The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
27.6%
The Omicron subvariant XBB.1.5, was estimated to account for 27.6% of Covid-19 cases in the first week of January, according to a report by the Centers for Disease Control and Prevention. The rapid spread of the new XBB.1.5. variant has prompted the World Health Organization to urge passengers on long-haul flights to wear masks.
4.4
A child or youth died once every 4.4 seconds in 2021 according to the latest estimates released by the United Nations Inter-agency Group for Child Mortality Estimation. An estimated 5 million children died before their fifth birthday and another 2.1 million children and youth aged between 5–24 years lost their lives in 2021.
2.7%
Global growth is forecast to slow down to 2.7% in 2023, a significant drop from 6% in 2021, as per the International Monetary Fund. This is the weakest growth profile since 2001 except for the global financial crisis and the acute phase of the COVID-19 pandemic.
12%
Intuitive Surgical announced it expects da Vinci surgical robot procedures to grow at least 12% this year. The surgical robot developer said it expects fourth-quarter revenue to total $1.66 billion, representing a 7% increase from the same period in 2021.
Latest news
Resonetics signs agreement to acquire Memry and SAES businesses for $900m
Resonetics entered an agreement to acquire the Memry and SAES Smart Materials businesses in the US in a deal valued at $900m.
Acquired from SAES Getters in Italy, the businesses have US operations in Bethel, Connecticut; New Hartford, New York; and Menlo Park, California. Resonetics is backed by funds managed by Carlyle and private equity firm GTCR.
The deal expands nitinol and components manufacturing capabilities to meet the growing need for technological advances in the industry in various therapeutic areas. The Memry business will add expertise related to electric discharge machining (EDM), along with laser processing and nitinol tubing.
SAES Smart Materials converts the nitinol raw material created from nickel and titanium raw material into different form factors.
Source: Medical Device Network
Evosep receives Novo Holdings funds to advance proteomics applications
Proteomics technology company Evosep has received an investment of $40m from global life science investor Novo Holdings to advance clinical proteomics applications.
Evosep will use the funds to advance the proteomics applications enabled by its standardised liquid chromatography platform.
Additionally, Evosep will be able to use the investment to expand its presence across the globe, especially in the growing US market. This expansion will provide more customers with a high-throughput proteomics solution. Novo Holdings principal Stephen Van Helden said: “Evosep’s technology can profoundly impact the diagnosis and treatment of diseases.
“Its platform addresses some of the most common technical pain points that have historically held back the widespread application of proteomics.”
Concurrent with Novo Holdings’ investment, Van Helden will join the Board of Directors of Evosep.
Source: Medical Device Network
Agilent and Akoya partner to develop multiplex assays for tissue analysis
Agilent Technologies and Akoya Biosciences have collaborated to develop multiplex-immunohistochemistry diagnostic products for tissue analysis.The companies have also agreed to market end-to-end workflow solutions for multiplex assays in the clinical research market.
Under the partnership, Agilent will integrate its Dako Omnis auto-staining instrument with Akoya’s imaging platform, PhenoImager HT, for multiplex chromogenic immunohistochemistry (mIHC) and immunofluorescent (mIF) assays. This integration will create a single end-to-end commercial workflow that will include reagents, staining, imaging and analysis.
Together Agilent and Akoya will develop chromogenic and immunofluorescent multiplex assays, which will include spatial analysis for companies that develop precision therapeutics for cancer.
Source: Medical Device Network
Clinical trials
Arthrex’s ACL TightRope implant gets FDA approval for paediatric indications
Arthrex has secured approval from the US Food and Drug Administration (FDA) for its ACL TightRope implant for paediatric indications. Developed for use in the surgical treatment of orthopaedic injuries, the TightRope implant is claimed to be the first and only fixation device for anterior cruciate ligament (ACL) injuries approved for paediatric application. With the support of Hospital for Special Surgery (HSS) orthopaedic surgeons Frank Cordasco and Daniel Green, the firm developed all-epiphyseal and transphyseal techniques and instrumentation for ACL surgery.
Source: Medical Device Network
Pristine Surgical’s Summit arthroscope secures FDA 510(k) clearance
Medical technology manufacturer Pristine Surgical has secured 510(k) clearance for its Summit 4K single-use surgical arthroscope from the US Food and Drug Administration (FDA). Summit has been designed to improve the safety, consistency and efficiency of arthroscopic procedures. It combines a 4K single-use surgical arthroscope with Pristine Connect, a cloud-based software, to provide a high-definition image with a new device every time. The company stated that Summit is simple to set up and completely sterile, ensuring safety for patients and staff.
Source: Medical Device Network
Vivos’ DNA oral appliance gets FDA 510(k) clearance to treat OSA
Vivos Therapeutics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its DNA oral appliance (daytime-nighttime appliance) to treat obstructive sleep apnea (OSA). The clearance enables the use of the class II device as a new treatment regimen for mild-to-moderate OSA.
The new treatment offered by the DNA appliance involves opening the airway by extending the palate and training the tongue to rest in the proper position as well as converting patients to nasal instead of oral breathing.
Source: Medical Device Network
Nines
US-based company Nines is a tele-radiology and artificial intelligence startup. Its product NinesAI is FDA-cleared to triage time-critical, life-threatening indications of mass effect and intracranial hemorrhage.
Source: Nines
Lucira Health
Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.
Source: Lucira Health
Bloomlife
US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.
Source: Bloomlife
