Steroids commonly offered to pregnant people at increased risk of preterm birth may be unnecessary and could lead to long-term health problems for the infants, according to new research led by McMaster University.
The research, published in The BMJ on August 2 analyzed data from 1.6 million babies and found that about 40 percent of babies with early corticosteroid exposure — defined as exposure at 34 weeks’ gestation or earlier — were born at term. The full-term babies had an increased risk of both short- and long-term health problems, including admission to the neonatal intensive care unit, breathing and growth problems and an adverse neurological outcome, the researchers found.
Corticosteroids are used to increase the chances of survival of very premature babies and reduce health problems. However, the effects on long-term child health are not well understood, especially in infants who exceed expectations and are born on term. The research shows that many babies exposed to steroids avoid preterm birth, but new risks arise for other future health complications.
“Preterm birth is very difficult to predict; we need better prediction models to prevent overexposure to interventions such as steroids because there is a potential risk,” said Sarah McDonald, senior author of the study and professor in the Department of Obstetrics and Gynecology at the McMaster University.
To conduct the study, researchers conducted a systematic review and meta-analysis of data from seven randomized controlled trials and ten population-based studies involving 1.6 million babies born since 2000.
More than half of infants exposed early to corticosteroids were born together at term (37 weeks or longer) and late preterm (34-36 weeks), and researchers found similar results in this combined group. For very preterm infants, antenatal steroids can potentially save lives and reduce serious morbidity, but as pregnancy progresses, the benefits shift to risks.
“Antenatal steroids are a double-edged sword: highly beneficial for babies born very preterm, and potentially harmful for babies born at term,” says McDonald, Canada Research Chair in Maternal and Child Disease Prevention and Intervention.
The authors say more research with long-term follow-up in randomized controlled trials is crucial. They also warn against a less liberal approach to steroid use during pregnancy.
The study was supported by the Canada Research Chairs program.
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Self-reported mental health measures among incoming collegiate student-athletes who had SARS-COVID-19
Anderson MN, Gallo CA, Passalugo SW, Nimeh JM, Buckley TA. J Athl train. 2023 [published online ahead of print, 2023 May 26]10.4085/1062-6050-0554.22.
Full text freely available
Take home message
Athletes with a history of COVID-19 infection may report slightly worse depression and anxiety scores than peers without a history of COVID-19.
Background
More than 75% of people have cognitive problems after a COVID-19 infection, and about one in three experience persistent neuropsychological effects such as depression and anxiety. It remains unclear whether athletes with a history of COVID-19 infection experience more depression or anxiety than athletes without a history of COVID-19.
Study objectives
The authors compared patient-reported anxiety and depression between incoming collegiate athletes with or without a history of COVID-19.
Methods
Participants were freshmen or transfer student-athletes in a more comprehensive concussion study that answered a question about their history of COVID-19 and any mental health measures. Participants reported on their mental health using the Satisfaction with Life Scale, Hospital Anxiety and Depression Scale, and State-trait Anxiety Inventory.
Results
The authors examined 79 athletes with a history of COVID-19 and 99 without a history of COVID-19. Overall, those with a history of COVID-19 had worse depression and anxiety scores, especially among women. However, these differences were small – often less than a one-point difference. When the authors examined how many student-athletes met clinical cutoffs for depression or anxiety, almost everyone in each group (>94%) did not meet clinical cutoffs for depression or anxiety, regardless of their history of COVID-19.
Viewpoints
Patients with a history of COVID-19 may have worse mental health outcomes than patients without a history of COVID-19. However, because many of the patients scored within normal limits, the clinical applicability of the difference may be questionable. It would have been interesting to know if the time since having COVID-19 or its severity influenced mental health outcomes among student-athletes. This type of analysis would require more student-athletes.
Clinical implications
The authors suggested that clinicians should be aware that student-athletes with a history of COVID-19 could be at greater risk for mental health problems if another event (e.g., concussion, joint injury) occurs.
