Alesis OSA1: Photonic Lipolysis to Target The Root Cause of Most OSA

First FDA-cleared, non-invasive device targeting the pathophysiologic mechanism of obstructive sleep apnea through localized adipose reduction for improved upper airway patency.

FDA Clearances K160880, K150336, K202361

Safety Track Record 11 Years, No Adverse Outcomes

Clinical Trial NCT06949969

We manufacture the Alesis OSA1 in America for the sleep medicine community.

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Clinical Foundation

Addressing the Anatomic Substrate of OSA

Recent MRI volumetric studies have established that tongue and parapharyngeal fat deposition represents a primary pathophysiologic mechanism in obstructive sleep apnea, independent of overall BMI.

100%

Submental Fat Reduction

All subjects in randomized IRB trial NCT06949969 demonstrated significant reduction in submental adipose tissue and neck circumference. Reduction in submental fat repositions the tongue to improve airway patency.

80%

AHI Improvement Rate

80% of subjects achieved 51-85% reduction in Apnea-Hypopnea Index with a 3-week treatment protocol.

63%

Significant Neck Reduction

63% of test subjects lost >0.9" neck circumference—equivalent to 10-20% total body weight loss—without systemic weight reduction.

40-50%

CPAP Non-Adherence

Discontinuation rate due to intrusiveness, discomfort, noise, and travel limitations—representing critical treatment gap.

48%

Tongue Fat Reduction (MRI)

Published AJRCCM data: 32% weight loss correlates with 48% lingual fat reduction and 80% AHI improvement (Wang et al., 2020).

Key Literature Supporting Targeted Fat Reduction

Wang et al., AJRCCM (2020): "Effect of Weight Loss on Upper Airway Anatomy and the Apnea-Hypopnea Index: The Importance of Tongue Fat" — MRI volumetric analysis demonstrates 32% weight loss produces 48% reduction in tongue fat (14,126mm³ to 7,337mm³) with corresponding 80% decrease in AHI (121 to 24.6).
Parapharyngeal and retroglossal fat deposits shown to narrow pharyngeal airway diameter independent of BMI and total neck circumference.
Bariatric surgery outcomes confirm AHI improvement occurs disproportionately early relative to total body weight reduction.
Localized adipose reduction in upper airway structures represents mechanistic target independent of systemic weight loss.
Clinical Trial NCT06949969: Randomized IRB study demonstrating 100% efficacy in submental fat reduction and 80% improvement rate in sleep apnea severity.

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Technology

Mechanism of Action: Photonic Lipolysis

Patented high-powered non-laser photonic energy induces lipolysis through mitochondrial chromophore activation (cytochrome c oxidase), triggering cellular response mimicking famine state without thermal or destructive effects on adipocyte viability.

Chromophore Activation

Specific wavelength photonic energy absorbed by mitochondrial cytochrome c oxidase in adipocytes, initiating photobiomodulation cascade.

Transient Membrane Permeabilization

Adipocyte membrane becomes temporarily porous through non-thermal mechanism, creating channels for lipid mobilization.

Triglyceride Release

Intracellular triglycerides exit as non-esterified fatty acids (NEFAs) and glycerol through membrane pores; concurrent stimulation of leptin, adiponectin/Acrp30, and IL-6 secretion.

Adipocyte Volume Reduction

Cell volume decreases as lipid content mobilizes; adipocyte remains viable with intact cellular machinery and restored membrane integrity post-treatment.

Dermal Remodeling

Concurrent photostimulation of fibroblasts increases collagen and elastin synthesis, producing skin tightening and improved tissue architecture

Clinical Protocol & Treatment Parameters

Treatment Duration: 12 minutes per session, administered twice weekly for 3 weeks (total: 6 treatments)
Anesthesia: None required; completely non-invasive outpatient procedure with no discomfort or downtime.
Patient Selection: OSA diagnosis confirmed by polysomnography (AHI ≥5), overweight patients, CPAP-intolerant or seeking alternatives to PAP therapy.
Selective Draping: Opaque draping available to protect facial areas where fat reduction is not desired (e.g., patients wanting airway improvement without facial volume loss).
Contraindications: Pregnancy, active malignancy in treatment area, photosensitivity disorders, porphyria.
Post-Treatment: Immediate return to all normal activities; zero recovery time or activity restrictions.
Monitoring: Pre- and post-treatment polysomnography, neck circumference measurements, patient-reported outcomes.

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Treatment Comparison

OSA1 vs. Current Standard of Care

Clinical Parameter	Alesis OSA1	CPAP/BiPAP	Oral Appliance	UPPP Surgery
Addresses Root Cause	✓	✗	✗	Partial
Non-Invasive	✓	✓	✓	✗
No Nightly Compliance Required	✓	✗	✗	✓
Zero Recovery Time	✓	✓	✓	✗
Adverse Event Profile	None reported	Common (skin irritation, claustrophobia)	Common (TMJ, dental)	Significant (pain, bleeding, infection)
Efficacy	Excellent	Excellent (if adherent)	Moderate	Variable
Patient Compliance	High	Poor (40%-50% discontinue)	Moderate	N/A

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Practice Implementation

Seamless Integration into Your Sleep Medicine Practice

Designed for efficient deployment within existing clinical workflows and comprehensive support infrastructure.

Clinical Protocol Support

Comprehensive treatment guidelines, patient selection criteria, and outcome tracking systems aligned with standard polysomnography metrics

Physician Training & Certification

Structured certification program with continuing medical education for treatment administration and patient management

Data & Outcomes Tracking

Electronic integration capabilities for seamless documentation, outcome monitoring, and contribution to ongoing clinical registry

Patient Education Materials

Evidence-based literature, informed consent documentation, and multimedia resources for patient counseling

Research Collaboration

Opportunity to participate in ongoing multi-site trials and contribute to peer-reviewed literature on treatment efficacy

Economics

Request a consultation on the economics of the Alesis OSA1

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Manufacturing & Regulatory

Quality & Compliance

FDA Clearances

K160880
K150336
K202361

Multiple 510(k) clearances establishing safety and efficacy across device iterations

Intellectual Property

11 Utility Patents
31 Countries Protected
U.S. Patents: 9,044,595; 9,498,641; 9,808,314; 10,946,210; 63/074,790

Technology invented 2011 by Terry J. Ward, Sr., M.H.A.; OSA provisional patent granted February 2025

Manufacturing

Made in USA
Manufactured by Photonica USA, LLC

Quality Assurance:
11 year safety record with zero adverse outcomes reported in clinical use

Partner with Alesis Medical

Join leading sleep medicine specialists offering advanced treatment options for OSA patients.

Direct physician inquiries welcomed: Contact Terry J. Ward, Sr., M.H.A., Managing Director & CEO

Call 1-800-248-5051 Schedule Zoom Meeting