Daily Archives: April 2, 2020

Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA

The submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab, a Compassionate Use Approval for a treatment device, and an Emergency Use Authorization for a PCR-based IVD for COIVD-19 detection

Ann Arbor, Mich., USA, April 02, 2020 (GLOBE NEWSWIRE) — In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV infection, and oncology indications, and has the potential to modulate the “cytokine storm” sometimes seen in COVID-19 patients. A “cytokine storm” is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.

CytoDyn received rapid approval from the FDA for the emergency treatment of extremely ill COVID-19 patients. On March 27, CytoDyn released initial positive results in the first four patients treated, having seen a reduction of the hyper-immune response three days following treatment initiation. As of April 1, CytoDyn reported that a total of 10 patients have received treatment under emergency use. On March 30, FDA cleared a second IND for a Phase II randomized trial to treat mildly to moderately ill coronavirus patients with Leronlimab, with enrollment to begin immediately. Amarex is currently managing the trial. On April 1, CytoDyn reported that it filed an IND amendment with the FDA for a protocol to treat severely ill COVID-19 patients with Leronlimab where the primary endpoint is mortality rate at two weeks. Amarex also prepared this submission.

On March 25, Amarex also executed a rush submission to the U.S. FDA for a Compassionate Use Approval (CUA) for treatment of COVID-19 patients with a device that is currently in testing under an existing Investigational Device Exemption (IDE) for a different medical condition. Based on the mechanism of action there is reason to believe that the device may be an effective treatment for COVID-19 patients displaying serious symptoms. Amarex prepared the submission in a matter of days, which included writing a new clinical trial protocol; the typical submission process can take five weeks or more.

On March 27, Amarex executed a rush submission to the U. S. FDA of an Emergency Use Authorization (EUA) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea, and Amarex and its client are therefore hopeful for a rapid FDA approval result.

“I count myself lucky to work with our Amarex team,” said Amarex President and CEO Dr. Kazem Kazempour. “They’re incredibly caring, dedicated people as well as skilled experts who have been quick to adapt to this rapidly-changing situation.”

About Amarex Clinical Research LLC, an NSF International Company

Since 1998, Amarex has been helping biotech, pharmaceutical, medical device and diagnostic companies conduct scientifically sound clinical trials and navigate complex regulatory environments in a wide range of therapeutic indications, including oncology, central nervous system, wound healing, infectious disease, cardiovascular and urology.

As part of NSF International, Amarex supports companies with regulatory affairs, project/trial management, clinical operations, biostatistics, data management, pharmacovigilance, data monitoring committees, medical writing and consulting.

About NSF International

NSF International has been protecting and improving human health for over 75 years. As a global public health organization NSF facilitates standards development, and tests and certifies products for the food, water, health sciences and consumer goods sectors to minimize adverse health effects. Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.

NSF’s health sciences services include training and education, consulting, clinical research, regulatory guidance, corporate compliance and, separately, auditing, DNA testing, certification and R&D for the pharma biotech, medical device and dietary supplement industries throughout the product lifecycle. NSF facilitated the development of the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.

About CytoDyn, Inc.

CytoDyn Inc. is a biotechnology company developing innovative treatments for multiple therapeutic indications based on Leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with Leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for Leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with Leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of Leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that Leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that Leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on Leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate Leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with Leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.

Please direct media inquiries to Ken Bearden at media@nsf.org or +1.734.769.5167.

Kenneth Bearden
NSF International
+1 734 769 5176
kbearden@nsf.org

ALIGN TECHNOLOGY COMPLETES ACQUISITION OF EXOCAD, A GLOBAL DENTAL CAD/CAM SOFTWARE LEADER

SAN JOSE, Calif. and DARMSTADT, Germany, April 02, 2020 (GLOBE NEWSWIRE) — Align Technology, Inc. (Align) (Nasdaq: ALGN) today announced that it has completed the acquisition of privately-held exocad Global Holdings GmbH (exocad), a global leader in the dental CAD/CAM software market that offers fully integrated workflows to dental labs and dental practices via a broad customer base of partners and resellers in over 150 countries.

