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.

Pittsburgh Rare Disease Community Transitions Beloved Event to Virtual


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This event means a great deal to hundreds of people. As such, we are dedicated to taking the necessary precautions in order to provide a safe atmosphere and ensure this event can go on successfully.

Seven years ago, volunteers in Pittsburgh began preparations for a 5K to support nonprofit Team PHenomenal Hope’s mission to end a rare lung disease, pulmonary hypertension (PH). Due to the COVID-19 pandemic, things may be vastly different this year, but that won’t prevent the PH community from participating virtually in the PHenomenal Hope 5K starting on Saturday, June 27.

PH is a rare disease that causes high blood pressure in the arteries of the lungs, which puts unnecessary stress on both the heart and the lungs. Currently, there is no cure, and, eventually, it can be fatal. One of the most aggressive symptoms of the disease is shortness of breath, which prevents patients from being able to do ordinary things, such as climbing the stairs, without becoming exhausted.

Team PHenomenal Hope’s mission is to fund medical research into improved treatments or a cure for those who suffer from pulmonary hypertension, and to implement programs and services that remove patients from isolation, build community, and provide hope.

Race Director Kayla Frattini has a personal connection to Team PHenomenal Hope’s mission: her mom. “My mother battled pulmonary hypertension for six years before ultimately succumbing to the progressive nature of it. I have seen first hand the effects this disease has on people and the few treatment options available. It is my goal to bring as much awareness, education, and research for this disease as possible.”

With the event going entirely virtual, participants may register any time at http://www.phenomenalhope5k.com for only $20. The event will last a week, beginning on Saturday, June 27 until Saturday, July 4, and will give participants the ability to track their movement throughout the week. Those who move the most by the end of the week will receive first, second, and third place prizes. Participants will also have access to bid on auction items, special encouraging communications, and other surprises throughout the week.

Frattini and her team of volunteers worked to make the 2019 event a record breaking year, bringing in more than 600 participants and $40,000 to support research for a cure. Although there is caution surrounding the COVID-19 pandemic, she is still reassured that this year will be successful.

“This event means a great deal to hundreds of people. As such, we are dedicated to taking the necessary precautions in order to provide a safe atmosphere and ensure this event can go on successfully. We have several new sponsors this year and we are looking forward to having another great event,” shared Frattini.

For more information, to register for the race, or to donate to the cause, go to http://www.phenomenalhope5k.com. Visit http://www.teamph.org to learn more about Team PHenomenal Hope.

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Career Partners International’s Retirement Options Continues to Certify Retirement Planning Coaches


Retirement Options, Career Partners International’s continues as the leading global provider of retirement coach certification and readiness assessments, has helped over 50 new global coaches to achieve the designation of Retirement Options Certified Coach. This certification allows the expert use of Retirement Options’ Retirement Success Profile™ and LifeOptions Profile™, two non-financial retirement planning assessments uniquely designed to help individuals plan for and enjoy a more fulfilling retirement.

Those recently certified include B. Foster Blair of B. Foster Blair, JD, PCC; William Love of RTD Financial Advisors; Stan Herman of Stan Herman, Retirement Coaching; Pamela Johnson of The Second Half; Elgin Summerfelt of Finding Your Life; David Emery of David A. Emery; Lori Strilka of Life Journeys Consulting, LLC; Cam Gilbey of Scotia Wealth Management; Kim Shea of Aging Purposefully; Paula Giovacchini of Gio Group, Inc.; David Hyatt of Effective Ministries Coaching and Consulting; Nancy Angus of Age BIG; Pamela Taylor of Taylor Life Transitions; Larry Wofford of Comprehensive Coaching Group; Jim Daly; Rick Passanisi, Stefa Katamay; Laura Gomez-Goyzueta; Tony Temprile; and Judith Nadratowski.

For more than two decades, Retirement Options Certified Coaches are experts on the subject of retirement planning and are regularly asked how to best prepare for this major life transition.

“The Retirement Options certification course is a complete and highly refined training program recommended without reservation for any coach professional seeking to add retirement life planning as a service in their practice. The program, materials, staff and instruction are all of highest quality and participants will realize that they have made a great investment in their own professional and personal development”.

The certification course equips you with the tools, training and support to effectively coach the largest demographic in the world, Baby Boomers. By administering two scientifically designed, validated assessments, the Retirement Success Profile™ and LifeOptions Profile™. These assessments deliver an accurate, personalized, and comprehensive information you need to provide high-impact retirement coaching and assess holistic areas of individuals or couples lives such as career and work, health and wellness, family and relationships, leisure, and personal development. Become certified in the administration, applications, and feedback available exclusively to Retirement Options Certified Coaches.

Retirement Options is hosting a one-hour complimentary webinar session at 12:00 p.m. Eastern on June 11th via ZOOM. To register now, click here.

Retirement Options is accepting enrollments for the next webinar certification course will be held from

August 3 – October 12, 2020 with weekly webinars on Mondays, and will be led by Joanne Waldman, Director of Training. To register, click here.

The Retirement Options Webinar Certification Course is accredited by the International Coach Federation (ICF) for Continuing Coach Education (CCE) hours.

About Retirement Options

Founded in 1989, Retirement Options is the industry leader in retirement coach certification and retirement readiness assessments. Through its two retirement readiness assessments, the Retirement Success Profile™ and the LifeOptions Profile™, Retirement Options provides a foundation for individuals to plan for and enjoy a more fulfilling retirement by exploring holistic aspects of life impacted by retirement such as work, family, wellness, leisure, and personal development. Retirement Options is a division of Career Partners International.

