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NeuroTronik Limited is a development-stage, venture-backed medical device company pursuing a unique neuromodulation approach to improve cardac output for patients who come to the hospital with Acute Heart Failure Syndrome. With a seasoned team of engineers, advisors, and investors, NeuroTronik is on-track in project milestone achievement. Though a moderately-sized project, the market potential is exceptional.

NeuroTronik is planning a $20 million Series B preferred stock financing in late 2015. Those proceeds are designed to take the therapy through and into commercial sales in Europe.

Our named investors are Hatteras Venture Partners, Synergy Life Science Partners, Mountain Group Capital, and Lord Baltimore Capital.

The CEO is Fred McCoy. The CTO is Steve Masson.

Norfolk Medical pioneered the oncology market in 1981 by developing one of the first vascular access ports for long-term access.  Since then, we have continued to develop innovative cutting-edge medical devices.  Our latest development is a device for diabetes that allows the body to be insulin independent.  Our device is the world's first active immunoisolation device that facilitates the exchange of oxygen, nutrients, and waste products while protecting against the bodies immune response without the use of additional drugs or immunosuppressant’s.  We are confident that the basic principles of the device can be applied to other applications from anemia and liver failure (NASH) to ALS.  We are currently in the pre-clinical stage of research and are actively looking for a strategic partner to develop this product. 

PhysioCue is a medical device company that has developed an anti-hypertension medical device, clinically shown to immediately reduce the high blood pressure of hypertensive patients. This device is non-invasive and works by controlled cold therapy with the carotid artery baroreceptor reflex. Unlike drug treatments, our PhysioCue therapy device is efficient, safe, easy to use, non-invasive, and has none of the side effects associated with anti-hypertensive drugs. We also develop mobile Health device.

PhysioCue’s Mechanism of Action is the body’s natural baroreflexive system which provides important monitoring and feedback for blood flow throughout the body. It activates baroreceptors in the wall of the carotid artery which stimulate the afferent and efferent pathways of the automatic nervous system. To lower excessive blood pressure the brain responds by modulating efferent pathways, which relaxes the blood vessels, slows the heart rate and reduces fluid in the body. These actions reduce the afterload on the heart by decreasing arterial resistance, which improves the heart’s ability to pump blood to the tissues. The increase in parasympathetic tone and decrease in sympathetic drive results in the restoration of sympathetic-vagal balance which reduces excessive blood pressure and improves cardiac structure and function.

PhysioCue’s video has been published on YouTube http://youtu.be/A1bMjg5a3MY ,

ProPep Surgical, LLC (www.propepsurgical.com), a privately held, Austin-based medical device company develops interoperative  nerve monitoring technologies for laparoscopic and robotic-assisted cancer surgery. 

 It has been well documented in the literature, that anatomic landmarks are not reliable in identifying the location of nerves hidden in tissue and too small to be seen. For decades surgeons have been using nerve monitoring during surgical procedures to provide real-time, accurate information on the condition and location of somatic nerves vital to a patient’s recovery and future quality of life.  The technology has proven to be so valuable that its use is considered standard of care in maxillofacial surgery, spine surgery, and neurosurgery.  

ProPep Surgical has adapted this proven technology to Laparoscopic and Robotic Radical Prostatectomy. The ProPep Nerve Monitoring system interfaces with the Laparoscopic Bipolar Instrument to enable the surgeon to stimulate the neural tissue. Knowing the location of a nerve enables the surgeon to handle that tissue differently in order to avoid nerve damage.

Additional clinical benefits:

The ProPep Nerve Monitoring System has been used during robotic-assisted prostate cancer surgery to not only identify the location of pelvic nerves critical to urinary continence but, most recently, pelvic nerves critical to erectile function.  This is a significant “game changer” because, although incontinence rates as high as 18% have been reported following “successful” robotic-assisted, prostate surgery, erectile dysfunction rates are conservatively reported to be up to 38% post-prostatectomy.  Obviously, a much bigger problem.

Completion of additional investment capital

On March 8th, 2013 our company completed a new investment round of funding with Stella Maris Capital, a venture capital firm.   This investment round included an immediate funding and additional capital based on milestones achievements. The additional capital is currently being funded based on milestone satisfaction. 

Additional Indications for Use:

We have completed  the Hysterectomy clinical study with Dr. John Crane, Director of Robotic Surgery, Banner McKee Medical Center, Loveland, CO to assess feasibility of performing intraoperative nerve monitoring (IONM) on pelvic nerves during robotic-assisted, radical hysterectomies.  Dr. Crane was able to positively identify the perineal branch of the pudendal nerve that plays a key role in urinary continence control.   The 510-k was filed with the FDA on 10/2014 for the Hysterectomy indication and we are awaiting response.  ProPep has also begun to explore the opportunity in the colorectal market and have conducted initial procedures.

