All posts by imreal

2023 Year in Review and Outlook for 2024


The Xtalks Life Science Podcast was pleased to host guests such as vaccine scientists Dr. Heather Platt and Dr. Ulrike Buchwald from Merck who discussed pneumococcal vaccination; Dr. Tania Kamphaus from the Foundation for the National Institutes of Health (FNIH) and patient advocate and founder of the non-profit NASH Knowledge Tony Villiotti who discussed advancements in blood-based biomarker tests for NASH; and Attorney Tope Leyimu who spoke about leading the proposed US Food and Drug Administration (FDA) ban on hair relaxer products containing harmful chemicals, among many others.

In 2024, Ayesha and the editorial team will remain committed to bringing audiences timely, high quality life science content. They will continue covering a broad range of news and hot topics from the pharma, biotech and medical device industries. In 2024, the podcast hopes to have even more thought leaders, innovators and industry experts on the show.

There is a lot planned for the Xtalks Life Science Podcast in 2024 so stay tuned!

Tune into the Xtalks Life Science Podcast, which will resume on Wednesday, January 10, 2024, for continued news, conversations and insights!

The weekly podcast is available for streaming every Wednesday on Spotify, Apple, Google and wherever you stream podcasts. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. 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/

Media Contact

Ayesha Rashid, Xtalks, +1 (416) 977-6555 x 272, [email protected], www.xtalks.com

SOURCE Xtalks

Women We Admire Announces Top 50 Women Leaders in Marketing for 2023


Women We Admire is pleased to announce The Top 50 Women Leaders in Marketing for 2023

NEW YORK, Jan. 2, 2024 Women We Admire is pleased to announce The Top 50 Women Leaders in Marketing for 2023. The list represents a diverse set of individuals spanning sectors from entertainment to technology to health and showcases the women who are trailblazing the future of marketing, brand management, digital strategies, and other related areas. In parallel, they lead their teams purposefully to innovate and drive meaningful change at their respective organizations.

Among this year’s awardees is Judy Toland, an award-winning and transformational CMO with an engineering background, who serves as Vice President of Global Audiences Marketing for Meta, where she oversees audience-led marketing, product strategy, and execution for all Meta business brands worldwide. With 24 years of experience, awardee Morgan Flatley serves as the Global Chief Marketing Officer and Head of New Business Ventures at McDonald’s, overseeing award-winning marketing efforts and innovative business ventures that expand the McDonald’s brand reach.

As the Chief Marketing Officer of Aramark, awardee Karen Parker employs a collaborative leadership style that strengthens key stakeholder relationships and alignment with complex business needs. She has been recognized for her expertise in brand development, communications, revenue growth, market positioning, and business profitability.

Please join us in celebrating the accomplishments of The Top 50 Women Leaders in Marketing for 2023.

Morgan Flatley (McDonald’s), Gail Horwood (US Novartis), Karen Parker (Aramark), Sara Correa (Bridgestone), Judy Toland (Meta), Fiona Carter (Goldman Sachs), Elizabeth Parkinson (The Ohio State University), Bernice Tsai (NewYork-Presbyterian Hospital), Jenny Lee (Boston Scientific), Anna Wright (Prysmian Group), Alicia Alston (Quad), Tricia Warnken (CHG Healthcare), Gayle Troberman (iHeartMedia), Janda Lukin (Campbell Soup Company), Vanessa Peace (American Cancer Society), Christine Brodeur (Vialto), Sylvia Cintron (Forward Air Corporation), Elizabeth Marshall (Trinity), Dana Jermstad (Prevea Health), Nancy Rewis (Berry College), Nicole Hart (Credit One Bank), Rose Holden (Comcast), Kara Rousseau (Walmart Connect), Erin McReynolds (Fremont Bank), Bradi Henao (Gordian), Janeen Vogelaar (Salo), Tycene Fritcher (Outcomes™), Kate Wingard (Brand Repair Inc.), and many others.

