Israeli startup Envizion Medical Ltd. said it is partnering with one of the largest private U.S. hospital chains to deploy its electromagnetic fields-guided feeding tube placement navigation technology in 150 hospitals nationwide. The company received U.S. FDA 510(k) clearance for the Envue navigation device and Envizion feeding tubes in April 2019.

“We are very excited about the opportunity our work with these hospitals can bring to the U.S.,” said Don Besser, Envizion’s president and CEO. “The potential for our navigation technology to both greatly reduce detrimental placements and cut down the time required to place tubes will help clinicians perform the task much more confidently and efficiently.”

The company will market Envue via its direct sales force and clinical application specialists.

Each year in the U.S., nearly 8 million feeding tubes are placed blindly in patients without technical assistance, upping the odds of misplacement and serious or life-threatening complications. For example, a tube accidentally place in the lungs could result in pneumothorax, pneumonia or even the death of the intubated patient. Between 3% to 5% of blind placements end up in the lungs, according to Envizion.

With the rise in hospitalizations due to the coronavirus pandemic, and the increased use of ventilators, more patients are requiring enteral nutrition, increasing that risk and putting added strain on time and resources.

“The demand for enteral feeding tubes, feeding pumps and accessories has risen significantly to roughly 30-40% more than prior to COVID-19,” Besser told BioWorld.

Cuts intubation time in half

Envizion’s solution enables clinicians to intubate patients in half the usual time, significantly cutting the risk of complications. To do this, the device uses electromagnetic tracking technology to guide clinicians in placing the tube from the nasal cavity through the esophagus all the way to the small intestine, where nutrients are absorbed by the body.

“The Envue system has multiple sensors embedded within the feeding tube and is placed on the patient’s body, which allows an accurate and personalized mapping of the patient’s body,” Besser explained. “A pathway is created by the sensors and the unique algorithms allow the clinician to identify a potential entrance point into the lung of the patient. Due to the guidance from the sensors, the positioning of the tube can be immediately corrected and then placed seamlessly within the small intestine.”

Once the placement route is mapped out, clinicians can view the image in 3D on a screen that offers axial, frontal and lateral views, ensuring the tube is always in the digestive tract and not in another part of the body. A white arrow tells users that they are placing the tube correctly, while a red one warns the tube is moving in a direction that could harm the patient.

Because of the electromagnetic field mapping, the tube tip’s location is able to stay on track even if the patient’s body moves.

The “Waze”-like tool for the digestive tract will be available in select countries in Europe and Asia within the next year, Besser said.

Founded in 2013, Tel Aviv-based Envizion has raised a total of $18 million to advance its technology. The company closed an $8 million series C round in April during the peak of the pandemic. Investors included private med-tech backers and family offices.

“The funds will be utilized primarily for the expansion of the U.S. activities and completion of various products that are in the pipeline,” Besser said.

That pipeline includes special feeding tubes for preterm infants and children that have an integrated sensor. Envizion hopes to make them available within the next year, he said.

Growing use of electromagnetic fields

Other companies are leveraging electromagnetic fields to address a variety of health care needs. Dune Medical Devices, of Alpharetta, Ga., has developed a percutaneous soft tissue biopsy device, Smart Biopsy, that uses the reflection of electromagnetic fields to identify the underlying electrical properties of the surrounding tissue. Because cancerous tissue has distinct electrical properties, physicians can detect the difference between malignant and benign tissue.

Bioelectronics Corp., of Frederick, Md., has FDA clearance for its Recoveryrx device for the treatment of postoperative pain and for prescription adjunctive treatment of edema following eye surgery. The nonopioid therapy, wearable therapy uses electromagnetic fields to reduce nerve hypersensitivity in the area of surgery, providing continuous drug-free relief.

And Jerusalem-based Brainsway Ltd. recently won FDA clearance for its deep transcranial magnetic stimulation system to aid in short-term smoking cessation in adults, adding to earlier nods for major depressive disorder and obsessive-compulsive disorder.

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