Merz Aesthetics® Receives Approval from Health Canada for RADIESSE® as an Aesthetic Injectable for the Treatment of Moderate Wrinkles in the Décolleté Area
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BURLINGTON, Ontario — Merz Aesthetics ® Canada announced today the Health Canada approval for Radiesse ® for the treatment of moderate wrinkles in the décolleté area. Radiesse ® is a regenerative biostimulator 1 capable of regenerating multiple components of the skin tissue, resulting in healthier-looking skin, 1,4,5 and is now approved for use in the décolleté area, adding to the product's versatility.
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This new regulatory milestone directly answers patient demand, given there is a significant shift toward regenerative biostimulation.
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'Despite being one of the most visible areas of our bodies, the décolleté area is often overlooked when it comes to aesthetics,'
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says Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics
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®
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'Radiesse ® presents a unique solution to improving décolleté wrinkles and provides our customers and their patients a non-surgical, effective option to address aging décolleté skin.'
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According to the International Society of Aesthetic Plastic Surgery (ISAPS), non-surgical procedures/minimally invasive treatments between 2018 and 2022 involving calcium hydroxylapatite increased by 171.8% globally between 2018 and 2022. 2 This approval was supported by a large, multicentre clinical trial 3,5,1 which supported the décolleté approval and has provided substantial evidence of the effectiveness of Radiesse ®, demonstrating a significant improvement in the appearance of moderate décolleté wrinkles. 3 ' The décolleté is notoriously difficult to treat. Skin in this area is thin, chronically sun-exposed, low in sebaceous glands, prone to accelerated loss of elasticity, and tends to form more complex scars than other regions. Health Canada's new approval of Radiesse® for this area is therefore exciting and welcome news. It is a true biostimulator that has almost 20 years of safety data for the face, and an agent we turn to regularly in our clinic for this area. So, it is great to be able to officially use this amazing product on the décolleté as well. The biostimulatory effects work by triggering collagen, elastin, and micro-vasculature renewal, thickening the tissue and softening lines. It is a powerful treatment that gives natural-looking radiant results. This new approval now gives us a proven, regenerative tool to rejuvenate the skin on the chest, ' says Dr. Dusan Sajic, a leading Canadian medical and cosmetic dermatologist.
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This year Radiesse ® celebrates its 20 th anniversary, having sold more than 15 million syringes globally since 2005. 3 Merz Aesthetics demonstrates a longstanding legacy and commitment to scientific innovation in the aesthetics field. 3 After two decades on the market, the new décolleté indication allows practitioners more versatility to expand the treatment spectrum from the face and hands to treatments for the décolleté. Additionally, the 1:2 dilution with 0.9% sterile saline increases the product adaptability allowing for personalized treatment to address patient needs.
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'This new indication for Radiesse ® to treat the décolleté area marks a significant milestone for the aesthetics market,'
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.
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'It not only expands the versatility of Radiesse ® but also addresses a growing patient demand for regenerative aesthetic solutions. By offering a proven, effective treatment for décolleté wrinkles, we are enhancing our commitment to innovation and patient care. This approval underscores our dedication to providing advanced, minimally invasive options that cater to the evolving needs of our patients.'
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Even in the current landscape, findings from Medical Insight's 2024 Global Aesthetic Market Study suggest that Radiesse ® has emerged as a category leader. 6 This success is backed by over two decades of scientific data and clinical experience by Merz Aesthetics ®, 4,2 with 250 publications, 3 and availability in over 85 countries. 3 About Merz Aesthetics ® Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients, and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient's needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics' global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.
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CBC
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The U.S. is cutting billions from science. Canadian researchers say it's time to step up
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Seven of the TRC's 94 calls to action focused on health, including a call to identify and close gaps in health outcomes, funding for existing and new Indigenous healing centres and recognizing the value of Indigenous healing practices. Fay Virginia Desjarlais, the family violence prevention co-ordinator at the Indigenous Health Centre of Tio'tia:ke, says the clinic is a sign there has been some progress. "There were gaps in the health system to really understand the needs of the Indigenous people living in Montreal," she said. "People didn't feel safe. A lot of advocates, elders and different organizations came together to say 'We need to do something.' " Desjarlais says hospitals and other health-care settings can be unwelcoming for many Indigenous people. She has seen patients face discrimination and racism, and has been through it herself with a family doctor. 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"I'm hopeful that once this is up and running that we have an opportunity to build centres in each of Nunavut's regions," she said. Beyond that, Aglukark wants to build up the Inuit workforce for the centre and other services and to establish more treatment centres in more communities. "It's very important for Inuit to lead and have that opportunity to provide the services in Inuktitut," she said. Dr. Terri Aldred, academic lead with the National Collaborating Centre for Indigenous Health, says progress on the calls to action around health has been "moderate." While she's impressed with new Indigenous health clinics and healing centres like the ones in Montreal and Iqaluit that are "rooted in our ways of knowing and being," Aldred says such projects need to be scaled up to meet the need. She says they also need sustainable, long-term funding. "Indigenous people that are able to access those services will start to have a different relationship with accessing health care," she said. "And we'll be able to build trust with those providers, and we'll have a positive ripple effect.
