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UK launch for Obalon’s swallowable balloon system

By: | Tags: | Comments: 0 | February 19th, 2016

The world’s first ‘swallowable’ weight loss balloon, the Obalon gastric balloon system, has been launched in the UK. Exclusively distributed by Purple Surgical in partnership with Spire Healthcare, the system can be placed in just five minutes by swallowing a small capsule, the size of a large vitamin pill.

Obalon Therapeutics claims the systems offers a real weight loss solution for those who have previously been unsuccessful in losing weight or who do not meet the BMI criteria for a surgical weight loss procedure.

It claims the system is suitable for people with a BMI >27; giving them the chance to lose an average of 8kgs (1st 3lbs) with a non-invasive, 12 week treatment, which has minimal impact on their everyday life.

“We are delighted to have reached an agreement with Spire Healthcare to be our exclusive clinical partner for Obalon to facilitate treatments outside of the M25,” said Robert Sharpe, CEO of Purple Surgical. “We believe that Spire’s expertise, high standards of care and nationwide coverage will provide both the desired quality and convenience for those seeking the Obalon treatment. Obalon is not just for a select few; it’s for those looking for a helping hand in weight loss, so we need to ensure that it is accessible to people all over the country”.

Procedure

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.

This is then followed by a short five minute placement procedure where the patient swallows a small capsule attached to a micro-catheter. Once the capsule arrives in the stomach, the outer layer dissolves. The balloon is then simply inflated to the size of an apple, through the micro-catheter, without the need for an endoscopy or sedation.

Once inflated, Obalon sits comfortably at the top of the stomach sending messages to the brain to decrease the feeling of hunger, which encourages reduced food consumption and calorie intake. Following a healthy eating plan in conjunction with Obalon ensures enhanced weight loss. Unlike other balloon treatments, there is no need to eliminate certain foods; you simply eat less due to a reduced appetite, the company claims.

“We are very excited about working with Purple Surgical for the launch of Obalon,” said Group medical director of Spire Healthcare, Dr JJ de Gorter. “It is a one-of-a-kind treatment with minimum side effects and excellent outcomes. Obalon can put people on the right path for long term weight loss success, enabling them to adopt healthier lifestyles, so that their weight loss is sustainable.”

South Korea

Separately, Obalon Therapeutics has received a strategic investment from AMOREPACIFIC Ventures and has entered into an exclusive international distributorship agreement with PacificPharma, an AMOREPACIFIC Group subsidiary, for its non-surgical device for weight loss.

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.

“It is a great pleasure to establish this collaboration with Obalon,” said Won-Joon Ahn, PacificPharma’s CEO. “We believe Obalon’s highly differentiated novel non-surgical device will be an important treatment option for patients in Korea and a solution for the unmet medical need for weight loss.”

“We are very pleased to have the opportunity to work with PacificPharma to commercialize our technology for weight loss in Korea,” said Andy Rasdal, Obalon’s Chief Executive Officer.  “We believe PacificPharma’s proven capabilities and expertise make them an ideal partner for Obalon.”

The company has received Investigational Device Exemption approval from the FDA and is enrolling its first US feasibility clinical trial evaluating the safety and efficacy of the device. The company has completed four clinical trials outside the US.

 Obalon

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