Next generation mRNA vaccines. A new PSMA-targeted approach for prostate cancer. A novel treatment for reducing LDL cholesterol. These are some of the innovations that will optimize and change healthcare in the coming year, according to an expert panel of clinicians and researchers.

Cleveland Clinic has announced the Top 10 Medical Innovations for 2022. The list of breakthrough technologies was selected by a committee of Cleveland Clinic subject matter experts, led by D. Geoffrey Vince, PhD, executive director of Innovations and chair of Biomedical Engineering at Cleveland Clinic.

“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,” said 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, theme 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 mRNA vaccines across a broad array of applications, such as cancer and Zika virus infection. The technology is cost-effective, relatively simple to manufacture, and elicits immunity in a novel way. Furthermore, the emergence of the COVID-19 pandemic demonstrated that the world needed rapid development of a vaccine that was 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 be used to manage some of healthcare’s most challenging diseases quickly and efficiently.

2. PSMA-Targeted Therapy in Prostate Cancer Each year, more than 200,000 American men receive a diagnosis of prostate cancer – making it the most commonly diagnosed cancer among men in the United States. Accurate imaging is critical for tumor localization, staging the disease and detecting recurrences. PSMA, an antigen found in high levels on the surface of prostate cancer cells, is a potential biomarker for the disease. PMSA PET scans use a radioactive tracer to attach to PSMA proteins, which are then combined with CT or MRI scans to visualize the location of prostate cancer cells. In 2020, this technology received FDA approval based on phase III clinical trials, which showed substantially increased accuracy for detecting prostate cancer metastasis compared to conventional imaging with bone and CT scans. When detected early by PSMA PET scans, recurrent prostate cancer can be treated through a targeted approach with stereotactic body radiation therapy, surgery and/or systemic therapy in a personalized manner.

3. New Treatment for the Reduction of LDL High levels of blood cholesterol, particularly low-density lipoproteins (LDL-C), are known to be a significant contributor to cardiovascular disease. In 2019, the FDA reviewed the application for inclisiran in treating primary hyperlipidemia in adults who have elevated LDL-C while on a maximally tolerated dose of statin therapy. Inclisiran is an injectable 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 along with statins. Its prolonged effect may help alleviate medication non-compliance, one of the leading causes of failure to lower cholesterol levels. Inclisiran was FDA approved 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 United States, 1 in 10 individuals has diabetes, which affects how the body processes food into energy. 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, resulting in individuals remaining full longer and eating less. Thus far, late phase III clinical trials reveal that the treatment significantly reduces hemoglobin A1C in type 2 diabetes and supports weight loss, making it potentially the most effective therapy for diabetes and obesity yet developed.

5. Breakthrough Treatment for Postpartum Depression Experts believe the rate of postpartum depression could be at least twice as high as what current statistics reveal because many cases go undiagnosed. Currently, counseling and anti-depressant medications are the primary treatments but some women do not respond to these therapies. In 2019, the FDA approved an intravenous infusion treatment designed 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 anti-depressants 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 only been able to treat patients’ hypertrophic cardiomyopathy (HCM) symptoms—using drugs developed to treat other heart conditions—with limited effectiveness. Currently, non-specific medications are prescribed to treat some of the symptoms that HCM shares with other cardiovascular diseases. These therapies include beta-blockers, anti-arrhythmic drugs, calcium channel blockers and anticoagulants. A new treatment, however, works to reduce the root cause of the problem 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 for this therapy of April 28, 2022. If approved, this would be the first medication explicitly dedicated to treating HCM and providing new hope to patients and physicians.

7. Non-Hormonal Alternatives for Menopause More than 50% of all menopausal women experience hot flashes, which can persist for an average of seven years. While effective and safe when used appropriately, hormone therapy involves some risk and not all patients are appropriate candidates or ready to try this treatment option. Fortunately, a new group of non-hormonal drugs, called NK3R antagonists, have emerged as a viable alternative to hormone therapy. These drugs disrupt a signaling pathway in the brain that has been linked to the development of hot flashes and 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 of these new drugs, it is clear that the next generation of non-hormonal treatments for menopausal hot flashes is on the horizon.

8. Implantable for Severe Paralysis Approximately one in 50 Americans, or 5.4 million people, have some form of paralysis. Most patients 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 technology to the bedside of patients who need it most.

10. AI for Early Detection of Sepsis Sepsis is a severe inflammatory response to infection and 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 common across other conditions, and the current standard for diagnosis is non-specific. Artificial intelligence (AI) has surfaced as a new tool that can help rapidly detect sepsis. Using AI algorithms, the tool detects several key 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.
11. Predictive Analytics and Hypertension Often referred to as the “silent killer,” hypertension, or high blood pressure, 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 remain unaware that they have hypertension until they experience a significant health crisis. Using machine learning, a type of artificial intelligence, 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 enable physicians to focus on interventions before they occur. Predictive analytics equip providers with the key that could open the door to preventing hypertension and many other diseases.