Company provides formal response to misleading recently published short report
SALT LAKE CITY, March 30, 2020 — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics, and its manufacturing partner, Jiangsu Dablood Pharmaceutical CO, Ltd. (Dablood), a partner entity of Da An Gene Co., Ltd., today made several updates and progress reports on its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test(Assurance AB)intended for laboratories and healthcare workers at the point-of-care in the U.S.
“An opinion piece critical of Predictive was posted online last week by individually unidentified author(s) who admitted they have taken a short position in shares of The Company,” said John Sorrentino, chairman of Predictive Technology Group. “We encourage every reader to do their own due diligence and review the documents posted today on Predictive Laboratories’ website. The author(s), hiding behind anonymity – and attempts to disclaim – also warn that ‘Hindenburg Research makes no representation, express or implied, as to the accuracy, timeliness, or completeness of any such information.’ Because the opinion piece itself warns readers of its short position-based bias and its unwillingness to guarantee the accuracy of any ‘information’ it espouses, The Company will not dignify the opinion piece with a point-by-point response, however we felt compelled to address a few egregious misrepresentations and untruths.”
The opinion piece asserts a material falsehood that “Dablood is NOT one of the companies approved by the Chinese government to offer COVID-19 tests. The official list of approved COVID-19 test providers is published by the Chinese government, was updated as of March 17th, and does not include Dablood or its affiliates.” If properly investigated, one can find that #5 on the referenced list is Da An Gene Co., Ltd. Guangzhou Darui Biotechnology, a subsidiary of Da An Gene Co., Ltd., has joint venture entity in Dablood. As such, Dablood operates under the Da An Gene Co., Ltd. license.
Regarding Predictive’s formal request for Emergency Use Authorization (EUA) from the FDA to distribute Assurance AB, the opinion piece states, in part, that “Predictive has no specific approval from requisite U.S. authorities to provide this test.” The Company views this statement as simply not true.
“The FDA’s recent guidance on COVID-19 antibody (i.e. serological) diagnostic tests clearly allows manufacturers to market these tests in the United States to laboratories and healthcare workers at the point of care, so long as the tests have been validated and notification is provided to the FDA,” said Bradley Robinson, CEO of Predictive Technology Group. “The Predictive/Dablood test meets these criteria. Additionally, The Company has formally submitted an EUA with the FDA. If granted, this would provide Predictive the ability to market the test for in-home use.”
Predictive Laboratories, Inc., a wholly-owned entity of The Company, operates a CLIA-certified and CAP-accredited laboratory which is responsible for the distribution of the Assurance AB.Predictive Laboratories has updated its website to include the following:
- Dablood Board of Directors
response to the erroneous and misleading Hindenburg opinion piece published on
March 27, 2020
- FDA confirmation receipt of
EUA application
- Representative of Foreign
Manufacturer Notice from Dablood to the FDA
- Manufacturer FDA EUA
Notification from Dablood to the FDA
- U.S. Agent Retainer
Agreement
“The Hindenburg piece repeatedly and inaccurately
attempts to cast Predictive solely as a stem cell company while ignoring The
Company’s other diagnostic assets, such as ARTguideTM and
FertilityDXTM, and its recently announced diagnostic assay collaboration
with Atrin Pharmaceuticals. In this context, a COVID-19 rapid antibody test is
a logical addition to Predictive’s portfolio. Nevertheless, they attempt to
cast Predictive as simply a stem cell company,” said Robinson. “Predictive
encourages thoughtful investors to consider the motives of these anonymous
authors when assessing the truthfulness and accuracy of any statement or report
in the opinion piece. Predictive will pursue any and all legal actions against
individuals and entities who intentionally mislead Predictive stakeholders.”
“The response to the announcement of Assurance
AB (March 25, 2020) has been very strong,” continued
Robinson.
“In particular, both international and domestic governmental agencies have
expressed strong interest in how rapid antibody testing can help with the
public health response to this critical pandemic. We want to acknowledge the
tireless activities by our employees and partners in developing a tool that can
be a part of solving this global health crisis.”
About
Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests, as well as companion therapeutics, in order to support a patient from diagnosis through treatment. The Companies’ tests and products empower clinicians to provide their patients with the highest level of care. Predictive’s subsidiaries include Predictive Laboratories, Predictive Biotech and Predictive Therapeutics. For more information, visit https://predtechgroup.com.
About
Predictive Laboratories, Inc.
Predictive Laboratories a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) is focused on hard-to-detect diseases. The laboratory is equipped with state-of-the-art equipment for any next-generation sequencing experiments including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies – www.predtechlabs.com.
