Next-generation mRNA vaccines are among the advancements likely to change healthcare this year
Next-generation mRNA vaccines. A new approach for treating prostate cancer. Novel therapy for reducing LDL. These are three of the breakthrough technologies that will change healthcare in 2022, according to a panel of Cleveland Clinic physicians and researchers led by D. Geoffrey Vince, PhD, Executive Director of Innovations and Chair of Biomedical Engineering.
“At Cleveland Clinic, a shared passion for the delivery of superior care and an embedded culture of innovation foster continuous healthcare improvement dialogue among our clinicians and researchers,” says Dr. Vince. “As such, our experts always have their finger on the pulse of new technologies slated to change the face of healthcare. The Top 10 Medical Innovations program was launched to share their insight with the broader healthcare community, and year after year, our professionals continue to successfully predict device, technology and therapy advances.”
Here, in order of anticipated importance, are the Top 10 Medical Innovations for 2022:
1. Next generation of mRNA vaccinology. Advancements in the generation, purification and cellular delivery of RNA have enabled the development of RNA therapies across a broad array of applications, such as cancer and Zika virus. The technology is cost-effective and relatively simple to manufacture. Furthermore, the COVID-19 pandemic demonstrated that the world needed rapid development of a vaccine that was easily deployable around the globe. Because of previous research that laid the groundwork for this technology, an effective COVID-19 vaccine was developed, produced, approved and deployed in less than a year. This landscape-changing technology has the potential to quickly and efficiently eliminate some of healthcare’s most challenging diseases.
2. PSMA-targeted therapy. Each year, more than 200,000 Americans are diagnosed with prostate cancer — the most commonly diagnosed cancer among U.S. men. Early detection and successful imaging are critical for tumor localization, staging the disease and detecting recurrences. Prostate-specific membrane antigen (PSMA), found in high levels on the surface of prostate cancer cells, is a potential biomarker of the disease. PSMA PET uses a radioactive tracer to locate and attach to PSMA proteins, making them visible by PET imaging. This approach can be used in conjunction with CT or MRI scans to visualize where prostate cancer cells reside. In 2020, this technology received FDA approval based on phase 3 trials that showed a substantially increased accuracy for detecting prostate cancer metastases compared to conventional imaging with bone and CT scans.
3. New treatment for the reduction of LDL. High levels of blood cholesterol, particularly low-density lipoproteins (LDL-C), are a significant contributor to cardiovascular disease. In 2019, the FDA reviewed the application for inclisiran in treating primary hyperlipidemia (including hereditary hypercholesterolemia) in adults who have elevated LDL-C while on a maximally tolerated dose of statin therapy. Inclisiran is an injectable, chemically synthesized small interfering RNA that targets the PCSK9 protein. In contrast to statins, it requires infrequent dosing (twice per year) and provides effective and sustained LDL-C reduction in conjunction with statins. Its prolonged effect may help alleviate medication noncompliance, one of the leading causes of failure to lower LDL-C levels. Inclisiran was approved by the FDA in December 2021 and is widely considered a game changer for heart disease patients.
4. Novel drug for treatment of type 2 diabetes. In the U.S., 1 in 10 individuals has diabetes. One potential therapy is a once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide receptor agonist (GLP-1) that aims to control blood sugar. Injected under the skin, GLP-1 and GIP receptors cause the pancreas to release insulin and block the hormone glucagon, limiting blood sugar spikes after a meal. Additionally, it slows digestion, helping individuals remain full longer and eat less. Late phase 3 trials reveal that the treatment significantly reduces hemoglobin A1C in type 2 diabetes and supports weight loss, potentially making it the most effective therapy for diabetes and obesity yet developed.
