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PathAI Diagnostics Unveils World’s First AI-Assisted Laboratory Developed Test for MASLD and MASH

PathAI

PathAI Diagnostics, a leading laboratory services company, today announced the world's first AI-Assisted Laboratory Developed Test (LDT) for the histologic scoring and staging of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). This pioneering advancement will be introduced at the American College of Gastroenterology 2023 (ACG2023) Meeting in Vancouver, Canada, from October 20-25. MASLD and MASH are posing an escalating healthcare challenge, affecting millions of individuals worldwide. Recent estimates suggest that approximately 37.8% of the global adult population suffers from some form of MASLD, with 5-6% of the U.S. adult population at risk of progressing to MASH—a potential precursor to severe conditions such as cirrhosis and liver cancer. 1-3 While the gold standard for MASLD/MASH scoring is liver biopsy, the scoring provided by pathologists can exhibit variability. 4-5 In fact, there can be as much as a 30% disagreement in MASH diagnosis between pathologists, and intra-observer variability can reach up to 41% for the same case. 6 Accurate scoring and staging are paramount, as each fibrosis stage corresponds to approximately a two-fold increase in liver-related mortality. 7 In order to better tackle this growing issue, PathAI Diagnostics developed AI.Dx MASH, a laboratory developed test, which provides AI-assisted histologic scoring that supports expert pathologists with enhanced insights for liver biopsy reporting. "We are excited to bring the world's first AI-assisted Laboratory Developed Test for MASH to market,” said Jim Sweeney, President of PathAI Diagnostics. “The tool uses our deep expertise in AI-powered pathology coupled with our world-class diagnostics laboratory to improve patient outcomes through AI-assisted histologic scoring for MASH." This groundbreaking tool utilizes an AI algorithm that has been proven to significantly reduce inter- and intra-operator variability in CRN scoring. Moreover, AI.Dx MASH reports include image overlays and quantitation, offering a comprehensive view of steatosis, lobular inflammation, hepatocyte ballooning, and fibrosis, thus facilitating more accurate diagnosis and staging. 8-11 “AI.Dx MASH provides a powerful tool for histologic MASH scoring by offering visual image overlays of key features to show how a score was reached,” said R. Shawn Kinsey, MD, gastrointestinal and hepatobiliary pathologist at PathAI Diagnostics. “This addresses one of the key challenges that leads to variability when assessing progression of the disease for a more accurate summary of a patient’s condition to inform future treatment and intervention.” Learn more about AI.Dx MASH and PathAI Diagnostics at Booth 613 at the 2023 American College of Gastroenterologists Meeting in Vancouver, Canada, October 20-25. Alternatively, explore PathAI Diagnostic’s full range of anatomic and molecular pathology services, spanning gastroenterology, dermatology, urology, and women's health, at www.pathaidx.com. About PathAI Diagnostics PathAI Diagnostics, formerly Poplar Healthcare, is a leading laboratory services company based in Memphis, TN, pioneering digital pathology and serving a nationwide client base of gastroenterologists, dermatologists, oncologists, urologists and gynecologists. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

October 19, 2023 10:00 AM Eastern Daylight Time

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Stanford Blood Center Adopts New FDA Blood Donation Guidelines for Enhanced Inclusivity

