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Tetra Bio-Pharma $TBP.ca and Altus Formulation Sign Joint Venture Agreement for Cannabinoid Drug Product Development $AERO $CBDS $CGRW $APH.ca

Posted by AGORACOM-Eric at 8:33 AM on Monday, April 29th, 2019
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OTTAWA, April 29, 2019 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc. (“Tetra” or “TBP”), (TSX VENTURE: TBP) (OTCQB: TBPMF), and Altus Formulation Inc. (“Altus”) today announced the signing of a Joint Venture Agreement under which the two companies will work together to develop a series of cannabinoid-receptor targeted therapeutics addressing multiple areas of high unmet need.

The Joint-Venture will synergize the capabilities of the two companies:

  • Products:  The companies have identified product candidates in the fields of pain, oncology and ophthalmology, addressing a total market size of over $10BN. (Source: MedTrack™)
     
  • New Routes of Administration: Altus’ SmartCelle™ insoluble drug delivery platform enables intravenous, topical, intra-nasal and oral delivery. Smartcelle’s™ proven ability to enhance the solubility of cannabinoids permits increased oral absorption and enables low volume parenteral and transmucosal delivery.  Intellitab™ and Flexitab™ technologies will deliver Safer to Use™ products to patients.
     
  • New Intellectual Property:  Altus’ distinct drug delivery technologies provide Tetra with significant strategic advantages over the competition and will enable Tetra to significantly improve some of the current products under development. In addition to SmartCelle™ these include Intellitab™ abuse deterrent technology platform and, Flexitab™ breakable sustained release tablet technology for enhanced dosing flexibility.  All platforms are protected by patents enforced globally. 

  • Commercial Development, Manufacturing and Supply.  Combining Altus and Tetra capabilities ensures these essential parts of the value chain are addressed early and efficiently.

Dr. Guy Chamberland, CEO and CSO of Tetra stated, “We are extremely excited about finalizing this agreement which will enable us to improve existing products and will allow us to exploit a  number of different delivery mechanisms including Intra-Nasal, Intravenous and Oral Sustained Release Tablets.   Furthermore, Altus’ technology will play a key role in strengthening Tetra’s Intellectual Property for its product portfolio.  This newly created joint-venture will also serve to benefit our patients, their care providers and help us in our quest to replace the use of opioids.”

Damon Smith President and CEO of Altus Formulations Inc. added, “We believe that by targeting cannabinoid receptors we open up a range of therapeutic pathways unaddressed by today’s medications. Whether alone or in combination, we believe such medications can provide great value to patients, not least to those suffering the blight of undertreated pain.  By combining our capabilities and focusing our resources to generate the right drug for the right patient, the Tetra/Altus joint venture overcomes many of the hurdles that have dogged cannabinoid medicine commercialization in the past. We greatly look forward to working with the Tetra team and to bringing these products to the market.

About Altus Formulation Inc.
Altus Formulation is a Quebec based drug formulation and development company using its proprietary and patent protected drug delivery technologies to generate novel, differentiated and cost-effective new products for its partners and their patients. With a focus on Safer to Use™ formulations, Altus’ technologies include Intellitab™ abuse deterrent technology, Flexitab™ breakable extended release tablets and SmartCelle™ technologies for delivery of low solubility large and small molecules.

For more information, please visit www.altusformulation.com

About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Health Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

CardioComm Solutions $EKG.ca HeartCheck(TM) CardiBeat and Smart Phone App Enter Final Stage of FDA 510(k) Review

Posted by AGORACOM-JC at 9:26 AM on Friday, November 23rd, 2018

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  • Market Release of HeartCheck(TM) CardiBeat and GEMS(TM) Mobile Application Set For Early 2019
  • Completed its response to the USA Food and Drug Administration for additional information following the Company’s filing of its premarket notification 510(k)
    • Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile Application
  • HeartCheck™ CardiBeat is the second of several planned Bluetooth-enabled ECG recording devices to be marketed by the Company

CardioComm Solutions, Inc. (TSXV: EKG) (“CardioComm” or the “Company“), a leading global provider of consumer heart monitoring and electrocardiogram (“ECG“) acquisition and management software solutions, has completed its response to the USA Food and Drug Administration (“FDA“) for additional information following the Company’s filing of its premarket notification 510(k), Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile Application.

The 510(k) application started its 90 day Substantive Review by the FDA on June 8, 2018. The FDA requested additional information from the Company regarding the device July 27, 2018, which stops the clock on the Substantive Review time line. The countdown of the 90 days will restart upon the FDA accepting the Company’s response to the requested additional information.

The FDA’s request for additional information required external and independent third party testing for electromagnetic and electrostatic discharge compatibility. The FDA also requested data confirming the device’s ability to record ECGs of equivalent clinical quality, as compared to ECGs recorded using conventional ECG electrode patches and ECG cables. CardioComm was provided a maximum of 180 days to reply to the FDA examiner. While the Company intended to respond to the FDA within 90 days, the requested testing and documentation through third parties did not allow a response to the FDA to be completed within this time frame. All device tests have now been passed and results compiled for the reply to the FDA. The Substantive Review clock will restart once the FDA receives and accepts the Company’s reply. Based on the FDA’s published timelines, the Company projects a possible completion of the 510(k) application review by the end of December 2018. The Company notes that the FDA has the ability to request more time to complete their review at the FDA’s discretion.

The HeartCheck™ CardiBeat is the second of several planned Bluetooth-enabled ECG recording devices to be marketed by the Company. The first was the Bluetooth HeartCheck™ECG PEN. As indicated in the Company’s May 22, 2018 press release, the GEMS™ Mobile Smartphone app will have compatibility with a number of different wireless ECG recording devices, including wireless 12 lead devices which will have direct applicability to remote patient monitoring and telemedicine markets.

The Company will provide updates on this and future 510(k) applications. To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations please visit the Company’s websites at www.cardiocommsolutions.com and www.theheartcheck.com. Refer to the Company’s May 22, 2018 press release for further information respecting the initial FDA filing.

About CardioComm Solutions

CardioComm Solutions‘ patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. CardioComm Solutions has earned the ISO 13485:2016 certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).

FOR FURTHER INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
1-877-977-9425 x227
[email protected]
[email protected]

Forward-looking statements

This release may contain certain forward-looking statements and forward-looking information with respect to the financial condition, results of operations and business of CardioComm Solutions and certain of the plans and objectives of CardioComm Solutions with respect to these items. Such statements and information reflect management’s current beliefs and are based on information currently available to management. By their nature, forward-looking statements and forward-looking information involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements and forward-looking information.

In evaluating these statements, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this release other than as required by applicable laws, including without limitation, Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.