ALACHUA – Edward Bonfiglio was on a routine foot patrol in Afghanistan when he was ambushed. A bullet tore through his left leg, rendering it lifeless below the knee. That didn’t last, thanks to a regenerative medicine company in Alachua.

Alachua-based biotech company, AxoGen, located at the Sid Martin Incubator, recently announced that Navy Corpsman Edward Bonfiglio, a patient who regained the use of his limbs thanks to a nerve graft from Axogen, has been selected by the American Association of Tissue Banks (AATB) to represent tissue recipients on the “Donate Life” float in the 2014 Rose Parade.

Since 2005, the AATB has sponsored the Donate Life Rose Parade float, which serves as a memorial to organ and tissue donors, according to the website. The theme of the 2014 float, “Light Up the World,” supports the organization’s mission of saving and enhancing lives through the gift of organ and tissue donation. The 125th Rose Parade, which features floats covered in flowers, will take place Jan. 1, 2014, 8 a.m. in Pasadena, Calif.

When he was shot, an injury to his sciatic nerve took away all function and feeling below his knee. Back in the United States, surgeons at Walter Reed National Military Medical Center in Washington, D.C., presented Bonfiglio with surgical repair options that included amputation of his left leg or repair of the severed peripheral nerve using Axogen’s nerve graft, with the goal of restoring function. Bonfiglio chose the nerve graft and today is able to walk and jog, and is currently training for the Paralympics.

“AxoGen is delighted that Edward Bonfiglio has been chosen by AATB to represent tissue recipients in the Rose Parade,” said Karen Zadarej, CEO of Axogen. “He has bravely served our country, is an advocate for tissue donation and an inspiration to patients with peripheral nerve injuries.  It is an honor to have provided the processed nerve allograft that contributed to saving his leg.” 

AxoGen’s website describes the difference between processed nerve allografts, which they pioneered, and autografts, which have been the gold standard for repairing peripheral nerves in the past.

Allografts are taken from human cadavers and processed to remove cellular debris by AxoGen. The process sterilizes the tissue and creates a nerve the body will not reject. Therefore, no drugs are required to prevent the body’s immune system from attacking it.

The autograft procedure removes nerves from another part of the patient’s body for reuse at the injury site. Since tissue is their own, the body won’t reject it. However, an autograft procedure requires two surgeries and can create a second site where tissue may become infected. Another concern is that the nerve removal site will generally lack feeling and scarring can also occur. Nerve grafts taken directly from a patient are usually removed from the leg or foot.

Another benefit of the allograft procedure is that surgeons can obtain a variety of sizes up to seven centimeters. The nerves are kept frozen until needed for surgery. A recent study found that allografts up to 5 centimeters produced results similar to autografts and patients’ nerves re-grow at a rate of roughly an inch a month.

"Allograft has not been done in enough patients to say that it's the same as autografts, but there are advantages if it ends up being equal," said Dr. Ed Akelman, an orthopedic hand surgeon at Rhode Island Hospital and chairman of the council on education at the American Academy of Orthopedic Surgeons.

Akelman said he has used the allografts and called them promising, but is waiting to see the results of more surgeries before switching allegiances from autografts.

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HAWTHORNE – Alachua County will be completing a transition that started years ago in the City of Hawthorne, which could help lower insurance rates for homeowners in the city.

The county took over the fire and rescue services for the City of Hawthorne in 2008, but remained in a station located outside city limits. Now the department is making a move into the city’s station.

In 2005 Hawthorne started its own fire department, after years of the county department serving the city’s needs. This change relocated Alachua County Fire Rescue to Grove Park and outside of the city. However, the city’s fire department had started just as the economy started to take a dip, and quickly became expensive.

“With revenues decreasing in 2008 the decision to disband city fire and police departments was made by the city,” said Ellen Vause, Hawthorne’s city manager. “It was unfortunate that the downturn of the economy coincided with the city starting its own fire department. The building has been empty since that time.”

Having the fire department back in the city station could be a good move for several reasons. First is the increased safety of having response time cut down with the location. Also, homeowners insurance will be cheaper for most residents because of the proximity of the location.

