Day: September 7, 2022

• The completion of the ISA’s review of the Collector Test Environmental Impact Statement (EIS) paves the way for TMC subsidiary, Nauru Ocean Resources Inc (NORI), to conduct its planned pilot collection system trials on its NORI-D exploration area in the Clarion Clipperton Zone of the Pacific Ocean beginning later this month.
• An integral part of the ISA’s regulatory and permitting process, the trials will be monitored by independent scientists from a dozen leading research institutions, providing critical environmental impact data to inform NORI’s application to the ISA for an exploitation contract.
• Upcoming integrated nodule collection system trials will mark the first such trials to be conducted in the CCZ since the 1970s.

NEW YORK, Sept. 07, 2022 (GLOBE NEWSWIRE) — The Metals Company (Nasdaq: TMC) (the “Company” or “TMC”), an explorer of lower-impact battery metals from seafloor polymetallic nodules, today announced that the International Seabed Authority has completed its review of the Environmental Impact Statement (EIS) and Environmental Monitoring and Management Plan (EMMP) submitted by its subsidiary, Nauru Ocean Resources Inc (NORI), and recommended that it proceed with its forthcoming collector test.

The conclusion of the International Seabed Authority’s review process allows NORI to proceed with its planned integrated pilot collection system trials in its NORI-D exploration contract area in the Clarion Clipperton Zone (CCZ) of the Pacific Ocean. NORI’s offshore strategic partner Allseas will test a system consisting of a prototype nodule collector at the seafloor and the riser system to bring nodules to the surface production vessel, Hidden Gem. Approximately 3,600 tonnes of polymetallic nodules are expected to be collected during the trial beginning later this month with an expected conclusion in the fourth quarter of 2022.

The trials will be monitored by independent scientists from a dozen leading research institutions around the world who will analyse the environmental impacts of both the pilot nodule collector vehicle and the nodule riser system. The data collected, together with many terabytes of existing baseline data collected by NORI throughout 16 offshore campaigns, will form the basis of NORI’s application to the International Seabed Authority for an exploitation contract.

Gerard Barron, CEO and Chairman of The Metals Company, commented: “Our team has worked tirelessly to produce an EIS, EMMP and integrate constructive feedback and recommendations from the ISA’s Legal and Technical Commission. With this green light from the ISA, the team of world-class engineers from Allseas and scientists from some of the world’s leading deep-sea research institutions that we’ve brought together can begin technology trials and our impact monitoring campaign. We have a couple of exciting and no doubt challenging months ahead of us. The environmental and operational data and insights from these trials will be an important step in ensuring the safe and efficient collection of polymetallic nodules to supply critical battery materials for the clean energy transition.”

Following the submission of its EIS to the International Seabed Authority in July 2021, the Republic of Nauru, the sponsoring state of NORI, undertook an open stakeholder consultation program to solicit comments and feedback. Based upon this feedback and with over 600 comments received, an updated EIS was submitted to the ISA in March 2022. Barron added: “I would like to thank the ISA’s Legal and Technical Commission for their detailed review and feedback which, together with stakeholder comments, has improved the EIS and demonstrates the robustness of the ISA’s regulatory review process.”

Previously, TMC and Allseas announced successful trials of the nodule collector vehicle in deep-water in the Atlantic [see video] as well as harbor wet-test commissioning and shallow-water drive tests in the North Sea.

Development of technologies to collect polymetallic nodules first began in the 1970s when oil, gas and mining majors including Shell, Rio Tinto (Kennecott) and Sumitomo successfully conducted pilot test work in the CCZ, collecting over fifteen hundred tons of nodules. More recently, contractors BGR and GSR conducted several trials of prototype nodule collector vehicles in deep water, and NORI’s forthcoming tests mark the first time this century that an integrated collection system – including a nodule riser – would be trialled in the CCZ.

About The Metals Company

The Metals Company is an explorer of lower-impact battery metals from seafloor polymetallic nodules, on a dual mission: (1) supply metals for the clean energy transition with the least possible negative environmental and social impact and (2) accelerate the transition to a circular metal economy. The Company through its subsidiaries holds exploration and commercial rights to three polymetallic nodule contract areas in the Clarion Clipperton Zone of the Pacific Ocean regulated by the International Seabed Authority and sponsored by the governments of Nauru, Kiribati and the Kingdom of Tonga.

