HONG KONG – Singapore-based Genesis Medtech International Pte. Ltd. has acquired the Chocolate Touch drug-coated balloon angioplasty asset from Pleasanton, Calif.-based Trireme Medical LLC.
The drug-device technology asset in question is designed with the intention of providing a safer and more effective treatment for patients suffering from peripheral vascular disease, compared to traditional balloon angioplasty.
The companies involved claim that the Chocolate Touch drug-coated balloon is the world's first balloon catheter to combine “therapeutic agent delivery with the next generation of controlled dilation angioplasty technique” for the treatment of peripheral vascular diseases.
Though financial details were not disclosed, Genesis Medtech has acquired the intellectual property license for the worldwide design, engineering, manufacturing, rights, claims, use, marketing, sale and distribution for use of the Chocolate Touch in the treatment, prevention, diagnosis or management of peripheral vascular diseases.
Warren Wang, the chairman and CEO of Genesis Medtech International, believes drug-coated balloons like the Chocolate Touch will become the future standard for superficial femoral artery treatment.
“A drug-coated balloon is similar to plain old balloon angioplasty procedurally – where a specially designed catheter with a tiny balloon is carefully guided through the artery to the blockage, then inflated to widen the opening and increase blood flow. But unlike plain old balloon angioplasty, drug-coated balloons possess an additional anti-proliferative medication coating the balloon, as well as an excipient to aid in delivering the medication into the vessel wall to further prevent the re-narrowing of the vessel,” Wang told BioWorld.
According to Genesis Medtech, what differentiates the Chocolate Touch from other drug-coated balloons is that it is built on an angioplasty balloon architecture that enables delivery of controlled dilatation techniques and intelligent stress relief to narrowed diseased vessels, which traditional angioplasty balloons cannot provide.
Given the controlled dilation and stress relief designs, Genesis Medtech claims the Chocolate Touch is able to achieve higher vessel patency (the degree of openness of a tube ) by reducing shear stresses on vessel walls.
“Utilizing a novel ‘pillows and grooves’ design, the features improves the safety and effectiveness of treating diseased peripheral arteries by reducing potential vessel recoil, vessel dissections and the need for bailout stenting,” said Wang.
“Coating an angioplasty balloon with drugs has been shown to be efficacious in the prevention of the narrowing of peripheral vessels. By combining the mechanical intelligence of the Chocolate Touch design with a drug delivery mechanism, we believe the Chocolate Touch represents a class of drug-coated balloon that has the potential to be the future standard of care for superficial femoral artery treatment, as well as getting physicians closer to minimizing the need to leave a foreign body implant behind.”
Genesis Medtech is intent on proving this through studies. It has enrolled 333 patients in a pivotal study at a total of 34 sites in the U.S., Europe and New Zealand as of July 1, 2020.
This also ties in with its plans to bring the Chocolate Touch to the U.S. and various other international markets.
It aims to complete a U.S. investigational device exemption pivotal clinical study, product development, manufacturing processes and obtain premarket approval from the U.S. FDA through its subsidiary, G Vascular Pte. Ltd.
“We are focused on getting FDA approval. We hope we are able to bring this product to patients globally either directly or through partnerships,” said Wang, who declined to nail down specific timelines for those goals.
"I'm impressed with Genesis' vision and the scale of execution. Partnering with Genesis gives our shareholders the confidence that Chocolate Touch will be approved and launched in the U.S., Europe, and Asia Pacific markets, benefiting patients on a global scale," said Eitan Konstantino, the chief executive officer of QT Vascular Ltd. Trireme Medical is a wholly owned subsidiary of Singapore-listed QT Vascular.
According to Genesis Medtech, the global drug-coated balloon market is expected to reach revenues of more than $1 billion by 2025 and grow at a CAGR of around 13% from 2018-2025.
Currently, the global market for drug-coated balloons is estimated to be around US$470 million. The market in China alone is currently estimated to be at US$50 million, with an expected CAGR of 22% in the next five years.