“The rates and insurance are based completely on a protection class that you fall into, and location is factored into that,” said Donna Boles, an agent with Hawthorne Insurance Agency Inc. “Previously some residents couldn’t even get a protection class that agencies would work with. Now it will be easier and cheaper for most clients.”

This deal has been several years in the making with the city and the county and everything is still in the planning stages as far as when the move will take place. It is already decided that the county will be funding all the renovations needed to the city’s station when the department moves in.

“This is a good move for Hawthorne and its residents. It will be safer and not to mention eliminate problem protection classes,” said Boles. “This gets me back into the game with many clients.”

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ALACHUA – A gene therapy company in Alachua and the University of Florida's ophthalmology department are closer to developing a treatment for a rare eye disease.

AGTC in Alachua and the university's ophthalmology department secured an $8.4 million grant from the National Eye Institute to help them study a treatment for a genetic form of vision impairment called achromatopsia.

"It's really quite a debilitating form of blindness," said William Hauswirth, a professor from UF who will be the principal investigator in charge of the research. There will be multiple sites where the studies are conducted, including New Jersey, Miami, Chicago, Wisconsin, Alachua-based AGTC, the University of Florida and the University of Oregon

"We already have very encouraging results in several animal models that this treatment has the potential to restore vision function,” Hauswirth said.

Achromatopsia is well understood, but funding has been the issue in treating it, he said. It's estimated there are 10,000 patients of the disease in North America and Europe.

The disease is caused by a missing gene which the company hopes to correct by injecting a virus behind the patient's retina carrying the missing pieces of the patient's genetics.

"It's not a complicated surgery," Hauswirth said.

The animal-testing phase of the research is already finished.

The grant will last for five years. FDA approval is still several years off, though. Human trials could begin within three to five years, treating about 50 patients, Hauswirth said. The human trials should go on for about four years.

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W - BREEDLOVE 1 - DSC 0962 copyPatti Breedlove directs the Sid Martin Incubator in Progress Corporate Park. She was made director this year while the incubator continues to gain international recognition.

ALACHUA - When Patti Breedlove started working at the Sid Martin Biotech Incubator in 1998 as a program coordinator, her first task was to throw a party for the first two companies who were "graduating" out of the incubator from startup companies to self-sufficient businesses. A lot has changed since then.

Breedlove, 65, is now the director of the Sid Martin Biotech Incubator in Progress Corporate Park in the city of Alachua. She is responsible for executing the overall vision of the incubator, which is to help small, fledgling companies in the biotechnology field grow. It provides these companies with space, equipment, mentoring and whatever else they might need, Breedlove said.

"She's not just a landlord, that's for sure," said Jackson Streeter, CEO of Banyan Biomarkers, a resident biotech firm at the incubator.

"She's extremely proactive," he said. Breedlove helps the companies recruit people to fill positions, arranges facility tours and spends time to get an understanding of what issues the businesses face and how she can help.

"She has a big network that she can reach out to," Streeter said, noting how she has helped Banyan search for investors.

Her schedule for a typical week might include making phone calls to try and improve the scientific equipment in the incubator, having lunch with real estate agents to help the biotech companies find land for facilities, meeting with representatives from marketing firms and giving tours to the Gainesville Chamber of Commerce.

Part of her job is forming a strategic vision for the incubator, but another part is being its external face and being an advocate, Breedlove said.

"Patti is such an outgoing, positive advocate of life sciences in the region," said Sue Washer, CEO of graduate company AGTC, which researches cures for rare lung and eye diseases.

As the face of the Sid Martin Biotech Incubator, Breedlove, who was only made the director this year, has recently seen some recognition for the success of her facility. It was ranked as the world's best biotech incubator by the Sweden-based research group, UBI.

"For a long time, we had no recognition," Breedlove said. "We're thrilled. It's really put a spotlight on our program."

UBI found Breedlove's incubator creates 2.8 times more jobs than the global average, and that despite the fact that European incubators provide nine times as much funding, they create 1.9 times fewer jobs.

