Missouri Firm With Silicon Valley Ties Faces Medicare Billing Scrutiny

khn.org | July 23, 2019

ST. LOUIS In many ways, Essence Group Holdings Corp. is a homegrown health care success story. Founded locally, it has grown into a broader company backed by a major Silicon Valley investor. Essence now boasts Medicare Advantage plans for seniors with some 60,000 members in Missouri and across the Mississippi River in Illinois. It ranks among the city’s top 35 privately held companies, according to the St. Louis Business Journal. And market research firm PitchBook Data values the company at over $1.64 billion. But a recent audit by the federal Health and Human Services inspector general, along with a whistleblower lawsuit, have put the St. Louis health care standout under scrutiny. Medicare officials also are conducting a separate audit of Essence. The same growth and use of big data that attracted venture capital cash are getting a renewed look from government officials who estimate that Medicare Advantage plans nationwide overcharge taxpayers nearly $10 billion annually. The April audit of Essence — the first in a series of upcoming audits scrutinizing some Medicare Advantage plans across the United States — revealed that the St. Louis company could not substantiate fees for dozens of patients diagnosed with stroke or depression.

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MEDICAL DEVICES

Adaptiiv collaborates with HP and Varian to enhance personalization in radiation oncology with 3D printed medical devices

Adaptiiv Medical Technologies Inc. | May 09, 2022

Adaptiiv Medical Technologies Inc. is collaborating with HP Inc. and Varian, a Siemens Healthineers company to advance the quality of and access to personalized cancer care for U.S. patients with 3D printed medical devices. HP's Multi Jet Fusion platform provides access to leading 3D printing technology that is used to produce high-quality, flexible, patient-specific parts at high throughput. HP 3D printing is suitable for use in healthcare because of the speed, quality, and economic advantages gained through HP's scalable manufacturing processes. "The combined technology scale of HP and Varian, along with the leading-edge personalization workflow of Adaptiiv, provides the improved solution that clinicians and patients deserve," said Louis Kim, Vice President, 3D Printing at HP. HP is proud to be a part of this collaboration to help advance the treatment of cancers worldwide." Adaptiiv will also work with Varian to expand access to personalized, patient-specific 3D printed medical devices. For more than 70 years, Varian has developed, built, and delivered innovative cancer care technologies and solutions for clinical partners around the globe to help them treat millions of patients each year. This agreement advances Varian's commitment to meeting evolving customer needs and improving the patient experience. "We are energized by Adaptiiv's innovation and this opportunity with HP to further expand our cancer care ecosystem. Addressing our customers' needs is our top priority, and we are confident that this commercial commitment will help us do just that by advancing interoperability with Adaptiiv's 3D printed medical devices for external beam radiation therapy," Ben Moga, Director, Strategic Alliances and Synergy Investments at Varian Earlier this year, Adaptiiv received U.S. FDA 510(k) clearance for the Adaptiiv On Demand service to manufacture and deliver 3D printed patient-specific medical devices. 3D printed medical devices conform to patient anatomy thereby improving the accuracy of dose delivery while the integration of Adaptiiv software into clinical workflows provides improved efficiencies, such as reducing patient set up time both in CT simulation and on the treatment unit. "This is a tremendous milestone for Adaptiiv's vision to democratize personalization in radiation treatment," said Adaptiiv CEO, Alex Dunphy. "Collaborating with brands like HP and Varian who stand for quality and innovation will ensure our solutions reach patients around the world. The last mile of radiation therapy needs to evolve and our solutions provide greater access to personalized care, while improving treatment and creating workflow efficiencies for cancer centres around the world." About Adaptiiv Adaptiiv Medical Technologies Inc. has a software platform that works in conjunction with 3D printing to create medical devices for use in radiation oncology. Adaptiiv is shaping the future of personalized healthcare through innovation and collaboration with industry leaders throughout the world.

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FUTURE OF HEALTHCARE

OmniLife Partners With Redox to Add Patient Referral Management Tool to Its End-to-End Communication Platform for Transplant Hospitals.