CBC
an hour ago
- CBC
National vaccine registry needed amid measles resurgence, Canada's outgoing top doctor says
As Dr. Theresa Tam retires as Canada's top doctor, she's calling for a national vaccine registry. Tam says the COVID-19 pandemic, which began in early 2020 and killed at least 60,000 Canadians, showed how badly one is needed to track vaccines and protect vulnerable communities. A national vaccine registry, she says, could help prevent and manage crises like the resurgence of measles that the country now faces. Tam says she's in favour of a "nationally interoperable network of vaccine registries" that connects all of the provincial and territorial health systems and helps identify pockets of the population where there is poor vaccine coverage. While the majority of measles cases so far have occurred in communities that are historically under-vaccinated, she told Dr. Brian Goldman, host of CBC's White Coat, Black Art, "we don't actually know exactly where the situation with vaccine coverage lies." Tam spoke to Goldman from Ottawa for a feature interview reflecting back on her career as the country's chief public health officer. The pandemic proved that the technology for a registry is there, she says, given that almost all provinces and territories made COVID-19 vaccine records available electronically during that time. Although it was the pandemic that made her both a household name — and a target for hate — Tam came to the role of top doctor three years earlier, in June 2017, after occupying a series of other leadership positions within the Public Health Agency of Canada (PHAC), including deputy chief. She has also served as an expert on a number of World Health Organization committees. WATCH | Dr. Theresa Tam on facing personal attacks during the pandemic: Leading Canada's public health response to COVID-19 was as much a personal challenge as it was a professional one, given Tam was also on the receiving end of racist and sexist vitriol during that time. "What I try to do, certainly at the time and even now, is just to focus on the job that I'm trying to deliver," she said. Those attacks were even harder on her staff — those monitoring the channels where the messages would come in, and who tried, as much as possible, to shield her from the worst of it, Tam says. "And one member of my staff used to also read me the incredibly lovely cards and messages that the public sent to encourage me to carry on. It was like the antidote to the other messages as well. So that really helped." One of Tam's provincial counterparts, Dr. Robert Strang, chief medical officer of health in Nova Scotia, says he has "huge respect for Dr. Tam." "Certainly working with her during COVID, we were all kind of in this kind of team together. Having her leading us as chief medical officers was a real pleasure and a privilege." Getting cross-Canada support for registry The challenge with getting a network of vaccine registries operating to help with measles and other infectious disease crises in future, Tam says, lies in getting all of the jurisdictions to sign on and co-operate to make their systems speak to one another. "There's in fact quite a lot of work on the way right now to develop those agreements with the provinces, as well as the more technical aspects of this," she said. A national registry, she says, will make things "so much easier" for public health departments, doctors, patients and parents. "That's the most important thing, that you will know whether your kids got the vaccine and that your health provider can have that information as well." Strang says there's agreement on the principle, but "the devil is always in the details." There are a number of groups, including PHAC, working to get the federation to do a better job of sharing health data, he says. "There's certainly support and agreement amongst the chief medical officers and public health leaders of this being a priority," Strang said. But Dr. Iris Gorfinkel, a Toronto family physician and researcher, says she suspects political considerations are behind some of the provinces "literally hoarding their medical data." "When politics stands in the way of science moving forward or health being prioritized, it becomes a serious, potentially life-threatening problem," said Gorfinkel, who is also the founder of PrimeHealth Clinical Research. Some provincial governments may be afraid voters will dislike sharing their health data, she says. But that shouldn't be a factor, given how easy it is to remove identifying details from the information so no one apart from an individual and their health-care provider knows their vaccine status, Gorfinkel says. We're already paying a heavy price — in lives and dollars — for not having a national registry, she says. "First, there's a tremendous waste of vaccines," Gorfinkel said. We saw that during COVID-19, she says, when Canada over-bought vaccines and struggled to administer them before they expired, eventually drawing international criticism for doing so while other parts of the world went without. In the case of the measles outbreaks, she says, "if we don't know where those are happening and we can't ship vaccines to where they're most needed, then what that means is we're not going to make the best use of the vaccines we have." And, of course, people and health systems pay when hospitals fill with people who have become ill from vaccine-preventable illnesses, Gorfinkel says. Looking abroad Other countries have made this work, among them Sweden, France, Finland, Germany, the Netherlands and Spain. In Norway, for example, a national registry that began in 1995 and at first tracked only routine childhood vaccinations, was expanded in 2011 to require mandatory reporting for all vaccines and age groups. Gorfinkel says some of these countries better embrace the sentiment that "what happens to my neighbour does affect me." Public health expert Amir Attaran, a vocal critic of Tam and PHAC during the pandemic, says far more could have been done at the federal level to get a national registry in place in this country, too. WATCH | Tam on why Canada needs better real-time health data: A professor in the faculties of law and school of epidemiology and public health at the University of Ottawa, Attaran says infectious disease experts like Tam have known since the SARS outbreak in 2003 that the country was woefully unprepared to properly track and respond to an outbreak due to poor data sharing. "And because of the experience of SARS in Canada, we should have been very switched on about this," said Attaran, who holds both a law degree and a PhD in biology. He says Canada's Statistics Act empowers the federal government to "require the provinces to cough up statistics," and that's exactly what public health data is. Canada's public health culture is self-defeating, Attaran says, because it recognizes the necessity of accurate and timely data but proceeds "under this false assumption that you can't get those data unless everybody agrees and everybody's happy with it. And then you fail to put in the political energy to bring about that consensus by agreement or coercion." Masking controversy While the pandemic highlighted the need for a national vaccine registry to manage outbreaks better, it also exposed challenges in public health communication. One of the most debated issues was masking. Attaran was among those who said Tam bungled the advice around masking in the earlier stages of the pandemic, for example. "Early in the pandemic, she told people, 'No, you don't need to mask,'" he said. Yet by then the virus had been identified as SARS-CoV-2, and we'd already learned from the 2003 SARS crisis that it required masking, he says. But in Nova Scotia, Strang says, the information scientists were working with early on suggested the virus behaved like an influenza, which spread through droplets, not aerosols. "We don't recommend widespread masking, necessarily, for everybody for influenza." Tam says public health leaders "need to do a better job in explaining to people how the scientific information are coming through, how we analyze it and how we turn them into guidance."
