MediBeacon, Inc.

MediBeacon approaching completion of Phase 3 study focused on kidney disease; Has submitted three of five required PMA modules needed for FDA approval ST. LOUIS, Nov. 16, 2022 /PRNewswire/ -- MediBeacon Inc., a portfolio company within the Pansend Life Sciences segment of INNOVATE Corp. (NYSE: VATE), today announced amendments to its commercial partnership with Huadong Medicine Co., Ltd., which trades on the Shenzhen Stock Exchange. MediBeacon is a medical technology company specializing in the advances of fluorescent tracer agents and transdermal measurement. Under terms of the amendments to existing agreements, which the companies originally entered into in July 2019, Huadong Medicine will provide approximately $10 million in funding through the end of Q2 2023. This includes $7.5 million or 50% of the remaining $15 million milestone investment due upon FDA approval of the MediBeacon® Transdermal GFR Measurement System (TGFR), at a pre-money valuation of approximately $400 million. This investment as well as additional non-dilutive funding enables accelerated development of future enhancements to the product globally. The amendments further strengthen the partnership towards approval of the MediBeacon TGFR in the U.S. and China. The MediBeacon TGFR is designed to measure Glomerular Filtration Rate (GFR), an indicator of kidney function, at the point of care without the need for blood sampling or urine collection. MediBeacon is in the process of completing enrollment in the global TGFR Pivotal Study at U.S. and China-based clinical sites. Earlier this month, at the annual meeting of the American Society of Nephrology, "Transdermal Glomerular Filtration Rate Measurement: Clinical Results from a Pilot Multi-Center Study Establishing Feasibility and Efficacy" was presented by MediBeacon Chief Scientific Officer Richard B. Dorshow, PhD.1 The presentation provided an overview of the results of the MediBeacon TGFR clinical studies conducted in advance of the ongoing Phase 3 study. Chronic Kidney Disease (CKD) is a progressive condition that affects over 800 million individuals worldwide, representing greater than 10% of the general population globally. In the U.S., more than one in seven people, or approximately 15% of American adults, are estimated to have CKD. As many as nine in ten adults with CKD and approximately two in five adults with severe CKD are unaware of their condition. CKD is extremely common and has emerged as one of the leading noncommunicable causes of death worldwide. Fortunately, however, people who are aware of their CKD or at risk for CKD can take steps to protect their kidneys with the help of their health care providers.2,3 MediBeacon has submitted three of the five PMA modules needed for full FDA review and approval. The Company has submitted PMA module 1 (Nonclinical Assays and Biocompatibility), PMA module 2 (Device Testing) and PMA module 3 (Device Manufacturing). The MediBeacon TGFR has been designated a Breakthrough Device by U.S. FDA and an Innovative Medical Device by China NMPA. MediBeacon TGFR Pivotal Study MediBeacon TGFR Pivotal Study (NCT05425719) is a Phase 3 open label, multi-center, safety and pharmacokinetic study of relmapirazin (MB-102) and the use of the MediBeacon Transdermal GFR Measurement System (TGFR) in normal and renal compromised subjects for the evaluation of kidney function. The safety and effectiveness of the MediBeacon TGFR for point of care non-invasive transdermal fluorescence detection of relmapirazin is being evaluated in subjects with kidney function from normal to Stage 4 CKD. Patient enrollment covers the entire range of human skin colors spanning fair to black pigmentation. The study's primary outcome measure is the correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Measured GFR (mGFR) obtained from blood samples collected over time.4 About Relmapirazin (MB-102) Relmapirazin (MB-102) is an investigational pyrazine-based compound which has been engineered to be inert, highly fluorescent and have the clearance properties of a GFR tracer agent in the body. The investigational relmapirazin solution for injection has been administered to over 400 subjects under Investigational Device Exemptions (IDE). The unique photophysical characteristics of relmapirazin have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of relmapirazin fluorescence over time and is converted into a tGFR by proprietary algorithms. About MediBeacon Inc. MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and transdermal detection. MediBeacon's use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon's 47 granted U.S. patents and 170+ granted patents worldwide provide extensive coverage of the MediBeacon TGFR, including relmapirazin, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology including potential applications in nephrology, gastroenterology, ophthalmology and surgery. For more information, please visit: About INNOVATE Corp. INNOVATE Corp. is a portfolio of best-in-class assets in three key areas of the new economy – Infrastructure, Life Sciences and Spectrum. Dedicated to stakeholder capitalism, INNOVATE employs approximately 3,900 people across its subsidiaries. For more information, please visit: . About Huadong Medicine Co., Ltd. Huadong Medicine Co., Ltd. (SZ.000963) is a leading Chinese pharmaceutical company based in Hangzhou, China. Founded in 1993, Huadong Medicine has fully integrated R&D, manufacturing, distribution, sales and marketing capabilities. Huadong Medicine's product portfolio and pipeline are specialized in oncology, immunology, nephrology and diabetes. The company has 11,000 employees and one of the most extensive commercial coverage and marketing capabilities in China. 'Patient Centered, Science Driven' is Huadong Medicine's value. For additional information, please visit 1 2 3 Csaba P. Kovesdy, "Epidemiology of chronic kidney disease: an update 2022", Kidney International Supplements, (2022) 12, 7-11, . 4 ClinicalTrials.gov Photo - SOURCE MediBeacon Inc.

