Month: September 2021

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Laserfiche Announces Launch of Cloud Document Management and Process Automation Solution to EMEA Region, Supports Digital Resiliency Strategies

LONDON, Sept. 22, 2021 /PRNewswire/ — Laserfiche today announced the availability of Laserfiche Cloud in the Europe, Middle East and Africa (EMEA) region. The leading SaaS provider of intelligent content management and business process automation’s cloud offering delivers an innovative and trusted system for securely managing content and automating business processes across the enterprise. With digital workflows, electronic forms, records management and analytics, Laserfiche Cloud connects people, platforms and processes to accelerate digital transformation, and enhance employee and customer experiences.

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“To succeed in an increasingly digital environment, organisations need to accelerate digital transformation with a focus on empowering their people, properly managing their information and automating their processes,” said Laserfiche President Karl Chan. “After more than a year of unprecedented business disruptions, Laserfiche Cloud enables business leaders to focus on enhancing staff and client experiences through technological innovation — whether working in-person, in a hybrid environment or completely remotely.”

Laserfiche Cloud provides users with full control over content and processes enterprise-wide, accelerating innovation with tools that help organisations securely govern information and enable collaboration. Built with granular control access, regulatory compliance, data security, digital collaboration and document management features, the solution serves as the centralised command centre for enterprises across industries. Organisations throughout the world that regularly handle personal data for customers based in Europe can implement Laserfiche Cloud to address compliance needs for regional regulations such as GDPR.

Additionally, prebuilt solution templates and customisable e-forms and processes support digital resiliency and agility as more businesses digitally transform to respond to disruptions such as COVID-19.

Laserfiche has been recognised as a 2020 Gartner Peer Insights Customers’ Choice for Content Services Platforms and a 2021 Product of the Year Award Winner by Cloud Computing Magazine.

To learn more about Laserfiche Cloud, visit the Laserfiche website.

About Laserfiche

Laserfiche is the leading SaaS provider of intelligent content management and business process automation. Through powerful workflows, electronic forms, document management and analytics, the Laserfiche® platform accelerates how business gets done, enabling leaders to focus on growth across the enterprise.

Laserfiche pioneered the paperless office with enterprise content management. Today, Laserfiche’s cloud-first development approach incorporates innovations in machine learning and AI to enable organisations in more than 80 countries to transform into digital businesses. Customers in every industry — including government, education, financial services, healthcare and manufacturing — use Laserfiche to boost productivity, scale their business and deliver digital-first customer experiences.

Laserfiche employees in offices around the world are committed to the company’s vision of empowering customers and inspiring people to reimagine how technology can transform lives.

Connect with Laserfiche:

Laserfiche Blog | Twitter | LinkedIn | Facebook

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New York Life Investments Alternatives and Coalition Greenwich Announce New Research on the Impact of the COVID-19 Crisis on Middle Market Private Equity Sponsors

Research Analyzes Insights on Investment Trends, Exit Strategies, Funding Sources, Emerging Challenges and Middle Market Opportunities

NEW YORK, Sept. 22, 2021 /PRNewswire/ —  New York Life Investments Alternatives in partnership with Coalition Greenwich today released a new research report that analyzes how middle market private equity sponsors responded to the global pandemic. The report is titled, “Lessons Learned: Insights from the COVID-19 Crisis for Middle Market Private Equity Sponsors,” and features research results from more than 100 interviews with managing directors and partners at middle market private equity sponsors in the U.S.

“The pandemic pressure tested middle market private equity sponsors on every level, yet sponsors more than rose to the occasion as seen by the strong rebound in deal volume in the second half of 2020 and into this year. From sharpening their investment processes to rapidly adopting new technologies, sponsors quickly adapted to the new environment to best support their current portfolio companies while also continuing deployment of capital across new deals,” said Christopher Taylor, Head of New York Life Investments Alternatives and CEO of Madison Capital Funding.

The research revealed that the COVID-19 pandemic has had a profound impact on the middle market private equity industry and has triggered lasting changes across sponsors’ core areas such as investing, deal sourcing, transaction financing, exit strategies and fundraising.

Key takeaways from the research data include:

  • New Deals Drove Deployment: For 60% of the middle market private equity sponsors participating in the study, new deals represented the most common driver of capital deployment in 2020, with add-on investments a distant second.
  • Sponsors Sharpen Investment Processes: The global pandemic forced sponsors to sharpen their skills and tighten procedures, with almost 30% of sponsors surveyed reporting that the crisis and subsequent rebound prompted them to tighten their discipline on valuations.
  • Relationships Prove Their Worth, Especially in Deal Funding: Sponsors surveyed ranked relationship history and covenant flexibility as the attributes they see as most important in financing partners in uncertain market environments.
  • Pandemic Had Mixed Effect on Exits: More than a third of sponsors surveyed report the pandemic delayed exits and extended holding periods. Sponsors report delays ranging from a few months to two years to provide portfolio companies more time to meet growth expectations.
  • Optimism Remains Among LPs: More than half of study participants believe the LP community remains optimistic about the investment climate; however, about 30% of study participants say LPs are turning negative on the environment—often due to valuation concerns.
  • ESG Adoption Continues: Three-quarters of specialist sponsors and half of generalists surveyed say they take ESG factors into account when making investments. However, most have yet to establish formal processes for assessing ESG or incorporating DEI factors and fewer than 5% of sponsors surveyed are UN PRI signatories.

“Looking ahead, sponsors remain poised to take advantage of favorable conditions in the middle market following their swift and decisive actions in 2020. Middle market deal flow continues to gain momentum as markets rapidly rebound and sponsors look to put record levels of dry powder to work ahead of potential tax changes,” added Taylor. “The COVID-19 crisis combined with last year’s economic and social upheavals not only had a lasting effect on business operations, investment decision making and portfolio management, but also shifted sponsors’ focus from the ‘E’ to the ‘S’ in ESG, underscoring the incredible importance of diversity, equity and inclusion across investment processes and portfolios.”

To read more about the survey results, download the complete research report here: Lessons Learned: Insights from the COVID-19 Crisis for Middle Market Private Equity Sponsors.

Methodology

Between February and April 2021, Coalition Greenwich, in partnership with New York Life Investments Alternatives, conducted a study to examine the effects of the COVID-19 crisis on middle market private equity sponsors. Coalition Greenwich interviewed 100 managing directors and partners at middle market private equity sponsors in the United States. These in-depth phone conversations centered on the impact of COVID on investment trends, exit strategies, funding sources, and emerging challenges and opportunities.

About New York Life Investments Alternatives

New York Life Investments Alternatives LLC (“NYLIA”) is a registered investment adviser that provides comprehensive capital solutions and other alternative strategies to a broad range of institutional clients. NYLIA is comprised of three highly specialized alternative investing boutiques: GoldPoint Partners, Madison Capital Funding, and PA Capital, collectively managing over $35 billion in assets under management (AUM) as of 7/31/2021*.

For more information, visit: https://www.newyorklifeinvestments.com/nyl-alternatives

About Coalition Greenwich

Coalition Greenwich, a division of CRISIL, an S&P Global Company, is a leading global provider of strategic benchmarking, analytics and insights to the financial services industry.  We specialize in providing unique high value data and actionable recommendations to help our clients improve their business results.

*Madison Capital Funding LLC’s (MCF) Assets Under Management (“AUM”) includes approximately $271 million of equity, mezzanine, fund and other subordinated investments and approximately $4.3 billion of third-party senior loan assets managed by MCF.  These assets qualify as Regulatory Assets Under Management (“RAUM”) as defined in SEC Form ADV.  AUM does not include approximately $265 million of RAUM consisting primarily of unfunded capital commitments to certain private funds managed by MCF.  The balance of the AUM, approximately $8.2 billion of senior loan commitments and $73 million of fund investments, are managed by MCF for its own account. These senior loan commitment assets and fund investments do not qualify as RAUM and, therefore, are not included in MCF’s Form ADV RAUM calculation for regulatory purposes.

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Adagio Therapeutics informa sobre o Programa de Anticorpos COVID-19, bem como sobre os Destaques de Negócios e Resultados Financeiros do Segundo Trimestre de 2021

Novos Dados que Corroboram o Potencial do ADG20 para o Tratamento e Prevenção da COVID-19 Serão Divulgados na IDWeek 2021

Número de Pacientes do Ensaio Clínico da Fase 2/3 do EVADE Global de ADG20 Expandido após Avaliação IDMC

Conclusão da IPO de US$355,8 milhões para financiar o avanço contínuo do portfólio de soluções com base em anticorpos para doenças infecciosas com potencial de pandemia

WALTHAM, Mass., Sept. 21, 2021 (GLOBE NEWSWIRE) — A Adagio Therapeutics, Inc., (Nasdaq: ADGI) uma empresa biofarmacêutica de estágio clínico focada na descoberta, desenvolvimento e comercialização de soluções com base em anticorpos para combate de doenças infecciosas com potencial pandêmico, divulgou hoje informações sobre seu principal programa de anticorpos COVID-19, ADG20, bem como destaques recentes de negócios e resultados financeiros do segundo trimestre de 2021.

