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We have developed the CloSys Hemostatic Device (HD)  - a highly differentiated technology for vascular closure after an interventional cardiology or peripheral procedure.  CloSys HD is unique in that it facilitates rapid closure but leaves NO foreign material behind in the patient.  It does this using a patented technology that eliminates heparin (anti-coagulant) from a small amount of the patient's blood and re-infuses this back to the puncture site and around the entire artery.  The de-heparinized blood rapidly and safely forms a clot to seal the artery naturally.  There are several other unique attributes of this product.  First  - it is the only product that will also seal "backsticks" or inadvertant punctures that go through the other side of the artery.  Backsticks are a leading cause of retroperitoneal hemorrhage.  Second - it preserves immediate re-access at the same site in the advent of an emergency.  

There is also an important economic value proposition offered by CloSys HD.  It will have a very low cost of goods so it could be sold for a price that will allow high margins to the manufacturer and cost savings to the hospital.  

We are approximately 25% of the way through a US pivotal trial and to date all performance and safety endpoints have been met.  There is a highly experienced management team and exceptional Board of Directors now associated with the company.    

The Colorado Institute for Drug, Device and Diagnostic Development (CID4) is a 501(c)3 not-for-profit entity committed to economic development through the creation and funding of Colorado Life Science companies. Our goal is to efficiently transform emerging life science innovations into commercial successes. First, we use a rigorous review process and advisory panel to select promising post-proof-of-concept technologies from Colorado’s outstanding research institutions and start-up companies. Second, we fund and actively manage product development while taking an equity position in existing companies and in new companies that we found with the inventors. Third, we facilitate additional seed and/or grant funding to further develop our portfolio companies technologies. By augmenting the value of these innovations, we position our portfolio companies to attract series A financing from venture capitalists and/or partnering opportunities with established pharmaceutical and biotechnology companies. We have funded 9 early stage companies since June 2010 and these companies have raised more than $30 million in additional private capital and grant funding.

DermSpectra has developed an innovative high resolution full body imaging system designed to aid early detection of skin cancers and diseases, and revolutionize medical documentation.  The DermSpectra Automated Total Body Digital Skin Imaging (DSI) System fills a key technology gap in medical imaging, empowers physicians with an objective tool to accurately and efficiently detect and monitor skin and body changes over time and raises the bar for patient care.

Deton is developing a novel non-invasive simple-to-use sample collection device for tuberculosis (TB) patients who are unable to provide a sample.

Proper diagnosis is essential to effectively treat the more than 9million new cases of TB every year. Typically, a sputum sample is collected to run the diagnostic test. However, in 22% of adults and in all children patients, sputum is impossible to collect. These patients have to rely on inadequate alternative collection methods that are invasive, high-cost, and resource-intensive. With our device, patients can now provide a sample even in low-resource setting and find out their TB status. Deton will enable 26M samples to be tested every year.

After promising clinical data, Deton is now raising $1.6M to build an ISO 13485 disposable product and to obtain pivotal clinical validation. Discussions with multiple potential diagnostic partners and first feedback from experts at World Health Organization show significant interest in adopting the device once effective validation has been completed. 

EmbraceHer is the women's reproductive health club developed by clinicians. We support the lifetime reproductive health of every woman from menstruation, fertility preservation, conception, infertility/IVF, maternity, postpartum, lactation, sexual health and menopause. Our digital platform provides targeted, clinically-sound health education, subscription-based telehealth services, and doctor-curated medical and health products for women. 

Our maternity product is the only mobile digital health offering developed and prescribed by Board-certified obstetricians, used by over half a million pregnant mothers.

GaitTronics has developed a robotic patient handling system called SoloWalk. SoloWalk provides effortless mobility for frail patients which would otherwise require two or more caregivers to assist them and put the patients at risk of falling. With SoloWalk's intelligent patient driven mobile system, a single caregiver can mobilize a patient. Additionally, an automatic fall protection system supports the patient automatically if a balance loss is detected, significantly reducing the risk of injury for patients and staff.

Currently, hospitals are only providing adequate mobility for 30% of their patients. With SoloWallk, these institutions can expect to significantly increase this proportion and reduce complications associated with immobility, including: functional decline, bed sores, increased delirium and increased length-of-stay. With the potential of reducing length-of-stay by two days, there is a significant ROI for using SoloWalk in an acute care setting.

Watch a demo of SoloWalk at http://youtu.be/tIcfEsnQ4uY .

Health Beacons is an early stage medical device company that is revolutionizing the standard of care for marking and surgically removing non-palpable breast tumors. Physicians are actively seeking an alternative procedure and are enthusiastic about ours, which employs RFID markers that are read with handheld readers, because it addresses all the shortcomings of the current method.  We have a fully functional prototype that has been used successfully in almost 40 human cases and are working on our 510K submission. Investment to date has been from founders, friends and family.  We are currently seeking $1.5M in an equity round to support regulatory clearance, and will require another $2-3M for commercialization which is planned for Q1 2016.

