Novel Non-Surgical Balloon Device for Weight Loss
Obalon and AMOREPACIFIC Commence Strategic Alliance to Launch a Novel Non-Surgical Device for Weight Loss in South Korea
Obalon Therapeutics, Inc. (www.obalon.com) has announced that it 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 novel 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 (KFDA).
“It is a great pleasure to establish this collaboration with Obalon,” said Won-Joon Ahn, PacificPharma’s Chief Executive Officer. “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.”
Obalon is developing a novel non-surgical, fully-reversible device for weight loss. The device consists of a capsule containing a balloon that is swallowed and then remotely inflated. The balloon is intended to occupy space in the stomach to create a feeling of fullness to help people eat less. Additional balloons can be swallowed and inflated during the treatment period as indicated for weight loss. At the end of the treatment period, the balloons are removed.
Obalon received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) and is enrolling its first U.S. feasibility clinical trial evaluating the safety and efficacy of the device. The Company has completed four clinical trials outside the U.S.
The Company has obtained CE Mark Registration for the Obalon Gastric Balloon System and has commenced initial commercial sales in the European Union. In the U.S., the device is not commercially available and is only being studied in clinical trials as an investigational device.