2006 BMEidea Winners: What are they up to?

First prize: Nanografts, University of California, Berkeley

With over 500,000 performed each year, coronary artery bypass surgery is the default procedure for people with severe heart disease. But the surgery, in which doctors remove a healthy blood vessel from the patient’s arm or leg and use it to build a detour around a blocked artery in the heart, isn’t without its drawbacks: 50% of vein grafts fail in 5-10 years, the surgery to harvest the vein is expensive and invasive, and some patients have veins that simply aren’t strong enough to act as a coronary bypass graft.

Synthetic grafts have long held promise as a way to improve on the vein graft, but have yet to be widely implemented. The biggest reason? They’re too big. The smallest currently possible diameter for a successful synthetic graft is around 5mm—too large to replace most coronary arteries, which range from 2-6mm. Additionally, many of today’s synthetic grafts are made from foreign materials that can be rejected by the body’s immune system, rendering them ineffective. It all adds up to a problem; or, looked at another way, an opportunity for innovation.

Craig Hashi is the innovator. The Berkeley bioengineering Ph.D. student, leader of the Nanografts team that grabbed first place in the 2006 BMEidea competition, has come up with a novel approach to synthetic grafts. He creates sheets made from polymer nanofibers, then seeds the sheets with the patient’s own bone marrow stem cells. The stem cells allow the sheets to mimic the native blood vessel tissue, reducing the risk of being rejected, and the nanofibers allow the building of grafts as small as .7mm in diameter. After letting the cells grow for a couple of days, the sheets are rolled into a tube, similar to the shape of an artery. Once implanted, the nanofiber tube degrades, leaving a fully functioning blood vessel.

Sound clean and simple? Not so much. Although Nanografts has certainly made progress since winning BMEidea funding, continuing their lab research and talking with venture capitalists, the biggest challenge remains the technology itself. This is radical stuff—giving the body the capability to grow wholly new veins—and will take time to develop. Says Hashi, “Right now, the biggest challenge we face is getting the technology to work—understanding what’s really going on with it. I’ve been finishing up a paper on the project, but we want to make sure we’re confident about the technology before we present something to the research community—we want to be able to show exactly how these stem cells work and what they do.”

Beyond the technical challenges, there are problems with using stem cells themselves. Due to the surgery timeline (the patient may not be able to wait several days for stem cells to grow), potential cost factors, and strict FDA regulations, the team believes moving away from a stem cell-based approach for the moment gives them the best shot at commercialization. “We understand that in order to commercialize this in the near future we’ll have to steer away from cell-based therapy,” says Hashi. “Adding stem cells is an extra step that slows down the implantation process, to say nothing of regulatory issues. But if you have a synthetic graft that’s readily available off-the-shelf, the surgeon can use it right away and implant it directly.”

Although the science is still in the early stages, Hashi has a plan for how to commercialize Nanografts. “Ideally, we’ll start with some small seed rounds, about 150-200k,” he says. “We’ll work six to nine months with that, and then hopefully talk to some more VCs, get a term sheet, and get in contact with people that can provide us with more corporate experience, more managerial direction. From there we take it to market.”

Participating in the BMEidea competition has given Hashi a way to connect with those VCs. “Getting national exposure as a result of winning the competition has gotten us a lot of attention that we wouldn’t have received otherwise,” says Hashi. “It really gives me credibility when I walk into a VC’s office. I can say, ‘I just won BMEidea, a national biomedical design competition. My team went through a rigorous competitive process and we were fortunate to win first place.’ It gives me not only confidence and credibility but a great way to begin the conversation.”

Update: The team, now incorporated as Nanovasc, received $4.7 million in venture capital funding in 2008.
 

Second prize (tie): UltraMed Ultrasound, Pennsylvania State University

Cancer experts believe that early detection is the best way to prevent the disease from turning fatal. Yet despite great advances in cancer research, early detection remains a significant challenge and mortality is still high—in 2006, cancer accounted for 25% of all illness-related deaths.

This Penn State team hopes to bring that number down with UltraMed Ultrasound, an improved ultrasound technology that makes the early detection of cancer easier.

The team, led by materials science PhD student Ioanna Mina and her professor, Susan Trolier-McKinstry, is concentrating initially on the early detection and diagnosis of breast cancer, particularly in women with high breast density. At present, doctors do not use ultrasound for routine breast cancer screening due to a high rate of false-positives (the machine detects cancer when in fact there is none). Mammography is the most popular breast cancer screening procedure, but comes with a major drawback: it fails to produce reliable results for women with dense breast tissue. Using mammography alone, only 55% of women with dense breast tissue and breast cancer are actually found to have the disease, meaning that almost half of all cases slip by undetected.