Questions for discussion
Why do you think there was such a negligible effect on athletes’ mental health after COVID-19 infection? Do you think we should be concerned about the mental health effects in athletes after COVID-19 infection?
Related posts
We must break the stigma of seeking mental health care among student-athletes Addressing the Mental Health Needs of NCAA Student-Athletes of Color: Fundamental Concepts from the NCAA Summit on the Mental Health and Well-Being of Diverse Student-Athletes Adolescent mental health, not football, is a reason for mental health problems in adulthood
Written by Mitchell Barnhart Reviewed by Jeffrey Driban
The completed transaction includes all cervical and lumbar fusion products, including the STALIF® technology platform
This acquisition makes Silony an important entry into the American market and significantly strengthens its range of stand-alone cages
Silony Medical will change its name to “Silony Spine” to underline its focus on spine fusion technology
FRAUENFELD, Switzerland, Oct. 19, 2023 /PRNewswire/ — Silony Medical International AG (the Company), a growing challenger to “big medtech” in the global spinal fusion market, has completed the acquisition of Centinel Spine’s Global Fusion Business. This combines Silony’s Verticale® posterior screw and rod fusion platform, its Roccia® and Favo® Interbody Fusion (IBF) systems with the STALIF® technology platform to deliver a premier occiput-to-sacrum, posterior, lateral and anterior spinal fusion portfolio create for open and minimally invasive spinal fusion cases.
Silony has been active in the US market since late 2018 – with this acquisition, Silony will leverage the Centinel Fusion Portfolio’s great team and distribution network to strengthen its position in the North American spine market and provide best-in-class surgeons and their teams offer spine fusion solutions that provide flexibility and freedom.
In the coming days and months, Silony will change its name to Silony Spine to underline its 100% commitment and focus on technological solutions for spine fusion. At the same time, we will begin a refresh of the STALIF platform to drive further adoption among the spine surgeon community. Shortly afterwards we will launch our next generation of technology instruments.
About Silony Medical, soon Silony Spine
Founded in 2013 by the internationally renowned hospital group Schön Clinic in Germany, Silony Spine is a market disruptor that aims to change the status quo of how product manufacturers collaborate with hospital systems. Silony Spine manages and designs spine hardware and devices that provide surgeons and hospitals with high-quality product solutions that are highly compatible with assistive technologies.
For more information, please visit the company’s website at www.silonyspine.com or contact:
Looking for a tasty way to add more vegetables to your meals?
This is it!
Our recipe for coriander coleslaw is the perfect side dish. The naturally sweet and spicy dressing is light, fresh and a delicious addition to the crispy cabbage.
Plus, this slaw is rich in vitamin K, calcium and magnesium, all crucial nutrients for building and maintaining strong bones.
Combine this dish with your favorite protein source and you have a balanced, bone-strengthening lunch or dinner.
Try our Cilantro Cabbage Slaw this week!
Coriander Coleslaw | GF, DF | BoneCoach™ Recipes
SERVES: 4
TOTAL TIME: 15 minutes
Ingredients
400 g shredded green and purple cabbage (you can use a pre-packed coleslaw mix!)
1/2 small red onion, finely chopped
1/2 cup (125 ml) cilantro, finely chopped
1/4 cup (62 ml) freshly pressed extra virgin olive oil
1/4 cup (62 ml) freshly squeezed lime juice
1 tablespoon (15 ml) honey
1/2 teaspoon (2 ml) sea salt
Directions
1) Mix all ingredients in a bowl. Mix to combine and chill in the refrigerator for 2 hours or overnight before serving!
Recipe created by BoneCoach™ Team Dietitian Amanda Natividad-Li, RD & Chef.
