Federal Funding Advances New Test to Detect and Determine Risk of Rupture for Brain Aneurysms

InteliSpark client, Neurovascular Diagnostics wins a research grant from the National Institutes of Health (NIH) for phase I of their project to develop a “one-stop” diagnostic test that can detect intracranial aneurysms, as known as brain aneurysms, and determine the risk of rupture based on biomarkers in the blood.

Ruptured brain aneurysms are devastating for patients and may result in cardiac arrests, permanent neurological problems, brain damage, hemorrhaging, and death. Treatment costs are far more costly for ruptured than unruptured brain aneurysms. Therefore, diagnosis of unruptured brain aneurysms is crucial.

But not all aneurysms lead to rupture. So, healthcare providers attempt to measure the risk of rupture prior to any invasive or costly medical intervention. Yet, current imaging procedures that measure the risk of rupture, via the metric of size, are invasive, expensive, require the use of X-rays, and may lead to medical complications.

The New York based startup, Neurovascular Diagnostics, has identified gene expressions in the blood to identify dangerous brain aneurysms and hypothesize that these expressions may serve as a biomarker to determine rupture risk.  In this phase I Small Business Innovation Research (SBIR) project, researchers will develop a “one-stop” test for both diagnosing and determining risk of rupture of brain aneurysms. 

This low-cost novel medical technology will provide greater access for at-risk patients and potentially save millions of dollars in unnecessary imaging procedures and treatments for brain aneurysms.

Discarded Kidneys Increase and Why a Messaging App May be Part of the Solution

InteliSpark client, OmniLife, formerly HealthTech Solutions, Inc., wins a grant from the National Institutes of Health (NIH) for phase II of their project in developing a mobile application for secure team communication, tailored specifically for kidney transplant teams. Researchers will also utilize machine learning (ML) to incorporate clinical decision support for surgeons in the app’s capability.

Kidney transplants are life-saving and cost-effective for many patients suffering from kidney disease and diabetes. But the kidney discard rate in the United States has significantly increased from 5.1% in 1988 to 19.2% in 2009. Over 100,000 patients remain on the kidney transplant waiting list, but 3,159 donated kidneys were discarded in 2015.

Co-founders of the startup OmniLife, Dalton Shaull and Eric Pahl, both of whom witnessed the organ donation process in their personal lives, set out on a mission to discover the reason for discrepancy between number of organs donated versus the number of organs utilized. By shadowing transplant coordinators, surgeons, and physicians, Shaull and Pahl were able to better understand the organ transplant process and find areas to significantly improve communication between Organ Procurement Organizations (OPOs) and Transplant Centers. They realized that poor communication was one of the biggest challenges in the organ transplant process.

This led to the creation of a secure messaging app to streamline communication between stakeholders. Dr. Robert Emery led a team of researchers to tailor the app specifically for kidney transplant teams in phase I of their NIH funded, Small Business Innovation Research (SBIR) project. 

In phase II, researchers will test and evaluate the app’s ability to improve donor management, coordination processes, and kidney utilization outcomes. Advancing to phase II funding is a key milestone in bringing this potentially life-saving technology to market. 

Discoveries in the Lab May Lead to New Treatment for Type 2 Diabetes

InteliSpark client, Senseion, LLC., wins a competitive research grant from the National Institutes of Health (NIH) to research a possible, new treatment for type 2 diabetes.

Diabetes is the seventh leading cause of death in the United States. Around 90 to 95% of Americans with the disease have type 2 diabetes which puts them at high-risk for heart attacks, strokes, kidney failure, going blind, and losing toes, feet, or legs. Type 2 diabetes is also incredibly costly for millions of families and the U.S. health care system.

Type 2 diabetes is a disease that occurs when either the body does not make enough insulin or resists the effects of insulin. Insulin is a hormone that helps keep glucose, as known as blood sugar, levels from getting too high or too low. Lack of or inefficient use of insulin, therefore, causes blood sugar levels that are too high.

A research team, led by Dr. Susheel Kumar Gunasekar, has discovered a signaling pathway that regulates both insulin sensitivity and insulin secretion. They have also identified a small molecule modulator that appears to normalize both glucose tolerance and insulin sensitivity. Researchers believe by modulating the signaling, they may develop new drugs to treat the disease.

In phase I of the project, researchers will test the feasibility of this treatment in the lab and will develop an initial class of drugs for further testing, ultimately leading to clinical trials. The hope is to advance into phase II of Small Business Innovation Research (SBIR) funding for drug development efforts.

This new drug, based on a unique mechanism for treating type 2 diabetes, could have a profound effect on millions of Americans suffering from the disease.

Life-Altering Research for Patients Suffering from Painful Vein Condition

InteliSpark client, InnoVein, Inc., was awarded $726,664 from the National Science Foundation (NSF) to develop a first-of-its-kind valve replacement for chronic insufficiency of the veins (CVI). As no cure currently exists for CVI, this innovative medical technology could be life-changing for CVI patients.

