Category Archives: Health

What is new in the field of Health. Trending topics, and cutting edge research in the are of Health. Press Releases that give us updates on Health.

Building in Solutions for Anticipated Challenges in CAR T Development Programs, Upcoming Webinar Hosted by Xtalks


These therapies require specialized sites, recruitment strategies and clinical development partners experienced in delivery of these complex programs.

CAR T-cell therapies are fundamentally changing the landscape of cancer treatment. Successful commercialization of multiple CAR T treatments, plus continued advancements in the technologies, combine to make this a very active segment of drug development. Despite the excitement and hope they have brought to the patient and research communities, the sponsors developing these therapeutics are encountering challenges that have delayed and seriously threatened the advancement of their programs. These therapies require specialized sites, recruitment strategies and clinical development partners experienced in delivery of these complex programs.

In this webinar, attendees will hear from speakers partnering with the sponsors developing novel CAR T therapeutics. Their corporate and personnel experience in delivering these complex programs has armed them with the lessons learned to design current and future CAR T programs in anticipation of expected challenges. Register to hear these speakers address the most common challenges and questions they hear from their CAR T sponsors.

Register today for an informative overview of how to address the challenges arising in CAR T-cell development programs. Attendees are encouraged to bring their questions, notepad and colleagues to this webinar!

Join experts from Worldwide Clinical Trials, Missy Green, MBA, Associate Director, Project Management; Jake Boyd, Director, Project Management, Oncology; Amy Raymond, PhD, PMP, Senior Director, Therapeutic Strategy Lead, Rare Diseases; and Daniel A. Perez, CCRP, Global Head, Patient Experience, Diversity & Inclusion, for the live webinar on Wednesday, June 14, 2023, at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit Building in Solutions for Anticipated Challenges in CAR T Development Programs.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Contact:

Vera Kovacevic

Tel: +1 (416) 977-6555 x371

Email: vkovacevic@xtalks.com

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Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems, Upcoming Webinar Hosted by Xtalks


As the number of patients suffering from such disorders increase, so does the demand for more convenient and patient-friendly drug delivery systems.

Chronic clinical conditions are among the leading causes of death and disability globally. Typically, individuals are required to medicate on a daily, weekly and/or monthly basis. Now more than ever, patients want to make treatment a smaller part of their life. The development and commercialization of self-administrable medicinal products outside a clinic, hospital or healthcare provider environment, is an attractive alternative for healthcare expenditure and patients because of the flexibility and desire to reduce clinic visits. As the number of patients suffering from such disorders increase, so does the demand for more convenient and patient-friendly drug delivery systems.

Over the past five years, significant improvements have been made to address dose volumes and treatment options, such as monoclonal antibody-based therapies. These treatments often have viscous, highly concentrated drug formulations that require higher doses and delivery volumes that are typically outside the range of standard syringe capabilities. Novel drug delivery technologies are being introduced, specifically, large volume, on-body drug delivery systems. The novelty of these solutions has increased the complexity of regulations and particularly how to navigate the regulations from a global perspective.

Currently, the majority of large volume wearable injectors are primarily present in North America and Europe, within which the principal global regulatory frameworks are led by, or based on, the United States and European regulations. These large-volume on-body delivery systems are typically co-packaged with pre-filled drug cartridges i.e., co-packaged combination products.

However, the pathway to approval differs between the US and Europe which can lead to diverse, complex regulatory strategies when developing a product that must meet both regulatory frameworks.

Register to learn about on-body drug delivery systems and addressing their complex global regulatory requirements.

Join experts from West Pharmaceutical Services, Inc., Paul Scannell, Director Regulatory Affairs Combination Products, EU; and Adam Coblentz, Principal, Regulatory Affairs Intelligence, for the live webinar on Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central).

For more information, or to register for this event, visit Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Contact:

Vera Kovacevic

Tel: +1 (416) 977-6555 x371

Email: vkovacevic@xtalks.com

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Bergeson & Campbell, P.C. Publishes Memorandum Outlining Key Supply Chain Considerations Regarding PFAS


PFAS – What to Know Now, and What to Expect

PFAS – What to Know Now, and What to Expect

Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk.

Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk.

Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) have prepared this 20-page memorandum to assist stakeholders in preparing a PFAS gameplan. It offers a high-level outline of issues, focusing on the most significant bans and restrictions, the most impactful potential legal developments regarding PFAS, and the most important steps chemical product manufacturers should be taking now to identify, diminish, and supplant, as appropriate, PFAS in their supply chains.

