Israeli biomedical firm TruLeaf Medical has completed the first stage of a pioneering human trial of its RoseDoc docking system, a catheter-based device designed to replace diseased heart valves without the need for open-heart surgery, its parent company announced this week.
Allmed Solutions (TASE: ALMD), which owns TruLeaf, said the procedure was successfully performed Sept. 5 in India on two patients suffering from severe, treatment-resistant congestive heart failure caused by leaking tricuspid valves. Both patients had no remaining therapeutic options and were treated under a compassionate care pathway.
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The first phase of a first-in-human clinical trial of TruLeaf Medical's RoseDoc docking system
(Photo: Allmed Solutions)
The RoseDoc system allows for a two-stage implantation: first, a docking station is placed via catheter, and later, a replacement valve is implanted within it. TruLeaf said the second stage, involving implantation of its valve, is expected to take place in the coming months under trial protocols.
The trial marks the first time the RoseDoc platform has been implanted in humans, offering what the company calls proof of concept for its technology, which targets transcatheter replacement of both mitral and tricuspid valves. Millions of patients worldwide suffer from defective valves but are unable to undergo invasive surgery or existing catheter-based treatments.
"This trial is not only an important step for TruLeaf-Medical, but also a huge step for the entire medical community and a ray of hope for millions of patients," says Prof. Oz Shapira, CEO of Allmed Solutions Group.
"As a heart surgeon, I deeply understand the absolute necessity of transitioning from a high-risk invasive and complex open-heart surgery to a simple, smart, safe and effective catheter-based solution. TruLeaf Medical RoseDoc platform has the potential to offer an effective treatment to millions of patients with valvular heart disease who have been deemed to be too high risk for surgery and are unsuitable for currently available catheter-based techniques."
TruLeaf Medical was founded in 2017 by Israeli entrepreneurs Benjamin Spenser, Nathanael Benichu and the late Dr. Uri Rosenstein. The team previously worked at PVT, where they helped develop the Sapien 3 valve, the first transcatheter device for patients with severe aortic stenosis, later acquired by Edwards Lifesciences.
The company is currently recruiting additional patients for its first-in-human trial in India and Uzbekistan and plans to expand to other countries. Allmed said the success of the initial procedures represents a critical milestone that could accelerate regulatory approvals and bring the technology to global markets.