Fibralign, a startup medical device company, just took home the grand prize in the 2014 MedTech Innovator competition, winning over 267 other startups. Their product, Biobridge, is a possible cure for secondary lymphedema, a debilitating disease with few available treatment options. Secondary lymphedema describes a condition in which the lymph system, which is responsible for removing extracellular fluid, is disrupted, resulting in the accumulation of extracellular fluid. This can lead to swelling in the extremities, which can cause significant discomfort and is cosmetically unappealing. This condition is most commonly associated with breast cancer patients who sometimes must undergo aggressive lymph node dissections in the armpit in order to stage their cancer, but it can happen in any condition in which the lymph system has been disrupted.
The Biobridge is an implant that has been shown to be able to guide the growth of new lymph channels. This technology can be used as an adjunct to existing treatments for the condition to hopefully improve outcomes.
The product itself is a collagen scaffold with very unique properties. “Scaffold” is a term used in tissue engineering that describes a three dimensional material that encourages cells to attach and grow along its microscopic structure. While collagen scaffolds are not particularly unique, the Biobridge uses a novel fabrication method that gives it a distinctive three dimensional structure that is very similar to collagen structures found within the body itself.
We had a chance to sit down with Greg King, the COO of Fibralign, to ask him some questions about this very exciting technology.
Justin Barad, Medgadget: Can you discuss the development of your technology? How did it start and when did you start seeing its potential?
Greg King: Our founders had a “penicillin moment” working in a Stanford Lab when they found that previously developed technology for working with liquid crystal materials used in the flat panel display industry could be applied to several biomaterials including collagen in a liquid crystal state to form 3D scaffolds. When they saw the resulting structure in the AFM image shown below they recognized that they had a breakthrough discovery. The image was like the skin scaffold of a newborn, with bundles of highly aligned collagen fibrils. As far as we know, this was never produced before in a lab. They were able to take collagen, a material commonly used for the past 30 years in various cosmetic and surgical applications, and fabricate scaffolds that mimicked different types of human tissue at the micro structural level. They started working with different research groups on a wide range of high-value tissue applications and used this experience to develop the core technology. They determined rather quickly that this was a fundamental technology that offered a large design space for addressing application requirements.
Medgadget: Can you tell us a little bit about when and how your company was founded?
Greg King: The company was founded in 2007 by Michael Paukshto, David McMurtry, Yuri Bobrov, George Martin and Eric Sabelman. They early years were lean, surviving primarily on sweat equity and some modest angel funding. During this time, the team developed its core technology, fabricated initial prototypes and secured an IP position and developed the manufacturing approach for scaling commercially. At the end of 2012, the Company made a business decision to focus on lymphedema as the initial product, expanded the core team and then moved from an incubator to a dedicated lab space with a cleanroom to support this development effort. Fibralign also benefited from grants from the DoD and NSF to support a large animal study and develop production tools for making its initial product. Can you tell us a little bit more exactly how BioBridge is used to treat secondary lymphedema? What results have you had so far in your animal studies?Secondary lymphedema can occur when the body’s lymphatic system is compromised from a trauma. In western countries this most commonly occurs after aggressive cancer treatments, involving surgery and radiation therapy, but it can also occur from infections and other injuries. This can disrupt the flow of lymphatic fluid in the affected limb that leads to swelling, great discomfort and serious infections.BioBridge is a bundle of small collagen fibrils aligned in one direction. It is made from medical-grade collagen and has been designed to support and repair the diseased tissue area, allowing new lymphatic vessels can form in the direction of BioBridge and restore function.In our successfully completed large animal study, we were able to show that new lymphatic vessels formed in diseased areas and about a 60% reduction in accumulated fluid only three months after BioBridge implantation. This compared to the control group that did not get BioBridge and showed no improvement.
Medgadget: What kind of effect will winning Medtech Innovator have on your company?
Greg King: We hope it helps attract attention needed for Fibralign to address this opportunity, providing visibility to investors, stakeholders and the broader community. We need to build awareness of what we’re doing to help treat this horrible and neglected disease, which impacts millions of people and currently has no cure.
Medgadget: Do you have any rough estimate when your product might come to market?
Greg King: We expect to have product in the market in 2015
Medgadget: What sort of clinical applications to you envision for the near future?
Greg King: We anticipate that BioBridge will initially be used as an adjunct to Vascularized Lymph Node Transfer, an existing surgical procedure used for treating lymphedema. Our expectation is that BioBridge will help improve the outcome of this procedure. We are working closely with Dr. Corinne Becker, who pioneered this surgical procedure.
Medgadget: Do you have any advice for our readers, many of whom are aspiring medical innovators and entrepreneurs?
Greg King: Pick something you’re passionate about because it will consume you and require tremendous energy to get anywhere. So make sure you like what you’re doing. Also get out and talk to your expected customers and test your hypothesis and product plans as early and often as you can. It sounds cliché, but this for some reason isn’t done enough in startups and in biotech in particular. Go out and validate your market opportunity before you commit effort and resources!