“Em todo o mundo, a COVID-19 continua a ser uma crise de saúde significativa que afeta quase todas as faixas etárias. Com o surgimento contínuo de novas variantes, terapias amplamente neutralizantes que podem ser usadas tanto para o tratamento quanto para a prevenção da doença são vitais para o enfrentamento dos surtos endêmicos atuais e futuros em potencial”, disse Tillman Gerngross, Ph.D., cofundador e diretor executivo da Adagio. “Nossa equipe está trabalhando em estreita colaboração com nossos parceiros globais de CRO na execução de nossos ensaios clínicos globais em andamento do ADG20, STAMP e EVADE, enquanto também se prepara para a esperada comercialização mundial do ADG20, se aprovado.

“O ADG20 é um anticorpo altamente diferenciado que estamos desenvolvendo por meio de ensaios principais para o tratamento e a prevenção da COVID-19. Estamos satisfeitos com a recente avaliação dos dados não cegos do ensaio EVADE pelo IDMC e pelo seu apoio aos nossos planos de expansão da inscrição para incluir adolescentes e mulheres grávidas ou lactantes”, disse Lynn Connolly, M.D., Ph.D., diretora médica da Adagio. “Já criamos um pacote de dados convincente para o ADG20 que inclui ampla neutralização do vírus SARS-CoV-2 original e as variantes preocupantes conhecidas em modelos in vitro, bem como um perfil favorável de farmacocinética e tolerabilidade na Fase 1 do nosso estudo. Além disso, na IDWeek deste ano, divulgaremos dados adicionais da Fase 1 do nosso estudo, bem como detalhes sobre o nosso processo de seleção de dosagem para tratamento e prevenção, que acreditamos confirmar ainda mais o importante papel que esse novo anticorpo pode desempenhar no combate à pandemia que estamos enfrentando.”

Destaques do Programa COVID-19 ADG20

  • Novos dados do ADG20 Serão Apresentados na IDWeek: Na Conferência Virtual IDWeek 2021, a Adagio pretende apresentar dados adicionais destacando o potencial do ADG20 para proteção contra a COVID-19 por até um ano, com base em sua meia-vida prolongada em humanos, juntamente com sua ampla e potente capacidade neutralizante demonstrada em testes laboratoriais. Além disso, os dados confirmam a avaliação de uma dose de 300 mg, administrada como uma única injeção intramuscular, nos ensaios clínicos globais STAMP de fase 2/3 (tratamento) e EVADE (prevenção) em andamento. Os dados serão apresentados em múltiplos cartazes que estarão disponíveis para os participantes cadastrados na plataforma virtual durante toda a conferência a ser realizada de 29 de setembro a 3 de outubro de 2021. As apresentações incluem:
    • 1086: Um Modelo Farmacocinético de Base Fisiológica de Farmacologia de Sistema Quantitativo de Corpo Inteiro (QSP/PBPK) que Prevê a Farmacocinética Intramuscular (IM) a priori de ADG20: um Anticorpo Monoclonal de Meia-vida Estendida em Desenvolvimento para o Tratamento e Prevenção da Doença do Coronavírus (COVID-19)
    • 633: Resultados Preliminares de um Estudo de Fase 1 de Dose Ascendente Única que Avalia a Segurança, os Títulos de Anticorpos Neutralizantes Virais no Soro (sVNA) e o Perfil Farmacocinético (PK) de ADG20: um Anticorpo Monoclonal de Meia-vida Estendida em Desenvolvimento para o Tratamento e Prevenção da Doença do Coronavírus (COVID-19)
    • 1089: Uso de um Modelo Farmacocinético de Base Fisiológica de Farmacologia de Sistema Quantitativo de Corpo Inteiro (QSP/PBPK) para Apoiar a Seleção de Dose de ADG20: um Anticorpo Monoclonal de Meia-vida Estendida em Desenvolvimento para o Tratamento e Prevenção da Doença do Coronavírus (COVID-19)
    • 1088: Um Modelo Farmacocinético de Base Fisiológica de Farmacologia de Sistema Quantitativo de Corpo Inteiro (QSP/PBPK) para apoiar a seleção de dose de ADG20: um Anticorpo Monoclonal de Meia-vida Estendida em Desenvolvimento para o Tratamento e Prevenção da Doença do Coronavírus (COVID-19)
  • Número de Pacientes Aumentado no EVADE após a Avaliação de Dados do IDMC: O independent data monitoring committee (comitê independente de monitoramento de dados – IDMC) para o estudo do EVADE Fase 2/3 do ADG20 para a prevenção da COVID-19 forneceu recentemente uma recomendação para a expansão do número de inscrições no estudo de Fase 3 para incluir adolescentes a partir de 12 anos e mulheres grávidas ou lactantes, bem como a diminuição na duração do monitoramento pós-injeção especificado pelo protocolo. As recomendações do IDMC têm por base a análise dos dados de tolerabilidade não cegos até o dia 28 da visita pós-tratamento de 200 participantes inscritos na parte inicial da Fase 2 do estudo.
  • A parceria com a Biocon Biologics amplia o alcance de um tratamento de anticorpos COVID-19 potente e amplamente neutralizante para pacientes na Índia e determinados mercados emergentes: No segundo trimestre de 2021, a Adagio fez uma parceria com a Biocon Biologics Ltd. para combater a crise da COVID-19 no sul da Ásia. A parceria concedeu à Biocon direitos de fabricação e comercialização de uma terapia de anticorpos com base no ADG20 na Índia e mercados emergentes selecionados adicionais, com base no processo de fabricação comercial desenvolvido para o ADG20. Como parte do acordo, a Biocon terá acesso aos dados dos ensaios clínicos de Fase 2/3 da Adagio, bem como seu pacote da prevista Autorização de Uso de Emergência e outros pedidos regulatórios em suporte à aprovação ou autorização de emergência na Índia e em determinados mercados emergentes.

Destaques Recentes da Empresa

  • David Hering, Especialista Global em Vacinas COVID-19, Nomeado Diretor de Operações: A Adagio recentemente nomeou David Hering como diretor de operações da empresa. O Sr. Hering, veio da Pfizer, onde recentemente atuou como líder global da divisão de mRNA, uma divisão criada especificamente para o gerenciamento dos esforços globais de COVID-19, bem como de futuras vacinas que utilizam a tecnologia mRNA, e liderou o lançamento da primeira vacina COVID-19 nos Estados Unidos. Antes do seu cargo mais recente na Pfizer, Hering foi presidente da Pfizer na América do Norte, onde liderou uma empresa com 700 pessoas, com um portfólio de produtos de vacinas para COVID-19 e doenças meningocócicas e pneumocócicas.
  • Oferta Pública Inicial (IPO) de US$355,8 milhões Concluída com Sucesso: Em agosto de 2021, a Adagio vendeu 20.930.000 ações ordinárias, incluindo a opção de compra dos subscritores de2.730.000 ações ordinárias adicionais a um preço de oferta pública de US$17,00 por ação. A receita bruta da oferta, antes da dedução dos descontos, comissões de subscrição e despesas da oferta a pagar pela Synchronoss, deve ser aproximadamente US$100 milhões.
  • Colaboração com Scripps: A Adagio celebrou um acordo de pesquisa exclusivo com o The Scripps Research Institute para a identificação de candidatos a vacinas amplamente protetoras para a prevenção da gripe e beta coronavírus.
  • Conselho Diretor Ampliado com Líderes do Setor para o Apoio ao Crescimento Futuro: A Adagio anunciou recentemente a nomeação de três veteranos e especialistas do setor para seu conselho de administração:
    • Tom Heyman, ex-presidente da Johnson & Johnson Development Corporation (JJDC);
    • Anand Shah, M.D., ex-representante adjunto de assuntos médicos e científicos da Food and Drug Administration dos EUA (FDA); e
    • Michael S. Wyzga, presidente da MSW Consulting, Inc. e ex-CFO da Genzyme

Resultado Financeiro do Segundo Trimestre de 2021

  • Em 30 de junho de 2021, a Adagio tinha US$392,5 milhões em caixa, equivalentes de caixa e títulos negociáveis, incluindo o produto líquido do financiamento da Série C concluído em abril. O caixa pro forma, equivalentes de caixa e títulos negociáveis em 30 de junho de 2021 era de US$719,6 milhões após a efetivação da nossa oferta pública inicial, que foi encerrada no dia 10 de agosto de 2021.
  • As despesas com pesquisa e desenvolvimento, incluindo pesquisa e desenvolvimento em processo para o segundo trimestre de 2021, foram de US$37,6 milhões.
  • As despesas com vendas, gerais e administrativas para o segundo trimestre de 2021 foram de US$7,1 milhões.
  • O Prejuízo Líquido do segundo trimestre foi de US44,7 milhões, ou US$0,18 por ação.