We hope this information is helpful. We would be pleased to provide additional information and assist with PFAS-related scientific, regulatory, or legal questions that you may have. The full document can be downloaded at: https://www.lawbc.com/uploads/docs/PFAS_Summary.PDF

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Compliancy Group is the New Hampshire Psychological Association Endorsed Solution for HIPAA and OSHA


Compliancy Group

Healthcare Compliance Simplified

“Mental health professionals are extremely busy. This is why we aim to make compliance as quick and painless as possible. We are honored to have been selected to provide NHPA Members a streamlined way to meet their requirements” – Liam Degnan, Director of Strategic Initiatives, Compliancy Group.

Compliancy Group is the New Hampshire Psychological Association (NHPA) Endorsed Solution for HIPAA and OSHA.

As the endorsed solution for HIPAA and OSHA compliance, Compliancy Group will provide NHPA Members an automated compliance management and tracking software at a special members-only rate. Compliancy Group’s software, the Guard, eliminates the burden of compliance in a simple, fast, and affordable way.

“Mental health professionals are extremely busy. This is why we aim to make compliance as quick and painless as possible. We are honored to have been selected to provide NHPA Members a streamlined way to meet their requirements” – Liam Degnan, Director of Strategic Initiatives, Compliancy Group.

Managing and understanding compliance can take time, making proper compliance an arduous task for busy practices. Compliancy Group’s guided software walks you through implementing an effective compliance program.

Compliancy Group Resources

HIPAA and OSHA Explained

HIPAA Compliance Checklist

HIPAA Recipe Book

About Compliancy Group

Compliancy Group’s simplified software and Compliance Success Team, remove the complexities and stress of compliance, helping healthcare professionals achieve it with ease. They give practices confidence in their compliance plan, increasing patient loyalty, and profitability of their practice while reducing risk.

As an Endorsed Solution, psychologists can be confident in their compliance program.

About the New Hampshire Psychological Association

The New Hampshire Psychological Association has been the voice of psychology in the State of New Hampshire and a steadfast champion of the mental health community. Operating from a positive core – grounded in compassion, dedication to the field, and community-mindedness – NHPA’s mission is to advance psychology as a science, as a profession, and as a means of promoting human welfare.

Locally and nationally recognized for its achievements, NHPA is an active and thriving organization for professionals with degrees in psychology and affiliated mental health fields.

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State of Hawai‘i Adopts Handtevy System to Improve Pediatric and Adult EMS Care


The State of Hawai‘i’s Emergency Medical Services (EMS) has partnered with Handtevy, a national leader in point-of-care emergency technology, to provide its award-winning mobile application and training program to all state-licensed EMS agencies. The Handtevy system will be accessible to all ground-based, 911-responding services in Hawai‘i, empowering EMS teams to consistently deliver the highest quality emergency care to both pediatric and adult patients.

The Handtevy system is a mobile application that provides access to accurate medication dosing, equipment sizing, protocol sets, and point-of-care checklists for EMS clinicians within seconds. The app is further enhanced by an award-winning metronome, a cutting-edge feature that expertly guides frontline personnel during critical CPR and defibrillation. In addition to this, it smoothly integrates with Hawai‘i’s EMS electronic health record platform, providing seamless, real-time documentation of interventions, thereby improving patient outcomes and operational efficiency.

During the week of May 8th, 2023, Handtevy’s nationally accredited educational course, widely adopted throughout the US, successfully certified over 40 instructors across the state, equipping EMS personnel with the latest knowledge, skills, and resources to confidently provide the highest quality care for all sick and injured patients.

“We are excited to bring this cutting-edge technology to front line EMS clinicians in Hawai‘i. EMS personnel will now have access to the latest lifesaving tools and techniques, ultimately leading to more lives saved,” said Dr. Alvin C. Bronstein, chief of EMSIPSB. “This unique initiative focuses on the special needs of sick and injured children and represents a significant milestone in the state’s delivery of pre-hospital pediatric emergency care.”

The Handtevy System is supported by the state’s Emergency Medical Services for Children program (EMSC) and funded by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under the EMSC State Partnership Grant. Federal funding for the Handtevy System was made possible through the dedicated efforts of the late Hawai‘i U.S. Senator Daniel K. Inouye, who championed the legislation that established the EMSC program.

“We are excited to work with Hawai’i’s EMS agencies and to support their efforts to improve emergency care for the 1.4 million residents of the state,” said Dr. Peter Antevy. “The combination of Handtevy’s mobile application and educational resources will provide Hawai’i’s EMS professionals with the tools they need to make a difference in the lives of those who reside on the islands, as well as the millions who visit each year.”

