Mauna Kea Technologies Announces Publication of a Meta-analysis Demonstrating Cellvizio’s Significant Role in Detection of Esophageal Dysplasia and Cancer

Results demonstrate a significant increase in the detection rate of neoplasia when Cellvizio is used as an adjunct to the standard of care, underscoring the key role of advanced imaging in slowing the rapid growth of esophageal cancer Meta-analysis builds on recent data demonstrating that the use of Cellvizio is also associated with lower health services utilization and fewer overall endoscopy procedures

Paris and Boston, July 6, 2022 – 6:00 pm CEST – Mauna Kea Technologies (Euronext: MKEA, ‘Mauna Kea’) inventor of Cellvizio^®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform today announced the peer-reviewed publication of a new meta-analysis in Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) entitled “High definition probe-based confocal laser endomicroscopy review and meta-analysis for neoplasia detection in Barrett’s esophagus”¹. The study demonstrates that the addition of Cellvizio as an adjunct to guide biopsies provides a significantly higher diagnostic yield for dysplasia and cancer and reduces sampling error compared to random four-quadrant biopsies alone, the standard of care.

Existing endoscopic screening and surveillance methods are insufficient in detecting Barrett’s Esophagus or esophageal cancer, as using the Seattle Protocol standard of care alone is prone to sampling error and poor sensitivity and specificity. At Digestive Disease Week^® (DDW) in May 2022, Dr. Bashar Qumseya presented data² based on roughly 5 million people and showing that, among those ages 45 to 64, esophageal cancer (EAC) rate nearly doubled from 2012 to 2019. Moreover, the prevalence of Barrett’s esophagus – the only known precursor to EAC – rose by about 50% in this age group in the same period. In the TIGE meta-analysis, the authors included 9 studies for a total of 688 patients and 1,299 lesions and assessed the benefits of probe-based CLE (pCLE) as an adjunct to random 4-quadrant biopsies in the surveillance of patients with Barrett’s esophagus for dysplasia and early EAC detection. Perpatient pCLE pooled sensitivity, specificity, and negative predictive value were 96%, 93%, and 98%, respectively. Compared to random biopsies, the per-patient pooled absolute and relative detection rate increases of neoplasia with pCLE were significant and equal to 5% and 243%, respectively.

Separately, at the ENDO 2022 World Congress of GI Endoscopy in May 2022, the results of a retrospective multi-center chart review³ of 60 patients with Barrett’s esophagus who were referred for endoscopic surveillance or treatment were presented. The authors were examining differences in gastroenterology health services utilization for eight items/ services among patients treated using Cellvizio as an adjunct versus standard of care alone. The Cellvizio cohort had 1.04 fewer endoscopies and anesthesia services, 7.49 less biopsy bottles, 1.30 fewer ablations, and 1.46 less brush cytology services. Therefore, the researchers concluded that Cellvizio is associated with an overall lower burden to the healthcare system.

“The results from these studies demonstrate that there are better tools that are easily accessible to physicians who are working to improve the detection rate of screening and surveillance programs, and ultimately reverse the alarming rise in prevalence of esophageal cancer,” said Nicolas Bouvier, Interim Chief Executive Officer of Mauna Kea Technologies. “Better detection rates and a lower utilization of healthcare services make Cellvizio a valuable adjunct to the standard of care in hospitals and ambulatory surgery centers alike.”

About Barrett’s Esophagus and Esophageal Cancer

Barrett’s Esophagus, often abbreviated as BE, is a condition that results from chronic gastroesophageal reflux disease (GERD), where the lining of the esophagus at the junction of the stomach undergoes significant physiological changes that can often be detected only with thorough screening and surveillance. Chronic GERD affects approximately 5-10% of the population globally, and if left unmanaged can progress to BE without proper surveillance. BE is the only known precursor to esophageal adenocarcinoma (EAC), one of the fastest growing causes of cancer deaths with very poor 5-year survival rates.

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio^®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients.

For more information, visit: maunakeatech.com

ASPEN MALNUTRITION AWARENESS WEEK: HELPING GI CLINICIANS INTERVENE AND TREAT MALNUTRITION

On September 19-23, 2022, during Malnutrition Awareness Week^TM, gastroenterologists and other healthcare professionals can gain new insights and tools to detect and treat malnutrition in their patients. This annual educational campaign presented by the American Society for Parenteral and Enteral Nutrition (ASPEN) will include five live CME webinars and a wide array of complimentary resources addressing malnutrition in adult and pediatric patients. Malnourished patients have longer hospital stays, twice the need for rehab or long-term care, and a 3.4 times higher rate of hospital deaths. In addition to its human toll, malnutrition raises hospital costs by 73% and can cost an additional $10,000 in hospital readmission stays.

The American Society for Gastrointestinal Endoscopy and the Society of Gastroenterology Nurses and Associates are among the growing number of organizations that support Malnutrition Awareness Week. The live webinars—which are free to ASPEN members and supporting organizations—start at 12 noon ET each day of that week. They will be offered on:

Each of the webinars provide 1-1.5 CME credits. Early registration is recommended as webinar capacity is limited.