Crystal Winkeler returns to BioGenerator after driving Canopy Biosciences to successful acquisition by Bruker ST. LOUIS – BioGenerator Ventures announced today that Crystal Winkeler, Ph.D., is joining the team as Managing Director. Prior to founding Canopy Biosciences, Winkeler was a Senior Investment Analyst for BioGenerator Ventures. BioGenerator Ventures is the only investor that invests exclusively in St. Louis companies. Its portfolio of more than 50 active St. Louis startup companies is comprised of many of the region’s most promising and fastest-growing companies, Benson Hill, MediBeacon, Arch Oncology, Geneoscopy, CoverCress, SentiAR, Plastomics, and Wugen. “As BioGenerator helps build the next generation of great St. Louis companies, we need highly talented individuals to lead this challenging process,” said Charlie Bolten, Senior Managing Director of BioGenerator Ventures. “Crystal is a proven investor and company builder, and it is an honor to welcome her back to the BioGenerator team.” Crystal was previously Chief Operating Officer and Vice President of R&D of Canopy Biosciences, a Bruker Company (Nasdaq: BRKR). Crystal co-founded Canopy Biosciences in the BioGenerator Labs and was instrumental in the growth of the company, including PE-backed acquisitions of both Zellkraftwerk and Core Diagnostics. She led efforts in fundraising, technology sourcing and licensing, commercialization, operations, and business development. At the time that she joined BioGenerator, Crystal led a large international team across sites in St. Louis, Leipzig and Hannover in Germany, and the Bay Area. “As Canopy’s Board Chairman, I witnessed Crystal’s leadership of the Canopy team through critical product launches and business development milestones,” said Frank Witney, Operating Partner at Ampersand Capital Partners. “I look forward to an opportunity to work with her again in this new role.” “Of all of the people I have met as a venture capitalist, Crystal is one of the most talented,” said Bill Schmidt, Managing Director of Cultivation Capital Life Sciences Fund. “I look forward to working on exciting new companies with Crystal and the BioGenerator team.” In her role at BioGenerator Ventures, Winkeler will lead investment teams focused on human disease with an emphasis on biopharma. "I am thrilled to return to the BioGenerator team," said Crystal Winkeler, Ph.D., Managing Director of BioGenerator Ventures. “I look forward to building great companies that will bring solutions to care providers, alleviate disease, and provide excellent returns to investors.” Winkeler holds a Ph.D. in Molecular Cell Biology from Washington University in St. Louis, where her research focused on molecular pathways that govern cell growth and proliferation in cancer. Since her graduate studies at Washington University, she has been an active member of the St. Louis entrepreneurial ecosystem, including work with The BALSA Group, Saint Louis University’s MEDLaunch program, Washington University’s LEAP program, and various other efforts that promote the region’s pipeline of life science deal flow and talent. *** About BioGenerator BioGenerator, the startup arm of BioSTL, creates and grows innovative St. Louis companies through its two complementary approaches — investing through BioGenerator Ventures and comprehensive startup support through BioGenerator Labs. Visit for additional information, and follow us on LinkedIn linkedin.com/company/BioGenerator and Twitter @BioGeneratorSTL. About BioSTL Since 2001, St. Louis nonprofit BioSTL has laid the foundation for the region’s innovation economy with a comprehensive set of transformational programs that advance St. Louis’ leadership in solving important world challenges in agriculture, medicine, healthcare, and other technology areas. BioSTL has introduced nationally-acclaimed initiatives in startup creation and investment (BioGenerator), strategic business attraction (GlobalSTL), physical environment (including the Cortex Innovation District and BioGenerator Labs), entrepreneur support, seed and venture capital, a diverse and inclusive workforce, and public policy. Find us online at biostl.org and follow us on twitter @BioSTL. CONTACT Maggie Crane | 314.422.6783 | mcrane@biostl.org

ST. LOUIS – In 2020, BioGenerator, the investment arm of BioSTL, invested more than $3.5 million into 22 St. Louis startup companies. These promising new ventures are developing products in agtech, therapeutics, medical devices, diagnostics, and digital health. BioGenerator is the only investor that invests exclusively in St. Louis companies. The 22 investments are part of BioGenerator’s overall investment portfolio of more than 50 active St. Louis startup companies, comprised of many of the region’s most-promising and fastest-growing companies including Benson Hill, MediBeacon, Arch Oncology, Geneoscopy, CoverCress, and Galera. Nine of those companies earned first-time investments. “The Covid pandemic presented challenges to our industry, but also created increased opportunity in remote patient care, digital health, and healthcare data analysis,” Charlie Bolten, Senior Vice President of