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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.”

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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

Xphyto $XPHY.ca $XPYHF to Produce Mescaline for Psychedelic Programs $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:21 AM on Wednesday, February 10th, 2021
  • Focused on the synthesis of pharmaceutical grade mescaline
  • Mescaline has shown particular promise for the treatment of addiction and depression.

Xphyto Laboratories Inc., Xphyto Therapeutics Corp.’s wholly owned Alberta subsidiary, has added mescaline production to its psychedelic medicine programs. Further to the Company’s press release dated February 3, 2021, the capacity under contract with Applied Pharmaceutical Innovation will focus on the synthesis of pharmaceutical grade mescaline. Mescaline has been anecdotally recognized as a relatively safe psychedelic drug and has shown particular promise for the treatment of addiction and depression.

“In addition to our European-based psilocybin biotechnology production, the Company has now expanded its portfolio of psychedelic compounds to include mescaline. Our goal is to develop industrial scale production processes for the wholesale market and for incorporation into XPhyto’s thin film drug delivery platforms” commented Hugh Rogers, CEO & Director. “We see a significant market opportunity in the production of pharmaceutical mescaline and the standardization of dosage formulations with precise, predictable and efficient drug delivery for clinical study and therapeutic use”

Mescaline (3,4,5-trimethoxyphenethylamine) is a naturally occurring psychedelic compound found in certain cacti, including peyote, San Pedro, and Peruvian torch, and is most commonly associated with traditional Native American religious rituals and ceremonies. Mescaline is a Schedule I drug in the United States; however, it is legal in certain religious ceremonies registered by the Native American Church and its use is expanding as a supplement to various types of meditation and psychedelic therapy.

In general, psychedelic compounds have emerged as a new class of drugs with the potential to improve the treatment of mental health related medical conditions such as depression, anxiety, addiction, and trauma-related stress disorder. The Company believes that the industrial-scale production of pharmaceutical grade psilocybin and mescaline will provide a strong foundation for its psychedelic medicine programs.

Read More:https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/755075-xphyto-to-produce-mescaline-for-psychedelic-programs/messages/2303018#message

Xphyto Unit $XPHY.ca $XPYHF Signs Psychedelic Deal with Applied Pharma $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:29 AM on Wednesday, February 3rd, 2021
  • Announces Psychedelic Pharmaceutical Production Agreement
  • Synthesis of pharmaceutical grade psychedelic compounds
  • Working toward regulatory approval for the commercial production process

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce that XPhyto Laboratories Inc. (“XPhyto Labs”), its wholly owned Alberta subsidiary, has signed an agreement (the “Agreement”) with Applied Pharmaceutical Innovation (“Applied”) for the synthesis of pharmaceutical grade psychedelic compounds and the parallel development of the standard operating procedures necessary to obtain regulatory approval for the respective commercial production process.

The industrial-scale production of standardized active pharmaceutical ingredients is an important part of XPhyto’s psychedelic pharmaceutical program as the Company anticipates a shortage of large-scale supply of certain approved and standardized pharmaceutical grade psychedelics.

Applied is a not-for-profit institution at the University of Alberta created to support translational drug development for industry and innovators. With an interdisciplinary team of over 30 pharmaceutical scientists, clinicians, regulatory, patent, and market experts, Applied provides industry with access to translational science in a framework that supports commercial success. This includes retention of IP and ownership of work product for the funder, focused and efficient project execution, and regulatory compliant operations.

Read More: https://agoracom.com/ir/XphytoTherapeutics

XPhyto Therapeutics $XPHY.ca $XPYHF Announces Drug Formulation Strategy and 2021 Milestones Innovation to Impact $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 7:56 AM on Thursday, January 28th, 2021
  • Construction of commercial drug manufacturing facility in Germany
  • Four clinical studies in neurological indications in 2021
  • Development of oral biosensor and contract development & manufacturing
  • Psychedelic transdermal and sublingual drug formulation development

VANCOUVER, BC / ACCESSWIRE / January 28, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company“) is pleased to announce its drug formulation and delivery business strategy and milestones for 2021. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto targets growth through commercialization of its product pipeline and focused investment in impact driven innovation with the potential for meaningful value creation.

