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VIDEO: XPhyto Therapeutics $XPHY.ca $XPHYF Three Divisions Firing On All Cylinders As They Move From The Lab to the Clinic $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 4:41 PM on Tuesday, May 4th, 2021
company

XPhyto Therapeutics $XPHY.ca $XPHYF Signs German Distribution, Storage and Logistics Agreement for 25-Minute COVID-19 PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:21 AM on Wednesday, April 21st, 2021
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XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce that it has entered into an agreement (the “Agreement”) with an established German pharmaceutical wholesaler and service provider (the “Distributor”) for the distribution, storage and logistics of XPhyto’s diagnostic products in Germany. The Agreement secures XPhyto a full-service distribution partner for its 25-minute SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-ID Lab is registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.

Pursuant to the Agreement, the Distributor will distribute, store and deliver Covid-ID Lab test kits according to the product specifications and all applicable regulations to XPhyto’s customers. In addition, the Distributor will provide the documentation and fulfillment of storage obligations, the fulfillment of reporting and notification obligations, and the processing of any returned products. The obligations and services to be rendered under the Agreement satisfy all of the logistical and regulatory requirements for the commercial sale of COVID-ID Lab in Germany.

“With this agreement, we have secured a strong partner with an established medical distribution network throughout Germany. This is an exciting and critical step towards commercial sales of COVID-ID Lab,” said Hugh Rogers, CEO and Director of XPhyto. “The Company’s commercialization strategy is focused on the German market for initial product launch and the creation of robust and sustainable sales.”

Covid-ID Lab is a multiplex viral RNA probe kit based on the reverse transcriptase-polymerase chain reaction (RT-PCR) method. Covid-ID Lab requires only a single 20-minute PCR thermal cycle for assay performance without prior RNA extraction as part of the sample preparation. Many widely available standard PCR instruments are suitable to run the test. Results are collected after the PCR cycle via easy-to-read optical indicator strips on a simple fluidics platform. The elimination of RNA extraction for sample preparation reduces cross-contamination risk and minimizes the need for lab materials and trained personnel. The rapid results, minimal laboratory equipment, and ease of use are expected to translate into reduced operating costs, greater convenience and portability.

XPhyto is currently in discussions with various potential customers, distribution and wholesale partners as well as potential licensees. The sales launch in Europe is targeted for April 2021. The Company will provide further information and updates in due course.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic.

About XPhyto Therapeutics Corp.

XPhyto Therapeutics Corp. is a bioscience accelerator focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization of emerging active pharmaceutical ingredients for neurological applications, including psychedelic compounds and cannabinoids. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.

Read More:https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/759431-xphyto-signs-german-distribution-storage-and-logistics-agreement-for-25-minute-covid-19-pcr-test/messages/2312832#message

XPhyto Therapeutics $XPHY.ca $XPHYF Adds Top-Level Executive Talent to its Global Operations $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:12 AM on Tuesday, April 20th, 2021
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  • Mr. Wolfgang Probst appointed as the Chief Operations Officer (COO) of XPhyto
  • Addition of Mr. Manfred Buchberger as the Head of Corporate Development

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce the appointment of Mr. Wolfgang Probst as the Chief Operations Officer (COO) of XPhyto and the addition of Mr. Manfred Buchberger as the Head of Corporate Development at XP Diagnostics GmbH (“XP Diagnostics”), a wholly owned German subsidiary of the Company. With European CE-IVD approval announced March 18, 2021, for the Company’s lead diagnostic product, Covid-ID Lab, XPhyto continues to enhance its commercial team as it anticipates near-term distribution and sales.

Mr. Probst is an experienced management and finance consultant with expertise in mergers and acquisitions, corporate re-organizations, and divestitures. He has a proven track record of leadership, strategic planning, and organizational restructuring having guided multiple startups from inception to financial success. Mr. Probst was responsible for successfully structuring XPhyto’s European operations and establishing associated partnerships and collaborations, both commercial and academic. As the newly appointed COO of XPhyto, Mr. Probst will be responsible for managing the Company’s global operations. Mr. Probst will remain a director of XPhyto and the managing director of XP Diagnostics.

Mr. Buchberger is a global leader in the medical diagnostics industry. For almost a decade, he was the CEO and a member of the Global Management Board of a major European medical diagnostics and analytics company with annual revenues of over 600 million Euro. His addition to the Company brings decades of diagnostics industry experience focused on international business development, sales, marketing, and product management. Mr. Buchberger has successfully created, implemented, and managed business growth strategies across Europe, North and South America, Middle East and Asia, including the successful launch of new medical diagnostic products.

