NOBIC Client Chosen Diagnostics’ Device Authorized as Breakthrough

Chosen Diagnostics’ NECDetect for Preterm Babies Authorized as Breakthrough Device by FDA

NEW ORLEANS, LA. (Nov. 16, 2020) — Chosen Diagnostics is pleased to announce that the US Food & Drug Administration (FDA) has granted its NECDetect, and its proposed indication for use, the designation of a ‘Breakthrough Device.’  A spinout of LSU Health, Chosen Diagnostics works to develop innovative diagnostic platforms for gastrointestinal inflammatory diseases in babies and children. Through noninvasive measures, NECDetect will be used to identify necrotizing enterocolitis (NEC), a gastrointestinal disease primarily seen in preterm infants.

Necrotizing enterocolitis is the most common gut inflammatory disease in preterm babies, impacting 6,000 infants a year in the United States alone, with a fatality rate of up to 50 percent. NEC occurs when tissues in the large intestine are damaged or die as a result of inflammation. Bacteria from the intestinal tract can then leak into the abdomen causing serious infections and/or death. Chosen Diagnostics’ hope is that by improving the diagnosis of the disease, it will assist in a decreased mortality rate of those infants impacted and allow for a reduction in the life-long health complications for those who survive.

“We are delighted to receive the Breakthrough Device Designation, as it is clear validation of the work we are doing at Chosen Diagnostics,” said Sunyoung Kim, Ph.D., chief executive officer of the company. “This FDA decision supports us creating healthcare solutions for neonatal and pediatric medical problems, and is a catalyst for improving clinical outcomes for the most fragile patient population. We look forward to working collaboratively with the FDA to advance our novel diagnostic assay,” said Rebecca Buckley, Ph.D., the company’s chief operating officer.

The FDA’s Breakthrough Devices Program is reserved for certain medical devices that provide for more effective diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as NEC.  Medical devices granted the designation are technological breakthroughs and/or offer significant improvement compared to current alternatives. Intended to get these innovative medical devices to market faster, the Breakthrough Devices Program expedites their development, assessment and review.

Chosen Diagnostics’ submission to the FDA focused on two features of NECDetect that distinguish the diagnostic test from the current standard of care and meet the criteria for the Breakthrough Device Designation: unequivocal, as well as early, identification of NEC.

In 2016, Chosen Diagnostics was awarded a $25K prize from NOBIC’s BioFund through winning the grand prize at the  BioChallenge Pitch Competition — an annual competition for emerging Louisiana life sciences startups developed by NOBIC. Since then, NOBIC’s commercialization team has worked alongside Chosen Diagnostics to help them navigate the obstacles of bringing their technology to healthcare systems across the nation. In 2019, Chosen Diagnostics became NOBIC tenants, which is where you can currently find them working on NECDetect.

For more information on Chosen Diagnostics, please visit, www.ChosenDiagnostics.com.

LSU Health Sciences Center New Orleans (LSU Health New Orleans) educates Louisiana’s health care professionals. The state’s health sciences university leader, LSU Health New Orleans includes a School of Medicine with branch campuses in Baton Rouge and Lafayette, the state’s only School of Dentistry, Louisiana’s only public School of Public Health, and Schools of Allied Health Professions, Nursing, and Graduate Studies. LSU Health New Orleans faculty take care of patients in public and private hospitals and clinics throughout the region. In the vanguard of biosciences research, the LSU Health New Orleans research enterprise generates jobs and enormous annual economic impact. LSU Health New Orleans faculty have made lifesaving discoveries and continue to work to prevent, advance treatment or cure disease. To learn more, visit http://www.lsuhsc.edu, http://www.twitter.com/LSUHealthNO, or http://www.facebook.com/LSUHSC.

AxoSim Receives Investment from Benson Capital Partners

Benson Capital Partners Announces First Investment in AxoSim, Inc.

AxoSim, Inc, Provider of BrainSim™ & NerveSim™ Neurological Drug Discovery Platforms, and BioFund Portfolio Company, Teams with Benson Capital Partners & Jefferson Capital Partners

Benson Capital Partners announces its first investment from its recently launched fund, Benson Capital Fund I, in AxoSim, Inc., a New Orleans-based neurological drug discovery platform company. AxoSim’s proprietary technologies, NerveSim™ & BrainSim™, empower scientists from leading biopharmaceutical companies to predict how the human nervous system will respond to therapies much earlier in the drug development process. Benson Capital Partners co-invested with Jefferson Capital Partners’ Opportunity Zone fund vehicle. AxoSim’s office and lab spaces are currently housed in the New Orleans BioInnovation Center on Canal St.

The development of new drugs for neurodegenerative diseases including Alzheimer’s, ALS, Parkinson’s & MS is painstakingly slow and inefficient. Over 94% of neurological drugs that look promising in animal testing fail once they are tested in humans, driving the average cost and time to develop a single new drug to $2.6B and more than 10 years. AxoSim’s revolutionary NerveSim™ & BrainSim™ platforms provide a more clinically relevant way to test drugs by mimicking the structure and function of the human nervous system, accelerating the development of safer and more effective treatments.

“AxoSim’s technologies and team have the ability to accelerate new treatments for debilitating neurological diseases to the clinic. We are excited that Benson Capital Partners’ first investment is in a company with both local and global impact, addressing a large and important market,” says Mike Katz, Managing Director of Benson Capital Partners. “We were impressed by the management team and the impressive roster of global pharmaceutical companies they have already attracted as their clients. Through partnerships like this, Gayle Benson will continue to honor her late husband Tom Benson by fostering entrepreneurship & innovation in New Orleans and the Gulf South Region.”

