Hello Everyone,
We are still seeing more devices designated as a breakthrough by the FDA, making it possible for new technologies to get to market faster than ever. Even technologies that may have been classified as biologicals are now given the breakthrough status, with enough evidence. A novel material for encouraging spinal tissue regeneration is the most recent. In previous years, because the material is novel and is implanted, an approval process could have taken 5 years or more. Now with the breakthrough status, the approval time will be dramatically reduced.
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We are, of course, still seeing new diagnostic devices approved, typically through the 510k pathway. A novel way of monitoring life signs is through noninvasive sensors. Several years ago, we saw the early stages of sensors woven into clothing, capable of measuring multiple life signs such as blood pressure, respiration, and oxygenation. Now, these sensors incorporated into clothing are receiving FDA approval. Usage can include clinical and home settings, increasing patients’ ability, and even healthy people being monitored continuously.
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Speaking of non-invasive, an exciting technology was just approved in Europe for treating cancer. This device uses electric fields to slow down cell division. Used in combination with current chemotherapy drugs, this is a novel approach to further disrupt cancer progression without adding additional pharmaceutical treatments.
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COVID-19 cases are a continuing issue worldwide, especially as we get into the winter and predicted rises in spread. There is good news, though, as vaccine development shows real promise. First, though, there is continuing work in telehealth platforms. These platforms can warn of early signs of COVID and monitor patients for reduced hospital stay. These platforms can then be used in the future for other uses, such as for elderly care and chronic condition patients. Large health systems are accelerating their already heavy emphasis on remote monitoring and telehealth platforms.
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There has been significant vaccine news in the past few weeks, with both Pfizer-BioNTech and Moderna finding their mRNA-based vaccines are 95% effective in preventing COVID-19. This is with a broad base of clinical trial participants, with even some evidence showing severe cases of COVID can be prevented. This is extremely promising for not just COVID but also the promise of mRNA and RNA based platforms for combating infectious diseases and even other conditions, namely cancer. The two vaccines do have some differences, however, most notably in their storage requirements. This is due to the different formulations used, not just between these two companies but all candidates. Every company does have a unique formulation, i.e., the composition of the vaccine itself. This can affect dosing, storage, and overall stability. The Pfizer vaccine requires a much colder temperature than the Moderna one, specifically needing dry-ice temperatures. Both vaccines can be stored in a standard refrigerator, however. The key difference is that the Pfizer vaccine lasts only 5 days at those temperatures, while the Moderna vaccine lasts 30 days. This can have a significant impact on where and how the respective vaccines can be deployed. The Pfizer vaccine may best be used in large urban centers and centralized facilities, while the Moderna vaccine can be used in more dispersed and rural areas.
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What Are SPACs, and Why Are They Back?
In case you missed it, Zoic has released new research on SPACs, providing comprehensive coverage on the SPAC IPO market, fundraising, SPAC IPO costs, industry segmentation, lifecycle, and more. Download our free primer below.