5. Breakthrough treatment for postpartum depression. Experts believe the prevalence of postpartum depression could be at least twice as high as what current statistics reveal because many cases go undiagnosed. Counseling and antidepressant medications are primary treatments, but some women do not respond to these therapies. In 2019, the FDA approved an intravenous infusion treatment to treat postpartum depression specifically. This novel therapy, administered around the clock for 60 hours, uses a neurosteroid to control the brain’s response to stress. This treatment design is groundbreaking as it targets the signaling thought to be deficient in hormone-sensitive postpartum depression. Additionally, this treatment appears to show benefits very quickly, while traditional antidepressants typically take two to four weeks to have a significant effect. This rapid treatment option would be a breakthrough for women with this often overlooked condition.
6. Targeted medication for hypertrophic cardiomyopathy. For decades, clinicians have treated patients’ hypertrophic cardiomyopathy (HCM) symptoms with only limited effectiveness. Nonspecific medications are prescribed to treat some of the symptoms that HCM shares with other cardiovascular diseases. These therapies include beta blockers, antiarrhythmic drugs, calcium channel blockers and anticoagulants. A new treatment, however, works to reduce the root cause of HCM in many patients. A first-in-class medication specifically targets heart muscle to reduce abnormal contractions caused by genetic variants that put the heart into overdrive. By acting specifically on this mechanism in HCM patients, this novel treatment not only improves symptoms and quality of life, but potentially could slow progression of the disease. The FDA has assigned a target action date of April 28, 2022, for this therapy. If approved, it would be the first medication dedicated to treating HCM, providing new hope for patients and physicians.
7. Nonhormonal alternatives for treating menopausal hot flashes. More than 50% of menopausal women experience hot flashes, which can persist for an average of seven years. Hormone therapy is effective and safe when used appropriately, but it does involve some risk. Also, all patients are not candidates for hormone therapy. Fortunately, a new group of nonhormonal drugs, called NK3R antagonists, has emerged as a viable alternative to hormone therapy. These drugs disrupt a signaling pathway in the brain implicated in the development of hot flashes. They have shown promise in clinical trials for relieving moderate to severe menopausal hot flashes as effectively as hormones. While additional studies are needed to fully understand the effectiveness and safety profile of these new drugs, it is clear that the next generation of nonhormonal treatments for menopausal hot flashes is on the horizon.
8. Implantable for severe paralysis. Approximately 1 in 50 Americans, or 5.4 million people, have some form of paralysis. While the cost of treatment is high, the value does not compare to the detrimental effects on patients. Most patients with paralysis experience a significant decline in their overall health. Recently, a team has offered new hope for these patients by leveraging implanted brain-computer interface technology to recover lost motor control and enable patients to control digital devices. The technology uses implanted electrodes to collect movement signals from the brain and decode them into movement commands. It has been shown to restore voluntary motor impulses in patients with severe paralysis due to brain, spinal cord, peripheral nerve or muscle dysfunction. While the interface technology is in its infancy, the FDA has designated the implantable a “breakthrough device,” reinforcing the need to move this novel technology to the bedside of patients who need it most.
9. Artificial intelligence for early detection of sepsis. Sepsis is a leading cause of hospitalization and death worldwide. Because septic shock has a very high mortality rate, early diagnosis of sepsis is critical. Diagnosis can be complicated because early symptoms are nonspecific. Artificial intelligence (AI) has surfaced as a new tool to help rapidly detect sepsis. Using AI algorithms, the tool detects several key sepsis risk factors in real time by monitoring patients’ electronic medical records as physicians input information. Flagging high-risk patients can help facilitate early intervention, which can improve outcomes, lower healthcare costs and save lives.
10. Predictive analytics & hypertension. Often called the “silent killer,” hypertension usually shows no symptoms while increasing risk for serious health problems, including heart disease, heart failure and stroke. Effective treatment options exist. However, many adults are unaware that they have hypertension until they experience a significant health crisis. Using machine learning, a type of AI, physicians are able to better select more effective medications, medication combinations and dosages to improve control of hypertension. AI also will allow physicians to predict cardiovascular morbidities and intervene before they occur. Predictive analytics may be the key to preventing hypertension and many other diseases.
For more on the annual Top 10 Medical Innovations, including descriptions, videos and year-by-year comparisons, visit Cleveland Clinic Innovations.
