RALEIGH – On Feb. 27 and 28 the Wallace H. Coulter Foundation and Duke University, in conjunction with the CED Life Science Conference, will be conducting the 2018 Coulter Investment Forum.

Coulter Foundation

The Coulter Investment Forum will spotlight life science companies representing a dozen top-tier universities from across the U.S. and offering solutions ranging from device to imaging, diagnostics to therapeutics. In addition, the CED Life Science Conference will showcase the most exciting and innovative North Carolina-based life science companies representing biotech, pharmaceuticals, medical devices, digital health, diagnostics, drug delivery and agricultural biotechnology. Featured companies from both events will be exhibited in the Innovation Room for exposure to investors, corporate partners, potential clients and fellow entrepreneurs.

In partnership with the CED, WRAL TechWire offers profiles of the following presenting companies:

Kinos Medical, Inc.

bgarvey@kinosmedical.com

CEO: Brian Garvey

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

  • What is the driving mission of your firm?

To make ankle replacement as effective as other joint replacements by providing the best performing and most comprehensive ankle replacement portfolio to the market.

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

We patented the only ankle replacement that recreates Anatomic Joint motion. This IP is the foundation for several advancements in ankle joint replacement that will drive our technology to become the standard of care.

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

We have built a network of future customers who are true believers in our business model and are dedicated to seeing our technology become the standard of care in the industry.

Inscope Medical Solutions, Inc.

www.inscopemedical.com

maggie.galloway@inscopemedical.com

CEO: Maggie Galloway

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

  • What is the driving mission of your firm?

Inscope Medical’s mission is transform patient outcomes in both routine procedures and emergencies with an integrated suite of leading imaging devices.

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

Inscope Medical is focused on improving the speed, safety, and effectiveness of airway intubation through our novel laryngoscopes. Our current device portfolio consists of two devices, the Inscope Video and the Inscope Direct. At less than 1/15th the cost of leading video laryngoscopes, our wireless Inscope Video device makes this life saving technology accessible in all settings from ambulances to ORs. Our Inscope Direct is the first laryngoscope with integrated and controllable suction. It’s designed for trauma intubations where secretions (like blood, vomit, or salvia) make visualizing the vocal cords a challenge.

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

We are providing better technology at a much more affordable price, which expands the market for video laryngoscopes to include segments that have needed the technology, but haven’t been able to afford it. Once we gain traction in laryngoscopes we will apply the same wireless video module from our laryngoscope to other imaging devices. This suite of devices will all stream to one tablet platform.

 Nanopore Diagnostics

https://www.nanoporedx.com

tcohen@nanoporedx.com

CEO: Tom Cohen

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

  • What is the driving mission of your firm?

Throughout the food industry, from farm to table, microbial pathogens are a major concern. A primary driver of this problem is the lack of on-site testing solutions that can screen for disease in a quick and affordable manner allowing pathogens to be identified while mitigation strategies can be the most effective. This is particularly true in the Salmon aquaculture industry where $430M is lost per year due to microbial disease. While effective treatment strategies are available there are no rapid, on-site testing options that can identify disease before it spreads across a facility and causes significant economic loss.

The mission at Diagnostics is to eliminate these and other costly inefficiencies due to microbial disease with the INDxer, our portable microbiology-testing platform. The iNDxer will produce results on-site in 45-minutes from sample collection, enabling end users to take swift and effective action. Results will include a quantitative assessment of a user-defined panel of bacterial, viral, fungal, or parasitic microbes that might be present in a collection of biological samples. The iNDxer will consist of a hand-held instrument operated through a smart-phone, an analysis and operational software package for the smartphone, and then a consumable kit specific to a particular application.

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

Our primary differentiator is our ability to test for microbial pathogens both on-site and in a high-throughput manner. On-site testing provides results days earlier than current lab-based testing methods. This ensures pathogen mitigation strategies are implemented as quickly as possible to minimize economic impact. High-throughput testing decreases total costs by allowing for multiple microbes to be screened for across multiple samples in a single assay.

We can screen over 50 samples (e.g., gill swab) for 4 microbial pathogens in a $100 assay, current products require 200 $5-10 assays to accomplish the same work. We are able to offer both of these significant competitive advantages in one product, portability and high-throughput capability, due to our highly-innovative technology platform, the, iNDxer.