Forward-Looking
Statements:
To the extent any statements made in this
release contain information that is not historical, these statements are
essentially forward-looking and are subject to risks and uncertainties,
including the difficulty of predicting FDA approvals, acceptance and demand for
human cell and tissue products and other pharmaceutical products, the impact of
competitive products and pricing, new product development and launch, reliance
on key strategic alliances, availability of raw materials, availability of
additional intellectual property rights, availability of future financing
sources, the regulatory environment, and other risks the Company may identify
from time to time in the future. These forward-looking statements are based on
the current plans and expectations of management and are subject to a number of
uncertainties and risks that could significantly affect the company’s current
plans and expectations, as well as future results of operations and financial
condition. A more extensive listing of risks and factors that may affect the
company’s business prospects and cause actual results to differ materially from
those described in the forward-looking statements can be found in the reports
and other documents filed by the company with the Securities and Exchange
Commission. The company undertakes no obligation to publicly update or revise
any forward-looking statements, whether as a result of new information, future
events or otherwise.
www.predictivelabs.com
Contacts:
Predictive
Laboratories
institutional@predictivelabs.com
commercial@predictivelabs.com
info@predictivelabs.com
855-497-3636
Element Media Group, Inc. Announces Acquisition of OTRO Studios
/in Element Global, Inc., Press Releases, Uncategorized /by Yes InternationalOTRO Studios Renamed Element Studios UK Upon Closing
LOS ANGELES – Element Global, Inc. (OTC: ELGL)(“Element Global”), a diversified holding Company, announced that its wholly-owned subsidiary, Element Media Group, Inc., acquired OTRO Studios, a premium production studio that creates content in partnership with talent from the world of sport and beyond, effective September 9, 2020. The renaming of OTRO Studios to Element Studios UK occurred at the close of this transaction.
John LaViolette, Co-CEO of Element Global said, “Element Studios UK has a unique opportunity to become the go-to studio for sports entertainment programming for both talent and buyers. In addition, we see meaningful synergies and opportunities to accelerate the company’s growth. We are also very excited to be able to work with and support newly appointed CEO Claire McArdle and their top-tier, multi award-winning management team. We look forward to being able to tap into their wealth of international programming, content and production experience.”
“We are thrilled to be a part of the Element Media Group team,” said Claire McArdle, Element Studios UK’s Chief Executive Officer. “We believe that this is a great outcome and will position us for significant future growth. The Element team really understands our vision for the future and will help us bring sports programming alive through the lens of entertainment.”
About Element Global, Inc.
Element Global, Inc (OTC: ELGL), a diversified holding Company with global business interests centered on media and production, distribution and streaming in original and licensed film and tv content globally. With acquisition targets and developing sports franchise, sports distribution, emerging technology, renewable energy, and mining and processing of electric base metals, the Company brings together these enterprises to capitalize on both domestic and international opportunities. As new energy and smart digital technologies converge globally, supporting emissions reductions through the electrification of power, transport, industry and buildings, ELGL’s visions itself to capitalize on the increases in demand in these industries, www.elementglobal.com.
About Element Studios UK
Element Studios UK is a premium production studio that creates content in partnership with talent from the world of sport and beyond. The multi-award-winning team behind Element Studios UK brings decades of experience in sports, entertainment, music, comedy, and factual across premium long form, short and mid form, social platforms, as well as live and experiential events. The company has unprecedented access to top talent and industry contacts, coupled with a strong track record of delivering internationally.
Safe Harbor Statement
Under the Private Securities Litigation Reform Act of 1995, certain forward information contained in this release contains forward-looking statements that involve risk and uncertainties, including but not limited to, those relating to development and expansion activities, domestic and global conditions, and market competitions.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005488/en/
Element Sports Group, Inc. (ELGL) Announces Appointment of Edward Pergjini As President
/in Element Global, Inc., Press Releases /by Yes InternationalIndustry Veteran Brings Track Record of Value Creation and Proven Expertise In Sports Industry
Element Sports Group, Inc., a wholly-owned division of Element Global, Inc., (OTC: ELGL) announces the appointment of Edward Pergjini as President, effective June 2, 2020. Mr. Pergjini will be responsible for executing on the Company’s strategic mandate, which is focused on acquiring professional soccer clubs (in Europe known as football clubs), as well as, sports distribution companies globally.
“I am delighted to welcome Edward as President of Element Sports Group,” said Co-Founder and Co-CEO of Element Sports Group, Inc., John LaViolette. “In Edward, we have a proven leader with significant years of operating experience, and deep relationships in the professional European soccer industry as well as the broader sports sector globally. Fluent in six languages, Mr. Pergjini is a true global executive, and we believe he is the ideal candidate to lead the Company forward to fulfill its strategic vision of becoming a competitive leader in the global sports industry.”
“I am honored to be stepping into the role of President and to have the opportunity to work with a dynamic management team committed to building a world class, sports driven, organization,” said Incoming President, Edward Pergjini.
