OrbusNeich’s Joint Venture Kicks Off TricValve Clinical Trial in Mainland China

HONG KONG, Apr 24, 2024 – (ACN Newswire) – OrbusNeich Medical Group Holdings Limited (“OrbusNeich” or the “Group”; stock code: 6929), a major global medical device manufacturer specializing in interventional devices for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures, announced today that the Group’s joint venture OrbusNeich P+F Company Limited (“ON P&F”) has commenced the clinical trial for the TricValve Transcatheter Bicaval Valve System (“TricValve”), to treat patients with hemodynamically relevant tricuspid insufficiency and caval reflux, on April 22, 2024 across Mainland China.

The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively. It has effectively treated a 56-year-old patient with severe tricuspid regurgitation, marking the commencement of the clinical trial across Mainland China.

Led by principal investigator Prof. Ge Junbo, Academician Zhongshan Hospital, Fudan University, and his team, the clinical trial aims to assess the safety and efficacy of TricValve. Prof. Ge Junbo had himself performed the implantation procedure on a patient. A team of experts of Zhongshan Hospital, one of the 13 medical institutions participating in the trial, believed the groundbreaking therapy could potentially revolutionize treatment options for patients, offering them new hope and improved outcomes.

Mr. Peter Peh, General Manager of OrbusNeich P&F, said, “We are pleased to see TricValve moving into clinical trial, marking the first successful implantation of a percutaneous transcatheter bicaval device in a patient by cardiologists in Mainland China, to address severe tricuspid valve regurgitation. Before that, patients with this valvular heart disease are typically deemed unfit for open-heart surgery. They had limited treatment options, and had to endure severe symptoms and a shortened lifespan. With the advent of TricValve, patients can look forward to having better quality of life and live longer. It is our privilege to offer this life-changing therapy to patients. As our first patient has been doing exceptionally well after the procedure, we hope to extend relevant care to more patients in the future.”

Via ON P&F, the Group has ventured into the structural heart domain. In addition to TricValve, ON P&F also has a comprehensive pipeline of structural heart interventional devices, including Vienna Aortic Valve, a transcatheter aortic valve replacement (TAVR) product; Vienna Mitral Valve — Replacement, a transcatheter mitral valve replacement (TMVR) product; Vienna Pulmonary Valve — Replacement, a transcatheter pulmonary valve replacement (TPVR) product, and balloon expandable valves, which are complementary additions to the Group’s series of self-expandable heart valve devices. The strategic move has opened doors for the Group to new opportunities in the transcatheter valve replacement and repair market recording double-digit growth in recent years. The notable shift from traditional open-heart surgery to minimally invasive transcatheter therapies will present the Group with substantial growth potential in the medium and long term.

About TricValve

TricValve, a transcatheter bicaval valve system, is comprised of two self-expanding biological valves used to treat patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The prostheses are implanted percutaneously into the superior and inferior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy.

TricValve obtained the CE Mark in 2021, received Breakthrough Device Designation from the FDA in 2020, and was granted an Innovative Medical Device designation by the NMPA in 2022.

About OrbusNeich Medical Group Holdings Limited

OrbusNeich is a major global medical device manufacturer specializing in interventional devices for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures. Headquartered in Hong Kong, China, OrbusNeich sells its products in more than 70 countries and regions worldwide. It is also actively expanding into neuro vascular intervention and structural heart disease. As at December 31, 2023, OrbusNeich has more than 240 granted patents and published patent applications worldwide. Its in-house R&D team has more than two decades of product development experience and has developed world-leading proprietary technologies.

For more information, please visit the Group’s official website: https://orbusneich.com/


Topic: Press release summary

Joint Civil & DoD CBRN Symposium is Returning for Its 12th Iteration

 The 12th Annual Joint Civil and DoD CBRN Symposium will convene senior leaders across military, government, industry, and academia to explore the CBRNE community’s continued efforts to advance the defense, readiness, and response to current and emerging chemical, biological, radiological, and nuclear threats. The 2024 Symposium will aim to advance an innovative, joint CBRN community essential to counter and defend the nation from CBRN events.

With the increasing complexity of the global security environment, the threat of an accidental or intentional chemical, biological, radiological, or nuclear attack on the U.S. is becoming a growing threat. Developing the technologies and solutions necessary to mitigate and respond to CBRN threats is critical. Attendees will gain valuable insights into the continued development of capabilities to increase the resiliency and preparedness of DoD, Federal, State & Local entities to understand, protect, and mitigate CBRN incidents and hazards.

2024 Speakers Include:

– HON Frank Rose – Principal Deputy Administrator, National Nuclear Security Administration

– Darryl Colvin, SES – Program Executive Officer, JPEO-CBRND

– Ian Watson, SES – Deputy Assistant Secretary of Defense for Chemical & Biological Defense, DoD

– Michael Bailey, SES – Director DEVCOM Chemical Biological Center

– Charles Hughes – Deputy to the Commanding General, 20th CBRNE Command

– Mary Ellen Callahan – Assistant Secretary, CWMD Office, DHS

– Susan Ferensic – Assistant Director, WMDD, FBI

DSI is now welcoming Sponsors and Exhibitors for the forum. To learn more please contact Amanda Delgado at adelgado@dsigroup.org or 201.940.6680.

