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FDA grants PMA-S Approval for Obalon Touch Inflation System

Obalon Therapeutics has gained approval of a Premarket Approval Supplement (PMA-S) application for the Obalon Touch Inflation System, an automated system utilized to inflate the Obalon Balloon, from the FDA.

The Obalon Touch is intended to be commercialised in combination with the Obalon Navigation System, which is designed to eliminate the need for X-ray imaging during balloon placement. A PMA-S application for the Obalon Navigation System was filed with the FDA in the third quarter of 2018 and is pending a decision by the FDA.    

No reports of deaths related to use of Obalon balloon system

Obalon Therapeutics has commented on the advisory issued by the FDA in June concerning the potential risks, including deaths, associated with liquid-filled intragastric balloons. The advisory was specific to the Apollo Orbera and ReShape Duo intragastric balloons and does not reference or apply to the gas-filled Obalon Balloon System. Obalon has not received any reports of any deaths related to the use of Obalon Six-Month Balloon System since it was launched in January 2017.

Obalon better than diet, exercise and lifestyle therapy alone

Patients with obesity treated with the Obalon gas-filled balloon capsules designed to help them eat less, lost 1.9 times more weight than patients who relied on diet, exercise and lifestyle therapy alone, according to research presented at ObesityWeek 2016. The study, “A 6-month Swallowable Balloon System Results in Sustainable Weight Loss at 1 Year: Results from a Prospective, Randomized Sham-Controlled Trial,” were presented by Dr Aurora Pryor, study co-author and Chief Bariatric, Foregut and Advanced GI Surgery, Stony Brook University.

FDA approves Obalon Balloon System

The FDA has approved Obalon Therapeutics’ Obalon Balloon System, a non-surgical, fully-reversible device for weight loss. The Obalon Balloon System is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI30-40) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behaviour modification programme.

Obalon balloon reduces BMI in six-month study

Patients who had a BMI30-40 lost nearly 7 percent of their weight, on average, after using the Obalon 6-Month Balloon System (Obalon Therapeutics), according to research presented at Digestive Disease Week (DDW) 2016. They also significantly improved in other health indicators, such as blood pressure and cholesterol levels data from the study, ‘The Obalon Swallowable 6-Month Balloon System is more effective than moderate intensity lifestyle therapy alone: results from a six-month randomised sham controlled trial’, showed.

Obalon completes US trial enrolment for balloon therapy

Obalon Therapeutics has completed patient enrolment for its multi-centre US pivotal trial of the Obalon balloon, a nonsurgical, fully-reversible device for weight loss. The trial utilises Obalon's most recent technology advancement that facilitates a six-month treatment period with the gas-filled balloon. Obalon expects the data from the trial necessary to file for approval with the FDA by the end of 2015.

Obalon agrees South Korean deal for OGB System

Obalon Therapeutics has received a strategic investment from AMOREPACIFIC Ventures and entered into an exclusive international distributorship agreement with PacificPharma, an AMOREPACIFIC Group subsidiary, for its non-surgical device for weight loss, the Obalon Gastric Balloon (OGB) System. Obalon has granted PacificPharma exclusive rights to market and distribute Obalon’s device for weight loss in South Korea, subject to regulatory approval of the device by the Korea Food and Drug Administration (KFDA).

Obalon gains US$30 million for US Pivotal Trial

Obalon Therapeutics has completed a $20 million Series D private equity financing and a $10 million term loan from Square 1 Bank, the proceeds will be used primarily to fund US clinical trials to support an FDA approval of the Obalon balloon, a novel, nonsurgical, fully-reversible device for weight loss, the company said.

The Obalon treatment consists of an initial consultation with a weight loss specialist, which involves an analysis of their medical history and the swallowing of a placebo capsule to verify the patient’s suitability.

Obalon to revolutionise obesity treatment in the Gulf

The Obalon balloon weight-loss technology launched in March 2014 in Saudi Arabia by Alsultan Saudi Medical Company, is fast replacing conventional treatment methods and winning the support of patients and medical experts alike. The technology, billed the first of its kind in Saudi Arabia, holds out much promise to countless overweight adults helping in weight loss without invasive medical procedures.

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