Sobre o ADG20
O ADG20, um anticorpo monoclonal direcionado à proteína Spike do SARS-CoV-2 e coronavírus relacionados, está sendo desenvolvido para a prevenção e tratamento da COVID-19, a doença causada pelo SARS-CoV-2. ADG20 foi projetado e criado para alta potência e ampla neutralização contra SARS-CoV-2 e sarbecovírus de clado 1 adicionais, direcionando-se a um epítopo altamente conservado no domínio de ligação ao receptor. O ADG20 exibe atividade neutralizante potente contra a cepa SARS-CoV-2 original, bem como todas as variantes preocupantes conhecidas. O ADG20 tem o potencial de impactar a replicação viral e a doença subsequente através de múltiplos mecanismos de ação, incluindo o bloqueio direto da entrada viral na célula hospedeira (neutralização) e a eliminação de células hospedeiras infectadas através da atividade efetora imune inata mediada por Fc. O ADG20 é administrado por meio de uma injeção intramuscular e foi projetado para ter uma meia-vida longa, com o objetivo de fornecer proteção rápida e durável. A Adagio está avançando o ADG20 por meio de vários ensaios clínicos em uma base global.

Sobre a Adagio Therapeutics

A ADAGIO (Nasdaq: (ADGI) é uma empresa biofarmacêutica de estágio clínico focada na descoberta, desenvolvimento e comercialização de soluções com base em anticorpos para doenças infecciosas com potencial pandêmico. O portfólio de anticorpos da empresa foi otimizado com os recursos de engenharia de anticorpos líderes da indústria da Adimab, e foi criado para fornecer aos pacientes e médicos uma combinação de potência, amplitude, proteção durável (via extensão de meia-vida), capacidade de fabricação e acessibilidade. O portfólio de anticorpos contra SARS-CoV-2 da Adagio inclui múltiplos anticorpos amplamente neutralizantes não competitivos com epítopos de ligação distintos, liderados por ADG20. A Adagio adquiriu a capacidade de fabricação para a produção do ADG20 com fabricantes terceirizados através da conclusão de ensaios clínicos e, se aprovado pelas autoridades reguladoras, através do lançamento comercial inicial. Para mais informação, visite www.adagiotx.com.

Declarações de Previsão
Este comunicado para a imprensa contém declarações consideradas declarações de previsão de acordo com o Private Securities Litigation Reform Act of 1995. Palavras como “antecipa”, “acredita”, “espera”, “pretende”, “projeta”, e “futura”, e expressões similares são usadas para identificar declarações de previsão. As declarações de previsão incluem declarações sobre, entre outras coisas, a ocasião, progresso e resultados dos nossos estudos pré-clínicos e ensaios clínicos do ADG20, incluindo a ocasião dos nossos pedidos planejados de IND, início e conclusão de estudos ou ensaios, e trabalhos preparatórios relacionados, o período durante o qual os resultados dos ensaios ficarão disponíveis, e nossos programas de pesquisa e desenvolvimento; nossa capacidade de obter e manter aprovações regulatórias para nossos candidatos a produtos; nossa capacidade de identificar pacientes com as doenças tratadas por nossos candidatos a produtos, e de inscrever esses pacientes nos nossos ensaios clínicos; nossas capacidades e estratégia de fabricação; e nossa capacidade de comercialização com sucesso dos nossos candidatos a produtos. Podemos não atingir os planos, intenções ou expectativas mencionadas nas nossas declarações de previsão, e você não deve depositar confiança indevida nas nossas declarações de previsão. Essas declarações de previsão envolvem riscos e incertezas que podem fazer com que nossos resultados reais sejam substancialmente diferentes dos resultados descritos ou implícitos nas declarações de previsão, incluindo, sem limitação, os riscos descritos no título “Fatores de Risco” no prospecto da Adagio arquivado na Comissão de Valores Mobiliários (“SEC”) em 6 de agosto de 2021 e nos relatórios futuros da Adagio a serem arquivados na SEC, incluindo o Relatório Trimestral da Adagio no Formulário 10-Q do trimestre encerrado em 30 de junho de 2021. Tais riscos podem ser amplificados pelos impactos da pandemia de COVID-19. As declarações de previsão contidas neste comunicado para a imprensa são válidas a partir desta data, e a Adagio não se compromete a atualizar essas informações, exceto se exigido por lei.

Contatos:

Contato com a Mídia:
Dan Budwick, 1AB
Dan@1abmedia.com

Contato com o Investidor:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

ADAGIO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(In thousands, except share and per share amounts)

June 30,
2021,		     December 31,
2020
Assets
Current assets:
Cash and cash equivalents(1) $ 392509 $ 114988
Prepaid expenses and other current assets 3550 2394
Total current assets 396059 117382
Deferred offering costs 1933 —
Total assets $ 397992 $ 117382
Liabilities, Convertible Preferred Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable $ 10716 $ 8153
Accrued expenses 27181 4919
Total current liabilities 37897 13072
Early-exercise liability 8 11
Total liabilities 37905 13083
Commitments and contingencies
Convertible preferred stock (Series A, B and C) $0.0001 par value; 16,944,484 shares authorized, issued and outstanding at June 30, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $505,399 and $169,900 at June 30, 2021 and December 31, 2020, respectively 504711 169548
Stockholders’ deficit:
Common stock, $0.0001 par value; 150,000,000 shares authorized at June 30, 2021 and December 31, 2020; 5,599,240 shares issued and outstanding at June 30, 2021; 28,193,240 shares issued and 5,593,240 shares outstanding at December 31, 2020 1 1
Treasury stock, at cost; 0 shares and 22,600,000 shares at June 30, 2021 and December 31, 2020, respectively — (85 )
Additional paid-in capital 4067 154
Accumulated deficit (148.692 ) (65.319 )
Total stockholders’ deficit (144.624 ) (65.249 )
Total liabilities, convertible preferred stock and stockholders’ deficit $ 397992 $ 117382

(1)     O caixa pro forma, equivalentes de caixa e valores mobiliários em 30 de junho de 2021 é US$719,6 milhões após efetivar nossa emissão e venda de 20.930.000 ações ordinárias da nossa oferta pública inicial ao preço de US$17,00 por ação após a dedução dos descontos de subscrição, comissões e custos estimados da oferta encerrada em 10 de agosto de 2021.

ADAGIO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

(In thousands, except share and per share amounts)

Three Months
Ended
June 30,		     Six Months
Ended
June 30,		     Period from
June 3, 2020
(Inception) to
June 30,
2021     2021     2020 (3)
Operating expenses:
Research and development(1) $ 35067 $ 69204 $ 48
Acquired in-process research and development(2) 2500 3500 —
Vendas, despesas administrativas e gerais 7124 10695 50
Total operating expenses 44691 83399 98
Loss from operations (44.691 ) (83.399 ) (98 )
Other income (expense):
Receita de juros 23 32 —
Other expense (5 ) (6 ) —
Total other income (expense), net 18 26 —
Net loss and comprehensive loss $ (44.673 ) $ (83.373 ) $ (98 )
Net loss per share attributable to common stockholders, basic and diluted $ (0,18 ) $ (0,66 ) $ —
Weighted-average common shares outstanding, basic and diluted 249769 125574 21250000

(1)    Inclui valores de partes relacionadas de US$247 para os três meses findos em 30 de junho de 2021, US$435 para os seis meses findos em 30 de junho de 2021 e US$0 para o período de 3 de junho de 2020 (início) a 30 de junho de 2020.
(2)    Inclui valores de partes relacionadas de US$2.500 para os três meses findos em 30 de junho de 2021, US$3.500 para os seis meses findos em 30 de junho de 2021 e US$0 para o período de 3 de junho de 2020 (início) a 30 de junho de 2020.
(3)    Os resultados do período de 3 de junho de 2020 (início) a 30 de junho de 2020 são os mesmos para os três e seis meses findos em 30 de junho de 2020.

 

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Adagio Therapeutics apporte des mises à jour du programme d’anticorps contre la COVID-19, et révèle les récents faits marquants de son activité et les résultats financiers du deuxième trimestre 2021

De nouvelles données étayant le potentiel de l’ADG20 pour le traitement et la prévention de la COVID-19 seront présentées lors de l’IDWeek 2021

La population de patients participant à l’essai clinique mondial EVADE de phase 2/3 de l’ADG20 a été élargie suite à l’évaluation de l’IDMC

Une introduction en bourse de 355,8 millions de dollars a été réalisée pour financer la progression continue du portefeuille de solutions à base d’anticorps pour les maladies infectieuses à potentiel pandémique

WALTHAM, Massachusetts (États-Unis), 21 sept. 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., (Nasdaq : ADGI) une société biopharmaceutique au stade clinique axée sur la découverte, le développement et la commercialisation de solutions à base d’anticorps pour les maladies infectieuses à potentiel pandémique, a annoncé aujourd’hui des mises à jour sur son principal programme d’anticorps COVID-19, l’ADG20, ainsi que des données marquantes récentes et les résultats financiers du deuxième trimestre 2021.

