MedInvent, LLC | 1841 Buerkle Road | White Bear Lake, MN 55110 1-866-960-9833 | www.nasoneb.com

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The Optimal Intranasal Drug Delivery Solution

The NasoNeb®

N A S A L N E B U L I Z E R S Y S T E M

Backed by Clinical DataNasoNeb-delivered pharmaceutical therapy demonstrated a statistically-significant 50 LPM increase in daily nasal peak inspiratory flow (NPIF) from baseline to endpoint in the treatment arm of a parallel, randomized, double-blinded, placebo-controlled clinical trial examining the response to Budesonide delivered via NasoNeb in a perennial allergic rhinitis patient population.5

Multiple studies, including a peer-reviewed journal article, demonstrate the NasoNeb System deposits a high concentration of medication to the nasal and paranasal sinus cavities, including the frontal recess/sinus, spheno-ethmoid recess, ethmoid cavity, sphenoid and maxil lar y sinuses, all turbinates, the middle meatus and olfactory cleft.2,7

Researchers have also indicated that the NasoNeb System may be a safer alternative to medicated irrigation, which often requires cold storage to maintain stability.4 Repeat exposure to cold fluids have been linked to the formation of exostoses of the paranasal sinus cavities in the peer-reviewed literature.1,3,4,8,9 The aerosolizing action of the NasoNeb System warms cold solutions to near ambient temperature.4

Ensure that your patients experience maximal medical therapy with low-volume, high concentration drug delivery by prescribing the NasoNeb Nasal Nebulizer.

The NasoNeb is available by prescription only through the NasoNeb Pharmacy Network℠

Find participating dealers on the web: www.nasoneb.com or call us toll-free: 1-866-960-9833

Exostoses of the paranasal sinus cavities

Post-Fess maxillary sinus deposition

Disclaimer: The NasoNeb® Nasal Nebulizer is designed for use by a single person and is not to be shared with others, which could spread infectious agents. Close supervision is necessary when using a nebulizer on or near children or invalids. Safety instructions must be followed including not using this system in the presence of any flammable anesthetic mixture with air or with oxygen or nitrous oxide.

NPIF graph courtesy of Robert Naclerio, MD; Exostoses photo courtesy of Raj Sindwani, MD; Deposition photo courtesy of Peter Manes, MD

Bibliography1. Adelson, RT, Kennedy DW: “Paranasal sinus exostoses: possible correlation with cold temperature nasal irrigation

after endoscopic sinus surgery” The Laryngoscope 2013, Jan: 123(1): 24 – 7 2. Yuri M. Gelfand, MD; Samer Fakhri, MD; Amber Luong, MD, PhD; Seth J. Isaacs, MD & Martin J. Citardi, MD: “A

Comparative Study of the Distribution of Normal Saline Delivered by Large Particle Nebulizer vs. Large Volume/Low Pressure Squeeze Bottle” 56th Annual Meeting of the American Rhinologic Society, September 25, 2010, page 38

3. Haffey, MD, Timothy; Woodard, MD, Troy, Sindwani, MD, Raj:“Paranasal Sinus Exostoses: An Unusual Complication of Topical Drug Delivery Using Cold Nasal Irrigations” The Laryngoscope 2012, Sep;122(9):1893-7

4. Holmes, MD, Janalee; Haffey, MD, Timothy; Woodard, MD, Troy, Sindwani, MD, Raj: “Ambient Warming of Nasal Irrigation Solutions: Implications for Safe Topical Drug Delivery and Patient Compliance”; COSM 2013 program, p 42

5. Kristal Brown, James Lane, Marianella Paz Silva, Marcy DeTineo, Robert M. Naclerio and Fuad M. Baroody: “A pilot study of the effects of intranasal budesonide delivered by NasoNeb® on patients with perennial allergic rhinitis” Int Forum Allergy Rhinol, 2014: 4:1:43-48.

6. Laube, Ph.D., Beth: “Devices for Aerosol Delivery to Treat Sinusitis” J. Aerosol Therapy, 2007:7:Supplement 1:S1-S187. Manes RP, Tong L, Batra PS.: “Prospective evaluation of aerosol delivery by a powered nasal nebulizer in the

cadaver model” Int Forum Allergy Rhinol, 2011; 1:366–3718. Ramakrishnan, MD, Jeevan B.; Pirron, MD, Jose A.; Perepletchikov, MD, PhD; Ferguson, MD FAAOA, Berrylin J.:

“Exostoses of the paranasal sinuses” Laryngoscope 2010 Dec: 120(12) 2532 - 2534 9. Schwarts, KM, Eckel, LJ; Black, DF; Lehman, VT; Diehn, FE; Hunt, CH; Lindell, EP: “Irrigation Nose: CT Findings of

Paranasal Exostoses” Open Neuroimag. J. 2012; 6:90-91 10. “Particle Size and Airflow: Implications for nasal and paranasal sinus delivery,” White Paper, MedInvent, LLC 11. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and

Research (CDER): “Guidance for Industry Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment” November 2006.

Federal Law (USA) restricts the sale of this device by or on the order of a physician.

Optimized for Drug Delivery to the Nasal and Paranasal Sinus CavitiesSituations where topical pharmaceutical delivery by the NasoNeb System is used include:

n Post-operative and non-surgical patients with crusting and infection

n Patients with recurrent nasal polyps

n Non-surgical patients who have failed or do not tolerate other therapy

n Patients suffering from recalcitrant allergic rhinitis

n Patients suffering from anosmia

The NasoNeb® Nasal Nebulizer delivers a deep, penetrating aerosol to the nasal and paranasal sinus cavities that is comfortable to use and offers fast delivery times, with safety advantages over irrigation and small particle nebulizers.2,4,6,7

The Importance of Particle Size and AirflowA large particle or droplet size ensures retention of medication within the nasal cavity and reduces the risk of pulmonary deposition, which may lead to inadvertent local and systemic side effects.6,11

“Particles or droplets that are aerodynamically smaller than the standard 5 micron upper bound of the respirable fragment size can be inhaled. For nasal deposition, the optimal droplet or particle size should be, on the whole, substantially larger than the respirable fragment size.” 11

Sufficient airflow is necessary to propel these droplets throughout the nasal and paranasal sinus cavities and achieve broad deposition.6

Small particle nebulizers deliver only 3% of the medication to the nasal cavity.6 Medicated irrigations are unnecessarily dilute, deposit only 1.4 – 2.8% of the liquid in the nasal cavity, and have been linked to iatrogenic side effects.2,4,6,7

NasoNeb Particle Size Percentage<5 microns 0.0083±0.0098%<10 microns 0.055±0.037%>10 microns 99.94%±0.0468%

NasoNeb System particle size measured by Laser Doppler Interferometer by a third party independent laboratory10

The patented NasoNeb System features a unique combination of particle size, airflow, and fluid volume not found in any other device. This results in a controlled therapy delivery only to the nasal and paranasal sinus cavities featuring broad intranasal drug deposition, high intranasal drug retention, and virtually no pulmonary deposition.2,7

n Large particles are designed to stay in the nasal and paranasal sinus cavities with virtually no pulmonary deposition

n A positive pressure airstream carries the aerosol deep into the nasal and paranasal sinus cavities, ensuring broad deposition while providing a comfortable aerosol for the user

n Fluid volume of 0.2 – 15 ml ensures a high concentration of medication that stays in the nasal cavity

n Fast delivery of 1 or more drugs in a single 1-2 minute session that fits easily into a daily routine

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