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Decisions to Stray From Clinical Oncology Pathways Are Often Justified, Roswell Park Analysis Shows


Stephen Edge, MD, led a new study on cancer care that departs from the recommendations of clinical pathways designed to support treatment decisions.

Stephen Edge, MD, led a new study on cancer care that departs from the recommendations of clinical pathways designed to support treatment decisions.

Pathways are not a cookbook, not a recipe to follow, and incentivizing strict adherence to pathways could lead to worse care.

Clinical oncology pathways are an important tool, helping cancer care providers and their patients to zero in on the most appropriate care plan. But a treating professional’s decision to depart from the recommendations of these decision-support resources may be well-founded and in the patient’s best interests, research being presented at the American Society of Clinical Oncology (ASCO) 2020 virtual meeting shows.

The new review from Roswell Park Comprehensive Cancer Center of nearly 3,000 care decisions made in the course of caring for more than 2,300 patients is one of the first analyses of the appropriateness of off-pathway cancer care.

“Clinical pathways are intended to standardize care where it’s appropriate to standardize it,” says surgical oncologist Stephen Edge, MD, FACS, FASCO, Vice President for Healthcare Outcomes and Policy at Roswell Park and lead author on this research.

“They serve a tremendously valuable function in that they distill vast amounts of relevant information into evidence-based recommendations. This can help doctors keep up with the latest advances and help patients understand their treatments, comfortable in the assurance that they are receiving the best care,” he notes. “But pathways are not a cookbook, not a recipe to follow, and incentivizing strict adherence to pathways could lead to worse care.”

In their analysis of 2,997 treatment decisions for 2,389 patients, the Roswell Park team determined that the vast majority of care — 84% — did accord with pathway recommendations. The reviewers note that the on-pathways rate was higher in cases involving adjuvant/neoadjuvant therapy than in care of patients with metastatic cancer — 87% vs. 78% — reflecting the nuances of caring for patients with advanced cancer.

Some of the most common reasons practitioners recommended a course of action that departed from the pathway were known drug toxicity, co-morbidity limiting therapy, prior therapy that precluded the pathway-recommended option and new drug indications.

Collaborators included Mishellene McKinney-Bost, RN, James Thompson, MD, Grace Dy, MD, and Boris Kuvshinoff, MD, MBA, all of Roswell Park.

The study, Abstract 7014, will be displayed on board 286 in the Health Services Research and Quality Improvement virtual poster session and discussed in a poster discussion session today, May 29.

Additionally, two Roswell Park faculty leaders were invited to serve as discussants for sessions during the meeting:

  • Grace Dy , MD, Chief of Thoracic Oncology, will be the discussant for “New Antibodies, New Targets: Are We Making Progress” within the Lung Cancer—Non-Small Cell Metastatic oral abstract session. Registered, logged-in attendees can access the presentation here.
  • Philip McCarthy, MD, Director of the Transplant & Cellular Therapy Center, will be the discussant for the session “New Kids on the Block (NKOTB): Novel Therapies in Multiple Myeloma” within the Hematologic Malignancies/Plasma Cell Dyscrasia oral abstract session. Registered, logged-in attendees can access the presentation here.

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This release is also available at: https://www.roswellpark.org/newsroom/202005-decisions-stray-clinical-oncology-pathways-are-often-justified-roswell-park

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at http://www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

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Experienced Industry Veterans Phil Case and Jeff Pearson join the Max Connect Team


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“I am thrilled to join the Max Connect team,” says Phil. “I have personally met and known dozens of agency owners in Utah and throughout the United States, but none have matched the digital marketing expertise and commitment to client growth that I have seen at Max Connect.”

Max Connect Marketing announced recent additions to an already high-caliber agency team, Phil Case and Jeff Pearson. Jeff and Phil bring a combined 36 years of senior marketing and sales experience.

In Phil’s role prior to joining Max Connect, he was the Managing Partner of Fluid Advertising, where he grew the agency from 4 to 35+ full-time employees in a 6-year period. His previous experience includes working with national and regional brands, such as BD Medical, Verizon, Sportsman Warehouse, Blackberry, Oldcastle Materials, Pluralsight, HP, and Circustrix. During his time at Fluid, Phil built three additional departments and added key service offerings such as account-based B2B marketing, Amazon Advertising and e-commerce conversion optimization. In 2018, Phil helped launch a 501(c)(6) The Utah Outdoor Association (UOA) to support the Outdoor Industry in Utah. He also took international cancer screening company, Anpac Bio-medical Science, public on the NASDAQ Exchange in January 2020, successfully raising over $17 Million in capital as part of the IPO.

Phil’s current and previous board service includes Wasatch Adaptive Sports, Utah Outdoor Association, ACG Utah, BYU Management Society, Entrepreneur Organization Utah and Mountain West Capital Network.

“I am thrilled to join the Max Connect team,” says Phil. “I have personally met and known dozens of agency owners in Utah and throughout the United States, but none have matched the digital marketing expertise and commitment to client growth that I have seen at Max Connect. Their willingness to constantly innovate and leverage new tools and cutting-edge techniques is impressive. Their insatiable curiosity with digital trends and consumption patterns allows the agency to maintain its leadership in data-driven marketing.”

Jeff joins Max Connect from Zimmerman Advertising, where he was their Chief Client Officer. In addition to his experience in the agency space with Zimmerman, Jeff has vast experience as an in-house marketing executive at companies including Lids Sport Group, hhgregg, and Whirlpool.