Stanford Blood Center

Stanford Blood Center ( SBC ) is thrilled to announce the implementation of the updated FDA blood donation guidelines known as the Individual Donor Assessment, effective October 19, emphasizing a more equitable and inclusive donor assessment process. Dr. Suchi Pandey, Chief Medical Officer for SBC, stated, “This historic change in approach to donor eligibility is significant progress. By asking all potential donors the same questions about their sexual behavior, this change reflects the fact that infectious diseases like HIV can be contracted by anyone, regardless of their gender or sexual orientation. Although we recognize that FDA will continue to review if additional updates can be made, Stanford Blood Center enthusiastically supports this change. The revamped process underscores a data-centric approach that ensures blood safety. Ultimately, the blood supply is supported by multiple layers of safety, including rigorous testing of blood donors with highly sensitive tests as well as the donor health questionnaire. The data from countries that have already implemented this change – including Canada and the United Kingdom – have shown that making this change does not put the safety of the blood supply at risk. Previously, certain sexual behaviors led to donor deferrals, but under the new guidelines, an "individual donor risk assessment" approach is adopted, focusing on high-risk sexual behaviors. Notably, any donor reporting new or multiple partners in the last three months will undergo further assessment, with specific guidelines around deferral periods for those taking PrEP or PEP medications. SBC has played a pivotal role in advocating for this change over many years, contributing data to the FDA, participating in the ADVANCE Study, and supporting AABB efforts to revise the Universal Donor History Questionnaire (UDHQ). This dedicated effort underpins the FDA’s shift in guidance, ensuring a safe blood supply while extending the inclusivity of blood donation. Stanford Blood Center remains steadfast in its mission to further enhance the policy, continuing to provide valuable data to the FDA for future improvements. This initiative reflects the first steps towards repairing relationships with the broader LGBTQ+ community and invites everyone to participate in this life-saving mission. Further information about the changes to donor eligibility, resources, and FAQs can be found here. Donation appointments can be made at stanfordbloodcenter.org, via the SBC app, by calling 888-723-7831 or texting 999-777. Donors should be in good health with no cold, flu, or COVID-19 symptoms. Be sure to eat well prior to donation, drink fluids, and bring a photo ID. If donors have been deferred at Stanford Blood Center in the past based upon MSM (Men-Who-Have-Sex-With-Men) criteria, please reach out to the SBC Resource Nurse at 650-725-7336 to confirm your eligibility and begin the process of requalification prior to coming in to donate. Donors with general eligibility questions can contact an SBC team member for assistance at 888-723-7831, by email at givebloodSBC@stanford.edu, or by texting 999-777. ### Stanford Blood Center (SBC) is an independent, community blood center that supplies blood products and testing services to multiple Bay Area hospitals and is a recognized leader in the fields of transfusion and transplantation medicine. SBC was created at the Stanford University School of Medicine in 1978 to meet the complex transfusion and transplant needs of Stanford Health Care and Lucile Packard Children’s Hospital Stanford, as well as provide clinical trial services and specialized blood products for researchers. Today, the center remains locally focused, serving community hospitals, patients and donors, while contributing to research and advancement that impact the world at large. More information is available at stanfordbloodcenter.org. Contact Details Liza Batallones +1 415-766-0846 stanford@landispr.com

October 18, 2023 01:07 PM Pacific Daylight Time

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How the Worker Shortage in Healthcare Could Impact Your Health

YourUpdateTV

A recent Harris Poll found that 68% of Americans are worried that the worker shortage in healthcare could have an impact on their own health. Recently, spokespeople from the American Academy of Physician Associates (AAPA), participated in nationwide satellite media tour to discuss the impact of the worker shortage in healthcare and how physician associates, or PAs, can help increase access to care. A video accompanying this announcement is available at: https://youtu.be/4XRJDYFt3R0 Healthcare workforce shortages are having a profound impact on patient access to care, with patients reporting feeling frustrated and anxious about their ability to get the care they need when they need it. The recent Harris Poll survey found that nearly three-fourths of all U.S. adults say the healthcare system isn’t meeting their needs, and more than 1 in 4 gave the healthcare system a failing grade. One of the most concerning ways provider shortages are impacting patients is the amount of time it is taking to get a needed health appointment. Patients are waiting an average of 3.9 weeks for a medical appointment. As one of the fastest growing medical professions in the country, PAs can make a positive and lasting impact on patient care. An overwhelming 91% of U.S. adults believe that PAs are part of the solution to addressing the shortage of healthcare providers and additionally, 90% of patients say that PAs increase access to care and make medical appointments easier to obtain. One significant issue is that PA practice laws vary by state across the country. The challenge here is that in far too many states, these laws haven't been updated to reflect the way medical care is delivered today. A resounding 91% of U.S. adults support updating PA practice laws and the mandate is clear: The public wants the healthcare system to be as efficient and accessible as possible and updating these laws is a win-win for patients and the entire healthcare system. For more information, please visit aapa.org/patientexperience. About the American Academy of Physician Associates (AAPA) AAPA is the national membership organization for all physician associates/physician assistants (PAs). PAs are licensed clinicians who practice medicine in every specialty and setting. Trusted, rigorously educated and trained healthcare professionals, PAs are dedicated to expanding access to care and transforming health and wellness through patient-centered, team-based medical practice. PA has been named one of the best jobs overall and one of the best healthcare jobs for the sixth year in a row by U.S. News & World Report The PA profession ranked number three this year in Best STEM jobs. Learn more about the profession at aapa.org and engage through Facebook, LinkedIn, Instagram, and Twitter. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