Further to XPhyto’s press release dated January 18, 2021, the Company’s core milestones for this year include the commercialization of infectious disease diagnostics, the clinical validation of transdermal and sublingual drug formulations and continued investment in psychedelic medicine.

Regarding XPhyto’s drug formulation business, the Company is pleased to set out the strategy and milestones for 2021 of its wholly owned German subsidiary, Vektor Pharma TF GmbH (“Vektor”). Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.

“2021 is expected to be a transformative year for Vektor. We will be building on significant momentum from 2020 as we advance our drug formulation, contract development, and psychedelic business,” said Prof. Dr. Thomas Beckert, managing director of Vektor Pharma TF GmbH. “The addition of scalable in-house manufacturing capability creates the potential for significant growth across virtually all of our development and commercialization programs.”

Vektor is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of thin film drug formulations, particularly transdermal patches and sub-lingual (oral) strips for the delivery of active pharmaceutical ingredients (“API”) for the treatment of pain and neurological conditions.

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XPhyto $XPHY.ca Announces Business Strategy and Milestones For 2021 Innovation to Impact $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 7:41 AM on Monday, January 18th, 2021
  • Commercialization of rapid COVID-19 PCR test
  • Clinical validation of transdermal and sublingual drug formulations
  • Psychedelic API production, drug formulation and clinical integration

XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company“) is pleased to announce its business strategy and milestones for 2021. The Company is on the cusp of transformational change as product development programs advance from the laboratory to the clinic. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto will target growth through commercialization of existing products and focused investment in impact driven innovation with the potential for extreme value creation.

The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. Following a successful business year 2020, XPhyto is well positioned to execute on important core milestones in all business divisions, which include the commercialization of infectious disease diagnostics, the clinical validation of transdermal and sublingual drug formulations and continued investment and development in psychedelic medicine.

Diagnostics

XPhyto’s lead diagnostic product is an accurate, rapid and highly portable PCR diagnostic test system which is secured under an exclusive global commercialization agreement from its German development partner, 3a-diagnostics GmbH (“3a”). PCR testing has emerged as the only internationally recognized standard for COVID-19 testing, which is expected to play a critical role in expediting the revitalization of many industries, particularly domestic and international travel. Successful validation of the PCR system was achieved in Q4 2020 and the Company is confident that European commercial (CE-IVD) approval will be achieved in Q1 2021. XPhyto is in discussions to secure manufacturing and distribution partners in Europe and the Middle East in anticipation of pending commercial approval and product launch in Q1 2021.

In addition to COVID-19 products, XPhyto and its partner 3a, are developing and commercializing a portfolio of low-cost oral biosensors. The Company’s lead biosensor product is an oral health screening test for the detection of peri-implantitis. There is a significant clinical need for the early detection of infection associated with dental implants prior to the onset of irreversible tissue and bone damage. The company is targeting late 2021 for European commercial approval and product launch for several biosensor screening tests.

Drug Formulations and Delivery

XPhyto’s drug formulation business is focused on neurological indications with significant market demand and the potential for meaningful patient impact. In 2020, XPhyto’s German subsidiary, Vektor Pharma TF GmbH (“Vektor”), a leader in the development of transdermal and sublingual drug formulations reported significant advancements in four therapeutic development programs. Vektor also successfully developed a sublingual drug formulation on contract for a major generic drug manufacturer and distributor.

In 2021, the Company plans to complete human pilot studies on its four lead therapeutic products: 1) Rotigotine transdermal patch for Parkinson’s disease; 2) CBD oral/sublingual strip for treatment resistant Epilepsy; 3) THC oral/sublingual strip for anorexia/nausea; and 4) CBD:THC (1:1) oral/sublingual strip for Multiple Sclerosis associated spasticity. The Company is currently in ongoing discussions with multiple potential commercial partners, licensors and distributors and will be reviewing monetization opportunities on a continued basis.

Psychedelics

Psychedelic compounds are a highly promising new class of active pharmaceutical ingredient (“API”) with strong potential for the treatment of mental health related medical conditions such as depression, anxiety, addiction, and trauma-related stress disorder. Psychedelics could provide a major improvement over currently available therapeutics for a global market with unmet medical need.

