Nasal Obstruction

Latera

Team

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Committed to Transforming Treatment

of Nasal Obstruction

Mike Rosenthal

Chief Strategic Officer & CTO

19+ yrs. R&D/Ops experience (CardioGenesis, FoxHollow, Avinger) Stanford BSME

 

Bill Beasley

SVP of Manufacturing and Operations

12+ yrs. Med Tech Ops/Exec experience (R2 Tech, FoxHollow, Neodyne Biosciences)
Notre Dame BS Life Sciences

Matt Brokaw

VP of Marketing and Sales

15+ yrs. medtech experience (Acclarent, Sonitus, Guidant)

Williams BA, Stanford MBA

Scott Baron

VP of Research & Development

15+ yrs. R&D/Ops experience (Acclarent, Abbott Vascular, Lockheed)

Stanford BSME

 

 

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Spirox, Inc.

3475 Edison Way, Suite O

Menlo Park, CA 94025

Duke Rohlen

Chairman

Duke has over 20 years of experience as an executive in medical device companies. Prior to Spirox, Duke served as CEO of Advanced Cardiac Therapeutics, Founder and CEO of CV Ingenuity (acquired by Covidien/Medtronic), President of FoxHollow Technologies (acquired by ev3/Medtronic), entrepreneur-in-residence for Alta Partners, and in other senior management positions. Duke received an M.B.A. from Harvard Business School and a B.A. from Stanford University.

 

Aftab R. Kherani, MD

Dr. Kherani joined Aisling Capital in 2008 and currently serves as a Partner. Previously, Dr. Kherani was an Engagement Manager at McKinsey & Company, where he was a member of the Pharmaceutical, Medical Product and Private Equity practices for two years.  Prior to McKinsey, Dr. Kherani was a Chief Resident in General Surgery at Duke University Medical Center, and completed a two-year post-doctoral research fellowship at Columbia University, College of Physicians & Surgeons.  Dr. Kherani received his M.D., B.S. in Biology, and A.B. in Economics from Duke University.

 

Ron Kuppersmith, MD, FACS

Dr. Kuppersmith is an otolaryngologist-head and neck surgeon and a faculty member of the Texas A&M Health Science Center College of Medicine. He has served as the President of the American Academy of Otolaryngology-Head and Neck Surgery, as President of the Texas Association of Otolaryngology-Head and Neck Surgery, and on the Board of Trustees of the College Station Medical Center. Dr. Kuppersmith attended the University of Michigan in Ann Arbor for his undergraduate degree and for medical school, and completed his residency in Otolaryngology-Head and Neck Surgery at Baylor College of Medicine. He also received his M.B.A. from the University of Washington in Seattle.

 

Jim Momtazee

Jim Momtazee joined KKR in 1996 and is Head of the Health Care industry team and on the Investment Committee of KKR's Americas Private Equity business. He currently serves on the board of directors of Air Medical Group Holdings, Arbor Pharmaceuticals, BridgeBio, PRA Health Sciences and Signostics.  He was also involved in the investments in HCA and Jazz Pharmaceuticals. Prior to joining KKR, Mr. Momtazee was with Donaldson, Lufkin & Jenrette where he worked on a broad range of corporate finance, mergers and acquisitions, and merchant banking transactions. He holds an A.B. and M.B.A from Stanford University.

 

Tony Natale, MD

Dr. Natale is a General Partner at Aperture Venture Partners.  He has invested across a number of therapeutic areas, and also has been a founder and director of several venture-backed life sciences companies. Dr. Natale trained in General Surgery and Otolaryngology/Head and Neck Surgery at the University of Connecticut and Hartford Hospital, and holds a B.A., Phi Beta Kappa, from the University of Virginia, an M.D. from the University of Florida College of Medicine and an M.B.A. from Yale University’s School of Management.

 

Camille Samuels

Cami Samuels joined Venrock as a Partner in 2014 and focuses on healthcare with an emphasis on biotech and consumer health.  Prior to Venrock, Cami was a Managing Director at Versant Ventures for a decade, and served as a board observer for several companies.  Before Versant, she was responsible for business development at Tularik, worked in corporate development at Genzyme and Millennium Predictive Medicine, and was a management consultant to healthcare and biotech companies at LEK Consulting.  Cami earned her Bachelor’s degree in Biology from Duke University and an M.B.A. from Harvard Business School, where she graduated as a Baker Scholar.