« À travers le monde, la COVID-19 continue de constituer une crise sanitaire significative affectant quasiment tous les groupes d’âge. Avec l’émergence continue de nouveaux variants, des thérapies largement neutralisantes qui peuvent être utilisées à la fois pour le traitement et la prévention de la maladie sont essentielles pour faire face aux épidémies endémiques actuelles et potentielles futures », a déclaré Tillman Gerngross, Ph.D., co-fondateur et président-directeur général d’Adagio. « Notre équipe travaille en étroite collaboration avec nos partenaires CRO mondiaux sur l’exécution de nos essais cliniques mondiaux en cours sur l’ADG20, STAMP et EVADE, tout en préparant également la commercialisation mondiale anticipée de l’ADG20, si elle est approuvée.

« L’ADG20 est un anticorps hautement différencié que nous faisons progresser à travers des essais clés à la fois pour le traitement et la prévention de la COVID-19. Nous sommes ravis de l’évaluation récente des données sans insu par l’IDMC pour l’essai EVADE, et de son soutien eu égard à nos plans visant à étendre le recrutement pour inclure les adolescents et les femmes enceintes ou allaitantes », a déclaré Lynn Connolly, MD, Ph.D., directrice médicale d’Adagio. « À ce jour, nous avons généré un ensemble de données convaincantes pour l’ADG20 qui inclut une large neutralisation du virus SARS-CoV-2 original et des variants préoccupants connus dans les modèles in vitro ainsi qu’un profil pharmacocinétique et de tolérance favorable dans notre essai de phase 1. En outre, lors de la semaine de l’IDWeek de cette année, nous publierons des données supplémentaires issues de notre essai de phase 1, ainsi que des détails concernant notre processus de sélection des doses pour le traitement et la prévention, qui, selon nous, soutiennent davantage le rôle important que ce nouvel anticorps peut jouer dans la lutte contre la pandémie actuelle. »

Faits importants du programme ADG20 COVID-19

  • De nouvelles données sur l’ADG20 seront présentées sur plusieurs affiches au cours de la semaine IDWeek : lors de la conférence virtuelle IDWeek 2021, Adagio prévoit de présenter des données supplémentaires soulignant le potentiel de l’ADG20 pour offrir une protection contre la COVID-19 pour une durée allant jusqu’à un an en se basant sur la demi-vie prolongée chez l’homme combinée à sa capacité de neutralisation large et puissante démontrée lors des tests en laboratoire. En outre, les données soutiennent l’évaluation d’une dose de 300 mg, administrée sous forme d’une seule injection intramusculaire, dans les essais cliniques mondiaux de phase 2/3 STAMP (traitement) et EVADE (prévention) en cours. Les données seront présentées sur plusieurs affiches, qui seront mises à la disposition des participants inscrits sur la plateforme virtuelle pendant toute la durée de la conférence, du 29 septembre au 3 octobre 2021. Les présentations comprennent :
    • 1086 : un modèle pharmacocinétique de système de pharmacologie quantitative du corps entier à base physiologique (QSP/PBPK) qui prédit à priori la pharmacocinétique intramusculaire (IM) de l’ADG20 : un anticorps monoclonal à demi-vie prolongée en cours de développement pour le traitement et la prévention de la maladie à coronavirus (COVID-19)
    • 633 : résultats préliminaires d’une étude monophasée de phase 1 évaluant l’innocuité, les titres d’anticorps viraux sériques neutralisant (sVNA) et le profil pharmacocinétique (PK) de l’ADG20 : un anticorps monoclonal à demi-vie prolongée en cours de développement pour le traitement et la prévention de la maladie à coronavirus (COVID-19)
    • 1089 : utilisation d’un modèle pharmacocinétique à base physiologique (QSP/PBPK) pour soutenir la sélection des doses de l’ADG20 : un anticorps monoclonal à longue demi-vie développé pour la prévention de la maladie à coronavirus (COVID-19)
    • 1088 : un modèle pharmacocinétique à base physiologique (QSP/PBPK) pour soutenir la sélection des doses de l’ADG20 : un anticorps monoclonal à demi-vie prolongée en cours de développement pour le traitement de la maladie à coronavirus (COVID-19)
  • La population de patients a été étendue pour l’essai EVADE suite à l’évaluation des données de l’IDMC :  le comité indépendant de surveillance des données (IDMC) pour l’essai de phase 2/3 dans le cadre de l’essai EVADE de l’ADG20 pour la prévention de la COVID-19 a récemment recommandé d’étendre le recrutement pour l’essai de phase 3 afin d’inclure des adolescents de 12 ans et des femmes enceintes ou allaitantes, ainsi qu’une diminution du temps de surveillance post-injection en clinique de phase 3 spécifié par le protocole. Les recommandations de l’IDMC sont basées sur son examen des données d’innocuité et de tolérance sans insu lors de la visite post-traitement au 28e jour provenant de 200 participants inscrits dans la partie de « pré-inclusion » de phase 2 de l’essai.
  • Le partenariat avec Biocon Biologics étend la portée d’un traitement à base d’anticorps contre la COVID-19 puissant et largement neutralisant pour les patients en Inde et dans certains marchés émergents : au cours du deuxième trimestre 2021, Adagio s’est associée à Biocon Biologics Ltd. pour lutter contre la crise actuelle de la COVID-19 en Asie du Sud. Ce partenariat octroie à Biocon les droits pour la fabrication et la commercialisation d’une thérapie à base d’anticorps basée sur l’ADG20 en Inde et sur des marchés émergents sélectionnés supplémentaires basés sur le processus de fabrication commerciale développé pour l’ADG20. Dans le cadre de cet accord, Biocon aura accès aux données des essais cliniques de phase 2/3 d’Adagio, ainsi qu’à son ensemble d’autorisations d’utilisation d’urgence anticipées et à d’autres soumissions réglementaires visant à soutenir l’approbation ou l’autorisation d’urgence en Inde et dans d’autres marchés émergents sélectionnés.

Récents faits marquants de l’activité

  • David Hering, expert mondial en vaccins contre la COVID-19, a récemment été nommé au poste de directeur de l’exploitation : Adagio a nommé David Hering au poste de directeur de l’exploitation de la société. M. Hering rejoint Adagio après avoir quitté Pfizer, où il a récemment occupé le poste de responsable mondial de l’activité mRNA, une entreprise spécifiquement créée pour gérer les efforts mondiaux en matière de COVID-19, ainsi que les futurs vaccins utilisant la technologie mRNA, et a dirigé le lancement du tout premier vaccin contre la COVID-19 aux États-Unis. Avant d’occuper son poste le plus récent chez Pfizer, M. Hering était président en Amérique du Nord chez Pfizer, où il dirigeait une entreprise de 700 personnes à travers un portefeuille de produits vaccins contre la COVID-19 et les maladies à méningocoque et à pneumocoque.
  • L’offre publique initiale (IPO) de 355,8 millions de dollars a été achevée avec succès : en août 2021, Adagio a vendu 20 930 000 actions ordinaires, y compris l’option de l’exercice intégral des souscripteurs d’acheter 2 730 000 actions ordinaires supplémentaires à un prix d’offre public de 17,00 dollars par action. Le produit brut de l’offre, avant escomptes et commissions de souscription et autres frais d’offre payables par Adagio, s’élevait à environ 355,8 millions de dollars.
  • Collaboration avec Scripps : Adagio a conclu un accord de recherche exclusif avec le Scripps Research Institute afin d’identifier les vaccins candidats largement protecteurs pour la prévention de la grippe et des coronavirus bêta.
  • Le Conseil d’administration s’est développé avec des leaders du secteur pour soutenir la croissance future : Adagio a récemment annoncé la nomination de trois vétérans de l’industrie et experts régionaux à son conseil d’administration :
    • Tom Heyman, ancien président de la Johnson & Johnson Development Corporation (JJDC) ;
    • Anand Shah, M.D., ancien commissaire adjoint aux Affaires médicales et scientifiques à la Food and Drug Administration (FDA) des États-Unis ; et
    • Michael S. Wyzga, président de MSW Consulting, Inc. et ancien directeur financier de Genzyme

Résultats financiers du deuxième trimestre 2021

  • Au 30 juin 2021, Adagio disposait d’une trésorerie, d’équivalents de trésorerie et de titres négociables de 392,5 millions de dollars, ce qui inclut le produit net issu de son financement de série C achevé en avril. Au 30 juin 2021, la trésorerie pro-forma, les équivalents de trésorerie et les titres négociables s’élevaient à 719,6 millions de dollars après avoir donné effet à notre offre publique initiale qui a été clôturée le 10 août 2021.
  • Les dépenses de recherche et développement, y compris la recherche et le développement en cours de processus pour le deuxième trimestre 2021, se sont élevées à 37,6 millions de dollars.
  • Les frais généraux, administratifs et de vente pour le deuxième trimestre 2021 se sont élevés à 7,1 millions de dollars.
  • La perte nette pour le deuxième trimestre s’est élevée à 44,7 millions de dollars, soit 0,18 dollar par action.