Mr. Pergjini joins Element with over 30-years of experience working with multinational companies across disciplines including, commercial strategy, team management, the construction and development of international brands, and the management of broad real estate heritages. He also has a strong understanding of cross-cultural marketing along with deep expertise in the economic and financial workings of professional European soccer clubs. Mr. Pergjini resides in France, and received his MBA from Fairleigh Dickinson University.
Element Global, Inc (OTC: ELGL), a diversified holding Company with global business interests centered on media and production, distribution and streaming in original and licensed film and tv content globally. With acquisition targets and developing sports franchise, sports distribution, emerging technology, renewable energy, and mining and processing of electric base metals, the Company brings together these enterprises to capitalize on both domestic and international opportunities. As new energy and smart digital technologies converge globally, supporting emissions reductions through the electrification of power, transport, industry and buildings, ELGL’s visions itself to capitalize on the increases in demand in these industries, www.elementglobal.com.
Safe Harbor Statement
Under the Private Securities Litigation Reform Act of 1995, certain forward information contained in this release contains forward-looking statements that involve risk and uncertainties, including but not limited to, those relating to development and expansion activities, domestic and global conditions, and market competitions.
Element Acquisition Corporation Announces Formation of Investment Committee
/in BioForce NanoSciences Holdings, Inc, Press Releases /by Yes InternationalGroup of Leading Media, Entertainment and Sports Executives Will Oversee Investments Across These Sectors
LOS ANGELES, CA, June 4, 2020–Element Acquisition Corporation (“Element”), a wholly owned division of BioForce Nanosciences Holdings, Inc. (OTC: BFNH), announces that it has created an Investment Committee comprised of leading executives with extensive experience in the media, entertainment and sports sectors.
The Investment Committee will oversee a strategy aimed at acquiring and investing in companies across these industries, and Element will serve as an acquisition vehicle for these transactions.
“We see significant investment opportunities in media, entertainment and sports and are excited to come together to build a new company spanning these dynamic industries,” said Investment Committee member and Co-CEO of Element Acquisition Corporation, John LaViolette. “Based on this shared vision, the other committee members and I plan to leverage our deep relationships and experience to identify compelling targets to partially or fully acquire, and we plan to announce a number of transactions in the coming weeks.”
The members of the Investment Committee are:
About Element Acquisition Corp.
Element Acquisition Corp. is a well-capitalized entity formed to pursue acquisitions in the media, entertainment, media technology and sports sectors. It was founded in 2020.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Certain forward information contained in this release contains forward-looking statements that involve risk and uncertainties, including but not limited to, those relating to development and expansion activities, domestic and global conditions, and market competitions.
Predictive Submits Emergency Use Authorization Application for Treatment of Acute Respiratory Distress Syndrome Secondary to COVID -19 with Umbilical Cord Mesenchymal Stem Cells
/in Predictive Technology Group, Press Releases /by Yes InternationalSALT LAKE CITY, April 13, 2020 (GLOBE NEWSWIRE) – Predictive Biotech, a wholly owned subsidiary of Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), announced that on April 9th it submitted an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the immediate use of mesenchymal stem cells (MSCs) derived from umbilical cord tissue for the treatment of Acute Respiratory Distress Syndrome (ARDS), secondary to SARS-CoV-2, coronavirus disease 2019 (COVID-19).
The pandemic caused by COVID-19 has shown to develop into severe ARDS in 30% of hospitalized patients with a 22%-62% mortality rate (Murthy et al., 2020) for those requiring hospitalization in an intensive care unit. Currently, there is no confirmed treatment that can demonstrate safety or efficacy for the treatment of COVID-19.
“Coronavirus can be deadly, in large part because the virus can cause ‘cytokine storms’ in which the patient’s own immune system triggers a runaway response causing more damage to the patient, than to the virus it’s trying to eliminate” said John Sorrentino, Chairman of Predictive Technology Group. “Respiratory distress kills hundreds of thousands of people each year worldwide. There is clinical data from early clinical trials that seem to indicate that the avoidance of the cytokine storm utilizing MSCs may be a critical component for the treatment of COVID-19 infected patients.”
A recent review article published in Pain Physician, concluded that, “The limited but emerging evidence regarding UC MSC [umbilical cord mesenchymal stem cells] in managing COVID-19 suggests that it might be considered for compassionate use in critically ill patients to reduce morbidity and mortality in the United States.”
The proposed IND clinical trial will utilize Predictive’s proprietary core technology of naturally occurring MSCs derived from umbilical cord tissue (UC-MSCs) to assess the efficacy as an add-on therapy to standard treatment of patients with severe Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19.
