Published On: Sun, Jun 13th, 2021

Ibex Medical Analytics Gets Breakthrough Device Designation From FDA

This will help fast track the clinical review and regulatory approval of Ibex's platform.

Ibex Medical Analytics founders CEO Joseph (Yossi) Mossel and CTO Chaim Linhart

Israeli medtech startup Ibex Medical Analytics uses artificial intelligence (AI) in cancer diagnosis. The company has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which will help fast track the clinical review and regulatory approval of the Ibex platform. The news comes just a few months after Ibex raised $38 million in a Series B financing bringing its total funding to $52 million to date.

The FDA’s Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. The designation enables close collaboration with and expedited review by the FDA, and provides formal acknowledgement of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.

Startup Nation has a number of companies which are developing new cancer treatments. Israel’s OncoHost is developing a new ways to test the blood of cancer patients in order to determine which treatments will be the most effective. Novellus is an Israeli clinical-stage biotechnology company focused on precision oncology (treatment for cancer).

The company was founded in 2016 by CEO Joseph (Yossi) Mossel and CTO Chaim Linhart. Ibex’s main product is Galen. The company boasts that the Galen platform demonstrated “outstanding outcomes in clinical studies and helps pathologists reduce diagnostic error-rate, obtain 100% quality control and enable a more efficient workflow.” The Ibex Galen Breast and the CE-marked Galen Prostate are the first-ever AI-powered cancer diagnostics solutions used in routine clinical practice in pathology labs.

But Ibex Analytics offers a new way to diagnose cancer. Early diagnosis is vital for there to be successful treatment of any kind of cancer. Even with all of the breakthroughs in cancer treatments over the years there will always be a tipping point after which a treatment either won’t work, or the cancer has spread and possibly done irreparable damage to vital organs.

“Oncology treatments have made great strides, but in order to save more lives it is also essential to see technological advances in cancer diagnostics”, said David Shulkin, MD, former Secretary, U.S. Department of Veterans Affairs and advisor to Ibex Medical Analytics. “Enhancing the accuracy of cancer diagnosis and improving the efficiency for the pathologist is paramount to improving quality and affordability of cancer care”, Shulkin said. “Ibex’s AI platform has demonstrated success in helping pathologists worldwide improve care for patients with cancer. This FDA designation is an important step forward in making this technology broadly available in the United States.”

“We are honored to have been granted the Breakthrough Device Designation. Ibex is committed to providing world class tools for pathologists to ensure every patient receives a timely and correct diagnosis, while supporting pathology labs and health systems to increase efficiency and accuracy,” said Joseph Mossel, Chief Executive Officer and Co-Founder of Ibex Medical Analytics. “Our Strong AI technology is already in clinical use globally, making a real impact on patient care. We are proud to work closely with the FDA and look forward to continue collaborating with the agency as we accelerate our clinical program in the United States”.

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