Novelrad: Micro-suturing Solutions for Transcatheter Vascular and Cardiac Repair

In the field of cardiology, particularly in recent years, groundbreaking minimally-invasive catheterization procedures have been developed as an alternative to complex surgery that involves opening the chest. These procedures include structural repairs to the heart, particularly heart valve replacements, implantation of heart support devices and the treatment of arterial aneurysms. However, such procedures require very large access holes to be made in the femoral arteries through which the catheters are inserted. Inadequate closure of these access holes following the procedure can lead to damage to the blood vessels, severe bleeding and even death.

The Novelrad team in the catheterization laboratory of the research unit at Shamir Medical Center

Novelrad was established to provide an optimal response to developments in the catheterization market. The company has developed a micro-sewing machine with a diameter of less than 3mm, which makes it possible to create continuous sutures of various patterns via a minimally-invasive approach. The multi-purpose suturing platform mimics the surgical 'gold standard' and is ideal for a number of indications in the cardiovascular system, and outside of it.

Shachar Rotem, founder, chair and CTO of Novelrad, and Netanel Sharabani, founder and CEO of the company relate how the company was founded by three entrepreneurs with extensive backgrounds in the field of medical devices. "We founded Novelrad based on a long-standing collaboration when we worked together as the founding team of Q-Core Medical. First, we built the team and only after that we decided on the product to be developed," says Shachar. Netanel explains: "In the first year, we operated on a self-financing basis. Throughout that year we met with leading doctors in the industry. We were looking for a venture that addresses a real clinical need along with a large market and a clear business model, and that's how we arrived at the cardiovascular field and the complex and unmeet need of closing blood vessels after catheterization procedures, especially those that require large access sites."

A Micro-suturing Machine that Enables Minimally Invasive Treatment
Novelrad's development, as mentioned, is a micro-sewing machine that mimics the surgical suturing method characterized by a continuous multi-point stitch. The device works like a 'suturing pen' – each press moves a tiny needle, smaller than a grain of rice, from one side of the tissue to the other and back. In this way, a wide variety of suturing patterns can be produced, similar to how a surgeon operates under full exposure. The system does not require the use of imaging tools such as ultrasound or X-ray for its positioning or operation. In fact, the doctor relies on a position indicator that is integrated into the suturing handle. "In this field, it is extremely important to build a system that is easy to operate and saves time," explains Shachar and adds: "Based on the experience we have gained, it takes less than a minute to perform our procedure and the learning curve is very short, even for less experienced doctors." Netanel mentions the clinical advantages of using the micro-sewing machine: "Suturing is the surgeon's preferred option, because it allows for quick and effective repair of the tissues, without causing damage or distorting the anatomy. Our innovation overcomes the problem of treating large holes by applying a multipoint continuous suture at the beginning of the procedure, before the hole is expanded. This offers full control throughout the entire procedure. The use of our system is expected to save time, reduce side effects and complications and shorten recovery time. In animal trials, we observed fast and effective closures of blood vessels, even when we performed access of sizes outside the range of current approaches."

Launching a Second Fundraising Round
Since its establishment, Novelrad has completed its seed round and won several grants from the Israel Innovation Authority. In order to protect its groundbreaking technology, the company has filed four patents so far, in the United States, Europe, Japan and China. "About a year ago," Shachar reveals, "we also won the prestigious European Innovation Council (EIC) grant worth 2.5 million euros, with an option for follow-up investment. "Just to give you an idea," he says excitedly, recalling a thrilling and important moment in which the founders felt that the company was part of Israel's recovery, "We submitted the grant application to the EIC in mid-October 2023, a few days after October 7th. Despite the difficulty in the first months, recruitment of employees to army reserve duty and the negative global repercussions, in March 2024 we received confirmation of winning the significant grant. It was an emotional moment."

Novelrad has completed the development phase and plans to begin the clinical trials phase in the second half of 2025. "We are in advanced discussions with a number of leading medical centers in the United States, Europe and Israel that have expressed interest in participating in the clinical research, and with some of them we have already signed memorandums of understanding," says Netanel.

Novelrad is currently embarking on another fundraising round from existing shareholders and new investors in order to complete the clinical trials, obtain regulatory approval, and market the first product designed to close blood vessels by 2027.

An Experienced Team that also Worked on the Next Development
The founding team was joined by Dr. Elchanan Bruckheimer, an expert catheterization specialist and director of the catheterization lab at Schneider Hospital. "Dr. Bruckheimer joined us as the company's Chief Medical Officer (CMO) shortly after its establishment and brought a great deal of experience and knowledge," relates Netanel and adds that the management team is completed by Ori Goldor, Director of R&D, Dr. Yossi Muncher, VP Regulatory, Clinical & Quality Assurance, and Yossi Cohen, Chief Financial Officer (CFO), who co-founded more than 12 companies in the field of medical devices as part of Rainbow Medical. The experienced management team is supported by a medical advisory team, which includes leading doctors, headed by Professor Ariel Finkelstein and Professor Horst Sievert. Shachar points out that the company supports the integration of young employees as part of a social agenda that focuses on developing the younger generation. "The existing team, which also includes young people, has led us to noteworthy achievements. In effect, in some areas, they are the ones pushing the company forward. The company is based in Kibbutz Metzer, out of love for the region and also to strengthen the periphery," adds Shachar proudly.

The team, which is operating in one of the most beautiful regions in the country, has already started working on the next development that Shachar believes will lead to a revolution in the field. "It's a catheter-based approach using the micro-sewing machine we developed, which is intended to perform suturing directly in the heart itself and treat cases such as closing a hole in the heart's septum, a common defect that, if left untreated, could lead to blood clots traveling to the brain and eventually a stroke," he reveals, adding that the next generation will soon advance another step.

Novelrad
Year established: 2019
Founders: Shachar Rotem, Netanel Sharabani and Ori Goldor.
Field of activity: Medical devices in the cardiovascular field
Guiding motto: The next generation of suturing solutions for vascular and cardiac repair through a catheter-based or minimally invasive approach

In cooperation with Novelrad