Daily Archives: September 17, 2021

Virgin Pulse Delivers Vaccination Management Solutions to Help Organizations Address and Adhere to New COVID-19 Mandates

Digital Vaccination Card

Employees can easily and securely enter their vaccination information and upload photo of vaccination card. Also allows employees to digitally carry their digital vaccination card at work or elsewhere.

PROVIDENCE. R.I., Sept. 17, 2021 (GLOBE NEWSWIRE) — In response to the Biden Administration’s recent COVID-19 Action Plan rules and international vaccine regulations and mandates, Virgin Pulse, the leading global provider of tech-enabled health, wellbeing and safety solutions, today announced that it has released new Vaccination Management and Mandate Compliance solutions to help organizations around the world meet evolving mandates and timelines and ensure the ongoing health and wellbeing of their workforce. Available October 4 as part of Virgin Pulse’s VP Passport™ workplace suite, these new capabilities provide real-time reporting, vaccination and testing status, symptom monitoring and next steps guidance so organizations can effectively navigate the ever-changing path of the COVID-19 pandemic.

Real-Time Visibility Dashboards

Employee-specific real-time vaccination information allows employers to make informed data-driven decisions: displays COVID-19 vaccination status, enables filtering by status, supports report exporting and so much more.

“Over the past 17 years, thousands of organizations around the world have trusted Virgin Pulse to protect and ensure the health, wellbeing and safety of their workforces today and in the future,” said Chris Michalak, CEO of Virgin Pulse. “This is a responsibility we are proud to embrace and one that requires us to deliver on our clients’ current requirements while anticipating their future needs which, as we have seen over the past 18 months, are not always linear or predictable. We launched VP Passport in less than 30 days to support organizations in ensuring a safe return to the workplace for their employees. Today, we have the opportunity to direct our expertise and innovation to help organizations clear yet another hurdle as they navigate the challenges of this pandemic.”

Given the fluid nature of these mandates, employers need a solution that meets today’s requirements and is future-proofed for the resurgence of COVID-19 cases. VP Passport equips employers with real-time visibility to vaccination and testing trends and access to intelligence necessary to make informed decisions about the health and safety of their workers in response to their current population health situation.

With VP Passport, employees can now answer a short survey related to vaccination and recent COVID-19 viral tests. These are securely stored within the Virgin Pulse platform where an uploaded digital copy of their vaccination record card is easily accessible for display. Upon request, an employee can display a badge reflecting their vaccination and/or testing status.

To help organizations adhere to the latest vaccination requirements and timelines and alleviate the increased organizational burden these mandates introduce, Virgin Pulse’s Vaccination Management and Mandate Compliance solutions provide:

  • Real-Time Visibility 
    A comprehensive dashboard with employee vaccination and testing status enables employers to manage risk and adhere to mandates at scale – whether they have 100 or 100,000 employees. A real-time view with a broad set of filters streamlines staying on top of complex and ever-changing policies. Employers can leverage the data to inform their path to compliance.
  • Digital Vaccination Card 
    Employees can self-report and securely store and digitally carry their vaccination card in their Virgin Pulse app for easy verification of vaccination status – at work or elsewhere. Employers can view the vaccination card in their dashboard for digital verification.
  • At-Home Testing Kits
    Employers can make at home testing kits available for their population through Virgin Pulse to address those that need to test prior to coming to the workplace.
  • Next-Step Communication
    Based on employee vaccination or testing status, employers can configure their specific guidance and next steps into the application to ensure effective communication and awareness of policies.
Customizable Vaccination Status Badge

A fully configurable badge that streamlines return to workplace by reflecting vaccination and/or testing status as well as helpful next steps guidance.

Availability
Virgin Pulse’s new vaccination management capabilities are delivered through Virgin Pulse’s VP Passport solution, which is available stand alone or integrated into Virgin Pulse’s Homebase for Health® platform. Current VP Passport clients will have access to these new features on October 4. For global clients, VP Passport is customizable to meet location and population specific mandates. For more information about VP Passport, visit https://community.virginpulse.com/virgin-pulse-vaccination-management-and-compliance-solution-for-employers

About Virgin Pulse
Virgin Pulse is the global leader and premier provider of digital health, wellbeing and safety solutions focused on helping users make the best decisions about their health at all stages of their health and wellbeing journey and reducing healthcare costs and. Featuring the industry’s only true Homebase for Health® that unifies and simplifies the health journey, Virgin Pulse fuses high-tech, high-touch, predictive analytics, AI and data to support clients and members across the entire health, wellbeing and benefits lifecycle—from screening and risk assessment to activation, behavior change and the adoption of sustainable, healthy habits to benefits navigation, condition management, gaps in care closure and digital therapeutics guidance. Today, 14 million+ users in more than 190 countries rely on Virgin Pulse’s digital and live solutions to change their lives—and businesses—for good. To learn more, visit VirginPulse.com and follow us on Twitter or LinkedIn.