Medical disclaimer
The information shared above is for informational purposes only and is not intended as medical or nutritional therapy advice; it does not diagnose, treat or cure any disease or condition; it should not be used as a substitute or substitute for medical advice from physicians and trained medical professionals. If you are under the care of a healthcare professional or are currently taking prescription medications, you should discuss any changes in your diet and lifestyle or possible use of nutritional supplements with your doctor. You should not stop taking prescribed medications without first consulting your doctor.
The risks of serious injury from most sports and exercise are surprisingly small, according to the results of a five-year study led by researchers at the University of Bath in Britain.
The research, funded by the British Medical Association, shows that even forms of sport sometimes considered risky by the public, such as cycling, are generally safe, suggesting that the benefits of taking part in fitness activities far outweigh the hazards.
This is the first time in England and Wales that researchers have attempted to describe and quantify the relative risks of trauma from sport or other physical activity. It is hoped that the results of the study will make it easier for both participants and activity organizers to make their activities even safer.
Data for the new study – published today in the journal Injury preventionpublished by BMJ – came from rural hospitals, where participants in sports and exercise showed extensive trauma.
The researchers found that between 2012 and 2017, a total of 11,702 trauma injuries resulted from sports and exercise.
Dr. Sean Williams, researcher at the Department for Health and the Center for Health and Injury and Illness Prevention at the University of Bath, and lead researcher on the study, said: “This work shows that practicing fitness activities is generally a safe and way is to exercise. useful pursuit.
“While no physical activity is completely without risk, the risk of serious injury is extremely low compared to the numerous health and wellness benefits gained from staying active.”
The study examined 61 sports and other physical activities undertaken nationally, regardless of their popularity, and provided a comparable estimate of the risks to participants.
Perhaps unsurprisingly, fitness activities (such as running, golf, dance classes and gym sessions) are the least likely to lead to injury. Running results in 0.70 injuries, golf 1.25 injuries and fitness classes only 0.10 per 100,000 participants/year.
Of the sports with the highest participation, football had the highest incidence of injuries (6.56 injuries/100,000 participants/year), although this is also relatively small.
Motor sports, equestrian sports and gliding (paragliding and hang gliding) were by far the riskiest activities of those surveyed, with motor sports causing 532 injuries, equestrian sports 235 and gliding 191 injuries per 100,000 participants.
The incidence in men (6.4 injuries/100,000 participants/year) was higher than in women (3.3 injuries/100,000 participants/year).
Why is exercise becoming riskier?
Perhaps worryingly, the risk of injury in popular sports and other physical activities is increasing internationally. In Victoria, Australia, for example, the annual number of hospital-treated sports injuries increased by 24% between 2004 and 2010, with an incidence of sports-related major trauma or death of 12.2 per 100,000 participants/year.
This trend is mirrored in Britain. This is highlighted by data from a regional trauma and spine unit, which has found an almost 500% increase in the incidence of serious motorsport accidents in the five years to 2015.
Dr. Madi Davies, lead author of the study and a former postdoctoral researcher at the University of Bath, said: “When I looked at the injuries recorded in 2012 – the year the study started – it was clear that the risks were significantly lower. than in later years of study.”
She called for further research, ‘in real time’, to understand exactly how and why more people are being injured.
She said: “While the finding that more people are being injured may be multi-faceted – trauma data recording has improved during the study, meaning more injuries are now being recorded – it is important that any increase in burden is responded to, and that this data is used to make activities safer.”
Serious injury is a clear burden on hospitalized participants, their families and the NHS. The aim of this research is to reduce these burdens by identifying the injury risk of each activity and then coordinating action.
“Many sports and recreational injuries are preventable,” says Dr. Williams. “Whether that’s through protective equipment, rule or law changes or education, once we identify how and where injuries occur, we can start thinking about ways to prevent them in every sport.”
It is hoped that this work will lead to the development of a national registry with real-time data analysis capabilities. The register would standardize the recording of serious injuries resulting from sport and physical activity, so that trends or patterns of risk can be quickly identified and responded to.