Predictive’s UC MSC product, CoreCyteTM,
has already been used as an allograft in over 50,000 patients. Physicians have reported to Predictive that over 1,100 patients have been treated with CoreCyte via intravenous administration. No serious adverse events have been reported with CoreCyte regardless of the route of administration. If Predictive’s EUA request is approved, CoreCyte would be available immediately to critically ill patients with ARDS due to COVID-19 infections.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests and companion therapeutics in order to support a patient from diagnosis through treatment.
Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictive’s tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit www.predtechgroup.com.
About Predictive Biotech, Inc.
Predictive Biotech is a leader in regenerative medicine, its products are derived from tissue sources rich in properties that support the body’s natural ability to heal itself. All products are safely, ethically and minimally processed to deliver allografts that preserve the naturally occurring characteristics and factors of the donor tissue. Predictive’s signature products are uniquely born from the Wharton’s jelly layer of the umbilical cord and amniotic fluid and tissue.With over 100,000 units delivered, product safety and consistency has been realized by thousands of practices throughout the United States. A national network of clinics, health systems, researchers and physicians leverage Predictive’s four proprietary products: AmnioCyte™, AmnioCyte Plus™, PolyCyte™, and CoreCyte™.
Forward-Looking Statements:
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks The Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect The Company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect The Company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by The Company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Predictive Biotech
Info@predictivebiotech.com
888-407-9761
Predictive Technology Group Announces Initial Order of One Million Units of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test from Distribution Partner, Wellgistics, LLC.
/in Predictive Technology Group, Press Releases /by Yes InternationalSALT LAKE CITY, April 8, 2020 (GLOBE NEWSWIRE) – Predictive Laboratories, a wholly owned subsidiary of Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), today shared that its distribution partner, Wellgistics, has submitted an initial order for immediate delivery of one (1) million units of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test(Assurance AB)intended for use by laboratories and healthcare workers at the point-of-care in the U.S.
“We have been working diligently with Wellgistics to get this first order put in motion, even prior to making our partnership announcement on April 3,” said Bradley Robinson, CEO of Predictive Technology Group. “This country is in high need of the Assurance AB testing for point of care use and we have brought all resources to bear to bring this product to the United States. Wellgistics has provided us with state-by-state demand guidance, to ensure that regions with the most urgent need have first access to the test. Our main priorities will be to focus on servicing those areas,” Robinson continued.
“When our partnership with Predictive was announced last week, our team was very aware of the coming tsunami wave of interest for this test,” said Brian Norton, CEO of Wellgistics. “This demand grows each day as more attention hits the media and is recognized as a viable solution toward identifying immunity and allowing people to go back to work. Presently, the Wellgistics team is hyper focused on closing the final gaps of the complex web of international logistics. We feel great about where we are, and we will provide new updates as quickly as they are available.”
Predictive announced website updates relating to Assurance AB including:
Instructions For Use, Quick Reference Guide and Fact Sheet for laboratories and healthcare workers at the point-of-care. The website also includes an instructional video on administering the Assurance AB test.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests and companion therapeutics in order to support a patient from diagnosis through treatment.
Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictive’s tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit www.predtechgroup.com.
About Predictive Laboratories, Inc.
Predictive Laboratories’ molecular and genetic diagnostics focus on hard-to-diagnose and hard-to-detect diseases. Leveraging its vast genetic library, Predictive offers earlier detection of a variety of diseases through genetic assessments to guide personalized precision medicine.
Equipped with a state-of-the-art CAP and CLIA accredited laboratory, Predictive operations perform next-generation sequencing experiments, including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies. Predictive arms physicians with the most robust diagnostic tools to provide personalized precision treatment for their patients. For more information, visit www.predictivelabs.com.
Forward-Looking Statements:
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Predictive Laboratories
Info@predictivelabs.com
855-497-3636
Predictive Technology Group Announces Distribution Agreement with Wellgistics, LLC for Its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test for Use by Laboratories and Healthcare Workers at the Point-of-Care
/in Predictive Technology Group, Press Releases /by Yes InternationalSALT LAKE CITY, April 2, 2020 — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics, today announced a distribution agreement between its subsidiary, Predictive Laboratories and Wellgistics, LLC of Lakeland, Florida for distribution in the U.S. of its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test (Assurance AB) intended for use by laboratories and healthcare workers at the point-of-care in the U.S.
Wellgistics, LLC, is one of the fastest growing wholesale pharmaceutical distributors in the United States. It is a logistics leader in the complex healthcare supply chain. Wellgistics is licensed in all 50 states as a Pharmaceutical Wholesale Distributor and is also licensed or permitted as Third-Party Logistics provider in all states. Its distribution facility, located in Lakeland, FL, is VAWD- accredited by the National Association of Boards of Pharmacy.
“From the onset of this global crisis, the Wellgistics’ leadership team has placed its sole focus on finding solutions for America. We felt confident that our competency in healthcare and pharmaceutical distribution would be sought out by product innovators to assist in delivering critically needed supplies throughout the country.” Said Brian Norton, CEO of Wellgistics.