Poster presentation at the American Urological Association’s annual meeting

Dr. Ronald Kuhn, Arkansas Urology, presented a poster at the American Urological Association’s annual meeting entitled Results of a Using a New Technology to Improve the Identification and Preservation of Nerve Tissue during Robotic Assisted Laparoscopic Radical Prostatectomy.  The presentation summarized the results of a 20 patient study Dr. Kuhn conducted wherein he evaluated whether the use of the ProPep Nerve Monitoring System would allow him to better identify and thus preserve nerves innervating the Levator Ani (LA) muscle known to play a critical role in urinary continence control.  

The results showed Dr. Kuhn was able to identify the nerves innervating the LA muscle in 100% of the cases.  The results also showed a correlation between 8 week post-op continence and the latency of the Compound Motor Action Potential (CMAP) waveform displayed on the ProPep Nerve Monitoring System.  (The appearance of this CMAP waveform indicates the stimulating probe of the ProPep Nerve Monitoring System is on a nerve.)    

ProPep Surgical awarded CPRIT grant award

ProPep Surgical was honored to be chosen for the Product development grant of 4.4MM from the Texas CPRIT ( Cancer Prevention and Research Institute of Texas).  ProPep plans to use the grant to conduct additional clinical studies, specifically, two clinical studies exploring how the use of the ProPep Nerve Monitoring System can help reduce nerve damage related side-effects such as erectile dysfunction and urinary incontinence in robotic-assisted prostate cancer surgery and urinary and fecal incontinence in robotic-assisted radical hysterectomy surgery. 

Sales

ProPep received FDA 510-k clearance in June of 2012 and launched in the US Q1 2013.  Since product approval  the ProPep Nerve Monitoring System has been used in more than 1000 prostatectomy procedures.   This was completed with one internal rep marketing the product in the field.  In 2014 , the ProPep Nerve Monitoring System is sold via two US distributors. Outside the United States, ProPep continues to expand its distribution network and currently has 25 distributors worldwide.

Results of user survey

ProPep surveyed its customers (surgeons)  regarding their use of the ProPep Nerve Monitoring System and the benefits they are seeing in their patients’ outcomes.  Some of the key findings were:

1. Surgeons using ProPep System range in experience from less than 200 robotic-assisted, radical prostatectomies (RARP) performed to over 2500
2. Patient Benefits:
   1. 75% of patients achieve better erections as measured by IIEF or SHIM score (validated data collection questionnaires)
   2. 100% of surgeons report better continence as measured by IIEF
3. Surgeon Value:
   1. 100% of surgeons report that using ProPep

1.  
   1.  

      1. changes the way they handle tissue during surgery

      2. makes them more confident of nerve location

1.  
   1. Over ½ of surgeons report that using ProPep adds less than 5 minutes to their cases

1.  
   1.  

      1. the remainder report it adds less than 10 minutes

1. 80% feel it should be standard of care for all RARP

Pulse Infoframe Inc strives to improve workflow using computer-assisted capture of patient data for specialists – our cloud based software enables better local and global sharing of the data for those who need it to make decisions – our end-user driven tools analyze the data to advance knowledge and thus patient care. Data can be directly entered into our system, and because we sit on top of any EMR system we access additional data that is not otherwise easily accessible. Once accessed, the data is de-identified, aggregated and mined producing meaningful information for our end-users. 

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We have applied our solution in various clinical verticals including speciality clinics (Melanoma, Oncology, Neonatology, etc), Imaging and PACS systems (with INFINITT PACS, ClearCanvas, etc) and clinical trials (tracking prostate cancer, Pharmacovigilance, economics, etc). Modules are versatile and can be templated to be used in a variety of systems for achieving the best workflow possible.

RSP Systems A/S is dedicated to improving the health and quality of life of people worldwide through its unique and patented solution for non-invasive diagnostics. The first targeted application is a product line of non-invasive glucose monitors, which will provide diabetics with a convenient, pain-free alternative to the current invasive solutions, which require the diabetic to puncture his or her skin to extract blood onto an expensive test strip.

Subwave Sensing is poised to be the future of fracture care by giving the traditional orthopaedic hardware market an infusion of intelligence that will improve patient outcomes, decrease treatment costs and fundamentally change how fracture care is treated in the United States.

Teijin Pharma Ltd. has unique profiles managing pharmaceutical and home healthcare products and also strong value chaines from basic research to sales, maintenance and follow up to patients in both business divisions.

We are actively dedicating to look for opportunities to collaborate with the US companies including startups, instituites and investors to introduce products/technologies into JP market with some amounts of investments for the best collaborations.

We are focusing on areas of respiratory, cardiovascular, orthopedics, rehab and neurological diseases.

Thrive Bioscience is commercializing automated, analytical cell management laboratory instruments with integrated disposables. Thrive systems target the existing manual cell culture market ($8B), the cell-based assay market ($14B) and multi-billion dollar emerging markets for cell therapeutics. Thrive systems monitor, maintain, and passage cell lines, as well as run assays and generate large amounts of previously unavailable data.

Current methods of cell culture, developed more than 50 years ago, are now a major bottleneck holding back research and medicine, and cost society billions of dollars annually in waste and lost opportunity. Thrive Bioscience is the first company to wholly automate cell culture in research, diagnostic, and therapeutic markets.

