Date: Aug 01, 2016 Author: George I. Seffers Source: AFCEA International (
click here to go to the source)
For entrepreneurs, the rewards of biomedical technology research are worth the risks.
The National Science Foundation is funding a remarkable array of biomedical technology solutions to help patients from mere hours after birth to days before death. Innovations include a protein-based implant for restoring vision, a method for 3-D printing with human tissue and a man-made material that mimics bone.
"We are trying to address very old medical problems with early stage engineering solutions," explains Jesus Soriano, a National Science Foundation (NSF) program director who manages the Smart Health and Biomedical Technologies portfolio. A plethora of projects falls under the foundation's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. Soriano's domain is one of 10, including the Internet of Things and advanced manufacturing and nanotechnology. "We support technologies that are so early stage that no one in the private sector would ever fund them because it would be irresponsible for those investors to use the money in that way."
Many projects, though, do receive support from other agencies, such as the National Institutes of Health and the U.S. Defense Department. The NSF effort aims to help entrepreneurs transition technologies from the laboratory to the commercial market to consumers. By enabling those technologies, the NSF aids in developing products that will make money and attract attention from the private sector, Soriano says.
"The transition of a technology when it's in academia to some degree of productization is very risky, very complex--and that's what we focus on," he explains, adding that the foundation concentrates on solutions with "high potential to become a great commercial opportunity and to help society."
He cites TeVido BioDevices, a woman-owned firm in Austin, Texas, that received funding to develop 3-D printing technology that improves reconstructive procedures for breast cancer survivors. The company's first product uses proprietary technology and the patient's own skin and fat cells to print a new nipple.
Laura Bosworth, TeVido CEO and co-founder, explains in videos posted on the company's website that women often turn to plastic surgery to create a bump similar to a nipple and tattoos to add color. The ink used is much lighter and less permanent than more traditional tattoo ink. Bosworth says she thinks TeVido's solution will last longer.
In one video, Bosworth juxtaposes her high-technology solution with the highly personal stories she hears from women who either need or have had reconstructive surgery. Those stories keep her going when the road to entrepreneurship seems especially rough, she indicates.
Soriano says TeVido's technology is worth the investment. "These folks are trying to help women who have gone through serious surgery after cancer. Women oftentimes are left disfigured, and they need breast reconstruction. This is an engineering solution that will take a long time but will help many, many people," he offers.
The NSF also supports the development of a material that is similar to natural bone and can foster healing of serious injuries when a filler material is needed. The more conventional treatment is to use transplanted bone, but that often presents challenges, such as the need for a second surgical site.
OrteoPoniX LLC uses collagen and hydroxyapatite, both of which are found in natural bone, to create a bone graft substitute scaffold. The artificial material mimics the composition of bone and allows the body's own bone cells to infiltrate the scaffold. Over time, natural bone replaces the synthetic graft.
Another project, from LambdaVision Inc., promises to help people who have lost their sight through either retinitis pigmentosa or age-related macular degeneration. Both conditions involve the loss of photoreceptor cells, commonly known as rods and cones. According to information the NSF has provided online, a LambdaVision implant is inserted behind the retina to replace the function of the damaged cells. The protein-based retinal implant captures and converts light into electrochemical signals in a method similar to photoreceptor cells. The light-activated protein in the implant provides a higher resolution than other solutions.
"We're hoping to see this probably within five to 10 years in the marketplace," says LambdaVision CEO Nicole Wagner in a YouTube video the foundation provided. "The challenge for us is that ... you don't want to put them in the eye and then take them out the next day. A lot of the studies we're going to be doing are going to be longer-term studies."
While most of the NSF-backed technologies likely will take years to develop, Soriano says there are exceptions. Three companies already have gained Food and Drug Administration (FDA) approval to bring their products to market. "I started this program only three or four years ago, so for us to have already three approvals, that's pretty crazy. Normally the technologies we are funding are so complicated and difficult, they are going to take years to reach the market," he declares. "[These companies] are almost like an exception, but it demonstrates that if we do our jobs properly, we can start helping people very soon."
One of those companies, HealthMyne, in Madison, Wisconsin, provides radiologists and oncology clinicians with an informatics system that combines imaging and electronic health record information for use in evidence-based analytics and decision support. At the heart of the system is an image analysis engine that generates information such as tumor size and other advanced quantitative metrics.
"This is fascinating technology. They are using machine learning and imaging recognition to create a system that is able to read magnetic resonance images," Soriano elaborates. "If I am the oncologist or the radiologist, and I have in front of me an image of a patient, the system is going to diagnose that and annotate it, and it will tell me the chances that this is a particular disease."
In addition, PuraCath Medical received FDA approval in January for its FireFly Peritoneal Dialysis Connector Disinfecting System. Peritoneal dialysis is an at-home treatment for kidney disease patients. It uses the patient's peritoneal membrane in the abdomen to filter waste products from blood because the kidneys can no longer do so.
The problem is that patients often have trouble with the complex procedure, resulting in medical complications, such as a severe infection known as peritonitis. The Firefly device provides a safe and easy-to-use, self-contained catheter that does not rely on patient compliance. "By reducing the risk of infection, you are enabling more people to have another therapeutic alternative that is more friendly," Soriano states.
Furthermore, Hospi Corporation, Newark, California, also has gained approval for its first product, the Macy Catheter, which is described on the company's website as a "simple and innovative medical device designed to facilitate discreet and comfortable rectal administration of medications." Alternative methods for administering medicines are required in cases where taking medicines orally is not possible. Some patients may vomit, for example. "[Hospi is] developing a next-generation catheter originally used to help patients in palliative care in hospices. Those patients cannot be hydrated, cannot be medicated or fed, and this technology, which may seem simplistic, actually enables people to have a more humane, less painful experience as they approach death," Soriano explains.
While the Macy Catheter is designed in part for those approaching the end of life, he observes that those who have just begun life will benefit from an increasing number of biomedical innovations. "Biomaterials are enabling all these wearables and new ways of helping babies. We're going to do a lot of pediatric bioengineering. New sensors will allow newborns to be monitored more humanely," Soriano offers.
An infant's skin can be so delicate that even applying a Band-Aid can present issues, he says. "We are funding companies with biomaterials that are enabling new modalities of sensing that allow the machines or the incubator to sense the baby without actually touching him or her," Soriano explains.
Some projects could touch a wide array of patients across all stages of life. For example, the appropriately named Continuus Pharmaceuticals, just outside of Boston, specializes in the continuous manufacturing of pharmaceuticals. By and large, the pharmaceutical industry still relies on batch manufacturing, which some say is inefficient and outmoded.
"The notion of continuous manufacturing is that you have a robot or machine, and you put the liquids or the powders on one side, and on the other side, the pills come out," Soriano says. "It is producing pills nonstop, 24 hours. This company is already partnering with big pharmaceuticals, offering its services."
Other NSF projects in development include a bioerodible, polymer-based hydrogel for treating various eye conditions; a method of taking proteins and peptides orally, meaning fewer injections; a portable blood-typing device; and oral analytics technology for speech therapy.
Overall, the SBIR/STTR effort is designed specifically for entrepreneurs whose ideas address "unmet biomedical needs with really early stage biotechnology," Soriano says. The mission, he adds, is to "help people with problems that have been neglected because nobody cares."
Each project begins with a big idea that shows the potential to grow into a small business. Without funding, those ideas would wither. But each technology developed, every business created, offers the potential to ease suffering in the years to come. "We are seeing here the future of medicine," Soriano says.