To view the full list, visit https://thewomenweadmire.com/2023/12/28/the-top-50-women-leaders-in-marketing-for-2023/

About Women We Admire

Women We Admire provides news and information on today’s women leaders in business, entertainment, sports, motherhood, medicine, law, and many other fields. We cover a broad range of topics and areas of interest aimed at recognizing the achievements of exceptional women while inspiring others to aim high and continue their journey towards reaching their full potential. Women We Admire and its affiliates circulate its content to over 32,000 individuals and businesses.

Media Contact
Editor, Women We Admire, 1 609-365-7014, [email protected], https://thewomenweadmire.com/

SOURCE Women We Admire

New Owners Bring Energy, Expanding Caring Transitions of Carlsbad, La Jolla, and Temecula


Helping people is no new task for Luis and Corine Peralta. The husband-and-wife duo have been involved with their community and are founders of the Smiles by Angles Foundation. This nonprofit provides new books and literacy to underserved children in hospitals, foster care, and other communities.

While searching for a new business opportunity, Luis stated that Caring Transitions matched their own mission of assisting others through difficult times. “We felt that the value proposition and the services [Caring Transitions] provides to seniors and their families was vital. Supporting seniors and their families while having the expertise to help them sort through what can be a challenging time aligned with our beliefs as we shift from the corporate world to entrepreneurship.”

With its expansion, Caring Transitions of Carlsbad, La Jolla, and Temecula now serves La Jolla, Encinitas, Carlsbad, San Diego, Fallbrook, Oceanside, San Marcos, Escondido, La Costa, Del Mar, Vista, Rancho Santa Fe, Ramona, Vista, Oceanside, Solana Beach, Cardiff, Bonsall, Temecula, Encinitas, Pala, Winchester and the surrounding areas. Caring Transitions currently has more than 300 franchise locations serving families nationwide.

“Luis and Corine were born to help others and their spirit and passion for their community is particularly strong,” said Ray Fabik, President of Caring Transitions. “The Peralta’s are a perfect fit for expanding the compassionate care Caring Transitions offers and providing exceptional service to those in southern California.”

To learn more about Caring Transitions, visit https://www.caringtransitionscarlsbad.com.

For more about franchising opportunities with Caring Transitions, visit https://www.caringtransitionsfranchise.com/.

About Caring Transitions

Caring Transitions, founded in 2006, is the most trusted and experienced national franchise specializing in senior relocation and transition services. With more than 300 locations throughout the United States, all owned and operated by Certified Relocation and Transition Specialists, Caring Transitions provides clients with supportive moves, auctions, rightsizing, and transitions. This includes expert advice plus a well-executed transition plan beginning with the initial sorting of personal belongings through packing, unpacking, resettling, and selling of items to the final clearing and cleaning of the property. For more information, visit http://www.caringtransitions.com or visit us on Facebook, https://www.facebook.com/CaringTransitions/.

Media Contact

Mike Toper, 919 Marketing, (919) 813-6511, [email protected], 919marketing.com

SOURCE Caring Transitions

Smile Brands Receives Real Leaders® Top Impact Companies Award for 3rd Straight Year


“It’s an honor to have again been recognized for our positive social impact by Real Leaders,” said Smile Brands’ CEO, Steven C. Bilt. “I’m immensely proud of what our Foundation has achieved over the past three years – adding two new outposts and more than tripling the number of patients served. This couldn’t have happened without the dedication of partners and volunteers across the globe who share our commitment to helping needy communities access care. Both at home and abroad – I believe the key to making a positive impact is hiring individuals with a shared commitment to touching the lives of all we serve.”

Smile Brands ranked #23 on this year’s Top Impact Companies list which features a mix of respected brands of all sizes from a variety of global industries. View the full list of Impact Award winners here.