Cell culture, especially the growth of human and other mammalian cells, is a fundamental tool used in science and medicine. As an example, the market for cell-based assays used in drug discovery accounts for $14B annually. One of the most rapidly growing and emerging segments requiring automated cell culture is the personal cell-based therapeutics market, for which human cells are genetically engineered, and then re-implanted into a patient.

TRANSVERSE MEDICAL INC is an early stage medical device company focused on the development of innovative technologies addressing the market of aortic embolic protection for Transcatheter Aortic Valve Replacement (TAVR), cardiovascular percutaneous interventions and surgical procedures. TMI’s proprietary Point-Guard™ technology is uniquely designed with the capability to conform to the aortic arch anatomy, deflect and filter embolic material from entering the major cerebrovascular arteries, collateral and adjacent arteries, and upon completion of procedure, safely and effectively remove the system with captured embolic debris.

Stroke rate is substantial in many established and emerging cardiovascular procedures.  Of particular interest in the field are the new Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Aortic Valve Implantation (TAVI) procedures.  There clearly exists an unmet need for an embolic protection and capture device that can be utilized during the procedures to significantly reduce acute strokes and adverse ischemic events, particularly in heart valve implantation & repair.

The risk of cerebral events and the need for protection during Transcatheter Aortic Valve Replacement is well documented in the literature and discussed by highly recognized key opinion leaders at major medical conferences around the world.  Stroke and the incidence of silent embolic events during TAVR are associated with high patient morbidity and mortaility.  This awareness of stroke, reported early on in the range of 2% to 11% prior to standardized endpoint definitions, is a concerning complication during TAVR and may have been attributed to early generation devices.  However, stroke continues to be reported in TAVR with rates in the range of 0.6% to as high as 7%, remaining roughly double those associated with surgical aortic valve replacment (SAVR). While the clinical and technical challenges of TAVR will continue to be addressed through lower profile devices and operator experience, the risk of stroke remains a major concern.

The market opportunity and adoption for TAVR continues to grow worldwide with a CAGR estimated at 19.8% (2014 to 2018) and worldwide market sales projection of $2.9 Billion in 2018. (Source: David Roman, Managing Dir., Global  Investment Research, Goldman, Sachs & Co.). The TMI Leadership Team estimates the Cerebral Embolic Protection Device (CPD) market to be at a conversion rate to CPD during TAVR at 50% by 2018, with worldwide market sales for CPD estimated at approx. $280 to $480 Million with an ASP of $3-5K. The Point-Guard™ advantages are expected to allow it to be used in 50% or more of such cases, projecting gross worldwide revenues of around $146 million by 2018.  Complications are limiting market growth (i.e., stroke) - - Controlling stroke (i.e., Point-Guard) can expand the markets and accelerate the expansion of TAVR use to lower risk patients, capture a larger portion of high/intermediate risk patients, set the "standard of care" (e.g 100% carotid filter use in US), and set the standard for other procedures (EP, AF, LAA, etc.).  Preliminary data presented at TCT 2014 by Dr. Axel Linke of University of Leipzig Heart Center in Leipzig, Germany showed significant reduction in early cerebrovascular accidents (CVA). Median Total Lesion Volume reported a 65% Reduction; Median Lesion Number reported a 57% Reduction; Rate of CVA reported a 67% Reduction. 

TMI is currently developing the POINT-GUARD™ Cerebral Embolic Protection System with VARIFLEX™ Conforming Technology. Point-Guard™ is the first complete embolic protection system engineered with VariFlex™ conforming technology, uniquely designed to conform to the aortic arch and branch artery ostia addressing the concern and possibility of residual flow redirecting around current embolic protection devices. The integration of VariFlex technology allows for maximum wall apposition to cover the aortic arch branch arteries with variable flexibilty and positioning. All other CPDs in the market have only met one or two areas of concern for CPD (Freeman, et al – “With all the embolic protection devices, potential limitations exist.”).  The Point-Guard is the only aortic embolic protection device designed to address all key features and functions of embolic protection during TAVR: conformity, deflection, filtration, and capture of emboli upon removal. Point-Guard will be the first cerebral embolic protection system to completely meet operator and procedural needs through ease of use, a low profile, safety and efficacy, compatible, and rapid delivery.

The Point-Guard™ is a class II product in the USA and can be cleared using the 510(k) process, with clinical trial results.  The number of clinical trial patients required is to be determined, but anticipated to be fewer than 100, including EU CE Mark clinical trial patients.  The CE Mark will be pursued first and is expected to require 50 or fewer patients with 30 day post-procedure follow-up.

TMI has raised $500K in private funding to date, is seeking additional seed funding of $1 million and series A funding of $6 million. 

Seed Funding will allow for completion of concept development & design freeze, pre-clinical development, testing, in vitro & in vivo studies, and first in human experience. Full Series A Funding will support European clinical trials (FDA Compatible), clinical product manufacturing & readiness, CE Mark approval & European pre-commercialization launch, strengthen IP and Filings, and general operation & administration.