More Info 
Media | media@metals.co
Investors | investors@metals.co

Forward Looking Statements

Certain statements made in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. The forward-looking statements contained in this press release include, without limitation, statements regarding the approval and review of our Environmental Impact Statement (EIS) by the international seabed authority, the development and use of an ecosystem-based management and monitoring plan (EMMP) as well as the design, use and accuracy of any technology developed by TMC and its partners, agents and/or service providers to support its operations. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside TMC’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: regulatory uncertainties and the impact of government regulation and political instability on TMC’s resource activities; changes to any of the laws, rules, regulations or policies to which TMC is subject; the impact of extensive and costly environmental requirements on TMC’s operations; environmental liabilities; the impact of polymetallic nodule collection on biodiversity in the Clarion Clipperton Zone and recovery rates of impacted ecosystems; TMC’s ability to develop minerals in sufficient grade or quantities to justify commercial operations; the lack of development of seafloor polymetallic nodule deposit; uncertainty in the estimates for mineral resource calculations from certain contract areas and for the grade and quality of polymetallic nodule deposits; risks associated with natural hazards; uncertainty with respect to the specialized treatment and processing of polymetallic nodules that TMC may recover; risks associated with collection, development and processing polymetallic nodules; risks associated with TMC’s limited operating history; the impact of the COVID-19 pandemic; risks associated with TMC’s intellectual property and the validity, use and ownership of any new technology or intellectual property subsisting therein; and other risks and uncertainties indicated from time to time in the Company’s Form 10K, dated and filed with the U.S. Securities and Exchange Commission (SEC) on March 25, 2022 as well as the Company’s Form 10Q filed with the SEC on August 15, 2022, including those under “Risk Factors” therein, and in TMC’s other future filings with the SEC. TMC cautions that the foregoing list of factors is not exclusive. TMC cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. TMC does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based except as required by law.

WALTHAM, Mass. and SHANGHAI, China, Sept. 07, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients in need around the world, today announced the appointment of Simon Lowry, M.D., as the company’s Chief Medical Officer. Dr. Lowry brings over 20 years of broad clinical expertise in the design and execution of early to late-stage clinical programs to Zenas, where he will lead the company’s global clinical, medical affairs, and pharmacovigilance functions.

“We are delighted to welcome Dr. Lowry to Zenas at this pivotal time for the company as we commence two phase three registration trials for our lead product candidate, obexelimab, in the fourth quarter of this year and initiate first-in-human clinical trials for multiple pipeline programs,” said Hua Mu, M.D., Ph. D, Chief Executive Officer at Zenas. “Dr. Lowry’s proven leadership, broad clinical development background, and extensive global clinical trial experience will further strengthen our ability to execute on our mission to transform the lives of patients with unmet medical needs by bringing best-in-class immune-based therapies to patients.”

Dr. Simon Lowry added, “There are many patients with autoimmune and rare diseases in need of effective new treatment options. The deeply experienced and talented Zenas team has made impressive progress advancing the company’s pipeline in a very short period of time, and I look forward to leading the ongoing advancement of Zenas’ clinical programs through commercialization while further expanding the company’s pipeline of innovative programs.”

Dr. Lowry is a medical doctor with 20 years of experience at large and emerging pharmaceutical and biotechnology companies directing successful development programs, leading clinical and medical affairs teams, and interacting with regulatory agencies across multiple areas of medicine, including rheumatology, immunology, and ophthalmology. Prior to joining Zenas, Dr. Lowry was Chief Medical Officer at Kinevant Science, a clinical-stage biopharmaceutical company focused on treating rare inflammatory and autoimmune diseases. Dr. Lowry was previously Head of Immunology R&D at Roivant Sciences, leading all development stage immunology assets into clinical development, and served as a key member of the leadership team. He also served as Chief Medical Officer at Sun Pharma North America, where he was responsible for four branded therapeutic areas (Immunology & Dermatology, Ophthalmology, Neurology and Oncology), and led all aspects of development and medical functions (including clinical development, medical information, field medical, HEOR, publications / medical communications, and operations). Early in his career, he worked at Novartis, where he served as Vice President, Global Medical Affairs Franchise Head, Immunology & Dermatology, and Pfizer, where he served in roles of increasing responsibility, including as Vice President, Oncology Medical Affairs Group Leader.

Prior to his pharmaceutical/ biotechnology career, Dr. Lowry practiced internal medicine at various institutions in the UK and Australia. He received his BA from Trinity Hall, Cambridge University, UK and his MB BChir medical degree from Cambridge University School of Clinical Medicine.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations in the US and China, Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Joe Farmer
Zenas BioPharma
IR@zenasbio.com

The Consul General in New York, Fabrizio Di Michele, and General Roberto Riccardi, of the Carabinieri Command for the Protection of Cultural Heritage Were Present at the Restitution Ceremony

NEW YORK, Sept. 07, 2022 (GLOBE NEWSWIRE) — New York has returned to Italy 58 antiquities valued at nearly $19 million. The artifacts, illegally stolen from the Italian territory, were recovered thanks to the cooperation between the judicial authorities of New York and the Cultural Heritage Protection Command of the Italian Carabinieri. The Consul General in New York, Fabrizio Di Michele, and General Roberto Riccardi, of the Carabinieri Command for the Protection of Cultural Heritage were present at the restitution ceremony, which took place at the office of Manhattan District Attorney, Alvin Bragg.

