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'Life sciences century' spurs new wave of med-tech companies in Western Pennsylvania

| Sunday, March 21, 2010

Using his home tool kit, Edward S. Wright built a pump to help his granddaughter control severe leg swelling that stemmed from a circulatory problem.

Thirty years later, Wright's daughter has developed a lighter, digital version of his idea. "And now, we're ready to go national and make the product available to more people," Carol Wright said.

With 11 employees and a small space in a North Fayette business park, Wright Therapy Products Inc. has minimal name recognition compared with Western Pennsylvania medical device giants such as Medrad and Philips Respironics. A growing number of other small companies in the region is perfecting or selling medical products ranging from better catheters to bone cutters and breathing devices.

"Strong academic centers like the Pittsburgh region do tend to show remarkable success in creating and drawing in new companies," said Wanda Moebius of the Advanced Medical Technology Association, or AdvaMed.

Most of the 6,000 medical device companies nationwide are in small towns and have fewer than 100 employees, the Washington-based trade group said. While the recession has slowed business startups and financing for now, Moebius said, "This is the life sciences century" and better, less-costly ways to treat an aging population will be crucial in coming years.

The state-financed Pittsburgh Life Sciences Greenhouse has worked with, or helped to fund, 300 fledgling companies in its eight-year history, CEO John Manzetti said. Nearly half — or 144 — have been focused on a new instrument or machine for a hospital setting, or something that a patient might use at home.

In many cases, the concepts come from researchers at Carnegie Mellon University, the University of Pittsburgh and other campuses. Leaders at the greenhouse, the region's primary funding and support source for medical startups, "troll the halls there, looking for light bulbs going off" then weigh whether the ideas are marketable, Manzetti said.

Pennsylvania's medical technology industry ranks seventh in size nationwide, with $5.49 billion in sales in 2006, according to an AdvaMed report.

Wright's compression therapy pump got its start not in a university laboratory, but at the D.T. Watson Children's Home in Sewickley. Edward Wright visited his granddaughter in 1980 as she was being treated for congenital lymphedema, and saw that the inflatable pump doctors were using controlled the size of her right leg but caused her foot to swell.

"There wasn't as much known about lymphedema then," Carol Wright said, adding that often, severely swollen limbs would be amputated. Lymphedema occurs in patients missing lymph nodes at birth or, most often, after nodes are removed during cancer surgery. At least 3 million people in the United States have the condition, which can be treated, but not cured.

Edward Wright made a pump with chambers that delivered varying degrees of pressure to a limb — more at the farthest point, less closer to the body. "Like squeezing a tube of toothpaste," Carol Wright said.

The pump worked so well, she said, that doctors at the Watson hospital referred other patients to her father. He formed a company in 1983 to sell his pumps across the region, and Carol Wright bought it in 1998.

Since then, she's downsized her late father's original 45-pound device to 7 pounds and added features such as password protection to keep patients with moderate to severe lymphedema from dialing up the pressure on their own, to cut their daily treatment times.

The Wright pumps, which cost $6,000, have been used to treat patients as young as 2 weeks, and as old as 99. One patient in her 30s had a leg that was 60 percent of her body weight. Facing amputation, "She got one of our pumps, and she got better," Wright said.

Wright Therapy recently secured an undisclosed amount of venture capital that will help to build a sales force to begin marketing the latest pump, which patients in Western Pennsylvania, Ohio and West Virginia have tested.

Help has come from the South Oakland-based life sciences greenhouse, which provided Wright's company with $25,000, and has invested a total $15 million in 60 companies.

"Pittsburgh has a very vibrant, tight-knit community" of medical technology entrepreneurs, organizations and investors, said Michele Migliuolo, a former executive-in-residence at the greenhouse who now heads the South Side-based startup NeuroInterventions Inc. "It's easy to get help, and easy to network."

The NeuroInterventions catheter system will start animal trials next month at the University of Massachusetts at Worcester, he said. It's designed to speed post-stroke treatment. Unlike conventional catheters used to clear blood clots in the brain, the company's device enters through the neck instead of the femoral artery, at the groin.

NeuroInterventions' catheter opens a clot, delivers blood thinners and suctions it out. "Time is brain," said Migliuolo, who has raised $1 million for development of the device, including $400,000 from the greenhouse and $100,000 from state-funded Innovation Works, which aids entrepreneurs.

