More Related Content
Similar to Spirox Announces First US Cases with Minimally Invasive Device for Nasal Valve Collapse
Similar to Spirox Announces First US Cases with Minimally Invasive Device for Nasal Valve Collapse (20)
Spirox Announces First US Cases with Minimally Invasive Device for Nasal Valve Collapse
- 1. FOR IMMEDIATE RELEASE
Spirox Announces First US Cases with Minimally Invasive Device for Lateral Cartilage Support
in Patients with Nasal Valve Collapse, a Major Cause of Nasal Obstruction
MENLO PARK, Calif. – July 14, 2016 – Spirox™, Inc., a company committed to transforming
treatment of nasal obstruction, today announced the first US cases with the LATERA™
Absorbable Nasal Implant following its FDA clearance. LATERA provides ENTs and facial plastic
surgeons with a new minimally invasive option to support the upper and lower lateral nasal
cartilages. Weak lateral cartilage can result in nasal valve collapse, an important, but often
undiagnosed, issue affecting the majority of patients1
undergoing nasal obstruction procedures
today.
“Nasal obstruction takes a significant toll on patient quality of life, but is often undertreated
and underdiagnosed. If we don’t look for nasal valve collapse in these patients, we’re not
addressing the entire problem. By providing an intuitive and effective way to support nasal
lateral cartilage, LATERA has the potential to improve breathing for our patients,” said Dean
Toriumi, MD, professor of Otolaryngology-Head and Neck Surgery at the University of Illinois at
Chicago, and past president of the American Academy of Facial Plastic and Reconstructive
Surgeons (AAFPRS).
Pablo Stolovitzky, MD, clinical assistant professor at Emory University and past chairman of the
Board of Governors of the American Academy of Otolaryngology-Head & Neck Surgery (AAO-
HNS), was among the first physicians to perform a LATERA case in the US. He noted, “LATERA is
an important development for nasal obstruction patients when a standard procedure treating
the septum and turbinates is often not enough. LATERA provides us with a minimally-invasive
solution to support nasal lateral cartilage. I was able to place the implant on my first attempt,
and I expect that the physician learning curve will be short.”
Prior to these US cases, a multi-center clinical study conducted in Germany showed that
patients that received a LATERA implant alone experienced a reduction in nasal obstruction
symptoms at one year, with results in the range of more invasive techniques and without a
cosmetic downside.
“We have worked with physician leaders to find a solution to a major clinical need. The
research and development behind the innovation is complex, but the technique is elegant and
intuitive,” said Duke Rohlen, Spirox chief executive officer. “LATERA gives physicians a new
option to support lateral cartilage, enabling a more complete means for addressing their
patients’ nasal obstruction symptoms.”
- 2. About Nasal Airway Obstruction
Nasal airway obstruction can be caused by several factors, including septal deviation, enlarged
turbinates, and weakened upper and/or lower lateral nasal wall cartilage leading to nasal valve
collapse. The nasal valve contributes as much as 80 percent of total nasal airway resistance,2
and even minor constriction of this area results in a clinically significant impairment of nasal
breathing for the patient.3
Nasal valvular incompetence may equal or even exceed septal
deviation as the prime cause of nasal airway obstruction.4
About Latera
LATERA is an absorbable polymer implant indicated for supporting the upper and lower lateral
nasal cartilage. The minimally invasive technology is intuitive and can be delivered by ENTs or
facial plastic surgeons. For a complete list of safety and effectiveness considerations reference
the LATERA IFU at www.spiroxmed.com.
ABOUT SPIROX, INC.
Spirox is committed to improving the quality of life for patients suffering from nasal
obstruction. The Menlo Park-based company’s first product – the LATERA Absorbable Nasal
Implant – is designed to address one of the most common, yet underdiagnosed, causes of nasal
obstruction today, nasal valve collapse caused by weakened lateral wall cartilage. For more
information, please visit www.spiroxmed.com.
LATERA is available in the US only. Spirox and LATERA and its logos are trademarks of Spirox,
Inc.
1. Bonaparte JP, Cheung L. Does the Cottle Maneuver predict outcomes after septal surgery?
American Academy of Otolaryngology-Head and Neck Surgery Annual Meeting (AAO-HNSF).
2015
2. Elwany S, Thabet H. Obstruction of the nasal valve. J Laryngol Otol. 1996 Mar; 110(3):221-4
3. Bloching MB. Disorders of the nasal valve area. GMS Curr Top Otorhinolaryngol Head Neck
Surg. 2007; 6:Doc07. Published online 2008 Mar 14
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
###
MEDIA CONTACT:
Matt Brokaw
mbrokaw@spiroxmed.com
(650) 281-1279