“Our newly established alliance with Predictive Laboratories allows us to leverage our complex distribution network in delivering the life-saving Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test to healthcare professionals all across the country. We are keenly aware and very impressed with the extensive steps taken by Predictive to ensure the highest levels of quality in their dual channel IgM/IgG product, which we believe will become the “gold standard” in the marketplace,” said Norton.
“We are pleased to partner with Wellgistics. They are an ideal partner and are able to scale and serve the most critical needs in the face of this global pandemic. Wellgistics’ logistics, expertise and infrastructure has demonstrated the ability to efficiently move products from around the world to the U.S. market and was an important component in our decision to partner with them. We are in production in advance of Wellgistic’s purchase orders and will update stakeholders on details over the next few days,” said Bradley Robinson, CEO of Predictive Technology Group. “We will support Wellgistics, their team and customers with Predictive Laboratories’ full scientific, operational and service team members,” added Robinson.
About the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test:
The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test is a rapid test for the qualitative detection of IgM and IgG antibodies associated with the SARS-CoV-2 virus. Assurance AB is a single-use, self-contained test that provides results in 15 minutes, helping authorities, employers and healthcare workers make informed decisions to contain the spread of COVID-19.
Assurance AB is intended for individuals who display signs and symptoms of COVID-19, individuals who were exposed to someone infected with COVID-19, or individuals who want qualitative information about whether or not they have IgM or IgG antibodies. Assurance AB is for use by laboratories and healthcare workers at the point-of-care.
What is antibody testing?
Antibody assays have the ability to detect past infections and indicate probable immunity. Antibodies are long-lasting and may be detected in the bloodstream several years after infection.
Assurance AB detects the presence of antibodies IgM and IgG, developed in response to the SARS-CoV-2 virus. The antibody and its relative levels may be used to indicate the stage of infection and estimate time since exposure to the virus for contact tracing.
Assurance AB Benefits
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests and companion therapeutics in order to support a patient from diagnosis through treatment.
Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictive’s tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit https://predtechgroup.com/
About Predictive Laboratories, Inc.
Predictive Laboratories’ molecular and genetic diagnostics focus on hard-to-diagnose and hard-to-detect diseases. Leveraging its vast genetic library, Predictive offers earlier detection of a variety of diseases through genetic assessments to guide personalized precision medicine.
Equipped with a state-of-the-art CAP and CLIA accredited laboratory, Predictive operations perform next-generation sequencing experiments, including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies. Predictive arms physicians with the most robust diagnostic tools to provide personalized precision treatment for their patients. For more information, visit www.predictivelabs.com
Forward-Looking Statements:
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Predictive Laboratories
Info@predictivelabs.com
855-497-3636
Predictive Technology Group and Manufacturing Partners Provide Updates of Its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test for Use by Laboratories and Healthcare Workers at the Point of Care
/in Predictive Technology Group, Press Releases /by Yes InternationalCompany provides formal response to misleading recently published short report
SALT LAKE CITY, March 30, 2020 — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics, and its manufacturing partner, Jiangsu Dablood Pharmaceutical CO, Ltd. (Dablood), a partner entity of Da An Gene Co., Ltd., today made several updates and progress reports on its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test(Assurance AB)intended for laboratories and healthcare workers at the point-of-care in the U.S.
“An opinion piece critical of Predictive was posted online last week by individually unidentified author(s) who admitted they have taken a short position in shares of The Company,” said John Sorrentino, chairman of Predictive Technology Group. “We encourage every reader to do their own due diligence and review the documents posted today on Predictive Laboratories’ website. The author(s), hiding behind anonymity – and attempts to disclaim – also warn that ‘Hindenburg Research makes no representation, express or implied, as to the accuracy, timeliness, or completeness of any such information.’ Because the opinion piece itself warns readers of its short position-based bias and its unwillingness to guarantee the accuracy of any ‘information’ it espouses, The Company will not dignify the opinion piece with a point-by-point response, however we felt compelled to address a few egregious misrepresentations and untruths.”
The opinion piece asserts a material falsehood that “Dablood is NOT one of the companies approved by the Chinese government to offer COVID-19 tests. The official list of approved COVID-19 test providers is published by the Chinese government, was updated as of March 17th, and does not include Dablood or its affiliates.” If properly investigated, one can find that #5 on the referenced list is Da An Gene Co., Ltd. Guangzhou Darui Biotechnology, a subsidiary of Da An Gene Co., Ltd., has joint venture entity in Dablood. As such, Dablood operates under the Da An Gene Co., Ltd. license.
Regarding Predictive’s formal request for Emergency Use Authorization (EUA) from the FDA to distribute Assurance AB, the opinion piece states, in part, that “Predictive has no specific approval from requisite U.S. authorities to provide this test.” The Company views this statement as simply not true.