Even though she has done well with less funding than incubators in Europe, getting seed funding is still sometimes an issue for Breedlove, as well as finding more space for the facility.

Setting a good culture, hiring the right people and giving them the freedom to do their jobs has been key to do more with the funding they have, Breedlove said. She runs the incubator like a business, rather than have it function like a massive university.

Things are a lot different in Alachua than when Breedlove started.

"I've seen a lot of changes since I started here in 1998," she said. "This area has really grown up in terms of technology. There's a real high energy in Alachua County in trying to grow new biotech companies."

Breedlove said she hopes to continue to see the area develop like it has over the past 15 years.

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HIGH SPRINGS – Employees at the City of High Springs have voted to be represented in future employee/employer negotiations by a union. The full and part-time non-professional, non-supervisory employees chose the American Federation of State, County and Municipal Employees (AFSCME), which is affiliated with the American Federation of Labor and Congress of Industrial Organizations, one of the largest national trade unions in the country

The High Springs Police Department which is currently represented by their own union, the High Springs Fire Department, the charter officers and commissioners are not included in the move to unionize municipal employees.

City officials say they have not received any paperwork from the union. They did, however, receive a tally of employee ballots in mid-June which indicated that of the 14 eligible voters in the proposed unionizing group, nine ballots were returned. All nine voted to join the union.

The city has not yet entered into any type of negotiations with the union. City Manager Ed Booth expects to meet with a union representative within the next two weeks to discuss initial contract negotiations and establish how the union will be set up. “At this time, I don’t believe a union steward has been elected and our employees have paid no union dues. I would imagine those items will be discussed at our upcoming meeting.”

Union representatives could not be reached to comment on the procedure of setting up or joining a union.

However, the Public Employee Relations Commission (PERC), the government group that oversees unions in Florida, offered information about the unionization process. PERC’s General Council Steve Meck went through the entire process step-by-step.

“All unions must be certified by PERC,” he said. “The process begins formally when the union files a representation petition with our office.” That appears to have happened in mid-February in this case, according to PERC’s records.

“A union can include or exclude the positions within the unit,” he said. “A unit can be wall-to-wall, which would include all employees. They can form a white collar unit or they can form a blue collar unit. Managerial and/or confidential employees are excluded from collective bargaining rights under Florida statutes,” said Meck. He listed “confidential employees” as someone who may assist a business’s president, for instance.

The petition to form a union was found sufficient to go forward Feb. 21, 2013, said Barry Dunn, PERC representative. “At that time,” said Meck, “a hearing officer is assigned to the case.”

A consent election was filed March 19, in which all parties filed joint factual stipulations indicating their agreement to form a union consisting of the employee positions listed. April 3, a hearing officer recommended the order after reviewing the stipulations and analyzing it. April 25, PERC’s chair and two-person commission approved the consent election agreement and directed that an election be conducted. At that time the case was transferred to their election division to conduct the election.

The Notice of Election went out May 3 to the employees eligible to vote in this case, Dunn said. PERC’s commission issued an order verifying the election results July 3, 2013.

“A serious showing of interest is about 30 percent of the employees in the proposed bargaining unit,” explained Meck. “Each employee must sign and personally date a statement expressing a desire to be represented by the union or to hold an election to determine if there are 30 percent of the employees who wish to form a union.”

The process is usually fairly quick if there are no problems or disputes, Meck said. “A period of two-and-a-half months may be all it takes to form a union. However, if disputes arise or the group is unusually large, it could take six months, at most, to resolve."

While employees have loosely discussed forming a union for the past few years, it is believed by some that the recent push to move forward with those plans was likely propelled by the decision of the previous city commission to balance the budget in part by reducing employee salaries by 6.7 percent and by withdrawal of budget funding for positions some commissioners wanted to see eliminated.

“Union contracts typically include a grievance procedure,” said local attorney Linda Rice Chapman. “Had my client, Christian Popoli, been represented by a union at the time he was wrongfully terminated from his position with the city, arbitration, instead of a costly legal suit, would have provided him with an additional remedy. It is a lot cheaper to file a grievance than to file a lawsuit,” she said.

