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Implants

PAVmed completes first-in-human implantations of its intraosseous infusion system

March 17, 2022 By Sean Whooley

PAVmed PortIO

PAVmed (Nasdaq:PAVM) has successfully completed the first human implants of its PortIO intraosseous infusion system, the company said today. New York-based PAVmed designed its PortIO system with an implantable intraosseous vascular access device and insertion kit. Instead of a catheter located in a vein, the system has a short extension from the device inserted by […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Vascular Tagged With: PAVmed

Second Sight Medical, Nano Precision Medical merging to create therapeutic implant company

February 8, 2022 By Sean Whooley

Second Sight Medical Nano Precision Medical

Second Sight Medical Products (NSDQ:EYES) and Nano Precision Medical agreed to a merger deal that will focus on drug-device medical implants. The two companies entered into a definitive agreement under which privately held Nano Precision Medical (NPM) will merge with a wholly-owned subsidiary of Second Sight in an all-stock transaction, with NPM the surviving company […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Implants, Mergers & Acquisitions, Optical/Ophthalmic, Pharmaceuticals Tagged With: Nano Precision Medical, Second Sight

Lyra Therapuetics initiates Phase 3 trial for chronic rhinosinusitis treatment

January 24, 2022 By Sean Whooley

Lyra Therapeutics LYR-210

Lyra Therapeutics (NSDQ:LYRA) announced today that it initiated the Phase 3 Enlighten I trial for its LYR-210 treatment. Watertown, Massachusetts-based Lyra’s Phase 3 Enlighten I clinical trial will evaluate LYR-210, delivered through Lyra’s proprietary XTreo drug-eluting implant, in adult, surgically naïve chronic rhinosinusitis (CRS) patients. The company designed LYR-210 for delivery in a brief, non-invasive, […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Otolaryngology Ear, Nose & Throat, Pharmaceuticals Tagged With: Lyra Therapeutics

Ocular Therapeutix touts positive trial results of ophthalmic insert for dry eye disease

December 6, 2021 By Sean Whooley

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) announced today that it reported positive results from a Phase 2 trial of its dry eye disease treatment. Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based Phase 2 clinical trial evaluated OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease. The randomized, double-masked, vehicle-controlled, multi-center trial evaluated two different formulations of […]

Filed Under: Auto-injectors, Clinical Trials, Drug-Device Combinations, Featured, Implants, Optical/Ophthalmic Tagged With: Ocular Therapeutix

Ocular Therapeutix claims win as court invalidates drug delivery patent from Mati

November 9, 2021 By Sean Whooley

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) announced today that an appeals court invalidated a drug delivery system patent held by Mati Therapeutics. The U.S. Court of Appeals for the Federal Circuit in Washington, D.C., invalidated the patent related to a drug delivery system containing dexamethasone, affirming the judgment made in June 2020 by the Patent Trial and Appeal […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Implants, Legal News, Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance Tagged With: Ocular Therapeutix

FDA approves Genentech’s Susvimo drug-eluting eye implant

October 22, 2021 By Sean Whooley

Genentech Susvimo Implant Image 1 For Media

Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD). South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Optical/Ophthalmic, Regulatory/Compliance Tagged With: FDA, Genentech, Roche

Ivantis to pay $60M in patent litigation settlement with Glaukos

September 15, 2021 By Sean Whooley

Glaukos logo

Glaukos (NYSE:GKOS) announced today that it entered into a settlement with Ivantis to terminate a three-year-old patent infringement lawsuit. San Clemente, California-based Glaukos’ patent infringement lawsuit, initiated on April 14, 2018, in the U.S. District Court for the Central District of California, Southern Division, concerned Ivantis’ Hydrus Microstent for reducing eye pressure in glaucoma patients. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Food & Drug Administration (FDA), Implants, Legal News, Optical/Ophthalmic, Stents Tagged With: Glaukos, Ivantis

Lyra Therapeutics appoints new CFO

September 13, 2021 By Sean Whooley

Lyra Therapeutics LYR-210

Lyra Therapeutics (NSDQ:LYRA) announced today that it appointed Jason Cavalier as its new chief financial officer, effective today. Cavalier succeeds the company’s current CFO, Don Elsey, who is retiring while he remains expected to serve in an advisory role to assist with the transition. Watertown, Massachusetts-based Lyra — which develops the XTreo platform designed to […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Implants, Otolaryngology Ear, Nose & Throat Tagged With: Lyra Therapeutics, Personnel, Personnel Moves

Lyra touts non-human trial of XTreo drug-eluting implant

September 10, 2021 By Sean Whooley

Lyra Therapeutics LYR-210

Lyra Therapeutics (NSDQ:LYRA) is touting preclinical data for its XTreo drug-eluting implant for dosing in local sinus tissues. Watertown, Massachusetts-based Lyra’s preclinical results were published — “Drug Release and Pharmacokinetic Evaluation of Novel Implantable Mometasone Furoate Matrices in Rabbit Maxillary Sinuses” — were published online in the peer-review journal, American Journal of Rhinology & Allergy. The […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Otolaryngology Ear, Nose & Throat Tagged With: Lyra Therapeutics

Glaukos submits supplemental PMA application for iStent Infinite

September 3, 2021 By Sean Whooley

Glaukos logo

Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system. San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy. […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Optical/Ophthalmic, Regulatory/Compliance, Stents Tagged With: FDA, Glaukos

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