“We are thrilled to partner with the AxoSim team in advancing critically important neurological drug development,” says Jo Truhe, a Partner with Jefferson Capital Partners. “We appreciate the opportunity to co-invest with Benson Capital Partners. We are completely aligned on the mission of providing much-needed capital to the region, particularly New Orleans.”

AxoSim is lead by CEO Lowry Curley, Ph.D., and Chief Business Officer Ben Cappiello. The company was spun out of the lab of Michael Moore, Ph.D. from Dr. Curley’s graduate research at Tulane University. In 2019, AxoSim significantly expanded its technology portfolio with the exclusive license of the BrainSim platform, pioneered by Thomas Hartung, MD, Ph.D. out of Johns Hopkins University. With the combination of these two platforms, AxoSim has become a premier player in the neurological drug discovery field. Over the past four years, the company has grown to a team of 26 employees and is scaling up its production and service capabilities.

“Translating promising results in the lab to success in humans is the biggest obstacle the pharmaceutical industry faces, and nowhere is that more apparent than neurodegenerative diseases. Our NerveSim™ & BrainSim™ have the potential to bridge that gap and drive the next wave of therapies for patients in desperate need. Working with Benson Capital and Jefferson Capital and their extensive networks will help accelerate our mission to empower advancements in human neuroscience,” says Dr. Lowry Curley. “This investment, along with our growing revenue and new federal grants, provides the capital we need to scale our platforms into industry-leading drug discovery solutions.”

AxoSim works with a growing number of the largest biopharmaceutical companies globally and their platform has a wide range of applications in both safety and efficacy, including neurological disease modeling. Additionally, they have been awarded over $4.2M in federal grant funding to advance and validate their technologies, including their recent announcement of two new grants worth over $870K to develop a patient-derived model of ALS and further expand their BrainSim™ platform.

AxoSim is also a New Orleans BioFund Portfolio company, having won our annual BioChallenge Pitch Competition in 2014, and received their first investment from the Fund in 2016. To date, BioFund Portfolio Companies have created or retained over 400 Full-Time-Equivalent Positions. The BioFund has now directly contributed $4 million to the local economy and has supported the creation of numerous long-term, high-wage job opportunities within and outside of biotech.

Be sure to keep up with Benson Capital Partners HERE.

Be sure to keep up with AxoSim HERE.

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NOBIC Tenant AxoSim Awarded $870K in Federal Funding

PRESS RELEASE: AxoSim Announces the Award of Over $870K in Federal Grants

 

Overview

–Two grants from the DoD Congressionally Directed Medical Research Program and the National Institutes of Health awarded to AxoSim–

–The CDMRP grant will support the development of a ALS NerveSim™ model to mimic the pathology of human motor nerves of patients–

–The NIH SBIR grant will be utilized to expand the BrainSim™ platform in multiple species

Press Release

AxoSim is excited to announce the award of two federal grants from the Department of Defense Congressionally Directed Medical Research Program (CDMRP) and the National Institutes of Health (NIH) totaling over $870,000. The CDMRP grant involves utilizing the company’s NerveSim™ platform to establish a clinically-relevant model of amyotrophic lateral sclerosis (ALS), specifically mimicking the human pathology of ALS. The NIH Small Business Innovation Research (SBIR) grant will utilize the company’s existing BrainSim™ platform to expand into multiple species, allowing the company to now compare chemical and drug effects across human and rodent species.

Using the existing NerveSim™ platform, the ALS NerveSim™ model will mimic the pathology of human motor nerves of patients suffering from ALS. ALS is a notoriously difficult condition to treat and more than 50 clinical trials have yielded only two therapies for the treatment of ALS, though neither is disease-modifying. With no translatable preclinical models available to drug developers, this project aims to fulfill a significant unmet need for a clinically-relevant model of ALS. The project employs patient-derived induced pluripotent stem cells (iPSCs) with a SOD1 genetic mutation, the most common gene associated with the familial form of the disease.

AxoSim’s BrainSim™ platform will be further refined to mimic the developing rodent brain and will be used for screening of potentially neurotoxic compounds. Using 3D image analysis and genetic assays, this model can also quantify the individual cell types in the spheroids, such as neurons, astrocytes, and oligodendrocytes. By evaluating myelin levels, BrainSim™ can be used for screening compounds that impact myelination. Electron microscopy (EM) can analyze cellular features and microelectrode arrays (MEA) can test the electrical activity of neurons.

Support from federal grants including the NIH has been crucial to the development of the NerveSim™ and BrainSim™ platforms. Past grants awarded by the NIH include Phase 1 and 2 Small Business Technology Transfer (STTR) Grants from the National Center for Advancing Translation Sciences, an SBIR Phase 1 Grant from the National Institute of Environmental Health Sciences, and multiple NIH grants while still in their academic laboratories at Tulane University and Johns Hopkins University prior to AxoSim’s licensing of the technologies.

About AxoSim, Inc.

AxoSim, Inc. is a premier provider of neurological drug discovery platforms. The company’s proprietary BrainSim™ and NerveSim™ platforms provide accurate, predictive models of the human peripheral and central nervous systems, rapidly delivering clinically actionable human data early in the drug development process. AxoSim’s platforms have applications for drug efficacy, disease modeling, and toxicology. Learn more at axosim.com.

Press Contact: pr@axosim.com

General Inquiries: info@axosim.com