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News and Updates

Professor Natan Tzvi Shaked,Qart Co-Founder and CSO, Invited to Speak at Aspire’s 2024 Conference in Manilla

QART Medical’s co-founder and chief scientific officer, was invited to speak at the 13th congress of the Asia Pacific Initiative on Reproduction’s (ASPIRE) in Manilla, Philippines. Prof Shaked, in his Academic role, is director of biomedical engineering at Tel-Aviv University.

Professor Shaked’s ASPIRE talk, titled "Sperm DNA Fragmentation Assay for Live Human Sperm During ICSI”, detailed the years of research output from the Biomedical OMNI (Optical Microscopy, Nanoscopy, and Interferometry) Group that he leads at Tel Aviv University that led to the spin out of QART Medical. Additionally, he explained the advanced research and development that he leads, to bring real time DNA fragmentation analysis, on a single-cell level, to its flagship product, the Q300™.

Following the talk and a Q&A session, Prof Shaked participated in a panel discussion, revolving around the importance of assessing DNA fragmentation in live, motile human sperm cells, to optimize IVF success rates.

ASPIRE, the Asia Pacific Initiative on Reproduction, was founded in 2001 by Bruno Lunenfeld and P C Wong, to improve knowledge and awareness of ART and infertility-related services, with the ultimate aim of improving the quality of patient care.

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Dr Yulia Michailov presented interim clinical outcome results from QART MEDICAL’s multi-center clinical study

QART Medical is honored to have the company’s interim clinical results presented at the Israel Fertility Association’s 66th annual conference.

The poster, titled “Preliminary Clinical Outcome Using the Q300™ Device in a Reproductive Laboratory Environment”, was one of 19 featured posters at this year’s conference. The poster summarizes the preliminary interim results from QART’s on-going, multi-center clinical study at Barzilai Medical Center in Ashkelon, Israel.

The study is meant to provide an understanding of the early clinical impact of the Q300™ in the IVF laboratory. The initial data suggests favorable outcomes, with further research necessary to identify the patient subgroups that can derive the greatest benefit from this system. The preliminary results focus on 14 couples attempting to achieve pregnancy. A copy of the poster can be found here: QART Medical Poster

The Israel Fertility Association (AYALA) conference, held yearly in Tel Aviv, brings together the country’s leading fertility experts with a focus on new technologies, techniques, and procedures.

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QART Medical, a Male Fertility Company, Discloses Recent Financing

March 5th, Raanana, Israel – Chartered-Opus investment managers was joined by Eastern Epic Capitals, a Singapore based venture capital fund which focuses on frontier technologies to create value and make the world a better place, led an extension of a Series A round of financing, as well as additional angel investment.

“We are happy to have Eastern EPIC Capitals join the long-standing commitment of QART investors at this very exciting inflection point in QART. Our flagship product, Q300™, is the first and only highly informative companion for male fertility treatments. Q300™ is now FDA, CE-Mark and AMAR (Israeli MoH) cleared for marketing, and we’ve started a multi-center clinical study to look at real-life aspects of its use, such as improvement in the clinical indicators of clinical success”, said Alon Shalev, CEO and Co-founder of QART Medical.

Dr Mitch Rosen, MD, an expert in reproductive endocrinology and fertility and the director of the UCSF Fertility Preservation Program, where QART’s Q300 system is now being evaluated “As counter-intuitive as it may sound, only sperm matters. I mean, oocytes are vital, but scarce. In each retrieval we typically withdraw half a dozen, up to a dozen of them… therefore we’re going to try and create embryos from all of them. With sperm cells, you could have hundreds of millions of those with likely unequal developmental capacity. They are tiny, transparent, they’re in motion, and they rotate and go in and out of focus. QART’s system and technology may revolutionize the selection process to capture the ideal sperm cell to enhance the chances of successful fertilization and pregnancy”


About QART Medical QART Medical is an ISO13485 certified MedTech company addressing the global infertility epidemic. To do so, QART has developed the Q300™, a breakthrough solution to male infertility issues that provides a quantitative characterization of sperm cell morphology to facilitate informed clinical decision making when selecting cells for use in in-vitro fertilization (IVF). QART aims to improve current success rates of Intra-Cytoplasmic Sperm Injection (ICSI) by quantitatively characterizing the morphology and composition of individual sperm cells with 3D imaging. The Q300™ is registered with the US FDA, has received Israeli regulatory registration for commercial sales, and bears the CE (Conformité Européenne) Mark.

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QART Medical’s Flagship Device, the Q300™ Now Bears the CE Mark.

Raanana, Israel – QART Medical has met another major regulatory milestone in its corporate strategy. QART’s flagship product, the Q300™, now bears the CE (Conformité Européenne) Mark, indicating declared conformity with regulations applicable to the product. This achievement follows approval from the Israeli Ministry of Health (a.k.a AMAR) and registration of the Q300™ with the US-FDA, allowing QART to market and sell the Q300™ United States, the EU and Israel.