“The FDA’s recent guidance on COVID-19 antibody (i.e. serological) diagnostic tests clearly allows manufacturers to market these tests in the United States to laboratories and healthcare workers at the point of care, so long as the tests have been validated and notification is provided to the FDA,” said Bradley Robinson, CEO of Predictive Technology Group. “The Predictive/Dablood test meets these criteria. Additionally, The Company has formally submitted an EUA with the FDA. If granted, this would provide Predictive the ability to market the test for in-home use.”
Predictive Laboratories, Inc., a wholly-owned entity of The Company, operates a CLIA-certified and CAP-accredited laboratory which is responsible for the distribution of the Assurance AB.Predictive Laboratories has updated its website to include the following:
“The Hindenburg piece repeatedly and inaccurately attempts to cast Predictive solely as a stem cell company while ignoring The Company’s other diagnostic assets, such as ARTguideTM and FertilityDXTM, and its recently announced diagnostic assay collaboration with Atrin Pharmaceuticals. In this context, a COVID-19 rapid antibody test is a logical addition to Predictive’s portfolio. Nevertheless, they attempt to cast Predictive as simply a stem cell company,” said Robinson. “Predictive encourages thoughtful investors to consider the motives of these anonymous authors when assessing the truthfulness and accuracy of any statement or report in the opinion piece. Predictive will pursue any and all legal actions against individuals and entities who intentionally mislead Predictive stakeholders.”
“The response to the announcement of Assurance AB (March 25, 2020) has been very strong,” continued Robinson. “In particular, both international and domestic governmental agencies have expressed strong interest in how rapid antibody testing can help with the public health response to this critical pandemic. We want to acknowledge the tireless activities by our employees and partners in developing a tool that can be a part of solving this global health crisis.”
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests, as well as companion therapeutics, in order to support a patient from diagnosis through treatment. The Companies’ tests and products empower clinicians to provide their patients with the highest level of care. Predictive’s subsidiaries include Predictive Laboratories, Predictive Biotech and Predictive Therapeutics. For more information, visit https://predtechgroup.com.
About Predictive Laboratories, Inc.
Predictive Laboratories a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) is focused on hard-to-detect diseases. The laboratory is equipped with state-of-the-art equipment for any next-generation sequencing experiments including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies – www.predtechlabs.com.
Forward-Looking Statements:
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
www.predictivelabs.com
Contacts:
Predictive Laboratories
institutional@predictivelabs.com
commercial@predictivelabs.com
info@predictivelabs.com
855-497-3636
Predictive Technology Group Announces Launch of Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test for Use by Laboratories and Healthcare Workers at the Point of Care
/in Predictive Technology Group, Press Releases /by Yes InternationalAssurance AB™ is a single-use, self-contained SARS-CoV-2 (COVID-19) antibody detection test that provides results in 15-minutes
SALT LAKE CITY, March 25, 2020 — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics today announced that in response to the demand for high volume test availability for the SARS-CoV-2 (COVID-19) global pandemic, Predictive Laboratories, a wholly-owned subsidiary of The Company has notified the U.S. Food and Drug Administration of its intent to immediately distribute the validated Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test (Assurance AB) test to laboratories and healthcare workers at the point-of-care in the U.S.
The Assurance AB test was developed to detect the presence of IgM and/or IgG antibodies to the SARS-CoV-2 virus. The test requires only a fingerstick to sample an individual’s blood which is then placed on the self-contained test device. The test takes 15-minutes to display results. The test results indicate the presence of antibodies associated with the SARS-CoV-2 virus.
“Our company is committed to help with the global challenge of testing for the COVID-19 virus.” said Bradley Robinson, CEO of Predictive Technology Group. “Testing strategies for the pandemic are fluid and changing daily. We have worked diligently with our partners who have experience in testing tens of millions of patients worldwide. We appreciate their assistance in allocating resources and transferring vital knowledge for identifying individuals that have had an immune reaction and developed antibodies in response to virus exposure. Domestic and international governmental agencies, healthcare groups, pharmacies and employers have shown a strong interest in our test,” added Robinson. The Company will distribute the Assurance AB test through its wholly-owned subsidiary Predictive Laboratories, Inc., a CLIA certified and CAP accredited laboratory.
John Nelson M.D. former president of the American Medical Association and Predictive scientific advisory board member commented “The overwhelming need for a quick and accurate test for this pandemic is obvious. Focusing on an antibody test helps accelerate results and protect healthcare workers. The Assurance AB test is a valuable tool for truly understanding the spread of COVID-19 in the U.S.”
Assurance AB can help authorities, employers and healthcare workers make informed decisions on whether or not to continue precautions. Point of care serology testing may allow individuals with antibodies the confidence to go back to the workplace and engage in their communities.
