Diversified Specialty Institute Holdings, Inc.

Establishment Labs Announces National Medical Products Administration Approval for Motiva Implants in China

Retrieved on: 
Thursday, November 9, 2023
Women, Biotechnology, Surgery, Health, Medical Devices, Health Technology, Consumer, Other Health, Science, NMPA, ESTA, National Medical Products Administration, Perception, Diversified Specialty Institute Holdings, Inc., Medical device, Cryptocurrency, Motiva

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced it has received National Medical Products Administration (NMPA) approval in China for Motiva® Implants.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced it has received National Medical Products Administration (NMPA) approval in China for Motiva® Implants.
  • “Our approval in China marks Establishment Labs’ entry into the second largest global and most dynamic market for breast aesthetics in the world,” said Juan José Chacón-Quirós, Chief Executive Officer.
  • “This is the first breast implant technology approved in China in more than a decade.
  • “We transformed the breast aesthetics market in South Korea with Motiva, and we are excited to replicate that success in China,” added John Lim, Founder and CEO of Motiva China Ltd., Establishment Labs exclusive distribution partner in the market.

Establishment Labs Announces FDA Clearance of Motiva Flora SmoothSilk Tissue Expander

Retrieved on: 
Monday, October 16, 2023
Health, Medical Devices, Other Health, Artifact, Partnership, RFID, Earnings before interest, taxes, depreciation and amortization, Food, Google Images, Metal, Breast cancer, Inflammation, Breast, Radiology, Breast pain, Michelle Brunner, Heart, VMAT, Radiation, Motiva, University, FDA, Applied science, Rabbit, CT, Magnet, Environment, Luigi Cozzi, Safety, History, Medicine, Mouse, MRI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Establishment, Human, Woman, Diversified Specialty Institute Holdings, Inc., Patient, Surgeon, ESTA, Pharmaceutical industry, Medical imaging, Omid Veiseh

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Motiva Flora® SmoothSilk® Tissue Expander.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Motiva Flora® SmoothSilk® Tissue Expander.
  • The Flora® SmoothSilk® Tissue Expander offers several proprietary innovations, including Establishment Labs’ patented SmoothSilk® surface technology.
  • By being magnet-free, Flora avoids the interference that magnets can cause during MRI and may improve the precision of radiation oncology treatment.
  • “This is an incredibly important day in the history of Establishment Labs, as the first of our implantable technologies has been approved by the FDA,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs.

Establishment Labs Announces Two-Year Mia Femtech Clinical Results and the Launch of Zen at 8th World Symposium on Ergonomic Implants

Retrieved on: 
Friday, October 13, 2023
Women, Biotechnology, Surgery, General Health, Health, Health Technology, Consumer, Clinical Trials, Diamond, Joy, Mia, RFID, WSEI, Bleeding, Zen, Seroma, ESTA, Safety, Hematoma, Temperature, IRB, Surgeon, Kaplan–Meier estimator, Diversified Specialty Institute Holdings, Inc., Medical device, Motiva

The Mia Feasibility Clinical Study is an IRB-approved prospective study that enrolled 100 subjects between December 2020 and April 2021.

Key Points: 
  • The Mia Feasibility Clinical Study is an IRB-approved prospective study that enrolled 100 subjects between December 2020 and April 2021.
  • A sub-study of 33 subjects underwent an MRI at 18 months with no ruptures in the cohort.
  • *
    In addition to announcing the Mia study data, Establishment Labs is also launching Zen™, which is part of its next generation Zensor™ RFID platform.
  • Motiva Ergonomix2 Diamond implants used in the Mia Femtech system feature Zen, and it will initially be available in select geographies with Motiva Ergonomix2 Round implants in the Joy program.

Movella Announces Commitment to Support Independent Creators Impacted by Entertainment Strikes

Retrieved on: 
Thursday, October 12, 2023
Data Management, Entertainment, Technology, General Entertainment, Audio, Video, Mobile, Wireless, Software, Animation, Frustration, Calibration, Indie, MVLA, VFX, Goldman Sachs, Workflow, Movement, Bundle, Environment, Unreal Engine, The Washington Post, Diversified Specialty Institute Holdings, Inc., Music, Video game, Marketing, Xsens

Movella Holdings Inc. (NASDAQ: MVLA) (“Movella”), a leading full-stack provider of sensors, software, and analytics that enable the digitization of movement, today announced its commitment to support independent creators and small studios in the animation, VFX, and game development fields.