Next-generation mRNA vaccines. A new approach for treating prostate cancer. Novel therapy for reducing LDL. These are three of the breakthrough technologies that will change healthcare in 2022, according to a panel of Cleveland Clinic physicians and researchers led by D. Geoffrey Vince, PhD, Executive Director of Innovations and Chair of Biomedical Engineering.
“At Cleveland Clinic, a shared passion for the delivery of superior care and an embedded culture of innovation foster continuous healthcare improvement dialogue among our clinicians and researchers,” says Dr. Vince. “As such, our experts always have their finger on the pulse of new technologies slated to change the face of healthcare. The Top 10 Medical Innovations program was launched to share their insight with the broader healthcare community, and year after year, our professionals continue to successfully predict device, technology and therapy advances.”
Here, in order of anticipated importance, are the Top 10 Medical Innovations for 2022:
1. Next generation of mRNA vaccinology. Advancements in the generation, purification and cellular delivery of RNA have enabled the development of RNA therapies across a broad array of applications, such as cancer and Zika virus. The technology is cost-effective and relatively simple to manufacture. Furthermore, the COVID-19 pandemic demonstrated that the world needed rapid development of a vaccine that was easily deployable around the globe. Because of previous research that laid the groundwork for this technology, an effective COVID-19 vaccine was developed, produced, approved and deployed in less than a year. This landscape-changing technology has the potential to quickly and efficiently eliminate some of healthcare’s most challenging diseases.
2. PSMA-targeted therapy. Each year, more than 200,000 Americans are diagnosed with prostate cancer — the most commonly diagnosed cancer among U.S. men. Early detection and successful imaging are critical for tumor localization, staging the disease and detecting recurrences. Prostate-specific membrane antigen (PSMA), found in high levels on the surface of prostate cancer cells, is a potential biomarker of the disease. PSMA PET uses a radioactive tracer to locate and attach to PSMA proteins, making them visible by PET imaging. This approach can be used in conjunction with CT or MRI scans to visualize where prostate cancer cells reside. In 2020, this technology received FDA approval based on phase 3 trials that showed a substantially increased accuracy for detecting prostate cancer metastases compared to conventional imaging with bone and CT scans.
3. New treatment for the reduction of LDL. High levels of blood cholesterol, particularly low-density lipoproteins (LDL-C), are a significant contributor to cardiovascular disease. In 2019, the FDA reviewed the application for inclisiran in treating primary hyperlipidemia (including hereditary hypercholesterolemia) in adults who have elevated LDL-C while on a maximally tolerated dose of statin therapy. Inclisiran is an injectable, chemically synthesized small interfering RNA that targets the PCSK9 protein. In contrast to statins, it requires infrequent dosing (twice per year) and provides effective and sustained LDL-C reduction in conjunction with statins. Its prolonged effect may help alleviate medication noncompliance, one of the leading causes of failure to lower LDL-C levels. Inclisiran was approved by the FDA in December 2021 and is widely considered a game changer for heart disease patients.
4. Novel drug for treatment of type 2 diabetes. In the U.S., 1 in 10 individuals has diabetes. One potential therapy is a once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide receptor agonist (GLP-1) that aims to control blood sugar. Injected under the skin, GLP-1 and GIP receptors cause the pancreas to release insulin and block the hormone glucagon, limiting blood sugar spikes after a meal. Additionally, it slows digestion, helping individuals remain full longer and eat less. Late phase 3 trials reveal that the treatment significantly reduces hemoglobin A1C in type 2 diabetes and supports weight loss, potentially making it the most effective therapy for diabetes and obesity yet developed.
