RALEIGH – Among the host of companies presenting at the CED Life Science Conference in Raleigh are numerous startups participating for the first time. Here are profiles featuring eight of those firms.

These profiles are presented in partnership with the CED.

Altis Biosystems

www.altisbiosystems.com

mike@altisbiosystems.com

CEO: Michael Biron

Link to CED Life Science Company Profile: https://cednc.org/company-profile/AltisBiosystems

  • What is the driving mission of your firm?

Our mission is to develop, manufacture, and sell innovative research tools to accelerate drug development.

  • What makes your company unique and therefore of interest to investors?

Altis is a biotechnology research tools company that has developed a stem cell technology, recreating both the small or large human intestinal epithelium for drug testing and microbiome research. Altis’s technology is a high throughput product that can produce a layer of proliferative stem cells and terminally differentiated cells, which can be maintained for a prolonged period of time. It is meant to replace Caco-2 cells (cancer cells) and reduce animal testing for drug screening, during preclinical studies. Altis’s product is reproducible, scalable, and can be used for a wide variety of assays, including cytokine/chemokine secretion, toxicology, co-cultures, transport, etc. Our goal is to reduce the cost and time of drug discovery, by providing a product that more closely replicates the human body’s native biology.

  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

Altis has begun working with its initial paying customers six months ahead of schedule. Altis also has collaborations with several pharmaceutical companies and CROs to further validate and characterize its product, including some of the leading companies in the industry. There are many other companies that are in the final stages of signing agreements to work with Altis. In addition to the immense interest from the pharmaceutical industry, Altis recently won two business development grants, including the NC IDEA Seed Grant and the Carolina Kickstart Award. Altis has signed an exclusive license to the intellectual property from the University of North Carolina and has two patent-pending on its product. Altis Biosystems is in the process of raising its seed round of funding.

BioHealthonomics, Inc.

http://biohealthonomics.com/

rjones@biohealthonomics.com

CEO: Cris Arnou

Link to CED Life Science Company Profile: https://cednc.org/company-profile/BioHealthonomicsInc

  • What is the driving mission of your firm?

BioHealthonomics, Inc. is a clinical stage biotechnology and healthcare company dedicated to developing and commercializing high-impact, safe and effective therapeutics that address critical unmet needs in the treatment of migraine headache and other ailments of the Central Nervous System, including ADHD, Alzheimer’s, Parkinson’s, Chronic Traumatic Encephalopathy (CTE) and Amyotrophic Lateral Sclerosis (ALS).

  • What makes your company unique and therefore of interest to investors?

Our unique value proposition is the compelling combination of effectiveness and safety offered by our technology – modulation of histamine receptors – for the treatment of migraine headache. Current treatments including Botox, NSAIDs and Sumatriptan are not very effective and tend to have significant side effects. The next wave of drugs for treatment of migraines is Calcitonin Gene-Related Peptide (CGRP) technology. Based on available clinical data BioHealthonomics’ technology is superior to the CGRP approach from the standpoints of safety, efficacy and cost. Research shows that CGRPs are effective in treating migraines in about 50% of patients, 50% of the time. On the other hand, clinical results for histamine receptor modulation therapy indicate it is up to 100% effective in up to 100% of subjects, with no side effects. No one is currently paying any attention to our technology as a potential treatment for migraine and other disorders of the Central Nervous System (CNS). A successful Phase II trial for histamine receptor modulation in migraine treatment will be a seismic event, threatening to make CGRP and other treatment therapies also-rans in this multi-billion dollar market.

  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

Founder and CEO Cris Arnou is a lifelong migraine sufferer. As such he is passionate about developing a safer, more effective and longer lasting treatment for migraine headaches. He singlehandedly developed the technical backbone of the technology (3 US Patents issued), acquired the rights to pre-clinical and Phase I clinical data that allow the company to move directly to a Phase II trial and assembled a world-class scientific advisory board consisting of headache and neurological experts. Investors will find that all this company needs to take off is the infusion of capital necessary to conduct the Phase II trial.

Falcon Therapeutics

www.falcontherapeutics.com

girouxkj@aol.com

CEO: Karen Giroux

Link to CED Life Science Company Profile: https://cednc.org/company-profile/FalconTherapeuticsInc

  • What is the driving mission of your firm?