À propos de l’ADG20
L’ADG20, un anticorps monoclonal ciblant la protéine spike du SARS-CoV-2 et des coronavirus connexes, est en cours de développement aux fins de la prévention et du traitement de la COVID-19, la maladie provoquée par le SARS-CoV-2. L’ADG20 a été conçu et élaboré en vue d’offrir de puissantes et vastes capacités de neutralisation du SARS-CoV-2 et des autres sarbecovirus du clade 1 permettant de cibler un épitope bien conservé dans le domaine de fixation du récepteur. L’ADG20 exerce une puissante activité neutralisante contre la souche originale du SARS-CoV-2 et tous ses variants préoccupants connus. L’ADG20 pourrait avoir un impact sur la réplication virale et la maladie subséquente grâce à de multiples mécanismes d’action, notamment le blocage direct de l’entrée virale dans la cellule hôte (neutralisation) et l’élimination des cellules hôtes infectées par le biais d’une activité médiée par Fc des cellules effectrices de l’immunité innée. L’ADG20 est administré par une seule injection intramusculaire et a été conçu pour avoir une longue demi-vie, dans le but de fournir une protection à la fois rapide et durable. Adagio fait progresser l’ADG20 grâce à de multiples essais cliniques à l’échelle mondiale.

À propos d’Adagio Therapeutics

Adagio (Nasdaq : ADGI) est une société biopharmaceutique au stade clinique axée sur la découverte, le développement et la commercialisation de solutions à base d’anticorps pour les maladies infectieuses présentant un potentiel pandémique. Le portefeuille d’anticorps de la société a été optimisé grâce aux capacités de pointe d’Adimab en matière d’ingénierie d’anticorps et est conçu pour fournir aux patients et aux cliniciens une combinaison inégalée de puissance, d’ampleur, de protection durable (grâce à l’extension de la demi-vie), de faisabilité de fabrication et de prix abordable. Le portefeuille d’anticorps anti-SARS-CoV-2 d’Adagio comprend plusieurs anticorps fortement neutralisants non concurrents dotés d’épitopes de liaison distincts, dirigés par l’ADG20. Adagio a conclu avec des sous-traitants tiers un contrat portant sur des capacités de fabrication pour la production de l’ADG20 jusqu’à l’achèvement des essais cliniques et, en cas d’approbation par les autorités réglementaires, jusqu’au lancement commercial initial. Pour plus d’informations, rendez-vous sur le site www.adagiotx.com.

Énoncés prospectifs
Le présent communiqué de presse contient des énoncés prospectifs au sens de la loi Private Securities Litigation Reform (Réforme sur la résolution des litiges portant sur des titres privés) de 1995. Des mots tels que « anticipe », « croit », « s’attend à », « l’intention », « des projets » et « à l’avenir » ou des expressions similaires sont destinés à identifier des énoncés prospectifs. Les énoncés prospectifs comprennent des énoncés concernant, entre autres, le calendrier, les progrès et les résultats de nos études précliniques et essais cliniques sur l’ADG20, y compris le calendrier de nos soumissions d’IND prévues, le lancement et l’achèvement d’études ou d’essais et de travaux préparatoires connexes, la période durant laquelle les résultats des essais seront disponibles et nos programmes de recherche et développement ; notre capacité à obtenir et conserver des approbations réglementaires pour nos produits candidats ; notre capacité à identifier les patients atteints des maladies traitées par nos produits candidats et à recruter ces patients dans nos essais cliniques ; nos capacités et notre stratégie de fabrication ; et notre capacité à commercialiser avec succès nos produits candidats. Nous pourrions ne pas réellement atteindre les plans, intentions ou attentes divulgués dans nos énoncés prospectifs et vous ne devez pas vous fier indûment à nos énoncés prospectifs. Ces énoncés prospectifs impliquent des risques et des incertitudes qui pourraient faire en sorte que nos résultats réels diffèrent sensiblement des résultats décrits ou sous-entendus par les énoncés prospectifs, y compris, sans s’y limiter, les risques décrits sous la rubrique « Facteurs de risque » dans le prospectus d’Adagio, déposé auprès de la Securities and Exchange Commission (« SEC ») le 6 août 2021 et dans les futurs rapports qu’Adagio déposera auprès de la SEC, y compris le rapport trimestriel d’Adagio sur formulaire 10-Q pour le trimestre clos le 30 juin 2021. De tels risques peuvent être amplifiés par les impacts de la pandémie de COVID-19. Les énoncés prospectifs contenus dans le présent communiqué de presse sont formulés à cette date, et Adagio décline toute obligation de mettre à jour ces informations sauf si la loi en vigueur l’exige.

Contacts :

Contact auprès des médias :
Dan Budwick, 1AB
Dan@1abmedia.com

Contact auprès des investisseurs :
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

ADAGIO THERAPEUTICS, INC.

BILANS CONSOLIDÉS CONDENSÉS

(NON AUDITÉ)

(En milliers, à l’exception des montants par action et actions)

June 30,2021 December 31,2020
Assets
Current assets:
Cash and cash equivalents(1) $ 392,509 $ 114,988
Prepaid expenses and other current assets 3,550 2,394
Total current assets 396,059 117,382
Deferred offering costs 1,933 —
Total assets $ 397,992 $ 117,382
Liabilities, Convertible Preferred Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable $ 10,716 $ 8,153
Accrued expenses 27,181 4,919
Total current liabilities 37,897 13,072
Early-exercise liability 8 11
Total liabilities 37,905 13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C) $0.0001 par value; 16,944,484 shares authorized, issued and outstanding at June 30, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $505,399 and $169,900 at June 30, 2021 and December 31, 2020, respectively 504,711 169,548
Stockholders’ deficit:
Common stock, $0.0001 par value; 150,000,000 shares authorized at June 30, 2021 and December 31, 2020; 5,599,240 shares issued and outstanding at June 30, 2021; 28,193,240 shares issued and 5,593,240 shares outstanding at December 31, 2020 1 1
Treasury stock, at cost; 0 shares and 22,600,000 shares at June 30, 2021 and December 31, 2020, respectively — (85 )
Additional paid-in capital 4,067 154
Accumulated deficit (148,692 ) (65,319 )
Total stockholders’ deficit (144,624 ) (65,249 )
Total liabilities, convertible preferred stock and stockholders’ deficit $ 397,992 $ 117,382

(1)     au 30 juin 2021, la trésorerie, les équivalents de trésorerie et les titres négociables pro-forma s’élevaient à 719,6 millions de dollars après avoir donné effet à notre émission et vente de 20 930 000 actions ordinaires dans le cadre de notre offre publique initiale au prix de 17,00 dollars par action après déduction des remises, commissions et coûts d’offre estimés qui ont été clos le 10 août 2021.

ADAGIO THERAPEUTICS, INC.

ÉTATS D’EXPLOITATION CONSOLIDÉS CONDENSÉS ET PERTE GLOBALE

(NON AUDITÉ)

(En milliers, à l’exception des montants par action et actions)

Three Months EndedJune 30, Six Months EndedJune 30, Period fromJune 3, 2020(Inception) toJune 30,
2021 2021 2020 (3)
Operating expenses:
Research and development(1) $ 35,067 $ 69,204 $ 48
Acquired in-process research and development(2) 2,500 3,500 —
Selling, general and administrative 7,124 10,695 50
Total operating expenses 44,691 83,399 98
Loss from operations (44,691 ) (83,399 ) (98 )
Other income (expense):
Interest income 23 32 —
Other expense (5 ) (6 ) —
Total other income (expense), net 18 26 —
Net loss and comprehensive loss $ (44,673 ) $ (83,373 ) $ (98 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.18 ) $ (0.66 ) $ —
Weighted-average common shares outstanding, basic and diluted 249,769 125,574 21,250,000

(1)    Comprend des montants associés de 247 dollars pour le trimestre clos au 30 juin 2021, de 435 dollars pour le semestre clos au 30 juin 2021 et de 0 dollar pour la période allant du 3 juin 2020 (création) au 30 juin 2020.
(2)    Comprend des montants associés de 2 500 dollars pour le trimestre clos au 30 juin 2021, de 3 500 dollars pour le semestre clos au 30 juin 2021 et de 0 dollar pour la période allant du 3 juin 2020 (création) au 30 juin 2020.
(3)    Les résultats pour la période allant du 3 juin 2020 (création) au 30 juin 2020 sont les mêmes pour le trimestre et le semestre clos au 30 juin 2020.

