Provide a general overview and discussion of the activities of management.
The Issuer’s management was involved with ongoing operations with the
HemoPalm and the AUF, and with identifying and meeting with potential joint
venture partners both development and marketing. The management team was
also involved in a financing during the month.
The HemoPalm development program continues with the development of
prototype cartridges, biosensor, analyzer, spectroscopic and packaging.
Company has completed testing on the key spectroscopic component of the
analyzer of HemoPalm blood analysis device.
During the month the COmpany engaged Ants Kahu & Associates to implement
quality management systems to meet FDA (Food and Drug Administration) and ISO
(International Organization for Standardization) requirements.
Ants Kahu & Associates will work closely with ChroMedX to develop and implement
the FDA quality system requirements (QSR) 21 CFR Part 820 and ISO 13485:2016.
These quality management systems are mandatory for any company developing and
manufacturing medical devices. These requirements are meant to ensure that
medical devices are safe, effective and in compliance with the regulatory body of the
country the device is to be sold in.
During the month the Company entered into a binding letter of intent (LOI) with
diagnostic marketing specialist DxEconmix Inc. (DxEx) headquartered in Glendale,
Calif., to conduct a high-value transaction for the company. The company is now
working with DxEconomix to establish a definitive agreement with a view to
maximize shareholder value.
ChroMedX retained DxEconomix in August, 2017, for an initial assessment period to
evaluate the HemoPalm blood analyzer's product viability, value offering and market
potential in preparation for the commercial product launch of the HemoPalm system.
Following the 90-day due diligence process ChroMedX has accepted a proposal from
DxEconomix and executed a binding LOI engaging DxEx for the purposes of
completing a value-based transaction of the company.
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