STS Medical Ltd revealed on Monday the receipt of regulatory clearance from the US Food and Drug Administration (FDA) for its composite sinus stent for the treatment of chronic sinusitis following Functional Endoscopic Sinus Surgery (FESS).
Chronic sinusitis is an inflammation of the sinuses caused by infection or allergy and characterized by facial pain and pressure, nasal congestion and headaches.
When drug treatments are ineffective, Functional Endoscopic Sinus Surgery (FESS) is often performed to increase airflow within the nose and sinuses, improve drainage, and remove diseased tissue. However, up to 30% of these surgeries are unsuccessful due to scarring and recurrent inflammation that closes the nasal openings and requires revision surgery. The company took on the challenge of developing a solution to dramatically reduce the number of revision surgeries performed.
A removable stent is placed after the FESS surgery that keeps the sinus cavity open for up to 28 days for the sinus tissue to heal. Stent removal is a minimally invasive procedure performed in the doctor's office without anesthesia. The company's stent improves patient outcomes and reduces the probability of revision surgeries.
In addition, the stent can be used for nose job failures, chronic allergic rhinitis and as a direct stenting as an alternative to sinuplasty, added the company.
STS Medical Ltd is a portfolio company of The Trendlines Group Ltd (SGX:42T) (OTCQX:TRNLY).
BenevolentAI reports positive Phase Ia safety and pharmacokinetic data for BEN-8744
Thermo Fisher Scientific unveils CorEvitas registry for generalized pustular psoriasis
Nektar Therapeutics commences Phase 2b rezpegaldesleukin clinical trial for alopecia areata
Innovent Biologics doses first participant in first-in-human phase one clinical trial of IBI3002
Ananda Developments secures CBD Drug Supply Agreement for endometriosis clinical trial
Trellus Health secures agreement with major US health plan for IBD management
Chemomab secures new patents for CM-101 monoclonal antibody
argenx receives FDA priority review for VYVGART Hytrulo in CIDP