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
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 […]
Apollo Endosurgery shares dip on Q4, FY2017 EPS miss
Shares in Apollo Endosurgery (NSDQ:APEN) fell today after the medical device maker missed earnings per share expectations on Wall Street with its fourth quarter and full fiscal year 2017 earnings report. The Austin, Texas-based company posted losses of $7.3 million, or 42¢ per share, on sales of $16.1 million for the 3 months ended December 31, […]
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 […]
Apollo Endosurgery touts 20-year Lap-Band data
Apollo Endosurgery today released 20-year outcomes data from its Lap-Band system, touting it as a safe and effective procedure which results in sustained, medically relevant weight loss. Outcomes data was presented at the 22nd World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders in London. Data came from follow-ups with 8,263 […]
Apollo Endosurgery wins CE Mark for 12-month Orbera weight loss balloon
Apollo Endosurgery said today it won an expanded CE Mark approval for its Orbera weight loss system, extending the indwell period of the gastric balloon from 6 months to a 12 month treatment period. The balloon device is designed to be inserted non-surgically in obese patients with body mass indexes of 30 to 40, the […]
Deaths prompt renewed FDA warning on intragastric balloons
UPDATED August 15, 2017, with comment from ReShape Medical. The FDA yesterday updated its warning of the risks associated with fluid-filled intragastric balloons after receiving new reports of the deaths of patients implanted with the devices. Intragastric balloons, made by Apollo Endosurgery (NSDQ:APEN) and ReShape Medical, are used to treat obesity. Placed in the stomach orally in a minimally […]