Allmed Solutions Achieves Landmark 'Needle-Stick' Heart Valve Replacement

Rhea-AI Summary

Allmed Solutions (ALMDF) announced a first-in-human success using its RoseDoc system to fully replace a major heart valve via a single needle-stick catheter procedure, avoiding open-chest surgery.

The two compassionate-use patients had severe tricuspid regurgitation with no surgical options; a proprietary docking system was implanted ~3 months earlier, and final valve implantation produced immediate clinical improvement with both patients discharged within five days.

The company plans continued patient recruitment in India and expansion to sites in Israel, South Africa, and Uzbekistan as it advances toward global regulatory approval and commercialization.

Positive

• First-in-human full valve replacement via needle-stick
• Both patients showed immediate clinical improvement
• Both patients discharged within five days after implantation
• Planned trial expansion to India, Israel, South Africa, Uzbekistan

Negative

• Report covers only two patients in compassionate-use cases
• Current data from an early-stage trial, not regulatory approval

Key Figures

Patients treated 2 patients First-in-human RoseDoc system trial

Docking-to-valve interval 3 months Time between docking system and valve implantation

Post-op discharge time 5 days Discharge after final valve implantation

TruLeaf founding year 2017 Founding of TruLeaf Medical

Market Reality Check

Market Pulse Summary

This announcement describes a first-in-human use of Allmed’s RoseDoc system, replacing a major heart valve via needle-stick catheterization in 2 critically ill patients. Both showed rapid recovery and discharge within 5 days. The company plans further recruitment in India and expansion to Israel, South Africa, and Uzbekistan. Investors may watch trial scale-up, safety and efficacy data, and progress toward global regulatory approval and commercialization.

Key Terms

catheterization medical

"via a minimally invasive catheterization procedure, entirely eliminating"

Catheterization is a medical procedure that uses a thin, flexible tube threaded into a blood vessel, heart chamber, or body cavity to diagnose or treat conditions—like measuring pressures, taking images, delivering medicine, placing stents, or draining fluids. For investors, catheterization matters because the number of procedures, device sales, reimbursement rules and regulatory approvals directly affect revenues and risks for hospitals, medical device makers and healthcare service providers; think of it as threading a hose to reach and fix a problem inside the body.

tricuspid valve medical

"massive leak in their tricuspid valve (the three-leaflet valve"

A tricuspid valve is a one-way heart valve located between the upper and lower chambers on the right side of the heart, made of three leaflets that open and close like a three-flap door to keep blood flowing in the right direction and prevent backward leakage. Investors watch it because diseases or dysfunction of this valve drive demand for diagnostics, drugs, surgical repairs and implantable devices, influence healthcare costs and patient outcomes, and can affect regulatory approvals and market opportunities in medical and biotech sectors.

compassionate care medical

"The investigational treatment was therefore provided under a compassionate care pathway"

Compassionate care is patient-focused medical support that prioritizes comfort, dignity and emotional support alongside clinical treatment, often during serious illness or end-of-life situations. Investors care because it shapes demand for services, affects reputations, regulatory scrutiny and reimbursement policies, and can create market opportunities for products or programs—think of it like customer service tailored for people in crisis rather than a one-size-fits-all transaction.

transcatheter medical

"developing the world's first-ever transcatheter valve replacement, the Sapien 3 valve"

Transcatheter describes medical procedures or devices delivered through a thin, flexible tube (catheter) that is threaded through blood vessels or small body openings to reach the heart or other organs without open surgery. It matters to investors because transcatheter approaches enable faster recovery, shorter hospital stays and larger patient pools for treatments that once required major operations, which can expand market demand and affect device and hospital revenues.

regulatory approval regulatory

"as it advances toward global regulatory approval and commercialization"

Regulatory approval is the official permission given by government agencies or authorities that allows a product, service, or business activity to be legally operated or sold. It is important to investors because receiving approval often indicates that a product has been reviewed for safety and compliance, which can influence its success and the company’s prospects in the market. Without this approval, launching or selling certain products may be restricted or prohibited.

AI-generated analysis. Not financial advice.

OR AKIVA, Israel, Dec. 9, 2025 /PRNewswire/ -- Allmed Solutions (TASE: ALMD), an Israeli biomedical company, has announced a dramatic success in a first-in-human trial, achieving the full replacement of a major heart valve in critically ill patients via a minimally invasive catheterization procedure, entirely eliminating the need for high-risk open-chest surgery.

Allmed Solutions and its subsidiary, TruLeaf Medical, have completed the final stage of a trial for their innovative RoseDoc system. The new technology allows for a diseased heart valve to be fully replaced with a new, functional one, performed solely through a needle stick access point.

The groundbreaking procedure was carried out on two patients suffering from severe heart failure caused by a massive leak in their tricuspid valve (the three-leaflet valve on the right side of the heart). For both patients, conventional medical and surgical options had been exhausted, and their condition was considered too severe to undergo standard open-heart surgery. The investigational treatment was therefore provided under a compassionate care pathway.

The replacement was completed in two stages. Approximately three months prior, a novel proprietary docking system was implanted in the patients' hearts. The final procedure, completed recently, involved the implantation of the valve itself - the RoseDoc system.

Restoring normal valve function resulted in immediate and dramatic clinical improvement. Both patients reported a substantial change in their functional capacity and were discharged home within five days of the final valve implantation.

Prof. Oz Shapira, CEO of Allmed Solutions and an Emeritus Professor of Heart Surgery, emphasized the significance of the achievement.

"The success recorded in recent days is a defining moment. The ability to fully replace heart valves via needle stick only, with no incisions and no opening of the chest, is an extraordinary breakthrough," Prof. Shapira said. "We are entering a new and safer era for patients."

Prof. Shapira highlighted that the uniqueness of this Israeli development lies in its innovative docking system. This system is the only one in the world that enables the catheter-based replacement of two different types of heart valves, both the tricuspid valve on the right side and valves on the left side of the heart.

This breakthrough offers significant hope for millions of patients worldwide who are currently considered too high-risk for conventional surgery, leaving them without an adequate medical solution.

TruLeaf Medical was founded in 2017 by three experienced Israeli entrepreneurs: Benjamin Spenser, Nathanael Benichu, and the late Dr. Rosenstein. The team had previously achieved major success developing the world's first-ever transcatheter valve replacement, the Sapien 3 valve, which was part of PVT, a company later acquired by the global medical-device giant Edwards Lifesciences.

Following the successful early trial, the company is continuing to recruit patients in India and plans to expand the trial to sites in Israel, South Africa, and Uzbekistan as it advances toward global regulatory approval and commercialization.

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SOURCE AllMeD Solutions

FAQ

What did Allmed Solutions (ALMDF) announce on December 9, 2025 about RoseDoc?

Allmed announced a first-in-human success replacing a tricuspid valve via a needle-stick catheter procedure using the RoseDoc system.

How many patients received the full needle-stick valve replacement in Allmed's announcement?

Two patients received the full valve replacement under a compassionate care pathway.

What were the clinical outcomes for the patients in the Allmed RoseDoc trial?

Both patients had immediate and substantial functional improvement and were discharged within five days after valve implantation.

Where will Allmed Solutions expand RoseDoc clinical trials after the initial results?

The company plans continued recruitment in India and expansion to trial sites in Israel, South Africa, and Uzbekistan.

Does the December 9, 2025 announcement mean RoseDoc has regulatory approval?

No; the announcement reports early compassionate-use trial success and indicates ongoing recruitment toward global regulatory approval.