ABOUT SMILE BRANDS
Smile Brands, based in Costa Mesa, California, is one of the largest providers of dental support services in the United States. Smile Brands supports a portfolio of over 75 brands including well-known regional brands; Bright Now! Dental, Castle Dental, Merit Dental, Midwest Dental, Monarch Dental, and Mondovi Dental. The company provides comprehensive business services through exclusive long-term agreements with affiliate dental groups allowing affiliated practices to spend more time caring for patients and less time on the administrative, marketing, and financial aspects of operating a dental office. The organization receives frequent recognition for its award-winning culture and has been recognized as a Best Place to Work by Glassdoor, Comparably, Stevie® Awards, and more. Visit smilebrands.com for more information.

ABOUT REAL LEADERS
Real Leaders is a membership community for impact leaders with a global media platform dedicated to driving positive change. It’s on a mission to unite farsighted leaders to transform our shortsighted world. Founded in 2010, Real Leaders recognized early on that businesses bore a responsibility to be as cognizant of their impact on employees, society, and the planet as they are on their bottom line. Real Leaders is a B Corporation, member of the UN Global Compact, and is independently owned.

LinkedIn: Real Leaders
Instagram: @Real_Leaders
Twitter: @Real_Leaders
Facebook: @RealLeadersMagazine
Hashtag: #RealLeadersImpactAwards

Media Contact

Jody Martin, Smile Brands, 714.428.1299, [email protected], smilebrands.com

SOURCE Smile Brands

Panthera BioSolutions Grand Opening and Ribbon Cutting Ceremony


“Panthera BioSolutions provides a collaborative playground for pharmaceutical development” states Jason Mastoris, Co-Founder at Panthera. I look forward to helping our customers progress or accelerate their R&D efforts, enabling them to get their products into the hands of patients as quickly as possible.”

PBS’s commitment to the regional life science ecosystem extends to nurturing the next generation of pharmaceutical professionals through designated, on-site hands-on training space at their facility. In addition to offering training and upskilling for new and incumbent industry talent, PBS will provide visibility to sustainable career paths within the industry, making it a cornerstone in developing a robust, life science workforce for the future.

“This is definitely a very exciting time for Panthera BioSolutions” according to Co-Founder, Hardik Patel. “We are genuinely thrilled about serving as a hands-on training facility for existing professionals seeking continuing education as well as those with limited opportunities to pursue careers in this industry.”

About Panthera BioSolutions

Panthera BioSolutions a biotechnology and pharmaceutical organization that provides bespoke manufacturing, e2e validation, facility, engineering and maintenance and laboratory services to life science customers striving to remain innovative and competitive across markets and milestones. The hands-on workforce training programs will benefit students, career changers and local companies.

Follow us on LinkedIn: https://www.linkedin.com/company/pantherabiosolutions

Invitation to Grand Opening / Ribbon Cutting Ceremony:

Panthera BioSolutions Grand Opening & Ribbon Cutting Ceremony Tickets, Thu, Jan 11, 2024 at 5:00 PM | Eventbrite

Media Contact

Jason Mastoris, Panthera BioSolutions, 1 817-893-6868, [email protected], www.pantherabiosolutions.com

SOURCE Panthera BioSolutions

Physician-Owned and Operated Intentional Self Aesthetics in New Canaan, CT to Host Grand Opening Celebration on Jan. 25


Grand Opening Celebration!

  • Where: Intentional Self Aesthetics, 23 Vitti Street, New Canaan, CT 06840
  • When: Thursday, January 25, 2024 from 4-7 p.m.
  • What: Guests will enjoy event-only discounts on services and products, a wine tasting, live demonstrations and giveaways
  • Visit our website to RSVP by Jan. 18

To reserve your spot for the Grand Opening Celebration, please RSVP on our website. To schedule a consultation, book an appointment or learn more about Intentional Self Aesthetics, call 203.594.1890 or visit intentionalselfaesthetics.com.

