ChroMedX!
;D
Thank you for your email – you have nothing to be sorry about. We are happy to hear from you and your report on market sentiment.
In regards to the warrants in April, I understand your concern. Whenever you have warrants out below the market this is a valid point. As I mentioned before a very large portion of these warrants are in the hands of large long-term focused shareholders who are not likely to sell and effect the market negatively to exercise their warrants. Also well over 1M of these have already been exercised. In my review I would say that less than 800,000 are with investors outside of this group. The warrants expire on April 24, 2018 which is approximately 3 months from now. While warrants can put downward pressure on the market they also help capitalize the Company.
Before and during clinical testing for FDA the ChroMedX business and product development team will likely decide to conduct multiple clinical studies. These clinical studies are conducted by third parties at hospitals or clinics and this does not require a pre-production or FDA device. The purpose of these studies are to demonstrate the advantages of the HemoPalm over competing devices/processes in the setting and show diversity of application. These are done strategically to increase the value proposition of the HemoPalm and can add significant value to the technology.
In regards to clinical testing and FDA regulatory approvals. Clinical testing takes place after the Company finalizes a pre-production device. The clinical testing process for the FDA involves testing blood samples against predicate device(s), this part of the process for an 510(k ) class II device should take around 90 days from start, this is a straightforward process and is very different from pharmaceuticals or class III medical devices. Once the clinical testing is complete the Company provides the results along with all other regulatory documentation that the Company works on an ongoing basis. The FDA then has 90 days to respond to the Company at which point they can confirm or ask for further information.
New CEO Lahav Gil and the product and business development teams are now reviewing the regulatory and business development strategy with Richard, Thomas and the DxEconomix team. As you know members of the Dx team have considerable executive experience with the majors in the space and high-value transactions. They are directing ChroMedX on how to generate the highest possible value in the shortest amount of time for the HemoPalm based on their experience and relationships with these Companies. Lahav Gil and his team have developed hundreds of medical devices across the med-tech sector and they are working now to create efficiencies and innovations to service these key strategic relationships. It is important to conduct this review now as once the technology is finalized and the Company conducts clinical testing for FDA it is a very difficult and expensive process to retroactively amend the technology to increase its valuation.
Thanks again,
Clark
Du nennst die Konkurrenz, übersiehst aber das es sich um eine NEUE
LEISTUNGSKLASSE beim HemoPalm handelt ! was der kann, kann keiner der auf dem
Markt befindlichen Geräte, und das die nächsten 20 Jahre ( +/-) aufgrund des Patentschutzes.
Das heißt im Umkehrschluss das die anderen Hersteller schauen müssen das sie nicht den Anschluss
verlieren, nicht Chromedx (vorausgesetzt die klini. Prüfung und damit die FDA Zulassung erfolgt)
ist selbiges aber erledigt, erledigt sich der hier oft beschriebene Rest auch im Sinne von Cromedx
und seiner "Fan Gemeinde" und die Dauerpessimisten schauen in die Röhre.
Gruß Starkoch
Ps : Nur meine Meinung und keine Aufforderung mit dieser Aktie zu handeln!
macht euch um mich keine Sorgen, komm schon klar :-)))
lasst euch nicht blenden ;-)
man liest sich zwischendurch mal wieder
happy trades
Optionen
| Boardmail an "Cobra7" |
Wertpapier: Scryb Inc |
Aber bitte, ich bin absoluter Laie und hier nur aus einem Bauchgefühl investiert.
Jessica Kuhn as Chief Operations Officer
January 23, 2018 – ChroMedX Corp. (the “Company”) (CSE: CHX, OTC: CHXIF, Frankfurt: EIY2), developer of the HemoPalm Handheld Blood Analyzer System, is pleased to announce the appointments of Dr. Richard Janeczko as Chief Commercial Officer (CCO) and Jessica Kuhn as Chief Operations Officer (COO). Dr. Janeczko and Ms. Kuhn’s positions are effective immediately.
“It is very exiting to start the scale-out of the ChroMedX executive team with the appointments of Jessica Kuhn and Dr. Richard Janeczko.” said Lahav Gil, CEO & Director, ChroMedX Corp.
Earlier this month the Company announced the appointment of med-tech visionary Lahav Gil as CEO and Director. Mr. Gil joined the Company as the founder of the medical device industrial design and productization firm, Kangaroo Group where he served as CEO until its sale to Canada’s largest medical device design company Starfish Medical in April 2017. At the time of the sale Kangaroo had 23 employees and were concurrently managing the development, productization and contract manufacturing of multiple medical device technologies under its ISO 13485 QMS.
Ms. Jessica Kuhn has worked in technology product development for over a decade. Jessica acted as COO at Kangaroo Group alongside CEO Lahav Gil where she managed operations and development on projects for key clientele until Kangaroo was sold in 2017. The board of directors now welcomes her as COO of ChroMedX.