At both hhgregg and Lids, Jeff was instrumental in the incredible growth and success of their e-commerce offerings, as he focused on driving omnichannel marketing initiatives across the organization. Through Jeff’s talents, Lids.com’s ecommerce revenues grew to more than 15% of total sales in 2018. Additionally, through Jeff’s marketing leadership, hhgregg reached a combined $2.5B in revenue across its e-commerce property and its 225 brick and mortar locations.

Jeff’s retail experience also includes new store openings, product launches, and social campaigns, as well as traditional marketing strategies and campaigns focused on driving store and website performance.

“I am excited for the opportunity to be part of the Max Connect Team and to work closely with clients to drive sales growth and long-term success for their businesses,” says Jeff. “After meeting the Max Connect Team, I was immediately impressed with their entrepreneurial spirit and their drive for excellence on behalf of their clients. I am excited to bring my professional experience to Max Connect and to immediately add value to the organization.”

About Max Connect

Max Connect Marketing is a nationally recognized digital marketing agency that connects organizations with audiences through data-driven marketing. As a Premier Google Partner, Max Connect is among the top digital marketing firms in the world.

Max Connect focuses on the hyper-targeting of audiences. We identify the right audience for your product or service, and then we get your message in front of that audience with high frequency using a combination of digital channels including Display, Social, Paid Search, Video Pre-roll, OTT, and Native Advertising. By focusing on the right audiences, Max Connect eliminates the waste in advertising dollars and maximizes every marketing dollar spent. To learn more, visit http://www.maxconnect.com.

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Max Connect Marketing                

(801) 260-2835

pr@maxconnect.com

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A Bread Baking Revolution is on the Horizon


KAMUT® wheat flour baguettes, courtesy of the Midwife & the Baker.

These days’ people are looking for things to do and making bread can actually be exciting.

America has been baking its heart out during the COVID-19 pandemic! According to Google Trends, the number of people that searched for “bread” in the month of March hit an all-time high. Whether kneading dough to let off steam, getting creative in the kitchen to quell anxiety, or to make homemade pizza for kids home from school, baking is still trending with #QuarantineBaking all over social media. Even celebrities are getting in on the act, from famous personalities to Top Chef host Padma Lakshmi, they are all trying their hand at bread-making and it seems the baking trend could linger post-pandemic!

During the four-week period ending April 11th, yeast sales alone jumped 410% year over year, according to market research firm Nielsen, and flour has been in such high demand that supermarket shelves are often empty. “We’ve noticed sales of KAMUT® brand wheat flour soaring, and our millers are working hard to keep up with demand,” said Trevor Blyth, Kamut International CEO.

Thomas “Mac” McConnell owner of the Midwife & the Baker commented that these days’ people are looking for things to do and making bread can actually be exciting and fulfilling. “Preparing it the night before, you anticipate what it’s going to look like in the morning,” he said adding, “It’s very satisfying and bread is really comforting if you bake it yourself or buy a great tasting loaf. However you get it, bread brings people pleasure.”

For many serious bread bakers, KAMUT® wheat flour is their first choice and they make some pretty amazing loaves with it. What makes it so special besides its flavor, which according to Mac makes, “the bread taste buttery even without butter and it colors well in the oven, the flavor is amazing,” is its high nutritional value that’s backed by the guarantees and research of the KAMUT® brand. Information on studies that involved use of KAMUT® brand wheat bread can be found here.

One of the top selling breads of the Midwife & the Baker is their KAMUT® wheat flour baguettes. Mac McConnell has been using KAMUT® wheat flour for the last 10 years and says, “One time I thought I’d try adding some regular white flour in with the KAMUT® flour, that did not go down well with my customers, they wanted to know what I had changed. They could not only taste the difference, but some people with wheat sensitivities were having challenges eating it. Never did that again!”

With 32% of people saying that they plan on making more home cooked meals after the pandemic, it’s worth looking at the long-term effect of this tendency especially since recent habits like scratch cooking and home baking seem likely to become a regular part of more consumers’ routine. According to a small survey of 300 U.S. consumers conducted in early April by market researcher AMC Global and OpinionRoute, “A third of respondents said they were baking more than usual during the pandemic, with 20% predicting they would continue to bake more in future.”

About KAMUT® Brand Khorasan Wheat

From 36 kernels and legends of discovery in Egyptian tombs, today KAMUT® brand khorasan wheat, an ancient grain, guaranteed under the KAMUT® brand, to never be hybridized or genetically modified, always organically grown, prized for its nutrition, ease of digestibility, sweet nutty-buttery taste and firm texture, can be found throughout the world in products including breads, pasta, pizza, cereals, snacks, pastries, crackers, beer, green foods, and cereal drinks.

Media please contact Giselle Chollett: giselle@adinnyc.com, 917.386.7116.

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Biotech World Leader Announces Series A Fundraising on Heels of Groundbreaking COVID-19 and Phase 3 Diabetic Wound Treatment Trials


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This groundbreaking transdermal system and Circularity’s new FDA-approved pharmaceutical-grade mini (14.5g) cartridges are expected to play a crucial role in the fight against COVID-19 for treating oxygen-starved, at-risk patients with underlying medical conditions.

An emerging biotech leader with operations in more than three dozen countries, Circularity Healthcare has announced its Series A fundraising campaign to raise growth capital as it prepares for its impending initial public offering. Poised to become a leader in proprietary circulatory health and noninvasive drug delivery technologies, the company has built a global infrastructure with impressive strategic partners in preparation for ramped-up manufacturing and marketing of its patented and patent-pending D’OXYVA® noninvasive rapid drug delivery devices, and D’OXYVA®-branded mini, single-use medical gas (gasotransmitter) cartridges.