The acquisition of exocad broadens Align’s digital platform reach by adding technology that addresses restorative needs in an end-to-end digital platform workflow to facilitate ortho-restorative and comprehensive dentistry. The acquisition brings exocad’s expertise in restorative dentistry, implantology, guided surgery, and smile design to the Align technology portfolio. It extends Align’s Invisalign and iTero digital solutions, paving the way for new, seamless cross-disciplinary dentistry in the lab and at chairside. exocad also broadens Align’s platform reach in the digital dentistry with close to 200 partners and more than 35,000 licenses installed worldwide.

Commenting on today’s announcement, Joe Hogan, Align Technology president and CEO said, “The acquisition of exocad is a natural next step in the collaboration between our two companies that began in 2017. Now, we are excited for the next phase in our journey to continue driving the evolution of digital dentistry. exocad’s visionary founders, Till Steinbrecher and Maik Gerth, and their experienced software team, will enhance our technology capabilities and enable future digital innovation. Together, we will extend exocad’s position as a key technology provider for the dental CAD/CAM industry and drive continuous innovation with the open and integrated approach that is the foundation of the company.”

exocad will continue to operate as it exists today, enabling it to support a broad ecosystem of partners and end-users and continue to deliver hardware-independent software solutions. exocad co-founders Tillmann Steinbrecher and Maik Gerth, along with their team, will remain with the Company and report into John Morici, Align Technology, senior vice president and CFO. Align plans to maintain all exocad products and services.

About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign® system, the most advanced clear aligner system in the world, and iTero® intraoral scanners and services. Align’s products help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about iTero digital scanning system, please visit www.itero.com.

About exocad GmbH
exocad GmbH is a dynamic and innovative software company committed to expanding the possibilities of digital dentistry and providing OEMs (Original Equipment Manufacturers) with flexible, reliable, and easy-to-use CAD/CAM software for dental labs and dental practices. exocad software has been chosen by leading OEMs worldwide for integration into their dental CAD/CAM offerings, and thousands of exocad DentalCAD licenses are sold each year. For more information and a list of exocad reseller partners, please visit www.exocad.com.

Align Technology Zeno Group
Madelyn Homick Sarah Johnson
(408) 470-1180 (828) 551-4201
mhomick@aligntech.com sarah.johnson@zenogroup.com

Forward-Looking Statements
This news release, including the tables below and other information publicly disseminated by us, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including quotations from management, and statements regarding (i) expected transaction benefits and synergies as a result of the acquisition, (ii) future development efforts and the potential for digital innovation market positioning, (iii) product and service offerings, and (iv) operational and personnel expectations, in addition to other matters discussed in this press release that are not purely historical data. We do not assume any obligation to update or revise any such forward-looking statements, whether as the result of new developments or otherwise. Forward-looking statements contained in this news release and the tables below relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement.

Among the factors that could cause actual results to differ materially from those contemplated include, without limitation:

