COVID19 resources from FITCI!

FITCI STARTUPS TACKLE THE #COVID19 CHALLENGE

THESE ARE THEIR STORIES

VIRINTEL LLC

Diagnostics Startup

CEO: Ilya Mazo

VirIntel is a diagnostics startup founded in April 2020 in response to the pandemic. The company is developing a serological antibody test for COVID 19 that will tell whether a person was infected with the coronavirus and has gained the immunity as well as will help to evaluate what kind of immunity the person has now. The company hopes that its test will show greater accuracy than current market tests, which often suffer from higher-than-acceptable false negativity/positivity. In addition, VirIntel is developing a computing data platform to evaluate and manage immunity-related data and infection risks. The VirIntel test could also support the search for a vaccine as a tool to monitor the vaccine efficacy. The company plans to work with underserved communities and organizations not served by bigger corporations. Leaders and co-founders, CEO Illya Mazo, COO Vladimir Litvak, and CTO Yuliy Litvak are local entrepreneurs and are leading VirIntels effort to perfect a serological test to identify if someone's immune system has learned to create antibodies against a particular infection. The test is a quantitative assay to detect and measure anti-SARS-CoV-2 antibodies in a patients' bloodstream. It is currently in the research stage with experiments conducted by its R&D team headed by Maria Kireeva, PhD at the FITCI lab space. The team is recruiting volunteers who have recovered from COVID-19 to donate a small blood sample for testing. Once fully developed, the test could determine the effectiveness of future vaccines to prevent COVID-19. VirIntel intends, as much as possible, to source and produce products locally. .

VERALOX THERAPEUTICS

Biotech Startup

CEO: Jeff Strovel

VERALOX Therapeutics is a small-molecule biotech company formed in September 2017. The company initially garnered attention for its first product, VLX-1005, a promising rare blood disorder treatment drug for heparin-induced thrombocytopenia and thrombosis (HITT). The company struggled as their partners in academic universities shut down due to the pandemic, even while forging ahead on preparing a New Drug Application to the FDA. Meanwhile, news from frontline doctors revealed an unexpected danger in COVID-19 infections, an increased risk of pulmonary embolism (micro clots in the lungs). Because VLX-1005, a new class of anti-thrombotic, doesn't cause excess bleeding, it can be used to turn the activation state of the platelets off. This does not kill platelets, but does prevent them from forming clots. Currently, VERALOX is gathering COVID-19 patient blood samples for testing. Once through GLP toxicology testing, the drug poses promising use as an emergency therapy if a second wave of COVID-19 infection occurs.

INTEGRATED BIOTHERAPEUTICS INC

Biotech Company

CEO: Javad Aman

Integrated BioTherapeutics (IBT) is a biotechnology company focused on discovering novel vaccines and therapeutics for emerging infectious diseases. Their two main pipelines are antiviral (filoviruses) and antibacterial (novel vaccines and therapeutics against bacterial infections). In addition, IBT has a CRO division providing discovery services and reagents for pharma/Biotech and academic institutions. Service including in-vitro screening (in-house models for testing whether the virus can be neutralized) and in-vivo models (allows translation of the in-vitro screening to an in-vivo model). Faced with an 80% dip in demand for research tools for universities and industry, they've effectively pivoted to offering services for COVID-19 research.Through collaboration with universities and companies to identify novel COVID-19 vaccines or antibody therapeutics, Integrated BioTherapeutics supports many targeted initiatives. The company is also working on a proposal to the National Institutes of Health that leverages their expertise in this arena.

