Avania | June 21, 2022
Avania, the preeminent, full-service global MedTech contract research organization announced that Astorg has acquired a majority stake in the company. Astorg, together with Kester Capital current investor who intends to retain a minority stake will actively support management’s plans to advance Avania’s development as a MedTech solution provider.
Headquartered in the Netherlands, Avania was formed in March 2020 from the combination of five complementary businesses and started a successful journey to establish a fully integrated platform to serve sponsors worldwide in advancing medical technology products from early development to post-market ensuring customized, scalable solutions that optimize efficiencies and streamline the advancement of medical technology.
Astorg brings an impressive global network of relationships in the MedTech space which will strengthen Avania’s pipeline and broaden its customer base while the capital access will help accelerate its growth, both organically and via acquisitions.
“The platform we have built has positioned us ahead of our competition in the MedTech CRO space, and this deal will bring additional investment to strengthen our infrastructure, capital for acquisitions, and added support as we continue to grow Avania into the clear market leader. The largest CROs do not have the specialization that we bring, and the regional niche providers do not have the scale and reach of Avania. This unique positioning, along with the continued changes to the MedTech regulatory landscape, will allow us to push ourselves to the next era of growth.”
Sapna Hornyak, president and CEO of Avania
“We are extremely pleased to partner with Sapna and her team, as well as Kester, on this transaction,” said Managing Partner of Astorg Mid-Cap Edouard Pillot. “Being one of the global leaders in a profitable and fast-growing niche market, Avania squarely fits with Astorg’s investment criteria, and we are delighted to have Avania as our first Mid-Cap Healthcare deal, sitting within Astorg’s broader healthcare portfolio.”
Avania is a leading, global full-service contract research organization focused on the management of clinical studies for medical technology, IVDs, biologics, and device-drug combination products internationally. Avania supports products from the first-in-human phase through the post-market phase with the same customized approach. When you need to advance your medical technology, it takes Avania. Avania’s vision is to be your trusted global partner in the evolution of your medical technology from innovation to commercialization to improving patient health and well-being.
Astorg is a leading private equity firm with over €17 billion of assets under management. We work with entrepreneurs and management teams to acquire market-leading global companies headquartered in Europe or the US, providing them with the strategic guidance, governance, and capital they need to achieve their growth goals. Astorg enjoys a distinct entrepreneurial culture, a long-term shareholder perspective, and a lean decision-making body. We have valuable industry expertise in healthcare, software, business-to-business professional services and technology-based industrial companies. Astorg has offices in London, Paris, New York, Frankfurt, Milan and Luxembourg.
About Kester Capital
Kester Capital is a primary buy-out specialist. Kester focuses on the healthcare, data & information and technology sectors, targeting businesses that require capital in order to unlock their potential.
Extremity Medical, LLC | April 07, 2022
Extremity Medical, LLC, a global medical device company focused on the development of innovative implants and instruments for upper and lower extremities, announcedthat it filed a lawsuit against Nextremity Solutions, Inc.; Zimmer Biomet Holdings, Inc.; and Zimmer, Inc., alleging infringement of an Extremity Medical patent* for its intraosseous fixation platform arising from the marketing of the InCore® Lapidus System by these companies. The complaint was filed in the U.S. District Court for the District of Delaware.
Extremity Medical has amassed an intellectual propertyportfolio that includes 49 patents in the U.S. and several foreign countries. The novel and patented technology of Extremity’s intraosseous fixation platform provides surgeons with a zero-profile solution for fusion and fixation of bones within the upper and lower extremities, with the ability to be implanted through minimal incisions. This technology is currently marketed globally by Extremity under the trade names IO FiX, IO FiX Plus, IO FiX 2.0, IO Freedom, CarpalFiX, ApeX and XMCP.
“Extremity Medical has invested a tremendous amount of effort and resources in research and development to create innovative technology to improve the lives of patients and meet surgeons’ needs. Our intellectual property is a critical component in making such advancements possible and we are committed to protecting it,”
Matthew Lyons, Extremity Medical Chief Executive Officer, Founder and Chairman of the Board
About Extremity Medical, LLC
Extremity Medical, was founded in 2008, and is a privately-held medical device company based in Parsippany, NJ. The company is known for creating innovative implants and instruments for upper and lower extremity orthopedic procedures, including fusion and motion preservation. The company is focused on developing solutions for challenging cases that promote better outcomes, especially in patients with poor bone quality.
Easterseals | June 23, 2022
Easterseals announced today that it has received a grant of $750,000 from the Abbott Fund, the foundation of the global healthcare company Abbott, to pilot the Project on Education and Community Health Equity from now through 2025. The three-year project aims to address systemic barriers to high-quality education and healthcare experienced by children and families in underinvested communities.
