Intersect ENT (NSDQ:XENT) yesterday named Hologic (NSDQ:HOLX) executive Tom West to be its new president & CEO effective July 22. West, who has been president of Hologic’s diagnostics solutions division since October 2014, is a Johnson & Johnson (NYSE:JNJ) veteran, Menlo Park, Calif.-based Intersect ENT said. The company in May tapped lead director Kieran Gallahue to […]
Apollo Endosurgery updates labeling on intragastric balloon
Apollo Endosurgery (NSDQ:APEN) said today that the FDA has approved its proposed labeling updates for the Orbera intragastric liquid-filled balloon system, which is used to treat obesity. The goal of the labeling updates is to improve patient safety and they will take effect immediately, according to the Austin, Texas-based company. The Orbera system and Reshape […]
Apollo Endosurgery touts results of stomach-stapling study
Apollo Endosurgery (NSDQ:APEN) has reported key data from 1,000 patients who underwent endoscopic gastroplasty using the company’s OverStitch device. Published in the journal Gastrointestinal Endoscopy, the data include a mean total weight loss of 14.8%±8.5% at 18 months. Three months following surgery, the impact on obesity-related comorbidities included the complete remission of: 13 of 17 cases […]
Analyst downgrades pressure medtech stocks
Several medical device companies took hits yesterday after analysts on Wall Street downgraded their stocks, on a day when the major market indices each closed up a hair, and even medtech firms that enjoyed upgrades came under pressure. Globus Medical (NYSE:GMED) suffered the most after Morgan Stanley analyst David Lewis cut his rating on the stock from […]
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 […]
Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system
Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes. The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce […]
Apollo Endosurgery closes $24m round
Apollo Endosurgery said today it closed a $23.7 million round of financing. In the offering, the Austin, Texas-based company offered approximately 4.3 million shares of common stock at $5.50 per share, including 562,055 shares sold under an underwriter’s option to purchase additional shares. All shares offered in the round were sold by Apollo, the company said, […]
Apollo Endosurgery prices $21m offering
Apollo Endosurgery today priced a stock offering worth nearly $21 million for its line of bariatric and gastrointestinal devices. Austin, Texas-based Apollo said it plans to float roughly 3.75 million shares at $5.50 apiece, for gross proceeds of $20.6 million. The offering also includes a 45-day option for underwriter Craig-Hallum Capital of another 562,055 shares, […]
FDA warns of 5 new deaths from liquid-filled intragastric balloons
Updated to include response from Apollo Endosurgery The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS). The additional deaths bring the total number of deaths worldwide from the Orbera intragastric balloon and ReShape integrated […]
7 medtech stories we missed this week: April 27, 2018
From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed […]
FDA clears shutdown of Lap-Band study for Apollo Endosurgery
Apollo Endosurgery (NSDQ:APEN) said late yesterday that the FDA approved the company’s move to terminate the Lap-Band lower body mass index post-approval study based on availability of long-term safety and effectiveness data on the device. The trial was part of a bid for expanded indications, through which the FDA required the Austin, Texas-based company to conduct a […]
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