An example where this has already happened concerns trampoline safety. Sales of garden trampolines boomed in 2005 and by 2014 up to 250,000 had been sold in Britain. The Royal Society for the Prevention of Accidents (RoSPA), working with the Royal College of Emergency Medicine, has identified a spike in trampoline-related injuries and made recommendations to improve safety, which range from limiting trampolining to one person at a time, keeping children under the age of six off trampolines and purchasing models that are enclosed in a safety net.
In addition, trampoline manufacturers were supported to meet safety standards, for example by adding padding around trampolines. Commercial partners were also involved to improve safety at trampoline parks.
As a result of the RoSPA directive, serious accidents have fallen significantly.
LOS ANGELES, Oct. 19, 2023 /PRNewswire/ — Expanding Innovations, Inc. (EI), an emerging technology leader in the expandable interbody cage sector of the spine industry, has announced the full commercial launch of the X-PAC Expandable Lateral Cage System (X-PAC LLIF).
Some of the first procedures using the cage were performed by Dr. Brandon K. Strenge of the Orthopedic Institute of Western Kentucky. Dr. Strenge noted, “The X-PAC Expandable Lateral Cage design incorporates the fundamental lateral interbody fusion principles of indirect decompression and bridging bone fusion. The maximal posterior expansion of X-PAC helps restore foraminal height, facilitating indirect decompression. In addition, the large open architecture and streamlined post-packing instrumentation create an ideal endplate-to-endplate fusion column.”
The launch of X-PAC LLIF represents the first in a series of planned commercial releases aimed at expanding EI’s portfolio of NON-SCREW-based Expandable Cage Technology. The company is actively developing solutions for ALIF, ATP and endoscopic procedures, and is integrating integrated fixation and hyperlordotic options within the LLIF portfolio.
“We are pleased with the positive feedback and adoption rate we observed during our initial market launch, as this is consistent with the success of our flagship product, the X-PAC Expandable Posterior Cage System (X-PAC TLIF). We look forward to the full commercial launch and the growth this means for our company,” said Robert Jaramillo, CEO of Expanding Innovations.
Expanding Innovations, Inc. (EI) has developed a revolutionary, NON-SCREW-based expandable technology that surgeons and patients can count on. The X-PAC Expandable Cage design replaces the traditional inner cage lifting screw with a powerful, continuous expansion mechanism, supported by unidirectional locking teeth, for controlled expansion. The EI portfolio includes the X-PAC expandable posterior and lateral cage systems, as well as the active development of X-PAC ALIF, ATP and ENDO platforms. For more information about Expanding Innovations, please visit www.expandinginnovations.com.
Ever thought about the crucial role hormones play for your health?
It may surprise you, but the very strength of your bones and your heart health are closely linked to these hormones.
As we age and are affected by other factors, our hormone levels can drop, putting us at greater risk for osteoporosis, sarcopenia and cardiovascular disease.
Do you want to learn or Bioidentical hormone replacement therapy is the breakthrough solution your body needs and in what situations is it NOT suitable?
Join me in this episode as I sit down Dr. Deborah Matthew, MDalso known as The happy hormone doctor. Together we navigate through the fascinating world of hormoneswith emphasis on them profound impact on bone health and shed light on the promising field of bioidentical hormone replacement therapy.
Episode timeline
0:00 – Episode begins
1:22 – Meet our guest, Dr. Deborah Matthew, MD
2:02 – Dr. Matthew’s journey to hormone health and bioidentical hormone replacement therapy (BHRT)
5:07 – Understanding hormone balance
8:32 – Traditional vs. Dr.’s approach Matthew: Emphasis on the importance of hormones in women’s bone health
15:04 – The role of hormones in men’s health: preventing osteoporosis with testosterone and estrogen
19:51 – Research natural remedies before considering BHRT
26:08 – Deep dive into BHRT: its benefits, considerations and potential risks
33:33 – Assessment of suitability of BHRT for men
34:48 – Different forms of BHRT
37:11 – How to connect with Dr. Matthew and her services
>> Click here to get your FREE copy of “This is NOT Normal! A Busy Women’s Guide to Symptoms of Hormonal Imbalance.”