VELOCIDY BIO

Biotech Company

CEO: Brian McNally

Velocidy Bio delivers solutions that decrease time-to-results for global biological laboratories, often condensing wait time from hours or days into minutes. These accelerated protocols enable scientists to increase productivity and reduce stress associated with delays in generating results. Initially, Velocidy Bio focused on reducing the time required to extract, amplify and analyze nucleic acids. Along with the company's Dutch biotech partner, Molecular Biology Systems (MBS), they introduced NEXTGENPCR, a revolutionary new method that decreases testing time for SARS-CoV-2 to eight minutes, compared to current systems that take over an hour. The product has the potential to revolutionize testing capabilities during the pandemic. Utilizing this method, a single shoebox-sized unit could perform 180 amplification runs a day. That is an almost ten-fold increase over the current US Centers for Disease Control (CDC) recommended instrumentation. According to Gert de Vos, MBS CEO, this protocol produces a simple yes/no answer and one instrument is capable of running 24/7, analyzing 22,860 samples per day. Brian McNally, CEO of Velocidy Bio, explains that a unit could potentially test every employee at nearby Frederick Memorial Hospital every day in about 3 hours. Velocidy Bio is the exclusive distributor of NEXTGENPCR machines for the USA, Canada and South America. Velocidy Bio is also collaborating with FITCI graduate GM Biosciences on a COVID-19 testing project. Details are in the works, but both partners are dedicated to creating a solution that doesn't sacrifice sensitivity or specificity for a rush to market. McNally says FITCI's support makes a difference, an especially common refrain among clients who want to follow their passion from the lab to the boardroom.

DANUVIUS BIOSCIENCES

BIOTECH STARTUP

CEO: Janos Luka

Established in 2020 as a spin-out of Bioworld Consulting Laboratories, Danuvius Biosciences develops monoclonal antibodies for therapies and diagnostic assays for treatment and diagnosis of multi-drug resistant bacterial infections. During the past few months, some customers and collaborators closed down, pushing joint projects to midsummer at best. This gave the team time to identify new infectious targets. Because COVID-19 symptoms are very similar to flu and other respiratory illnesses, Danuvius Biosciences decided to adapt its rapid (10 minutes) multiplex diagnostic assay to detect and identify the most common infectious agents associated with respiratory infections. The assay will be able to detect and differentiate between Adenovirus; Human enterovirus/rhinovirus; Influenza A and B; Mycoplasma pneumoniae; and Human Coronaviruses (HKU1, NL63, 229E, OC4), in saliva or nasal swabs in a qualitative or semi-quantitative format. The company intends to include SARS and CoV-2 in the multiplex assay, which has already been validated for Influenza (LoD 5 x 102/ml) and adenovirus (LoD 3.9 x 102 /ml) in saliva and nasal swabs. Once fully developed and validated, this rapid Point of Care multiplex assay will be able to detect and identify the infectious agent in minutes in physician's office or hospital, facilitating correct treatment of patients. Validations for the other infectious agents are also in progress.

HAWKEYE MEDTECH

HEALTHCARE

CEO: Ashok Kapur

Hawkeye MedTech, Inc. created TotalCare, a unique telemedicine platform that lets patients schedule virtual visits with their own healthcare providers. TotalCare is HIPAA compliant, with patient identity verification, fraud prevention and geolocation validation features that are crucial for medical application. The company started market validation as the COVID-19 crisis began unfolding. As Medicare and other insurances temporarily remove HIPAA and other protections, Hawkeye MedTech is digging in. The platform lets patients get the care they need from the comfort of their home or office, while adhering to the highest principals of patient privacy and security. CEO Ashok Kapur, The Edge Accelerator graduate, says, "We take patient privacy seriously." Kapur explains that the rush to move healthcare services online was "a blessing in disguise, because it made onboarding providers easier. "We did a very controlled rollout of TotalCare." Users both sides can get familiar with the platform and offer feedback, which Hawkeye MedTech channels into updates. "I was fortunate to witness use of TotalCare in ruling out COVID-19 on two occasions," says Kapur. "It was very satisfying to see our product being used at this critical moment to ease patient stress and provide them with much needed medical care, without creating an additional exposure."

