Ingenuity in the Fight Against Cancer
A Silicon Valley innovator, Robert Goldman, has turned his entrepreneurial instincts towards cancer treatment.
“Life was good and then my younger sister developed cancer.”
These are the poignant words of Robert Goldman, the inventor of digital music download technology and the man trying to fundamentally change how cancer treatment is delivered. Having witnessed three family members lose the fight against the disease, he decided to turn his entrepreneurial instincts to medical devices, specifically one that would enhance the effectiveness of classic chemotherapy.
“I am an entrepreneur and an inventor and people in this area think they can solve everything,” Goldman admits. Unbothered by his lack of medical training or knowledge, he did his research and, from scratch, invented a medical device that may change the face of conventional cancer treatment.
A dual balloon catheter designed to isolate a specific treatment region from blood flow, the IsoFlow catheter allows the infusion of fluids into the region and the perfusion of blood past the region to keep the blood flow intact during treatment.
A unique feature of the IsoFlow infusion catheter is the ability to deliver medications sideways while using pressure to push the medications into the targeted area. The IsoFlow catheter is inserted over a guide wire for precise positioning within a patient’s body. Once in place, medication is infused and isolated when both of the catheter’s balloons are simultaneously inflated using fluid via a single inflation lumen. Goldman’s company Vascular Designs secured FDA marketing clearance for the IsoFlow catheter as a Class II medical device in May 2009. The company now has four patents pending for the innovative ideas behind IsoFlow.
“It provides direct contact between the tumor and the chemo, it also weakens the tumor by decreasing the flow of oxygenated blood. It also makes the tumor more susceptible to the chemo,” Goldman explains to eyeforpharma.
But how do you go from iTunes to intravenous drug delivery? Goldman freely admits he had no clue about medicine or medical devices when he began. “I just had the idea of targeting the tumor directly, so that's where I started, and it’s interesting when you deal with things a third of a millimeter, it’s incredibly small. I had to shift my thinking as to how you do it in such a limited space. Then you get into the feasibility of how it’s deployed and how you use it.” Goldman worked with physicians at top US medical schools when trying to develop the device. “The physicians were really helpful in designing what was essentially their own device as they were going to be the end users.”
Certainly, feedback from doctors since its launch has been overwhelmingly positive, which is unsurprising when you consider that the blunderbuss approach of systemic chemotherapy has been hardly refined at all in the past half a century. The ultimate goal of the IsoFlow catheter device is to enable physicians to increase drug concentrations while at the same time reducing systemic exposure.
“The challenge you have in treating tumors is with systemic chemo, there are a tremendous number of side effects, that’s the first problem. Secondly, depending on the location in the body, if there isn't good blood flow the chemo may never get to the tumor, but with the device, it actually pushes the chemo directly into the tumor. This can potentially lessen the horrible side effects of chemo, thus making treatments more effective,” says Goldman.
“A lot of times people give up hope because their chemo is so horrible as a treatment – this approach means it is not as debilitating.”
Not a statistical game
The approval process for a medical device differs drastically to that of a potential new drug. Following a number of clinical studies, device studies and animal studies, the FDA issued its 510(k) approval for the device. The 510(k) is simply a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device; “essentially it’s marketing clearance”, explains Goldman.
“In the world of medical devices, it’s not a statistical game, we cause no harm to the patient and we have stories of people doing better after the treatment. With medical devices as opposed to drugs, it’s about case studies not trials, so with the FDA, the law is you can’t cause patients any harm, and from that point on you can use any prudent device for any prudent use.” The Vascular Designs website contains details of a number of case studies, where patients have been successfully treated using the IsoFlow catheter device.
Funding for the future
Although over 100 patients have been treated so far, a lack of funding had halted trials and further development of the device, which Goldman says requires a slight redesign. He bemoans the reluctance of investors to walk the walk in the medical devices field.
“In Silicon Valley, most of the seed money goes to technology. It’s very difficult, almost impossible to raise money for medical devices, because in the world of medicine you can get funding for drugs if you’ve got a good candidate… it’s like the lottery but you’ve got better odds. With medical devices, it’s not the case… it’s manufacturing, it’s hard work, it takes time, there’s the regulatory approval process, and because of that, it’s considered to be a risky investment. Investors can put money in something that’s almost a sure thing and get a much bigger pay-off.”
We want to reach and help as many people as we can, and we are hopeful that this will be the largest crowdfunding campaign in the history of IndieGoGo. There's a technology something like Pebble where they raised something like $20 million for a watch. We’re concentrating on doing good for others. We are effectively doing this as a gift for people who have been affected by cancer, it’s a way of effectively paying it forward to help other cancer sufferers.
Vascular Designs has lasted for years on “family money”, but the significant progress it had made with the IsoFlow system slowed down considerably as cash began to run out. This led them to launch the first ever crowdfunding campaign for an FDA-approved medical device, which will commence on IndieGoGo at the end of October. This will fund a redesign of the device and its manufacture, as well as a major increase in distribution. The target? Half a million dollars. Hardly chump change, but the game-changing nature of this device in fighting a disease that will affect one in three of us may mean Goldman isn’t being overly ambitious.
“We want to reach and help as many people as we can, and we are hopeful that this will be the largest crowdfunding campaign in the history of IndieGoGo. There's a technology something like Pebble where they raised something like $20 million for a watch. We’re concentrating on doing good for others. We are effectively doing this as a gift for people who have been affected by cancer, it’s a way of effectively paying it forward to help other cancer sufferers.”
The IsoFlow catheter device seems like a simple concept in hindsight, but as Goldman explains, it is a simple concept – until you actually try to do it. Several years and many setbacks later, he finally has an approved device that has helped people suffering from cancer. Indeed, its use may not be limited to oncology; Goldman says that Vascular Designs are now looking into clearance for its use in other conditions and with other similar treatments which require specific directional application – stem cell therapy, for example.
“There has been a number of other discussions in areas such as stem-cell therapy, which is a very directed treatment. The possibilities are very exciting.”
Goldman’s sister died from colon cancer in 2003 at the age of 38. He views the crowdfunding mission as an “advocacy movement”, which he believes will attract people who have been affected either directly or indirectly by cancer.
“That will move this technology really strongly into the marketplace. Everyone has a mission in life and my mission is to take something that was so horrible, and use it to help as many people as I can.”
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