In ASPEN’s Malnutrition Solution Center are complimentary access to nutrition screening and assessment tools, fact sheets, videos, podcasts, and more.

Visit nutritioncare.org/MAW to register for the webinars and to access the resources.

About ASPEN

The American Society for Parenteral and Enteral Nutrition is dedicated to improving patient care by advancing the science and practice of nutrition support therapy and metabolism. It is an interdisciplinary organization whose members are involved in the provision of clinical nutrition therapies, including parenteral and enteral nutrition. With members from around the world, ASPEN is a community of dietitians, nurses, nurse practitioners, pharmacists, physicians, scientists, students, and other health professionals from every facet of nutrition support clinical practice, research, and education.

For more information about ASPEN, please visit nutritioncare.org

TENURED AAAHC FACULTY AND EXPERT SURVEYORS TO LEAD VIRTUAL CONFERENCE FOR AMBULATORY PRACTICES

Robust Agenda Features Standards Guidance, Quality Improvement Award Winners

(Skokie, Ill.) July 11, 2022 — On August 1-3, 2022, the Accreditation Association for Ambulatory Health Care (AAAHC) will host its summer 2022 Achieving Accreditation virtual conference. The flagship event is designed to provide essential insights for currently accredited primary care facilities, office-based surgery centers, and ambulatory surgery centers, as well as organizations seeking to gain an understanding of AAAHC Standards and accreditation readiness.

The immersive, three-day Achieving Accreditation conference offers participants an in-depth review of practical applications to AAAHC Standards, including an introduction to the new v42 Standards and related terminology. Using a blend of live discussion groups and video sessions, Achieving Accreditation provides physicians, clinical managers, nurses, and administrators the opportunity to polish their existing skillsets while gaining up-todate guidance on Standards in preparation for initial accreditation or reaccreditation and to stay accreditation ready throughout the 1095 Strong journey.

“Participants attend our highly regarded Achieving Accreditation conference with questions and the desire to connect with peers,” said Noel Adachi, MBA, president and CEO of AAAHC. “AAAHC expert faculty and staff guide attendees through essential content in a collaborative format creating the foundation for the 1095 Strong, quality every day philosophy with relevant insights and a host of new peer contacts.”

Led by esteemed AAAHC faculty and surveyors, attendees will gain experience through tailored quality improvement (QI) workshops, group collaboration, and a variety of interactive peer panels and elective breakout sessions led by industry experts. August sessions will cover a wide range of relevant topics including promoting workplace mental health, advanced infection prevention, and Life Safety Code.

As an added value, virtual conference attendees will have 24/7 access to learning opportunities that will extend beyond the event, with select program content available in the days leading up to Achieving Accreditation. Plus, the entire conference recording will be available for one month after the event for participants interested in delving deeper on their own time. Achieving Accreditation participants can receive up to 15 AEUs, 2 IPCH (Infection Prevention Contact Hours), and up to 17.5 CEUs.

The August Achieving Accreditation conference will also feature a special presentation to unveil the winners of the coveted 2021-22 Bernard A. Kershner Innovations in Quality Improvement (QI) Award and People’s Choice Award.

“As a former co-winner of the Kershner QI Award, I can appreciate each and every finalist and their focus on improving patient safety through noteworthy quality improvement studies in their organizations,” said Julie

Lynch, MS, BSN, RN, director, Institute for Quality Improvement. “Everyone will want to participate in the unveiling of our 2021-22 Kershner QI Award winners.”

To round-out this year’s robust lineup of educational seminars and events, AAAHC will host a live, in-person Achieving Accreditation conference on December 2-3, 2022 at the Red Rock Las Vegas. “AAAHC looks forward to welcoming industry members back with twodays of engaging, onsite instruction,” added Adachi.

For additional details about the Achieving

Accreditation program, including online registration and a complete session agenda, please visit: aaahc.org/Achieving

About AAAHC

Founded in 1979, AAAHC is the leader in ambulatory health care accreditation, with more than 6,600 organizations accredited. We accredit a wide range of outpatient settings, including ambulatory surgery centers, office-based surgery facilities, endoscopy centers, student health centers, medical and dental group practices, community health centers, employer-based health clinics, retail clinics, and Indian/Tribal health centers, among others. AAAHC advocates for the provision of high-quality health care through the development and adoption of nationally recognized standards. We provide a valuable survey experience founded on a peer-based, educational approach to onsite review. The AAAHC Certificate of Accreditation, along with specialized programs including Advanced Orthopaedic Certification and Patient-Centered Medical Home Certification, demonstrates an organization’s commitment to providing safe, high-quality services to its patients—every day of the 1,095-day accreditation cycle. AAAHC Accreditation and Certification Programs are recognized by third-party payors, medical professional associations, liability insurance companies, state and federal agencies, and the public.

For more information on AAAHC, please visit: aaahc.org

Download Tables, Images & References