Healthcare Software focusing in on Mental health & Addictions. The main goal is to place these individuals on a path to recovery.

TREAT product line is commercially available as an EHR serving the unique needs of community behavioral health, rehabilitation, and other community-based providers. The design of our system is centered on a client-centered recovery model principle with best practice assessments linked to an interdisciplinary plan of care which is at the core of our methodology. TREAT’s modules create a record of client care that functions at multiple levels and builds upon itself. From assessments, to care planning, to documentation, to decision support, TREAT provides an integrated solution centered on client care.

Assessment Tools

Our TREAT product has a catalog of over 120 different assessment tools, and can be customized to include new tools upon request. Assessments are linked with our Interdisciplinary Plan of Client Care (IPCC) and Progress Notes modules to offer a truly integrated approach to patient care.

IR2Dx Company Overview:

IR2Dx has developed a proprietary, breakthrough analysis and reporting system for multi-marker diagnostic test panels, to provide highly personalized treatment strategies for patients with Type 2 diabetes.  While control of glucose levels remains an important factor in the treatment of the disease, the IR2Dx platform evaluates the individual disease pathways for each patient, providing critical information regarding multiple markers and their overall pattern, all of which contribute to management of underlying disease.  This information can then be used by physicians to guide treatment decisions to deliver precision medicine in diabetes. 

Today, there are approximately 382 million people with diabetes in the world, and this number is expected to grow to 592 million by 2035.  The worldwide available market for early detection and drug response diabetes diagnostics is greater than $20 billion.  IR2Dx can enter the market within the current reimbursement and regulatory environments, and is ready to launch its first products in H1 2015 through commercial laboratories.

The IR2Dx platform provides personalized treatment information and recommendations to physicians based on a proprietary decision tree algorithm, greatly enhancing the clinical utility of a laboratory report.  Existing reimbursement levels for the panel markers in the U.S. and key international markets adequately cover the addition of the IR2Dx analysis and reporting. 

The platform is a software-based decision analysis tool. The analysis is performed on results from commercially available diagnostic tests run using standard laboratory bench top systems, requiring no tailored equipment, no custom design of the test system itself, and no capital investment.  Lab technicians upload the multi-marker panel testing results to the IR2Dx proprietary web portal to access the company’s decision support tool analysis product. In the initial commercialization phase, each laboratory will have a specific customized software product, and will pay for each report on a per-use basis. 

In the current U.S. regulatory environment for such products, with “health management IT functionalities”, such as the IR2Dx analysis and reporting system, near-term requirements for premarket review are unlikely, though the FDA may give additional guidance at any time. The IR2Dx platform is protected by a strong and broad intellectual property portfolio combining substantial data and know-how with issued patents in the U.S. and Europe. The company’s issued patents carry claims for use of its analysis platform and combination of markers for treatment guidance “with all glucose lowering drugs.”

 The company anticipates launch of the proprietary IR2Dx platform in H1 2015, introducing its first clinical decision support products through commercial laboratories. 

N8 Medical is a development-stage medical device company focused upon commercializing antimicrobial medical devices and coatings to address the multibillion dollar public health and economic burden associated with medical device-related hospital acquired infections and healthcare associated infections (HAIs).  N8 Medical’s key differentiator from competitors is the application of a novel, proprietary class of pharmaceutically active compounds known as ceragenins, Cationic Selective Antimicrobials, or CSAs (ceragenins or CSAs) to medical devices for the purpose of providing antifouling or anti-infective properties. N8 Medical believes that ceragenins offer unparalleled efficacy and cost advantages over other coatings and means of addressing HAIs. Further, the use of ceragenins as a platform technology under its CONTEGO™ brand across numerous device segments with multiple coating options provides N8 Medical with a unique, sustainable competitive advantage over other medical device companies.  

N8 Medical is seeking $6 million in investment capital, which it believes will be sufficient to fund development, FDA approval and CE Marking of its proprietary coated CONTEGO™ endotracheal tube (ETT), and initial commercialization activities. N8 Medical has designed its antimicrobial ETT to reduce ICU stays by a single day or more, thereby saving the hospital $3,000 to $5,000 in non-reimbursable costs per ICU patient, and, significantly, by freeing up an ICU bed one day earlier for a new revenue-generating patient and resulting in better profitability for providers and substantial opportunity cost savings.  Thus, N8’s CONTEGO™ ETT presents a compelling value proposition for hospitals.  N8's internal valuation model aligns with relevant market data and comparable companies, indicating a successful antimicrobial device company could achieve a value of over $100 million.