Key Points: 
  • Movella Holdings Inc. (NASDAQ: MVLA) (“Movella”), a leading full-stack provider of sensors, software, and analytics that enable the digitization of movement, today announced its commitment to support independent creators and small studios in the animation, VFX, and game development fields.
  • The ripple effect goes beyond actors and writers, impacting animators, VFX artists, and video game developers, many of whom are going independent to avoid large, layoff-ridden companies.
  • “Today’s entertainment landscape is rapidly evolving with the independent creator economy gaining prominence as studios increasingly turn to independent creators including influencers to fill content gaps,” said Dale Pistilli, Vice President of Marketing, Movella.
  • Xsens enables creators to capture dynamic motion in various environments without the need for extensive calibration or extensive post-production cleanup.

Arcturus Therapeutics Joint Venture mRNA Manufacturing Partner, ARCALIS, Awarded Additional Financial Grants from Japanese Government

Retrieved on: 
Wednesday, October 4, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Vaccine, DNA, Diversified Specialty Institute Holdings, Inc., Therapy, Arcturus Therapeutics, Infection, ARCT, RNA, Messenger, MRNA vaccine, Liver, Arcturus

In total to date, $165 million has been awarded to ARCALIS by the Japanese government to build mRNA Drug Substance, mRNA Drug Product manufacturing capabilities and to construct a DNA template manufacturing facility.

Key Points: 
  • In total to date, $165 million has been awarded to ARCALIS by the Japanese government to build mRNA Drug Substance, mRNA Drug Product manufacturing capabilities and to construct a DNA template manufacturing facility.
  • The mRNA Drug Substance manufacturing facility was completed in July 2023.
  • ARCALIS will provide cGMP-integrated vaccine manufacturing, from mRNA drug substance to bulk nanoparticle-formulated drug product.
  • “This support has already enabled the completion of a state-of-the-art mRNA Drug Substance manufacturing facility, and we are excited to now extend this collaboration with the construction of an associated DNA manufacturing facility.

Arcturus Therapeutics and Cystic Fibrosis Foundation Extend Agreement to Advance ARCT-032, an Investigational Messenger RNA (mRNA) Therapeutic to Treat Cystic Fibrosis

Retrieved on: 
Tuesday, September 26, 2023
Health, Infectious Diseases, Genetics, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Valencia CF Foundation, Vaccine, Diversified Specialty Institute Holdings, Inc., Infection, ARCT, Cystic fibrosis, RNA, Messenger, Lung, CFTR, Cystic Fibrosis Foundation, Liver, CF, Disease, Arcturus

The CF Foundation agreed to increase its financial commitment to ~$25 million to advance ARCT-032, a novel messenger RNA (mRNA) therapeutic candidate formulated with Arcturus’ LUNAR® delivery technology.

Key Points: 
  • The CF Foundation agreed to increase its financial commitment to ~$25 million to advance ARCT-032, a novel messenger RNA (mRNA) therapeutic candidate formulated with Arcturus’ LUNAR® delivery technology.
  • This agreement extends a prior research program, initiated in 2017, which has resulted in the advancement of ARCT-032 into ongoing clinical studies.
  • “We are thrilled to extend our productive relationship with the Cystic Fibrosis Foundation, and we are grateful for their meaningful financial support,” said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus.
  • “ARCT-032 has the potential to express fully functional CFTR protein in the lung, thereby addressing the root cause of cystic fibrosis.

Study Shows Novel sa-mRNA Vaccines Offer Robust, Broad, Enduring Protection Against COVID-19 Variants

Retrieved on: 
Tuesday, September 19, 2023
Health, Infectious Diseases, Genetics, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, Vaccine, Infection, European Scientific Cooperative on Phytotherapy, Diversified Specialty Institute Holdings, Inc., Influenza, Omicron, AE, Vaccination, SARS-CoV-2, Nephrology, SARS-CoV-2 Omicron variant, Public, Aes, Hereditary angioedema, Drug, Haemophilia, ARCT, CSL, Cell, RNA, Delta, Messenger, HAE, Iron deficiency, Patient, Beta, Liver, Poster, Immunodeficiency, Conference, North West Ambulance Service, B.1, Arcturus

Three sa-mRNA vaccines were used in the study, which was presented as a poster at the European Scientific Working Group on Influenza's 9th ESWI Influenza Conference in Valencia, Spain.

Key Points: 
  • Three sa-mRNA vaccines were used in the study, which was presented as a poster at the European Scientific Working Group on Influenza's 9th ESWI Influenza Conference in Valencia, Spain.
  • However, sa-mRNA also provides the body with instruction to make copies of the mRNA, amplifying the amount of protein made.
  • This advanced technology has shown the potential to offer longer duration of immune response at considerably lower doses compared to conventional mRNA vaccines.
  • Similar trends were observed for other SARS-CoV-2 variants including Beta, Delta, Omicron BA.1, Omicron BA.2, and Omicron BA.4/5.

