Israeli medical device maker Art Medical filed an urgent motion with the Central District Court for a temporary trustee and a stay of proceedings. The company faces liabilities approaching $15 million. It has raised about $100 million since its founding and received support from the Bill & Melinda Gates Foundation.
Regulatory setback
The FDA rejected the company's De Novo classification request in October. That pathway is designed for innovative devices with no legally marketed equivalent. Investors then declined to provide additional financing.
Company and obligations
Art Medical was founded in 2008 and employs 53 people in Netanya. It holds about 100 registered patents and distribution agreements with Teva and MOSS. Its largest disclosed obligation is a $10.6 million debt to Avanos Medical, secured by its intellectual property.
What the platform does
The company's platform manages nutrition for mechanically ventilated patients in intensive care. It combines smart feeding tubes, sensors, and algorithms to prevent complications. These include malnutrition, overfeeding, reflux, and ventilator-associated pneumonia.
The filing asks the court to appoint a trustee to preserve assets and examine a sale as a going concern. It also calls for urgent action on patient safety and continuity of care. The company would notify hospitals and distributors, stop new patient connections, and coordinate transitions to alternatives.
Read more: ynet.co.il