Neurovascular Diagnostics, Inc. wins Phase I SBIR Grant

InteliSpark client Neurovascular Diagnostics, Inc. has been awarded a Phase I Small Business Innovative Research (SBIR) grant worth $224,032 from the National Science Foundation (NSF). The grant is for the SBIR project “A Blood-Based Test to Identify Patients with Intracranial Aneurysm.”  The goal of the SBIR project is to develop a novel blood diagnostic to detect unruptured intracranial aneurysms (IA) in asymptomatic patients.

About 2-5% of the U.S. population (about 6-17 million Americans) have an unruptured IA, and these individuals are largely asymptomatic and thus unaware of the potential danger they are in. Currently, there are not any good screening tools to identify patients with unruptured IAs. Due to inefficient technology, about 30,000 Americans suffer IA rupture each year without warning. The diagnostic screening technology developed in this project will identify people who have unruptured IAs, enabling patients to be monitored and receive preventative treatment, which can drastically reduce the rate of rupture. This project aims to develop a molecular diagnostic to detect biomarkers of unruptured aneurysms using the transcriptomes of circulating neutrophils. Preliminary results have shown that circulating neutrophils isolated from blood samples could be used to predict unruptured IA presence with 80% accuracy.

This Phase I project will increase the sample size of the previous discovery and validation cohorts to give more confidence in the discovered biomarkers as well as increase the accuracy of the proposed diagnostic.

Senti Biosciences, Inc. wins Phase I SBIR Grant

InteliSpark client Senti Biosciences, Inc. has been awarded a Phase I Small Business Innovative Research (SBIR) grant worth $225,000 from the National Science Foundation (NSF). The grant is for the SBIR project “An Engineering Platform for Adaptive Medicines.”  The goal of the SBIR project is to develop a cell-based platform technology that can sense inflammatory sites and respond by producing anti-inflammatory factors to treat autoimmune diseases.

“There are more than 80 types of autoimmune disease with more than 23.5 million Americans affected. Autoimmune diseases are the number one cause of morbidity for women in the U.S., and one of the top 10 causes of death for women under 65 years old.” Current treatments for autoimmune diseases are effective for some patients, but a majority either are not receptive or become unmanageable. Standard drugs result in systemic immune suppression, which can cause severe and chronic side effects. There is a substantial market need for anti-inflammatory drugs that can act locally at the site of inflammation, and deliver the "right dose at the right time" depending on the severity of the flare. If successful, the adaptive cell therapy platform being developed in this proposal will serve as the basis for a next-generation therapy to existing biologics.

The substantial technical and clinical progress made in recent years in synthetic biology and cell therapies is enabling development of this type of product. The goal is to design and optimize synthetic gene circuits to program cells to locally sense inflammatory signals such as TNFalpha and release anti-TNF drugs. The plan is to introduce these circuits into adult stem cells that have been used safely in numerous clinical trials against autoimmune diseases and have a well-established commercial development path. The engineered cells will be tested in culture to show input/output response to different levels of TNFalpha, and then tested in mouse models of disease. If successful, lead candidates will be further developed in a Phase II application.

SensoDx, LLC. wins Phase II STTR $1M Award

InteliSpark client SensoDx, LLC. has been awarded a Phase II Small Business Technology Transfer (STTR) grant worth $999,998.25. The grant is for the STTR project “Field Drug Identification Kit.”  The goal of the STTR project is that the proposed product is a microfluidics point-of-care (POC) cartridge, in conjunction with a miniaturized instrument, that together permit real-time detection of illicit drugs in the field.

 Illicit drug trafficking has increasingly been used to fund terrorist groups since the end of the Cold War. As illicit drugs increasingly finance terrorism, soldiers in the U.S. Army are increasingly playing an active role in identifying these drugs in difficult and demanding environments.

Over the past decade, the John T. McDevitt laboratory located at New York University has pioneered the development of a series of powerful programmable bio-nano-chip sensor systems that are suitable for a wide range of chemical, biological and cellular assays. Developed initially as “electronic taste chips”, these mini-sensor systems are fashioned with the same micro-fabrication methods used by the microelectronics industry. These devices are created such that they can be reprogrammed for new applications in an efficient manner, while at the same time yielding sensors with strong analytical performance characteristics.

