The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
40
Titan Medical announced that it plans to implement cost-cutting measures that include temporary furloughs for 40 employees. The furlough, which impacts employees at the subsidiary’s Chapel Hill, North Carolina, facility, goes into effect immediately.
$600m
Boston Scientific announced it will acquire Apollo Endosurgery for more than $600 million. The Marlborough, Massachusetts-based company will acquire the endoluminal surgical device maker for a cash price of $10 per share.
£8.5 bn
GE announced that its GE HealthCare subsidiary closed an offering of senior notes worth $8.5 billion. The spinoff is anticipated to go through in the first week of January 2023.
11
A federal judge sentenced Theranos founder Elizabeth Holmes to more than 11 years in prison for defrauding investors about the potential of her company’s blood testing device.
Latest news
Zimmer, Boston Scientific set to lead positive medical device pricing trend in 2023: analysts
Medical device pricing will be “one of the most important positive narratives” of next year and drive “modest upside” to sales and margins, according to analysts at Goldman Sachs. Recent pricing improvements “should only be the beginning,” the analysts wrote, with medtech companies set to make more gains as multi-year purchase contracts catch up with prior inflation. The analysts tipped Zimmer Biomet and Boston Scientific to be among the biggest beneficiaries but expect most companies, with Baxter being an exception, to benefit from the pricing trend.
Historically, medical device companies have faced pressure from customers to keep prices low. However, as inflation increased this year, companies succeeded in securing higher prices in larger contracts. In inflation-adjusted terms, pricing deteriorated but the successful renegotiations resulted in a smaller hit than the analysts forecast going into 2022.
Source: MedTech Dive
Lenus Health and Us2.ai team up for digital heart failure diagnosis service
The UK government announced more than £800m of funding for the National Institute for Health and Care Research (NIHR) to boost innovation and growth in healthcare and improve patient safety.
A partnership between digital healthcare platform Lenus Health and med-tech start-up Us2.ai is helping improve access for patients to echocardiograms, speeding up waiting times for vital heart failure diagnostics in the NHS.
The two companies have created a one-stop digital heart failure diagnosis service that supports health professionals to deliver echo and ECG diagnostic testing in community settings. In addition, the service is also allowing consultant cardiologists to review data in a single dashboard and consultants can record the diagnostic outcome without needing to schedule an appointment for the patient. The agreement will see Us2.ai’s CE marked echocardiogram viewing and measurement tools be operationalised within the Lenus platform.
Source: Digital Health
Health inequities lead to early death in many persons with disabilities
A new report by the World Health Organization shows evidence of a higher risk of premature death and illness among many persons with disabilities compared to others in the society.
The Global report on health equity for persons with disabilities published today shows that because of the systemic and persistent health inequities, many persons with disabilities face the risk of dying much earlier—even up to 20 years earlier—than persons without disabilities.
They have an increased risk of developing chronic conditions, with up to double the risk of asthma, depression, diabetes, obesity, oral diseases, and stroke. Many of the differences in health outcomes cannot be explained by the underlying health condition or impairment, but by avoidable, unfair and unjust factors.
Launched ahead of the International Day of Persons with Disabilities, the report shows the number of people with significant disabilities worldwide has risen to 1.3 billion (or 1 in 6 people). This number reinforces the importance of achieving full and effective participation of persons with disabilities in all aspects of society and embedding the principles of inclusion, accessibility and non-discrimination in the health sector.
Source: World Health Organization
Clinical trials
UW researchers develop blood test for early Alzheimer’s disease detection
Researchers from the University of Washington (UW) in Seattle, Washington, US, have developed a new blood test for the detection of a ‘toxic’ protein years before the emergence of Alzheimer’s disease symptoms. The laboratory test, developed by the university’s team, measures levels of amyloid beta oligomers in blood samples.
Amyloid beta proteins are said to misfold and clump together to form small aggregates known as oligomers, which are believed to develop into Alzheimer’s. The UW team assessed the test on blood samples obtained from 310 research subjects. These subjects had made their blood samples, as well as some of their medical records, available earlier for research on Alzheimer’s. The test, dubbed SOBA, performed the detection of oligomers in the blood of patients with Alzheimer’s disease. Oligomers were also detected by SOBA in the blood of 11 individuals from the control group, which was composed of individuals with no signs of cognitive impairment.
Source: Medical Device Network
BioAge Labs reports positive data from muscle atrophy treatment trial
BioAge Labs has reported positive data from a Phase Ib clinical trial of apelin receptor APJ agonist BGE-105 to treat muscle atrophy. The placebo-controlled, double-blind trial has been designed for assessing BGE-105’s pharmacodynamics and safety. In the study, 21 volunteers underwent bed rest for ten days while receiving BGE-105 or placebo infusions.
The findings showed that treatment with BGE-105 resulted in a statistically significant improvement in muscle size, quality, and protein synthesis, compared to a placebo, in healthy volunteers aged 65 years or above, during ten days of strict bed rest. Volunteers receiving treatment with BGE-105 demonstrated a 100% improvement in thigh circumference. In addition, a 58% improvement in vastus lateralis cross-sectional area was found in ultrasound measurements and a 73% improvement in vastus lateralis thickness.
Source: Clinical Trials Arena
AI detects prediabetes in CGM data, opening up new use for device: study
Klick Applied Sciences, after analyzing 12 hours of continuous glucose monitor data with artificial intelligence (AI), says it can identify healthy, prediabetic and diabetic individuals. In the study, about 600 people wore a CGM for an average of 12 days to generate a dataset that the researchers used to develop machine learning models. The 12-hour model correctly identified two-thirds of patients with prediabetes and achieved “high accuracy” in detecting healthy individuals and people with type 2 diabetes.
According to the Centers for Disease Control and Prevention, more than one in three American adults have prediabetes, while 80% of those cases are undiagnosed. A simple blood sugar test is used to check for prediabetes, providing a diagnosis that can lead people to lower their risk of developing Type 2 diabetes.
Source: MedTech Dive
Nines
US-based company Nines is a tele-radiology and artificial intelligence startup. Its product NinesAI is FDA-cleared to triage time-critical, life-threatening indications of mass effect and intracranial hemorrhage.
Source: Nines
Lucira Health
Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.
Source: Lucira Health
Bloomlife
US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.
Source: Bloomlife