BioGenerator, said. “As we developed concepts around a changing healthcare environment, we also continue to see strong opportunity for St. Louis in our core sectors of therapeutics and agriculture. “Exits within our maturing portfolio are important to providing the fuel needed to create the next generation of great St. Louis companies,” Bolten said. “With returns from the acquisition of Canopy Biosciences by publicly-traded Bruker, we were able to accelerate our efforts and this was BioGenerator’s biggest year ever in terms of the number of companies we supported. We’re proud to introduce BioGenerator’s robust 2020 investment portfolio that showcases St. Louis’ strengths in innovation.” Eight of the 22 companies with 2020 BioGenerator investments are led by current or former BioGenerator Entrepreneurs in Residence (EIR) – talented individuals identified and funded by BioGenerator to build and lead these startups. “St. Louis has a tremendous opportunity to build innovative startup companies by leveraging its deep strengths in agriculture and food technologies,” said Martha Schlicher, PhD, Entrepreneur in Residence at BioGenerator. “In my role at BioGenerator, I am helping to create new St. Louis companies that address global issues in food production and food quality.” 2020 BioGenerator Investments: Adarza Biosystems is commercializing a platform technology that can simultaneously detect hundreds of proteins, antibodies, or other substrates from a single drop of blood, providing insight into an individual’s health status. Adarza previously relocated to St. Louis from Rochester, New York when BioGenerator made its first investment in the company. Aegis Digital Health is building a multi-asset company comprised of high-value digital health products with synergies in marketing, sales, target customers, business models, and across technology platforms. Aegis is led by a BioGenerator EIR. Atomation is a business-to-business solutions company that uses an innovative Internet of Things (IoT) platform and process to connect existing objects to the internet with proprietary software to capture and turn raw data into useful information, allowing businesses to transform operations and optimize their bottom line. Atomation was recruited to St. Louis from Israel by BioSTL's international recruitment arm GlobalSTL. Cadex Genomics develops and markets liquid-based molecular assays used by physicians to improve care for their cancer patients. Cadex relocated to St. Louis from Foster City, California with investment from BioGenerator and now works from the BioGenerator Labs. Cofactor Genomics uses RNA to help clinicians understand, diagnose, and predict drug response, particularly in cancer, that can’t be assessed by DNA alone. Founded by three former Human Genome Project scientists at Washington University in St. Louis, Cofactor has built a proprietary platform capable of performing complex characterization of clinical samples. CuriMeta is commercializing an advanced real-world clinical data platform. The company empowers its customers – pharmaceutical and medical device companies – to address their most pressing questions in healthcare with greater speed and precision. CuriMeta is led by a BioGenerator EIR. Daya CNS is evaluating novel, non-opioid drug candidates for acute and chronic pain management in conditions such as cancer, post-surgical recovery, and following serious injury. The company is led by an experienced management team of pharmaceutical industry experts. Echelon Med Tech is developing medical devices and other technology to benefit the warfighter. Echelon’s technologies also have high commercial potential in civilian settings. Echelon is led by a BioGenerator EIR and is associated with BioSTL’s new Center for Defense Medicine. Edison Agrosciences, which previously was relocated to St. Louis from North Carolina by BioGenerator and is led by a former BioGenerator EIR, commercializes innovative approaches for the production of plant-based industrial materials, with a primary focus on renewable sources of natural rubber that can be produced in the US. The global supply of natural rubber (90% of which is from SE Asia) is threatened by multiple environmental and economic factors. Edison was supported as part of pilot efforts that led to BioSTL’s new Center for Defense Medicine. Healthy Bytes, which relocated to St. Louis from New York with BioGenerator investment in 2019, is a tech-enabled services company that connects Registered Dieticians to employers, providers, and patients, utilizing existing benefit plans to provide nutritional counseling at no additional cost. Kypha, led by a BioGenerator EIR, is developing technology that provides reliable and timely results in any clinical setting, dram­atically improving the way autoimmune and inflammatory conditions are monitored and treated. Kypha relocated to St. Louis from Louisville, Kentucky with a previous BioGenerator investment, and it acquired BioSensia of Dublin, Ireland in 2018. Lymbus Oncology is advancing novel therapeutics that will unlock the potential of immune checkpoint inhibitors in patients who do not respond to current therapies. The