>> Click here to visit Dr.’s main website. to visit Deborah
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About Dr. Deborah Matthew, MD:
Dr. Deb Matthew MD, The Happy Hormones Doctor, is a bestselling author, international speaker, educator, wife and mother of four boys. After years of suffering from fatigue and irritability due to hormonal imbalances, her search for a solution for her personal health led her to change everything about her medical practice. She has been featured on national podcasts, radio and broadcasts including NBC, ABC, CBS and FOX.
Medical disclaimer
The information shared above is for informational purposes only and is not intended as medical or nutritional therapy advice; it does not diagnose, treat or cure any disease or condition; it should not be used as a substitute or substitute for medical advice from physicians and trained medical professionals. If you are under the care of a healthcare professional or are currently taking prescription medications, you should discuss any changes in your diet and lifestyle or possible use of nutritional supplements with your doctor. You should not stop taking prescribed medications without first consulting your doctor.
Between May 2016 and February 2018, a total of 101 patients (85 women, 84%) with established RA were included. These patients had a mean age of 58 ± 13 years, a mean disease duration of 14 ± 11 years, and a mean follow-up age. -from 41 ± 15 months. Positive rheumatoid factors and anti-CCP antibodies were detected in 80 (79%) and 83 (82%) patients, respectively. Erosions were present in 63 (62%) patients; 70 patients (69%) received corticosteroids (including 9 at a dose > 10 mg/day), 78 received conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), including 61 (60%) with MTX, and 59 (58%) received targeted biological DMARDs (bDMARDs). During the inclusion visit, 13 patients initiated a first-line bDMARD or switched to another bDMARD due to inadequate disease control. Detailed characteristics of our study sample are shown in Table 1.
Table 1 Characteristics of patients from the two cohorts at baseline.
Results
The number of annual consecutive visits ranged from 2 to 5 (88 patients with 3 visits, 72 with 4 visits, and 65 with 5 visits). Disease flares occurred in 38 patients during the mean follow-up period of 41 ± 15 months. Of these 38 patients, targeted therapy was added or modified in 26 patients due to inadequate disease control: 10 started on a bDMARD or a targeted synthetic (ts)-DMARD and 16 switched from a bDMARD to a new b- or tsDMARD (Table S1) . The mean time to treatment adaptation was 35 ± 13 months.
Primary endpoint: evaluation of the predictive value of SEMA4A for the occurrence of treatment failure
Baseline SEMA4A levels > 94 ng/ml were predictive of treatment failure, defined by the occurrence of flares AND treatment escalation (n = 26 patients), with an HR of 2.73 (95% CI 1.24 –5.96) (Fig. 1A). Results were unchanged after excluding the 13 patients with active disease at baseline who requested addition or change to a bDMARD (HR: 2.83, 95% CI 1.14–7.52).
Figure 1
Predictive value of SEMA4A for the progression of rheumatoid arthritis in Paris cohort 1. (a) Time to treatment failure (defined as flares AND treatment escalation) according to circulating SEMA4A concentrations (≤ or > 94 ng/ml). (b) Survival without disease flare according to circulating SEMA4A concentrations (≤ or > 94 ng/ml).
Secondary endpoints
Elevated SEMA4A levels (>94 ng/ml) at baseline were predictive of flare occurrence (n = 34 patients) during the follow-up period (Fig. 1B) with a hazard ratio (HR) of 2.43 (95% confidence interval ). , CI 1.27–4.68). Results were unchanged after excluding the 13 patients with active disease at baseline (HR 2.36, 95% CI 1.15–4.89).