On March 18, 2021, XPhyto announced European commercial approval of Covid-ID Lab, a rapid 25-minute point-of-care PCR test for COVID-19. Mr. Probst and Mr. Buchberger will be responsible for executing the global product launch and businesses development of Covid-ID Lab.

Covid-ID Lab is a multiplex viral RNA probe kit based on the reverse transcriptase-polymerase chain reaction (RT-PCR) method. Covid-ID Lab requires only a single 20-minute PCR thermal cycle for assay performance without prior RNA extraction as part of the sample preparation. Many widely available standard PCR instruments are suitable to run the test. Results are collected after the PCR cycle via easy-to-read optical indicator strips on a simple fluidics platform. The elimination of RNA extraction for sample preparation reduces cross-contamination risk and minimizes the need for lab materials and trained personnel. The rapid results, minimal laboratory equipment, and ease of use are expected to translate into reduced operating costs, greater convenience and portability.

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/759347-xphyto-adds-top-level-executive-talent-to-its-global-operations/messages/2312660#message

XPhyto Therapeutics $XPHY.ca $XPHYF Announces European Approval for 25 Minute COVID-19 PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:35 AM on Thursday, March 18th, 2021
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  • CE Mark received for in vitro diagnostic (IVD) test for the detection of SARS-CoV-2
  • Rapid results with ease of use – single 20-minute PCR cycle plus 5-minute detection process
  • High sensitivity – 104.73 c/PCR limit of detection with 95% confidence interval
  • High specificity – zero cross-reactivity on 19x respiratory infectious disease panel
  • High robustness – no impact on results from minor changes in process parameters
  • 100% repeatability and laboratory precision observed
  • Sales launch in Europe planned for April 2021

XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce the European approval of its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-ID Lab is now registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.

“Our test is one of the fastest PCR-based COVID-19 tests currently approved. With a sample collection to result time of 25 minutes, Covid-ID Lab combines the speed of a rapid screening test with the accuracy of a PCR diagnostic,” said Hugh Rogers, CEO and Director of XPhyto. “Covid-ID Lab is designed for point-of-care testing, particularly in satellite and small-scale labs, such as transportation hubs, borders, care facilities, schools, pharmacies, and hospitality settings.”

Covid-ID Lab is a multiplex viral RNA probe kit based on the reverse transcriptase-polymerase chain reaction (RT-PCR) method. For assay performance, Covid-ID Lab requires only a single 20-minute PCR thermal cycle without prior RNA extraction as part of the sample preparation. Many widely available standard PCR instruments are suitable to run the test. Results are collected after the PCR cycle via easy-to-read optical indicator strips on a simple fluidics platform. The elimination of RNA extraction for sample preparation reduces the risk of cross-contamination and minimizes the need for lab materials and trained personnel. The rapid results, minimal laboratory equipment, and ease of use are expected to translate into reduced operating costs, greater convenience and portability.

During validation of the assay, the limit of detection for SARS-CoV-2 RNA was determined to be 104.73 c/PCR within a 95% confidence interval. Specificity of 100% against 19 other pathogens of serious respiratory infections was demonstrated on a respiratory verification panel. Precision was determined through evaluation of variance of the analysis results due to random deviations, a repeatability/intra-assay precision evaluation (same lab, user, equipment, etc.), and a laboratory precision evaluation (different lab, user, equipment, etc.). Robustness was measured by evaluation of the impact of minor changes on process parameters (transport medium, PCR cycler model, ramp rate, template volume, hybridization mixing ratio, etc.). The validation studies were carried out accordingly to ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology and VQ-015 Validation of Methods, European Medicines Agency. The quality management system was in accordance with EN ISO 13485: 2016 and EN ISO 9001: 2015.

Read More:https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/757566-xphyto-announces-european-approval-for-25-minute-covid-19-pcr-test/messages/2308737#message

XPhyto Therapeutics Partner $XPHY.ca $XPHYF Receives ISO Certification for 25-Minute COVID-19 RT-PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 10:10 AM on Wednesday, March 10th, 2021
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  • Launching of Covid-ID Lab, A Rapid, Accurate & Robust COVID-19 Test System
  • Licensing & Distribution Partnerships Coming

XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce successful EN ISO 13485 certification for the rapid point-of-care, SARS-CoV-2 RT-PCR Test System (“Covid-ID Lab”). This standardization and quality assurance certification provides authorization for distribution of Covid-ID Lab upon receipt of CE mark (CE-IVD) approval. The Company expects CE-IVD approval as an in vitro diagnostic product in March 2021.

EN ISO 13485 is the internationally recognized European standard for quality control and management systems in the design and manufacture of medical devices. It is accepted as the basis for CE certification of medical devices under relevant European directives and regulations.