About Intentional Self Aesthetics
Intentional Self Aesthetics was created by Owner and Medical Director Dr. Teresa Alasio with the mission to prioritize confidence, self-awareness and self-compassion for every client. With the understanding that everyone’s journey is unique, Intentional Self Aesthetics focuses on each client’s own values and desires, offering programs and services that align with their individuality and contribute positively to their self-image and confidence.

Dr. Alasio’s goal is to provide each client with clear, personalized, professional advice, making sure they understand the potential benefits and risks, and assisting them in choosing treatments that align with their personal goals and values. Intentional Self Aesthetics offers a variety of best-in-class, results-driven treatments using products that are cruelty-free, eco-friendly and promote social responsibility.

About Dr. Teresa Alasio, Owner and Medical Director
Dr. Teresa Alasio is an accomplished Board-Certified Physician and Medical Director. With a diverse range of expertise, Dr. Alasio has made significant contributions to the field of medicine over her nearly 20-year career and is an experienced and highly skilled physician and thought leader. Dr. Alasio has found aesthetics to be the ideal practice environment to combine her skills and passion, and intentionally built her practice in her hometown of New Canaan, Connecticut. Not only does being local afford an opportunity to work close to home and near her family, but she also recognizes the importance of being part of the thriving community that is New Canaan and actively participating as a local business owner.

Dr. Teresa Alasio’s professional journey is marked by academic excellence and extensive training. Dr. Alasio earned her Doctor of Medicine degree from Mount Sinai School of Medicine, where she also did her residency training, serving as Chief Resident in her final year. Throughout the years, Dr. Alasio has continuously improved and honed her skills through fellowship, continuing lifelong education activities and service on national committees. Additionally, she has made significant contributions to the medical community through presentations and publications, sharing knowledge and expertise with peers and colleagues.

In addition to academic and professional accomplishments, Dr. Alasio has demonstrated a commitment to social responsibility and community engagement, serving on the Board of Directors for the Domestic Violence Crisis Center of Stamford in the past as well as Co-Chair of the annual Voices of Courage Luncheon. Dr. Alasio has also been recognized as a dedicated and compassionate healthcare provider, earning praise from patients and colleagues alike for exemplary patient care and service, and has been nominated in the past as a “Health Care Hero” by Westchester Magazine.

Dr. Alasio holds Board Certification in Aesthetics from the American Association of Procedural Medicine (AAOPM) and is also Board-Certified in Anatomic Pathology and Cytopathology. Dr. Alasio is a Certified Life Coach from The Life Coach School.

Media Contact

Dr. Teresa Alasio, Intentional Self Aesthetics, 203-594-1890, [email protected], https://intentionalselfaesthetics.com/

SOURCE Intentional Self Aesthetics

Children’s Miracle Network Hospitals® Announces 11 New National Champions Advocating for Pediatric Healthcare


After experiencing frequent heart arrhythmias after she was born, Adeline’s doctors sent her to a specialist at Duke Children’s, a member hospital of Children’s Miracle Network Hospitals. Adeline was subsequently diagnosed with Long QT Syndrome, a potentially life-threatening condition. After receiving a therapeutic pacemaker at seven days old, Adeline is now a happy, energetic second grader, living life to the fullest thanks to donations that help her doctors study and better understand her condition. Donations support research and medical advancements for Long QT Syndrome.

At a young age, Brooke began to show signs she was struggling, culminating in the eighth grade when she attempted to take her own life. Lost and unsure where to turn, Brooke’s mom decided Shodair Children’s Hospital, which specializes in psychiatric care for children and adolescents, was their best option. The treatment team was able to offer safety, hope, and the therapy Brooke and the entire family desperately needed. Thanks to donations, Brooke was able to receive the care she needed. Today she’s thriving and wants to help other kids so they know they don’t have to suffer alone. Donations help cover uncompensated medical care for psychiatric services.