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W. L. Gore & Associates améliore le portefeuille d’endoprothèses GORE® VIABAHN® avec la pose d’un profil plus bas

Les améliorations apportées aux dispositifs de grand diamètre comprennent l’accessibilité par des gaines plus petites tout en permettant une meilleure visualisation grâce à l’ajout de marqueurs radio-opaques

25 ans d’innovation continue

PUTZBRUNN, Allemagne, 22 septembre 2021 /PRNewswire/ — Dans le cadre de ses efforts pour améliorer continuellement les solutions médicales pour les patients souffrant de maladies vasculaires complexes, W. L. Gore & Associates, Inc. (Gore) a annoncé le lancement dans la région EMEA de l’endoprothèse GORE® VIABAHN® à profil plus bas et à grand diamètre avec surface bioactive PROPATEN. Les améliorations apportées à ce dispositif s’appuient sur une endoprothèse leader sur le marché, qui est devenue un outil important pour le traitement des maladies vasculaires complexes. La conception innovante du dispositif VIABAHN® réduit le profil de pose des grandes endoprothèses de 9 à 13 mm de diamètre jusqu’à 3 CH, ce qui permet de les poser dans des gaines plus petites. Des gaines d’introduction plus petites ont permis de réduire le risque de complications liées à l’accès vasculaire chez certaines populations de patients.1 En outre, de nouveaux marqueurs radio-opaques, désormais présents sur les configurations de dispositifs de plus grand diamètre, améliorent la visualisation sous fluoroscopie, facilitant le positionnement et la pose du dispositif, ainsi qu’un placement précis et prévisible. « Outre les marqueurs radio-opaques qui facilitent le positionnement et le déploiement, le nouveau profil plus bas permet d’utiliser une gaine plus petite, ce qui réduit potentiellement le risque de dommages au niveau du site d’accès », a déclaré Manuel Alonso, docteur en médecine, chirurgien vasculaire, Oviedo, Espagne. « Associée à la traçabilité et à la flexibilité, cette nouvelle offre de profil plus bas deviendra très utile dans ma pratique pour traiter les patients complexes dans tous les états pathologiques. »

GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

« L’histoire de l’endoprothèse GORE® VIABAHN® est l’histoire d’une collaboration entre médecins pour quatre indications centrées sur le patient et d’une performance prouvée à maintes reprises », a déclaré Benjamin Beckstead, responsable de la catégorie vasculaire chez Gore.

Depuis son lancement dans l’UE en 1996, le dispositif a évolué grâce à de nombreuses améliorations et a pris en charge des centaines de milliers de patients dans le monde entier. Actuellement, le dispositif VIABAHN® est utilisé dans de nombreuses indications cliniques telles que les lésions de l’artère fémorale superficielle (AFS), les lésions iliaques, la resténose intra-stent des lésions de l’AFS et les lésions du circuit d’accès artério-veineux (AV).*

Pour plus d’informations, rendez-vous sur le site https://www.goremedical.com/eu/products/viabahn

* Pour obtenir des indications complètes et d’autres informations importantes sur la sécurité des produits commerciaux Gore mentionnés dans le présent document, reportez-vous aux instructions d’utilisation.

1. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 to 2007. JACC : Cardiovascular Interventions 2008;1(3):317-326.

W. L. Gore & Associates Logo

Gore conçoit des dispositifs médicaux qui traitent toute une série de maladies cardiovasculaires et d’autres problèmes de santé. Avec plus de 50 millions de dispositifs médicaux implantés pendant plus de 45 ans, Gore s’appuie sur sa réputation pour améliorer le pronostic des patients à travers la recherche, la formation et la démarche qualité. L’efficacité des produits, la facilité d’utilisation et la qualité du service permettent aux médecins, aux hôpitaux et aux assureurs de réaliser des économies significatives. Gore est au service des cliniciens et grâce à cette collaboration, nous améliorons des vies.

À propos de Gore

W. L. Gore & Associates est une entreprise internationale spécialisée dans la science des matériaux et dont l’objectif est l’amélioration du secteur et des conditions de vie. Depuis 1958, Gore répond à des défis techniques complexes dans des environnements exigeants – de l’espace aux plus hauts sommets du monde en passant par le fonctionnement interne du corps humain. Avec plus de 11 000 associés et une forte culture axée sur le travail en équipe, Gore génère un chiffre d’affaires annuel de $3,8 milliards de dollars.

gore.com

Les produits énumérés peuvent ne pas être disponibles sur tous les marchés.

GORE, together, improving life, PROPATEN et HELEX, et les modèles sont des marques déposées de W. L. Gore & Associates.

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W. L. Gore & Associates Enhances GORE® VIABAHN® Endoprosthesis Portfolio With Lower Profile Delivery

Improvements to large diameter devices include accessibility through smaller sheaths while providing enhanced visualization by adding radiopaque markers

25 years of continued innovation

PUTZBRUNN, Germany, Sept. 22, 2021 /PRNewswire/ — As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W. L. Gore & Associates, Inc. (Gore) announced the EMEA launch of the lower profile, large diameter GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface. The device enhancements build on a market-leading stent graft device, which has become an important tool for treating complex vascular disease. The innovative VIABAHN® Device design reduces the delivery profile for larger 9–13 mm diameter stent grafts by up to 3 Fr, enabling delivery through smaller sheaths. Smaller introducer sheaths have resulted in a lower risk of vascular access complications in select patient populations.1 Additionally, new radiopaque markers, now also on the larger diameter device configurations, enhance visualization under fluoroscopy, facilitating positioning and device delivery, as well as precise and predictable placement. “In addition to the radiopaque markers that facilitate positioning and deployment, the new lower profile enables use of a smaller sheath, potentially reducing the risk of damage at the access site,” said Manuel Alonso, M.D., Vascular Surgeon, Oviedo, Spain. “Combined with the trackability and flexibility this new lower profile offering will become very instrumental for treating complex patients across disease states in my practice.”

GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

“The story of the GORE® VIABAHN® Endoprosthesis is a story of physician collaboration across four patient-centric indications and of proving performance over and over,” said Benjamin Beckstead, Gore Vascular Category Leader.

Since its EU launch in 1996, the device has evolved with numerous enhancements and supported hundreds of thousands of patients worldwide. Currently, the VIABAHN® Device is used in various clinical indications such as in superficial femoral artery (SFA) lesions, iliac lesions, in-stent restenosis of SFA lesions and AV Access circuit lesions.*

For more information, visit https://www.goremedical.com/eu/products/viabahn

* For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

1. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 to 2007. JACC: Cardiovascular Interventions 2008;1(3):317-326.

W. L. Gore & Associates Logo

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives.

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 11,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.8 billion.

gore.com

Products listed may not be available in all markets.

GORE, Together, improving life, PROPATEN, VIABAHN and designs are trademarks of W. L. Gore & Associates.

Photo – https://mma.prnewswire.com/media/1628622/GORE_VSX_LDPro_final_highres.jpg

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Pritzker Military Museum & Library Announces Finalists in International Design Competition for the Cold War Veterans Memorial

Somers, Wisconsin, Sept. 21, 2021 (GLOBE NEWSWIRE) — In April 2021, the Pritzker Military Museum & Library, located in Chicago, launched an international competition for the new Cold War Veterans Memorial to be built in Somers, Wisconsin. After reviewing an impressive number of inspiring design concepts, four finalists have been selected to advance to Stage II of the competition. The Cold War Veterans Memorial will be a critical piece of the Pritzker Archives and Memorial Park Center (PAMPC) currently under development.

“In missions on and off the battlefield, Americans of all stripes made immense sacrifices in defense of our national interest. They deserve to be recognized, and the weight of this era deserves to be understood. This Memorial will provide a place where their contributions are honored,” said Col. Jennifer Pritzker, Founder of the Pritzker Military Museum & Library.

The four finalists are representatives from the U.S., Italy, Japan, and Jordan. These individuals and groups achieved the highest scores against strict criteria, including individuality, relevance, and conceptualization. The design challenge was to provide a conceptual design for the Cold War Veterans Memorial that embraces the mission statement, exemplifies the guiding vision, and achieves the design goals. The finalists include:

  • INFINITE LIFE – Michele De Lucchi con Francesco Forcella (project architect), Nicholas Bewick, Junmei Liu, Emanuele Novembre, Guido Tarantola, Mayya Sargsyan of AMDL CIRCLE in Milan, Italy
    • Although this Memorial project was born out of the importance of respecting and honoring those that served during the Cold War period, we also see its relevance as a heroic symbol towards our continually evolving universe and the existence of human life.

For this reason, we have chosen not only the metaphor of infinity, by evoking the ‘Moebius Loop or Orbit’ in our design concept, but also to create an experience and place from which to think about our complex global interrelationships, in the hope that they can find a harmony that links every single person and preserves the physical environment in which we all live.