Our mission is to create personalized therapies to treat cancer in patients that, right now, have no hope.

  • What makes your company unique and therefore of interest to investors?

Our approach to cancer therapies uses the patient’s own skin cells to create a personalized medicine comprised of an army of cells that home in and kill metastatic cancer cells. Your cells, your treatment, reduces risks. We work in tandem with the standard of care therefore providing a clear path toward market acceptance. We are a proprietary platform technology with proof of concept in many of the most difficult to cure cancers which gives us a robust pipeline and flexibility to adapt to a particular partner’s area of interest.

  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

At Falcon, we have not only thought through the science but also the business of manufacturing these potentially life saving therapies at a commercial scale. We are building on the successful foundation of those who have blazed the trail prior. From the onset, we seek to reduce cost of goods by developing a proprietary manufacturing platform to produce all therapies in the current and future pipeline. By standardizing our process, the results are a robust, repeatable, cost-effective therapy for reimbursement consideration. Our team is comprised of exceptional scientists, regulatory superstars, clinical geniuses, cell and gene therapy manufacturing veterans and a wealth of industry experts. This allows us to combine the learning of the best in class to shorten our pathway to commercial success.

EncepHeal Therapeutics

www.encepheal.com

alazarus@encepheal.com

CEO: Aaron Lazarus

Link to CED Life Science Company Profile: https://cednc.org/company-profile/EncepHealTherapeutics

  • What is the driving mission of your firm?

Our goal is to break the cycle of addiction using next-generation neurotherapeutics.

  • What makes your company unique and therefore of interest to investors?

There are currently no FDA approved treatments for cocaine and methamphetamine. The most successful of the attempted therapeutics were too addictive to move forward. There is a need for an effective treatment for cocaine and methamphetamine with little to no abuse liability. Our first-in-class therapeutic for cocaine and methamphetamine displays a unique binding site at the target that has been proven to reduce craving and show non-addictive tendencies. We are working with the experts in this space at the National Institute on Drug Abuse (NIDA) and the Wake Forest Center for the Neurobiology of Addiction Treatment (CNAT) to move this technology forward.

  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

The first is the market. There are no FDA approved treatments for cocaine and methamphetamine. NIDA estimates a first-in-class therapeutic would be equivalent to annual sales of Suboxone, which has made over $1 billion annually. Second, pharmaceutical companies lack of expertise in the in the early development of therapeutics to treat substance abuse. Therefore, the experts for drug development in this space are found at our partners, NIDA and the CNAT. This partnership provides us not only with highly specialized research and animal models, but also guidance, direction, and potential sources for capital.

Indexus Biomedical LLC

cdeka@indexusbiomed.com

CEO: Chiranjit Deka

Link to CED Life Science Company Profile: https://cednc.org/company-profile/IndexusBiomedicalLLC

  • What is the driving mission of your firm?

To make advanced diagnostics affordable and accesible to all

  • What makes your company unique and therefore of interest to investors?

Indexus has a unique approach and a revolutionary patent-pending technology IP portfolio that will allow it to push the envelope of the diagnostic industry even as the company reduces risks for its investors. It does so by integrating routine diagnostics with advanced specialty testing on novel multifunctional platforms. Our flagship product, the TriSense Dx, combines automated hematology, flow cytometry and immunoassays on a single low-cost device. This $25K instrument will replace a $500K lab by eliminating the need for multiple expensive instruments.   TriSense Dx will deliver ultra-sensitive specialty tests for confirmatory diagnosis of infectious diseases, blood cancer, cardiac disease, vector-borne diseases,  and more on a single POC analyzer that also provides the routine hematology analysis , the complete blood count test

We will offer multiple spin-off and exit points by creating derivative products in addition to the integrated TriSense Dx system. Derivative product include a mini flow cytometer for life sciences research, and a point-of-care hematology analyzer for diagnostic laboratories.

