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 […]
Obalon slips on Q4, 2017 misses; shareholders sue
Obalon Therapeutics (NSDQ:OBLN) shares are under pressure today as the market reacts to fourth-quarter and full-year results that failed to meet both its own expectations and the consensus forecast on Wall Street. Separately, Obalon revealed in a regulatory filing that shareholders are pursing class action lawsuits alleging that the Carlsbad, Calif.-based company and its management […]
South Korea approves Apollo Endosurgery’s Orbera weight loss balloon
Apollo Endosurgery (NSDQ:APEN) has won approval in South Korea for its Orbera intragastric weight-loss balloon system. The Orbera system includes a silicone balloon that is placed into a patient’s stomach endoscopically and filled with saline. The balloon is designed to lessen the patient’s stomach capacity and thereby reduce the amount of food that the patient […]
Obalon: Whistleblower’s allegations ‘without merit’
Obalon Therapeutics (NSDQ:OBLN) said today that a probe by its audit committee found that the whistleblower allegations that last month sundered a $35 million offering are “without merit.” In January the San Diego-based company terminated the offering after the whistleblower told its independent auditors, KPMG, of the allegations of improper revenue recognition during the fourth quarter. […]
Obalon Therapeutics prices $35m offering
Obalon Therapeutics (NSDQ:OBLN) today priced an upcoming $35 million offering, looking to float 5.5 million shares at $5.50 per share. The San Diego-based medical device company won pre-market approval from the FDA for its ingestible, gas-filled balloon designed for weight loss in September 2016. The Obalon device is indicated for weight loss in adults 30 to 100 pounds overweight, with a […]
Obalon preps $35m offering
Obalon Therapeutics (NSDQ:OBLN) said this week that it’s planning a share flotation worth $35 million that could swell by another $5 million if an over-allotment option is fulfilled. The San Diego-based medical device company won pre-market approval from the FDA for its ingestible, gas-filled weight-loss balloon in September 2016. The Obalon device is indicated for weight loss in adults 30 to […]
GI Dynamics loses CE Mark certificate for EndoBarrier
GI Dynamics (ASX:GID) said yesterday that its notified body in Europe withdrew its certification for CE Mark approval for its EndoBarrier device, meaning the company can no longer sell the obesity and diabetes treatment in the European Union. CEO Scott Schorer told MassDevice.com today during a telephone interview that Boston-based GID passed an intensive, week-long inspection of […]
ReShape touts efficacy, safety of weight loss products in multi-study presentations
ReShape Lifesciences (NSDQ:RSLS), formerly known as EnteroMedics, this week presented data from three of its technologies designed to treat obesity and metabolic diseases, touting the safety and efficacy of its products. Data on the San Clemente, Calif.-based company’s three technologies was presented at the ObesityWeek 2017 conference in Washington D.C. this week. “Obesity has become […]
EnteroMedics rebrands as ReShape Lifesciences
EnteroMedics (NSDQ:ETRM) said today it is rebranding under the moniker ReShape Lifesciences, shifting its NASDAQ ticker to “RSLS”. The move comes after the St. Paul, Minn.-based company acquired ReShape Medical earlier this month for $38 million, along with its ReShape integrated dual balloon system designed to facilitate weight loss in obese adult patients. The new name […]
EnteroMedics acquires ReShape Medical in $38m cash-and-stock deal
EnteroMedics (NSDQ:ETRM) said today that it acquired ReShape Medical in a cash-and-stock deal worth about $38 million. The deal called for St. Paul, Minn.-based EnteroMedics to pay $5 million in cash, plus 2.4 million shares of stock and nearly 188,000 series C convertible shares. At yesterday’s closing price of $1.79 per ETRM share, the stock shares […]
Gelesis touts study of hydrogel obesity drug
PureTech subsidiary Gelesis today touted results from a pivotal weight-loss study of its obesity drug, Gelesis100. The study met one of its two primary endpoints, with 58% of adults in the treatment arm experiencing clinically-meaningful weight loss of 5% or more. Get the full story at our sister site, Drug Delivery Business News.
- 1
- 2
- 3
- …
- 16
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
Google+