CVI is a painful and disabling condition that occurs when the valves in leg veins do not allow blood to flow properly back up to the heart. Blood can flow backwards and collect in the legs, creating pain, swelling, skin thickening, varicose veins and ulcers in the legs of millions of patients suffering from the condition.

Austin Walker, biomedical engineer and co-founder of the startup InnoVein, Inc., is developing a prosthetic valve to address the underlying cause of the disease. This novel valve replacement treatment is less invasive compared to existing treatment technology. It also avoids the costs associated with CVI such as wound care, hospitalizations for infections, related surgical procedures, and rehabilitative care.

In phase II, researchers will improve upon the design created in phase I and conduct animal testing to assess the safety of the medical device and prepare for future clinical trials. Not all NSF-funded, Small Business Innovation Research (SBIR) grants advance to phase II. This is no small achievement for InnoVein, Inc. and reflects the tremendous potential to transform their innovative idea into commercial technology with societal health benefits.

This groundbreaking research offers hope to millions of patients that await a cure for this painful condition. Additionally, the commercialization of this new device will significantly reduce health care costs. 

Food Scientists Win Research Grant to Address Diet-Related Health Issues

InteliSpark client, Antithesis Foods, LLC, secures $225,000 from the National Science Foundation (NSF), via the Small Business Innovation Research (SBIR) program, to conduct research in developing an alternative for high-calorie, nutrient-poor, palatable foods. This project will create chickpea-based, nutrient dense ingredients to incorporate in a broad range of processed foods.

Processed foods are high in sodium, saturated fats and sugar and offer little nutritional value. Eating large amounts overtime can lead to serious health issues such as obesity and type II diabetes. Around 27 million Americans have type II diabetes and over 93 million Americans are obese according to the Centers for Disease Control and Prevention. Despite the growing awareness of diet-related health risks, Americans continue to consume processed foods due to taste, convenience and affordability.

Food scientists at Antithesis Foods, LLC decided to address this enormous challenge by creating healthy foods that are just as satisfying as junk foods. The ingredients will consist of the textures and tastes that are appealing in junk foods, while providing the benefits of being high in protein and fiber, and low in calories. Antithesis Foods, LLC will assess a novel microwave technology with the aim of creating low-cost, appealing, nutrient dense foods.

Food scientists hope this will result in a large commercial impact with the development of new products, brands, and production and processing equipment for these new ingredients. More importantly, they hope this will have a significant impact on population health by decreasing the rates of obesity and type II diabetes.

Innovation in 3-D Printing for Stronger and Lighter Products

InteliSpark client, Igneous IP Holdings, LLC, secures $225,000 for a Small Business Innovation Research (SBIR) grant from the National Science Foundation (NSF) for phase I of their project in developing new technology for 3-D printing, the field more formally known as additive manufacturing.

Stronger and lighter parts made with materials such as carbon fiber and glass fiber, are in high demand across many fields in the manufacturing industry. For instance, the transportation industry is incorporating these materials to design stronger and lighter aircrafts, cars and high-speed trains. Benefits include significant reductions in energy consumption, greenhouse gas emissions, material consumption, and improved safety and efficiency of a product.

Yet, the 3-D printing industry is struggling to meet this increased demand through inherent technical limitations. The industry uses vat photopolymerization, a process of selectively curing liquid resin (flexible, organic compound) through targeted light-activated polymerization (process where small molecules combine chemically to produce a chain-like molecule called a polymer). Though manufacturers rely on this process to create large models quickly and accurately, the process is expensive for some applications and creates parts that are more prone to degradation.

Researchers at the startup Igneous IP Holdings, LLC are proposing a new technology to incorporate into 3-D printing that will accelerate production speed and overcome size limitations. Researchers will modify the high-resolution vat photopolymerization process through the development of a novel foam resin technology. The end results are parts that are stronger, 75% lighter and less expensive to produce compared to traditional 3-D printing processes, as well as a smaller environmental footprint.

Renerva Advances Nerve Recovery Technology through Federal Funding

InteliSpark client, Renerva, LLC, wins a highly-selective grant from the National Institutes of Health (NIH) for phase I of their research project to accelerate patient recovery from recurrent laryngeal nerve (RLN) injury. Researchers will assess the ability of a novel injectable medical device to supplement traditional nerve graft procedures for RLN injury.

RLN injuries, occurring most commonly during neck surgery, lead to vocal fold paralysis (VFP), also known as vocal cord paralysis. This may result in life-threatening airway obstruction and the need for a tracheostomy, a medical procedure that creates an air passage through the neck.

For some patients, nerve recovery occurs on its own, but many patients with paralysis require intervention to correct airway obstruction and voice changes. The most common intervention is reinnervation, or the surgical grafting, of laryngeal muscles to restore function. To allow time for natural recovery, the current practice is to wait 6-24 months prior to intervention. However, this delay allows long-term changes to occur to the damaged nerves which results in poor recovery.

