy confirmed immediate forward hyoid bone pull upon brace donning.

Patient Demographics

  • Trial Institution UCSF Medical Center
  • Cohort Size 8 Patients (7 Men, 1 Woman)
  • Average Age 58.9 Years
  • Average BMI 27.8 kg/m²
  • Regulatory Track FDA IDE #G139285

Trusted by Clinicians, Preferred by Patients

"It is saving my life. I am lucky to be the first one in the trial."
"I find that I sleep better and have not had the usual side effects from sleep apnea. It is far superior to the CPAP machine."
— FIH Trial Patients 1 & 2
"This procedure is very comfortable for ENTs, because it is similar to other surgeries that we perform on a frequent basis. The procedure takes place in the region where we typically operate."
— Otolaryngologist (ENT)
"The Corsomed device provides support for the lateral walls, which is an important advancement. We know that Inspire does not work effectively on patients with lateral wall collapse."
— Sleep Medicine Physician

Accelerated Path to Market and 510(k) Clearance

Foundation

Pre-FIH & Patents

Exclusive UCSF license, 4 core patents issued, and completed FIH trial.

Phase 1

Verification & Validation

Hardware V&V, wearable ergonomics upgrade, and reimbursement planning.

Phase 2

510(k) Submission

510(k) clearance pathway via LRK product code.

Phase 3

Pivotal Trial & Sales

10-center FDA trial to drive commercial roll-out and Category I CPT coding.