ATLANTA – Georgia may not be an official biotech or med-tech hotbed, but it's moving in that direction as demonstrated by the breadth of companies and researchers featured during the September Georgia Life Sciences Summit 2008, sponsored by Georgia Bio (Atlanta).
Despite venture capital funding difficulties in recent times, the state has seen steady growth, with 300 life sciences companies calling the southern state home that now boasts nearly $8 billion in annual sales of 400 life science products.
Another sign of the times is that, for the first time, the Biotechnology Industry Organization (Washington) will bring its annual meeting here in 2009, an event that draws more than 20,000 attendees, said James Greenwood, BIO's president/CEO, who helped kick off the Summit.
While device companies have thus far played a smaller role in the Georgia sector, industry representatives pointed out that med-tech is hot and, given demographics and growth of emerging technology, that trend is likely to continue. Like Silicon Valley in California or Research Triangle Park in North Carolina, Georgia industry representatives are now touting the Innovation Crescent, a geographic region that extends from Atlanta to Athens, as a key area rich with a diverse concentration of new and mature companies, as well as organizations such as the Centers for Disease Control and Prevention, headquartered in Atlanta.
"A big driver going forward for the device sector is demographics," said Al Lauritano, director of business development, BD Technologies (Research Triangle Park, North Carolina) during a session about medical devices in Georgia. "There's been continuing, record increases in venture capital invested in med tech, probably because of the lower risk compared to pharmaceutical and biotech developments. But payouts are smaller as many exits are under $100 million.
Lauritano predicted that med tech appears hot now, but he warned that diversification strategies are wise. "I see continued M&A opportunities not just because VCs want returns on their investments, but because companies such as BD are looked at as a growth company. Expect hurdles to rise as high-value med-tech products seek therapeutic-like claims. It's going to change the regulatory requirements for the sector. In the drive for growth, there's going to be the assumption of more risk."
While Lauritano's session focused specifically on medical device companies and even showcased three very different examples of firms that are thriving from their southeastern headquarters, the Life Science Summit overall included numerous mentions of advances in medical technology, despite the obvious focus on biotech.
For instance, in another session focused on up-and-coming life science companies in Georgia, all three emerging Atlanta-based companies were med-tech oriented, not biotech or pharmaceutical firms. They included MedShape Solutions, which is developing shape-memory materials for orthopedic devices, drug delivery systems maker AerovectRx and Icon Interventional Systems, which is developing new types of cardiovascular stents.
But each presenter pointed out that the only way they are going to distinguish their products from the pack is by innovation.
"Vascular intervention is a crowded space," said Jack Merritt, president/CEO at Icon. "It's a market in which Icon decided to choose a different path. We want to execute a disruptive change. We have a stent with the thinnest walls ever conceived. It results in a flexible platform and we believe it will result in better patient outcomes."
Icon's Nuloy stent system is formed from a new alloy, allowing the stent to be formed with a wall thickness roughly half that of conventional products but stronger, providing 41% chance of restenosis compared to the average 74% chance for other stents and a reduced chance of strut fracture. With preclinical work completed, the company is just now launching pivotal studies in Europe.
Then, an emerging company hopping on the orthopedics bandwagon is doing so with a twist. MedShape's memory materials are active solids capable of controlled shape change or strain recovery in response to external stimuli. The materials can be pre-programmed to respond to specific external stimuli, and the company has dubbed them as smart implant materials that will eventually be used in fracture management devices.
Given the aging population with bones that more easily fracture, the company has had good luck in getting funded because their concept is on target.
"We've had good success in obtaining funding and striking licensing deals," said Kurt Jacobus, MedShape president/CEO, adding that his company's biggest challenge has been on the personnel and recruiting side.
"How do you find a way to keep clinicians engaged and provide enough freedom to see this job as an attractive opportunity? It took us a year to put in place a compensation and equity structure to make that happen," he said.
In another session on advances in neuroscience, a researcher from the Walter H. Coulter Department of Biomedical Engineering, a collaboration between Atlanta-based Georgia Institute of Technology and Emory University, pointed out that he sees neuroscience as a juncture of technology and applications, beyond the traditional pharmaceutical-only approach to therapy.
"We have great technology development that motivates new ways to do the science," said Stephen DeWeerth, PhD, whose work focuses on computational and robotic modeling of the neural control of movement.
"Neural interfacing allows us to reach in, stimulate and measure neural tissues. And we're looking to do that less invasively," he said.
DeWeerth pointed to a prime example of these advances in a company that was spun out of the local universities: Axion Biosystems (Atlanta) is developing technology that will allow scientists to directly interact with live brain or nerve tissue to provide information for diagnosis or treatment and even drug screening.
CartiMesh knee repair on the horizon
Among the emerging technologies and companies featured at the summit was an innovative living implant for healing damaged knee cartilage – a concept pioneered by Genzyme (Cambridge, Massachusetts) with its cell therapy known as Carticel. But researchers from Georgia Institute of Technology (Georgia Tech; Atlanta) have added a nanotechnology enabled twist to the concept, producing what could be the next best solution for millions of aching knees.
"We came up with this idea because of the Carticel products from Genzyme," Yash Kolambkar, a PhD candidate at Georgia Tech and co-inventor of CartiMesh, told Biomedical Business & Technology. "The problems associated with Carticel are that you don't know how long the solution of cells stays there. We use a nanofiber mesh – a thin membrane to cover the defect site and keep it in place to create a dual-layered construct."
Damage to knee cartilage – caused by injury, obesity or simply repetitive use over time (aka, getting older) – is permanent and leads to osteoarthritis, since that tissue has little capacity to regenerate. Until now, that is, with a little help from science.