REBUIMMUNITY LLC

BIOTECH COMPANY

CEO: Yunbiao Lu

RebuImmunity, LLC is a small pharmaceutical entity developing recombinant chimeric proteins for clinical drug research and development needs. These proteins play a key role in human physiology and pathology. Their utilization increases the efficacy of drugs by making them more direct and specific, with less side effects, while putting RebuImmunity on the leading edge of biomedical and immunology research. The company's patent-pending human-source chimeric protein (BY-001) is a promising novel drug aimed at treating patients with autoimmune diseases, including recipients with allografts. Its origin in human nature makes in vivo safety more reliable. In response COVID-19, RebuImmunity proposed a chimeric protein (RADA2-Fc4) that contains only the certain binding domain of a protein in ACE-2, but does not include catalytic domain of angiotensin II, this structure prevents the protein from interfering with circulating angiotensin II levels. The Fc4 part in this chimeric protein can form a three-part structure, which is necessary for 2019-nCoV binding. Studies show that COVID-19 uses the receptor binding domain (RBD) for its invading cells. In effect, this drug uses existing therapeutic targets as a springboard for the treatment of COVID-19. RebuImmunity is currently seeking support from the National Science Foundation (NSF) to implement the project.

GOFIGHTCOVID

Non Profit

Founder: Gary Lopez

The Edge graduate Gary Lopez helms Tiny Code, an emergency communication device that facilitates essential communication during natural disasters, but COVID-19 prompted him to start GoFightCovid, a free delivery platform for those who are most at-risk for contracting the devastating virus. "I wanted to contribute to the community", insists Lopez. "So far, wee've made more than 100 food deliveries to families in the DMV area. "Via the website, gofightcovid.com, people can request supplies, volunteers can plot deliveries and leaders coordinate logistics. "We are lucky to work with The Frederick Rescue Mission. They give us all the food/supplies we need, and then we use our small network of volunteers to deliver them."

CARRTECH LLC

HEALTCARE

CEO: Sue Carr

Sue Carr is a graduate of FITCI's first intensive accelerator series, The Edge. A former pharmacist with 35+ years' experience, Carr and her partners created a next-generation filtered needle for safer, easier, quicker drug delivery with less medical waste. According to Carr, it is a much-need update to the current, cumbersome 2-needle system which can result in needle-stick and glass shard injuries. The innovative product earned features in the Frederick News-Post and the Washington Business Journal, even as Carr was named "DC Lives Red Hot Entrepreneur of 2020." The CarrTech team pitched at numerous events, including Salisbury University's Perdue School of Business Shore Hatchery Competition but COVID-19 hit just as the company started making traction. Potential investors quickly shifted away from new ventures, choosing to focus limited resources on current, proven relationships instead. In fluid motion, CarrTech applied to the National Science Foundation (NSF) for a project pitch for COVID-19, earning an opportunity for a full NSF grant application. CarrTech is also applying for investment opportunities through TEDCO, Maryland's economic development arm for early stage technology and life sciences companies. Still cautiously optimistic, Carr is determined help fellow healthcare providers and their patients by getting improved technology to market. The company's FDA pre submission is moving forward.

POOCHON SCIENTIFIC

BIOTECH

CEO: Dr. Jon Hao

Poochon Scientific provides mass spectrometry-based protein analysis services and Sanger DNA sequencing services. CEO Jon Hao says he sees a special responsibility to help fight COVID-19. "While Poochon is focused on protecting the safety of our employees and their families, we are ensuring that our services reach our clients, contributing our scientific expertise to the development of antiviral and vaccine approaches." The company helps biomedical research institutions, biotechnology and pharmaceutical companies through DNA sequencing and Proteomics solutions. Notable clients and partners include Bio Factura, Leidos, Bristol-Myers Squibb, Baylor College of Medicine and the National Cancer Institute.

MOLECULAR TOOLS

BIOTECH STARTUP

CEO: Olena Lar

Dr. Olena Lar founded Molecular Tools in 2018 with the mission to translate scientific discoveries into easy-to-use standardized tests for biomedical research and clinical diagnostics. Right before the pandemic, Molecular Tools released their first product, an Unconjugated Bilirubin Quantification Kit, designed for easy and direct measurement of unconjugated bilirubin in biological specimens. When the global health emergency put a halt on most research, Dr. Lar joined CianDx- diagnostic lab in Frederick, MD, to support COVID-19 testing.