Research shows that many young children, particularly children with disabilities and children of color, face significant gaps in access to crucial health and social services that can provide the targeted support they need to be prepared to succeed in school. One example: according to a study by the American Academy of Pediatrics, Black children with autism and other disabilities are diagnosed an average of more than three years after their parents expressed concerns about their development. This delay in diagnosis means these children miss out on age-appropriate care and the chance to improve their health and cognitive skills, often resulting in them entering kindergarten with knowledge and skill deficits that many are not able to overcome throughout their K-12 educational journey.
The Project on Education and Community Health Equity will create an integrated system that addresses the educational and healthcare needs of children to help them be kindergarten ready and reach their full potential. This includes work in three areas: expanding access to essential physical and mental health screenings and care for children; providing targeted social services to help families overcome gaps in basic needs, nutrition, transportation, and other social and economic barriers; and ensuring that early childhood administrators and educators have the right training to identify and address health and social challenges and provide culturally appropriate support for children. The project will be implemented at Easterseals Childhood Development Centers in Southern California, Atlanta and North Georgia, and the greater Washington, D.C., area.
"Addressing the healthcare needs of infants and toddlers as early as possible in their lives is one of the critical ways in which Easterseals serves young children and families across the country. The Project on Education and Community Health Equity will allow us to better address healthcare disparities experienced by young BIPOC children and their families in historically underserved and marginalized communities, and to better understand the connection between more equitable access to healthcare and kindergarten readiness. Centering communities of color in our efforts is a critical strategy to close the gap. Outcomes from the project promise to inform its future expansion to early childhood and early education programs throughout the Easterseals Network of 70 affiliates in communities nationwide."
Erika L. Watson, National Director of Childhood Development, Education and Equity at Easterseals
"We're proud to support Easterseals' important work to help close equity gaps in education and community health," said Melissa Brotz, president of the Abbott Fund and vice president of Global Marketing and External Affairs at Abbott. "We're committed to advancing health equity and fighting racial health disparities, and our partnership with Easterseals will help reduce barriers to care for children, their families and their communities."
The Project on Education and Community Health Equity builds on results seen through another Easterseals program, the Black Child Fund. Launched in 2021 with support from the Abbott Fund and others, the Black Child Fund advanced early identification and interventions among Black children with autism and other disabilities to reduce health disparities often experienced in early childhood. The Abbott Fund investment launched pilots at Easterseals locations serving Chicagoland and Greater Rockford, DuPage and the Fox Valley Region (IL), and Kansas City and St. Louis (MO).
Through these pilot programs, an 87% increase in the number of Black families seeking services and support was realized, with more than 300 Black children screened for early diagnosis of autism and other disabilities in just one year. Of these children, 80% were five years old or younger, with 75% requiring and receiving additional services through Easterseals. An important outcome of these pilots has been the strengthening of relationships within Black communities across these Easterseals service areas to ensure more equitable and more culturally responsive services and supports to young children of color with disabilities and their families.
The Centers for Medicare and Medicaid Services (CMS) released data revealing that during the pandemic public health emergency, rates for primary and preventive services among children in Medicaid and the Children's Health Insurance Program (CHIP) declined substantially. This decline in care for millions of children from low-income families will potentially have a significant impact on long-term health outcomes for the nearly 40 million children in the U.S. who rely on Medicaid and CHIP, including three-quarters of children living in poverty and many with special healthcare needs including infants, toddlers, and young children with disabilities.
"Through the Project on Education and Community Health Equity, it is Easterseals' intention to address the disparities in healthcare among young children in low-investment communities and to understand the connection between health equity and early childhood educational attainment. We intend to center the experiences of children of color and their families, for whom inequities have only been exacerbated because of the pandemic," Watson concluded.
The Abbott Fund's partnership with Easterseals supports Abbott's 2030 Sustainability Plan, which aims to advance health access and equity through partnership. Abbott's ongoing commitment to address health equity challenges includes targeted programs to increase diversity in clinical trials, create opportunities in STEM for women and underrepresented groups, and empower communities to break down social and economic barriers to better health.
Easterseals is leading the way to full equity, inclusion, and access through life-changing disability and community services. For more than 100 years, we have worked tirelessly with our partners to enhance quality of life and expand local access to healthcare, education, and employment opportunities. And we won't rest until every one of us is valued, respected, and accepted. Through our national network of Affiliates, Easterseals provides essential services and on-the-ground supports to more than 1.5 million people each year – from early childhood programs for the critical first five years, to autism services, medical rehabilitation and employment programs, veterans' services, and more. Our public education, policy, and advocacy initiatives positively shape perceptions and address the urgent and evolving needs of the one in four Americans living with disabilities today. Together, we're empowering people with disabilities, families, and communities to be full and equal participants in society.
About Abbott and the Abbott Fund
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
FUTURE OF HEALTHCARE
Virta Health | June 07, 2022
Virta Health, the leader in type 2 diabetes reversal, revealed preliminary five-year results from its landmark clinical trial at the American Diabetes Association 82nd Scientific Sessions. Presenting four unique abstracts, Virta highlighted myriad, lasting health improvements for people with type 2 diabetes and prediabetes, including blood sugar control, clinically-significant weight loss, reduced inflammation, and improvements in other markers of cardiometabolic health.