UltraMed will be able to detect cancer in those types of tissue by upping the ultrasound frequency, which in turn increases the image resolution. Current ultrasound transducers (the part that generates the sound) operate at a frequency of 1-16 MHz; the team’s new transducer will operate between 50 MHz and 1 GHz. At such high resolution, individual cells will be able to be distinguished as benign or cancerous no matter how dense the breast tissue, making early detection possible.

Like many BMEidea projects, this is complex (and promising) technology that will take time to develop. Since winning funding, the team has concentrated on developing a prototype of the transducer array, as well as designing and fabricating second-generation electronic systems for the device. According to Trolier-McKinstry, they are now in the process of testing those systems.

As far as commercialization is concerned, Trolier-McKinstry and Mina are working with Penn State to investigate establishing a start-up company in the area. The company would provide both a means of generating funding for research as well as a vehicle to commercialize the results. The business plan that the team developed for the BMEidea competition is being used as part of the basis for Penn State’s decision. A patent application on the technology was submitted in early May.

Prototype development and commercialization efforts aside, Trolier-McKinstry believes the BMEidea experience has thus far been educational. “As a professor,” she says, “it’s been a great learning experience for me. It’s also given Ioanna a chance to explore beyond the typical the typical bounds of a graduate student in the field of engineering.”

Mina agrees. “Participating in this competition and attending the NCIIA conference has, more than anything else, put me in contact with a lot of different people with a lot of different perspectives,” she says. “Through them I’ve been able to step back from the project a little and see how important this device really is—how important it is to commercialize it.”
 

Second prize: AnemiCAM, Brown University

Anemia, a pathological deficiency in hemoglobin, the oxygen-carrying component of the blood, can cause fatigue, organ dysfunction, poor pregnancy outcomes and, in children, can impair growth and motor and mental development. While the disease affects an estimated 3.5 million Americans, it is an epidemic in the developing world, affecting 50% of the population in some countries. Although easily diagnosable with a simple blood test and highly treatable thereafter, screening for anemia is a significant challenge in the developing world because physicians often lack the necessary laboratory infrastructure for blood testing—and even in areas with the right facilities, needle reuse is a serious problem.

The AnemiCAM team is looking to change all that. Winners of second place in the 2006 BMEidea competition, AnemiCAM is a simple, handheld device that enables physicians to quickly and non-invasively assess hemoglobin levels in the blood. No more needles, no more risk. And the device can be manufactured for less than $100.

AnemiCAM is based on simple principles. To do a quick anemia check, doctors typically pull down a patient’s lower eyelid and check the conjunctiva, the tissue that covers the front of the eye and lines the inside of the lid. If the tissue is pale, hemoglobin levels in red blood cells may be low, indicating anemia.

But this check isn’t definitive; accurate diagnosis still requires a blood test. Using a white LED, proprietary liquid crystal technology, photodetector, battery pack, and simple processing microchip, AnemiCAM examines the conjunctiva spectroscopically, allowing diagnosis to be made in less than ten seconds and with an estimated 95% accuracy when compared with needle-based blood tests.

The AnemiCAM team has made big strides since winning BMEidea (and NCIIA Advanced E-Team grant) funding a year ago. They have developed a second-generation prototype, performed a clinical trial, and will publish the results shortly. In 2006 they founded Corum Medical, a company built around the product, and on January 1, 2007 signed a license agreement with Brown to manufacture and sell AnemiCAM.

According to team leader, graduate student in BME and Corum co-founder John McMurdy, there are two main areas of concern for the team right now: getting the prototype ready, and getting further funding. As far as the technology is concerned, McMurdy says they are “working on getting the second prototype cut down to size. Our current prototype cost about $2,000; the next prototype, using our proprietary liquid crystal technology, will see a huge reduction in price and size, to about the size of an iPod shuffle.”

Other concerns for the prototype include power management (making sure the battery is long-lasting and doesn’t have to be replaced often), and making sure the device is easy to use, requiring little-to-no technician training.

The team is also making strides in its initial target market of Nigeria, employing an African trade consultant and a handful of PR people. “Right now we have two people in Lagos, Nigeria,” says McMurdy. “They’re talking to doctors, getting exposure for the device, collecting information, and generating word-of-mouth interest.”