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

Experienced and diverse team: Our co-founding team combines significant technology development experience with business development and strategy expertise in the ag-tech industry. Ideal Target Market: The aquaculture industry young enough that we have the potential to entrench ourselves as the gold standard testing platform. In addition, it is highly consolidated (top 20 companies farm 82% of product), free of significant government regulation, large ($380M in Salmon, $1.8B across all aquaculture), and rapidly growing (4-7% annually) Wide applicability: The iNDxer microbial diagnostic platform has universal applicability and with only minor tweaks can penetrate additional market verticals including a $1.5B opportunity in the food processing industry, a $1.8B combined opportunity in animal husbandry and companion animals, and a $8B opportunity in human clinical diagnostics. Strong exit potential: Comparable exits of $300M+ in the molecular diagnostics space

AsclepiX Therapeutics

www.AsclepiX.com

wperrow@asclepix.com

CEO: Wendy Perrow

Video link(s): https://www.youtube.com/watch?v=EshIq3Lbeo4

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

  • What is the driving mission of your firm?

To create Disruptive Next Gen Therapies for Ophthalmology, Cancer, and Transplant that have unique MOA and transformative outcomes for patients.

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

AXT107 is a Breakthrough product to treat Diabetic Macular Edema (DME) and wet AMD as it inhibits VEGF and Activates Tie2 is one monotherapy injection that may be dosed 2 times per year. AXT107 has demonstrated superior efficacy and longer duration of action versus the market leader Eylea in in vivo experiments. We have additional products for cancer and transplant to prevent rejection.

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

We have an experienced management team with a track record of success with breakthrough technology from our founders at Johns Hopkins University. We have received $8.3 M in non-dilutive funding from the National Eye Institute, the National Cancer Institute, Coulter Foundation and others which has allowed us to advance our lead product into the toxicology program and man in ~one year and demonstrate efficacy and safety for the cancer and transplant products.

Renerva, LLC.

https://www.renerva.com/

lsoletti@renerva.com

CEO: Lorenzo Soletti

Video link(s): https://youtu.be/Ts5av-4wtlc

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

  • What is the driving mission of your firm?

We are committed to developing the next generation of surgical solutions to improve peripheral nerve repair for patients affected by debilitating nerve injury/damage.

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

Our first product, the peripheral nerve matrix, or PNM, is an injectable gel derived from porcine nerve tissue. PNM has shown a tremendous impact in improving the structural repair and functional recovery of nerve affected by several injury modalities. There is no product on the market that can claim to improve neither the speed nor the level of functional recovery following nerve injury.

PNM can claim both. Furthermore, PNM will provide surgeons treating peripheral nerve injuries the broad applicability and ease of use that current neurosurgical solutions lack.

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

We are targeting a sizable and well understood existing market with a highly differentiated product and strong value proposition. PNM is protected by multiple issued U.S. patents. The regulatory path of PNM was validated by the FDA (Class II medical device via the Denovo 510(k) path), and our technology will be reimbursed by existing codes.

We have a quality management system in place, we reached design freeze for the PNM, and developed a fully contracted production supply chain (current gross margin >95%).

We will start clinical trials by the end of 2018. Renerva has a talented management team and a deep network of business, regulatory, and technical consultants, as well as clinical and scientific advisory boards including world-renowned experts and key opinion leaders.

 East River BioSolutions, Inc.

www.EastRiverBio.com

andrea@eastriverbio.com

CEO: Andrea Nye

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

  • What is the driving mission of your firm?

To provide first-in-class tissue-specific biomaterials to scientists seeking a superior environment in which to develop, test and deliver treatments to patients more quickly and less expensively.

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

East River BioSolutions is revolutionizing the $7B+ cell culture market with its tissue-specific biomaterials, enabling faster, more accurate and actionable results for scientists working in pharmaceutical development, cell biology research and regenerative medicine. Rather than isolated components or synthetic materials, the Company’s innovative product platform provides a natural, physiological cell culture environment in which to develop, test and deliver treatments and cures to patients more quickly and less expensively.

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

Limitations involved in faithfully replicating physiology and biology outside of the body produce misleading scientific results and limit R&D capacity, costing crucial time and money in the quest to optimize and accelerate drug development efforts.

East River BioSolution’s proprietary platform of tissue‐specific biomaterials enable the most accurate and actionable results for biotech research, helping to bridge the multi-billion-dollar gap between research and breakthrough clinical discoveries.

Sanguina

tstribling@sanguina.com

CEO: Tom Stribling

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

  • What is the driving mission of your firm?

Driven by trends towards patient empowerment and convenience, Sanguina is developing inexpensive and accessible point-of-care and over-the-counter blood tests and platforms, starting with AnemoCheck, an FDA-cleared, rapid, color-based, disposable hemoglobin level test, to populations who need them most.

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

Our company aims to market technologies as consumer health products in the growing space of patient self-management and self-diagnosis. As such, our products are disruptive, but also low-risk. While we offer convenient healthcare screening options for the general public, we also provide value to chronically ill patients and their healthcare providers by offering more efficient and inexpensive home-based methods for self-monitoring and self-management of their disease.