This groundbreaking transdermal system (which in human studies has been shown to significantly improve oxygen-rich blood flow) and Circularity’s new FDA-approved pharmaceutical-grade mini (14.5g) cartridges are expected to play a crucial role in the fight against COVID-19 for treating oxygen-starved, at-risk patients with underlying medical conditions. The D’OXYVA®-branded cartridges, the world’s first mini carbon dioxide cartridges approved by the U.S. FDA (and manufactured at the world’s largest specialty pharmaceutical gas producer’s FDA-audited factory in Pennsylvania), will be sold to doctors, clinics, and hospitals nationwide to treat a wide variety of conditions that can benefit from cellular and tissue oxygen therapy.

The fundraising campaign comes on the heels of Circularity’s expanded multi-year, multi-country, multi-site, Phase 3 human clinical trials led by David G. Armstrong, professor of clinical surgery at the University of Southern California’s Keck School of Medicine, and newly launched COVID-19 clinical trials led by H. Geoffrey Watson, M.D., of Oakland, California. The COVID-19 trial will focus on treating the most at-risk COVID-19 patients, 90 percent of whom suffer from low blood oxygen levels resulting from underlying conditions like diabetes, hypertension, blood pressure, cardiovascular complications, sepsis, and septic shock.

A big part of the science behind D’OXYVA® are the 2019 Nobel Prize in Physiology or Medicine-winning findings that showed how oxygen levels affect cellular metabolism and physiological function, paving the way for oxygen to be used as a promising new method to fight many diseases, including various types of cancer.

Circularity estimates that the total cost of the yearly treatments for the most critical and vulnerable millions of COVID-19 patients will amount to roughly $70 billion, and that more than 90 percent of deaths can be avoided. The company is also expected to capture a share of the COVID-19 vaccine market with its ability to deliver vaccines painlessly without needles (using its D’OXYVA transdermal delivery system) and with likely much higher efficacy. This is especially ideal for patients who are averse to needles.

Circularity is also nearing updated FDA approval because of its expanded Phase 3 diabetic foot ulcer human clinical trial. The trial has already produced promising evidence to support the safety, tolerability, and efficacy of Circularity’s patented D’OXYVA® device and pharmaceutical-grade carbon dioxide as an adjunctive treatment in speeding up the healing of diabetic foot ulcer wounds. The device uses medical-grade carbon dioxide delivered painlessly and gently through skin pores to significantly increase the oxygen-rich blood flow necessary for vital organs to function well.

“We are well-positioned right now for exceptional, immediate, and long-term growth,” says Circularity Healthcare president and CEO Norbert Kiss. “We have strategic partnerships with a combined market capitalization of over $100 billion to support our massive growth trajectory.”

“Unlike many companies in our current challenging economic climate, we have minimal debt on our balance sheets, significantly improved asset valuation, a rapidly growing customer base, and an established, large supply chain virtually all inside the United States, propelled by massive demands for many years to come, with an estimated current inventory retail value of millions of dollars,” says Norbert .

The growing demand for home healthcare and point-of-care options is expected to trigger a rise in demand for packaged medical-grade gases and equipment. The global medical gas market was valued at $7.5 billion in 2016 and is expected to witness a CAGR of 9 percent during the forecast period until the year 2024.

Due to growing concerns about aging, obesity, and diabetes, Research and Markets in December 2017 estimated that the global market for chronic wound care equipment would grow from $18 billion in 2017 to $22 billion by 2022. The United States accounts for 35-40 percent of the global market and is expected to grow at 7 percent CAGR. In contrast, D’OXYVA’s mass-market adoption will offset billions of unwanted healthcare expenditure, considering that a single diabetic foot ulcer standard of care in the United States annually costs about $30,000 in indirect and direct costs on average per person.

Eighty percent of cases still result in amputations, and 80 percent of amputees die within three years of amputation. This is the potential future for about 10 million people if D’OXYVA treatment is not adopted. Circularity’s Phase 3 human diabetic foot ulcer clinical trial centers on healing diabetic foot ulcers at one-tenth of the time and cost of competing modalities, while achieving zero reports of adverse side effects after eight years.

“We can produce devices for 100 million households and cartridges in various sizes for over 300 million people within 18 months with our dedicated production lines,” says Kiss. “Furthermore, Circularity is exploring the opportunity to work with the U.S. government to make the initial millions of applications widely available and affordable to those who need it most. This could generate roughly $50 billion in sales revenue from devices and $70 billion in sales of our drugs.”

The company’s clinical trials are led by some of the most respected medical professionals at top universities in the country, including the University of Southern California, Harvard University, Northwestern University, and Drexel University College of Medicine. Additionally, Circularity is represented by the leading FDA team at K&L Gates LLP (Circularity’s main global, corporate, regulatory, and IP law firm since its inception) and works closely with regulatory teams from the world’s largest specialty pharmaceutical gas producers.

D’OXYVA® is currently available for use in hospitals and at home (over the counter) through its Investigational Device Exemption status under FDA regulations. The company has seen impressive growth volumes over the past two months, with pending orders from some of the largest hospitals and healthcare networks around the world for its regulated D’OXYVA®-branded products, and an 86 percent repeat customer rate for orders of its over-the-counter products.

