MARY

 O’GRADY,  PETER  LI,  SHERRI  HALL,    

SHISHIRA  NAGESH,  THORA  THORGILSDOTTIR  
THE  JOHNS  HOPKINS  UNIVERSITY  
 
Saving  Dialysis  Patients  
BACKGROUND  –  THE  VASCULAR  ACCESS  PROBLEM    

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.

                                                                                                                                   
1
 Diabetes  Statistics.  American  Diabetes  Association.  Apr.  25,  2011.  http://www.diabetes.org/diabetes-­‐
2
 Swapna  et  al.  Heart  Disease.  2001.  

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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 ever-
increasing 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
flow is achieved when needles are punctured Vein
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  2.  The  Hemova  attached  to  a  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

                                                                                                                                   
3
 Mountaintop  Medical.  Kalorama  Information.  April  2009.  

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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
     

THE  TEAM    

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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