Media Inquiries, please contact: Press@virginpulse.com

A video accompanying this announcement is available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/4de90b55-4493-49fb-b020-68242e2be132

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/2a895b0c-2c22-4777-9754-c264c219e31b

https://www.globenewswire.com/NewsRoom/AttachmentNg/e144f6e9-6176-459f-81d9-1f0e5b7556e7

https://www.globenewswire.com/NewsRoom/AttachmentNg/8810a096-a5f5-4642-aa12-6a3448c91beb

Junshi Biosciences and Coherus to Present Positive Progression Free Survival and Overall Survival Results from JUPITER-06, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma

– Interim results to be presented September 17 at the European Society for Medical Oncology (ESMO) Congress 2021 –

– Data support the use of toripalimab with chemotherapy as first-line therapy for patients with ESCC –

– Coherus and Junshi Biosciences plan to submit a BLA supplement for 1L ESCC in 2022 –

SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced positive interim results from the pivotal study “JUPITER-06” (NCT03829969), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone.

The results will be summarized by Dr. Feng Wang, Professor at Sun Yat-sen University Cancer Center (SYUCC), Guangzhou, in a mini-oral session during the ESMO Congress 2021 on Friday, September 17, 2021 at 12:05 pm Eastern Time. The abstract (# 1373MO) is now available on the ESMO website.

“The findings of this interim analysis provide strong evidence that the addition of toripalimab to chemotherapy as a first-line treatment for advanced or metastatic ESCC patients has superior PFS and OS than chemotherapy alone,” said Dr. Wang. “We look forward to updated analyses of overall survival of the JUPITER-06 study in the future and believe that these results will build a strong argument to support the use of toripalimab in combination with chemotherapy as a new standard first-line treatment in patients with advanced or metastatic ESCC.”

“A strong and consistent efficacy and safety profile is emerging for toripalimab across multiple tumor types as data read out from pivotal clinical trials in melanoma, nasopharyngeal carcinoma, urothelial cancer, lung cancer and now also esophageal squamous cell carcinoma,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “We believe toripalimab could be a potential new treatment choice where patients truly need better options. We will collaborate with Coherus to advance a BLA supplement for ESCC to make toripalimab available as quickly as possible for these patients in the U.S.”

“With JUPITER-06, toripalimab has once again exhibited compelling efficacy in a first-line setting,” said Denny Lanfear, CEO of Coherus. “The significant PFS and similarly robust overall survival data demonstrate that toripalimab in combination with chemotherapy could provide significant clinical benefits to patients with advanced or metastatic esophageal squamous cell carcinoma. We plan to work closely with our partner, Junshi Biosciences, to pursue a BLA supplement for this new indication expeditiously.”

About JUPITER-06
A total of 514 treatment-naive advanced or metastatic patients were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin chemotherapy followed by toripalimab or placebo maintenance. The primary endpoints were PFS as assessed by a blinded independent central review (BICR) and overall survival (OS).

  • At a prespecified interim analysis on March 22, 2021, with median follow-up of 7.4 and 7.3 months in the two arms, there was a significant improvement in OS for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.43-0.78], P=0.00037) with median OS of 17.0 vs. 11.0 months;
  • One-year OS rates were 66.0% vs.43.7% for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm, respectively;
  • A significant improvement in PFS assessed by BICR was also detected for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.46-0.74], P<0.00001);
  • The OS and PFS benefits were observed across key subgroups, including all PD-L1 expression subgroups;
  • The incidence of Grade ≥3 adverse events (AEs) (73.2% vs 70.0%) and fatal AEs (8.2% vs 8.2%) were similar between the two arms. No new safety signals were observed.

Junshi Biosciences and Coherus are planning in 2022 to submit a biologics license application supplement to the United States Food and Drug Adminstration for toripalimab for first-line treatment, in combination with platinum-based chemotherapy, of advanced or metastatic ESCC. In China, the supplemental New Drug Application of this indication has been accepted by the National Medical Products Administration (NMPA) in July, 2021.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the efficacy and safety of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designations for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA, and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first fully human neutralizing monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

UDENYCA® is a trademark of Coherus BioSciences, Inc.

Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

Humira® is a registered trademark of AbbVie Inc.

Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA® business; Coherus’ and Junshi Biosciences’ ability to co-develop toripalimab, and Coherus’ ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus’ ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for Coherus and Junshi to file a BLA in the United States for toripalimab for ESCC in 2022; the potential for Coherus and Junshi to file additional BLAs in the United States for toripalimab over the next three years for multiple rare cancers and highly prevalent cancers; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, esophageal squamous cell carcinoma, or any indication; Coherus’ plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus’ ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021

and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+ 1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

Coherus Contact Information:
IR Contact:
McDavid Stilwell
Coherus BioSciences, Inc.
mstilwell@coherus.com
+1 (650) 395-0152

Media Contact:
Sheryl Seapy
Real Chemistry
sseapy@realchemistry.com
+1 (949) 903-4750

Align Technology Introduces First Professional Whitening System Optimized for Invisalign Aligners and Vivera Retainers Powered by Ultradent’s Opalescence Tooth Whitening Systems

‘Invisalign Professional Whitening System – powered by Opalescence’

New Invisalign Professional Whitening System revolutionizes teeth whitening with an all-in-one solution that enables Invisalign trained doctors to straighten and whiten teeth at the same time.

  • Align signs multi-year agreement with Ultradent, a leader in tooth whitening for over 30 years, to offer Invisalign trained doctors an exclusive professional whitening system with the leading Opalescence PF whitening formula
  • New Invisalign Professional Whitening System revolutionizes teeth whitening with an all-in-one solution that enables Invisalign trained doctors to straighten and whiten teeth at the same time

TEMPE, Ariz. and SOUTH JORDAN, Utah, Sept. 16, 2021 (GLOBE NEWSWIRE) — Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced an exclusive supply and distribution agreement with Ultradent Products Inc., a leading developer and manufacturer of high-tech dental materials, devices, and instruments worldwide.

As part of the multi-year agreement, Align will offer Invisalign trained doctors an exclusive professional whitening system with the leading Opalescence PF whitening formula from Ultradent, optimized for use with Invisalign clear aligners and Vivera retainers. The system will carry the co-branded name of ‘Invisalign Professional Whitening System – powered by Opalescence’ and will offer the same great whitening outcomes and streamlined practice experience dental professionals expect from the Opalescence PF product during active tooth movement with Invisalign aligners, as well as during passive retention using Vivera retainers. The Invisalign Professional Whitening System will be commercially available globally in 2022.

“A brighter, whiter smile is an important part of the Invisalign patient journey. In fact, a survey of North American Invisalign practices (1) shows that half of their patients ask for teeth whitening during or after they complete Invisalign treatment,” said Raj Pudipeddi, Align Technology chief product and marketing officer, and SVP and managing director of the Asia Pacific Region. “We believe that by providing an all-in-one solution that combines a leading teeth-whitening system with the most advanced clear aligner system in the world, we enable Invisalign trained doctors to enhance their patients’ treatment experience with a seamless workflow that also enables practice efficiency and growth. We’re very excited to partner with Ultradent to offer the first professional whitening system optimized for use with Invisalign clear aligners and Vivera retainers. Invisalign system trained doctors can use Opalescence PF for in-office teeth whitening treatment and for doctor supervised at-home whitening.”

“We’re honored to partner with Align to make the top professional teeth whitening products available to more clinicians and patients around the world,” said Ultradent President and CEO Dirk Jeffs. “Providing Align with teeth whitening products, ideal for use with Invisalign aligners and Vivera retainers, is a considerable step toward our mission of improving oral health globally and we look forward to pursuing this mission together.”

“Many of my patients would like whiter teeth as well as a straighter smile,” said Dr. Brian Amy, an orthodontist and Align Faculty member practicing in Oklahoma City. “The new Invisalign Professional Whitening System allows me to provide both simultaneously using the brands I trust.”

“After testing this system in my practice, I can confirm that the Invisalign Professional Whitening System is easy to administer and offers a great patient experience by combining whitening with Invisalign aligners or Vivera retainers,” said Dr. Jennifer Bell, a restorative and cosmetic dentist and Align GP Advisory Board Member practicing in Holly Springs, North Carolina. “The simple ordering mechanism minimizes burden on my practice to store and manage whitening products, while providing the brighter, whiter smiles we have come to expect from the Opalescence PF product.”

Ultradent is an ISO13485 certified facility and will manufacture the products according to those standards.