“This is in line with our original scheduled launch of our comprehensive PR, sales, and marketing campaigns, combined with the anticipated release of our clinical evidence,” says Joel Ellis, national VP of sales. “We have been aggressively expanding sales operations by continually hiring new sales representatives in virtually all areas of our business.”

Along with adding to its sales team, Circularity is launching half a dozen new clinics with leading doctors this week, with plans to multiply those new clinics to expand to hundreds of locations nationwide within the coming months.

The Series A fundraising is open to venture capitalists, private equity investors, qualified institutional buyers, angel investors, and angel investor groups. Potential investors can contact the company directly at (626) 817-6698. For more information on the clinical trials, please visit – https://doxyva.com/covid-19/.

Forward-Looking Information:

This press release may contain forward-looking information. This includes, or may be based upon, estimates, forecasts and statements as to management’s expectations with respect to, among other things, the quality of the products of Circularity Healthcare, LLC, its resources, progress in development, demand, and market outlook for non-invasive transdermal delivery medical devices. Forward-looking information is based on the opinions and estimates of management at the date the information is given and is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those initially projected. These factors include the inherent risks involved in the launch of a new medical device, innovation and market acceptance uncertainties, fluctuating components and other advanced material prices, new federal or state governmental regulations, the possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. The forward-looking information contained herein is given as of the date hereof and Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC makes no representations or warranties as to the accuracy or completeness of this press release and shall have no liability for any representations (expressed or implied) for any statement made herein, or for any omission from this press release.

About Circularity Healthcare, LLC

Headquartered in Pasadena, California, Circularity Healthcare is an emerging biotech leader around the world in proprietary circulatory health and noninvasive skin delivery technologies. Since 2011, the company has been committed to radically changing the standard of care and improving lives by developing, manufacturing, and marketing affordable medical devices and pharmaceutical products to promote consumer health and wellness. For more information, please visit https://doxyva.com.

About Norbert Kiss

CEO and Co-Founder Norbert Kiss leads the Circularity Healthcare team, and spearheaded the development of the company’s technology and business platforms. Norbert has nearly a quarter of a century of executive and entrepreneurial experience, both domestically and in more than 60 countries involving startups; think and do tanks; and large brands in technology, intellectual property, regulatory affairs, and sales and marketing. He has been involved in the transdermal and cardiovascular space for more than a decade.

Connect with D’OXYVA on Social Media:

https://twitter.com/doxyvahealth

https://www.facebook.com/DOxyva

https://www.instagram.com/doxyva_health/

https://www.youtube.com/c/circularitydoxyvas

For media inquiries (including interview requests with leading medical experts), please contact:

Jennifer Boadila-Palaez

Jennifer.Boadilla@doxyva.com

(626) 244-8090



Maverick Energy Solutions Launches New Line of PPE Products to Support Pandemic Efforts Helping to Keep Employees and Customers Safe


Eric Larsen, president of Maverick Energy Solutions, wears a KN95 mask. The mask is part of the company’s new line of PPE (personal protective equipment) products for contractors.

LED lighting installers and electricians are interfacing with business owners, in warehouses and offices. With concern over what could be brought into their customers’ place of business, we knew our distributors needed quality PPE to take care of their customers.

Responding to the tremendous need for masks during the COVID-19 pandemic, Maverick Energy Solutions has launched a new line of PPE (personal protective equipment) products for contractors. With their unique connections and understanding of market challenges, Maverick was able to source two different types of masks in the hands of their customers in only three weeks.

Helping to keep both contractors and customers safe during the pandemic is a top priority for Eric Larsen, president of Maverick Energy Solutions. “LED lighting installers and electricians are interfacing with business owners, in warehouses and offices,” he said. “With concern over what could be brought into their customers’ place of business, we knew our distributors needed quality PPE to take care of their customers. That opportunity, to help people and minimize the spread of the virus, drove us to be ready to ship quickly.”

The new PPE products include KN95 and a three-ply mask. The KN95 is a white, four-layer mask that filters 95 percent of airborne particles, including dust, smoke, gas, and air pollution. The nose-bridge design and skin-friendly fabric means it can be worn without irritation. The disposable, three-ply mask is soft, comfortable, skin-friendly, and breathable. Both masks are CE marked.

To get the products to the marketplace quickly, Larsen explained that “we leveraged a lot of what we’ve learned in sourcing LED lighting when it came to procuring the masks. What it takes to be successful in sourcing is having a team that is skilled at evaluating vendors and partners, who knows exactly what our expectations are for quality, how our products have been designed, and are used to making sure we get a product meets our specifications and the specification of our customers. They helped us pull together all the elements very quickly.”

Maverick has been doing this for their lighting products for five years. To achieve their goals for the PPE products, they only needed to pivot. “We’ve gotten very good at finding the right partners who understand our needs and can manufacture our products efficiently, who are price competitive, and have the highest quality,” Larsen added.

“We saw a need where people can’t find and get PPE, so we made the decision to move quickly, and we were able to help them out in three weeks rather than the normal 60-90 days,” Larsen noted. “We supply them with a good product at a good price. At the same time, it helps to fulfill a real need so that people can get back to work. That’s a big deal for people to get back to work and feel safe. It means even more to us, to be able to give back and make a difference in peoples’ lives.”

To place an order for PPE, https://maverickled.com/pages/ppe, or call (214) 571-6374.