Arcturus Therapeutics Announces Second Quarter 2023 Financial Update and Pipeline Progress

Retrieved on: 
Monday, August 7, 2023
COVID-19, Research, Infectious Diseases, FDA, Genetics, Clinical Trials, Biotechnology, Pharmaceutical, Health, Science, Vaccine, Diversified Specialty Institute Holdings, Inc., Travel, Omicron, Arcturus Therapeutics, Vaccination, Marketing, SARS-CoV-2, Ornithine transcarbamylase deficiency, Infection, NDA, Pfizer–BioNTech COVID-19 vaccine, ARCT, Meiji, CSL, Multimedia, RNA, Messenger, Government, Ministry, CGMP, Patient, MedRxiv, OTC, Cystic fibrosis, Geometry, Liver, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Food, MNT, Pharmaceutical industry, Cryptocurrency, Arcturus

Superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was also demonstrated as a key secondary endpoint.

Key Points: 
  • Superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was also demonstrated as a key secondary endpoint.
  • Revenue decreased by $16.6 million during the three months ended June 30, 2023 as compared to the prior year period.
  • We have collected approximately $300.0 million in upfront payments and milestones from CSL Seqirus as of June 30, 2023.
  • Additionally, we received $23.6 million under the manufacturing and supply of ARCT-154 from CSL Seqirus during the quarter ended June 30, 2023.

Colombian Flower Is Now Available To Australian Patients Through Strategic Partnership Between Clever Leaves And Australian Natural Therapeutics Group

Retrieved on: 
Wednesday, July 26, 2023
GMP, Seizure, Diversified Specialty Institute Holdings, Inc., Partnership, Depression, Anxiety, Cancer, Therapeutic Goods Administration, Quality of life, Sleep apnea, Research, Inflammation, Dementia, Patient, Pain management, TGA, PTSD, Drug, Pharmaceutical industry, EU

TOCANCIPÁ, Colombia and SYDNEY, Australia, July 26, 2023 (GLOBE NEWSWIRE) -- Clever Leaves Holdings Inc. (NASDAQ: CLVR, CLVRW) (“Clever Leaves” or the “Company”), a global medicinal cannabis company, announced that its Colombian flower is now available to patients in Australia through a partnership with Australian Natural Therapeutics Group (“ANTG”), one of the leading medicinal cannabis providers in Australia.

Key Points: 
  • TOCANCIPÁ, Colombia and SYDNEY, Australia, July 26, 2023 (GLOBE NEWSWIRE) -- Clever Leaves Holdings Inc. (NASDAQ: CLVR, CLVRW) (“Clever Leaves” or the “Company”), a global medicinal cannabis company, announced that its Colombian flower is now available to patients in Australia through a partnership with Australian Natural Therapeutics Group (“ANTG”), one of the leading medicinal cannabis providers in Australia.
  • The products are available to medical patients in Australia under ANTG’s “Global Selects” brand portfolio.
  • ANTG’s evolving brand portfolio signifies its commitment to providing Australian patients with a consistent supply of medicinal-grade plant medicine.
  • ANTG’s CEO Matt Cantelo said, “Knowing that Clever Leaves´ Colombian flower is available for patients in Australia as part of our “Global Selects" portfolio is something that we are very proud of.

Establishment Labs Celebrates Opening of Sulàyöm Innovation Campus and Outlines New and Expanded Capabilities

Retrieved on: 
Wednesday, July 19, 2023
Surgery, Medical Devices, Women, Professional Services, Training, Health, Consumer, Environmental, Social and Governance (ESG), Education, Heart, Diversified Specialty Institute Holdings, Inc., Woman, Research, Carbon, Science, Discovery, Harwell Science and Innovation Campus, Breast, Establishment, R, ESTA, Pharmaceutical industry

The Sulàyöm Campus will support Establishment Labs’ continued global growth with additional capacity and capabilities in manufacturing, R&D, digital media, training, and medical education.

Key Points: 
  • The Sulàyöm Campus will support Establishment Labs’ continued global growth with additional capacity and capabilities in manufacturing, R&D, digital media, training, and medical education.
  • The added manufacturing more than doubles Establishment Labs’ capacity, allowing the company to provide over half the current world demand for breast implants.
  • We chose to name our innovation campus Sulàyöm as a reminder of our heritage and of our unwavering commitment to women around the world,” said Juan José Chacón-Quirós, CEO and Founder of Establishment Labs.
  • This is what Sulàyöm means to Establishment Labs.”
    The opening ceremony will include a Discovery Session showcasing Establishment Labs innovations in science, technology, and product development.