XPhyto has entered into two psychedelic agreements: first, for the development of industrial scale biotechnology processes for the production of psilocybin, and second, for research and development related to multiple psychedelic compounds, including psilocybin, mescaline, LSD, MDMA, DMT, among others.

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/753246-xphyto-announces-business-strategy-and-milestones-for-2021-innovation-to-impact/messages/2298545#message

CLIENT FEATURE: Xphyto Therapeutics $XPHY.ca Providing Investor Access to Leading Edge Bioscience Opportunities $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 12:37 PM on Thursday, January 7th, 2021

(CSE:XPHY / OTC:XPHYF / FSE:4XT)

  • Completed Successful SARS-CoV-2 RT-PCR Diagnostic Test Kit Validation
  • Secured Exclusive Psychedelic Drug Development Agreement
  • Appointed European Healthcare Executive to Board of Director
  • Engaged German Partner for Development of Psilocybin API Production
  • Announced Update on Contract Drug Delivery Program
  • Announced Update on Oral Thin Film Drug Delivery Program
  • Provided Update on Parkinson’s Transdermal Patch

Three Xphyto Divisions:

1. Vektor Pharma TF: World-class thin film drug delivery platforms for transdermal and oral dissolvable dosage forms

2. 3a-Diagnostics: Rapid, low-cost screening tests for pandemic and dental health applications

3. Xphyto Laboratories Inc.: Development of industrial production processes for emerging active pharmaceutical ingredients, including psychedelics and cannabinoid isolates

1. Vektor Pharma TF GmbH – Drug Delivery

100% owned XPhyto subsidiary

Global leader in design, testing and manufacture of therapeutic film drug delivery systems

  • Major pharma clients – past, present and future
  • Focused and nimble team – rapid turnaround on new opportunities

Versatile platform technology

  • Transdermal patches (TDS) – slow and steady release
  • Oral dissolvable film (ODF) sublingual strips – instant bioavailability

EU GMP facilities in Baden-Württemberg, Germany

Holder of numerous German narcotics import and manufacturing licences

XPhyto Drug Development Pipeline – Stage 1 & 2

  • Platform technology
  • Scalable product development pipeline
  • High-growth and new API opportunities
  • Neurological indications
  • Generic and hybrid-generic drug formulations

2. 3a-Diagnostics GmbH – Rapid Testing

XPhyto has an exclusive development, technology purchase and licence agreement

Specializing in the development, production, and marketing of low-cost point-of-care screening test systems:

  • COVID-19 rapid PCR Kit
  • COVID-19 disposable ultra-rapid test
  • Oral biosensors for the instant detection of bacterial and viral pathogens
  • Influenza A, H1N1 (swine flu), H5N1 (avian flu), Strep A, stomatitis, periimplantitis and periodontitis
  • Biosensor screening platform for high-throughput for identification of new biosensor targets for new biosensor products

Development partially funded by grants from the German Federal Ministry of Education and Research (BMBF)

Lead Products:

COVID-19 rapid PCR Kit

  • Diagnostic level accuracy, rapid results (<25 minutes), minimal lab equipment
  • European commercial approval and product launch planned for Q1 2021

Periimplantitis oral biosensor

  • For the early detection of infection associated with dental implants
  • Biosensor releases an extremely bitter compound when exposed to the causative pathogenic bacteria
  • European commercial approval and product launch planned for Q4 2021 

3. XPhyto Laboratories Inc. & Vektor Pharma TF GmbH – Psychedelics

100% owned XPhyto subsidiaries

Exclusive agreements with leading German and Canadian universities

Germany:

  • Development of psychedelic drug formulations – sublingual and transdermal
  • Development of biotechnology process for industrial scale production of psilocybin API
  • 12-month development program commenced Q3 2020

Canada:

  • Certified analytical testing for cannabis and psychedelics
  • Development programs for industrial scale and EU GMP production of mescaline, MDMA, DMT, and cannabinoid isolates
  • Novel psychedelic drug formulations