Active military and government and state personnel attend complimentary. Those interested in participating in the Joint Civil & DoD CBRN Symposium can visit Defense Strategies Institute’s website at https://jointcbrn.dsigroup.org/. Anyone interested in learning more or sending questions contact Emma Watters at ewatters@dsigroup.org or 201.987.0183.

Defense Strategies Institute
Emma Watters
201-987-0183
https://jointcbrn.dsigroup.org/

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  • Government

Hong Kong – Joint publicity efforts by CAD and Police to promote Small Unmanned Aircraft Order (with photos)

Joint publicity efforts by CAD and Police to promote Small Unmanned Aircraft Order (with photos)

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     To enhance the safety awareness of the public and tourists of small unmanned aircraft (SUA) operations, the Civil Aviation Department (CAD) conducted a joint publicity event with the Police today (December 13) at both sides of Victoria Harbour and in the vicinity of the Peak. By distributing leaflets and displaying promotional banners, members of the public were briefed on relevant requirements under the SUA Order, as well as restricted flying zones (RFZs) in the vicinity of the two spots.

     To facilitate the flight demonstration of home-grown aircraft C919 this Saturday (December 16), the CAD will establish a temporary RFZ in and around Victoria Harbour. Flying activities, such as the flying of unmanned aircraft systems (drones and model aircraft), will be restricted. The CAD will announce details of the temporary RFZ on the electronic portal for small unmanned aircraft “eSUA”.

     Commenced on June 1, 2022, the SUA Order (Cap. 448G) regulates SUA operations under a risk-based approach which takes into account the weight of the SUA and the operational risk level. If a person commits an offence under the SUA Order, the person is liable to a maximum fine of $100,000 and imprisonment for two years upon conviction.

Announcing 3rd Joint Fires Summit

 In its 3rd iteration, the Joint Fires Summit will bring together DoD, military services, industry, and academia to discuss the current initiatives towards delivering cutting-edge surface-to-surface fires systems that will significantly increase range and effects over currently fielded US and adversary systems. The 2024 Joint Fires Summit will focus on the technologies and policies necessary to modernize weapons systems and processes across the joint force as well as to develop and field cutting edge fires and strike capabilities to meet the growing challenges of strategic competition across the globe. These efforts are part of a growing priority as potential enemies continue to invest in their defense capabilities while also developing hypersonic and other standoff weapons systems.

Topics of Discussion Include:
– Driving Army Modernization Efforts through Advanced Air & Missile Defense Capabilities.
– Providing Strategic Deterrence, Global Strike, and Combat Support to increase Fires Capabilities.
– Expediting Delivery of Critical Capabilities to Advance Fires Modernization Priorities.
– Delivering Integrated Air Warfighting Capability to Meet the Needs of Modern and Future Operation Environments.
– Modernizing Multidomain Fires Capabilities to Achieve Cross-Domain, Cross-Warfighting Strategic Advantage.
– Enhancing Pacific Fires Capabilities for Strategic, All-Domain Advantage.
– Increasing Resiliency and Agility of U.S. Army Field Artillery Systems to Deliver More Precise Effects on Future Battlefields.
– and much more.

DSI is now welcoming Sponsors and Exhibitors for the forum. To learn more please contact Dudley Duverne at dduverne@dsigroup.org, or (201) 987-1803.

Active military and government and state personnel attend complimentary. Those interested in participating in the Joint Fires Summit can visit Defense Strategies Institute’s website at https://fires.dsigroup.org/. Anyone interested in learning more or sending questions contact Emma Watters at ewatters@dsigroup.org or 201.987.0183.

Defense Strategies Institute
Emma Watters
201-987-0183
https://fires.dsigroup.org/

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Categories

  • Government

Hong Kong – Mainland-Hong Kong Joint Operation against illegal immigration

Mainland-Hong Kong Joint Operation against illegal immigration

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     The Immigration Department (ImmD) mounted a joint operation codenamed “Mungoshunt-3” with the Hong Kong Police Force and Guangdong Provincial authorities to combat non-ethnic Chinese illegal immigrants for three consecutive days from November 4 to November 6. During the operation, a total of 127 persons were arrested in Hong Kong and Guangdong Province.
      
     Officers from ImmD and Hong Kong Police Force had conducted territory-wide anti-illegal immigrant operation and raided the suspected hideouts of illegal immigrants. The ImmD had also mounted a series of territory-wide anti-illegal worker operations to step up enforcement actions against non-ethnic Chinese illegal immigrants. In addition, to combat illegal immigrants sneaking into Hong Kong by sea, Marine Police had collaborated with Mainland authorities to ramp up sea patrol and interception of suspicious vessels.
      