 

Stacy Enxing Seng

Stacy Enxing Seng is a Member of the Board of Directors for Sonova Holding AG, Hill-Rom and Solace Therapeutics. Prior to the Medtronic acquisition of Covidien, Enxing Seng served as an Executive in Residence as well as the President, Vascular Therapies, for Covidien. Stacy joined Covidien in July 2010 through the $2.6B ev3 acquisition where she was a founding member and executive officer responsible for leading ev3's Peripheral Vascular Division from inception. She has also held various positions at Boston Scientific Corporation, SCIMED Life Systems Inc., Baxter Healthcare and American Hospital Supply. Stacy received a M.B.A. from Harvard University and has a B.A from Michigan State University.

 

Our Physician Advisors are leaders in otolaryngology, and play a key role in advancing our mission through active collaboration and regular strategic guidance.

Ron Kuppersmith, MD, MBA

Board of Directors

Texas A&M Health Science Center, College Station, TX

Past President, AAO-HNSF

Marvin Fried, MD

Scientific Advisor

Albert Einstein College of Medicine, New York, NY

Past President, ARS

Sam Most, MD

Scientific Advisor

Stanford University,

Stanford, CA

Board of Directors, AAFPRS

Iyad Saidi, MD, PhD

Co-Founder, Scientific Advisor

Metropolitan ENT and Facial Plastic Surgery, Alexandria, VA

 

Brent Senior, MD

Scientific Advisor

University of North Carolina,

Chapel Hill, NC

Past President, ARS

Abtin Tabaee, MD

Scientific Advisor

Weill Cornell Medical College,
New York, NY

Dean M Toriumi, MD

Scientific Advisor

University of Illinois at Chicago,
Chicago, IL

Past President, AAFPRS

 

Duke Rohlen

Chief Executive Officer

20+ years of experience as a medical device company executive

Founder/CEO, CV Ingenuity; CEO, Advanced Cardiac Therapeutics; President, FoxHollow; VP Business Development, Lumend Stanford BA, Harvard MBA

 

Neil Hattangadi, MD

President & Chief Operating Officer

15+ yrs. experience
Executive VP/GM, Volcano; Investor, SAC & Citadel; VP, FoxHollow/ev3; McKinsey Duke BSE, Oxford MSc, Harvard MD

Doug Koo

Chief Financial Officer

22+ yrs of CFO experience (CV Ingenuity, Advanced Cardiac Therapeutics, wine.com), Gemini Consulting

UC San Diego BA, Stanford MBA

 

Don Gonzales, MD

Co-Founder, Chief Medical Officer

Founder, Entrigue Surgical and Mimosa Medical
ENT Trained Surgeon (Cornell Medical School Tulane Residency)

 

 

What is Nasal Airway Obstruction?

Nasal breathing delivers 70% of airflow to the lungs.1 More than 20 million Americans suffer from nasal airway obstruction (NAO), which limits airflow through the nose with significant quality of life consequences.2

Symptoms may include:

 

  • Difficulty breathing at rest and/or while exercising
  • Reduced sleep time or quality
  • Reduced daytime productivity

Lateral wall collapse may equal or even exceed septal deviation as the prime cause of nasal airway obstruction.4,5,6

What causes Nasal Airway Obstruction?

Lateral (side) wall: The upper/lower cartilage in the side of your nose can flex or collapse inward when a person breathes.

Septum: The cartilage wall between the nostrils can bend and block the nasal passage.

Turbinates: Ridges of bone and tissue inside the nose can limit airflow when enlarged.

1

2

3

Even slight narrowing of the nasal valve can lead to significant reduction in airflow.3 Structural blockages in three areas are common:

Lateral (side) wall

COTTLE MANEUVER

Does your breathing improve when you pull on your cheek to hold your nostril to the side? If yes, talk to your doctor about options to support your lateral cartilage, which may include the LATERATM implant.

If we don’t look for nasal valve collapse in these patients, we’re not addressing the entire problem

A clinician can use a number of approaches to determine whether the lateral wall is contributing to a patient's nasal airway obstruction, including:

Diagnosis and Treatment Options

 

  • Symptom improvement from use of nasal strips
  • Breathing improvement during the Cottle Maneuver, a simple breathing test (see image on left)

If a patient has weak lateral cartilage, they may benefit from support for the lateral wall. The LATERATM implant is a minimally invasive option for supporting upper and lower lateral wall cartilage.

How does LATERA work?

