GI Dynamics (ASX:GID) said yesterday it won Institutional Review Board approval to launch a pivotal trial of its EndoBarrier device exploring its ability to treat diabetes and obesity. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat type […]
Obalon plunges on trimmed 2018 sales guidance
Obalon Therapeutics (NSDQ:OBLN) shares took a big hit yesterday and continued their slide today after the weight loss balloon maker said it expected to hit the low end of its 2018 sales guidance. Carlsbad, Calif.-based Obalon said last year’s revenues are headed toward the low end of its prior outlook for $9.0 million to $9.9 […]
Obalon lands $30m in capital from new deals
Obalon Therapeutics (NSDQ:OBLN) said this week that it inked two financing deals that could provide the company with up to $30 million in capital. The San Diego, Calif.-based company sells the only FDA-approved, swallowable intragastric balloon system for the treatment of obesity. In one deal, Obalon entered a common stock purchase agreement with Chicago-based institutional investor […]
Obalon wins FDA nod for Obalon Nav system
Obalon Therapeutics (NSDQ:OBLN) said today that it won FDA clearance for its Obalon Navigation system intended for use in placing the company’s Obalon Balloon system. The newly cleared Obalon Navigation system uses magnetic resonance imaging during placement and displays a real-time image of the balloon, the San Diego-based company said. The system is intended for use […]
Apollo Endosurgery deals Lap-Band to ReShape Lifesciences for up to $17m
Apollo Endosurgery (NSDQ:APEN) said today that it dealt its Lap-Band gastric banding device to ReShape Lifesciences (NSDQ:RSLS) in return for up to $17 million and ReShape’s intra-gastric balloon, which Apollo plans to eventually discontinue. Austin, Texas-based Apollo said the exchange closed yesterday with $10 million in cash and the balloon from ReShape. Further payments of $2 […]
GI Dynamics inks deal to launch Indian EndoBarrier trial
GI Dynamics (ASX:GID) said today it inked a deal with Apollo Sugar, a collaboration between Apollo Health & Lifestyle Limited and Sanofi, to jointly launch a safety and efficacy study of the EndoBarrier system in India. Through the deal, the groups will launch a clinical trial that aims to collect data from 100 randomized patients, with […]
BaroNova touts TransPyloric Shuttle pivotal study data
BaroNova late last week released the primary results from the pivotal ENDObesityII study of its TransPyloric Shuttle device intended to treat obesity. Results from the trial were presented at the Obesity Week 2018 conference’s scientific sessions, the San Carlos, Calif.-based company said. “Obesity is a worldwide epidemic with up to 40% of adult Americans suffering from […]
Dexcom wins CMS nod for latest glucose monitor
Dexcom (NSDQ:DXCM) said today that its G6 continuous glucose monitoring system will be covered for Medicare beneficiaries. The company’s product won coverage as a therapeutic CGM system, making it available to beneficiaries who closely manage their insulin dosing. Get the full story at our sister site, Drug Delivery Business News.
GI Dynamics eyes 2019 EU market return for EndoBarrier
GI Dynamics (ASX:GID) said yesterday that it tapped a new notified body in Europe, nearly a year after losing CE Mark approval there, as it eyes a market return for its EndoBarrier device by the end of next year. In the European Union, notified bodies are used as part of the regulatory system to assess product […]
Obalon Therapeutics wins FDA nod for Obalon Touch inflation system
Obalon Therapeutics (NSDQ:OBLN) said this week it won approval from the FDA for a premarket approval supplement application for its Obalon Touch inflation system. The newly cleared Obalon Touch is an automated system designed to inflate the Obalon balloon, a gas-filled balloon intended to promote weight loss in obese patients, the San Diego-based company said. “We […]
GI Dynamics raises $5 million for diabetes/obesity device
Investors have agreed to buy $5 million worth of GI Dynamics’ (ASX:GID) common stock, representing 6.9 million shares. The Lexington, Mass.-based company said it will use the money to fund the continued development of its EndoBarrier device and for general working capital. EndoBarrier is a plastic gut sleeve designed to treat type 2 diabetes and obesity […]
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