OmniLife | March 25, 2022

OmniLife, a health technology communication and collaboration platform, has partnered with Redox, the industry-leading electronic health record integration and healthcare interoperability platform, to create a new integrated patient management tool as part of its overarching platform that provides end-to-end communication solutions for transplant hospitals. The new patient modules, OmniReferral and PatientStatus, will allow transplant centers to easily review new referrals and share updates on patient status to providers and allows transplant centers to customize their own digital forms to make it easier for providers to refer and then monitor the activity and status of transplant patients. The tool also integrates into the EHR patient checklists and allows centers using EHRs to easily share patient status updates with referring providers. OmniReferral and PatientStatus is built to be organ agnostic, allowing centers to use the tool across all organ departments and with any referring provider. OmniLife has been leading efforts to improve communication, decision making, and secure information exchange between all stakeholders in the greater allotransplant ecosystem. Additionally, OmniLife is currently participating in a clinical trial funded by the National Institutes of Health (NIH) for a Small Business Innovation Research (SBIR) which includes notable centers such as UPMC Children’s Hospital of Pittsburgh, Loma Linda University Transplant Institute, and Stanford Health Care Transplant Program. About OmniLife OmniLife is a certified Benefit Corporation focused on maximizing the gift of life for purposes of transplantation and research. OmniLife is the only end-to-end communication and clinical workflow software platform that is built specifically to create a more connected and collaborative allotransplant ecosystem.

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MEDICAL DEVICES

GeneQuantum Healthcare's Two Next Generation Bioconjugate Drugs, GQ1005 and GQ1007, Have Been Approved for Clinical Trials in Australia

GeneQuantum Healthcare | May 16, 2022

GeneQuantum Healthcare Co., Ltd. a global innovative biotechnology company dedicated to the development of bioconjugate drugs, announced that two of the company's bioconjugate drug candidates have won the approval for clinical trials in Australia, further enhancing GeneQuantum's pipelines in the clinical stage. They are GQ1005, an ADC with an excellent bystander killing effect, and GQ1007, a first-in-class antibody-immune-agonist-conjugateboth with global intellectual property rights. "The core technologies that we have focused on since the founding of GeneQuantum, bring the company into the harvest period for exciting next generation bioconjugate drugs. The EC approval of GQ1005 and GQ1007 in Australia is an important milestone for the company. More than once, GeneQuantum's enzymatic site-specific conjugation platform and the stable linker technology have demonstrated the advantages through several IND enabled drug candidates. GeneQuantum conjugation technologies are widely compatible to different molecular modalities with various Mechanism of Action. Committed to the core value of "breakthrough for humanity", GeneQuantum is dedicated to developing safe, effective, and affordable novel therapeutics for patients with cancer around the world." Dr. Gang Qin, founder, Chairman and Chief Executive Officer About GeneQuantum Healthcare Co., Ltd. GeneQuantum Healthcare Co., Ltd. is a global biotechnology company dedicated to the development of innovative biotherapeutics. The company is focused on the development of next generation bioconjugate therapeutics to address the unmet medical needs of patients globally. This press release contains statements relating to GeneQuantum's future business, future events or developments, and related statements may constitute forward-looking statements. Statements are based on current expectations and assumptions that are subject to risks and uncertainties, which may cause actual results to differ materially. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, follow-up clinical data and analysis; factors that may cause any delay, transfer or change; regulatory authority decision whether and when to approve drug applications; factors that may lead actual results to seriously deviate from current expectations, etc. No forward-looking statement can be guaranteed. Except as required by applicable laws, GeneQuantum assumes no obligation to update or revise any forward-looking information or statements.

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HEALTH TECHNOLOGY

Texas Children's Hospital And Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization In India

Texas Children Hospital | December 29, 2021

Texas Children's Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General ofIndia(DCGI)to launch inIndiawith other underserved countries to follow. Dubbed "The World's COVID-19 Vaccine", it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children's Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic: CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELD™ vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response. CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies. CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies. While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELD™. In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. "Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world," said Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production." The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world's fight against the COVID-19 pandemic. Without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries. "This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant," said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Widespread and global vaccination with our Texas Children's-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow." "Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children's Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge". Mahima Datla, Managing Director, Biological E. Limited ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BCM VENTURES Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

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