Technology in Anesthesiology

Gelesis is a biotech company utilizing biomimicry to tackle obesity and gastrointestinal-related diseases. Its oral hydrogel technology, Plenity, was approved by the FDA in 2019 after clinical studies showed it helped 60% of users lose weight over the course of six months. A new study shows that the tech has largely maintained those results throughout its launch into real-world settings. Plenity takes the form of swallowable capsules that are meant to be taken before meals with water. After being swallowed, the capsules leave behind a gel that mimics the cellular structure of raw vegetables. The gel is intended to make patients feel full for longer periods of time. Plenity is considered a medical device, rather than a medicine, because it helps patients by means of mechanical action. The prescription-only treatment is intended to be used alongside a healthy exercise and diet routine approved by a doctor.

Gelesis presented the results of their real-world data analysis of Plenity at the annual American Diabetes Association Scientific Sessions in late June. Of the roughly 900 patients analyzed, 86% experienced an average weight reduction of 9% in six months – compared with 60% of patients averaging a weight reduction of just 6% during clinical trials. Newly emerging from the real-world data, those who self-report having the lowest quality diet at the beginning of the treatment have better chances of responding well to the hydrogel technology. In their presentation, Gelesis mentioned that not everyone responds to GLP-1 agonists (a class of medicine used to treat type 2 diabetes and obesity) the same and stressed the importance of having a variety of effective treatments available.

Source: asamonitor.pub/3XrfsaE

In June, Anumana earned its fourth FDA breakthrough device designation. Anumana, a health technology company, is utilizing AI technology to diagnose heart conditions as early as possible. Their most recent breakthrough algorithm is designed to diagnose cardiac amyloidosis. Cardiac amyloidosis is a condition that causes the heart to have difficulties pumping blood normally due to a buildup of abnormal tissue in and around the heart, sometimes resulting in heart failure or death. Diagnosing cardiac amyloidosis is difficult for doctors because it shares many of its most common symptoms with more common ailments. Pfizer and Anumana worked together to develop this algorithm, which operates by doing an in-depth analysis of standard ECGs to spot early indicators often imperceptible to doctors. The algorithm will soon enter retrospective clinical trials to test its ability to accurately identify cardiac amyloidosis, meaning they will put the algorithm to use on sets of preexistent ECG data and assess the results. The path from clinical trials to FDA clearance will be expedited thanks to the technology’s breakthrough designation.

Source: asamonitor.pub/3r6noCl

Neuronetics has expanded the use of the NeuroStar system for treatment-resistant depression to treat patients with major depressive (MDD) and obsessive-compulsive (OCD) disorders. The NeuroStar technology promotes neuroplasticity by relinking targeted regions of the brain. TMS therapies are a highly important alternative for patients who don’t experience relief from talking therapies and/or medicine.

The new FDA clearance is for Neuronetics’ OCD MT Cap, which is an add-on to the NeuroStar device. While the TMS NeuroStar technology offers relief to many patients who failed to find relief from more traditional treatments, it also has drawbacks. The NeuroStar TMS therapy requires patients to visit a treatment clinic five days a week for seven weeks, with each treatment session lasting 20 minutes. In addition to 20-minute sessions, setup times can last as long as 30 minutes. The new OCD MT Cap slashes setup times by 40%. The newly approved product helps by locating the patient’s precise motor threshold (MT). The MT is the amount of energy required to deliver treatment. The MT Cap determines each patient’s MT by locating the motor cortex and delivering just the right amount of energy so that their hands or fingertips do not move. That determines the MT and the dose of energy that will be applied to the prefrontal cortex during treatment.

Source: asamonitor.pub/3JvcbBl

Nearly half of adults in America aged 50 or older are at risk for osteoporosis-related bone fractures.

Scientists Emily Germain-Lee, MD, and Se-Jin Lee, MD, PhD, decided to send mice into space to better understand and tackle this problem. Conditions such as muscle and bone loss are accelerated in microgravity environments. That is why the researchers decided to send the mice to the International Space Station’s National Laboratory. Some of the “mighty mice” were genetically modified while others were treated with drugs. In both cases, myostatin was either deleted or blocked. For the mighty mice being treated with drugs, both myostatin and activin A were blocked. Myostatin and activin A are both known to be responsible for bone and muscle mass regulation. Mutations in the myostatin gene are responsible for the famous double-muscled condition in cattle.

The research found that while the normal mice lost bone and muscle mass in space, the genetically modified mice were able to keep nearly all of their extra muscle mass while in space. Moreover, the mighty mice that were treated using drugs that targeted both genes actually gained bone and muscle mass. The research suggests promising new pathways to be targeted for human patients struggling with the loss of bone and/or muscle mass.

Source: asamonitor.pub/3PTRUd4

The CDC reported that between 2010-22, there were more than 110,000 suspected cases of alpha-gal syndrome (AGS) identified. However, because the diagnosis of alpha-gal syndrome requires a positive diagnostic test and a clinical exam, and some individuals with alpha-gal syndrome may not get tested, it is estimated that as many as 450,000 people might have been affected by AGS in the U.S., according to two reports issued by the CDC in the Morbidity and Mortality Weekly Report. Studies show that many health care providers in the U.S. are not familiar with an emerging and potentially life-threatening allergic condition AGS, also known as the red-meat allergy or the tick bite meat allergy. Of those aware of AGS, knowledge about diagnosis and management is low.

In one study, 1,500 family/general practitioners, internists, pediatricians, nurse practitioners (NPs), and physician assistants (PAs) across the country were surveyed, and results showed that nearly half of respondents had not heard of AGS, approximately one-third reported that they were ‘not too confident’ in their ability to diagnose or manage patients with AGS, and 5% felt ‘very confident’ in their ability. In another study, CDC researchers examined laboratory test results from 2017-22 from a laboratory that, until August 2021, was the primary commercial lab offering testing in the U.S. More than 300,000 specimens were submitted by health care providers on behalf of patients with presumed clinical suspicion of AGS, and more than 30 percent were positive.

Alpha-gal is a sugar found in meat from mammals (pork, beef, rabbit, lamb, venison, etc.) and products made from mammals (e.g., gelatin, cow’s milk, milk products, some pharmaceuticals). AGS is a serious allergic condition some people experience after they consume food or products containing alpha-gal. Growing evidence suggests that AGS is primarily associated with the bite of a lone star tick in the U.S., but other kinds of ticks have not been ruled out. Localities in the southern, midwestern, and mid-Atlantic regions of the United States identified more people who tested positive.

People who suffer from AGS may experience wide ranging symptoms, including hives or itchy rash; nausea or vomiting; heartburn or indigestion; diarrhea; cough; shortness of breath or difficulty breathing; drop in blood pressure; swelling of the lips, throat, tongue, or eye lids; dizziness or faintness; or severe stomach pain.

Source: asamonitor.pub/3OPatxK