CartiMesh consists of engineered tissue integrated with a biodegradable polymeric scaffold. To create the implant, articular cartilage cells are first isolated from either the patient's own cartilage or from a donor. Cells are then culture-expanded to the large numbers necessary for the implant. Then the cells are seeded on electrospun nanofiber meshes and cultured with certain biochemical cues for two weeks.
The meshes are scaffolds that mimic the extracellular matrix to which the cells in the body are accustomed. At the end of the culture period, the resulting CartiMesh is a dual-layered construct with a layer of cartilaginous tissue produced by the cells and a layer of nanofiber mesh with strong mechanical integration of the two layers.
"Even if we use donor cartilage cells, no specific processing is required because cartilage is immune-privileged tissue, eliminating rejection issues." Kolambkar said. "Nanofiber mesh has been around a long time. We just invented the dual construct."
Genzyme's Carticel uses a procedure known as autologous chondrocyte implantation (ACI) and was the first cell therapy to be approved by the FDA in the mid-1990s. It is used by orthopedic surgeons to treat patients who have clinically significant articular cartilage lesions on the thigh bone part of the knee caused by acute or repetitive trauma that have not responded to a prior cartilage repair procedure.
The surgeon provides Genzyme with a biopsy of healthy cartilage taken from a patient's knee in an arthroscopic procedure. Technicians at Genzyme's cell culture lab then grow millions of cells from the biopsy, and the cells then are delivered to the hospital, where the surgeon implants them into the patient's knee defect.
Studies had indicated good results for a term of up to seven years, but long-term data on Carticel is still in the works.
CartiMesh is seen as being a permanent solution.
CartiMesh, which was co-invented with Robert Guldberg, PhD, also a Georgia Tech professor, would be implanted so that the cartilaginous tissue fits into the defect and the nanofiber mesh is used to suture the implant in place. The strong mechanical integration between the two layers gives the construct mechanical stability in the harsh joint environment, which is essential for its survival, Kolambkar said.
Guldberg also is research director within the Georgia Tech/Emory Center for the Engineering of Living Tissues (GTEC), supported by the National Science Foundation (Arlington, Virginia) and the Georgia Research Alliance (Atlanta).
Within six to 12 months, it is expected that the cartilaginous tissue of CartiMesh would integrate with the surrounding host cartilage, the nanofiber mesh would safely degrade into the body and the cartilage joint surface would return to its normal structure and function.
The ultimate goal: elimination of joint pain and resumption of full mobility.
All of this is assumed, of course, because CartiMesh has yet to be tested in animals or people.
"We're focusing on licensing opportunities rather than going through trials on our own," said Ivan Mihailov, a law student at Emory University (Atlanta) who is working with Kolambkar to develop CartiMesh via GTEC. "We've developed bulletproof financials estimating that it would take $15 million to develop but would yield $50 million in revenues after it enters the market.
"We'll be hanging out afterwards, shamelessly handing business cards," Mihailov said at the Life Sciences Summit.
Kolambkar said his group was indeed approached by a few angel investors at the conference.
DiagNano's dots offer more accurate detection
While Georgia Tech student Brad Kairdolf was studying biomedical engineering, his wife Alyssa was diagnosed with thyroid cancer. Because the first pathology report was negative, she ended up having to go back into surgery a week after the initial biopsy when further analysis of the tissue sample confirmed cancer.
The time lag and subjective nature of the initial diagnosis was frustrating and ultimately was Kairdolf's impetus to develop a better diagnostic tool. His educational focus confirmed, he later launched DiagNano (Atlanta) in 2006, a company spun out of the Georgia Tech College of Management and Emory University Law School TI:GER project.
The company is based on a special coating technology he co-developed in the lab of Shuming Nie, PhD, a professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory. Nie is one of the most highly regarded researchers focused on quantum dots, which are light-emitting semiconductor crystals.
Alyssa was cancer-free for four years when Kairdolf presented DiagNano's unique diagnostic tool – custom quantum dot nanoparticles capable of imaging at the molecular level for more accurate disease diagnosis – at last week's Georgia Life Sciences Summit in hopes of attracting investors.
"We're using quantum dot technology for sensitive and specific diagnostic detection," Kairdolf told BB&T. "They are like fluorescent dyes, but have unique properties that make them better than dyes. We can make different colors to code for different molecules that we're looking for. The idea is to look at multiple markers for diseases to speed up diagnoses and to give very accurate readings of the biomarkers we're looking for."
Quantum dots fluoresce to identify biomarkers.
"We can make them different colors to code for different molecules that we're looking for," Kairdolf said. "We're trying to do multiplex analysis – analyzing multiple signals at the same time. The idea is to look at multiple markers for disease to speed up diagnoses and to give very accurate readings of biomarkers we're seeing."
One of the problems with quantum dots, which have been around for a while, is their inherent stickiness.
"Stickiness can lead to a false diagnosis," said Kairdolf. And it's DiagNano's non-stick coating that makes quantum dots far more effective and reliable. "It helps to eliminate background noise and make it more sensitive."
Immunohistochemistry is a diagnostic technique currently used by pathologists and they are able to identify just one biomarker per slide. "We can give the pathologists something they are familiar with, but we're able to use these quantum dots to look at multiple markers at the same time," he said. "They can also use also use hardware and software to measure the light coming from the quantum dots to objectively analyze how much of the biomarker is present."
If pathologists can more accurately and quickly identify diseases such as cancer, physicians can provide more targeted and personalized therapies. Kairdolf and his team call it a patient-specific cancer fingerprint.
And although the company's initial focus is on cancer, the diagnostic technology could in theory be applied to any disease for which tissue biopsy analysis is needed.
Kairdolf said DiagNano is currently working with a $50,000 grant, but is seeking more grants and a licensing deal.
Following the Georgia Life Sciences Summit presentation, Kairdolf confirmed numerous inquiries from prospective suitors.