Q300™ is a QPM (quantitative phase microscope) based optical imaging system for analysis and selection of individual sperm cells for IVF (in vitro fertilization). Q300™ performs morphological human sperm cell analysis that provides high resolution 3D imaging of sperm cell structure and internal organelles. Q300™ empowers embryologists to make objective, quantitative, recorded, and highly-informed decisions about the sperm cells that they intend to select for injection into oocytes during the most prevalent IVF procedure, ICSI (intra cytoplasmic sperm injection).

Q300™ utilizes state-of-the-art digital-holographic-microscopy, advanced image processing algorithms, machine vision and complete log and traceability of each sperm cell that is analyzed and considered for injection. These unique offerings position the Q300™ to revolutionize the ability to detect, measure, and quantitatively analyze sperm cells, providing objective information in real-time to aid in the sperm selection process.

A multi-center clinical outcome study, exploring the impact of using the Q300™ on IVF success is now on-going. Initial clinical outcome results are highly favorable. “We are pleased with the CE Mark and are eager to bring the QART’s groundbreaking technology to the European market”, said QART Medical’s CEO and co-founder Alon Shalev.

About QART Medical

QART Medical is an ISO13485 certified MedTech company addressing the global infertility epidemic. To do so, QART has developed the Q300™, a breakthrough solution to male infertility issues that provides a quantitative characterization of sperm cell morphology to facilitate informed clinical decision making when selecting cells for use in in-vitro fertilization (IVF). QART aims to improve current success rates of Intra-Cytoplasmic Sperm Injection (ICSI) by quantitatively characterizing the morphology and composition of individual sperm cells with 3D imaging. The Q300™ is registered with the US FDA, has received Israeli regulatory registration for commercial sales, and has received CE (Conformité Européenne) Mark approval.

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QART Medical’s Q300™ First of a Kind Multi-Center Clinical Study Results – Published in Biomedicines Journal

QART Medical’s flagship product, the Q300™ was used in a first-of-its-kind multi-center clinical study, performed at four Israeli IVF clinics. Results of this study were recently published in Biomedicines titled, “Stain-Free Sperm Analysis and Selection for Intracytoplasmic Sperm Injection Complying with WHO Strict Normal Criteria”.

This multi-center study evaluated the Q300’s accuracy of measurement and usability when employing quantitative phase microscopy (QPM) for label-free sperm-cell selection for intracytoplasmic sperm injection (ICSI). Senior embryologists were asked to select 11 apparently normal and 11 overtly abnormal sperm cells, in accordance with current clinical practice, using a micromanipulator and 60× bright field microscopy. Surprisingly, only 19% of the subjectively pre-selected “normal morphology” sperm cells were found to be in compliance with the consensus WHO2021 criteria, according to which, embryologists all over the world have been trained for decades.

These results highlight the potential for QART Medical’s Q300™ to revolutionize the field of reproductive medicine and allow clinicians to make evidence-based decisions, in real-time, for the benefits of patients and humanity.

QART Medical thanks our partners at the Meir, Barzilay, Shaarei-Tzedek, and Wolfson Medical centers. The article can be accessed at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10604130/




About QART Medical

QART Medical is an ISO13485 certified MedTech company addressing the global infertility epidemic. To do so, QART has developed the Q300™, a breakthrough solution to male infertility issues that provides a quantitative characterization of sperm cell morphology to facilitate informed clinical decision making when selecting cells for use in in-vitro fertilization (IVF). QART aims to improve current success rates of Intra-Cytoplasmic Sperm Injection (ICSI) by quantitatively characterizing the morphology and composition of individual sperm cells with 3D topographic imaging. The Q300™ is registered with the US FDA, has received Israeli regulatory registration for commercial sales, and is in the process of CE-Mark registration.

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Q300 Israeli Ministry of Health Medical Device Division (AMAR) Approval

QART Medical is excited to announce a major milestone for our company: Our flagship product, the Q300™ has received approval from the Israeli Ministry of Health Medical Device Division (AMAR) to be marketed and commercially sold in Israel. The Q300™ system empowers embryologists to make objective, quantitative, recorded, and highly-informed decisions about the sperm cells that they intend to select for injection into oocytes during the most prevalent IVF procedure, ICSI (intra cytoplasmic sperm injection).

The Q300™ is a first of its kind, clinically-adapted QPM (quantitative phase microscopy) system, which includes state-of-the-art image processing algorithms, machine vision and complete log and traceability of each sperm cell that is selected for injection.

These unique offerings uniquely position the Q300™ to detect, measure, and quantitatively analyze sperm cells, providing objective information in real-time to aid in the sperm selection process.

About QART Medical

QART Medical is an ISO13485 certified MedTech company addressing the global infertility epidemic. To do so, QART has developed the Q300™, a breakthrough solution to male infertility issues that provides a quantitative characterization of sperm cell morphology to facilitate informed clinical decision making when selecting cells for use in in-vitro fertilization (IVF). QART aims to improve current success rates of Intra-Cytoplasmic Sperm Injection (ICSI) by quantitatively characterizing the morphology and composition of individual sperm cells with 3D topographic imaging. The Q300™ is registered with the US FDA, has received Israeli regulatory registration for commercial sales, and is in the process of CE-Mark registration.

