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CoolSeal receives CE mark, Japan PMDA approval; now available in over 20 countries worldwide

LOUISVILLE, COLORADO, Sept 23 (Bernama-GLOBE NEWSWIRE) —Bolder Surgical today announced the global launch of its CoolSeal™ Vessel Sealing platform. CoolSeal has been in use since October 2020 in the U.S., and with the new international regulatory approvals the devices are available in over 20 countries around the world.

Bolder Surgical provides surgeons precision electrosurgical instruments to perform minimally invasive surgery safely and effectively in pediatric and adult procedures including general, gynecological and bariatric surgical applications.

The CoolSeal Vessel Sealing suite includes the 3 mm Mini (formerly JustRight Sealer) and the 5 mm Trinity Sealer/Divider/Dissector. Both devices are powered with the gold-standard efficacy of advanced bipolar RF vessel sealing technology.

 “Having successfully used the 3 mm vessel sealer for many cases in pediatric surgery, the Trinity 5 mm device is an excellent addition to my selection of surgical instruments,” said Dr. Satoshi Ieiri, pediatric surgeon, Kagoshima University Hospital. “The slim, curved jaw design and added sealing capacity supports procedures on larger children, adolescents and adults. It is a true all-in-one instrument that enables precise dissection and produces quick sealing times with minimal thermal distribution and great advantages.”

 With an average thermal spread less than 1 mm and slim, dual action jaws, CoolSeal devices combine the finesse of true surgical instruments with the gold-standard efficacy of advanced bipolar RF vessel sealing. The devices are designed for multi-functional performance that can mean fewer instrument exchanges, helping streamline workflow and reduce operative time.

Bolder Surgical continues its path of innovation through focused investment in R&D to move the company beyond its origin in pediatric devices.  “We’ve successfully leveraged our expertise in microsurgical devices and energy delivery to create the CoolSeal portfolio,” stated Robert Kline, President and CEO of Bolder Surgical. “The portfolio is designed to give surgeons innovative, versatile options that minimize surgical impact, from the smallest patients to adolescents and adults. We are extremely proud that physicians across the globe can now access this innovative technology.”

CoolSeal products are now available in over 20 countries worldwide including member countries of the European Union, the United Kingdom, Japan, Australia, and the Middle East. For information visit BolderSurgical.com.

Attachment

• Trinity Full Perspective Open Jaws

Tricia Strong
Bolder Surgical
719 433 4836
tstrong@boldsurg.com

SOURCE : Bolder Surgical Holdings

KUALA LUMPUR, Sept 22 (Bernama) — In April, 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 finalists are representatives from the US, Italy, Japan, and Jordan. These individuals and groups achieved the highest scores against strict criteria, including individuality, relevance, and conceptualisation.

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.

The others are THE CONFLICT – Mai Abu-Shanab and Jalal Al-Sadi of m+j architect studio atelier in Amman, Jordan; ORBITS OF TIME – Jenny Wu and Dwayne Oyler of Oyler Wu Collaborative in Los Angeles, California, USA; and, ETERNAL CIRCULATION – Shinsaku Munemoto of Shinsaku Munemoto & Associates, Architects in Kyoto, Japan.

According to a statement, the Cold War Veterans Memorial will be a critical piece of the Pritzker Archives and Memorial Park Center (PAMPC) currently under development.

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.

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 winning design will be announced publicly in March next year.

— BERNAMA

^{Vinodh Menon, Founder of The Cakery, went from comedy producer to online cakes and has never looked back since. His vision for The Cakery is to expand it across Malaysia.}

– An online bakery born in a pandemic –


KUALA LUMPUR, Sept 21 (Bernama) — What happens when a pandemic brings a stand-up comedy producer’s business to a grinding halt? He goes on to set-up an online bakery of course!

Vinodh Menon began his entrepreneurial adventure in October of 2016. Within 4 years he grew his fledgling PR agency, into a stand-up event production and online event ticketing company, hosting events for thousands, working with stand-up comics from Malaysia, Singapore, and India. While the going was good, fate had a different plan in mind, and in March of 2020, the first lockdown was announced, and nothing was ever the same again. Forced to look for an alternative source of income, and with very little options at hand, Vinodh decided to set-up his own online bakery, lovingly known as, The Cakery.

“Baking and me are ‘night and day’, aside from knowing how to wash dishes, there is very little I can offer in a kitchen, let alone a bakery. ‘Necessity is the mother of all inventions’, as my mother would always say, and after noticing several home-baker friends making considerable sales on social media, I realised that if I applied my marketing and public relations experience to the trade, I could do better, and so The Cakery was born,” said Vinodh Menon, Founder of The Cakery.