According to the AFSCME website, “AFSCME is the nation’s largest and fastest growing public services employees union with more than 1.6 million working and retired members.” In addition, AFSCME boasts “approximately 3,400 local unions and 58 councils and affiliates in 46 states, the District of Columbia and Puerto Rico.”

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W - FILE - Santa Fe River 1 DSCF6040 copyIn May 2012, area residents surveyed the High Springs boat ramp at Santa Fe River, only to find much of the river was gone. The river rebounded weeks later, but the Suwannee River Water Management District remains concerned about its outlook.

ALACHUA – Ann Shortelle, executive director of the Suwannee River Water Management District (SRWMD), presented to the Alachua City Commission new scientific findings on Monday.

The presentation was based on the minimum flows and levels of the lower Santa Fe River and its priority spring as well as the Ichetucknee River and its priority springs.

Minimum flows and levels are the amount of water withdrawn without causing significant harm to the water sources, Shortelle said.

The SRWMD looks at environmental values to measure the flow, levels and any significant harm for each of the water bodies. For the Ichetucknee River and springs, it looks at recreation. For the lower Santa Fe River and springs, it looks at fish and wildlife habitats and passage of fish, said Steve Minnis, director of governmental affairs and communications for SRWMD.

Red flags rose in the lower Santa Fe River and springs when there was too much ground water withdrawn.

Ground water crosses through boundaries, so withdrawals in one district can and may affect the water body in another district, Minnis said.

This begins the recovery process.

Due to significant harm that was caused, the SRWMD has asked the North Florida Regional Water Supply Partnership Stakeholders Advisory Committee for input and has peer review meetings.

The Ichetucknee River and springs are under a prevention period. If nothing is resolved, then those water bodies will be in recovery as well.

The next committee meeting is Aug. 19 at 1 p.m. in the Wilson S. Rivers Library and Media Center, Building 200, Room 102 at Florida Gateway College in Lake City.

The committee meets once a month.

It is the primary place where they work on recovery and prevention, Shortelle said.

The upcoming peer review meeting dates are in the process of being set. People who wish to participate can sign up with “Notify Me” on the website for updates.

“Recovery strategies for lower Santa Fe River and priority springs will also benefit the prevention strategies for the Ichetucknee River and priority springs,” Minnis said.

The water management district will set the minimum flow and levels on the springs. They already have done so for the rivers.

SRWMD has asked the University of Florida Water Institute to review its science.

Shortelle described three main tools used in the plan.

The first is water conservation. It is the least cost alternative to recover or prevent significant harm to the river and springs.

Use less water.

“Every drop counts,” Shortelle said.

The second is regulatory tools. Strategies have not yet been developed. That will be part of the process from the public input meetings.

The same goes for the third—projects. The water management district and committees will be evaluating different projects. They are looking at traditional ways of getting more water into the system.

“It’s all of our jobs,” Shortelle said.

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WALDO – The fire station in Waldo might see some change, but the residents probably won’t notice anything different about the service.

Alachua County, which took over the fire department for the City of Waldo two years ago, will be building a new fire station in town.

“The fire department went to the county about two years ago because we could no longer afford it,” said Kim Worley, Waldo’s city manager.

The city is still working out the deal, but is already in the process of selecting the land and getting it surveyed. The station will be moving from its current 14380 Earle St. location, and the new location will be at the corner of U.S. Highway 301 and N.E. 144th Ave. at the bottom of Cole Street.

The land will be donated to the City of Waldo, which they will then donate to the county to build the new station. Waldo will also be able to keep the building that the fire department is currently housed in as a part of the deal. The new land is 5.9 acres and valued about at $32,400, Worley said. However, the city will get it for free.

“We will be paying for the survey, the title search and then our attorney will draw up a contract once we have a legal description of the property,” Worley said.

Residents in Waldo may be anxious about this change, but they can be assured it will not mean a changeover in staff or loss of jobs.

“If anything, the station will be larger so they could add additional staffing,” Worley said. “Otherwise it is all the same, just a new location,”

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