The US Food and Drug Administration has approved a first-of-its-kind nasal implant that aims to dramatically reduce the number of operations for millions who suffer from chronic sinusitis, or inflamed sinuses, the Israeli startup that has developed the device said.
STS Medical Ltd. (S.T.Stent), an Israeli portfolio company of the Trendlines Group Ltd., has developed a self-expanding tube that can be inserted into the nasal passage to prevent common post-surgical complications such as inflammation and scarring.
“This is a significant milestone which will allow us to market our product in the US,” said Joseph Flomenblit, CEO of S.T.Stent, in a phone interview. “Our company was new to the FDA approval process. But once the FDA was able to see how well it worked, we got approval without any hesitation.” The company announced the approval on Monday.
Millions of people worldwide suffer from chronic sinusitis, an inflammation of the sinuses that is caused by infection or allergy, which results in nasal congestion, face pain and headaches. When drug treatments don’t work, functional endoscopic sinus surgery is often performed to increase the flow of air to the nose and sinuses, to improve drainage and remove any diseased tissue. But, because of scarring and returning inflammation, some 30 percent of these operations fail.
The tube developed by S.T. Stent is made of nitinol, a nickel and titanium metal alloy that is well-suited for sinus tissues because of its unusual elasticity and its shape memory, a characteristic that allows the implant to be delivered into the body in a compact shape and then activated into its functional form.
The tube works by keeping the nasal passage open, allowing the tissue to heal correctly without any blockage. Once the tissue has healed, the stent can easily be removed by a physician in minutes, using a minimally invasive procedure.
The company predicts that the stent will improve patient outcomes and reduce the probability of additional surgical procedures by 50%, even though the initial clinical trial of 30 patients demonstrated 100% success with zero secondary surgeries, said Flomenblit.
In the future, the device can be used to treat ailments such as chronic hay fever, help in the healing of nose jobs and provide an alternative to sinuplasty, a balloon-like procedure used to drain mucus blockages in the nose, the company said.
If things go as planned with partners, the implant is expected to be available for use in Israel within six months and in the US by the end of the year, Flomenblit said.
“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,” said Steve Rhodes Chairman and CEO of Trendlines Group, in the company’s statement.
US-based medical technology firm Entellus Medical Inc., which focuses on the development and commercialization of products for minimally invasive treatment of chronic and recurrent sinusitis, is one of the companies that has expressed interest, said Flomenblit.
The company has two other patents pending with the FDA and several partners and distributors have expressed interest, said Zeev Brookfield, chairman of S.T.Stent, in the press release.
Flomenblit confirmed that several other products are awaiting FDA approval, but did not revealed specific details.