“This new restitution of archaeological assets of great value is proof of the extraordinary results that the collaboration between Italy and the United States in the sector of combating the illicit trafficking of artifacts and works of art has continued to produce for over twenty years. Our Countries firmly believe in the value of the protection of cultural heritage, at the center of a joint activity that makes us very proud,” remarked the Ambassador of Italy to the United States, Mariangela Zappia.

“The artifacts recovered today are of immense historical and artistic importance,” commented the Consul General Di Michele. “This repatriation operation follows two other similar operations recently concluded with the New York District Attorney. In the last nine months alone, over 400 works of art have been returned to our country.”

The returned goods, which cover a large period of time ranging from 1100 BC to 300 AD, of which 21 works from the collections of the Met, were formally delivered to Consul General Di Michele, in the presence of the Executive Assistant District Attorney of New York County Lisa Delpizzo and General Riccardi. “Yet another opportunity to thank the US authorities for the generous collaboration offered to the recovery of cultural heritage,” Riccardi observed. “Once again, thanks to the synergies created with the Trafficking Unit of the DAO of Manhattan and the Homeland Security Investigations, with the good offices of Italian diplomacy, we bring home objects that belong to our history, identity and culture,” concluded the general, thanking his American colleagues.

For more information:
LaPresse SpA Communication and Press Office Director
Barbara Sanicola – barbara.sanicola@lapresse.it

Download video at https://download.apmultimedianewsroom.com/Video/2022/20220906ItalianArtRepatriationmpeg.mpeg

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/91489e3e-f270-4c67-be10-515d398dae89

The photo is also available at Newscom, www.newscom.com, and via AP PhotoExpress.

September 7, 2022

• Leiden University Medical Center joins global network of partners in the development of Philips Spectral Angio CT suite and its use in clinical research, bringing spectral CT imaging technology into an integrated hybrid angio CT suite with the aim of innovating a range of treatment procedures
• CIRSE 2022 presentation by University of Insubria (Varese, Italy) details positive results of study that uses spectral CT to better guide lung tumor biopsies  
• Philips and University of Pennsylvania announce collaboration to investigate spectral CT guidance during interventional oncology procedures and its potential to confirm treatment effectiveness in real time

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced new milestones in the development of the world’s first spectral detector angio CT solution – Philips Spectral Angio CT suite – bringing the company’s breakthrough spectral CT imaging technology into an integrated hybrid angio CT suite. By combining its award-winning [1] Spectral CT 7500 system and its Image Guided Therapy System – Azurion with FlexArm – in a fully integrated interventional suite solution, Philips aims to give physicians immediate access to these two key imaging modalities in a single room, enabling innovation in minimally-invasive procedures in areas such as oncology, stroke, and trauma care.

Philips today announced a new clinical partner and highlighted clinical studies that focus on the added value of using spectral CT imaging technology during interventional procedures.

Expanding Philips’ clinical network
Leiden University Medical Center (Leiden, the Netherlands) has joined Philips’ global network of clinical partners to investigate how its spectral detector angio CT solution could potentially offer new treatment opportunities and improve patient care.

“We are excited to co-create an innovation that could play a defining role in improving patient care in the space of interventional oncology,” said Mark Burgmans, MD, Head of Interventional Radiology at Leiden University Medical Center. “Adding spectral CT imaging to the interventional suite will enable us to offer new treatment opportunities, avoid moving patients from one imaging suite to another, and offer the unique benefits of spectral CT information when you need it.”

Other leading clinical institutes that Philips is working with on this innovation are Mayo Clinic (Rochester, MN, U.S.) and Baptist Health’s Miami Cardiac & Vascular Institute (Miami, FL, U.S.).

Philips Spectral Angio CT suite combines the company’s latest diagnosis and treatment technologies. Philips Image Guided Therapy System – Azurion with FlexArm – is the company’s next-generation image-guided therapy platform, integrating best in class imaging systems, software, and specialized diagnostic and therapeutic devices to support exceptional treatment for the most complex procedures. The addition of Philips’ award-winning Spectral CT 7500 system means physicians only need one scan to capture all the spectral information required to differentiate and quantify different tissues. Spectral CT enables improved detection, delineation, and quantification of lesions, leading to better-informed planning for minimally-invasive procedures and more precise interventions. It has already proved its worth in other areas of oncology – for example, it has demonstrated higher sensitivity in detecting malignant findings and improved readings of incidental findings [2][3]. With its ability to improve tissue characterization, the Spectral CT 7500 offers significant benefits over conventional CT.

Through continuous research, Philips is building clinical evidence that supports the added value of spectral CT imaging for diagnosis and treatment guidance.