(1) 2017 online survey of Invisalign doctors, data on file at Align Technology.

About Align Technology, Inc.
Align Technology designs, manufactures and offers the Invisalign system, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat approximately 10.9 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. 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. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

About Ultradent Products, Inc.
Ultradent Products, Inc., is a leading developer and manufacturer of high-tech dental materials, devices, and instruments worldwide. Ultradent’s vision is to improve oral health globally. Ultradent also works to improve the quality of life and health of individuals through financial and charitable programs. For more information about Ultradent, call 800.552.5512, visit ultradent.com or find us on LinkedInFacebook, and Instagram.

Forward-Looking Statements

This news release contains forward-looking statements, including the expectations for and the terms of the agreement between Align and Ultradent the availability and capabilities of the combined Invisalign aligner and Opalescence offering, our beliefs regarding the market for the combined offering and the potential benefits to doctors, their offices and patients, and other similar comments or statements that are forward-looking in nature. Forward-looking statements contained in this news release 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.

Factors that might cause such a difference include, but are not limited to:

  • the impact of the COVID-19 pandemic on 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 continual evolution of the pandemic, including any periodic reimplementation of preventative measures in various global locations;
  • difficulties predicting customer and consumer purchasing behavior and changes in consumer spending habits as a result of, among other things, prevailing economic conditions, levels of employment, salaries and wages, and consumer confidence, particularly in light of the pandemic and as pandemic-related restrictions are eased regionally and globally;
  • unexpected or rapid changes in the growth or decline of our domestic and/or international markets;
  • increasing competition from existing and new competitors;
  • rapidly evolving and groundbreaking advances that fundamentally alter the dental industry or the way new and existing customers market and provide products and services to consumers;
  • the ability to protect our intellectual property rights;
  • continued compliance with regulatory requirements;
  • declines in, or the slowing of the growth of, sales of our intraoral scanners domestically and/or internationally and the impact either would have on the adoption of Invisalign products;
  • the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers;
  • 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;
  • a tougher consumer demand environment in China generally, especially for manufacturers and service providers whose headquarters or primarily operations are not based in China;
  • the risks relating to our ability to sustain or increase profitability or revenue growth in future periods (or minimize declines) while controlling expenses;
  • the impact of excess or constrained capacity at our manufacturing and treat operations facilities and pressure on our internal systems and personnel;
  • the compromise of customer and/or patient data for any reason;
  • the timing of case submissions from our doctors within a quarter as well as an increased manufacturing costs per case;
  • foreign operational, political and other risks relating to our international manufacturing operations; and
  • the loss of key personnel or work stoppages.

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, 2020, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2021 and our latest Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, which was filed with the SEC on August 4, 2021. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1742977a-2b2f-4438-a77a-ac27bbc577de

141 fly to Langkawi from Ipoh on maiden flight

IPOH, Sept 17 — A total of 141 passengers, including 23 children, took off on the first flight from the Sultan Azlan Shah Airport here today to Langkawi under the travel bubble pilot project.

Perak Infrastructure, Energy, Water and Public Transport Committee chairman Datuk Mohd Zolkafly Harun said AirAsia is offering Ipoh-Langkawi-Ipoh flights thrice a week on Wednesdays, Fridays and Sundays starting today.

“The flight to Langkawi uses an Airbus A320 aircraft with a maximum capacity of 180 passengers and the maiden flight at about 1.30 pm today had a load of 80 per cent,” he told a media conference at the airport here today.

Also present were public health medical specialist Dr. Mohd Zamri Md Ali and Ipoh Malaysia Airport Berhad manager Tugiman Sabudin.

Mohd Zolkafly said passengers were required to undergo a COVID-19 screening test and those who tested positive were not allowed to continue their journey, after which they would be subjected to existing standard operating procedures (SOPs) for case management.

According to Mohd Zolkafly, over 50 per cent of the flight capacity or more than 70 passengers have so far booked their seats for the next Langkawi flights on Sunday and Wednesday.

He said the state government had also taken various measures to restore the confidence of tourists to visit Perak, include implementing specific vaccination programmes for tourism industry players.

“A lot of preparations have been done to ensure that the domestic tourism sector is active again and ready to receive visitors and tourists, especially when our state borders are fully opened,” he said.