  • the impact of the COVID-19 pandemic on the the health and safety of our employees, customers, patients, and our suppliers as well as the physical and economic impacts of the various recommendations, orders and protocols issued by local and national governmental agencies in light of the evolving situation
  • the ability to: (i) realize expected synergies or benefits in connection with the transaction within the expected timeframes or not at all and (ii) timely, cost-efficiently and effectively integrate exocad’s business without adversely impacting operations of either Align or exocad;
  • the effect of the closing of the transaction on (i) Align’s and exocad’s relationships with their respective customers, suppliers, strategic partners and competitors and their operating results and businesses generally (including the diversion of management time on transaction-related issues) and (ii) the ability to retain and hire key personnel;
  • uncertainties associated with any aspect of the transaction, including those related to (i) fluctuations in foreign exchange rates and transaction costs, and (ii) litigation in connection with the transaction itself or ongoing matters acquired from exocad;
  • the potential that our due diligence did not uncover risks and potential liabilities associated with the exocad acquisition;
  • risks relating to financial reporting including those resulting from the implementation of new or changed accounting policies and practices as well as associated system implementation in the context of the transaction as well as our ability to forecast financial results;
  • the potential impact of the transaction on our future tax rate and payments based on the consolidation of the global group and our ability to integrate foreign operations;
  • the potential negative effects of the closing of the transaction on the market price of Align’s common stock;
  • difficulties predicting customer and consumer purchasing behavior;
  • expectations regarding the continued growth of our international markets;
  • increasing competition from existing and new competitors;
  • rapidly evolving and groundbreaking advances that are fundamentally changing the dental industry and the way new and existing participants market and provide products and services to consumers;
  • our ability to protect our intellectual property rights;
  • our expectations regarding sales growth of our intra-oral scanner sales in international markets and our belief that technology features and functionality of our iTero scanners and exocad products will increase adoption of Invisalign and increase sales of our intra-oral scanners;
  • the possibility that the development and release of new products or enhancements to existing products do not proceed in accordance with the anticipated timeline or may themselves contain bugs or errors requiring remediation and that the market for the sale of these new or enhanced products may not develop as expected, or that the expected benefits of new or existing business relationships will not be achieved as anticipated;
  • the compromise of employee, customer and/or patient data for any reason;
  • changes in consumer spending habits as a result of, among other things, prevailing economic conditions, levels of employment, salaries and wages and consumer confidence; and
  • foreign operational, political and other risks relating to our international manufacturing operations.

The foregoing and other risks are detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including, but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2019, which was filed with the Securities and Exchange Commission (SEC) on February 28, 2020. Securities and Exchange Commission filings can be accessed over the Internet at http://www.sec.gov/edgar/searchedgar/companysearch.html. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.

AirBoss Defense Group Selected by FEMA to Support the US National COVID-19 Response

Delivering Powered Air Purifying Respirators and High Efficiency Filters to Federal Government

The ADG FlexAir™ PAPR System

The FlexAir™ PAPR System is a compact, lightweight respirator system powered by an onboard battery in a waist-mounted blower, designed and manufactured in the United States.

LANDOVER, Md., April 01, 2020 (GLOBE NEWSWIRE) — AirBoss Defense Group (ADG) announced today that the U.S. Government has placed an initial order for 100,000 American-made FlexAir™ Powered Air Purifying Respirators (PAPR) and 600,000 High Efficiency Filters for urgent response to the COVID-19 pandemic. The FlexAir™ PAPR is designed to enable medical providers and first responders unencumbered protection over extended periods of time while providing critical medical care.  The value of the contract is expected to be $96.4M and deliveries will begin immediately and are expected to be completed over the next 13 weeks.

The FlexAir™ PAPR System is a compact, lightweight respirator system powered by an onboard battery in a waist-mounted blower, designed and manufactured in the United States.  The flexible design permits the use of 2 High Efficiency particulate filters, providing a high level of protection against biological viruses like COVID-19.

“This is war, and President Trump is using the full force of the federal government and the full power of private enterprises like ADG to rapidly mobilize our industrial base to fight the hidden enemy of COVID-19,” said Dr. Peter Navarro, White House Director of the Office of Trade and Manufacturing Policy.  “ADG has stepped up with lightning speed, and their willingness to help meet the urgent need for powered respirators will save American lives. This crisis has shown that maintaining and supporting a strong U.S. manufacturing base is of critical importance to our nation’s economic security and national defense.”

Patrick Callahan, CEO of AirBoss Defense Group said, “ADG is honored to apply our engineering and manufacturing capabilities towards protecting the lives of front-line medical professionals and first responders.  FlexAir™ PAPR systems are designed to provide caregivers ultimate protection against biological threats, including COVID-19, enhancing the life-saving capabilities of our dedicated health care workers.  The entire company is completely focused on delivering these products on an accelerated timeline, to Federal, state and local authorities as well directly to frontline health care professionals. As our products are manufactured in the United States, we are prepared to quickly provide lifesaving products as the need for protective equipment evolves.”

