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BACKGROUND – THE VASCULAR ACCESS PROBLEM
Saving Dialysis Patients
In 2008 over 48,000 Americans with diabetes began treatment for end stage kidney disease (ESRD).1 This brought the total number of patients on kidney dialysis due to diabetes to over 202,000.1 Although an extremely severe condition, ESRD can be managed by undergoing hemodialysis, which replaces the function of the kidneys by filtering blood through an external machine. This treatment requires an artificially created access point to the bloodstream by means of a surgical procedure. However, the failure rate and lifespan of current dialysis access options are grossly inadequate. The three current options for dialysis access – arteriovenous (AV) fistulas, AV grafts, and central venous catheters – on average fail within six, three, and half a year, respectively. Once they fail, new accesses must be created until the patient eventually runs out of access sites, costing Medicare $600 million each year and resulting in 18 percent of dialysis patient mortality.2 HEMOVA: A PARADIGM SHIFT IN DIALYSIS ACCESS
For the past 50 years, innovation in dialysis access has been focused on improving grafts and catheters. However, they unavoidably lead to stenosis and infection. Hemova challenges the concept that a catheter or graft is the ideal form of dialysis access. The Hemova creates a paradigm shift away from the mindset that stenosis and infection are unavoidable and that innovation must mitigate or delay the effects of stenosis and infection. Instead, we seek to prevent their occurrence from the onset. In collaboration with clinicians from The Johns Hopkins Hospital, we have developed a unique form of vascular access that greatly extends the longevity and safety of access sites. The Hemova is a wholly implantable device that connects to veins with naturally high flow rates, providing access by means of a subcutaneous port. This form of access avoids several problems that cause current Fig 1. The Hemova devices to fail: 1. The Hemova reduces the risk of vessel wall injury from unnaturally high flows that lead to stenosis, a narrowing of the blood vessel, which causes 85 percent of graft and fistula failures and hundreds of thousands of intervention procedures each year.
Diabetes Statistics. American Diabetes Association. Apr. 25, 2011. http://www.diabetes.org/diabetes-‐ Swapna et al. Heart Disease. 2001. 1
2. The Hemova significantly reduces infection risk by having a completely subcutaneous port using the skin as a natural barrier to infection. Additionally, a novel cleaning system further reduces the chance of device infection. 3. The Hemova avoids the second leading cause of catheter failure – fibrin sheaths, reducing blood flow through the indwelling catheter. By eliminating the indwelling catheter, the device can maintain normal flow rates throughout its lifespan. Addressing the major causes of failure for current access sites gives the Hemova the potential to outlast current devices by many years. This significantly reduces the healthcare burden and improves quality of life for hundreds of thousands of patients. MARKET LANDSCAPE
Dialysis is a $60 billion industry and is growing at a rate of 5.9 percent each year.3 The everincreasing diabetes population is one of the primary causes of kidney failure accounting for 44 percent of the dialysis population.1 Vascular access alone is a $1 billion market, which includes sales and placement of all catheters, grafts, and fistulas. THE HEMOVA
The Hemova is a paradigm shift technology that eliminates inherent problems of other technologies by accessing veins that have naturally high flows. It is a fully implantable blood access device placed under the skin and connected to a vein with naturally high flow rates such as the femoral vein in the leg (see Figure 1). Access to blood Vein flow is achieved when needles are punctured into the port. One of the most revolutionary aspects Tubing Valve of the device is its ability to be connected directly to the vein, rather than using a damaging indwelling catheter. Implantation Valve requires only basic vascular surgery skills. During surgery, the device is sutured to the vessel at two points (Figure 2), and the port is Triple
Port placed just underneath the skin on the outside of the thigh. The port is ready for use in dialysis approximately one week after the procedure. Fig
vein In addition, our novel valve mechanism allows for communication with the bloodstream only when a patient requires dialysis, thus avoiding clotting and infection issues. The valve is activated via a small needle that is inserted into the middle port to open and close the valves. Two larger needles, which connect to the dialysis machine, are then placed in the larger ports. When the dialysis machine is turned on, a portion of the blood flow is diverted into the
Mountaintop Medical. Kalorama Information. April 2009. 2
Hemova. It travels through the tubing, out one of the ports and through the dialysis machine to be filtered. The blood returns through the other port, travels down the tubing, and returns to the blood stream. After dialysis, the middle port is again activated to close the valves. The blood flow in the vein then resumes natural flow. INTELLECTUAL PROPERTY & REGULATORY Two provisional patents have been filed to protect our technology and two utility patents by the end of the year. The Hemova is built upon several patentable features, including the method for accessing the blood vessel, the novel valve, and the cleaning mechanism. Initial patent searches have been conducted to map out the related product categories, verifying freedom to operate space within the patent landscape. Although potentially a Class 3 device, a predicate device has been identified allowing the device to follow a 510(k) pathway to FDA clearance. This strategy has been discussed with Hogen Lovells informally leading to the belief that FDA clearance can be obtained with a small clinical trial of 50 patients lasting 12 months. CURRENT STATE & FUTURE PLAN We are currently conducting bench testing on our alpha prototype shown in Figure 3. We have an approved ACUC and we hope to implant our device in a sheep in 2-3 weeks. We have already tested the concept of our device in 3 pigs. We will continue to conduct animal studies throughout the rest of 2011 and 2012 and plan to hire a CEO in 2012 with experience in clinical trials and commercialization. At the end of 2012 we will also conduct a 6 patient pilot study before our 50-patient, 12-month clinical trial in 2013 to obtain FDA clearance. WE hope to gain FDA clearance in 2015 and launch our product the same year.
Fig 3. Alpha prototype and close up of port and valves
Hemova Medical was founded by a team of five graduate biomedical engineers from The Johns Hopkins University, in close collaboration with a team of clinical faculty at The Johns Hopkins Hospital. Members of the core team have been involved in two separate medical device ventures, hold an issued patent for an orthopedic device, and have had significant industry experience. Finally, we have developed a business mentor relationship with a former Chief Business Officer of the TauTona Group, a private equity fund dedicated to the development of exceptional medical device technologies. Currently, the company is managed wholly by the five founding members, with equity evenly divided, though we are seeking a professional management team.
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