MENLO PARK, Calif., April 25, 2017 /PRNewswire/ -- Spirox, Inc., a company committed to improving the quality of life for patients suffering from nasal obstruction, announced the publication of positive results from the first in human study of the LATERA™ absorbable nasal implant. LATERA is designed to support lateral nasal cartilage to address nasal valve collapse (NVC), a major contributor to nasal obstruction. The data show that patients who received LATERA had a significant and sustained reduction in nasal obstruction symptoms through 12 months with no adverse change in appearance. The results were published in the April issue of Facial Plastic Surgery – "Absorbable Implant to Treat Nasal Valve Collapse."
NVC occurs as a result of weak nasal cartilage collapsing inward when a person inhales. NVC is one of the most frequent causes of nasal obstruction, a condition that affects more than 20 million individuals in the United Statesi alone and can reduce the quality of a patient's everyday life.ii
"These results are very promising, as they demonstrate the safety and efficacy of the LATERA implant and provide an optimal approach for correcting a common cause of nasal obstruction," said Dr. Marion San Nicoló, MD, University Clinic of Munich, LMU and Principal Investigator in the study. "I believe that the LATERA implant is an important advance that has the potential to transform the treatment of NVC."
The study was conducted at three sites in Germany and included 30 adult patients with NVC. Patients had severe or extreme symptoms as established by the validated Nasal Obstruction Symptom Evaluation (NOSE) instrument. A total of 56 LATERA implants were placed in these 30 subjects, 26 of whom received implants on both sides of the nose. Patients were assessed at 1 week and 1, 3, 6 and 12 months post-procedure.
Key findings of the study include:iii
About Nasal Obstruction and Nasal Valve CollapseNasal obstruction limits airflow and makes breathing through the nose more difficult. This condition affects more than 20 million Americans,i and is characterized by difficulty breathing at rest and/or while exercising, and reduced sleep time or sleep quality.iv Nasal valve collapse (NVC) is one of the most common causes of nasal obstruction, and occurs as a result of weak nasal cartilage collapsing inward when a person inhales. NVC is as prevalent as septal deviation among nasal and sinus patients.v,vi
About LATERALATERATM is an absorbable nasal implant, designed by ENT physicians. LATERA supports the nasal cartilage to address nasal valve collapse (NVC), which reduces nasal obstruction symptoms and help patients breathe better.
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 undertreated, causes of nasal obstruction today, nasal valve collapse (NVC). For more information, please visit www.spiroxmed.com. LATERA is available in the U.S. only. Spirox and LATERA and its logos are trademarks of Spirox, Inc.
For more information about LATERA including the indications for use, contraindications and warnings, please see the LATERA IFU.
i Value calculated based on 2014 US population estimate from US Census and World Bank data in conjunction with incidence numbers cited in Stewart et al. Epidemiology and burden of nasal congestion. Intl J Gen Med 2010; 2010:3 37-45.ii Rhee et al. Nasal Valve Surgery Improves Disease-Specific Quality of Life. Laryngoscope 115: March 2005.iii Marion San Nicoló, MD et al. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plastic Surgery 2017;32:233-240.iv Stewart M G. et al.Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130 (2) 157- 163.v Constantian 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. 1996 Jul; 98(1): 47.vi Ricci, 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.
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NVC occurs as a result of weak nasal cartilage collapsing inward when a person inhales. NVC is one of the most frequent causes of nasal obstruction, a condition that affects more than 20 million individuals in the United Statesi alone and can reduce the quality of a patient's everyday life.ii
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"These results are very promising, as they demonstrate the safety and efficacy of the LATERA implant and provide an optimal approach for correcting a common cause of nasal obstruction," said Dr. Marion San Nicoló, MD, University Clinic of Munich, LMU and Principal Investigator in the study. "I believe that the LATERA implant is an important advance that has the potential to transform the treatment of NVC."
The study was conducted at three sites in Germany and included 30 adult patients with NVC. Patients had severe or extreme symptoms as established by the validated Nasal Obstruction Symptom Evaluation (NOSE) instrument. A total of 56 LATERA implants were placed in these 30 subjects, 26 of whom received implants on both sides of the nose. Patients were assessed at 1 week and 1, 3, 6 and 12 months post-procedure.
Key findings of the study include:iii
- Average NOSE score reduction of 48.4, 43.3 and 40.9 at 3, 6 and 12 months, respectively.
- Statistically significant average NOSE score reduction at 3, 6 and 12 months (p < 0.001).
- No adverse change in cosmetic appearance at 12 months post procedure.
About Nasal Obstruction and Nasal Valve CollapseNasal obstruction limits airflow and makes breathing through the nose more difficult. This condition affects more than 20 million Americans,i and is characterized by difficulty breathing at rest and/or while exercising, and reduced sleep time or sleep quality.iv Nasal valve collapse (NVC) is one of the most common causes of nasal obstruction, and occurs as a result of weak nasal cartilage collapsing inward when a person inhales. NVC is as prevalent as septal deviation among nasal and sinus patients.v,vi
About LATERALATERATM is an absorbable nasal implant, designed by ENT physicians. LATERA supports the nasal cartilage to address nasal valve collapse (NVC), which reduces nasal obstruction symptoms and help patients breathe better.
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 undertreated, causes of nasal obstruction today, nasal valve collapse (NVC). For more information, please visit www.spiroxmed.com. LATERA is available in the U.S. only. Spirox and LATERA and its logos are trademarks of Spirox, Inc.
For more information about LATERA including the indications for use, contraindications and warnings, please see the LATERA IFU.
i Value calculated based on 2014 US population estimate from US Census and World Bank data in conjunction with incidence numbers cited in Stewart et al. Epidemiology and burden of nasal congestion. Intl J Gen Med 2010; 2010:3 37-45.ii Rhee et al. Nasal Valve Surgery Improves Disease-Specific Quality of Life. Laryngoscope 115: March 2005.iii Marion San Nicoló, MD et al. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plastic Surgery 2017;32:233-240.iv Stewart M G. et al.Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130 (2) 157- 163.v Constantian 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. 1996 Jul; 98(1): 47.vi Ricci, 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.
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SOURCE Spirox, Inc.