Renerva, LLC plans to accelerate recovery after RLN injury through a novel injectable gel, Peripheral Nerve Matrix (PNM), and as a result, reduce the consequences of delayed repair. This research project, led by Dr. Lorenzo Soletti, co-founder and CEO of the biotech startup, represents one of the many NIH-funded research projects, via the Small Business Innovation Research (SBIR) program, in developing innovative medical technology for improved public health.

Promising New App to Help Patients Take Medications Correctly

InteliSpark client, Insightfil, was awarded a Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for phase I of their project in developing a comprehensive medication management plan to promote medication adherence for improved patient health.

Research shows that about 50% of patients in the U.S. do not take their prescription medications as prescribed. Many patients have complicated medication regimens involving more than three types of drugs, which puts these individuals at a higher risk of not taking medications correctly. Non-adherence to prescription drug regimens leads to more hospital visits, increased healthcare costs, and poorer health outcomes.

This project, led by Dr. Edward Acworth, CEO and founder of the startup Insightfil, will address medication non-adherence by developing a solution that positively impacts all stakeholders including patients, doctors, pharmacies, and insurers. This medication management solution includes convenience packaging combined with a smartphone app that both verifies if a patient opens a medication pack and delivers essential and medicine-related information in real-time. In other words, not only will a patient realize he or she missed a dose, so will the patient’s doctor.

Researchers believe this will contribute to a more accurate information exchange between all stakeholders, leading to decreased healthcare costs and improved health outcomes for patients. Once Insightfil develops a successful prototype in phase I, they plan to advance to phase II and conduct a pilot study in 1-2 pharmacies serving 5,000 patients.

Potentially Life-Saving Diagnostic for Unruptured Brain Aneurysms

InteliSpark client, Neurovascular Diagnostics, Inc., secures $750,000 for a Small Business Innovation Research (SBIR) grant from the National Science Foundation (NSF) for phase II of their project to test and validate a new blood-based diagnostic that detects unruptured brain aneurysms in patients.

About six million people in the United States have an unruptured brain aneurysm. Approximately 30,000 people suffer from a ruptured brain aneurysm annually, 50% of which are fatal. Many show no symptoms until it is too late. The lack of adequate diagnoses of unruptured aneurysms puts these individuals in a potentially dangerous situation. Additionally, the treatment costs are significantly more for ruptured than unruptured aneurysms.

Neurovascular Diagnostics, Inc. will build upon the success of phase I of their project and validate and test a new diagnostic. In phase I, researchers discovered that a panel of about 50 circulating RNAs (ribonucleic acid) isolated from blood samples predicted unruptured brain aneurysms with over 90% accuracy. In phase II, researchers will utilize blood samples from 400 individuals with and without brain aneurysms across 3 clinical centers to test the accuracy of their new diagnostic. 

Drs. Vincent Tutino and Hui Meng, CEO and CMO respectively, at Neurovascular Diagnostics, Inc., are utilizing technology they developed at the State University of New York at Buffalo. Both of their academic training and research in neurovascular diseases and intracranial aneurysms led them to develop this desperately needed diagnostic screening tool and to form the startup Neurovascular Diagnostics, Inc.

This new diagnostic has the potential to provide millions of Americans access to affordable screening, which may save many lives and prevent the permanent neurological deficits that survivors from ruptured brain aneurysms experience daily.

Improved Infant Formula on the Horizon through Innovative Research

InteliSpark client, Zymtronix Catalytic Systems, Inc., was awarded a research grant from the National Institutes of Health (NIH), via the Small Business Innovation Research (SBIR) program, to test the feasibility of their novel technology in producing complex human milk oligosaccharides (HMOs) more efficiently and affordably for improved infant formulas.

HMOs, the third largest component found in human breast milk, lead to stronger immune systems in breast-fed babies compared to formula-fed babies. HMOs feed good bacteria in the gut and are also absorbed into the baby’s blood stream to support the developing immune system.

But not all parents have the option to breast feed. Researchers have attempted to introduce HMOs into infant formula, but the biggest challenge is accessibility and affordability of complex synthetic glycans.   

Dr. Alexander Hoepker, lead biochemist at the Cornell University spinoff, Zymtronix Catlytic Systems, Inc., will lead phase I of this research project to demonstrate key steps for the production of HMOs. Researchers will utilize the company’s unique technology in enzyme immobilization to significantly improve HMO production efficiency while establishing substantial cost savings.

Enzymes serve as biological catalysts by speeding up chemical reactions. Enzyme immobilization occurs when enzymes attach to inert matrices allowing for increased functional efficiency and reusing of an enzyme. Zymtronix sees the potential application for the production of HMOs.

Improved infant formula with the introduction of HMOs may lead to long-lasting, positive effects on formula-fed babies.