Programmable Bio-Nano-Chip (p-BNC) technology that will permit detection of illicit drugs in the field. During Phase II, SensoDx plans to: a) expand the classes of drugs that it targets from three to five, by the addition of drugs representative of a Cathinine and a hallucinogen; and b) increase the panel size for the detectable drugs from three to eight drugs. The ultimate goal is to detect all eight drugs in a single test that takes less than 5 minutes.

RemPhos Technologies LLC Wins Phase II $1M Grant

InteliSpark client RemPhos Technologies, LLC. has been awarded a Phase II Small Business Innovative Research (SBIR) grant worth $999,742.97. The grant is for the SBIR project “Miniature, point-of-care device for establishing sterile connections in combat environments.”  The goal of this SBIR research is to develop a portable novel UVC LED light-source device for medical catheters that effectively disinfects the luminal surface and luer connectors in a safe, nonchemical, low temperature fashion without the need for consumables like Curos™ caps, in less than 2 minutes.

RemPhos developed a simple, hand-held, portable and reusable high intensity UVC light source (LED/housing + optics + cooling + low voltage power/control) for automated simultaneous disinfection of catheter lumens and luer connectors. The assembly directs the emitted UVC light in the 250-280nm range at ~20 mW, focusing the energy with a 50 mm focal length into the lumen via a proprietary optical method. Their data and data from a few other groups have shown that UV light can indeed sterilize catheters.

The product being created in this project a portable novel UVC LED light-source device for medical catheters that effectively disinfects the luminal surface and luer connectors in a safe, non-chemical, low temperature fashion. This will enable physicians to quickly guarantee their catheter equipment is sterile before using it, no matter where they might be. If successful, this system will be of tremendous use to medics and combat lifesavers, and ultimately increase their ability to save lives on the battlefield. The proposed UV disinfection product fits perfectly into existing operations and in their mission of using our talented engineers to design LED lighting solutions that will have a positive effect on people’s lives.

The vision for the company over the next five years is to continue growth in existing markets, while also expanding our product lines into additional markets, particularly the medical space.

Apama Medical, Inc. acquired by Boston Scientific (NYSE:BSX)

Apama Medical was acquired by Boston Scientific in deal that is worth $300 million for its’ radiofrequency balloon catheter system designed to treat atrial fibrillation.  InteliSpark’s predecessor (Centurion Technology) helped Apama Medical secure $1.2 million in National Science Foundation Phase I, Phase II, and Phase IIB funding.  This funding, which began in 2010, played a critical role in the early stage development of Apama’s novel RF balloon catheter system.

Apama’s novel RF balloon is a single-shot, multi-electrode device designed to combine the benefits of RF point-by-point and balloon-based ablation approaches, the company said, claiming the system delivers differentiated energy levels and shorter procedure times. The system features an incorporated digital camera with LED lights and sensing electrodes for real-time visualization of the procedure and catheter electrode contact.

The deal, which Boston Scientific announced last Monday, includes an initial $175 million in cash up-front from the Marlborough, Mass.-based company and an additional $125 million in contingent payments between 2018 and 2020 based on clinical and regulatory milestones.

Adhesys Medical, Inc. Wins $1.3M Award with SOCOM

InteliSpark client Adhesys Medical, Inc. has won a $1,329,609 contract with the United States Special Operations Command for the project, “Novel Medical Adhesive and Applicator for Field Use”.

Adhesys Medical proposes the continued research and development of MARglue, a polyurethane-based adhesive, designed to save lives in the operating room and on the battlefield. In its intended use, it will allow casualties to survive until they reach a Medical Treatment Facility (MTF) by controlling hemorrhage.

There are two pieces of technology that are integral to the final product: the adhesive properties and the applicator device.  Through this work we will expand our knowledge on the properties of our already developed adhesive in order to optimize it’s use in medical emergencies to save lives.  We will also work with military personnel to develop a field-ready, easy to use applicator suitable for treatment of traumatic wound on the battlefield.  Through the continued research and development of this technology Adhesys Medical seeks to improve the survival rates for casualties during their transition from the battlefield to an MTF.