For more information on the Handtevy system, please visit http://www.handtevy.com or contact the Hawai’i State Department of Health’s Emergency Medical Services & Injury Prevention System Branch (EMSIPSB), which houses Hawai‘i’s EMS for Children (EMSC) Program.

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Catapult Healthcare Solutions awarded Health Care Staffing Services Certification from The Joint Commission


Catapult Healthcare Solutions, a national healthcare staffing and workforce management services company, has earned The Joint Commission’s Gold Seal of Approval® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards. The Gold Seal is a symbol of quality that reflects a health care organization’s commitment to providing safe and quality patient care.

Healthcare staffing firms place temporary staff in organizations that direct or provide patient care. Healthcare Staffing Services Certification demonstrates Catapult Healthcare Solutions efforts to address how qualifications and competencies of staff are determined, placement of staff and how their performance is monitored.

Catapult Healthcare Solutions underwent a rigorous virtual review on May 12, 2023. During the accreditation process, a team of Joint Commission reviewers evaluated compliance with related Healthcare Staffing Services Certification standards spanning several areas including competency of healthcare staff, performance reviews, compliance, and emergency management. Joint Commission standards are developed in consultation with health care experts and providers, measurement experts and patients. The reviewers also conducted interviews with various leadership within the organization to understand the company’s history, vision, mission, and culture. During the process, we are pleased to share that Catapult Healthcare Solutions received no recommendations for improvement in its initial audit. The outcome of the evaluation underscores our efforts and unwavering dedication to upholding the nationally established benchmarks set by The Joint Commission, both presently and in the future.

“Health Care Staffing Services Certification recognizes health care staffing firms committed to fostering continuous improvement in patient safety and quality of care,” says Deborah Ryan, MS, RN, interim executive vice president, Accreditation and Certification Operations, The Joint Commission. “We commend Catapult Healthcare Solutions for using certification to strengthen its program structure and management framework, as well as to enhance its staff recruitment and development processes.”

“Catapult is extremely honored to have earned this certification from The Joint Commission and the principles it serves towards ongoing quality standards, patient safety and performance improvement”, said Joseph Turner, President of Catapult Healthcare Solutions. “This recognition signifies our organization’s commitment to providing the most qualified healthcare professionals and service to our client partners and healthcare organizations across the continuum of care.”

“Our organization and colleagues are proud to have received The Joint Commission’s Gold Seal of Approval recognizing our unwavering dedication to both meeting and exceeding the most rigorous standards in both health care and patient care,” said Patrick Burke, CEO of Catapult Solutions Group. “We are dedicated to providing a higher standard of service to all those we serve and the advancement of the clinical delivery model for the betterment of healthcare organizations.”

Catapult Healthcare Solutions is a subsidiary of Catapult Solutions Group, which was ranked #1 Fastest Growing Staffing Firms by Staffing Industry Analysts in 2022, in addition to Modern Healthcare’s Best Places to Work in 2022 and 2023, Dallas Morning News Top 100 Places To Work in 2022, and Best Companies to Work for in Texas by The Texas Association of Business in 2022. Catapult Healthcare Solutions offers both rewarding local and travel contract assignments and workforce solutions throughout the country for registered nurses, allied health and non-clinical healthcare professionals. Their approach is centered as a progressive culture, people enabled healthcare staffing and technology company dedicated towards fostering direct personal relationships and positive clinical outcomes with an overarching ethos towards “A Hire Standard” in helping to Catapult Your Healthcare Direction.

For more information, please visit The Joint Commission website.

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Dr. Marta Pazos, Skincare Coach, Cosmetic Chemist, and Innovator, Launches Two-Week Skin Coaching Series


Dr. Marta Pazos, founder of Rejuvalift Beauty, creates a skincare coaching video series.

“I’ve helped thousands with skin ailments and developed cutting-edge skincare solutions. Now, I’m taking that knowledge straight to consumers via hands-on, high-quality videos created in a simple format where I teach all courses.” – Dr. Marta Pazos, Founder of Rejuvalift Beauty.

Dr. Marta Pazos, Skincare Coach, Cosmetic Chemist, and Innovator, Launches Two-Week Skin Coaching Series

The founder of Rejuvalift Beauty has helped thousands with skin ailments and has worked for the biggest cosmetic brands developing cutting-edge skincare solutions.

Dr. Marta Pazos, the founder of Rejuvalift Beauty, announces the launch of her 15-Step Skincare Rejuvenation Program, a skincare coaching series of educational videos discussing skin ailments and treatments based on her two decades in the industry. The program helps consumers become their own best solutions for treating their skin. The cosmetic brand is the first to offer a coaching program that complements its product line. The Dr. Marta Skincare Coaching series is now included for free with any Rejuvalift product purchase.