After a long journey with invitro fertilization, Amy and Jayna found out they were expecting triplet boys. At 20 weeks gestation, Amy had to be hospitalized for an emergency procedure followed by bed rest. Barrett, Jack and Leighton were born at just over 24 weeks. Unfortunately, Leighton passed at four days old and through this unimaginable loss, Amy and Jayna held strong for Jack and Barrett who would have a long road ahead with many procedures. Due to their need for specialized care, Jack and Barrett were separated at two different member hospitals of Children’s Miracle Network Hospitals off and on over the span of two months. Thanks to donations through Children’s Miracle Network Hospitals, Amy and Jayna were provided funds to assist them in traveling between hospitals and home and were able to see their boys through NICVIEW cameras funded by donations when they couldn’t physically be there.  Donations provide NICU equipment, travel assistance, and NICVIEW cameras for families.

Anna Grace was born with a limb difference that doctors initially thought might prevent her from ever walking. At two years of age, Anna Grace underwent surgery at Cincinnati Children’s and just 10 days later was in her prosthesis and taking her first steps. And she hasn’t stopped since. Donations through Children’s Miracle Network Hospitals helped Anna Grace receive cutting edge physical therapy equipment and prosthetics to ensure she can live to her fullest potential. Donations enable access to cutting-edge physical therapy equipment and prosthetics.

From a young age, Nylah struggled to maintain a healthy weight which took a toll on her self-image and mental wellbeing. After being diagnosed with pre-diabetes, her family doctor referred her to the Play Strong program at Nationwide Children’s Hospital where she was given the tools and resources to make small changes over time that helped transform her mind and love of self. Donations support programs like Play Strong for children struggling with weight and self-image.

At the age of 14, Isaac suffered a terrible fall while performing a stunt in cheerleading practice, leaving him unable to move from the neck down. Isaac was transferred to Children’s Specialized Hospital, located in New Brunswick, NJ, and began therapeutic programs funded by donations, including extensive physical rehabilitation to help him regain mobility. Despite his challenges, Isaac is able to encourage everyone around him through his sweet and vibrant nature. Donations directly support therapeutic programs and services for mobility recovery.

Joseph weighed one pound nine ounces when he was born four months early. He spent the next 130 days in the Neonatal Intensive Care Unit (NICU) at CHRISTUS Shreveport-Bossier Health System, where he recovered from two brain surgeries and a heart surgery. Thanks to donations to Children’s Miracle Network Hospitals, Joseph and his NICU medical team had access to specialized life-saving equipment. Today, Joseph is an energetic first grader who is thriving with the help of weekly outpatient physical and occupational therapy. Donations provide access to specialized life-saving equipment in the NICU.

At the age of three, Nolan was diagnosed with retinoblastoma, a form of cancer that develops in the eye, after his mom noticed something strange in his eye. Just two weeks later Nolan’s eye was removed, and subsequently went through six months of chemotherapy, ringing the bell to mark the end of treatment just before his fourth birthday. Donations to CHRISTUS Children’s in San Antonio helped fund innovative surgery and cancer care, all instrumental in Nolan’s treatment. Donations fund surgical innovation and cancer care for children like Nolan.

Just before his second birthday, JP was diagnosed with Potocki-Lupski Syndrome (PTLS), after undergoing genetic testing. PTLS caused significant developmental delays including feeding and speech difficulties and low muscle tone. Thanks to early interventions by his specialists at Orlando Arnold Palmer Hospital for Children, JP can walk, run and dance with his seven siblings. Donations support clinicians, programs, and technology for developmental challenges.

Born at just 27 weeks, Ella was diagnosed with periventricular leukomalacia (PVL), a softening of brain tissue due to a brain bleed. After spending the first four months of her life in the neonatal intensive care unit (NICU), she was eventually referred to a specialist for children with cerebral palsy at St. Louis Children’s where she underwent surgery to allow her to walk independently. While recovering Ella was able to enjoy services at the hospital that helped her still feel like a kid, like visits from the therapy dog and time in the playroom. Donations create programs like Camp Independence for children with movement disorders.