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

Our company is powered by an effective core team with key expertise in medical start-up companies, marketing, chemistry, engineering, clinical medicine, regulatory affairs, and quality control. Together, we have a proven track record of success, including complete development of a product from ideation to FDA clearance funded entirely by $1M in non-dilutive grant funding.

i-Function

http://www.i-Function.com

pkallestrup@i-Function.com

CEO: Peter Kallestrup

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

  • What is the driving mission of your firm?

The driving mission of i-Function® is to restore or improve the capacity of older adults and people with cognitive impairments to do technology related everyday tasks. The growing number of aging adults, individuals with mental illness, traumatic brain injury or a cognitive impairment such as mild cognitive impairment, often lack the functional skills needed to perform everyday tasks in a broad range of areas such as banking (whether using an ATM or doing online banking), shopping, way-finding, navigating the complex health care universe (including medication management) or using critical technologies such as smart phones or the internet.

These challenges often threaten their ability to work or live independently and ultimately incur enormous costs for the individual, their families and society. The current practice of improving basic cognitive abilities alone via various types of brain exercises, games, etc., while improving cognitive test performance, does not restore the ability to perform everyday living activities. Enhancing functional skills requires training on these activities (normally taking place via in-person training by a trained clinician, caregiver or a family member); currently expensive and generally not available to most of those in need. i-Function® bridges the “real world functioning skills gap” between daily life, functional skills and technology and can help people regain their prior functional skills or assist them with the acquisition of new functional skills such as those needed to manage emerging and existing technologies.

This takes place through a proprietary, unique & evidence based functional skills assessment and training software platform that can be delivered remotely and on multiple devices such as laptops, tablets, smart phones, etc. The solution allows for restored independence, increased productivity, improved ability to learn new skills, higher quality of life and a reduction of costs.

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

i-Function® is unique and therefore of interest to investors because of the following factors:

• i-Function® is commercializing the first (and only) research based integrated functional skills assessment and training software solution, currently with sales over $100,000. The i-Function® Solution is currently out-licensed to two paying global pharmaceutical companies

• Initial three functional skills assessment and training studies have produced very positive results (so far R&D investment is >$1M)

• In September 2017 the NIH funded a SBIR for a new 22 months study ($450,000)

• The i-Function® solution has been used by researchers at several top medical facilities including Harvard Medical School and Johns Hopkins

• Commitment (incl. funding) is in plac

• The i-Function® team consists of three co-founders with top credentials in the areas of: Cognition and functioning in aging with technology focus – Sara Czaja, PhD.; Cognition and functioning in neuropsychiatric conditions – Philip Harvey, PhD. ; US & international healthcare business creation & expansion – Peter Kallestrup, MS.

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

Investors should be interested in i-Function® because we are passionate about our vision: To make functional skills assessment and training broadly available at a reasonable price for the 25-40 million Americans with the need but who today do not have this option for either financial, geographical or other reasons. Investors should be interested in i-Function® because we are focusing on providing a science and data driven solution that addresses the increasing challenges related to the digitalization of society, an aging population and continuous pressure on individual and global budgets. Last but not least, investors should be interested in i-Function® because of our team – we have worked all our professional lives to gain the necessary knowledge and abilities and establish the relevant US and international contacts to successfully create, further develop and commercialize the i-Function® solution.

XaTek Inc.

https://www.xatek.com/

jz.xatek@gmail.com

CEO: John Zak

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

  • What is the driving mission of your firm?

To develop innovative diagnostics that serve the emergent clinical needs of both the patient and caregiver

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

A new drug category comes along once every generation and with each new drug class comes a need for innovative diagnostics that solve the clinical issues that invariably emerge along side these drugs. Medicine is witnessing that inherent technology vacuum right now – and XaTek is responding with an important life saving diagnostic device.

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

XaTek is comprised of forward thinking problem solvers, designers, and engineers led by an experienced and commercialization-minded management team. XaTek does not respond to a changing market – we create the market change.

Novonate

www.novonate.com

eric@novonate.com

CEO: Eric Chehab

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

  • What is the driving mission of your firm?

Novonate is committed to designing products that address needs in neonatal care. We are currently focused on revolutionizing the standard of care associated with umbilical catheter securement for neonates in the intensive care setting.

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

Our team leveraged several years of work and research within Stanford University to allow us to hit the ground running once Novonate was formed in 2017. With several funding sources, including over $300k in grant and non-dilutive support, we plan to commercialize our device in 2018.

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

Our team is made of a diverse set of engineers and physicians from Stanford University who are passionate about this field of medtech. We are deeply integrated into the Stanford Biodesign community, as well as StartX, the Rosenman Institute, and the Atlantic Pediatric Device consortium.