A skincare coach, cosmetic chemist and innovator, Dr. Marta gives participants an insider’s look at achieving healthier skin and uncovers tips on pro-aging techniques. She has created this one-of-a-kind curriculum to coach attendees on achieving their skincare goals in less than five minutes daily. Emmy-winning and longtime TV anchor John Biffar of PeaceVision™ studio, produced the curriculum.

“My dual experience as a researcher and product developer gives me a unique perspective on skin’s needs, with a focus on Global methods, originating in the Far East” said Dr. Marta. “I’ve helped thousands with skin ailments, worked for some of the biggest cosmetic brands globally, and developed cutting-edge skincare solutions. Now, I’m taking that knowledge straight to consumers via hands-on, high-quality videos created in a simple format where I teach all courses.”

The first five videos are now being offered on a free preview as Dr. Marta embarks on a nationwide media and promotional appearance tour. This curriculum also includes an introductory video that breaks down each subject into easy-to-understand topics for the general public. Attendees receive insight and education on caring for their skin, the body’s biggest organ, without surgery. Among the courses are:


  • How to Love the Skin You’re In
  • Your Body’s Tools & Hormones
  • Can Sleep Really Affect Your Skin?
  • How the Environment Affects Your Skin
  • Preventing Age Spots & Skin Cancer
  • Understanding Skin Care Labels
  • Is Hydrating & Moisturizing the same?

“In today’s world, we commonly have nutritional coaches, life coaches, and exercise coaches, amongst others,” added Dr. Marta. “I hope we can add a skin coach to that list. The visible results and increased knowledge are priceless.”

The course is priced at $79.00 Click here to sign up. Purchase a Rejuvalift product and receive it free with coupon code provided with online or Retail store purchase. Information on http://www.drmarta15.com or Rejuvalift Beauty, visit http://www.rejuvaliftbeauty.com.

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About Dr. Marta:

Dr. Marta Pazos is a creator, innovator and owner of the Rejuvalift Brand, with over 20 years of experience developing specialty formulations for cosmetic and skincare products. As the lead cosmetic chemist for Rejuvalift®, Dr. Marta leverages her expertise as a formulation chemist to develop products using the minimum number of ingredients to deliver non-surgical advanced tightening and lift results.

Her passion for skincare began in her teenage years when she battled acne. She quickly learned that when you look good, you feel good. Her skincare journey and interest in chemistry led her to the U.S. from her native Spain. A Fulbright scholar, Dr. Marta earned her doctorate in Polymer Science from the University of Akron. Since then, her career has taken her to North America, Europe and Asia assignments.

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New Lyme Disease Vaccine Research Study For Children Aims to Combat Growing Tick Threat


With the tick season well underway, a new vaccine research study is being conducted in both Bridgeport and Stamford, Connecticut to help protect children from the growing threat of Lyme disease. The study, which is focused on children between the ages of 5 and 17, aims to add a weapon that aids in the prevention of Lyme disease in this vulnerable population.

Lyme disease is a serious illness that can be transmitted by the bite of an infected tick. Symptoms can include fever, fatigue, joint pain, and headaches, and if left untreated, the infection can lead to more serious complications such as neurological problems or heart disease. This year, experts are predicting a particularly bad tick season, which makes the need for research into Lyme disease prevention even more urgent.

The new vaccine research study, which is being led by a team of experienced healthcare professionals and researchers, will focus on the evaluation of the safety of a vaccine for Lyme disease in children. The study will involve a group of children who will receive the study vaccine, and their immune response and overall health will be closely monitored over the course of the study.

“We believe that a vaccine for Lyme disease could be an important tool in the fight against this growing public health threat,” said Dr. Amy Kappelman, an investigator on the study. “This year’s tick season is expected to be particularly bad, and we need to find better ways to protect children from this dangerous disease.”

The research team hopes that this study will provide valuable insights into the development of an effective vaccine for Lyme disease in children.

The clinical research study is currently recruiting participants, and interested families are encouraged to contact the research team for more information. To learn more about this study, visit alsaresearch.com or call 203-374-9816 for the Bridgeport location or 203-325-8529 for Stamford.

About ALSA Research

ALSA Research is a leading research institution with two dedicated clinical research facilities situated in Bridgeport, CT and Stamford, CT. Our team of experienced researchers and healthcare professionals are dedicated to conducting innovative research studies that can help to advance the field of medicine and improve the lives of patients.