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Israeli Innovation Authority Investment in QART Medical

QART Medical is pleased to announce that we have been chosen by the Israeli Innovation Authority to receive an investment as part of their wartime aid package. We thank the Authority for their continued support and confidence.

.חברת QART Medical נבחרה ע"י רשות החדשנות לקבל השקעה לסיוע בעת מלחמה

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QART Co-founder & CSO Recent Publication in Nature Photonics

Raanana, Israel – QART Medical is honored to share that Professor Natan T. Shaked, co-founder and Chief Scientific Officer of QART Medical and Chair of the department of biomedical engineering at Tel Aviv University, has published a paper in Nature Photonics titled "Label-free Biomedical Optical Imaging”. This paper explores various label-free optical imaging technologies, which are non-destructive approaches to visualizing biomedical samples for both research and clinical diagnosis.

Among other topics, this paper reviews the advanced technologies that are implemented in QART’s flagship device, the Q300™. The Q300™ is a breakthrough solution that uses quantitative phase microscopy (QPM) to provide IVF (in vitro fertilization) clinicians with real time, objective, and quantitative morphological information on individual cells and is now in clinical outcome studies.

The paper can be found at the following link: https://www.nature.com/articles/s41566-023-01299-6

About QART Medical

QART Medical is an ISO13485 certified MedTech company addressing the global infertility epidemic. To do so, QART has developed the Q300™, a breakthrough solution to male infertility issues that provides a quantitative characterization of sperm cell morphology to facilitate informed clinical decision making when selecting cells for use in in-vitro fertilization (IVF). QART aims to improve current success rates of Intra-Cytoplasmic Sperm Injection (ICSI) by quantitatively characterizing the morphology and composition of individual sperm cells with 3D topographic imaging. The Q300™ is registered with the US FDA and is in the process of CE-Mark registration and Israeli regulatory registration for commercial sales.


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QART Medical Featured in the Rochester Business Journal – Luminate N.Y. Spotlight

QART Medical was featured in the Rochester Business Journal as a startup participating in Luminate NY, a startup accelerator for companies who employ a novel use of optics, photonics, and imaging.

“'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.'"

QART's feature can be found here: Israeli imaging startup addressing male factor infertility | Luminate N.Y. Spotlight | Rochester Business Journal (rbj.net)

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Publications

1

M. Haifler, P. Girshovitz, G. Band, G. Dardikman, I. Madjar, and N. T. Shaked, “Interferometric phase microscopy for label-free morphological evaluation of sperm cells,” Fertility and Sterility, Vol. 104, Issue 1, pp. 43-47, 2015

2

M. Balberg, M. Levi, K. Kalinowski, I. Barnea, S. Mirsky, and N. T. Shaked, “Localized measurements of physical parameters within human sperm cells obtained with wide-field interferometry,” Journal of Biophotonics 10, 1305–1314, 2017

3

S. Mirsky, I. Barnea, and N. T. Shaked, “Label-free quantitative imaging of sperm for in-vitro fertilization using interferometric phase microscopy,” Journal of Fertilization: In Vitro, IVF – Worldwide, Reproductive Medicine, Genetics & Stem Cell Biology, 2016

4

P. Jacob Eravuchira, S. K. Mirsky, I. Barnea, M. Levi, M. Balberg, and N. T. Shaked, “Individual sperm selection by microfluidics integrated with interferometric phase microscopy,” Methods, Vol. 136, pp. 152-159, 2018

5

P. Girshovitz and N. T. Shaked, “Doubling the field of view in off-axis low-coherence interferometric imaging,” Nature – Light: Science and Applications (Nature LSA), Vol. 3, e151, pp. 1-9, 2014

6

P. Girshovitz and N. T. Shaked, “Compact and portable low-coherence interferometer with off-axis geometry for quantitative phase microscopy and nanoscopy,” Optics Express, Vol. 21, Issue 5, pp. 5701-5714, 2013

7

N. T. Shaked, “Quantitative phase microscopy of biological samples using a portable interferometer,” Optics Letters Vol. 37, No. 11, 2016-2019, 2012

8

P. Girshovitz and N. T. Shaked, “Fast phase processing in off-axis holography using multiplexing with complex encoding and live-cell fluctuation map calculation in real-time,” Optics Express, Vol. 23, Issue 7, pp. 8773-8787, 2015

9

P. Girshovitz and N. T. Shaked, “Real-time quantitative phase reconstruction in off-axis digital holography using multiplexing,” Optics Letters, Vol. 39, No. 8, 2262-2265, 2014

10

P. Girshovitz and N. T. Shaked, “Generalized cell morphological parameters based on interferometric phase microscopy and their application to cell life cycle characterization,” Biomedical Optics Express, Vol. 3, No. 8, pp. 1757-1773, 2012