Worcester Business Journal

14 Worcester Business Journal • August 1, 2016 www.wbjournal.com S M A L L B U S I N E S S & E N T R E P R E N E U R S << " Your small business is our business." We know what it takes to own a business and we know you have your hands full. Let us take care of all your cash management needs, so you can concentrate on the business at hand. www.southbridgesavingsbank.com facebook/southbridgesavings 800-939-9103 - Bob Mangan AVP, Cash Management CHARLTON | HOLDEN | NORTH OXFORD | SOUTHBRIDGE SPENCER | STURBRIDGE | WEBSTER | WORCESTER Cash Management • Business Bank N' Pay SM • Remote Deposit Service • Credit Card Processing • Payroll Services 905 Hartford Turnpike Shrewsbury, MA 01545 508-842-1213 www.elevationee.com Three-year-old Holliston biotech seeks to fulfill $1.5-billion potential O ver the past year, Holliston- based Biostage has revamped its upper management, changed its name and used its technology to par- tially recreate the esophaguses of several Yucatan pigs. The company, which until March was known as Harvard Apparatus Regenerative Technology, is the maker of Cellframe organ implants, bioengi- neered organ regeneration technology that has proven it can successfully rec- reate parts of a pig's esophagus. Now the next question is, will it work on humans? Biostage thinks it can. The small biotech company, with 22 employees, is in the process of putting together its investigational new drug (IND) filing with the U.S. Food and Drug Administration for Cellspan esophageal implants. If approved, human testing could begin in 2017, said president and CEO Jim McGorry. The three-year-old company hopes the implant will meet the FDA's orphan drug criteria, which would get the $672,000 IND application fee waived. The goal is commercialization by 2020. "We're right at that moment, if you will, of moving to preclinical to clinical right now. And that's an exciting moment," McGorry said. Regenerative approach The esophageal implant is one of four being developed by Biostage, including Cellspan bronchial, tracheal and pediat- ric esophageal implants. The current priority, however, is the Cellspan esoph- ageal implant, which the company hopes will be transformative for patients with esophageal cancer. Today, patients diagnosed with esophageal cancer can undergo a proce- dure called an esophagectomy. After part of the esophagus is removed due to tumor or trauma, either the stomach or a part of the colon can be pulled up into the chest, as a replacement for the esophagus. It's a high-risk procedure that can lead to life-threatening compli- cations and costly medical care. The Cellspan esophageal implant, Biostage hopes, is a solution to this problem. Stem cells are gathered from a patient's abdomen via a biopsy, isolated, expanded, and then seeded onto one of Biostage's biocompatible synthetic scaf- folds. After three to five days in a rotat- ing bioreactor, the device is surgically implanted in place of a removed section of the esophagus. After three weeks, the scaffold is removed, and after a few months, the esophageal tissue has com- pletely regenerated itself, creating a new, healthy organ. Two weeks into the animal study, there was already enough regenerated tissue for the animal to eat and thrive without complication, said Saverio La Francesca, Biostage's chief medical offi- cer, who has been responsible for spear- heading the development of the Cellframe technology. Complete organ regeneration takes a few months, and some animals are still ongoing, he said. It's a combination product – part medical device, part cells – and is desig- nated that way by the FDA, McGorry said. It could reduce surgical complica- tions and expand treatment options to patients deemed unfit for surgery, and lower long-term costs, according to the company. "Our sweet spot is cells on a scaffold," McGorry said. That combination has produced some interesting results at Connecticut Children's Medical Center, where Biostage bioreactors and scaffolds are used to build an implant for esophageal regeneration in mini swine. In the sec- ond to last week of July, the first set of pigs were just over 40 days into their trial, and so far, the results were impres- sive, said Dr. Christine Finck, CCMC BY LAURA FINALDI Worcester Business Journal Staff Writer surgeon-in-chief and chief of the divi- sion of pediatric surgery. The pigs' esophaguses are regenerat- ing, with a little bit of scar tissue. The idea is that if the cell-seeded scaffold can regenerate a pig's entire esophagus, it might also work in children born with esophageal atresia, meaning the two ends of their esophagus are not connected, Finck said. She estimates her team will treat four more sets of pigs by this time next year. "I'm hoping that we land upon a clin- ically relevant, off the shelf, patient-spe- cific scaffold to help with tissue regen- eration of the esophagus," she said. From H.A.R.T. into Biostage In the fall of 2013, Harvard Bioscience, Inc. spun off its regenera- tive medicine business into what was then known as Harvard Apparatus Regenerative Technology, Inc., now Biostage. Harvard Biosciences contrib- uted $15 million in cash and its regen- erative medicine business, and complet- ed the spin-off through distribution of all common stock shares of Biostage to Harvard Biosciences stockholders, according to U.S. Securities and Exchange Commission filings. It was then Harvard Biosciences and Biostage entered into a 10-year product distribution agreement, ensuring each company will exclusively distribute the other party's products, developed by such other party for sale in markets served by the other. Bioreactor sales to Harvard Bioscience account for 100 percent of Biostage's current revenue

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