  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

Indexus Biomedical’s leadership team brings over 150 years of combined experience in developing and launching successful in-vitro diagnostic products, with leadership roles at global corporations such as Beckman Coulter, Abbott Diagnostics, IDEXX Laboratories and Bayer Diagnostics. Indexus Biomedical CEO, Chiranjit Deka (Chira) is an innovator and serial entrepreneur with over 25 years of experience in the diagnostic and biotechnology industry. Chira provided leadership at both global IVD corporations and two previous start-ups, both of which were acquired large corporations (by Beckman Coulter and IlIumina Inc. respectively). Chira has over 20 patents and patent applications, including 8 issued US patents. Indexus has strong collaborations with leading clinical and research organizations, including the CDC, Duke University Medical School, and UNC Medical School, who are actively helping co-develop new applications on the TriSense Dx system.  This team will deliver high return on investment to its investors.

Clinical Sensors, Inc.

http://www.clinicalsensors.com

philippe.chemla@clinicalsensors.com

CEO: Philippe Chemla

Link to CED Life Science Company Profile: https://cednc.org/company-profile/ClinicalSensorsInc

  • What is the driving mission of your firm?

Clinical Sensors’ mission is to save lives by rapidly identifying sepsis, a life-threatening complication that occurs in intensive care patients, as this complication develops.

  • What makes your company unique and therefore of interest to investors?

Sepsis is a huge healthcare problem. In the US alone, over 1.6 million people develop sepsis each year and of those 260,000 die. One in three patients who die in a hospital have sepsis. To reduce this number, Clinical Sensors is developing a point-of-care sensor to measure nitric oxide from a blood sample in seconds. Our goal is to implement this measurement in the intensive care unit and hospital floor to routinely monitor anyone at elevated risk or concern for sepsis.

  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

Since 2014, we have raised over $4.5 million in non-dilutive funding and anticipate a Series A financing in 2018. We have proven our concept in animals and are currently evaluating our technology in an IRB-approved study at the UNC Burn Unit. We will partner with leaders in hospital point-of-care devices to rapidly and efficiently capture this large market opportunity. CSI is the second company founded by Professor Mark Schoenfisch after Novan Inc., which went public in 2016.

Myocardial Solutions, Inc.

www.myocardialsolutions.com

john.funkhouser@myocardialsolutions.com

CEO: John Funkhouser

Video link(s): https://www.youtube.com/watch?time_continue=7&v=0VJvQvJ-NIM

Link to CED Life Science Company Profile: https://cednc.org/company-profile/MyocardialSolutionsInc

  • What is the driving mission of your firm?

Myocardial Solution is working to fundamentally turn cardiology and heart health into a preventive and individualized practice by putting powerful, new subclinical heart data into the hands of physicians.

  • What makes your company unique and therefore of interest to investors?

Myocardial Solutions’ propriety test, MyoStrain, gives a comprehensive heart health assessment in just ten minutes utilizing a MRI scanner without radiation or contrast. MyoStrain is able to detect dysfunction before symptoms occur and monitor the impact of drugs on heart function.

  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

It is rare that a diagnostic test can have such a powerful clinical impact for patients, while having a health economics profile that generates enormous savings to the healthcare system and profits to local hospitals.

VitalFlo

vitalflohealth.com

luke@vitalflohealth.com

CEO: Luke Marshall

Link to CED Life Science Company Profile: https://cednc.org/company-profile/VitalFlo

  • What is the driving mission of your firm?

VitalFlo is redefining the standard of care for asthma management by providing actionable recommendations to patients when they need it most: before they have an asthma attack. Our lung health analytics platform, powered by our handheld medical device and digital health management app, enables asthmatic patients to track their lung health and asthma medications at home. VitalFlo’s vision is to build a future without asthma attacks.

  • What makes your company unique and therefore of interest to investors?

VitalFlo’s lung health analytics platform is used to predict asthma attack risk and enable preventative intervention. Our analytics are powered by clinical-quality lung function data, collected by our at-home mobile spirometer and smartphone app, and environmental exposure data. Doctors can use VitalFlo’s real-time data and analysis to remotely diagnose patients, prescribe treatment, and to make sure that treatment is the most effective possible.

  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

In the US alone, the $50 billion annual market is driven by 25 million patients who are currently suffering from asthma symptoms. Every year, asthma patients end up in the Emergency Room 1.6 million times, and there are over 3,600 asthma-related patient deaths. All of these statistics are worse today than they were 40 years ago. VitalFlo has built the best team of entrepreneurs and experts, all laser-focused on building game-changing solutions to these challenges.