About Maverick Energy Solutions

Maverick Energy Solutions is based in Carol Stream, Illinois. They’ve carved a niche for themselves over the last five years and are committed to manufacture and distribute high-quality, sustainable, well-designed, and affordable LED lighting for commercial applications. With an elegant design and affordable products that are “Install Easy” for contractors and electricians, Maverick Energy Solutions has made energy savings their top priority for a greener and brighter future. For more information, visit https://maverickled.com/.

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Schrader Plastic Surgery Reopens Following New Guidelines


Dr. Nicole Schrader

Dr. Nicole Schrader

Nicole Schrader, MD, FACS, announces the reopening of Schrader Plastic Surgery with COVID-19 specific protocols in place. These protocols include limited office time, universal PPE use, enhanced disinfectant procedures including instrument cleaning and sanitation of exam rooms between patients.

Prior to their appointments, clients undergo extensive screening and receive detailed protocol instructions. Patients are requested to arrive alone. Minor children and those requiring a caretaker may be accompanied by one adult. Forehead scanners will check patient temperatures prior to entering the office. Appointments for anyone with a temperature will be rescheduled. COVID-19 tests are not conducted at Schrader Plastic Surgery. Anyone with symptoms compatible with the virus, or who has a test pending, must reschedule his or her appointment. This office does not treat patients with the virus. Because of the increased risk for individuals over the age of 60 and those with medical conditions like heart disease, diabetes, cancer, high blood pressure, chronic diseases of the kidneys, liver, and lungs, and auto-immune problems, the office has implemented guidelines for scheduling visits.

Low-risk patients will be scheduled as usual with special procedures in place.

Medium risk patients may schedule appointments at the discretion of the provider.

High-risk patients will be advised to carefully consider whether or not an office visit is necessary, especially if they are 80 years old or older. Telemedicine visits are recommended for these high-risk patients to determine their level of need for an office visit. The provider reserves the right to reschedule high-risk patients as a health and safety precaution.

Virtual check-in and check-out has been implemented. Most patients will check in from the security of their cars. This includes using their cell phones to relay their symptoms and reasons for their visits, essentially eliminating the waiting room. Most patients will be escorted directly from their vehicles to exam rooms. The number of patients seen hourly has been reduced in order to maintain proper distancing guidelines and to reduce public interaction within the office.

All staff will be completely outfitted with PPE (personal protection equipment). That includes masks, eye protection, gloves, and where appropriate, protective gowns. Everyone on the staff is screened for fever and other symptoms of the virus two times a day. Face masks or facial coverings are required of all patients as long as they are on the premises. Patients will be asked to wear PPE, clean their hands, and make use of the provided hand sanitizer. Office cleaning adheres to COVID-19 specific protocols. Prior to patients entering them, exam rooms are thoroughly disinfected using recommended, high-level disinfectants. Door handles, countertops, chairs, and keyboards are all included in the disinfectant procedure. Telemedicine will remain available for all patients who have concerns about in-office visits and for those who do not require in-office visits.

Dr. Schrader is a double board-certified physician specializing in facial plastic reconstructive surgery, otolaryngology (ear, nose, and throat), and head/neck surgery in Princeton, NJ. Her expertise includes minimally invasive facial surgery, soft-tissue reconstruction, rhinoplasty, and rejuvenation of the aging face. Dr. Schrader has more than 20 years of experience with 13+ years in private practice.

To schedule a virtual or in-office appointment, please call our office at 609-279-0009. You can also use the online form to contact our office. For more information on the specific services offered by Dr. Schrader and her staff at Schrader Plastic Surgery, please visit our website.

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From Promising Potential to Platform Clinical Trial


“The patients and the medical and research experts all shared the same passion and purpose–to solve the mysteries of NF2–but traditional approaches were getting in the way of needed solutions,” said Annette Bakker, PhD, President of the Children’s Tumor Foundation.

The Children’s Tumor Foundation (CTF) announced today a significant advancement in care for neurofibromatosis type 2 patients with the launch of a new clinical trial called INTUITT-NF2, an innovative platform trial which will evaluate multiple treatments simultaneously. This initiative is a result of the landmark work of CTF’s visionary Synodos for NF2 research collaborative, its NF2 Accelerator Initiative, an investment from Takeda Pharmaceuticals, the participation of scientists at the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), and the vital Synodos NF2 leadership from Massachusetts General Hospital (MGH), Johns Hopkins University (JHU) and Indiana University (IU). The Principal Investigator of INTUITT NF2 is Dr Plotkin from MGH and the five additional participating centers are Johns Hopkins University (JHU), New York University (NYU), University of California at Los Angeles (UCLA), the Mayo Clinic in Minnesota (Mayo), and the University of Miami (UM). This alliance across the academic, pharma, and patient landscapes has shortened the time from initial research to active trial, thereby bringing promising treatment options to patients who need them.

The name INTUITT-NF2 stands for ‘Innovative Trial for Understanding the Impact of Targeted Therapies in NF2’, and its innovation is in responding to – and acting against – specific traits unique to NF2 patients. Neurofibromatosis causes tumors to grow on nerves throughout the body, with most NF2 patients affected by vestibular schwannomas on the eighth cranial nerve, which carries sound and balance information to the brain. NF2 affects 1 in 25,000 people of all populations equally, and in addition to schwannomas can develop meningiomas and ependymomas, with patients suffering hearing loss, severe balance problems, facial weakness/paralysis, and debilitating seizures, among other serious conditions. The INTUITT-NF2 trial will enroll patients with progressive tumors of any type – schwannoma, meningioma, or ependymoma – to allow for the simultaneous study of the various tumor types, rather than one tumor type alone. This approach will accelerate the information gathering and results analysis processes.