Additional advantages of the Assurance AB test include:
Because of the rapid spread of the COVID-19 virus, several states including California and New York have recently expressed immediate need for rapid antibody testing. While there are benefits to viral testing, serology antibody testing allows patients to know if they have been exposed to the virus and if they have developed antibodies typically associated with immunity.
Assurance AB COVID-19 IgM/IgG Rapid Antibody Test is being manufactured in cooperation with Jiangsu Dablood Pharmaceutical CO, Ltd. Dablood Pharmaceutical has successfully distributed 38 million tests to date throughout Asia and Europe. To the best of Predictive’s knowledge, Dablood Pharmaceutical is one of very few companies approved by the Chinese government to co-develop and manufacture rapid antibody tests. Dablood Pharmaceutical is one of the largest diagnostic kit manufacturers in China and is currently producing up to 1.5 million units of the rapid antibody test per day in China. Predictive evaluated other potential developers and suppliers and believes Dablood Pharmaceutical provides not only existing inventory, its high-volume production capacity enables them to rapidly increase production to provide high-quality tests to meet rapidly expanding global demand. Dablood Pharmaceutical has been recognized by the Chinese government for its effort of developing and producing testing products to help the detect the COVID-19 and has received approval for distribution of its test across the domestic Chinese market and the European Union with a CE mark.
Predictive is also pursuing procurement authorization through the Biomedical Advance Research and Development Authority (BARDA) under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in Health and Human Services (HHS). The Company cautions that if the federal government decides to restrict adequate reimbursement or the foreign import of products manufactured in Asia, the Company will not be able to provide access to these tests in the U.S.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests, as well as companion therapeutics, in order to support a patient from diagnosis through treatment. The Companies’ tests and products empower clinicians to provide their patients with the highest level of care. Predictive’s subsidiaries include Predictive Laboratories, Predictive Biotech and Predictive Therapeutics. For more information, visit www.predtechgroup.com.
About Predictive Laboratories, Inc.
Predictive Laboratories a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) is focused on hard-to-detect diseases. The laboratory is equipped with state-of-the-art equipment for any next-generation sequencing experiments including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies.
www.predictivelabs.com
Forward-Looking Statements:
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Predictive Laboratories
institutional@predictivelabs.com
commercial@predictivelabs.com
info@predictivelabs.com
855-497-3636
Predictive Technology Group Addresses Use of Mesenchymal Stem Cells in Treatment of Secondary Issues Related to Coronavirus
/in Predictive Technology Group, Press Releases /by Yes InternationalSALT LAKE CITY, March 17, 2020 (GLOBE NEWSWIRE) — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), today announced that last week it began communication with domestic and international agencies and groups to be a supplier of mesenchymal stem cells (MSCs) for the potential clinical treatment of patients suffering from secondary issues related to the coronavirus (COVID-19). In other related news today the American Society of Interventional Pain Physicians (ASIPP) issued a statement on COVID-19, discussing practices and urging authorities to approve expanded umbilical cord stem cell infusions as a treatment. WWW.asipp.org/asipp-updates/STATEMENT-FROM-ASIPP-ON-COVID-19
ChinaXiv recently reported (March 2, 2020) the outcomes of seven patients with COVID-19 pneumonia enrolled in a clinical trial at Beijing YouAn Hospital, China. The clinical outcomes, as well as changes in inflammatory and immune function levels, and adverse effects of the enrolled patients were assessed over the 14 days following MSC injection. The patients were treated with MSCs derived from the Wharton’s jelly layer of the umbilical cord. The pulmonary function and symptoms of all seven patients with COVID-19 pneumonia were significantly improved within 2 days of the MSC transplantation.
Utilizing regenerative medicine technology with the administration of MSCs may help mitigate underlying COVID-19 associated lung damage. While this treatment is not a method to vaccinate nor cure the virus, the results reported in this publication indicate that infected patients may be more likely to combat and survive the related secondary issues of a COVID-19 infection if regenerative technologies are applied.
“Given our expertise and proprietary processes for isolating the MSC’s from source tissue, combined with our strong safety record in delivering tens of thousands of allografts to the market, it is not surprising that we have received a high number of inquiries regarding our potential involvement with this global health crisis,” said Bradley Robinson, CEO of Predictive Technology Group. “We are watching the development of clinical trials from around the world and remain poised to help in any we can, pending regulatory guidance. Our experience and capital investments over the past few years has equipped us with the expertise and ability to scale to meet demand,” added Robinson.
MSCs have the ability to differentiate into a variety of cell types and are able to resist viral attacks with the expression of interferon gamma stimulated genes (ISGs). With the ability to express ISGs, stem cells would be expected to survive even when transplanted into a patient with an active COVID-19 infection. Stem cells rejuvenate and regenerate cells in the body through various processes involving reduction of inflammation, secretion of substances that protect cells, transfer of mitochondria, reduction of cell death, anti-oxidative effects and improvement of immune system function. These effects are likely to increase survival in patients infected with COVID-19.