“We are pleased to remain on schedule with the launch of Covid-ID Lab and will continue to move forward as efficiently as ever,” said Hugh Rogers, CEO and director of XPhyto. “At the same time, our experienced launch team is working hard to bring Covid-ID Lab to market and to establish German and international licensing and distribution partnerships.”

Covid-ID Lab was designed to be a rapid, accurate and robust COVID-19 test system with reduced operating costs and increased convenience and portability. As previously announced on February 24, 2021, the company placed its first production order from 3a for 9,600 individual tests. Delivery of this first order is expected by mid-March 2021 and is primarily intended to provide potential German and international distributors and licensees and their respective government regulators with test samples for review and evaluation. Initial commercial manufacturing is planned for Germany, with additional capacity in other jurisdictions expected to follow. The sales launch in Europe is targeted for April 2021. XPhyto is currently in discussions with potential distribution and wholesale partners in Europe and the Middle East.

XPhyto and 3a are also developing a portfolio of oral biosensor screening tests for detection of bacterial and viral infectious diseases, including influenza A, group A strep, stomatitis, periimplantitis, and periodontitis. Additional pandemic-focused biosensors are in development, specifically for H1N1 (swine flu), and H5N1 (avian flu). The Company is planning the commercial launch of its first biosensor product in the second half of 2021.

Read More:https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/756960-xphyto-partner-receives-iso-certification-for-25-minute-covid-19-rt-pcr-test/messages/2307349#message

XPhyto Therapeutics $XPHY.ca $XPHYF Completes Corporate Rebranding and Launches New Website $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:05 AM on Thursday, March 4th, 2021
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  • Rebranding Reflects XPhyto’s Commitment To Operational Achievement
  • Product Development Advance From The Lab To The Clinic
  • Cusp Of Two Major Commercial Milestones Related To Our Rapid Point-Of-Care COVID-19 PCR Test System
  • A Bioscience Accelerator At The Leading-Edge Of The Life Science Industry

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), is pleased to announce that the Company has completed a corporate rebranding and launched a new website which can be viewed at www.xphyto.com.

The rebranding decision reflects the Company’s commitment to operational achievement in 2021 as a number of product development programs advance from the laboratory to the clinic. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto is targeting value creation through commercialization of its development pipeline and focused investment in impact driven innovation.

“The Company is excited to introduce a fresh look at such a pivotal point in our business growth,” said Hugh Rogers, CEO & Director of XPhyto. “With all technical requirements fulfilled, we are on the cusp of two major commercial milestones related to our rapid point-of-care COVID-19 PCR test system. With expected ISO certification and CE-IVD approval pending, we are excited to enter the next phase of our business with a positive, crisp and energetic new image.”

The Company will provide further information and updates in due course. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic. Further, its COVID-19 related test products are not yet approved and are still subject to risks associated with the regulatory approval process.

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/756560-xphyto-completes-corporate-rebranding-and-launches-new-website/messages/2306460#message

XPhyto Therapeutics $XPHY.ca $XPHYF Places First Order for 25-Minute Covid-19 RT-PCR Tests $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:05 AM on Wednesday, February 24th, 2021
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  • Placed First Order for its Rapid Point-Of-Care COVID-19 Test System
  • 9600 Individual Tests Ordered
  • Mid-March Delivery
  • Additional Pandemic-Focused Biosensors in Development

XPhyto Therapeutics. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company“), is pleased to announce that it has placed the first order for its rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”) from its exclusive diagnostic development partner, 3a-diagnostics GmbH (“3a”).

The first order of Covid-ID Lab is for 9,600 individual tests, which are packaged in 200 kits of 48 tests each. Delivery of the first order is expected by mid-March 2021 and will be primarily used to supply prospective distribution partners and licensees and their respective government regulators with test samples for review and evaluation. The tests will be manufactured in the German state of Baden-Württemberg.

“We are pleased to report that all steps towards the launch of Covid-ID Lab remain on track within an ambitious timeline,” said Hugh Rogers, CEO, and Director of XPhyto. “Our experienced market launch team is working quickly to bring the product to market, as well as to establish licensing and distribution partnerships. We are confident that Covid-ID Lab, as a 25-minute PCR test with minimal technical and personnel requirements, will be a stand-out product in the COVID-19 test market.”

Covid-ID Lab was designed to be a rapid, accurate, and robust COVID-19 test system with reduced operating costs and increased convenience and portability. XPhyto expects 3a to receive ISO 13485 medical device manufacturer approval by the end of February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March. Initial commercial manufacturing is planned for Germany, with additional capacity in other jurisdictions to follow. The sales launch in Europe is targeted for April 2021. XPhyto is currently in discussions with potential distribution and wholesale partners in Europe and the Middle East.