October 18, 2023 02:31 PM Eastern Daylight Time

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Redx Pharma has "a lot to be excited about" after successful fundraise

Redx Pharma PLC

Redx Pharma PLC (AIM:REDX) Chief Financial Officer Peter Collum speaks to Thomas Warner from Proactive after the clinical-stage biotechnology company announced a £14.1mln fundraise from existing investors that will take its working capital to more than £28mln. Collum explains that the additional funding will extend the company's cash runway from early 2024 into the third quarter, enabling them to achieve critical milestones in their portfolio development plan. He says that one of the key highlights is the Phase 2a data release for their lead asset, the selective ROCK2 inhibitor known as Zelasudil, with a focus on treating Idiopathic Pulmonary Fibrosis (IPF). IPF is a severe lung condition with limited treatment options, making this development crucial for patients. Additionally, Redx Pharma is initiating a Phase 1 trial for their oral pan-ROCK inhibitor, RXC008, targeting Fibrostenosis in Crohn's disease patients. This innovative approach offers hope to patients facing invasive surgery as the only current treatment option. Collum emphasises Redx Pharma's strong track record of developing high-quality small molecule compounds, attracting collaborations with prominent pharmaceutical companies. With a pipeline of promising assets, he says that the company "has a lot going on and a lot to be excited about for the future." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 18, 2023 12:15 PM Eastern Daylight Time

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Centre for Neuro Skills Announces New Houston Medical Director

Centre for Neuro Skills

Centre for Neuro Skills (CNS), a leader in traumatic brain injury and stroke rehabilitation services, today announced the appointment of Dr. Natasha Rose, M.D., as Medical Director of CNS’ Houston clinic. “Dr. Rose has an extensive medical background working with post-acute brain injury patients and overseeing in-patient rehabilitation units,” says Dr. Matthew Ashley, Chief Medical Officer of Centre for Neuro Skills. “We are thrilled to have her on our team, leading the charge in Houston.” As Medical Director for CNS’ state-of-the-art rehabilitation clinic in Houston, Texas, Dr. Rose joins a highly-trained clinical staff dedicated to treating traumatic brain injury and stroke patients. Dr. Rose will provide medical oversight and collaborate with case managers, therapists and specialists to oversee patient care and create neurorehabilitation programs. Dr. Rose received her medical degree from the University of Michigan in Ann Arbor. She completed a transitional year at Oakwood Hospital and her physical medicine and rehabilitation residency at Baylor College. Her fellowship focused on brain injury and stroke patients. Dr. Rose is also a member of the American Academy of Physical Medicine and Rehabilitation. The CNS Houston clinic is located in Webster, just 20 minutes south of downtown Houston. CNS has three other clinics across Texas in Dallas, Fort Worth and Austin, as well as three California clinics in Los Angeles, San Francisco and Bakersfield. Each clinic offers unique environments that provide excellent preparation for community reintegration. All CNS clinics share the common goal of providing quality neurorehabilitation therapy through inpatient, outpatient, day treatment and residential rehabilitation programs. “I’ve always felt that I could help people through my role as a physician,” said Dr. Rose. “I look forward to advancing patient care and outcomes through CNS’ specialized neurorehabilitation programming.” *** About Centre for Neuro Skills Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. CNS covers a full spectrum of advanced care from residential and assisted living to outpatient/day treatment. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas. For more information about Centre for Neuro Skills, visit: www.neuroskills.com, Facebook, Twitter, LinkedIn, YouTube. Media, please note: Visual assets, including photos, are available. To request an interview with CNS leadership or clinical staff, please contact Robin Carr at 415.766.0927 or CNS@landispr.com. # # # Contact Details Landis Communications Inc. Robin Carr +1 415-766-0927 cns@landispr.com Company Website https://www.neuroskills.com/