Additionally, there is evidence of stem cells aiding in the protection against viral infection. The influenza virus A/H5N1 is known to cause acute lung injury. With the injection of human MSCs, A/H5N1 was reduced in mice and the treatment increased rates of survival (Chan, et al, PNAS 113:3621, 2016).
Umbilical cord tissue is particularly rich in MSCs, which is why many parents choose to store them. As new clinical therapies are discovered, the importance of storing stem cells from perinatal tissue (umbilical cord and placenta) will become a critical source for individuals needing stem cell therapies in the future.
Predictive Technology Group was the first to market and is the current market leader in the United States for the procurement and processing of umbilical cord tissue for clinical use. Predictive has operated its FDA-compliant commercial biologics manufacturing facility for several years. This facility is cGMP and cGTP compliant, ISO13485 certified, and FDA registered. All clinical manufacturing occurs in an ISO 7 certified sterile cleanroom with extensive and advanced testing to assure the absence of contamination.
“We are well positioned to have the procurement, processing and cell culturing expertise and scale to offer stem cell therapy for secondary issues related to COVID-19 infections in both domestic and international markets. While effective vaccines are being developed, US-based stem cell transplants represent a real opportunity to fight the virus and increase survival rates with patients infected worldwide,” Bradley Robinson added.
As the major commercial supplier of umbilical cord MSCs in the United States, Predictive is well positioned to continue its leadership role in ensuring a stable supply of this potentially life-saving intervention that has been associated with promoting the regeneration and repair of lung tissue damaged by acute respiratory viral infections, such as those caused by COVID-19. The company plans to evaluate potential research and commercial collaboration opportunities to supply stem cells either directly through Predictive, or in collaboration with other private and/or public entities.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests, as well as companion therapeutics, in order to support a patient from diagnosis through treatment. The Companies’ tests and products empower clinicians to provide their patients with the highest level of care. Predictive’s subsidiaries include Predictive Laboratories, Predictive Biotech and Predictive Therapeutics.
For more information, visit www.predtechgroup.com
Forward-Looking Statements:
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.
Contacts:
For more information, visit www.predtechgroup.com
BIOFORCE NANOSCIENCES HOLDINGS, INC. ANNOUNCES ITS 1 FOR 5 REVERSE STOCK SPLIT, EFFECTIVE FEBRUARY 28, 2020
/in BioForce NanoSciences Holdings, Inc, Press Releases, Uncategorized /by Yes InternationalVirginia Beach, Virginia- Feb. 27, 2020-– Bioforce Nanosciences Holdings, Inc. (BFNH:OTC) (BFNHD:OTC) implemented a 1-for-5 reverse split of its common stock to be effective prior to the opening of the market tomorrow, Friday, February 28, 2020.
The stock begin trading on a post-split basis under the symbol, BFNHD, for 20 business days, after which it will return to trading under the symbol, BFNH.
The majority stockholders approved BFNH’s reverse stock split, and on December 2, 2019, the record date of the corporate action, and the board of directors approved the implementation of the reverse stock split at the ratio of 1-for-5.
As a result of the split, every 5 (five) shares of issued and outstanding old common stock will be exchanged for 1 (one) share of new common stock under the new CUSIP number 09064C206. No fractional shares of common stock will be issued as a result of the reverse stock split. In lieu of receiving fractional shares, all such fractions shall be rounded up so that shareholders of record receive one whole share for each fractional share.
Each stockholder’s percentage ownership interest in BioForce Nanosciences Holdings, Inc., their proportional voting power, and the rights and privileges as the holders of the common stock remain unchanged and unaffected.
The reverse stock split did not change the total number of shares of common Stock or preferred stock authorized for issuance by the Company; 900,000,000 total number of common shares, par value $0.001 per share, and 100,000,000 shares of preferred stock, par value $0.001 per share, authorized.
Shareholders holding share certificates will receive information from BioForce’s transfer agent regarding the process for exchanging their shares of common stock. No service charge will be paid by existing shareholders for the exchange of the shares, and the Company will pay all expenses of the transfer and issuance of new shares.
The Board of Directors believes that the reverse stock split should encourage greater interest in the Company’s common stock by the investment community, and believes that the recapitalization of its market price of the Company’s common stock might become acceptable to institutional investors, professional investors and other members of the investing public.
For further information about this release, contact Richard Kaiser, 757-306-6090, info@bioforceeclipse, yes@yesinternational, www.yesinternational.com and www.bioforceeclipse.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Certain forward information contained in this release contains forward-looking statements that involve risk and uncertainties, including but not limited to, those relating to development and expansion activities, domestic and global conditions, and market competitions.