This milestone development in NF2 research and care is the result of insights that came out of the Foundation’s Synodos for NF2 effort, which launched in 2014 and in collaboration with NCATS identified brigatinib as a promising drug for NF2 patients. The Synodos project brought together a multidisciplinary team of scientists from 12 world-class labs at academic and medical centers of excellence to address the confounding problem patients and researchers alike faced in that research results appeared to contradict each other – with some work showing positive results and others negative results. This siloed approach to the disease was hampering progress, and all agreed that an “audacious new way” was needed. Patients heeded that call and provided funding to the Children’s Tumor Foundation to launch a new, and for its time, a somewhat radical approach to the disease. In this model, called Synodos, researchers would work together on a Manhattan-project style approach to the disease, and they would share data and results in real-time. The funders behind that approach (lead funders the Galloway family, Carol Harrison Kalagher, the Thoms family) also ensured that patients be included in the research and clinical meetings that would define these methodologies.

The multidisciplinary Synodos team launched its work (Synodos stands for “on the same path, together”), and established the first-ever NF2 preclinical drug pipeline with cell and animal models connected to a sequencing enterprise so as to better understand the biology behind drug response and non-response. This information was shared among all members of the group for phase one of the project, and eventually made public available to any researcher through the establishment of dataportal.org.

“The launch of the Synodos project was driven by our belief that by bringing all stakeholders together we could solve the medical problems that seemingly had no answers,” said Annette Bakker, PhD, President of the Children’s Tumor Foundation. “The patients and the medical and research experts all shared the same passion and purpose – to solve the mysteries of NF2 – but traditional approaches were getting in the way of needed solutions. Thanks to the persistence of the patients and the courageousness of the researchers, the group revealed new insights into NF2 biology and established a platform from which could spring high-potential therapies not just for NF2 but other types of NF and even other types of disease.”

With a guarantee of shared data and a certainty of collaboration in hand, the Synodos team found that initial results did not meet efficacy criteria, but that new and vast insights into NF2 biology had been generated. Scientists from NCATS, led by Marc Ferrer, PhD, offered high throughput capabilities to the Synodos team to potentially uncover new drug opportunities. In that process, Takeda’s Brigatinib (an approved drug for use in non-small cell lung cancer unrelated to NF) was discovered to show robust efficacy in both vestibular schwannomas and in meningiomas. This breakthrough meant that while more understanding was still needed to identify the exact mechanisms behind this finding, it appeared that Brigatinib shrinks NF2 tumors.

“This finding was proof positive that merging innovations from the private sector together with sophisticated tools within the public sector can increase our understanding of disease,” said Dr. Marc Ferrer of NCATS.

Leading the INTUITT-NF2 trial are Scott Plotkin, MD, PhD of Massachusetts General Hospital and Jaishri Blakely, MD, of Johns Hopkins University. The goal of this new trial is to rapidly and efficiently screen multiple therapies simultaneously so as to enable faster approval studies that have the highest indication for success. The U.S. Food and Drug Administration (FDA) recently approved the initiation of this trial, and details on patient recruitment will be announced soon.

The INTUITT-NF2 trial will expand the possibilities for NF2 care in multiple ways. In a traditional clinical trial, patients are enrolled to test one drug treatment that will measure response for one specific tumor type (even if patients have more than one type in their bodies, as is often the case for NF2 patients). If that tumor type does not respond to the treatment, then the trial potentially fails, and patients wait as the development process has to restart again, perhaps with a different drug, or with a new process that looks at a different tumor type. The “one tumor type, one drug at a time” approach slows down the development of treatments for NF2.

By contrast, the INTUITT-NF2 trial will enroll patients with schwannomas, meningiomas, and ependymomas. For a given drug, the study will determine whether any one (or more) tumor types respond better than the others. This novel approach provides the opportunity to find active drugs for tumor types that have never been eligible for clinical trials previously. INTUITT-NF2 will also study multiple drugs over time as they become available (the study is beginning with brigatinib only). In this model, a patient whose tumors grows on brigatinib could be eligible to receive treatment with another drug within a short period of time.

Dr. Scott Plotkin of MGH, one of the initial Synodos leaders, has spearheaded the upcoming INTUITT basket trial, which should start seeing its first patients enrolled later this month.

“This new trial for NF2 patients will realize two principal objectives on our way to the development of approved treatments for NF2,” said Dr. Plotkin. “First, by focusing on all tumor types within patients, we are able to expand patient eligibility for the trial, meaning we will increase our knowledge pool on how these treatments perform in patients. And secondly, the trial design allows for the addition of drugs to be tested rather quickly, again increasing what we know about their real-life impact on NF2 patients.”

The Principal Investigators of the trial are Scott Plotkin of MGH and Jaishri Blakeley of JHU. Participating clinicians include Jeffrey Allen, MD (NYU); Leia Ngiemphu, MD (UCLA); Dusica Babovic-Vuksanovic (Mayo), and Christine Dinh, MD (UMiami).

Both the Children’s Tumor Foundation (CTF) and Takeda Pharmaceuticals are supporting the financing of the INTUITT-NF2 trial. CTF’s investment is through its NF2 Accelerator Initiative, with lead funding from the Thoms Fund and KBF Canada.

To learn about NF2 research and the progress being made against neurofibromatosis, please visit ctf.org.

To learn more about the INTUITT-NF2 trial, please visit https://clinicaltrials.gov/ct2/show/NCT04374305.