  • THE CONFLICT – Mai Abu-Shanab and Jalal  Al-Sadi of  m+j architect studio atelier in Amman, Jordan
    • This cold war memorial is intended to honor individuals and groups and give a permanent recognition to accomplishments, as quietly made, by countless individuals and groups as they pursued the expansion of freedom and democracy, creating a place for reflection and remembrance, inspiring the public to perceive freedom for centuries to come.
  • ORBITS OF TIME – Jenny Wu and Dwayne Oyler of Oyler Wu Collaborative in Los Angeles, California, USA
    • The proposed design envisions a memorial that embodies the ideals and mission of Memorial Park, making more tactile a context that can’t be measured in a single name or event: only in glimpses of history. Within these glimpses is layered a timeline of both personal and collective experiences emblematic of the Cold War – a paradigm that rebalances the interconnected narratives of American innovation and service.
  • ETERNAL CIRCULATION – Shinsaku Munemoto of Shinsaku Munemoto & Associates, Architects in Kyoto, Japan
    • This memorial intends to preserve the memories, records, and achievements of the veterans in perpetuity. By uncovering the layer of land, one space separates into two. The space of the “past” underneath meets the layers of the veterans’ work and time, where one can relive the veterans’ history and memories of the Cold War. The satellite dish formed above forges the “present” space to transmit the histories and memories. Through the hole opened in the unfolded land, the archive is seen, bridging the “past” records to the “present,” creating an ETERNAL CIRCULATION of education and communication.

“We were impressed by the number of inspiring design submissions that were received,” states Donald J. Stastny, FAIA, FAICP, FCIP, Competition Manager. “It wasn’t an easy decision, but we are very confident in the four finalists chosen to move forward. Their conceptual designs best embraced the mission and vision of the Memorial, and we can see them serve as an attraction for visitors.”

The Cold War Veterans Memorial’s guiding vision is to create permanent recognition that stimulates ongoing thought and study that honors American military members and civilians who served and sacrificed during the Cold War era (1945-1991). In line with the Pritzker Military Museum & Library’s mission, the Cold War Veterans Memorial aims to increase the public understanding of military history.

Stage II

In Stage II, the four groups of selected finalists will evolve their concepts for the Memorial and create more fully defined design concepts by late February 2022. Procedures in this stage include a virtual competition briefing, Q&A, mid-course review, and design exhibit.

The Competition Leadership Group will conduct an individual review of each design submittal and provide an advisory report of its findings to the Jury. The Jury will analyze each design and determine whether the integrity of the design concept embodied in the Stage I entry has been maintained in the Stage II design submittal and how it addresses the mission, vision, and design goals for the Memorial. The winning design will be announced publicly in March 2022.

View the finalists’ submissions here. All information on the design competition, including the design manual, Jury process, regulations, and schedule, can be found at coldwarveteransmemorial.org.

Pritzker Archives & Memorial Park Center

The PAMPC was created out of a need for additional space to house some of the circulating book collection and the archival collections of the Pritzker Military Museum & Library and will be completed in phases over an estimated ten years.

The first phase of the project will include the Pritzker Military Archives Center to house the collections and provide workspace for the continued curation for future exhibits; Commercial Archives based on demand where private collectors, public institutions, and others may store their archives; a facility specializing in firearms education and training; a Community Green Space expertly landscaped with walking and biking paths; and the Cold War Veterans Memorial.

About the Cold War Veterans Memorial

In line with the Pritzker Military Museum & Library’s mission, the Cold War Veterans Memorial aims to increase the public understanding of military history. It will be a lasting tribute to the courage and tenacity found in the U.S. Armed Forces and civilian personnel who faithfully and honorably served during the Cold War era, September 2, 1945, to December 26, 1991. The Memorial will be a publicly accessible display where citizens can honor, reflect, and learn about the bravery and sacrifice displayed to further our country’s freedom. To learn more, visit www.coldwarveteransmemorial.org.  

About Pritzker Archives & Memorial Park Center

Located in Somers, Wisconsin, The Pritzker Archives & Memorial Park Center supports the Pritzker Military Museum & Library’s mission of preserving the past, present, and future of the citizen soldier. This state-of-the-art archive center is a space to restore, preserve, and provide storage for collections that include books, artifacts, and other historical materials. Other components of the project include a 9,687 square-foot Gallery that will display exhibits drawing from the Pritzker Military Museum & Library in Chicago, Commercial Archives, a facility specializing in firearms education and training, Cold War Veterans Memorial, and community green space. To learn more, visit www.pritzkerarchivespark.com.

 

About the Pritzker Military Museum & Library

The Pritzker Military Museum & Library aims to increase the public’s understanding of military history, military affairs and national security by providing a forum for the study and exploration of our military – past, present, and future – with a specific focus on their stories, sacrifices, and values. With national and global reach, these spaces and events aim to share the stories of those who served and their contributions as citizen soldiers, helping citizens everywhere appreciate the relationship between the armed forces and the civilians whose freedoms they protect. A non-governmental, non-partisan organization, the Museum & Library features diverse collections, scholarly initiatives, and public programs from its flagship center in downtown Chicago to its world-class research center and park currently under construction in Somers, Wisconsin.

Erika Davis
Pritzker Archives & Memorial Park Center 
erika.davis@tawani.net
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New Research: Ending Energy Poverty by 2030 Can Create 500 Million New Jobs in Africa and Asia

The Rockefeller Foundation study finds that investing in distributed renewable energy systems creates 30 times more jobs and saves 4 billion tons of greenhouse gas emissions compared to fossil fuel alternatives

NEW YORK, Sept. 21, 2021 /PRNewswire/ — New research by The Rockefeller Foundation finds that investing in distributed renewable energy systems could end energy poverty and create 25 million direct jobs in the power sector in Africa and Asia by 2030, while saving 4 billion tons of greenhouse gas emissions.  By comparison, investing in fossil fuels over the same period creates less than half a million direct jobs, the great majority of which would be temporary. The report, Transforming A Billion Lives: The job creation potential from a green power transition in the energy poor world, calculates that this could be achieved with an annual investment of USD130 billion in distributed renewable energy systems. In addition to these direct jobs in the power sector, this new clean power would also create nearly 500 million new jobs in agriculture, health care, education, and small and medium-sized enterprises and set in motion a green transition across energy-poor countries over the next decade.

“The world is at a crossroads.  Fortunately, technological advances have given humanity the tools for transformative change, so for the first time in history, we can address the climate crisis while empowering people with the jobs and electricity they need to care for their families, pursue opportunities, and thrive,” said Dr. Rajiv J. Shah, President of The Rockefeller Foundation.  “We must now find the courage, and the resources, to come together and change how the world works and how people live.  Nothing less will do.”

Currently, there are 3.6 billion energy poor people – nearly half the world’s population – who either don’t have access to electricity, or have access to unreliable power, or are underserved, and the vast majority live in Africa in Asia.  At the same time, significant breakthroughs in technology over the last decade have made renewables the cheapest option for new power in more than two-thirds of the world.

Transforming A Billion Lives: The job creation potential from a green power transition in the energy poor world explores a “what if” scenario – looking at what it would take to significantly scale up access to distributed renewable energy (DRE) systems to end energy poverty and set in motion a green power transition across the energy poor world.  This new research, which was conducted by Catalyst Off-Grid Advisors and reviewed by IKEA Foundation, International Renewable Energy Agency, International Solar Alliance, and Sustainable Energy for All, underlines how the economic and investment case has flipped in favor of renewable technologies.

Transformative Impact
The report combines qualitative case studies with predictive economic modelling to map the job creation potential that would flow from a rapid increase in investment in DRE across all 63 energy poor countries in Asia and Africa.  This includes scaling up renewable energy mini grid systems to power solar lanterns, ice making factories used by fishing communities, milk chillers and irrigation pumps for farmers, refrigerators and life-saving medical equipment in clinics and hospitals, and more.  Based on a detailed assessment of 75 “productive uses” (or electricity that is aimed at enhancing income generation opportunities and productivity in key sectors of the economy), the report examines eight economic sectors: agriculture production, animal production and preservation, food and agriculture processing, essential goods and services provision, mobility, heavy industry, large and medium enterprise, and small and micro enterprises. Key findings include:

  • Ending energy poverty in energy poor countries in Asia and Africa through scaling access to DRE could create 25 million direct jobs, 61% of which would be related to modest grid-tied systems that could service a medium-sized business or a cluster of small enterprises engaged in activities like milling, carpentry, or tailoring.
  • This is 30 times the number of jobs that would be created by a by a comparable investment in large, centralized fossil fuel assets, with the great majority of these jobs being temporary and focused on the construction of power plants.
  • 491 million additional new jobs could be created in an array of downstream applications, and 671 million existing jobs could be improved by the availability of clean, reliable power.
  • Almost half of these jobs are located in South Asia, the majority in India; a quarter in the Sub-Saharan Africa region; and a quarter in the East Asia & Pacific region.
  • 4 billion tons of CO2  emissions could be saved – equivalent to the electricity use of 726 million home’ for one year, compared to a fossil fuel dependent development pathway.
  • Distributed renewable energy is a more cost-effective electrification pathway for emerging markets, compared to a fossil-fuel-led path, when capital expenditures (funds used by a company to acquire or upgrade physical assets such as property, buildings, or equipment) and fuel costs are considered.