ADG is an umbrella survivability group that provides military, law enforcement, medical providers, industrial providers and first responders with a diverse portfolio of protective equipment that spans the entire survivability spectrum. AirBoss Defense, an ADG brand, is a recognized world leader in rapid deployment negative pressure isolation shelters, medical protection equipment, and personal respiratory protective products. AirBoss Defense’s emergency response and protective equipment is utilized by the U.S. Department of State, Office of Strategic Medical Preparedness, FEMA and CDC infectious disease treatment centers.

In addition, AirBoss Defense provides protective equipment to emergency medical response teams and hospitals in over 1,500 U.S. cities, as well as over 30 countries worldwide. The company successfully responded during the MERS and Ebola outbreaks, by providing critical protective equipment to government and civilian medical customers.  The company will continue to engage in the response to the COVID-19 outbreak through the rapid delivery of domestically manufactured personal protection equipment and patient isolation systems to the medical community.

For more information, please visit www.adg.com.

FORWARD LOOKING INFORMATION DISCLAIMER

Certain statements contained or incorporated by reference herein, including those that express management’s expectations or estimates of future developments or ADG’s future performance, constitute “forward-looking information” or “forward-looking statements” within the meaning of applicable securities laws, and can generally be identified by words such as “will”, “may”, “could” “is expected to”, “believes”, “anticipates”, “forecasts”, “plans”, “intends” or similar expressions.  These statements are not historical facts but instead represent management’s expectations, estimates and projections regarding future events and performance.

Statements containing forward-looking information are necessarily based upon a number of opinions, estimates and assumptions that, while considered reasonable by management at the time the statements are made, are inherently subject to significant business, economic and competitive risks, uncertainties and contingencies.  ADG cautions that such forward-looking information involves known and unknown contingencies, uncertainties and other risks that may cause ADG’s actual financial results, performance or achievements to be materially different from its estimated future results, performance or achievements expressed or implied by the forward-looking information.  Numerous factors could cause actual results to differ materially from those in the forward-looking information, including without limitation: impact of general economic conditions; dependence on key customers; sufficient availability of raw materials at economical costs; weather conditions affecting raw materials, production and sales; ADG’s ability to maintain existing customers or develop new customers in light of increased competition; ADG’s ability to successfully integrate acquisitions of other businesses and/or companies or to realize on the anticipated benefits thereof, changes in accounting policies and methods, including uncertainties associated with critical accounting assumptions and estimates; changes in tax laws and potential litigation; ability to obtain financing on acceptable terms; environmental damage and non-compliance with environmental laws and regulations; potential product liability and warranty claims and equipment malfunction.  This list is not exhaustive of the factors that may affect any of ADG’s forward-looking information.

All of the forward-looking information in this press release is expressly qualified by these cautionary statements.  Investors are cautioned not to put undue reliance on forward-looking information.  All subsequent written and oral forward-looking information attributable to ADG or persons acting on its behalf are expressly qualified in their entirety by this notice.  Forward-looking information contained herein is made as of the date of this press release and, whether as a result of new information, future events or otherwise, ADG disclaims any intent or obligation to update publicly this forward-looking information except as required by applicable laws.  Risks and uncertainties about ADG’ business are more fully discussed under the heading “Risk Factors” in AirBoss of America Corp.’s (“AirBoss”) recent Annual Information Form and are otherwise disclosed in AirBoss’ filings with securities regulatory authorities which are available on SEDAR at www.sedar.com.

AirBoss Defense Group
3341 75th Avenue, Suite GG
Landover, Maryland
Contact: David Costello
Tel: 617.875.2492
Email: david@risingtidemhd.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c77ab8f1-fb3f-4fba-b8a0-0af5c8207413