QART-Medical receives ISO13485 certificate



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QART Medical is a MedTech startup, focusing on male fertility utilizing cutting edge bio-photonics technologies, originating from a decade’s work of Prof. Natan T. Shaked’s group in Tel-Aviv University.


CORPORATE HISTORY IN A NUTSHELL:

Academia

2010

2011-2015

2015-2017

Prof Shaked joins T.A.U

Basic research @T.A.U

Momentum Accelerator @ T.A.U

Industry

8/18

9/19

6/20

3/21

8/21

3/22

QART Spin out

Seed financing by Chartered

Q300 design finalized

Q100 Project launched

Q300 clinical study starts

Q100 joins clinical study


QART Medical was co-founded in 2018 by Alon Shalev, a seasoned MedTech inventor, entrepreneur and Prof. Natan Shaked, a world renowned expert in quantitative phase microscopy, to substantially improve clinical outcome of IVF, by providing highly extensive, quantitative, objective and recordable information to the embryologist performing the IVF procedure. Benchmarking such information to the community’s standard measures (e.g., WHO2021 criteria for morphology and motility of human sperm cells) would be a huge step forward in addressing male-factor infertility. Moreover, as QART technology allows comprehensive 3D imaging of each sperm cell without using chemical stains, QART lays the ground for the “deep tech” revolution in male fertility, by yielding features that were up-to-date unavailable to the clinics performing IVF, yet, are considered of uttermost importance, e.g. estimation of DNA fragmentation level and midpiece morphology.


QART’S Q300 SYSTEM PROVIDES:

  • Comprehensive, stain-free imaging of sperm cells

  • Quantitative characterization of sperm morphology as if the cells are chemically stained

  • All information being logged for Quality Management purposes

  • Comparison with consensus objective criteria (e.g. WHO2010 guidelines)

  • Disruptive 1st and only Quantitative Phase Microscopy (QPM) technology adapted to the clinic.

  • Cutting-Edge Features: 3D and 4D information, DNA fragmentation index (DFI)

QART Medical’s two products - the Q100 and Q300 – are in clinical studies, both planned to be FDA registered in Q3 2022. These studies have indicated good usability of the systems, as well as good agreement between the “gold-standard”, which is measurements of the stained sperm cells under bright-field microscopy, and the QART system measurements of the very same cells, but without using staining, which can now be performed for the first time during IVF procedures (where cell staining is not allowed).

QART plans to initiate post-approval commercial registries in the US and Japan in Q1 2023, and is now completing a mezzanine financing, led by Chartered-Opus, and other internal share-holders, raising up to $4 million at a $25 million pre-money valuation. This financing has a USD $1.2 million slot, open for deferred closing by dec 2022.

Q3-22

Q4-22

Q2-23

Q4-23

PERFORMANCE & USABILITY STUDY

CLINICAL OUTCOME STUDIES

US, JP MARKETING

FDA

CE

PRODUCT R&D 300

GO-TO-MARKET PREPARATION

SOFT LAUNCH


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