Major blood loss with hemorrhagic shock is one of the leading causes of fatalities in military operations. Of the potentially survivable deaths sustained during Operation Iraqi Freedom and Operation Enduring recorded between 2001 and 2011, 91% were associated with hemorrhage.  Because most battlefield casualties die of their injuries before reaching an MTF, there is a great need for new technologies that mitigate hemorrhage.  Furthermore, there were 1,645 battery-injury major limb amputations between Oct. 7, 2001 and June 1, 2015 in U.S. operations in Iraq, Afghanistan and Syria. Many of these amputations may have been prevented with improved proximal hemorrhage control.

MARglue is an excellent first-aid-device for military emergencies. This adhesive will stop bleeding within 60 seconds, working independent of the body’s own clotting mechanism, through the use of quickly assembled and easy to use applicator. MARglue can be applied directly into wound cavities, and as the cavity is filled, the glue closes injured vessels and attaches to the surrounding tissue. For traumas resulting into limb bleeding, MARglue can be applied directly on the area. Due to its high viscosity, it is not easily washed away by excess blood. Deep wounds, like those resulting from a bullet, can be treated by applying the adhesive directly into the point of entry, filling the cavity with adhesive. Finally, topical wounds can be closed by applying the adhesive on the wound while compressing the wound edges.  In any application, MARglue forms a strong yet flexible barrier that is non-toxic, biocompatible and has shown first biodegradation after 90 days.  Yet, the adhesive is easily removed in a surgical environment.  MARglue has a proven shelf life exceeding 9 months in a wide range of temperatures and environments.  This technology will allow for a soldier-compatible medical device that will lead to an increase in soldier survival and decrease amputation rates by providing wound closure between the battlefield and an MTF.  MARglue will also enable medics and soldiers to carry less gear while increasing treatment safety and effectiveness.

GrokStyle, Inc. Wins Phase II Grant with NSF IIP

InteliSpark client GrokStyle, Inc. has won a $747,959 contract with the National Science Foundation Division of Industrial Innovation Partnership for the Phase II Small Business Innovation Research (SBIR) project, “Innovative Visual Search and Similarity for Decor, Apparel, and Style”.

The broader impact/commercial potential of this project is to develop visual search for product recognition in the furniture and home décor vertical. Text-based searches have revolutionized the ability of people to complete tasks more quickly and efficiently as they are able to find the information they desire in an organized, compiled, and logical manner. Visual search provides the next level of disruption in search capabilities by allowing users to find information even more rapidly and accurately by using images. The deep learning-based software being developed will allow consumers to find products they are interested in, and co-purchase related products, quickly. Further, users will be more engaged through exposure to designer photographs of products (inspirational photography). By helping customers find exactly what they are looking for in a timely manner, user engagement and productivity will be increased. Further, related style-based recommendations will increase purchasing overall. Increased spending stimulates economic growth by increasing taxable revenue by retailers, and through increased sales taxes generated from the purchases. 

This project seeks to develop a visual search engine that is poised to disrupt retail and ecommerce by switching the focus from text-based to visual search-based exploration. The platform initially targets interior décor and furniture where deep learning techniques are trained to recognize products across a wide range of conditions

 A client-facing REST API will allow retailers, designers, and media companies to programmatically access functionality of the platform, and build their own user interfaces and apps on top of the deep learning technology. Lastly, it is proposed to develop a white-label app that can be customized for individual retailers who want to distribute this visual search capability to their customers. Achieving these objectives will create state-of-the-art performance in visual search for applications in interior design, apparel search, real estate search, and product look-up.

Zenflow, Inc. Wins Direct to Phase II Grant with NIDDK

InteliSpark client Zenflow, Inc. has won a $636,601 contract with the National Institute of Diabetes and Digestive and Kidney Diseases for the Direct to Phase II Small Business Innovation Research (SBIR) project, " Spring System for Permanent Relief of Urinary Obstruction Related to Benign Prostatic Hyperplasia”.

 Urinary retention, frequency, and urgency related to benign prostatic hyperplasia (BPH) represent an unmet clinical need for many millions of men in the US. Medications can be expensive, have side effects like loss of libido, and prove ineffective in 30-43% of patients. Surgery is effective, but can result in post-operative pain and carries a high risk of permanent sexual side effects such as retrograde ejaculation and erectile dysfunction. A number of shortcomings have prevented minimally invasive attempts from attaining widespread adoption. Mechanical devices have failed due to difficult placement, migration, and encrustation caused by urine exposure, whereas energy therapies have failed to achieve durable results.

