Sinopsys Announces Issuance of European Patent Covering its Novel Stent for the Delivery of Dexamethasone and other Therapeutics to Key Sinus Anatomy

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Sinopsys is in discussions with healthcare providers and pharmaceutical companies regarding the licensing of its stent for use in clinical trials that study the potential efficacy of direct delivery to the ethmoid sinus of saline and/or the steroid, Dexamethasone, for the contol of inflammation and the potential reduction of the viral load in COVID-19 patients.

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The issuance of this patent recognizes the novelty of the underlying technology and complements the first-generation patent filings for Sinopsys, making it a key component of our intellectual property portfolio

Sinopsys Surgical, Inc. (Sinopsys), a medical technology company focused on treatment of sinusitis and related conditions announced that the European Patent Office has granted EP Patent No. 2624876 covering Sinopsys’ implantable stent for the delivery of therapeutic agents including pharmaceuticals and saline. Previously-issued members of this patent family include US patents 9,022,967 and 9,308,358.

The Company previously received 510K clearance by the Food & Drug Administration (FDA) for use of the stent in the treatment of Epiphora (blocked tear ducts) and an Investigational Device Exemption (IDE) for the delivery of saline to the ethmoid sinuses via the stent in treatment of Chronic Sinusitis (CRS). With the stent now CE marked for the short or long-term treatment of CRS with saline, Sinopsys is planning its European product launch in H1 2021.

Sinopsys has a global patent estate covering its stent design, the implant procedure, and the use as a delivery device to the ethmoid sinus which studies have shown is a common source of infection for patients suffering from CRS.

“The issuance of this patent recognizes the novelty of the underlying technology and complements the first-generation patent filings for Sinopsys, making it a key component of our intellectual property portfolio” said Richard Babb, CEO of Sinopsys. “Our approach overcomes the challenges of accessing the ethmoid sinus through a ‘bottom up’ approach which often requires invasive, irreversible sinus surgery that, in some patients, is ineffective.”

Mr. Babb continued: “Sinopsys’ stent can be used for short or long-term treatment and easily removed by a medical professional when treatment is completed. Through clinical studies, our goal is to further expand the use of this innovative platform for other indications that may benefit from targeted saline and therapeutic delivery to the sinus anatomy.”

About Sinopsys Surgical, Inc.
Sinopsys’ stent is a sterile, single-use, long-term, surgically placed medical device composed of medical grade polydimethylsiloxane (PDMS), commonly known as silicone. The reversible, implant procedure takes under one hour without general anesthesia. The stent is designed to access the ethmoid sinus for the delivery of saline, for which it is currently approved in Europe, and for delivery of pharmaceutical therapeutics, for which additional clinical studies must be conducted. Additional information about the company can be found at http://www.sinopsyssurgical.com.

Forward-Looking Statements
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA (or other regulatory body) approvals, acceptance and demand for new products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, and other risks the Company may identify in the future.

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Richard Babb, CEO
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