TEL AVIV — An Israeli medical-device start-up is tackling one of the most dangerous occurrences in surgery — and it's doing it with glue.
LifeSeal is a glue-like substance that augments and, in some surgeries like hernias, replaces the traditional and painful sealing procedures of staples, tacks and sutures.
The privately-owned Israeli company behind the high-tech glue, LifeBond, says it should help in the treatment of post-operative leaks in closures of gastrointestinal and other surgical wounds. Patients get back up to speed more quickly and are more comfortable as they do.
Orahn Preiss-Bloom, one of LifeBond's co-founders, says the company's proprietary materials, which combine gelatin and an enzyme and are delivered by an applicator, were inspired by two sources: research by Professor Gregory Payne at the University of Maryland and the use of the enzyme for food applications in Asia.
The company is backed by some of Israel's top venture-capital firms as well as by Robert Taub, a prominent medical-innovation investor. And the idea is strong enough that Johnson & Johnson (TICKER: JNJ), the New Jersey-based international health-care giant, has put money down on LifeBond.
The technology is currently in European clinical trials. And with an eye to entering the U.S. market as well, CEO Gideon Sturlesi and Preiss-Bloom are looking for partners and raising capital.
TWO CURRENT APPLICATIONS
Started in 2007 and employing 35 people from headquarters in Caesarea, Israel, LifeBond for now is focusing the technology's application on gastrointestinal surgery and bariatric weight-loss procedures as well as in hernia surgery.
Colon-cancer surgeries require what the doctors call anastomosis, removal of diseased intestine and reattachment to restore the gastronintestinal tract's functionality. The further down in the colon a surgeon must work, the higher the risk that a seal will leak, Sturlesi says. In some 15% to 25% of lower-colon operations, the seals leak, exposing the patients to infection and additional surgery, even death.
In such procedures, after a surgeon applies staples to close the colon, he or she spreads LifeSeal – using a glue-like applicator – along the line of the closure. The sealant provides a secure and elastic barrier to infection while the body heals. Tissue grows in and the sealant gradually dissipates.
LifeBond's second current major application, which the company calls LifeMesh, targets another very common surgery: hernias, the breaks in people's abdominal walls.
To secure a protruding intestine back into the abdomen, surgeons usually tack a mesh into place to close the break. These tacks cause inflammation and pain.
Here, the same proprietary material used in LifeSeal becomes an adhesive. In both open hernia surgery and procedures with a laparascope, the surgeon coats a standard mesh patch with LifeSeal and places it to secure the abdominal wall. The surgeon can reposition the mesh if and when necessary. LifeBond says the product keeps the patch in place as the body's tissues grow in and then dissipates.
LifeBond's two co-founders are Preiss-Bloom, 32, a New Yorker who is chief technology officer; and Ishay Attar, 42, who was vice president of business development at what is now Trendlines Medical, a tech-firm incubator. Both have master's degrees in biomedical engineering from the Technion, the Israel Institute of Technology. Attar remains a shareholder but doesn't hold a position with LifeBond.
CEO Sturlesi, 53, joined the company two years ago. Previously he was executive vice president at Lumenis, the producer of laser equipment for medical and cosmetic applications, and he was a co-founder of Galil Medical, a producer of cryosurgical technology. LifeBond's chairman is Ittai Harel, general partner of Pitango, a Herzliya, Israel, venture-capital firm and investor in LifeBond.
Worldwide market: $450 mln
LifeBond's first two target markets are substantial. The company estimates that annually in the U.S., 300,000 colorectal anastomosis procedures are done each year. The company pegs the worldwide market for this application at $450 million, a third of it in the U.S. And LifeBond says 2 million hernia repairs are done annually worldwide, half of them in the U.S. That's overall also a $450 million market.
LifeBond's investors include the Israeli venture-capital firms Aurum, Giza and Pitango. Also an investor, and a director, is Robert Taub, who founded Omrix, a producer of sealant used to control bleeding during surgery. J&J acquired Omrix in 2007.
In 2011, when LifeBond raised $20 million in a third-round financing, the New Brunswick, N.J., health-care giant J&J joined the round. Its specific investment hasn't been disclosed. LifeBond previously raised $1.5 million and $8.5 million in its Series A and Series B rounds respectively.
LifeBond is now in a Series D round, aiming to raise a total of $25 million by early 2015, and current investors have committed about half that figure.
In first-half 2013, LifeBond did a first clinical study in Sweden to test the application method for LifeSeal and to evaluate the product for safety. That study met its goals and this year LifeBond enrolled patients in a second study at eight centers in Belgium, Israel and Sweden. The company is expecting the results of that trial in November. The study's goal is to receive the CE Mark, which means that the product meets EU standards.
Sturlesi says the company has started the U.S. Food and Drug Administration process to develop the studies it needs to gain clearance to market LifeSeal in the U.S.
The company sees additional applications for LifeBond's system in surgeries involving the eye, brain, lungs, spine, urological system, and ear, nose and throat.
"We are there to support the natural healing process of the body," Sturlesi says.
No comments:
Post a Comment