These transformative health outcomes coincided with medication reduction or elimination for many trial patients, including Jane Ann Dimitt.
For over two decades, Jane Ann was prescribed increasing levels of medications as her blood sugar and weight continued to climb. By the time she joined Virta in 2015, her A1c had reached 11.4%; the next step was insulin. Through Virta’s treatment, Jane Ann lowered her blood sugar to 5.5% (below even the prediabetes threshold) and lost over 50 pounds, while drastically reducing her reliance on medications. She also saw improved mobility, decreased inflammation and neuropathy, and now has the energy to play with her grandchildren—all without needing the insulin doctors said was imminent.
The outcomes of Jane Ann and Virta’s other trial patients contradict the belief that progression of diabetes—and a lifetime of increasing medications—is inevitable. One-fifth of Virta patients completing five years of treatment saw full remission. One-third of patients achieved A1c below 6.5% without any diabetes medications, or only requiring Metformin. Notably, inflammatory markers, triglycerides, and HDL cholesterol all improved significantly.
These outcomes, in conjunction with previous research demonstrating improvements in cardiovascular disease risk factors, depression symptoms, sleep, and knee pain, establish the promise of Virta’s approach to impact a wide range of conditions amid America’s metabolic disease epidemic. In the U.S., costs are rising as patient outcomes continue to worsen, including surges in amputations, hyperglycemic events, and diabetes-related deaths during the COVID-19 pandemic.
Meanwhile, getting patients to stick with an intervention remains a significant challenge in diabetes therapy. Rates of medication adherence—that is, whether patients take their medications as prescribed—fall as low as 34% over the first three years for those starting insulin. For the National Diabetes Prevention Program, considered the gold standard in lifestyle interventions, only 13% of patients were retained at one year.
In contrast, in Virta’s trial nearly 50% of participants with type 2 diabetes were retained at five years. Of those who continued past year two, 72% remained for an additional three years to year five. For Kim Shepherd, who lost 55 pounds, eliminated 10 different medications, reversed her diabetes, and even saw her GERD (acid reflux) and plantar fasciitis disappear, the reasons to stick with the treatment are clear.
“Diabetes runs in my family, and I know that this disease can rob you of your whole life; it can take your eyes, your feet, and your kidneys. I have 4 kids and 9 grandkids to keep up with. I’ve learned to love hiking and biking. Nothing is worth losing all of that and going back to how I was before.”
Additional key outcomes demonstrating the success of Virta’s approach at five years include
Sustained blood sugar control. Virta patients experienced persistent improvements in blood sugar on average, while requiring significantly fewer medications.
Medication deprescription. Half of patients prescribed insulin at the start of the trial no longer needed it at five years. Across all diabetes drugs, prescriptions were reduced by nearly 50%.
Weight loss. Average weight among Virta participants decreased by 7.6%, exceeding the 5% benchmark for clinically significant weight loss by more than 50%.
Broad improvement in cardiometabolic health. In addition to improvements in triglycerides, HDL cholesterol, and markers of inflammation, patients even showed encouraging signs in reversing the progression of chronic kidney disease.
“Virta’s patients are helping redefine what long-term success can look like in type 2 diabetes care. The patient outcomes set a new standard for real-world applications of diabetes treatment."
Dr. Alan Moses, former Senior Vice President and Global Chief Medical Officer of Novo Nordisk, and Virta advisor
Trial participants with prediabetes also saw meaningful improvements, with progression rates far below what has been demonstrated in other studies. Further, Virta patients sustained 6% weight loss over five years, exceeding the clinically-significant benchmark for diabetes prevention and far surpassing the 2% weight loss observed in the NIH Diabetes Prevention Program lifestyle intervention.
The study is also notable for its longevity. Five-year published results are extremely rare in digital health, where most studies follow populations for no more than a year, and usually significantly less. For many Virta patients, the five-year clinical trial has facilitated a lasting lifestyle change, improving not only traditional markers of health but overall mood, quality of life, and outlook on the future.
Says patient Denise Lamb, who has maintained diabetes reversal alongside a nearly 70 pound weight loss, “My journey has been phenomenal. The Virta program has not only helped me achieve healthy blood glucose, but also attain a far better weight, normal blood pressure, and better understanding of my body. Virta’s lifestyle changed my lifestyle!”
About Virta Health
Virta Health helps people reverse type 2 diabetes and other chronic conditions. Current approaches manage disease progression through increased medication use and infrequent doctor visits. Virta reverses type 2 diabetes through innovations in technology, nutrition science, and continuous remote care from physicians and behavioral experts. In clinical studies, 94% of patients reduce or eliminate insulin use, and weight-loss exceeds FDA benchmarks by nearly 150%. Virta works with the largest health plans, employers, and government organizations and puts 100% of its fees at risk based on clinical and financial outcomes.