Baseline SEMA4A concentrations were significantly increased in patients who experienced flares during the follow-up period (78 ± 30 ng/ml vs. 60 ± 24 ng/ml, p < 0.001) (Fig. 2A). SEMA4A levels were also significantly higher in the 13 patients with active disease at baseline who requested the addition or modification of a bDMARD, compared with the 88 patients on stable treatment (84 ± 33 ng/ml vs. 63 ± 26, p = 0.011). Although baseline SEMA4A concentrations were higher in patients experiencing flares AND treatment escalation compared to those on stable treatment (75 ± 31 ng/ml vs. 63 ± 26 ng/ml, p = 0.060), this did not reach significance (Fig. 2B). Patients with elevated SEMA4A levels at baseline maintained higher DAS28 levels throughout the follow-up period, with significant differences at visits 1, 2, and 5 (Fig. 2C).
Figure 2
Baseline circulating SEMA4A levels according to the occurrence of (a) disease flare or (b) treatment failure (defined as flares AND treatment escalation) during the prospective follow-up period in Paris cohort 1. (c) Course of the DAS28 during the follow-up period according to baseline SEMA4A concentrations (≤ or > 94 ng/ml). All data are presented as the mean ± SEM. *p < 0.05, **p < 0.01 and ***p < 0.001, determined by Student's t-test.
Integration of SEMA4A with other predictors of treatment failure
A baseline DAS28 > 3.2 (HR 2.17, 95% CI 1.01–4.72) and the presence of active synovitis, defined by at least grade 2 Doppler activity8, detected at at least one joint on power Doppler ultrasound (PDUS) (HR 3.60, 95% CI 1.07–12.15) were predictive of further treatment failure. These results were not changed after excluding the 13 patients with active disease at baseline.
Baseline age, disease duration, ACPA or RF positivity, smoking status, presence of erosions, series of targeted DMARDs, corticosteroid treatment, and CRP levels were not predictive of treatment failure (Table 2). Multivariate Cox analyzes adjusted for these covariates confirmed that SEMA4A was the only independent predictor of treatment failure (HR 2.71, 95% CI 1.14–6.43).
Table 2 Univariate and multivariate Cox analyzes to identify independent predictors of treatment failure (primary endpoint) and RA flares (secondary endpoint) in Paris cohort 1.
SEM4A was also confirmed as an independent predictor of flares, along with DAS28 and synovial hyperhemia (Table 2).
We then assessed the possible combination of DAS28, PDUS and SEMA4A concentrations to predict the occurrence of treatment failure and flares (Table 3). The combination that provided the best predictive value was a DAS28 > 3.2 and/or presence of active synovitis on PDUS and/or SEMA4A concentrations > 94 ng/ml (HR 10.42, 95% CI 1.41–76 .94 for treatment failure and 4.88, 95% CI 1.50–15.89 for flares) (Fig. 3A,B). Matrix models also highlighted the ability of the combination of these 3 parameters to predict the occurrence of treatment failure and flares (Fig. S1): Treatment failure and flares of RA occurred in 53% and 73% of patients with DAS28 > 3.2 at baseline and the presence of active synovitis at PDUS and SEMA4A concentrations > 94 ng/ml, respectively. Furthermore, only one patient with a DAS28 ≤ 3.2, no active synovitis and SEMA4A ≤ 94 ng/ml experienced treatment failure and RA attacks.
Table 3 Predictive value of circulating SEMA4A alone or in combination DAS28-CRP and/or active synovitis on power Doppler ultrasound for the occurrence of treatment failure (primary endpoint) and RA attacks (secondary endpoint) in Paris cohort 1.
figure 3
Predictive value of SEMA4A, alone or in combination with a Disease Activity Score (DAS) 28 > 3.2 and/or the presence of active synovitis on power Doppler ultrasound (PDUS) in cohort 1 from Paris. (a) Time to treatment failure (defined as flares AND escalation of treatment) according to circulating SEMA4A concentrations (> 94 ng/ml) and/or a DAS28 > 3.2 and/or the presence of active synovitis on PDUS. (b) Survival without disease flare according to circulating SEMA4A concentrations (> 94 ng/ml) and/or a DAS28 > 3.2 and/or the presence of active synovitis on PDUS.