 Zenflow has developed the Spring System to provide a superior minimally invasive and permanent solution for men who experience inadequate relief or side effects from drugs, but decline to undergo invasive surgical procedures such as transurethral resection of the prostate (TURP). Unlike other minimally invasive attempts, the Spring nitinol implant is delivered through a flexible cystoscope in an easy, ten-minute office procedure that does not damage tissue. With uniquely low COGS of less than $200, the Spring will also substantially reduce costs to the healthcare system substantially over all existing treatment options.

After refining the placement procedure in early studies, we have verified that the Spring implant can be placed accurately and reliably by a trained urologist.

ACIS Wins Phase II Grant with NIGMS

InteliSpark client ACIS, LLC has won a $670,777 contract with the National Institute of General Medical Sciences for the Phase II Small Business Innovation Research (SBIR) project, "Novel Single Cell Assay for Quantitative Analysis of Cell Heterogeneity by Noninvasive Probing of Molecular Composition of Specific Organelles in Individual Cells”.

ACIS, LLC proposes a conceptually novel cellular heterogeneity assay, based on confocal Raman spectrometry and Biomolecular Component Analysis (BCA). The goal of Phase II is to implement a BCA toolbox in a commercial confocal micro- Raman instrument for quantitative assessment of cellular heterogeneity and potential quantitative classification of cellular states based on macromolecular compositions in specific organelles, a single cell assay developed during the Phase I, Phase II focuses on bringing this new device to the market.

 This project is motivated by the fact, that there is no currently any commercial tool, which provides direct probing of local biomolecular concentration in live cells. At the same time, this tool is extremely valuable for solving a number of problems, which require determination of quantitative markers for different cellular states (i) in diseased cell population (cancer-non-cancer, different cancer stages etc), (ii) during cell-drug interaction, and (iii) in the intracellular processes (apoptosis, proliferation, differentiation, etc).

The outcome of this project will be a commercial confocal micro-Raman system with an implemented BCA toolbox, along with customized software for quantitative assessment of cellular heterogeneity, which can be used for a broad range of biomedical applications in many sectors such as clinical labs, Biomedical cellular Research labs, Pharmaceutical industries, National Cancer Institutes, etc.

Widetronix, Inc. Wins Phase II Grant with NHLBI

InteliSpark client Widetronix, Inc. has won a $773,585 contract with the National Heart, Lung, and Blood Institute for the Phase II Small Business Innovation Research (SBIR) project, " High Energy Density, Long Life, Betavoltaic Power Cells for Pacemakers and Other Implantable Devices”.

Pacemakers are small devices that help control abnormal heart rhythms, called arrhythmia, which can lead to serious, life-threatening conditions, including organ damage, cardiac arrest, and death. Indeed, pacemakers are a highly important treatment option for cardiac arrhythmia with 1,002,664 implanted in 2009, including 225,567 in the U.S, growing at an annual rate of 55.6%. Given the aging population and increased likelihood of arrhythmia as a person ages, the number of implants is expected to increase in the future.

There are two main limitations associated with the majority of currently marketed pacemakers, both of which are tied to the battery: usable lifetime and device volume. Typical pacemakers need to be replaced every 5 to 7 years due to the specified lifetime of their electro-chemical batteries, meaning 20% of pacemaker implantations are replacement devices and 76% of those replacements are battery related. This constraint results in significant cost, up to $80,000/per implant in the U.S., as well as health risks and inconvenience for the patient. Pacemaker volume is also an important issue for patients and physicians. Current batteries constitute over 50% of the volume of a conventional model. While pacemaker size has reduced over time, the current footprint remains visible under the skin, and hence, less than ideal from a quality of life perspective.

The goal of this research project is to develop a next generation battery for pacemakers and other medical implants through the development of novel textured silicon carbide (SiC) betavoltaics that will provide a more compact and long-lived power source for next-generation implantsThe development under the Phase II will focus on pushing the texturing of the SiC device toward its material limit, etching deeper into the SiC while narrowing the features, thereby allowing the betavoltaic to take full advantage of the extra surface area gained through the texturing process. The goal is to increase the active area density by 6x (from 2.43 cm2/cm2 to 14.58 cm2/cm2), resulting in an energy density that surpasses existing pacemaker batteries (5.8 kJ/cc) and moves us closer to our medical implant partners desired goal.