Children’s Miracle Network Hospitals, the largest fundraising network for children’s hospitals in the U.S. and Canada, partners with leading pediatric healthcare providers to give kids a world of possibilities.

“The stories of our National Champions emphasize the transformative impact of charitable donations on pediatric healthcare,” said Aimee Daily, Ph.D., President & CEO, Children’s Miracle Network Hospitals. “When you support our mission, you help kids grow up healthier, stronger, and ready for tomorrow.”

National Champions are a group of ambassadors for Children’s Miracle Network Hospitals located throughout the U.S. As National Champions, they’re key to informing the public that children’s hospitals are charities in need of donations. By sharing first-hand experiences, Champions and their families show just how vital local, unrestricted fundraising is for member hospitals to meet the needs of their communities.

Visit cmnhospitals.org to learn more about how Children’s Miracle Network Hospitals and its network support the health of more than 12 million kids each year.

About Children’s Miracle Network Hospitals: 
Children’s Miracle Network Hospitals was founded more than 40 years ago with the vision to Change Kids’ Health, Change the Future. We’ve raised over $8.5 billion for 170 children’s hospitals by empowering and engaging with local communities and businesses – and we’re not done yet. All donations benefit local member hospitals to fund what’s needed most, like critical life-saving treatments and healthcare services, innovative research, vital pediatric medical equipment, child life services that put kids’ and families’ minds at ease during difficult hospital stays, and financial assistance for families who could not otherwise afford these health services.

Together, we can change kids’ health. Together, we can change the future. To learn about Children’s Miracle Network Hospitals and your local member children’s hospital, visit cmnhospitals.org.

Media Contact

Children’s Miracle Network Hospitals, Children’s Miracle Network Hospitals, 8012147400, [email protected], https://cmnhospitals.org

SOURCE Children’s Miracle Network Hospitals

Blue Heron Consulting Reiterates Mission to Improve the Veterinary Profession in Unveil of New Slogan


Blue Heron Consulting has released its new slogan, “Improving the veterinary profession,” earning a permanent home within the company’s revamped logo. This change signifies the nation’s leading veterinary consulting team’s commitment to the profession, ensuring their mission of improving the lives of veterinary professionals is at the center of everything they do.

DANVILLE, Ky., Jan. 2, 2024 /PRNewswire-PRWeb/ — Blue Heron Consulting has released its new slogan, “Improving the veterinary profession,” earning a permanent home within the company’s revamped logo. This change signifies the nation’s leading veterinary consulting team’s commitment to the profession, ensuring their mission of improving the lives of veterinary professionals is at the center of everything they do.

The slogan is a new symbol of an existing purpose. “At BHC, we’ve always been focused on making the veterinary profession better for all. This new design is meant to illustrate that dedication at a higher level.” says Jason Maag, Chief Operating Officer for Blue Heron Consulting.

Its handwritten look will be featured prominently on all future Blue Heron Consulting assets, reminding the industry that veterinary professionals have always been, and will continue to be, why Blue Heron Consulting exists.

About Blue Heron Consulting: Blue Heron Consulting is the nation’s leading veterinary consulting team with a mission to improve the lives of veterinary professionals. At their core is a coaching and support team that works to amplify your strengths, build systems to remove gaps in care and workflows, and create a culture of leadership within your team. Learn more about Blue Heron Consulting by visiting www.bhcteam.com.

Media Contact

Cassidy Matano, Blue Heron Consulting, 1 (859) 365-0780, [email protected], www.bhcteam.com

SOURCE Blue Heron Consulting

E Tech Group Announces Brand Name Change of Recently Acquired System Integrator, E-Volve Systems


“We’ve gained the ability to market and deliver large scale projects that may not have been available to us prior to the acquisition due to our size,” said Kevin Stout, previous E-Volve Systems founder and president and current vice president at E Tech Group. “We’ve also gained a tremendous network of team members whose skillsets seem to be limitless.”