Predictive value of SEMA4A in the subgroup of patients with low disease activity or remission
Among the 58 patients with a DAS28 < 3.2 at baseline, treatment failed in 11 (19%) patients during the observation period. In this population, increased SEMA4A concentration was the only variable predicting the occurrence of treatment failure (HR 3.50, 95% CI 1.02–12.01). The presence of active synovitis detected on at least one joint on PDUS and other clinical or biological variables did not predict treatment failure (Table S2).
In the 37 patients with a DAS28 < 2.6, treatment failure occurred in 4 patients (11%) and elevated SEMA 4A showed a trend for predicting treatment failure (HR 3.30, 95% CI 0.82–152.11, p = 0.069).
Elevated SEMA4A concentration was also identified as the only predictor of flares (n = 16, 28%) in this subgroup of 58 patients with DAS28 < 3.2 (HR 3.68, 95% CI 1.33–10.17 ).
Analysis of cohort 2 from Pelegrin Hospital, Bordeaux
Study population
A total of 40 patients (29 women, 73%) were included. These patients had a mean age of 57 ± 14 years, a mean disease duration of 5 ± 6 years, and active disease with a mean DAS28 of 5.12 ± 1.40. Positive rheumatoid factors and anti-CCP antibodies were detected in 27 (79%) and 28 (82%) patients, respectively. Erosions were present in 16 (40%) patients; 26 patients (65%) received corticosteroids. During the inclusion visit, 15 patients started MTX as first-line treatment and 25 started tocilizumab. Tocilizumab initiators were older, had longer disease duration and disease activity, and received corticosteroids more often than MTX initiators. Detailed characteristics of our study sample are given in Tables 1 and S3.
Analysis of the course of SEMA4A serum levels according to response to treatment
Of the 40 patients included, 4 experienced no response to treatment, 10 had a moderate response and 26 had a good response. As previously observed, baseline SEMA4A levels correlated with the DAS28 (r = 0.29, p = 0.038) and a trend was observed with CRP (r = 0.26, p = 0.10). At month 3, SEMA4A concentrations correlated with DAS28 and CRP (r = 0.31, p = 0.029 and r = 0.38, p = 0.017, respectively). Furthermore, baseline SEMA4A concentrations were significantly increased in active patients at inclusion, defined by a DAS28 > 3.2 (Fig. S2A). Interestingly, baseline SEMA4A levels were significantly higher in patients who otherwise experienced no or moderate response (198 ± 30 ng/ml) compared to patients with a good response (176 ± 24 ng/ml, p = 0.035) (Fig. S2B ). It was found that serum SEMA4A levels decreased significantly between m0 and m3, especially in the group of patients with good clinical response (Fig. S2C). This result was observed in the subgroups of patients starting MTX or tocilizumab (Fig. S2D,E).
The partnership aims to incorporate Aclarion’s Nociscan surgical decision technology into ATEC’s AlphaInformatiX platform to better inform spine surgery
ATEC is a medical device company committed to revolutionizing the approach to spine surgery through clinical differentiation
Aclarion’s Nociscan is the first augmented intelligence platform to measure biomarkers of intervertebral disc health in the lumbar spine, helping doctors identify the location of chronic low back pain
BROOMFIELD, CO, October 23, 2023 (GLOBE NEWSWIRE) – via NewMediaWire —Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that uses biomarkers and proprietary enhanced intelligence algorithms to help physicians identify the location of chronic low back pain, today announced that the company has executed a non-binding Letter of Intent (“LOI”) to to form a strategic partnership with ATEC Spine, Inc., the wholly owned operating subsidiary of Alphatec Holdings, Inc. (Nasdaq: ATEC).
