Blackhawk Engages SPharm and Initiates Process to Obtain Medical Device Establishment License in Canada
Vancouver, British Columbia - TheNewswire - May 20, 2020 - Blackhawk Growth Corp. (CSE:BLR); (CNSX:BLR.CN); (Franfurt:0JJ); (OTC:BLRZF) (the "Corporation" or "Blackhawk") is pleased to announce that it has signed an agreement with Val-d'Or, Quebec based healthcare consulting company SPharm Inc., pursuant to which SPharm will assist Blackhawk in completing an application for a Medical Device Establishment Licence (MDEL). Blackhawk is pursuing the MDEL as a step towards the distribution and sale in Canada of the 2019-nCoV Ab test kit (the "Test Kit") developed by Innovita (Tangshan) Biological Technology Co., Ltd.
A MDEL is issued for the purposes of importing or distributing (selling) medical devices for human use in Canada. An MDEL is issued by Health Canada's Regulatory Operations and Enforcement Branch (ROEB), based on an attestation that the establishment meets all of Health Canada's MDEL regulatory requirements. During an inspection by Health Canada, MDEL holders must demonstrate to Health Canada that they meet the regulatory requirements they attested to having in place related to the medical devices that they intend to import or distribute (sell) in Canada.
The application for the MDEL is a critical step in allowing Blackhawk to import and distribute the Test Kit in Canada. Blackhawk holds the rights to distribute the Test Kit in Canada, and certain other jurisdictions, pursuant to an agreement with Emergence Technology Pty. Ltd. ("Emergence"). At this time, distribution of the Test Kit has not been approved in Canada, and clearance must be received from Health Canada before any sale or distribution of the Test Kits takes place in Canada.
"With antibody testing coming to the forefront in Canada, I am thrilled to see Blackhawk pursue an MDEL," said Frederick Pels, CEO of Blackhawk. "As we further establish ourselves as leaders in this space, this license will not only benefit us in regards to these Test Kits but may also be called upon for many of our other initiatives. I look forward to keeping shareholders updated with our progress and hope to see Innovita's test kits approved in Canada very soon."
"Entrusting Blackhawk with distribution rights for Canada will ensure tests are delivered into the right hands as efficiently as possible once clearance from Health Canada is received. We are pleased to continue to foster our relationship with Blackhawk and support their efforts to bring efficient and cost-effective COVID-19 testing to Canada," said James Saunders, CEO of Emergence.
About SPharm Inc.
SPharm is a Canadian consulting firm specializing in health product (drug, medical devices) regulatory affairs, approval and development services. Their team of experts assists pharmaceutical, biotechnology, natural health products and medical device companies from around the world throughout the various phases of their product development, regulatory approval and up to successful and timely market access. For more information on SPharm, please visit their website here: https://spharm-inc.com/
For further information please contact:
Frederick Pels, Chief Executive Officer
Cautionary Note Regarding Forward-Looking Statement
All statements in this press release, other than statements of historical fact, are "forward-looking information" with respect to the Company within the meaning of applicable securities laws, including with respect to the issuance of MDEL by Health Canada and the planned distribution of Test Kits in Canada. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company's public filings under the Company's SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.