Does a donated heart or kidney deserve fancier digs than a ham sandwich? The folks at Paragonix Technologies think so.
The Cambridge Mass.-based startup just landed a $710,000 accelerator loan from the Massachusetts Life Sciences Center to support development efforts for its Sherpa organ transport devices.
The Sherpa, according to Maier, is a portable, disposable device that is designed to improve the viability and increase the lifespan of a donated organ, versus the current standard of care, which is your run-of-the-mill Igloo cooler.
Lisa Maier, president of the company, took some time to talk to MassDevice about Paragonix, which she founded in 2010, as well as the Sherpa device and how she hopes to change the way organs are transported.
MassDevice: So, your technology, the Paragonix Sherpa, is going to put Igloo coolers out of the organ business right?
Lisa Maier: The problem we’re trying to solve is that there are far more people needing transplanted organs than there are organs available.
Part of the problem is that the current standard is the Igloo cooler or an ice chest.
Once an organ is removed from the body it needs to be preserved. The current method for organ preservation is simply placing the organ into sterile plastic bags filled with a preservation solution and then placing [the organ] on ice. These methods have significant limitations for organs, especially the extended preservation of transported organs.
Our solution, the Paragonix Sherpa, is a novel organ preservation and transport device. We’re targeting overcoming the limitations of the Igloo cooler. What we do is provide optimal organ preservation by giving the organ nutrients and oxygen. At the same time, we’re perfusing the organ with a nutrient rich solution.
So compared to the current standard of care, the Sherpa has the convenience and ease of use as the Igloo cooler but the clinical benefits of hypothermic perfusion, which is basically the perfusion of fluid through an organ at low temperatures, approximately 4 degrees Celsius.
MassDevice: Let’s talk organs a little bit. What are the most common organs transplanted and does the Sherpa work with those specifically?
LM: Kidneys and livers are the most common transplants performed. Our primary indications include kidney and heart preservation.
MassDevice: Let’s take a heart for example. In the current standard of care, for how long once the organ is removed from a patient can it remain viable?
LM: Really, you only have 4 hours. You can’t do east to west coast in the United States really. What we’re targeting is extending heart preservation threefold to 12 hours.
We have pre-clinical data to validate and show the efficacy of the Paragonix Sherpa. It opens up the unique opportunity, not only to bring recovered organs further distances, but also to find the most suitable recipient for that transplant organ. It eases the race against time and widens the geographic area in which organs can be recovered and allocated.
MassDevice: Who are your competitors? Who is in this space besides Paragonix?
LM: We already mentioned the Igloo cooler, which is using ‘static storage,’ because you’re not perfusing the organ. And then, in terms of perfusion approaches, there are really two different types of approaches, which include cold perfusion at 4 degrees Celsius and warm perfusion, which is done at body temperature.
The Paragonix Sherpa devices are in the category of cold perfusion.
Our advantage is that we’re not only providing cold perfusion, but we’re actually oxygenating the solution, which is pumped through the organ. This means that as soon as the organ is recovered from the donor, we can provide oxygenated perfusion to the transplant organ. We improve viability of the organ.
MassDevice: Do kidneys have the same time constraints as the heart?
LM: A kidney can go a little longer, about 24 hours. With the kidney Sherpa we’re looking to improve the quality of the transplant organ. There is clinical evidence showing that perfusion of a transported kidney, prior to transplantation, improves patient outcome, simply because you’re keeping the donated kidney more viable during the time between the organ donor and the recipient.
MassDevice: Where are you at in the testing and he regulatory pathway for the device?
LM: We’re moving from pre-clinical studies towards clinical studies over the next 12 months to validate our preclinical data on human organs. The kidney Sherpa will be cleared through the 510(k) pathway and we’re still looking into the regulatory pathway for the heart Sherpa.
MassDevice: How will you use the recent $750,000 loan from the Massachusetts Life Science Center?
LM: With the award from the Accelerator loan we can advance our clinical and development program for regulatory submission during the first quarter of 2013. In addition, we’re going to hire six full time employees in Mass. in 2012, paving the way for a 2013 commercialization.
MassDevice: Are you going to raise any more money?
LM: The endorsement of the MLSC accelerator program will commence our series A round, which we’re gearing up to commence now.
MassDevice: So, you’re back out on the trail.
LM: Don’t think I ever left it.
MassDevice: What’s been the hardest part about being on the pitch?
LM: I think it’s been an incredibly exciting path. The business case hasn’t been difficult; its pitching to the right investors at the right time. We have many loyal investors who see the progress made and they see the potential of the company.