The LATERA Absorbable Nasal Implant is used to support upper and lower lateral cartilage in the nose. The minimally invasive technology is intuitive to learn and use, and is delivered inside the nasal wall by ENTs or plastic surgeons. Supporting the cartilage in this manner may reduce nasal airway obstruction symptoms and help patients breathe better. The LATERA implant is made of a material that absorbs over a period of approximately 18 months, so can deliver support without limiting future treatment options.

LATERA Implant

Download LATERA Instructions for Use (IFU)

Implant is placed under the skin at the location shown

What have patients experienced with the LATERA implant?

LATERA showed significant quality of life improvement for nasal obstruction patients with lateral wall or nasal valve collapse. While individual results may vary, LATERA patients saw the following improvements in:7

Other risks related to the LATERA implant included: discomfort, infection, reaction to material, and device retrieval.

Patients experienced a reduction in nasal obstruction symptoms of 56% at 6 months, as measured by the NOSE survey.8,9 Patients got these results without negative cosmetic effects. Risks included temporary symptoms such as:

  • Reduced nasal congestion or stuffiness
  • Less trouble breathing through the nose

 

  • Improved ability to get enough air through the nose during exercise or exertion
  • Reduced nasal blockage or obstruction

 

  • Less trouble sleeping
  • Mild bruising and inflammation

 

  • Awareness of the implant

 

  • Mild pain or irritation

Downloadable PDFs for More Information

- Dean M Toriumi, MD

  University of Illinois at Chicago

  Past President, AAFPRS

Upper Lateral Cartilage

Lower Lateral Cartilage

Turbinate

Septum

 

References:

 

http://www.entnet.org/content/your-nose-guardian-your-lungs

http://www.entnet.org/content/stuffy-nose

http://care.american-rhinologic.org/snoring_nasal_congestion

 

  1. Crawford-Brown, Theoretical and Mathematical Foundations of Human Health Risk Analysis; 1997.
  2.  Stewart et al Intl J Gen Med 2010; Rhee et al JAMA Facial Plast Surg 2014. Nasal Obstruction Symptom Evaluation (NOSE) survey is a quality of life surveysupported by the AAO Consensus Statement. Otolaryngology–Head and Neck Surgery: 162 STEWART et al February 2004.
  3. Wever, The Nasal Airway: A Critical Review; Facial Plast Surg 2016;32:17–21. Camacho et al, The Effect of Nasal Surgery on Continuous Positive Airway Pressure Device Use and Therapeutic Treatment Pressures: A Systematic Review and Meta-Analysis; SLEEP, Vol. 38, No. 2, 2015. Lin, Meyers, et al, Nasal Aerodynamics.
  4. Constanstian MB, Clardy RB. The Relative Importance of Septal and Nasal Valvular Surgery in Correcting Airway Obstruction in Primary and Secondary Rhinoplasty. Plastic and Reconstructive Surgery. 1995 Jul; 98(1): 47
  5. John S. Rhee, MD, MPH, Jill M. Arganbright, MD, Brian T. McMullin, MD, and Maureen Hannley, PhD. Evidence supporting functional rhinoplasty or nasal valve repair: A 25-year systematic review. Otolaryngology-Head and Neck Surgery (2008) 139, 10-20.
  6. Eugenia Ricci, M.D. et al. Role of Nasal Valve in the Surgically Corrected Nasal Respiratory Obstruction: Evaluation Through Rhinomanometry. American Journal of Rhinology. September-October 2001, Vol. 15, Nov. 5.
  7. Data are individual results for a single site in the Spirox study, in 21 patients at 6 months.
  8. Data on file from a 30-patient Spirox clinical study conducted in Germany, in patients with confirmed nasal valve collapse as a primary factor for their nasal airway obstruction. Patients were 60% female, aged 24-77, 93% Caucasian. Study follow-up is ongoing. https://clinicaltrials.gov/ct2/show/NCT02188589?term=spirox
  9. Nasal Obstruction Symptom Evaluation (NOSE) survey is a quality of life survey supported by the AAO Consensus Statement. Otolaryngology–Head and Neck Surgery: 162 STEWART et al February 2004.

Patents: The following U.S. patents apply to Spirox™ products, including but not limited to the Latera™ System: US 2014-0243975; US 2015-0012090; and US 2016-0058556. Other patents pending and issued, including US 7,780,730; US 8,133,276; and US 8,784,488. This page is intended to serve as notice under 35 U.S.C. § 287(a).

 

©2016 Spirox, Inc. All rights reserved. MKT00480 Rev. D

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