     During the operation, the ImmD joined forces with Hong Kong Police to conduct sudden raid at over 218 target locations and intercept 60 suspicious vessels and 990 persons, successfully seized two vessels and arrested 70 persons. For the arrested persons, two Mainlander illegal male immigrants aged 23 and 28 and one Indian male aged 29 holding recognizance form were arrested for “aiding and abetting others to land in Hong Kong unlawfully and remain in Hong Kong”. Twenty-two male illegal immigrants, consisting of two Mainlanders, nine Bangladeshis, seven Pakistanis, three Indians and one Vietnamese, aged 22 to 56, were arrested. During the anti-illegal worker operation, five Mainlanders and 31 non-ethnic Chinese were arrested for breach of recognizance’s condition, taking up unapproved employment and overstaying in Hong Kong respectively. Arrested Mainlanders consisted of one male and four female, age 38 to 59, while the 31 arrested non-ethnic Chinese consisted of six male and 25 female, age 23 to 50, among which seven were holders of recognizance forms issued by the ImmD, which prohibit them from taking up employment. During the operation, nine suspected employers were arrested, consisted of eight male and a female, age 36 to 79.
      
     Mainland authorities from Guangdong Province had arrested 57 persons, including seven arrangers and 50 non-ethnic Chinese intended to sneak into Hong Kong illegally, consisting 35 Bangladeshi, 12 Pakistani and three Indians.
      
     An ImmD spokesman said, “As stipulated in the Immigration Ordinance, ‘Arranging passage to Hong Kong of unauthorized entrants’ and ‘Assisting unauthorized entrant to remain’ are serious offences. Offenders arranging passage to Hong Kong of unauthorized entrants face a maximum fine of $5,000,000 and up to 14 years’ imprisonment while offenders assisting unauthorized entrant to remain face a maximum fine of $500,000 and up to 10 years’ imprisonment. The ImmD would continue to colloborate with Hong Kong Police Force and relevant department to step up enforcement actions and conduct joint operation to combat illegal immigration activities.”
      
     The spokesman said, “Any person who contravenes a condition of stay in force in respect of him or her shall be guilty of an offence. Also, visitors are not allowed to take employment in Hong Kong, whether paid or unpaid, without the permission of the Director of Immigration. Offenders are liable to prosecution and upon conviction face a maximum fine of $50,000 and up to two years’ imprisonment. Aiders and abettors are also liable to prosecution and penalties.”
      
     The spokesman warned, “As stipulated in section 38AA of the Immigration Ordinance, an illegal immigrant, a person who is the subject of a removal order or a deportation order, an overstayer or a person who was refused permission to land is prohibited from taking any employment, whether paid or unpaid, or establishing or joining in any business. Offenders are liable upon conviction to a maximum fine of $50,000 and up to three years’ imprisonment. Under the prevailing laws, it is an offence to use or possess a forged Hong Kong identity card. Offenders are liable to prosecution and upon conviction face a maximum fine of $100,000 and up to 10 years’ imprisonment.”
      
     The spokesman reiterated that it is a serious offence to employ people who are not lawfully employable. Under the Immigration Ordinance, the maximum penalty for an employer employing a person who is not lawfully employable, i.e. an illegal immigrant, a person who is the subject of a removal order or a deportation order, an overstayer or a person who was refused permission to land, has been significantly increased from a fine of $350,000 and three years’ imprisonment to a fine of $500,000 and 10 years’ imprisonment to reflect the gravity of such offences. The director, manager, secretary, partner, etc, of the company concerned may also bear criminal liability. The High Court has laid down sentencing guidelines that the employer of an illegal worker should be given an immediate custodial sentence.
      
     According to the court sentencing, employers must take all practicable steps to determine whether a person is lawfully employable prior to employment. Apart from inspecting a prospective employee’s identity card, the employer has the explicit duty to make enquiries regarding the person and ensure that the answers would not cast any reasonable doubt concerning the lawful employability of the person. The court will not accept failure to do so as a defence in proceedings. It is also an offence if an employer fails to inspect the job seeker’s valid travel document if the job seeker does not have a Hong Kong permanent identity card. Offenders are liable upon conviction to a maximum fine of $150,000 and to imprisonment for one year. In that connection, the spokesman would like to remind all employers not to defy the law by employing illegal workers. The ImmD will continue to take resolute enforcement action to combat such offences.
      
     Under the existing mechanism, the ImmD will, as a standard procedure, conduct an initial screening of vulnerable persons, including illegal workers, illegal immigrants, sex workers and foreign domestic helpers, who are arrested during any operation with a view to ascertaining whether they are trafficking in persons (TIP) victims. When any TIP indicator is revealed in the initial screening, the ImmD officers will conduct a full debriefing and identification by using a standardised checklist to ascertain the presence of TIP elements, such as threats and coercion in the recruitment phase and the nature of exploitation. Identified TIP victims will be provided with various forms of support and assistance, including urgent intervention, medical services, counselling, shelter or temporary accommodation and other supporting services. The ImmD calls on TIP victims to report crimes to the relevant departments immediately.