company’s technology was identified in Hong Kong and brought to St. Louis by Cadre Biosciences, a multi-asset pharmaceutical company developed by BioGenerator and its EIR program. Myonid Therapeutics is advancing therapeutics for liver diseases and heart failure. Its technology was developed at Saint Louis University and the University of Health Sciences and Pharmacy in St. Louis. Myonid is being managed by Cadre Biosciences, a multi-asset pharmaceutical company developed by BioGenerator and its EIR program. Neurolutions is a clinical-stage medical device company developing a revolutionary platform of neurorehabilitation devices leveraging brain computer interface technology. The company’s first product candidate, the IpsiHand, is being developed for upper extremity rehabilitation in chronic stroke patients. Neurolutions is based on technology invented at Washington University. New Agtech company in stealth mode, led by a BioGenerator EIR, focuses on new insect control biologics for food crops that will combat the growing number of insects resistant to current commercial products. The company’s programs are designed to circumvent insect resistance mechanisms. OpenCell Technologies is developing a platform to make cell and gene therapies effective, affordable and scalable. The company is based on technology developed at Washington University. BioGenerator’s diagnostic and medical device umbrella, Synchrony Bio, is incubating OpenCell Technologies. OxaluRx is developing an oral therapy to treat genetic hyperoxaluria, a potentially devastating orphan metabolic disease of high unmet medical need. OxaluRx was created by RiverVest’s Archer Seed Fund and is led by Walter Smith, former CEO of BioGenerator company Confluence Life Sciences, which was acquired in 2017 by Aclaris Therapeutics. Precision Virologics has technology from Washington University that will provide the next-generation vaccines required to combat emerging infectious diseases. In Covid-19 preclinical studies, Precision’s vaccines can accomplish effective immunization with just a single nasal spray while also eliminating the need for “cold chain” storage, making it easier and less costly to distribute. RhoDx is a molecular diagnostics company developing nucleic acid analysis tools for cancer detection in liquid biopsies. The company’s technologies will enable cost-effective, early detection of cancer through population-level screening in pre-symptomatic individuals. SentiAR is a pioneer in visualization technologies for surgical applications. SentiAR’s CommandEP is the first holographic guidance system to be used during an invasive cardiac procedure, allowing physicians to visualize 3D models in real-time via a wearable headset. SentiAR was founded based on technology from Washington University. VaxNewMo is developing technology licensed from Washington University to enable broader and more affordable vaccines in a shorter time frame. The company is using its proprietary manufacturing platform to combat “superbugs.” WELLTH Holdings grows high-potential, consumer products that provide health, wellness, or well-being benefits by infusing capital, connections, and consumer products expertise. In a Nutshell: In 2020, BioGenerator’s largest investments were in CuriMeta, Aegis, Lymbus, and Echelon. Nine companies received first-time investments: Aegis Digital Health Cadex Genomics CuriMeta Echelon Medtech Lymbus Oncology Myonid Therapeutics OpenCell Precision Virologics RhoDx Eight companies are led by current or former BioGenerator Entrepreneurs in Residence: Aegis Digital Health CuriMeta Echelon Edison Agroscience Kypha Myonid Therapeutics New agtech company in stealth mode WELLTH Holdings BioGenerator’s 2020 Entrepreneurs in Residence: Martha Schlicher, PhD – food and agriculture Chad Stiening, PhD – diagnostics Paul Olivo, MD, PhD – diagnostics Davis Walp – healthcare David Christenson – healthcare Stephen Von Rump – healthcare Michael Tones, PhD – therapeutics Lu Alleruzzo – therapeutics business development Michael Thomas – defense medicine *** About BioGenerator BioGenerator, the investment arm of BioSTL, produces a sustained pipeline of successful bioscience companies and entrepreneurs in St. Louis by creating, growing and investing in promising new enterprises. Visit for additional information, and follow us on LinkedIn linkedin.com/company/BioGenerator and Twitter @BioGeneratorSTL. About BioSTL Since 2001, BioSTL has laid the foundation for St. Louis' innovation economy with a comprehensive set of transformational programs that advance St. Louis’ leadership in solving important world challenges in agriculture, medicine, healthcare, and other technology areas. BioSTL has introduced nationally-acclaimed initiatives in startup creation and investment (BioGenerator), strategic business attraction (GlobalSTL), physical environment (including the Cortex Innovation District and BioGenerator Labs), entrepreneur support (Fundamentals), seed and venture capital, a diverse and inclusive workforce, and public policy. Find us online at biostl.org and follow us on twitter @BioSTL. CONTACT Maggie Crane | 314.422.6783 | mcrane@biostl.org