Source: BERNAMA News Agency

‘Innovation for Cool Earth Forum 8th Annual Meeting’ kicks off Oct 6 – 7

KUALA LUMPUR, Sept 17 — The ICEF Secretariat has announced that Japan’s Ministry of Economy, Trade and Industry (METI) and New Energy and Industrial Technology Development Organization (NEDO) will host ‘Innovation for Cool Earth Forum 8th Annual Meeting (ICEF2021)’ online from Oct 6 to 7.

Every year since 2014, METI and NEDO have hosted the Innovation for Cool Earth Forum (ICEF) to gather leading international figures in Tokyo to discuss how to combat climate change through technological innovation, according to a statement.

ICEF’s mission is to nurture discussion and collaboration among participants and disseminate the industry’s latest innovations in energy and environmental technologies by providing a place where experts can share their knowledge on how to tackle the 21st century’s greatest environmental challenge.

A distinguished steering committee, consisting of members from worldwide, strives to bring the best minds together to develop a programme which addresses forces of change while ensuring they are based on solid evidence.

In the world, a variety of initiatives across industry, government and academia are being rapidly accelerated toward a Decarbonized Society.

There are many diverse climate change challenges, and all stakeholders in society, including the private sector and governments, are called upon to tackle specific actions from short and long-term perspectives.

Source: BERNAMA News Agency

JKR signs MoU on data integration programme to monitor federal projects in Sabah

KOTA KINABALU, Sept 17 — The Public Works Department (JKR) and Sabah JKR today signed a memorandum of understanding (MoU) to carry out the Control and Reporting System (SKALA) data integration programme to further facilitate the process of monitoring the implementation of federal projects in the state.

Deputy Works Minister Datuk Arthur Joseph Kurup said the integration of the system could benefit Malaysian JKR and Sabah JKR officers in managing projects being implemented in the state.

“Through the monitoring of the projects, it will be able to provide accurate and up-to-date information to improve the efficiency of online communication and reporting.

“This enables federal and state development project data to be accessed jointly. This data sharing will also speed up the process of reporting the physical progress of the project to enable stakeholders to obtain information immediately, besides saving costs,” he told reporters after witnessing the signing of the MoU here.

The MoU was signed by Public Works director-general Datuk Mohamad Zulkefly Sulaiman and Sabah JKR director Ali Ahmad Hamid.

The signing ceremony was also witnessed by Sabah Deputy Chief Minister Datuk Seri Bung Moktar Radin

Elaborating further, Arthur said cooperation between the federal and state agencies needed to be enhanced in an effort to accelerate the implementation of government projects and programmes towards digital transformation.

Meanwhile, Bung Moktar said the MoU was timely due to the current challenges the country is facing, especially the COVID-19 pandemic.

Source: BERNAMA News Agency

4-day 18th Annual Meeting of Science and Technology in Society forum begins Oct 2

KUALA LUMPUR, Sept 17 — The STS forum, a non-profit organisation will hold its 18th Annual Meeting from Oct 2 to 5, which will be LIVE ONLINE from Kyoto, Japan.

World leaders, including professional scientists, policymakers and business leaders, will gather online to discuss the pressing science and technology issues the world is facing and to build an international network.

The forum will host 20 sessions online this year. Some examples of the topics are ‘Global Pandemic–Lessons Learned and Forecast’; ‘Green Recovery for Sustainable Society’; ‘Disruptive Technologies for Industries’; and, ‘The Second Quantum Revolution and Society’.

According to a statement, more than 100 distinguished speakers have confirmed their online presence.

Among others, Policymakers: Mariya Gabriel, Commissioner, European Commission, EU; Laksana Tri Handoko, Chairman, National Research and Innovation Agency, Indonesia; Helen Elizabeth Clark, 37th Prime Minister of New Zealand.

Business leaders: Nathan Myhrvold, Founder and Chief Executive Officer, Intellectual Ventures, U.S.A.; Terry Brady, President and CEO, Underwriters Laboratories Inc, U.S.A.; and, Ahmad O. Al-Khowaiter, Chief Technology Officer, Saudi Arabian Oil Company, Saudi Arabia.

Academia: Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseases, U.S.A.; George Fu Gao, Director-General, Chinese Center for Disease Control and Prevention, China; and, Gerald H. Haug, President, German National Academy of Sciences Leopoldina, Germany.

International organisation/media: Seth Berkley, CEO, Gavi, the Vaccine Alliance; Magdalena Skipper, Editor-in-Chief, Nature, U.K.; and, Holden Thorp, Editor-in-Chief, Science, U.S.A.

Invitation requests can be submitted from https://www.stsforum.org/kyoto2021/ or more details available at https://www.stsforum.org/

Source: BERNAMA News Agency