October 18, 2023 08:01 AM Pacific Daylight Time

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PathAI Announces Launch of AIM-TumorCellularity (AIM-TC), an AI-Based Tumor Cellularity Assessment Product to Inform Advanced Molecular Testing

PathAI

PathAI, a global leader in AI-powered pathology, today announced the launch of AIM-TumorCellularity (AIM-TC), the latest algorithm product available for use by laboratories utilizing the AISight Image Management System (IMS). 1 AIM-TC enables automated assessment of tumor cellularity, or tumor fraction, which is utilized to determine if there is sufficient tumor tissue to support advanced next generation sequencing (NGS) testing. Insufficient tumor DNA is a common failure mode in comprehensive genomic profiling and results in the destruction of precious tissue without molecular biomarker information to inform care decisions. AIM-TC solves for this by running on a standard hematoxylin and eosin (H&E) whole slide image and can automatically determine the tumor area and percentage of tumor nuclei. “As a molecular pathologist myself, I know how important accurate tumor cellularity assessment is. Many laboratories struggle with high NGS failure rates due to insufficient tumor content in the sample, leading to wasted time and expense.” said Andy Beck M.D. Ph.D., Chief Executive Officer and Co-Founder of PathAI. “Because of this, it’s become standard practice for pathologists to manually assess tumor fraction. We now have the opportunity to automate this step with AI, allowing pathologists to focus on other tasks.” Tumor cellularity assessment can be time consuming and onerous, particularly when the tumor content is low. 2,3 For high volume laboratories, AIM-TC can reduce the amount of pathologist time spent on tumor cellularity assessments while also providing standardized, quantitative metrics to support more accurate determination of the required tissue inputs. “AIM-TC is a great example of how AI can augment the pathology laboratory and eliminate routine, stressful and time-consuming activities, allowing pathologists to focus on what they do best,” said Tobias Kull, PhD., bioinformatician in the Molecular Pathology Unit of University Hospital Zurich. “We expect that if implemented widely in our practice, AIM-TC can save hundreds of hours of pathologist time that can instead be used for case sign-off and patient care.” AIM-TC is currently available in Non-Small Cell Lung Cancer (NSCLC) and will be launched in 12 additional tumor types (including breast cancer, colorectal cancer, prostate cancer, gastric cancer, pancreatic cancer, ovarian cancer, melanoma, renal cell carcinoma, hepatocellular carcinoma, and urothelial carcinoma) in the coming months. To learn more about AISight, PathAI’s Image Management System, or AIM-TC, please visit our website, request a meeting with our team, or visit us at PathVisions in Orlando, Florida (Booth #206; October 29-31, 2023). 1 AIM Tumor Cellularity and AISight are Research Use Only. Not for use in diagnostic procedures. 2 Smits AJ, et al. The estimation of tumor cell percentage for molecular testing by pathologists is not accurate. Mod Pathol. 2014 Feb;27(2):168-74. 3 Viray H, et al. A prospective, multi-institutional diagnostic trial to determine pathologist accuracy in estimation of percentage of malignant cells. Arch Pathol Lab Med. 2013 Nov;137(11):1545-9. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and laboratory use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of pathology samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

