Israeli imaging startup addressing male factor infertility

Via the Rochester Business Journal

The Q300 used to image sperm cells.
The Q300 used to image sperm cells

One in eight couples in the United States, and one in six globally, experience infertility. QART Medical, an Israeli-based imaging startup company, is addressing the problem by providing IVF experts (embryologists) with access to novel information when they select individual sperm cells for IVF procedures.

“In a world with declining fertility rates, we want to help people become parents by facilitating highly informed selection of sperm cells and providing objective information about individual cells to dramatically improve IVF success rates,” said Alon Shalev, CEO and Co-Founder of QART Medical. “Our technology allows for real-time 3D analysis of sperm cells and comparison with WHO consensus parameters, thus enabling embryologists to make objective, evidence-based decisions. This means that they no longer have to rely on subjective opinions when selecting sperm cells that will be injected into oocytes (eggs).”

We caught up with Shalev to learn more about QART Medical’s development.

Understanding the limitations of IVF

Alon Shalev
Alon Shalev, CEO and Co-Founder of QART Medical

The current methods that embryologists use to assess and select sperm cells to inject directly into eggs in vitro are subjective, variable, and non-quantitative. Essentially, the human eye cannot adequately analyze live sperm cells and compare them in real-time to consensus quantitative reference values provided by the World Health Organization (WHO). Methods that allow for more comprehensive analysis of a semen sample, such as those involving chemical or biological staining, render the cells unusable for IVF procedures.

Almost a decade ago, the inability to extract so called “mission-critical” information when using conventional imaging methods became the focus of a number of research projects at the Biomedical Optical Microscopy, Nanoscopy, and Interferometry (OMNI) Research Group at Tel Aviv University, headed by Professor Natan T. Shaked. Shaked, QART’s other co-founder, is now the head of the Biomedical Engineering Department at Tel-Aviv University, which is among the top five universities in the world when it comes to generating successful startups. In 2018, QART Medical spun out of that research, allowing Shalev and his team to interface directly with clinicians and embryologists to glean unique insight into the needs the industry faces today.

QART Medical provides comprehensive information about individual sperm cells in a non-harmful, non-invasive way

QART’s flagship product, the Q300™, provides novel information to clinicians and empowers them to make evidence-based decisions centered on empirical data.

“Our solution takes advantage of a unique property of human sperm cells; the fact that they naturally rotate about their central axis, which allows us to acquire their perspective projections for tomography,” said Shalev. “In this tomographic process, using QPI (quantitative phase imaging), we image the sperm cells while they rotate and are able to extract their internal and external morphology based on numerous holographic images.”

Instead of forcing embryologists to arbitrarily pick sperm cells to inject into eggs, QART’s system delivers accurate and unequivocal morphological measurements in real-time and compares the results to established criteria from the WHO guideline publications. QART’s system integrates into the existing IVF workflow with minimal training needed, which means IVF labs can quickly adopt this innovative technology and should be able to give their patients higher chances of success.

In July ’23, QART began a clinical trial at the UCSF Center for Reproductive Health designed to determine the impact that using the Q300™ has on embryologists’ ability to select sperm cells compliant with WHO criteria. Eager to continue expanding its footprint in the U.S., QART is in late-stage conversations with the University of Rochester Medical Center about beginning a new clinical trial at the Strong Fertility Center.

Focusing on the underserved subspecialty of male-factor infertility, QART estimates that the global total addressable market opportunity for QART’s solution exceeds $1.3B, even before including China’s IVF market potential. Initially, the company is targeting the U.S., where patients often choose to be treated by clinics which offer access to cutting-edge technology, and Japan, where policy makers have recently authorized insurance plans to cover fertility procedures in an effort to reverse the country’s declining birth rate. QART estimates that these two markets alone account for 650,000 IVF cycles each year, an addressable market of just under $300 million with a roughly 10% annual growth rate.

Rochester’s OPI community fuels QART Medical’s future

To speed the commercialization of its technology and advance its business, QART Medical is one of ten companies participating in Luminate NY, a NextCorps accelerator program for startups whose core technology is enabled by optics, photonics, and imaging. It turned to Luminate and its vast network for help in accessing capital, developing new clinical opportunities and partnerships, and generating a greater awareness of its offering.

“QART Medical is working hard to build its business, solidify its technology and forge important relationships in the OPI and greater Rochester community,” said Dr. Sujatha Ramanujan, managing director of Luminate. “We are proud of the work they are doing to address a pressing issue and are confident that it will have a global impact.”

For more information, visit qart-medical.com. To watch startups in Luminate compete for $2M in follow-on funding, register for the free Luminate Finals event on Sept. 27 from 11:30 a.m. to 1 p.m. at bit.ly/LumFinals2023. To get updates on Luminate and the emerging technologies being developed in Rochester, go to luminate.org.