Research results show better targeted biopsies using spectral CT guidance
At this year’s Cardiovascular and Interventional Radiological Society of Europe Annual Meeting (CIRSE 2022, September 10-14, Barcelona, Spain) a presentation is being given by Filippo Piacentino, interventional radiologist at the University of Insubria (Varese, Italy), on the value of spectral CT imaging guidance for performing high-confidence tumor biopsies [4]. The results being presented illustrate the potential for Philips’ spectral CT technology to better guide biopsies by distinguishing between active and non-active regions in a tumor. Ensuring that a biopsy contains a high number of actively dividing cancer cells is important for high-confidence diagnosis.

“With conventional CT, large masses may appear as a largely uniform mass, making highly targeted biopsy difficult,” said Filippo Piacentino. “By fusing images from Philips’ XperGuide live needle guidance with images from spectral CT, that are color-coded based on the effective atomic number of tissues and provide a large amount of additional information, we can now investigate the possibility of obtaining better defined biopsy targets with a fewer number of inconclusive biopsies.”

New clinical collaboration on reduction of the risk of tumor recurrence
Philips also today announced a research collaboration with the University of Pennsylvania (Pennsylvania, PA, U.S.) to study the practicality of using spectral CT-based tissue temperature mapping to provide real-time feedback during tumor thermal ablation procedures to confirm its effectiveness before the patient leaves the room. This will potentially reduce the risk of localized tumor recurrence.

“Announcing these important milestones in the development of our unique Philips Spectral Angio CT suite shows our strong commitment and progress in co-creating the future of image-guided therapy,” said Karim Boussebaa, General Manager of Image Guided Therapy Systems at Philips. “By combining the best of our award-winning modalities into a single suite we aim to unlock new treatment approaches that could benefit both patients and their physicians.”

Visit Philips at CIRSE 2022
To learn more about Philips Spectral Angio CT suite, visit Philips at CIRSE 2022 and join the Philips symposia in which leading physicians will share their latest clinical insights on using this new imaging approach in interventional oncology. You can register via our dedicated CIRSE 2022 webpage.

[1] Minnie Award for Best New Radiology Device
[2] Analysis by Aarhus University Hospital Aarhus, Denmark. Results from case studies are not predictive of results in other cases. Results in other cases may vary.
[3] Analysis by University Hospital Cleveland, USA. Results from case studies are not predictive of results in other cases. Results in other cases may vary.
[4] Filippo Piacentino, ‘Spectral CT as innovative imaging guidance in large lesions lung biopsies. XperGuide and Z-effective fusion for more defined targets, more diagnostic samplings and more biomarkers information’. CIRSE 2022

For further information, please contact:

Joost Maltha
Philips Global Press Office
Tel: +31 6 10 55 8116
Email: joost.maltha@philips.com

Fabienne van der Feer
Philips Image Guided Therapy
Tel.: +31 622 698 001
E-mail: fabienne.van.der.feer@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 79,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachment

• Philips Spectral Angio CT suite

September 6, 2022

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body

Pittsburgh, Pennsylvania – Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.

This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.

Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:

• Pacemakers
• Implantable cardioverter defibrillators (ICD)
• Neurostimulators
• Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
• Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
• Aneurysm clips
• Embolic coils
• Intracranial aneurysm intravascular flow disruption devices
• Metallic cranial plates, screws, burr hole covers, and bone substitute devices
• Metallic splinters in the eye
• Ocular implants (e.g., glaucoma implants, retinal implants)
• Certain contact lenses with metal
• Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
• Magnetic denture attachments
• Metallic gastrointestinal clips
• Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
• Implantable ports and pumps (e.g., insulin pumps)
• Hypoglossal nerve stimulators
• Devices labeled as MR (Magnetic Resonance) unsafe
• Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask if available, for continued therapy. Patients should properly dispose of the mask that has magnets after an alternative is obtained.

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Warning: Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 15 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.

Impacted masks include (see attached image):

• Amara View Full Face Mask
• DreamWisp Nasal Mask
• DreamWear Full Face Mask
• Wisp and Wisp Youth Nasal Mask
• Therapy Mask 3100 NC/SP

More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of August 30, 2022, Philips Respironics has received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.

Patients with questions may contact Philips Respironics’ customer service at 1-800-345-6443, (Monday – Friday; 8:30 AM ET to 8:00 PM ET) for more information about non-magnetic mask options. Patients may also contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice.

Any adverse events experienced with the use of masks containing magnetic clips should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

This voluntary medical device corrective action has been reported to the regulatory agencies in the countries where these masks are available.

Media contact:
Mario Fante
Philips Global Press Office
Tel.: +1 603 560 9226
E-mail: mario.fante@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 79,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachment

• Overview of impacted masks