By combining the unique structural data powered by ATEC’s AlphaInformatiX with the innovative biomarker data that allows Aclarion’s Nociscan solution to identify each intervertebral disc as painful or not, surgeons will have unprecedented data on one platform. The platform is designed to improve clinical outcomes while reducing overall procedural costs for patients with chronic back pain.
Pat Miles, CEO of ATEC, commented: “Developing spinal technologies through innovation requires discipline, time, knowledge and resources. This collaboration with Aclarion reflects our belief in the importance of biochemical markers within the treatment paradigm. Nociscan is exactly the kind of innovation that can advance our shared goal of integrating and advancing technologies that improve the predictability and reproducibility of spine care.”
Aclarion’s proprietary decision support tool, Nociscan, is the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies.
Aclarion’s published studies confirm the comparative advantage of Nociscan in achieving differentiated surgical outcomes. In April 2023, Aclarion announced a published, peer-reviewed 85% 2-year success rate for discogenic low back pain surgery in patients whose treatment strategy was consistent with Nociscan-identified discs. This result was a 22 percentage point improvement over patients whose treatment strategy was inconsistent with Nociscan-identified discs (85% vs. 63%; p=0.07).1
1 https://pubmed.ncbi.nlm.nih.gov/37014434/
“We share a common vision with ATEC on the value of advanced decision support information to improve patient care. This strategic partnership is an important milestone for Aclarion. Pat and the ATEC team are revolutionizing spine surgery, and we appreciate their support,” said Brent Ness, CEO of Aclarion.
The LOI is considering a multi-step strategic partnership. Under the LOI, ATEC and Aclarion will work together to identify Key Opinion Leader (KOL) surgeons who can evaluate the Nociscan technology. Feedback from these surgeons will form the basis for clinical evaluations designed to assess the utility of Nociscan in combination with EOS imaging, the foundation of ATEC’s AlphaInformatiX platform. Based on positive synergies, ATEC and Aclarion will jointly commercialize Nociscan in specific markets. In exchange for selected access to ATEC’s surgeon network for the evaluation and development of Nociscan, Aclarion will grant ATEC certain exclusive distribution rights to include Nociscan as part of an integrated procedural solution.
Chronic low back pain (cLBP) is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disorders and low back pain. Conventional imaging and diagnostics provide valuable structural information, but are limited in identifying the source of the pathogenic pain.
About Aclarion, Inc.
Aclarion is a healthcare technology company that uses magnetic resonance spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers and enhanced intelligence algorithms to optimize clinical treatments. The company is entering the chronic low back pain market for the first time with Nociscan, the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies. For more information please visit www.aclarion.com.
About ATEC
Alphatec Holdings, Inc. is, through its wholly owned subsidiaries, Alphatec Spine, Inc., EOS imaging SA and SafeOp Surgical, Inc., a medical device company committed to revolutionizing the approach to spine surgery through clinical differentiation. ATEC’s organic innovation machineT.M is focused on developing new approaches that integrate seamlessly with the company’s growing AlphaInformatiX Platform to better inform surgery and achieve the goals of spine surgery more safely and reproducibly. ATEC’s vision is to be the standard bearer in the spine field. For more information visit us at www.atecspine.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These forward-looking statements are based on management’s current plans and expectations and are subject to a number of uncertainties and risks that could materially affect the company’s current plans and expectations, as well as its future results of operations and financial condition. These and other risks and uncertainties are discussed in more detail in our filings with the Securities and Exchange Commission. Readers are encouraged to read the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as well as other disclosures in the prospectus and subsequent filings with the Securities and Exchange Commission. . Forward-looking statements in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Revelation
The information above has been prepared by Aclarion and reflects the opinion of Aclarion only. Nothing in this statement should be construed as any endorsement or approval of Aclarion or any of its products by ATEC.
Investor contacts: Kirin M. Smith PCG Advice, Inc. 646.823.8656 ksmith@pcgadvisory.com
Media contacts: Jodi Lamberti SPRIG advice 612.812.7477 jodi@sprigconsulting.com