STEPFUSION SOLUTIONS

TECHNOLOGY

CEO: Bruce DeShong

The Tate Home Assistant is StepFusion's first product line, now in development. It is a series of everyday items with smart sensors to support dementia care at home, in senior-living communities, and in dedicated nursing facilities. Founder Bruce DeShong says the products' creation was inspired by his own experience, losing both parents to this tragic disease. Planned products, such as a digital clock, tv remote, or weight sensor, are perfectly aligned to keep elderly patients and other at-risk populations connected to care givers, even as people become increasingly isolated. The Tate Home Assistant is constantly monitoring the well-being of seniors in nursing homes or in independent living situations. The product can determine how the person is doing or feeling, whether they are showing any COVID-19 symptoms. This information is reported to family or care providers immediately, so they can take the appropriate actions. Tate Home Assistant products provide connection and peace of mind, especially when in-person visits are not possible.

INTEGRATED PHARMA SERVICES LLC

BIOTECH

CEO: Mina Izadjoo

Integrated Pharma Services (IPS), is an Award-Winning Contract Research Organization (CRO) started by Dr. Mina Izadjoo, the company's president and Chief Science Officer. As a small, women-owned biosciences company, IPS engages Ph.D. level scientists and skilled technical staff to design, troubleshoot, conduct, analyze, and report scientific data. IPS's unique expertise and customized approach results in high-quality scientific data for clients, leading to expedient and improved product development. IPS's fully equipped labs contain all the essential elements for working with live microorganisms, including an elaborate biorepository of bacterial and fungal agents, including antibiotic-resistant clinical isolates. The company recently added 4-D Bioprinting capability. Clients range from small to multi-billion-dollar companies. Recently, IPS received $100K grant from the State of Maryland for manufacturing much-needed surgical masks. This makes IPS the 1st Maryland women-owned company in mask manufacturing. IPS tests antiviral properties of new products and devices, including essential personal protective equipment (PPE) and is offering consulting and testing services for COVID diagnostic kits, as well as environmental monitoring services. Dr. Izadjoo is a microbiologist/immunologist with more than 25 years experience and a substantial roster of awards. She earned the title "Distinguished Scientist" in accordance with the Public Law 94-36 while serving as Chief of Microbiology and Wound Biology and Translational Research (WBTR) Division at the Armed Forces Institute of Pathology (AFIP) in Washington, DC.

ROOSTERBIO

BIOTECH

CEO: Margot Connor

RoosterBio's steep trajectory from one-man show to international market disruptor makes it a true FITCI success story. The company graduated from the incubator in 2018 and is already outgrowing its current space. Even with many "Roosters" working from home during the crisis, the company remains laser focused on the rapid commercialization of scalable regenerative cures using human mesenchymal stromal/stem cells (hMSC). RoosterBio's products and services - mesenchymal cells, bioprocess growth and EV collection media - already changed how companies and institutions produce, consume and use living cells, effectively eliminating the bottlenecks in stem cell accessibility. Exciting news, since clinical research suggests that hMSCs might be helpful against the end stage of severe COVID-19, or acute respiratory distress syndrome (ARDS), or to mitigate some of the damaging inflammatory response. Founder Jon A. Rowley, PhD, says that may give patients a fighting chance against severe COVID-19. "Our cGMP-quality cellular starting materials and culture medium involve traceable materials that our customers can transition rapidly into clinical manufacturing." That equates to faster results. It helps RoosterBio, too. "The more we are empowered by our valuable customers and funding agency partners, the better we can leverage economies of scale to bring down the cost of cellular therapy clinical products for use against COVID-19 or similar biothreats." Workers continue to perform designated essential tasks on-site, such as preparing and shipping cells and media, maintaining liquid nitrogen storage and equipment maintenance. RoosterBio consistently ranks among Frederick's best places to work. The Maryland Tech Council named them "Emerging Company of the Year Finalists" in 2019 and Pitchbook listed them as "The Most Valuable VC-Backed Company in Maryland Led by a Woman CEO (Margot Connor)." Acquisition International recognized RoosterBio with the "Excellence in Regenerative Medicine Acceleration USA" award.

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