About Children’s Tumor Foundation

The Children’s Tumor Foundation is a 501(c)(3) not-for-profit organization dedicated to funding and driving innovative research that will result in effective treatments for the millions of people worldwide living with neurofibromatosis (NF), a term for three distinct disorders: NF1, NF2, and schwannomatosis. NF causes tumors to grow on nerves throughout the body and may lead to blindness, deafness, bone abnormalities, disfigurement, learning disabilities, disabling pain, and cancer. NF affects 1 in every 3,000 births across all populations equally. There is no cure yet – but the Children’s Tumor Foundation mission of driving research, expanding knowledge, and advancing care for the NF community fosters our vision of one day ending NF. For more information, please visit http://www.ctf.org.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit takeda.com.

Join The Frontier Of Healthcare 3D Printing


3DHEALS 2020

3DHEALS 2020

I’ve been involved with 3DHeals since 2015 and highly recommend it as a top organization, network and knowledge base for anyone involved in 3D printing, bioprinting or new technology for healthcare and medical future.

3DHEALS, LLC is pleased to announce its global virtual summit 3DHEALS 2020, June 5th- June 6th, focusing on healthcare innovations using 3D printing, bioprinting, and related technologies. The event expects 500+ attendees from 20+ countries, and 20 early-stage startups to participate in Pitch3D, a fast-paced pitch event to institutional investors. 3DHEALS 2020 addresses the need for a global cross-disciplinary forum. It will feature more than 70 world-class experts from more than 60 organizations and companies to showcase technological developments, share insights, tackle challenges, and present opportunities for future collaborations. The content-rich two-day multi-track virtual summit allows the attendees to learn practical knowledge from world-class experts, including hands-on application-focused workshops. The organizers have conducted more than 29 speaker interviews, which can also be downloaded as podcasts.

The virtual summit is not just two days of webinars, but a simulated virtual networking experience, where speakers, exhibitors, and attendees can engage through the conference’s dedicated mobile app, before, during, and after the meeting. The fee for the conference is 100 USD.

The two-day virtual event offers nineteen sessions. While there is no dedicated COVID-19 panel, many presentations address how 3D printing and bioprinting communities respond to the pandemic.

Highlighted presentations and panels include the following:

In the first keynote presentation, Sam Onukuri, Head and Senior Fellow at Johnson & Johnson 3D Printing, will explain how the world’s largest healthcare company is leveraging 3D printing technology to transform the design, manufacturing and delivery ecosystem across Johnson & Johnson’s medical device, consumer and pharmaceutical businesses.

In the second keynote presentation, Dr. Alan Dang, an orthopedic spine surgeon and co-founder of PrinterPezz, will share the “behind-the-scenes secrets” of how PrinterPrezz democratizes medical device innovation and helps its customers go from concept to production.

The biofabrication and bioprinting panels collect some of the brightest minds in the world of tissue engineering and biofabrication, tackling 3D printing nearly every organ system from brain tissue, vasculatures, to heart valve. Many speakers are well-known scientists, including professors Stephanie Willerth, Adam Feinberg, Jordan Miller, who are also co-founders behind some of the newest startups in the bioprinting space. More established companies critical to tissue engineering and cell therapy will also join the conversation, including Melanie Mathieu from Prellis Biologics, Jon Rawley from Roosterbio, John O’Neil from Xylyx, Taciana Pereira from Allevi, and Kevin Caldwell from Ossium Health, and Qrquidea Garcia (“Orchid”) from JNJ.

A related panel focusing on 3D printing on the International Space Station also deserves much attention from speakers from Techshot, ISS/CASIS, and Allevi (Ricky Solorzano).

The legal and regulatory panel will include the most comprehensive list of legal and regulatory concerns, focusing on healthcare 3D printing applications. The topics include intellectual property/patent issues(Roger Kuan, Haynes and Boone LLP), product liability, FDA pathways, manufacturing standards, and more. Steven Bauer, from FDA CBER, will address concerns related to cell therapy and stem cells.

The early morning Global Perspective sessions are reserved for international speakers to share their unique experiences, needs, and hopes. Both America Makes director John Wilczynski and NAMIC director Dr. Chaw Sing Ho, along with experts from Turkey, India, and Taiwan, will share how 3D printing and bioprinting innovations can thrive in both local and global healthcare environs. The audience will also learn about how different countries are implementing the concept of 3D printing for Point of Care, with experts from UCSF, Stanford, Germany (Kumovis), India (Anatomiz3D), Korea (MEDICALIP), and developing countries. More than ten 3DHEALS community managers will also present city-based healthcare 3D printing innovation ecosystems and share their progress.

As one of the largest sectors in FDA cleared devices, metal and orthopedic 3D printing will permeate throughout the entire conference, from keynotes to dedicated panels focusing on materials, designs (nTopology, ANSYS, MEDICALIP), and end-user applications head to toe (Printerprezz).

As a fast-growing sector, the dental 3D printing panel will feature an unprecedented group of speakers from a combination of academia (University of Michigan, USC, UOP) and industry (Boneeasy, Origin) focusing on critical issues facing the industry both short and long term.

The material science panel will feature speakers from Henkel, Evonik, Origin, and 3Degrees for an in-depth discussion on what roles material manufacturers should play in 3D printed medical devices, investment opportunities, and the latest trends.

The investor panel will feature VCs in the medtech and life science space, including NEA, Intuitive Surgical, Evonik, and more.

The entrepreneur fireside chat session will invite CEOs of Aspect Biosystems and Fluidform to share their perspectives based on their startup journeys.