And what has been the response to the device so far?

“Overwhelmingly positive,” says McMurdy. “Most people say that the device would be incredibly useful—but only at a certain price point. Our main focus is on making it affordable. We have to hit a certain price point before the device can have a widespread impact in our target markets.”

The team is actively pursuing funding, meeting with angel groups and venture capital firms. “We’ve had several follow-up meetings so far,” says McMurdy. “There is definitely a lot of interest around the device.”

In the meantime, BMEidea and Advanced E-Team funding has been, according to McMurdy, “absolutely crucial” for AnemiCAM. “[BMEidea and E-Team] support has helped us continue moving the project forward before getting the major angel or VC funding. It’s helped us bridge the gap between having little-to-no funding and significant seed money. Without that extra help, the engineering would not be moving forward right now.”

Update: Corum Medical won SBIR Phase I funding in 2008, as well as $25,000 from the Charles E. Culpeper Biomedical Initiative Pilot Program.
 

Third prize: Robopsy, Massachusetts Institute of Technology

The Robopsy team is making an inefficient process much more efficient.

A typical lung biopsy today takes two hours to complete, with doctors using a CT scan to find a suspect mass in a patient, inserting the needle, and taking a sample. The problem is that the doctor can’t be in the room during the scan due to radiation; instead, they watch the scan through a computer monitor and then return to the room to find the right spot for the biopsy manually. As the needle is gradually inserted, the doctor and support staff continually shuttle between the radiation-shielded control room (during scanning) and the CT room (when manipulating the needle), moving the patient in and out of the CT machine again and again.

A little invention that could simplify the process is Robopsy, a lightweight, disposable, dome-shaped device that holds a biopsy needle and sits on a patient's chest during a CT scan. Sitting in the CT room, the doctor uses a laptop to manipulate the needle remotely, putting an end to shuffling between rooms and guesstimating where the needle should go. The team believes Robopsy will not only cut down on procedure time, but also give doctors the ability to target very small lesions (~5mm) that cannot be targeted by hand, and reduce instances of pneumothorax (partial or full lung collapse) caused by missed punctures.

The team has made good progress since winning third place in the BMEidea competition. The two main team members, MIT mechanical engineering graduate students Conor Walsh and Nevan Hanumara, have dedicated themselves full time to the project. After nailing down the design specifications, they’ve started testing the device using CT machines at Massachusetts General Hospital.

They’ve also found other sources of funding, including $5,000 from the Boeing Prize at the 2005 MIT IDEAS competition and $4,000 from the Cambridge-based Center for the Integration of Medicine and Innovative Technology. In an exciting development, the team took first place in the MIT 100k Business Plan Competition, securing $30,000 for business development.

Challenges still remain, involving both the technical and business aspects of the project. Says Hanumara, “As far as the product itself goes, we’re designing a disposable robot as opposed to a more expensive, more durable one that would be retained from procedure to procedure. From one point of view it seems that designing a disposable robot is quite simple—if you’re throwing it out, why put a lot of care into the design? But we’ve discovered it’s actually much more difficult than that: you have to make sure it’s 100% reliable, just over a short period of time. So the mechanical design has been surprisingly challenging.”

For Walsh, the business end of the project has its own challenges. “We’re trying to hash out the best commercialization plan possible for the device,” he says. “We know it’s a valuable medical device that can improve patient care, but we also have to figure out the value proposition. We have to determine exactly how much time the device is going to save, and how much hospitals are willing to pay for that improvement.”

But while challenges still lie ahead, Walsh and Hanumara believe they have already benefited from taking part in the BMEidea competition. According to Walsh, the competition was “a great match for both of our interests. It’s definitely given us a platform to build on. I think the great thing about the competition is that it allowed us to gather our thoughts and put them into a coherent document. We were lucky enough to be recognized for that when we took third. And when other people see that we’ve been recognized, it makes a great stepping stone for meeting people.”

Hanumara echoes Walsh’s sentiments. “I thought that just going through the application process—just submitting to the contest—was very worthwhile. I know there were only thirty entries to BMEidea in 2006, which doesn’t sound like a lot, but that’s because the requirements are very strict. You really need to have your ducks in a row before submitting to BMEidea. Sitting down and thinking everything through beforehand was valuable in itself.”

Update: Robopsy went on to win first place in the 2008 ASME Innovation Showcase, a Massachusetts Technology Technology Transfer Consortium Award, and first place in the MIT MechE Excellence in Medical Device Design Prize.