A young company developing a product to address secondary lymphedema, a chronic disease with no cure, stole the show at a venture competition held during a recent medical device conference. Working with Stanford University (Stanford, California), Fibralign (Sunnyvale, California) developed BioBridge, a surgical device designed to support the formation of new functional lymphatic vessels.

The company has completed a large animal study to validate the technology and is now preparing for a clinical study. Fibralign was voted the winner of the annual MedTech Innovator competition by an audience at the 22nd annual medical device conference hosted by law firm Wilson Sonsini Goodrich & Rosati (WSGR). The company won prizes valued at $150,000, including $100,000 in cash provided by RCT Ventures, $25,000 in cash provided by Johnson & Johnson Development Corporation, and $25,000 worth of lab space at Janssen Labs.

Fibralign was one of 267 companies that submitted its business plan for the competition in April. A panel of investor judges reviewed the entries and selected 10 semi-finalists and four finalists. Then, at the WSGR conference, the audience voted in real-time for the winner, Fibralign, using their mobile devices.

Fibralign's first product, BioBridge, is developed to address Secondary Lymphedema, a global chronic debilitating disease that affects over 120 million people and has no cure. The company successfully completed a large animal study that validated BioBridge-treated diseased lymphatic tissue. Fibralign is now preparing for 510(k) submission and a clinical study.

Lymphedema is an abnormal buildup of fluid that causes swelling, most often in the arms or legs. The condition develops when lymph vessels or lymph nodes are missing, impaired, damaged or removed. Secondary lymphedema occurs as a result of a blockage or interruption that alters the flow of lymph through the lymphatic system and can develop from an infection, malignancy, surgery, scar tissue formation, trauma, radiation or other cancer treatment.

"It's a big area and we don't see a lot of emerging technologies to try to address it," Greg King, COO of Fibralign, told Medical Device Daily. "It's one of these kind of forgotten diseases because doctors don't know what to do with it."

King said an estimated 1.3 billion people worldwide are at risk of getting secondary lymphedema. He said traditional treatments involve trying to manually push out fluid buildup in the limbs using various techniques including massage therapy or compression sleeves/stockings.

These methods can be very time consuming, he said, and are not reimbursed by government or private insurance. In severe cases, there is a surgical procedure to rebuild or fix damaged areas of the lymphatic system, but it requires a very skilled surgeon and outcomes are fairly low, King said.

The BioBridge is a thread-like scaffold that looks like dental floss or suture, and it is designed to help repair diseased tissue. The scaffold helps support the tissue so that new lymphatic vessels can grow, he explained.

The company has already completed a large animal study that validated BioBridge-treated diseased lymphatic tissue and is preparing its 510(k) submission and a clinical study.

"We think by next year we'll have a product on the market place," King said.

Michael Paukshto, one of the company's founders and the CTO, told MDD that the technology has potential applications beyond secondary lymphedema. The company currently has 11 issued patents and 14 pending patents.

As for the competition at WSGR, King said the award provides Fibralign some needed visibility to better address this significant opportunity. "The competition was a fantastic experience because it put a much-deserved spotlight on great startups selected from around the world. These companies provide a diverse range of breakthrough products that offer creative ways to improve patient care."

RCT Ventures produced the competition and contributed a $100,000 cash prize for the winner. "Fibralign was voted the winner by an audience made up of over 600 venture capitalists, coroporates, and industry professionals," said Paul Grand, managing director at RCT Ventures. "That kind of exposure and engagement would typically take months or years and has the potential to result in a financing or key industry partnership."

Another perk of winning the competition, Fibralign will get a presentation slot and complimentary full access registration at the annual AdvaMed conference in October, to be held in Chicago. //