Avenda Health’s oncology platform receives FDA clearance

Culver City-based Avenda Health received the green light from the Food and Drug Administration last month for iQuest, a patient management software that identifies and monitors prostate cancer.

Powered by artificial intelligence, iQuest differentiates itself with patient-specific diagnostic data and deep-learning algorithms. The technology creates a map that pinpoints the exact location of prostate cancer in a patient, enabling personalized and precise treatments.

The problem iQuest solves, Avenda says, is a one-size-fits-all approach to treating all prostates. The reason why the method is used is that the current MRI technology cannot fully identify the growth of the tumor and cancer in the prostate. According to Avenda, about 50% of patients lose their sexual or urinary function.

Moreover, existing artificial intelligence, or AI, products are primarily diagnostic, as opposed to medical, in digital radiology or digital pathology.

“It’s used by urologists after a prostate cancer diagnosis (and Gleason grade) to help the doctor decide what to do next,” said Dr. Shyam Natarajan, founder and CEO of Avenda. Health, he said that only MRI can estimate the extent of the disease. Gleason grades help to understand the prognosis of men with prostate cancer.

The iQuest platform provides physicians with a 3D view of cancer and provides a better understanding of the extent of the disease to aid in treatment planning, reducing residual cancer after surgery or other procedures and maintaining a better quality of life.

“We are excited about iQuest’s potential to unlock precision care in prostate cancer as it is a key enabling technology to make focal therapy a reality for urologists and patients,” said Natarajan.

“In order for a doctor to treat effectively, they need to know where the cancer is and what healthy tissue is being spared. This is critical information that iQuest now provides. This is a major step forward in changing the standard of care in prostate cancer and providing effective treatment that preserves the quality of life for providers and patients across the United States.” It brings us very close.

Ten years of research

In addition to iQuest allowing physicians to pinpoint the location and severity of cancer as opposed to treating whole organs, patients benefit from treatment selection, planning, guidance and follow-up assessments.

Tumor imaging using Avenda’s iQuest.

Building the platform was no easy task, as iQuest now sits on nearly a decade of research from hundreds of thousands of data points and multiple clinical studies. One of the iQuest studies showed that urologists improved their tumor detection efficiency from 37% to 97%.

Avenda spun out of UCLA five years ago. Natarajan said having a suitable regulatory framework is one of the key challenges of the effort. The company currently has 18 full-time employees, including experts in AI, urology and imaging.

“AI and software are very new at the FDA, especially products that help make clinical decisions,” Natarajan said. “Thankfully, after several meetings with the FDA, we were able to clearly identify and validate our platform – culminating in the approval we just received.”

The technology that enables iQuest is known as fusion biopsy, a technique that combines MRI and ultrasound to better guide urologists in making accurate diagnoses.

Avenda has made the iQuest compatible with several treatment options, including the company’s own soft-tissue-laser ablation device, the FocalPoint. FocalPoint can treat prostate cancer in the office with ultrasound guidance.

Considering that one in eight men will be diagnosed with prostate cancer in their lifetime, according to the American Cancer Society, iQuest’s market is huge. Six of the 10 cases were diagnosed in men 65 and older, with an average age of 66 at the time of diagnosis.

Will it be available soon?

As far as profits from the technology are concerned, Natarajan said, Avenda is working with institutions in the beta period, but anticipates that it will be available to patients in the near future.

“At the heart of what we do is to believe that patients should never have to choose between quality of life and cancer control,” said Dr. Brittany Berry-Posse, founder and chief operating officer of Avenda Health. “By providing personalized cancer mapping, iQuest opens the door to more precise treatments. This clearance goes a long way not only for our company, but for the future of prostate cancer care.

Avenda raised $10 million in a Series B funding round led by VCapital, more than four months ago. The Chicago-based firm’s exit technology portfolio includes Similar Machines, CleverSafe and Imaginer Technology Group. VCapital invested in CleverSafe in 2005, and the company was later acquired by IBM in 2015.

The capital, which brought Avenda’s total funding to $16 million last August, will be used to accelerate the use of iQuest and continue the development of clinical evidence. The round also included participation from Plug and Play Ventures and Wealth VC Club.

“Our company’s mission is to provide better care for clinicians and their patients while maintaining the quality of life often lacking in prostate cancer treatment. Our technology is addressing key issues in men’s health, and we look forward to making a real difference in prostate cancer care,” Natarajan said in a statement. This funding will play a critical role in expanding our technology capabilities and reach, which will include experienced urology, medical device and AI leaders.”

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