“Over the past decade, distributed and renewable energy technologies have been rapidly replacing fossil fuels as the most cost-effective building blocks for powering economic development,” said Per Heggenes, CEO of IKEA Foundation.  “DREs in particular have become a faster, nimbler, and more cost-effective solution for driving inclusive growth and reaching under-served populations.  As the report highlights, they also have the potential to be at the heart of a global energy transition, which is urgently required.”

Earlier this year, The Rockefeller Foundation and IKEA Foundation announced a partnership to lay the groundwork for a global energy alliance to combat the climate crisis and energy poverty.  Committing $500 million each, this billion-dollar collaboration marks the largest philanthropic initiative to scale renewable energy for an equitable energy transition and global economic development.

“Access to energy transforms every facet of life, with reliable electricity often the first step toward helping a community lift itself out of poverty,” said Damilola Ogunbiyi, CEO and Special Representative of the UN Secretary-General for Sustainable Energy for All, and Co-Chair of UN-Energy. “Decentralized Renewable Energy solutions are a particularly powerful engine for economic development creating jobs and opportunities to empower women and girls.”

About The Rockefeller Foundation

The Rockefeller Foundation is a pioneering philanthropy built on collaborative partnerships at the frontiers of science, technology, and innovation to enable individuals, families, and communities to flourish. We work to promote the well-being of humanity and make opportunity universal. Our focus is on scaling renewable energy for all, stimulating economic mobility, and ensuring equitable access to healthy and nutritious food. For more information, sign up for our newsletter at rockefellerfoundation.org and follow us on Twitter @RockefellerFdn.

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ConvaTec Enhances Innovation Management with Anaqua

Anaqua’s AQX platform to help global medical products group protect and optimize its valuable IP portfolios

LONDON, Sept. 21, 2021 (GLOBE NEWSWIRE) — Anaqua, the leading innovation and intellectual property management technology provider, today announced that global medical products and technologies group ConvaTec will use Anaqua’s AQX platform to help more effectively manage their valuable patent and trademark portfolios.

The agreement further strengthens Anaqua’s position in the medical solutions markets, with a growing number of clients from these sectors collaborating with Anaqua as their preferred IP management provider.

With operations in more than 100 countries, ConvaTec is a global medical and technologies company focused on therapies for the management of chronic conditions, with leading market positions in advanced wound care, ostomy care, continence care, critical care, and infusion care. ConvaTec products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care.

Christina Allegrini, Vice President, Deputy General Counsel & Global Head of Intellectual Property at ConvaTec, said: “Our company vision is to pioneer trusted medical solutions to improve the lives we touch. As part of this, one of our key strategic pillars is to innovate in our work and solutions, supported by increased investment in R&D. Therefore, it is critically important that we manage our innovation and IP effectively and efficiently – and Anaqua will help ensure we do that.”

ConvaTec will use Anaqua’s AQX platform for patent and trademark management, annuities and renewals (in conjunction with Anaqua Services), and patent analytics through integration with Anaqua’s AcclaimIP.

Bob Romeo, CEO of Anaqua, said: “We are proud to be working with and supporting ConvaTec, a company driven by innovation to better serve people around the world in need of advanced medical care. For our part, we look forward to helping ConvaTec protect their innovation and IP management needs. We are also delighted to add another global company to our growing portfolio of clients in the healthcare and life sciences sectors.”

About Anaqua
Anaqua, Inc. is a premium provider of integrated intellectual property (IP) management technology solutions and services. Anaqua’s AQX platform combines best practice workflows with big data analytics and tech-enabled services to create an intelligent environment designed to inform IP strategy, enable IP decision-making, and streamline IP operations. Today, nearly half of the top 100 U.S. patent filers and global brands, as well as a growing number of law firms worldwide use Anaqua’s solutions. Over one million IP executives, attorneys, paralegals, administrators, and innovators use the platform for their IP management needs. The company’s global operations are headquartered in Boston, with offices across the U.S., Europe, and Asia. For additional information, please visit anaqua.com, or on LinkedIn.

About ConvaTec
ConvaTec is a global medical products and technologies company focused on therapies for the management of chronic conditions, with leading market positions in advanced wound care, ostomy care, continence and critical care, and infusion care. Headquartered in the UK, the company has operations in more than 100 countries and almost 10,000 employees worldwide. ConvaTec products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. To learn more about ConvaTec, please visit convatecgroup.com.

Company Contact:
Amanda Hollis
Associate Director, Communications
Anaqua
617-375-2626
ahollis@Anaqua.com
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ConvaTec améliore la gestion de l’innovation avec Anaqua

La plateforme AQX d’Anaqua va aider le groupe mondial de produits médicaux à protéger et optimiser son portefeuilles de propriété intellectuelle

LONDRES, 21 sept. 2021 (GLOBE NEWSWIRE) — Anaqua, le leader dans le domaine de la gestion de l’innovation et de la propriété intellectuelle (PI), a annoncé aujourd’hui que le groupe mondial de produits et technologies médicales ConvaTec utilisera la plateforme AQX d’Anaqua afin de gérer plus efficacement ses portefeuilles de brevets et de marques.

L’accord renforce la position d’Anaqua sur les marchés des solutions médicales, avec un nombre croissant de clients de ce secteur qui collaborent avec Anaqua pour la gestion de leur PI.

Présente dans plus de 100 pays, ConvaTec est une entreprise mondiale de médecine et de technologies axée sur les thérapies pour la gestion des maladies chroniques, avec des positions de leader sur le marché du traitement avancé des plaies, des stomies, de la continence, des soins intensifs et de la perfusion. Les produits de ConvaTec offrent de nombreux avantages cliniques et économiques, notamment la prévention des infections, la protection des peaux à risque, l’amélioration des résultats des patients et la réduction du coût total des soins.

Christina Allegrini, vice-présidente, directrice juridique adjointe et responsable mondiale de la propriété intellectuelle chez ConvaTec, a déclaré : “La vision de notre entreprise est d’être le pionnier de solutions médicales fiables pour améliorer les vies que nous touchons. Dans ce cadre, l’un de nos principaux piliers stratégiques est l’innovation dans notre travail et nos solutions, soutenue par des investissements accrus dans la recherche et le développement. Par conséquent, il est essentiel que nous gérions notre innovation et notre propriété intellectuelle de manière efficace et efficiente – et Anaqua nous aidera à le faire.”

ConvaTec utilisera la plateforme AQX d’Anaqua pour la gestion de ses brevets marques, les annuités et les renouvellements (en conjonction avec Anaqua Services), et l’analyse des brevets grâce à l’intégration avec AcclaimIP d’Anaqua.

Bob Romeo, PDG d’Anaqua a déclaré : “Nous sommes fiers de travailler avec ConvaTec et de soutenir une société motivée par l’innovation visant à mieux servir les personnes qui ont besoin de soins médicaux avancés à travers le monde. Pour notre part, nous sommes impatients d’aider ConvaTec à protéger leur innovation et leurs besoins en gestion PI. Nous sommes également ravis d’ajouter une autre entreprise multinationale à notre portefeuille croissant de clients dans les secteurs des soins de santé et des sciences de la vie.”

À propos d’Anaqua
Anaqua, Inc. leader dans le domaine de la gestion de l’innovation et de la propriété intellectuelle. La plateforme AQX d’Anaqua combine les meilleures pratiques de flux de travail avec des analyses de données et des services technologiques pour créer un environnement intelligent conçu pour informer la stratégie PI, permettre la prise de décision PI et rationaliser les opérations PI. Aujourd’hui, près de la moitié des 100 premiers déposants de brevets américains et des marques à travers le monde, ainsi qu’un nombre croissant de cabinets de conseil dans le monde utilisent les solutions Anaqua. Plus d’un million de cadres, d’avocats, d’assistants juridiques, d’administrateurs et d’innovateurs utilisent la plateforme pour leurs besoins de gestion PI. Le siège social de l’entreprise est basé à Boston, avec des bureaux aux Etats-Unis, en Europe et en Asie. Pour de plus amples informations, veuillez consulter le site anaqua.com, ou LinkedIn.

À propos de ConvaTec
ConvaTec est une entreprise mondiale de produits médicaux et de technologies axée sur les thérapies pour la gestion des maladies chroniques, avec des positions de marché dominantes dans le traitement avancé des plaies, les soins pour stomies, la continence et les soins intensifs, ainsi que les soins par perfusion. Basée au Royaume-Uni, l’entreprise est présente dans plus de 100 pays et emploie près de 10 000 personnes dans le monde. Les produits de ConvaTec offrent une gamme d’avantages cliniques et économiques, notamment la prévention des infections, la protection des peaux à risque, l’amélioration des résultats des patients et la réduction du coût total des soins. Pour en savoir plus sur ConvaTec, veuillez consulter le site convatecgroup.com.

Contact de la société :
Amanda Hollis
Directeur associé, Communications
Anaqua
617-375-2626
ahollis@Anaqua.com


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