E Tech Group’s acquisition of E-Volve Systems was finalized on February 23, 2023. This strategic move allowed E Tech Group to significantly expand its range of services, thereby enhancing the overall value offered to its clients. The acquisition was a step towards integrating complementary strengths, consolidating market presence, and fostering innovation in service delivery.

“The name change at this time is a formality as E-Volve Systems has been a part of the E Tech Group since late February 2023,” said Matt Wise, Chief Executive Officer of E Tech Group. “Their contributions have positioned E Tech Group to elevate its service offerings and reach with the added benefit of resources located throughout North America as well as a broader suite of services, allowing us to automate every facet of a facility, from process and discrete automation through cybersecurity and data intelligence services, leveraging a team of over 600 automation specialists.”

About E Tech Group
E Tech Group is one of the largest automation engineering and system integration firms in North America. With locations across North America and more than 600 team members and more than 450 engineers, the company provides automation, control and information solutions to the Life Sciences, Data Centers, Consumer Products, Food & Beverage, and other industrial industries. In addition to its organic growth, E Tech Group has recently grown through the successful acquisition and integration of Glenmount Global Solutions, Superior Controls, Automation Group, and E-Volve Systems. For more information, visit the company’s website, LinkedIn, Facebook, and YouTube.

Media Contact

Jennifer Palumbo, E Tech Group, (512) 366-3887, [email protected], https://etechgroup.com/

Georgia Whalen, Rivergate Marketing, 978-697-2664, gwhalen@rivergatemarketing.com

SOURCE E Tech Group

Sonavex Announces Successful Clinical Study of EchoMark & EchoSure and Initiation of the MAFASA Randomized Controlled Trial


FDA IDE approval of Sonavex’s randomized trial comes months after meeting the endpoint of its first clinical study

BALTIMORE, Jan. 2, 2024 /PRNewswire-PRWeb/ — Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).

EchoMark & EchoSure will allow medical professionals to collect essential vascular parameters in the dialysis clinic to assess AV fistula maturation. In September 2023, Sonavex completed a study which demonstrated the ability of users without ultrasound experience to successfully collect accurate measurements of AV fistula maturation with EchoSure. These data were presented at the 50th annual VEITH symposium in November.

In December 2023, FDA approved Sonavex’s randomized controlled trial, MAFASA, which is set to enroll 304 patients. This trial is designed to provide Level 1 data to demonstrate how the use of EchoMark & EchoSure will reduce time to AV fistula maturation and reduce the costs of managing dialysis patients as compared to standard of care by providing more timely measurements. Dr. Stephen Hohmann, a highly respected Dallas-based vascular surgeon with expertise in dialysis access surgery will serve as the National Principal Investigator for the trial.

“Initial clinical results validate the safe and effective use of EchoMark & EchoSure,” said Dr. Stephen Hohmann. “I look forward to leading this large, randomized, multicenter trial to demonstrate the impact that the technology has on improving care for dialysis patients.”

“The results from Sonavex’s first study corroborate our team’s vision for how EchoMark & EchoSure can be used for AV fistula patients,” said David Narrow, Chief Executive Officer of Sonavex. “We are excited to embark upon the MAFASA trial to better quantify the clinical and economic benefit of the technology and anticipate enrollment to commence in Q1 2024.”

About Sonavex, Inc.

Sonavex, Inc. is a Baltimore-based medical device company originally spun out of Johns Hopkins. The company has developed a portfolio of novel ultrasound solutions that empower patient care by delivering critical visual and quantitative data to improve outcomes and reduce costs. For more information, please visit www.sonavex.com.

Media Contact
David Narrow, Sonavex, Inc., 1 4438622024, [email protected], www.sonavex.com

SOURCE Sonavex, Inc.