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EmeritusDX Announces Launch of New Molecular Test, MetaDX™


News Image

“By launching this test, we continue down our committed path of improving patient outcomes as well as reducing overall treatment costs.” Robert Embree, CEO

EmeritusDX, a rapidly growing cancer diagnostics and information company, today announced the commercial availability of MetaDX™, a PCR-based assay designed to provide personalized treatment guidance for patients diagnosed with prostate cancer. Performed on biopsied prostate tissue, MetaDX™ measures the AR-V7/AR-WT Ratio to predict the patient’s resistance to Androgen Deprivation Therapy (ADT) early on in the treatment process.

“MetaDX™ addresses an important treatment decision for patients diagnosed with prostate cancer,” said Robert Embree, Chief Executive Officer, EmeritusDX. “By launching this test, we continue down our committed path of improving patient outcomes as well as reducing overall treatment costs.”

Advanced prostate cancer tends to be hormone sensitive and is often treated with androgen deprivation therapy. However, resistance to this therapy can develop through first, second, and third lines of therapy. “Our goal is to alert physicians when resistance to therapy is identified in these patients so that effective alternative treatments are provided in the earliest possible phase.”

The MetaDX™ assay is currently available from EmeritusDX’s Irvine, CA laboratory. The test is performed on paraffin embedded prostate tissue and is reported out within 3-5 days. Clients have the option of ordering this test as a reflex or on demand.

About EmeritusDX

EmeritusDX is a cancer diagnostic and information company. Our expertise is in delivering actionable clinical information. Within our world-class laboratory, we perform testing that guides the diagnosis and treatment of cancer patients. Our partners include hospital and private pathology laboratories, biotechnology companies, academic institutions, contract research and pharmaceutical development organizations, and more. We understand the dependency on our accurate and timely results and our commitment to excellence in this regard is unwavering.

If you would like more information about this topic, please call 800-959-2846 or email contact@emeritusdx.com

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New ioVet Oral Rinse Reduces Dental Plaque and Gives Pets Healthier Mouths and Fresher Breath


Safely and effectively promote periodontal health in your pets with ioVet Oral

ioVet Oral rinse reduces dental plaque and gives pets healthier mouths and fresher breath

“Through an important technology breakthrough, ioVet Oral can help maintain optimum periodontal health so pets can enjoy a healthier, longer, and happy life,” Iotech International’s Chairman Herb Moskowitz, DDS.

Now, you can safely and effectively promote periodontal health in your pets thanks to ioTech International’s latest oral care offering – ioVet Oral. ioVet Oral is the first of its kind canine and feline drinking water additive periodontal product. Containing molecular iodine, ioVet Oral provides pets with clinically proven healthier mouths and fresher breath.

Proven in clinical studies, molecular iodine added to pet drinking water is significantly more effective than daily brushing in reducing dental plaque and gives your pets healthier mouths and fresher breath.

To use, simply add 1 milliliter (ml) of ioVet Oral for each 8 oz. of water to your pet’s water dish each morning. Each package provides a syringe to ensure the proper amount of ioVet Oral is dispensed into the water dish.

Among the benefits of molecular iodine for pets are:

  • Safe and easy to use
  • Clinically proven based on Veterinary Oral Health Council (VOHC) approved studies
  • Effectively promotes gum (perio) health
  • More effective than daily brushing
  • Nutritional
  • Does not cause microbial resistance
  • Non-staining formulation
  • Cost-effective preventative care
  • Effective breath freshener

“Pets can’t maintain good dental hygiene on their own. Bad breath, gum infections, bone and tooth loss, can be caused by poor dental hygiene. As well, systemic diseases like diabetes and cardiovascular disease can be worsened with poor dental hygiene. Through an important technology breakthrough, ioVet Oral can help maintain optimum periodontal health so pets can enjoy a healthier, longer, and happy life,” said Iotech International’s Chairman Herb Moskowitz, DDS.

For more information, visit the company’s website at http://www.iotechinternational.com or iovetproducts.com. Contact Iotech International at support@iotechinternational.com or call 561-509-0205 ext. 5.

ioTech International is a leading developer and manufacturer of award-winning oral care products based on the Company’s patented, breakthrough molecular iodine technology. Molecular iodine is the only biocidal iodine species, accounting for all its germicidal activity. Safe and effective, molecular iodine is an essential nutrient humans require for optimal health. Products based on ioTech’s molecular iodine technology have been adopted for use in medical, dental, agricultural, consumer, and pet health markets. ioRinse, ioTech’s award-winning rinse, and other ioTech products are available at leading dental offices, the Company’s website (http://www.iotechinternational.com), and Amazon. ioVet Oral, ioTech’s pet water additive, is available at leading veterinary offices, the Company’s website, and Amazon. ioTech International headquarters are in Boca Raton, FL.

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