Clinical validation planned for Germany and Canada

Hub On AGORACOM / Corporate Profile

VIDEO – $SOBR Safe Has Built The World’s First Touch-Based Solution To Prevent Drunk Driving Accidents For Truck Fleets, Industrial Workplaces and School Bus Fleets $LCTC $BLO.ca

Posted by AGORACOM-JC at 4:49 PM on Thursday, December 10th, 2020

“Nearly 50% of industrial injuries and fatalities are alcohol related.  Commercial Fleets suffer from over 11,000 alcohol related accidents every year.  That rate is climbing and technology has failed to keep pace with this epidemic”  

We hear it happening all the time … and can never understand why technology can’t be created to prevent the senseless amount of deaths and injuries every year on our roads and our workplace. SOBR Safe has answered the call with incredible technology that has to be seen to believed.

Watch this powerful interview with David Gandini, Chairman & Chief Revenue Officer SOBR Safe (SOBR: OTCQB).

Prominent Government Relations Expert Joins SOBRSafe Team $SOBR $LCTC $BLO.ca

Posted by AGORACOM-Eric at 11:33 AM on Thursday, November 12th, 2020
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SOBR™ Safe, Inc. (OTC: SOBR) (www.sobrsafe.com), developers of the patented SOBR® Safe™ system, and its latest proprietary development, the non-invasive alcohol detection and screening system SOBR®Check™, announced today that it has contracted with Stephen Scofes for him to serve as Director of Government Affairs/Public Sector Procurement, with a focus on state legislature, law enforcement and public safety.

Steve is the Chairman and Chief Executive Officer of leading government relations and procurement firm Scofes & Associates Consulting, and brings to SOBR Safe a ready-built team of experts in their respective fields – including Steve’s partner, General Wesley Clark (ret.). Professionally involved in governmental affairs since 1985, Steve’s primary areas of expertise include legislative and political strategy, as well as business development, providing clients a sound strategy in the procurement of state, local and federal contracts. He currently represents and has represented some of the largest companies in the United States, such as Toyota, Kroger, Koch, Eli Lilly, Dell Technologies, Google, Cisco, Nokia, Blackstone and US World Meds to name a few – including work especially relevant to SOBR Safe in the manufacturing and transportation industries. Scofes & Associates has offices in Lansing, Detroit, Chicago, Indianapolis, Austin and Washington D.C.

“Steve is not just an expert at navigating the complex inner workings of government – he is also a proven producer with a track record of driving substantial returns,” stated SOBR Safe CEO Kevin Moore. “We believe he can open critical doors for us nationwide, stimulating material interest in and support for SOBR®Check™ and subsequent solutions. That a leader as accomplished as Steve has chosen to join SOBR Safe at this stage we feel speaks to our technology’s potential to create safer environments and safer lives.”

Scofes added, “My passion has always been to exercise our legislative system to create positive change, and rarely have I had the opportunity to work with a team possessing such conviction and innovative spirit – or a solution so potentially far-reaching. Communities across the country are ready to prevent the problem, and it is this company mission that has inspired me to join the SOBR Safe team.”

Each year, alcohol-related injuries, deaths and lost productivity costs American employers and insurers up to $63 billion; another $42 billion is spent on substance abuse treatment…a combined $105 billion crisis. One-half of all industrial accidents involve alcohol, and commercial fleets suffer from over 11,000 alcohol-related accidents each year. SOBR Safe believes its solution addresses this problem, and once successfully tested will be immediately applicable for delivery, service, and school bus fleet management, as well as workplace access control in manufacturing facilities and warehouses.

About SOBR® Safe, Inc. (www.sobrsafe.com)

SOBR Safe, Inc. is developing the patented SOBR® Safe™ system, and its latest proprietary product, the non-invasive alcohol detection and screening system SOBR®Check™. SOBRCheck is a potentially disruptive solution in alcohol consumption detection a touch-based technology with anticipated applications in school buses, commercial trucking fleets, facility access control and more. Across industries, the headlines are consistent: alcohol is a clear and present danger – impaired operation destroys lives, families and companies alike. SOBR Safe’s mission is to eliminate the destructive impact of alcohol on our roadways and workplaces…with just the touch of a finger.