"There is an entrepreneurial spirit here in Pittsburgh, and we are starting to get noticed outside the region" by firms that provide capital, said Alan West, another veteran of the greenhouse's executive-in-residence program, which encourages professionals with experience in launching products to move on to one of the companies they help.

West now runs Carmell Therapeutics Inc., which is building blood plasma-based plastics to promote healing. Hospitals now use a spinning process to form a concentration of a patient's blood platelets, then place it near a wound or surgery site. Still, "as we get older our regenerative powers lessen, so this doesn't work in every patient," he said.

Carmell's product is ready-made and uses banked blood. Animal tests have been done, and clinical trials with humans could start in a year. The company uses laboratory space at Allegheny General Hospital on the North Side, and is an outgrowth of the Allegheny Singer Research Institute, the hospital's technology transfer arm.

Often, companies generated in the Pittsburgh region and nurtured by the greenhouse, Innovation Works and local investors are bought out by bigger companies, Manzetti said.

Some take root in the region. Wright said her company, with an expanded staff working two shifts, could turn out 8,000 standard-size and custom-made pumps each year at its current plant.

Her passion for building the company relates in part to her niece, who continues to do well, Wright said. "We want to make a profit, but there's no joy in that unless you can really help people," she said.

Gadgets for patients

Some are destined for use in operating rooms. Others could help to treat patients at home.

Here's a look at a few of the medical technologies that some small companies in the region have created. All are listed by a primary illness or condition the device is designed to treat.

Catheterization: Flexicath Ltd., an Israeli venture that moved to the region, makes the FirmGrip intravenous catheter. For patients who need infused fluids for one to two weeks, it would replace catheters that need to be changed every two days, meaning fewer needle sticks, said James "Chip" Hanlon, chief operating officer. Clinical trials are nearing completion: product rollout will be centered around Pittsburgh, he said.

Location: South Oakland. Employees: 1.

Heart, other surgeries : Thermal Therapeutic Systems Inc. got federal clearance this month for its portable Veratherm device that controls the temperature of the thoracic cavity in the chest, or peritoneal cavity in the abdomen, for delivery and circulation of sterile fluids. CEO Raymond Vennare said a large East Coast hospital system could try it soon; a major launch could come at year's end.

Location: Edgewood. Employees: 4 founders.

Healing: Carmell Therapeutics Inc. is developing a ready-to-use, blood plasma-based plastic that doctors can place near a wound or surgery site to speed recovery. A patient's own platelets, concentrated through spinning, are used now, with varying success, CEO Alan West said. Animal tests have been done; human tests could be done in a year.

Location: North Side. Employees: 3.

Incisions: Cohera Medical Inc.'s TissuGlu adhesive is being tested in patients in Germany and is designed to close incisions for plastic surgery and other procedures such as hernia repair or breast reduction, while eliminating the need for post-surgical drains that can cause complications, Sales could start in Europe next year, and in the United States in 2012.

Location: North Shore. Employees: 19.

Lymphedema : Wright Therapy Products makes a compression therapy pump that inflates and improves circulation in arms, legs and other areas that swell because of this condition, which can be congenital but more often is caused by cancer surgery to remove lymph nodes. The latest model is to be launched for nationwide sales this year.

Location: North Fayette. Employees: 11.

Orthopaedic surgery : Blue Belt Technologies Inc.'s Precision Freehand Sculptor works with a standard surgical drill to trim bone correctly for joint replacements, for example. Sensors on the tool follow the surgeon's preset pattern. The company hopes to start selling the device this year.

Location: East Liberty. Employees: 10 full-time.

Respiratory distress : ALung Technologies Inc.'s device uses a small catheter to remove carbon dioxide, and supply oxygen, to a patient with chronic breathing issues who is hospitalized due to flu, for example. The Hemolung is in trials in Germany and India; with success, European distribution could start this fall. Trials in the U.S. could start in 2011.

Location: South Side. Employees: 15.

Sleep apnea : Circadiance LLC's SleepWeaver cloth mask attaches to a breathing device patients use to control the disorder, which causes brief interruptions of sleep. Sales have grown by 20 percent per month over the past year, and international sales should start soon, said CEO David Groll, who developed the mask.

Location: Export, Westmoreland County. Employees: 6 full-time.

Stroke : NeuroInterventions Inc. is developing a time-saving catheter to travel through the neck to treat, and extract a blood clot. Current catheters go through the groin, taking longer to reach the brain. Animal trials for the device are to start in April at the University of Massachusetts at Worcester.

Location: South Side. Employees: 1.

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