Healthcare Innovations Digest in 2021

Here’s the list of innovations up to June 2021:

1. First-in-Class mRNA vaccines against SARS-CoV-2 prevent COVID-19
2. The global rise of 3D & multiplex printing in healthcare
3. Artificial intelligence deployed for health
4. “Recruitment-MP” – the future of transplant surgery?
5. The ultrasound-guided therapeutic delivery system

First-in-Class mRNA vaccines against SARS-CoV-2 prevent COVID-19

Introduction

Vaccines provide protective immunity against pathogens. The basic mRNA vaccine technology has been around since the early 1990s, however, technical challenges prevented clinical success, until the pandemic hit. Two independent mRNA vaccines, created by Moderna and a BioNTech-Pfizer partnership, won FDA emergency use authorization (EUA) to prevent COVID-19 in December 2020.

Summary of the Innovation

COVID-19 mRNA vaccines contain nucleoside-modified mRNA surrounded by a lipid nanoparticle (LNP), which both protects the mRNA encoding Spike protein and delivers it to targeted cells. Two doses of the vaccine provide enough adaptive “memory” for the immune system to rapidly remove the SARS-CoV-2 virus. Published clinical trial data indicate that Moderna’s mRNA-1273 vaccine had 94% efficacy at preventing COVID-19 illness, including severe disease in adults. BioNTech’s BNT162b2 provided 95% protection against COVID-19 in people 16 years and older.

Applications of the Innovation

Beyond the immediate crucial need to end the current pandemic, the mRNA vaccine technology has great potential to be used as the workhorse of vaccine design against anticipated pathogen threats, which can be rapidly scaled if needed.

Limitations/ Risks

• BioNTech’s vaccine requires a cold-chain distribution maintained at -80°C to -60°C.
• Moderna’s can be stored between -25° to -15°C.
• Pharmacovigilance will be crucial for this new class of drugs.
• The vaccines may not be effective against emerging SARS-CoV-2 variants.

The global rise of 3D & multiplex printing in healthcare

Introduction

The pandemic has confronted healthcare professionals with equipment shortages on one hand and overwhelming demands to quickly identify treatments for COVID-19 in the context of a declared state of emergency and disrupted logistics on the other. In the past year, 3D printed and multiplex solutions have moved to the frontlines to solve the supply and demand issues.

Summary of the Innovation

3D printing or additive manufacturing is the process of making three-dimensional solid objects, typically layer by layer, from a computer-aided design (CAD) file using a specialized printer. Custom dot matrices can be printed for screening of drugs. 3D printing has supplied all manner of healthcare needs including ventilator valves, masks, other respiratory medical device parts, nasopharyngeal swabs, personal protective equipment, anatomical training aids, and even whole isolation ward units.

Applications of the Innovation

Importantly, 3D printing has also produced completely new devices that are fulfilling an unmet medical need. An example of this is a 3D printed oesophageal stent that contains the chemotherapy drug 5-fluorouracil (5-FU) for controlled localized release to treat esophageal cancer. The in vitro release studies, headed by Anton Blencowe at the University of South Australia, Adelaide, demonstrated a sustained release of 5-FU for 110 days with constant diffusion.

Limitations/ Risks

• Further in vivo and clinical studies are needed.
• Unknown safety aspects include the potential for breakdown-products, be they microparticles or chemicals, that could impact health in unpredictable ways.
• Theoretical potential for an inflammatory reaction against the stent.

Artificial intelligence deployed for health

Introduction

Artificial intelligence (AI) giants Microsoft, Google, Apple, and Amazon have each contributed to AI initiatives in the past year aimed at ameliorating COVID-19. Importantly, despite the strong focus on COVID-19, AI was able to make significant contributions to other areas of health such as heart disease during the pandemic as well.

Summary of the Innovation

The ejection fraction of the heart describes the percentage of blood exiting the left ventricle of the organ with each contraction. A low ejection fraction may indicate an underlying heart problem. A clinical trial headed by Peter A. Noseworthy at the Mayo Clinic used AI to detect low ejection fraction from electrocardiography (ECG) measurements in a real-world setting. For every 1,000 patients screened, the AI correctly diagnosed 5 patients with a low ejection fraction that the current standard of care failed to identify.

Applications of the Innovation

The results of the clinical trial suggest that an AI algorithm based on ECGs would be beneficial in the setting of routine primary care. The algorithm could also enable wearable products and telehealth applications where patients/ consumers are able to monitor their own heart health, routinely.

Limitations/ Risks

Without the guidance of medical professionals, consumers could misinterpret the meaning of their heart ejection fraction as it is not the only measure of heart health.

“Recruitment-MP” – the future of transplant surgery?

Introduction

Regulatory T cells (T_regs) are a subpopulation of T cells that generally suppress effector T cells of the adaptive immune system. Depending on the context researchers are interested in either mitigating their effects as in the case of cancer immunotherapies or increasing their effectiveness for treating hyperactive immune conditions.

Summary of the Innovation

Transplant rejection is a major limitation of potentially life-saving organ donation. To address this the innovation of a T_reg “Recruitment-MP” was published in the journal Science Advances by senior author Steven R. Little of University of Pittsburgh, Pennsylvania.

• Key point 1: “Recruitment-MP” is a synthetic, degradable, controlled release microparticle system for CCL22
• Key point 2: CCL2 is a chemokine that recruits circulating T_reg via the corresponding CCR4 receptor
• Key point 3: In mice “Recruitment-MP” prolonged hindlimb transplant survival indefinitely (>200 days)

Applications of the Innovation

The innovation may make major cosmetic reconstructive surgeries such as hand and face transplants more feasible. It may also make transplants of last resort such as kidney, liver, heart, or lung more durable.

Limitations/ Risks

Clinical trials are needed. The long-term consequences of CCL2 release in the body are unknown. A potential risk is that the “Recruitment-MP” could inadvertently create a safe haven for circulating tumor cells to expand and cause cancer.

The ultrasound-guided therapeutic delivery system

Introduction

Many biologic drugs are toxic if they are not delivered precisely to the disease site. Often disease sites can only be accessed via systemic circulation. Microparticles are one solution to mask toxic drug components for delivery. An emerging approach is to allow medical doctors to guide the therapeutic to the disease site manually, using ultrasound.

Summary of the Innovation

Fluorous tags, or FTags, can efficiently disperse therapeutic proteins, such as antibodies, into

ultrasound-sensitive liquid perfluorocarbons. Scott H. Medina of Pennsylvania State University, and colleagues developed this innovation in a paper published in the journal ACS Nano.

• Key point 1: FTags, transiently mask proteins, efficiently dispersing them into ultrasound-sensitive liquid perfluorocarbons.
• Key point 2: these nanoemulsions can be acoustically tracked, guided, and activated using clinically relevant diagnostic ultrasound.
• Key point 3: real-time imaging was used to simultaneously monitor and activate FTag–protein complexes allowing controlled cytosolic antibody delivery in vitro and in vivo.

Applications of the Innovation

The technology appears ideal for targeting tumors and other lesions that are by definition variable in terms of their location and shape. It could be thought of as a form of molecular surgery and perhaps well suited for use by surgeons, potentially using AI-enhanced imaging.

Limitations/ Risks

The next step is to demonstrate enhancement of an established drug’s therapeutic effects or improved safety using the technology in clinical trials.

   

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