October 18, 2023 10:00 AM Eastern Daylight Time

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Poolbeg Pharma unveils new collaboration agreement

Poolbeg Pharma PLC

Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) CEO Jeremy Skillington speaks to Thomas Warner from Proactive after announcing the pharma & biotech company has signed a new collaboration agreement with an unspecified NASDAQ-listed biopharma company. He explains that the collaboration is aimed at developing an optimized oral drug for metabolic conditions, with Poolbeg receiving funding to produce a prototype drug encapsulating one of the partner's drugs for the same condition. The focus is on improving drug delivery and achieving the ideal site of action, which could enhance efficacy and safety. Skillington expresses optimism about the collaboration potentially evolving into a full licensing agreement, highlighting the goal of generating early revenues for Poolbeg. The partnership's core attraction lies in Poolbeg's validated encapsulation technology, which is believed to enhance the partner's products' bioavailability and effectiveness. The CEO emphasises the significance of delivering drugs to their ideal site of action, particularly for metabolic diseases. By targeting the drug orally to the precise location of action, it can lead to reduced dosage requirements and improved safety. He says that Poolbeg continues to work on various initiatives, including the orange GLP-1 program and an oral vaccine program funded by the Irish government. The move towards oral delivery aims to enhance convenience for patients and expand the company's reach beyond traditional injectable treatments. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 18, 2023 06:21 AM Eastern Daylight Time

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Mydecine Innovations Group gearing up for human trials after completing Aquis listing

Mydecine Innovations Group Inc

Mydecine Innovations Group Inc (OTC:MYCOF, NEO:MYCO) CEO Joshua Bartch speaks to Thomas Warner from Proactive London about the biotechnology company's ambitious goals in the psychedelic medicine sector. Bartch explains that Mydecine focuses on developing "second generation" drugs derived from first-generation psychedelic molecules like LSD, MDMA, and psilocybin. Their aim is to enhance the efficacy of these drugs while addressing challenges like half-life, scalability, cost, and accessibility. He emphasises the company's efforts to make these drugs more adaptable to the existing medical infrastructure, aiming to increase accessibility by five to tenfold. Highlighting the UK's progressive stance on psychedelics, Bartch announced Mydecine's recent listing on London's Aquis Exchange, emphasising the potential benefits for both current and future shareholders. The company is gearing up for phase one human trials of their lead drug candidates by early 2024, with their MYCO-006, a second-generation MDMA analogue, showing promising results in preclinical studies. Addressing perceptions of psychedelic medicine industry, Bartch notes a significant shift, saying that major biotech investors and institutions, once skeptical, are now showing keen interest. Contact Details Proactive United States Proactive United States +1 347-449-0879 action@proactiveinvestors.com

October 18, 2023 06:15 AM Eastern Daylight Time

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Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness

Dr. Wolff

HONG KONG SAR - Media OutReach - 18 October 2023 - Many woman experiencing menopause are troubled by vaginal dryness. It can cause discomfort when sitting, standing, exercising, during urinating and even working, and can greatly impact their quality of life. In Hong Kong, every 2 out of 3 women has experienced symptoms of Vaginal Dryness 1. Yet, it remains a taboo topic, making it difficult for women to discuss their intimate health concerns with family, friends, or doctors, resulting in only one-quarter of affected woman seeking treatment 2. Vaginal secretions gradually decrease as a woman ages, resulting in decreased lubrication and elasticity of the vaginal tissue. This can result in vaginal dryness and associated symptoms such as dryness, itching, burning, and pain 3. Given that these symptoms closely resemble those associated with other vaginal flora issues, many women have been perplexed and resorted to over-the-counter remedies, which may exacerbate the situation 2. Symptoms of vaginal dryness can also be mistaken for poor hygiene. In fact, excessive cleansing of the intimate area with conventional soaps and vaginal douching, may risk irritating the vaginal skin and disrupt the vaginal flora, leading to worsening of the condition. Soothing Vaginal Dryness with the right products Dr Dawn Harper, a general practitioner in United Kingdom known for her expertise on menopause, emphasises on the importance for women suffering from vaginal dryness to use a moisturising cream with high water content and lipids which can provide lasting soothing relief for women experiencing Vaginal Dryness. Introducing Hormone-Free Dr. Wolff’s Vagisan Moisturising Cream and Moisturising Cremolum Dr. Wolff’s Vagisan Moisturising Cream Effectively relieves dryness, itching, burning and pain associated with vaginal dryness Contains high water content and soothing lipids, keeps skin of intimate area soft and supple Contains lactic acid and is thus adjusted to the healthy pH level in the vagina Hormone-free and can be applied intravaginally and to the external genital area Clinically proven to relieve symptoms of vaginal dryness Dr. Wolff’s Vagisan Moisturising Cream can not only moisturises the internal and external skin of the vagina, but also supplies it with nourishing lipids, leaving the skin of the intimate area supple and soft. Several clinical studies have been performed with Dr. Wolff’s Vagisan Moisturising Cream, proving its efficacy and tolerability. Not only did the cream show superior efficacy as well as tolerability as compared to a water-based non-hormonal gel 4, but it was statistically significantly non-inferior to a hormone-containing cream (estriol 0.1%) in terms of improvement on subjective symptoms of vaginal dryness 5. Also available as an innovative pessary for greater convenience without the use of an applicator: Dr. Wolff’s Vagisan Moisturising Cremolum Smooth melting pessary, forms into a cream in the vagina together with vaginal fluids Individually wrapped for more hygiene and convenience Hormone-free and can be applied intravaginally Free from preservatives A Dr.Wolff’s clinical study 6 also found that the Dr. Wolff’s Vagisan Moisturising Cremolum provided a long-lasting soothing effect that lasted 3 days or longer for majority of participants. It significantly improves the symptoms of dryness, itching, burning, and pain associated with vaginal dryness and provides relief from first application, allowing these women to achieve a better quality of life. Furthermore, 90% of test participants rated the moisturising cremolum as very easy or simple to use. For more questions on the products mentioned above, please refer to Dr. Wolff’s Vagisan official site: https://www.vagisan.hk/ 1 Survey Aug 2016, Vaginal Dryness, n=400 Hong Kong women (aged 41-55), conducted by AIP Global, Singapore 2 Womens’s Health Concern (2022,) https://www.womens-health-concern.org/wp-content/uploads/2022/12/25-WHC-FACTSHEET-VaginalDryness-NOV2022-B.pdf 3 Family Health Service (2022, February) https://www.fhs.gov.hk/english/health_info/woman/14768.html 4 Stute, P., May, T. W., Masur, C., & Schmidts-Winkler, I. M. (2015). Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. Climacteric: the journal of the International Menopause Society, 18(4), 582–589. https://doi.org/10.3109/13697137.2015.1036854 5 Garcia de Arriba, S., Grüntkemeier, L., Häuser, M., May, T. W., Masur, C., & Stute, P. (2022). Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study. PloS one, 17(5), e0266633. https://doi.org/10.1371/journal.pone.0266633 6 Clinical trial over 6 weeks with n=79 postmenopausal women with vaginal dryness ( https://clinicaltrials.gov/study/NCT05211505?intr=cremolum&rank=1&tab=table ) About Dr. Wolff Founded in 1905, Dr. Wolff is one of the largest medium-sized family-owned businesses in the Germany. The Dr. Wolff Group consists of the owner-managed companies Dr. Kurt Wolff, Dr. August Wolff and their international subsidiaries. Distinguished by the development and creative marketing of real innovations for more than 100 years, the company concentrates on products which embody verifiable advantages for consumers.For more information, please visit: Dr. Wolff Group ( drwolffgroup.com ) Contact Details Dr. Wolff Singapore Caliente Tong caliente.tong@dr-wolff.sg

October 18, 2023 04:28 AM Eastern Daylight Time

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