Within its first 10-days, The Cakery sold an eye-brow raising 33 cakes. In the following 8-months, The Cakery went on to sell over 300 orders per month, and expand its delivery to include, Kuala Lumpur, Selangor, and Penang. Its menu includes cakes, cupcakes, brownies, macarons, and cookies for any and every occasion. Vinodh prides himself with ensuring the customer’s wants are at the heart of every order, which has led to plenty of custom creations that delight the eye, and perfectly represents the uniqueness of every customer.

“Whether it was events or cakes, I always aspire for the customer to have a great time thanks to my show, and now, my cake. Cakes play such a crucial role in any occasion, and allowing the customer to design the cake, makes every cake special,” adds Vinodh.

Sales numbers aside, The Cakery has helped others keep afloat during these turbulent times. Its tasty treats are put together by group of bakers, located in Kuala Lumpur, Selangor and Penang. All of whom have a minimum of 5 years’ experience as home bakers, and some of whom negatively impacted by the pandemic.

While the going has been encouraging, The Cakery aims to grow to Ipoh, Seremban, and Johor Bahru, to a national brand.

For more information on The Cakery, feel free to visit its Facebook and Instagram pages @thecakerymy.

Source: The Cakery

KUALA LUMPUR, Sept 21 (Bernama) — Adagio Therapeutics Inc, a clinical-stage biopharmaceutical company has reported updates on its lead COVID-19 antibody programme, ADG20, as well as recent business highlights and second quarter 2021 financial results.

“Our team is working closely with our global CRO partners on the execution of our ongoing global clinical trials of ADG20, STAMP and EVADE, while also preparing for the anticipated worldwide commercialisation of ADG20, if approved,” said co-founder and chief executive officer of Adagio, Tillman Gerngross, Ph.D. in a statement.

ADG20 COVID-19 programme highlights include New ADG20 Data to be Presented in Multiple Posters during IDWeek; and, Partnership with Biocon Biologics Expands the Reach of a Potent and Broadly Neutralizing COVID-19 Antibody Treatment to Patients in India and Select Emerging Markets.

At the IDWeek 2021 Virtual Conference, Adagio plans to present additional data highlighting the potential for ADG20 to provide protection from COVID-19 for up to one year based on its extended half-life in humans combined with its broad and potent neutralising ability demonstrated in laboratory testing.

Meanwhile, recent business highlights include David Hering, Global COVID-19 Vaccine Expert, Appointed as Chief Operating Officer; US$355.8 Million Initial Public Offering (IPO) Successfully Completed; and, Board of Directors Expanded with Industry Leaders to Support Future Growth.

In August 2021, Adagio sold 20,930,000 shares of common stock, including the full exercise of the underwriters’ option to purchase an additional 2,730,000 shares of common stock at a public offering price of US$17.00 per share. (US$1 = RM4.188)

In addition, as of June 30, Adagio had cash, cash equivalents and marketable securities of US$392.5 million, which includes net proceeds from its Series C financing completed in April, while pro forma cash, cash equivalents and marketable securities as of June 30 is US$719.6 million after giving effect to its initial public offering which closed on Aug 10.

Research & development expenses including in-process research and development for the second quarter of 2021 were US$37.6 million, while selling, general & administrative expenses for the second quarter of 2021 were US$7.1 million.

More details at http://www.adagiotx.com.

— BERNAMA

KUALA LUMPUR, Sept 21 (Bernama) — The Celltrion Group announced the Korean Ministry of Food and Drug Safety (MFDS) has approved regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19.

This is for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition (the obese, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19.

This marks the first time a monoclonal antibody treatment for COVID-19 has received full approval to treat patients with COVID-19 from the Korean MFDS, according to a statement.

“Recent clinical data have helped improve healthcare professionals’ and public health authorities’ understanding of the potential role of regdanvimab in the treatment of patients with mild-to-moderate symptoms of COVID-19,” said Head of Medical and Marketing Division at Celltrion Healthcare, Dr HoUng Kim, Ph.D.

The administration time for the recommended dosage of regdanvimab (CT-P59), a single intravenous (IV) infusion of 40 mg/kg, has been reduced from 90 minutes to 60 minutes.

Celltrion has successfully enrolled more than 1,315 people in its global Phase III clinical trial, which evaluated the efficacy and safety of regdanvimab (CT-P59) in 13 countries including the US, Spain, and Romania.

Data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalisation or death by 72 per cent for patients at high-risk of progressing to severe COVID-19 and 70 per cent for all patients.

In addition, pre- clinical data for regdanvimab (CT-P59) demonstrated strong neutralising activity against the Delta variant (B.1.617.2, first identified in India) with results showing 100 per cent survival rate with virus eradication from all animals treated with therapeutic dosage of CT-P59.

As of September 2021, more than 14,857 people have been treated with regdanvimab (CT-P59) in 107 hospitals in the Republic of Korea.

More details at https://www.celltrionhealthcare.com.

— BERNAMA