STS Medical receives FDA regulatory clearance

9th January 2018

S.T. STENT

Enaie Azambuja

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STS Medical Ltd. has announced that it received regulatory clearance from the FDA for its composite sinus stent. Millions of people worldwide suffer from chronic sinusitis, an inflammation of the sinuses caused by infection or allergy and characterised 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. S.T.Stent took on the challenge of developing a solution to dramatically reduce the number of revision surgeries performed.

S.T.Stent, founded in 2013, developed a removable stent to be placed after the FESS surgery - that keeps the sinus cavity open for up to 28 days, long enough for the sinus tissue to heal. Stent removal is a minimally invasive procedure performed in the doctor's office, without the need for anesthesia.

The stent improves patient outcomes and reduces the probability of revision surgeries. In addition to chronic sinusitis, the stent can be used for nose job failures, chronic allergic rhinitis, and as a direct stenting as an alternative to sinuplasty.

"Following excellent results in our clinical trials performed on 30 patients earlier in 2017, we are extremely pleased to have received regulatory clearance from the FDA. This is a significant milestone for S.T.Stent which will allow us to market our product in the U.S.," remarked Joseph Flomenbilt, Ph.D., CEO of S.T.Stent.

Chairman and CEO of The Trendlines Group, Steve Rhodes adds: "We are very proud of the progress that the S.T.Stent team has made towards bringing their truly innovative sinus stent to market. We look forward to following their progress in improving patient outcomes and reducing surgeries in a market seeking a solution to this common problem."

S.T.Stent Chairman, Zeev Bronfeld commented, "With one patent issued and two pending, followed by FDA clearance, the Company is well-positioned for commercialisation. A number of potential partners and distributors have already expressed interest in cooperation with the company."