XPhyto and 3a are also developing a portfolio of oral biosensor screening tests for detection of bacterial and viral infectious diseases, including influenza A, group A strep, stomatitis, periimplantitis, and periodontitis. Additional pandemic-focused biosensors are in development, specifically for H1N1 (swine flu) and H5N1 (avian flu). The Company is planning the commercial launch of its first biosensor product in the second half of 2021.

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/755962-xphyto-places-first-order-for-25-minute-covid-19-rt-pcr-tests/messages/2305102#message

XPhyto Therapeutics $XPHY.ca $XPHYF Builds Commercial Team to Launch 25-Minute Covid-19 Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:32 AM on Monday, February 22nd, 2021
  • Expedited formation of commercial team to launch its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system
  • Expects medical device manufacturer approval by the end of February
  • European regulatory approval as a commercial in vitro diagnostic device by early March.

XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company“), is pleased to announce that the Company has expedited the formation of an experienced commercial team to launch its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-ID Lab was developed by XPhyto’s exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”). XPhyto expects 3a to receive ISO 13485 medical device manufacturer approval by the end of February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March.

The market launch team consists of world-class clinical and pharmaceutical executives and service providers who bring the experience and expertise necessary to effectively and rapidly drive the commercialization of Covid-ID Lab. Collectively, the team brings decades of experience in the biotech and pharmaceutical industries, including: executive leadership, business development, regulatory compliance, product launch, international marketing and sales, production, quality assurance, and M&A. In particular, members of the team have led medical diagnostic company growth from inception to over 500 million Euro per year in multinational sales.

“We are extremely fortunate to now have a team with deep expertise in medical diagnostic product commercialization. The team has extensive experience from regulatory approval to international production and sales,” said Hugh Rogers, CEO and Director of XPhyto. “As we near expected regulatory approval, XPhyto’s business is rapidly evolving from innovation to impact. We are working hard to put the Company in the best possible position to execute on our business strategy.”

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/755782-xphyto-builds-commercial-team-to-launch-25-minute-covid-19-rt-pcr-test/messages/2304693#message

Xphyto $XPHY.ca $XPHYF European CE-IVD Application for 25-Minute COVID-19 RT-PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:11 AM on Tuesday, February 16th, 2021
  • Expects approval as a medical device manufacturer by late February
  • European regulatory approval as a commercial in vitro diagnostic device by early March.
  • Covid-ID Lab was designed to be a rapid, accurate and robust test system with reduced operating costs and increased convenience and portability.

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce all actions and procedures required for XPhyto Therapeutics Corp.’s European regulatory application for the rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system have been completed. 3a-diagnostics GmbH, Xphyto’s exclusive German diagnostics development partner, expects ISO 13485 approval as a medical device manufacturer by late February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March.

“We are very pleased with the team’s swift development progress,” said Hugh Rogers, CEO & Director of XPhyto. “Our goal was to create the fastest and most portable COVID-19 PCR test on the market. We are confident in our prospects for an expedited approval and look forward to commercial launch in short order”

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/755390-xphyto-european-ce-ivd-application-for-25-minute-covid-19-rt-pcr-test/messages/2303789#message

VIDEO – AGORACOM Beyond The Expert Welcomes Venture Capitalist Leigh Hughes To Discuss Mountain Valley MD $MVMD, Valeo Pharma $VPH $VPHIF and Xphyto Therapeutics $XPHY $XPHYF

Posted by AGORACOM-JC at 6:36 PM on Thursday, February 11th, 2021

AGORACOM followers have given us great feedback on our hit series “Beyond The Press Release” (BTPR) in which we speak with small cap CEO’s about important press releases in greater depth and, quite frankly, in layman’s terms for investors to truly understand their significance.  

Nowhere is this more important than in the world of disruptive technologies, biotech and pharma.  Each of these industries share two distinct traits:

  • The possibility for explosive growth with disruptive new products
  • Difficulty in conveying disruptive new products that, by their nature, have never been seen before by investors.

Whereas BTPR tells these stories from the side of small cap public companies, Beyond The Expert (BTE) tells these stories from the perspective of experts on these topics – and we couldn’t think of anyone better to start off this series than Leigh Hughes.  

Leigh is a Venture Capitalist who I’ve personally watched conduct incredible due diligence and invest into many small cap companies that have generated incredible returns over 12-18 month periods.    

Leigh is so good at what he does that many global private equity funds and institutions take his call and often follow him into investments he chooses to make.  Moreover, he serves as an advisor to several small cap companies.

If you ever wanted to truly learn how to become a great small cap investor, it doesn’t get much better than this.  

Without further adieu, watch this great interview with Leigh Hughes and make sure to provide us with your feedback via comments on Twitter, YouTube or wherever you may be watching or listening.