“I am so pleased to welcome Jessica to the ChroMedX team, after having played such an integral role in the management of the operations of Kangaroo. Aside from simply being a wonderful person to work with, Jessica’s ability to build culture, create systems and policy, manage special projects and basically run the day to day operations of an agile and effective company with multiple teams and projects on the go, will be an invaluable asset to ChroMedX. As COO Jessica’s first responsibility will be to manage the build-out of our core team and operations as we continue on our path of establishing the HemoPalm as the premier blood analyzer in the space.” said Lahav Gil, CEO & Director, ChroMedX Corp.
Dr. Janeczko brings over 25 years of experience in the in-vitro diagnostics industry having held executive roles in numerous diagnostic companies before he founded healthcare economic consulting firm DxEconomix Inc. in 2013. Richard joined the board of ChroMedX in December 2017 and has now joined the executive team as CCO leading the commercial strategy of the HemoPalm Handheld Blood Analyzer System.
“Having Richard on-team is a great pleasure and strengthening asset. His in-depth knowledge of the space and his industry connections will help us conceptualize and implement as we strive to build the world’s truly best “at the bedside” blood analyzer, integrating seamlessly into clinical workflow and reducing barriers to adoption, and ensuring that we implement the right strategy towards a high-value transaction.”
As Chief Commercial Officer Dr. Janeczko is responsible for the management of marketing and business development activities related to the development and positioning of the HemoPalm Handheld Blood Analyzer System. Dr. Janeczko’s core focus is to optimize the market potential of the HemoPalm and ensure the Company’s readiness for the completion of a high value transaction. This includes the alignment of the product development plan and technology roadmap with market needs as well as compatibility with critical care clinical management practices and cost-effectiveness goals. As CCO Richard will be corresponding with and assessing individual strategic players to determine how the HemoPalm specifically aligns with their market strategies to maximize the Company’s value offering to existing product lines. In addition, Richard will be organizing relationships with clinical sites in order to run HemoPalm trials under various scenarios for both regulatory and market development purposes.
About Dr. Richard Janeczko
Dr. Janeczko is a 25-year veteran of the in-vitro diagnostics industry, specializing in the marketing and management of molecular assays, proteomics, companion diagnostics, and personalized medicine. He has led multiple diagnostic marketing projects from design and development through regulatory approval and market launch. He is a strong advocate of health economics as the key driver for new technology adoption in a global healthcare reform environment. In 2013, he formed DxEconomix to provide unique IVD marketing services based on system-wide economic impact of diagnostics and value-based pricing. DxEconomix has extensive experience in health economics, clinical sciences, and health technology assessment and adoption in multiple markets including USA, Canada and Europe.
Dr. Janeczko served as VP Emerging Markets and Technology at Luminex Corporation, as EVP Business Development and CSO at Tm Bioscience Inc., and as CEO of General Synthesis and Diagnostics. He played a lead in raising capital for Tm Bioscience and eventual sale of the company to Luminex Corp. (Austin, Texas). He holds a PhD in Biochemistry from the University of Alberta, a BSc in Microbiology from Strathclyde University, and is a member of several professional organizations and institutions.
About Jessica Kuhn
Ms. Kuhn has extensive experience managing projects in technology product development. She was formerly COO of Kangaroo group where she worked to implement systems and processes to improve and build stability in Kangaroo’s operations, while managing development projects for key clients. Before that she was Project Manager, Research & Development at Sunwell Technologies where she headed clean-tech development projects with partners from around the world. She holds an MBA from Rotman School of Management, a MASc in Mechanical Engineering and a BASc in Chemical Engineering from the University of Toronto.
The Company also announces that it has granted an aggregate of 3,500,000 options to purchase common shares of the Company exercisable at a price of $0.60 per share and expiring on January 24, 2023, to certain directors, officers and consultants of the Company.
ChroMedX News & Disclosure
allerdings ist er diesmal ja eher verhalten, fast langweilig. :-)) will wohl bafin nicht nochmal aufwecken :-)))
Das Unternehmen ist auf dem Weg. Die Zulassung scheint auf dem Weg! Einige werden entäuscht sein wenn ich sage das wir uns noch einige Zeit gedulden werden müssen, das ändert aber nichts im geringsten an meiner Ansicht und an den derzeitigen Fakten das unsere Chromi ein Star werden kann! Ich persönlich denk rein viertel bis halbes Jahr müssen wir einkalkulieren und den Stand der Zulassung abwarten. Es bleibt weiterhin spannend und ich mein vertrauen wurde bisher nicht! entäuscht!
Aktien = 80% Wartenzeit.. gehen wir es an.. nicht das Ziel aus den Augen verlieren.
Ich bin dabei.. :-)
Die regelmäßigen News finde ich auch sehr gut. Chrom scheint zu verstehen, das in D doch einige Kleininvestoren am Start sind. Mich würde mal interessieren wie viele Aktien in D von uns gehalten werden.
Mit dem Wissen von heute,
hätte ich gestern andere Fehler gemacht ;-)
https://www.marketwatch.com/story/...ity-management-system-2017-11-13 mit Googel übersetzen.