5. Breakthrough treatment for postpartum depression. Experts believe the prevalence of postpartum depression could be at least twice as high as what current statistics reveal because many cases go undiagnosed. Counseling and antidepressant medications are primary treatments, but some women do not respond to these therapies. In 2019, the FDA approved an intravenous infusion treatment to treat postpartum depression specifically. This novel therapy, administered around the clock for 60 hours, uses a neurosteroid to control the brain’s response to stress. This treatment design is groundbreaking as it targets the signaling thought to be deficient in hormone-sensitive postpartum depression. Additionally, this treatment appears to show benefits very quickly, while traditional antidepressants typically take two to four weeks to have a significant effect. This rapid treatment option would be a breakthrough for women with this often overlooked condition.
6. Targeted medication for hypertrophic cardiomyopathy. For decades, clinicians have treated patients’ hypertrophic cardiomyopathy (HCM) symptoms with only limited effectiveness. Nonspecific medications are prescribed to treat some of the symptoms that HCM shares with other cardiovascular diseases. These therapies include beta blockers, antiarrhythmic drugs, calcium channel blockers and anticoagulants. A new treatment, however, works to reduce the root cause of HCM in many patients. A first-in-class medication specifically targets heart muscle to reduce abnormal contractions caused by genetic variants that put the heart into overdrive. By acting specifically on this mechanism in HCM patients, this novel treatment not only improves symptoms and quality of life, but potentially could slow progression of the disease. The FDA has assigned a target action date of April 28, 2022, for this therapy. If approved, it would be the first medication dedicated to treating HCM, providing new hope for patients and physicians.
7. Nonhormonal alternatives for treating menopausal hot flashes. More than 50% of menopausal women experience hot flashes, which can persist for an average of seven years. Hormone therapy is effective and safe when used appropriately, but it does involve some risk. Also, all patients are not candidates for hormone therapy. Fortunately, a new group of nonhormonal drugs, called NK3R antagonists, has emerged as a viable alternative to hormone therapy. These drugs disrupt a signaling pathway in the brain implicated in the development of hot flashes. They have shown promise in clinical trials for relieving moderate to severe menopausal hot flashes as effectively as hormones. While additional studies are needed to fully understand the effectiveness and safety profile of these new drugs, it is clear that the next generation of nonhormonal treatments for menopausal hot flashes is on the horizon.
8. Implantable for severe paralysis. Approximately 1 in 50 Americans, or 5.4 million people, have some form of paralysis. While the cost of treatment is high, the value does not compare to the detrimental effects on patients. Most patients with paralysis experience a significant decline in their overall health. Recently, a team has offered new hope for these patients by leveraging implanted brain-computer interface technology to recover lost motor control and enable patients to control digital devices. The technology uses implanted electrodes to collect movement signals from the brain and decode them into movement commands. It has been shown to restore voluntary motor impulses in patients with severe paralysis due to brain, spinal cord, peripheral nerve or muscle dysfunction. While the interface technology is in its infancy, the FDA has designated the implantable a “breakthrough device,” reinforcing the need to move this novel technology to the bedside of patients who need it most.
9. Artificial intelligence for early detection of sepsis. Sepsis is a leading cause of hospitalization and death worldwide. Because septic shock has a very high mortality rate, early diagnosis of sepsis is critical. Diagnosis can be complicated because early symptoms are nonspecific. Artificial intelligence (AI) has surfaced as a new tool to help rapidly detect sepsis. Using AI algorithms, the tool detects several key sepsis risk factors in real time by monitoring patients’ electronic medical records as physicians input information. Flagging high-risk patients can help facilitate early intervention, which can improve outcomes, lower healthcare costs and save lives.
10. Predictive analytics & hypertension. Often called the “silent killer,” hypertension usually shows no symptoms while increasing risk for serious health problems, including heart disease, heart failure and stroke. Effective treatment options exist. However, many adults are unaware that they have hypertension until they experience a significant health crisis. Using machine learning, a type of AI, physicians are able to better select more effective medications, medication combinations and dosages to improve control of hypertension. AI also will allow physicians to predict cardiovascular morbidities and intervene before they occur. Predictive analytics may be the key to preventing hypertension and many other diseases.
For more on the annual Top 10 Medical Innovations, including descriptions, videos and year-by-year comparisons, visit Cleveland Clinic Innovations.
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