A Medical Device Daily
HepaLife Technologies (Vancouver, British Columbia), which is focused on creating an artificial liver device and developing in vitro toxicology and preclinical drug testing platforms, reported that several of its research objectives have been achieved.
Along with measuring positive P450 activity, urea production and ammonia clearance from its PICM-19H liver cell line – currently being studied for eventual use in an artificial liver device by patients suffering from acute liver failure and chronic liver disease – the company reported that its research has demonstrated that PICM-19H cells can be maintained independently of STO feeder cells.
PICM-19H cell culture without the aid of STO feeder cells would allow for a more defined cell culture system and may also be important for potential FDA approval of its artificial liver device, HepaLife said.
The company said its research has been further expanded to include the study of various factors that may improve and extend the length of time that PICM-19H cells can be stored at room temperature instead of heated incubators, designed to artificially mimic body temperature.
To date, HepaLife said the PICM-19H cells remain functional and viable after one week of room temperature storage. However, further extending the storage time in culture at room temperature could allow for easier long-distance transportation of these cells. Moreover, the ability to place these cells in “suspended animation” at room temperature will enable more efficient utilization of the artificial liver device in its clinic or hospital setting, the company said.
Arian Soheili, president and CEO, said, “The benefits and cost savings of being able to ship the most important and perishable component of an artificial liver device – the cells – around the country without special incubator equipment would be tremendous.”
He added: “When it comes to developing a fully functional, therapeutically effective artificial liver device, the key is not in the hardware itself – rather, it’s the biological component that goes inside.”
Saying that “most artificial liver systems being developed at other labs and companies have not lived up to initial expectations as a consequence of problems relating to their inability to grow liver cells quickly and safely, poor cell functionality and inconsistent results from filtering or dialysis devices,” Soheili said his company’s cell line to date “has performed beyond our expectations.”
Ablatherm-HIFU available in Canada
EDAP TMS (Lyon, France) said that its non-invasive treatment for prostate cancer now is available to North American patients through a clinical installation in Toronto. The Ablatherm-HIFU prostate cancer treatment is now being offered at the Don Mills Surgical Unit, a private surgical facility.
The facility is licensed by the province of Ontario and under the direction of Dr. William Orovan, a urologist and chair of the department of surgery at McMaster University (Hamilton, Ontario). Orovan is a former president of the Ontario Medical Association.
Ablatherm-HIFU is a precise, targeted procedure that delivers a beam of high-intensity focused ultrasound to the prostate. A probe is placed into the rectum through which the focused ultrasound waves are directed into the cancerous prostate tissue without damage to the intervening tissue. A rapid rise in temperature inside the prostate cells to 85 degrees Celsius destroys the cancerous cells. The procedure is completed in two to three hours without blood loss or exposure to radiation.
EDAP said prostate cancer is second only to lung cancer as the cause of cancer-related deaths in North American males. It is estimated that about 250,000 new cases of prostate cancer are diagnosed in North America each year, the company said.
EDAP TMS said it has entered into an exclusive sales agreement with Maple Leaf HIFU Co. allowing Maple Leaf to market the Ablatherm device in Canada and develop access to Ablatherm-HIFU technology throughout that country.
“This clinically proven treatment is a revolutionary advance in the fight against prostate cancer,” said John Warner, MD, an uro-oncologist practicing in Vancouver, British Columbia. “We are excited to finally bring the Ablatherm treatment to North America so many more can discover its benefits.”
The company said Ablatherm-HIFU is an effective treatment for patients with localized prostate cancer whose disease is confined to the prostate gland itself, referred to as clinical stage T1 or T2. It also can be performed on patients who have undergone radiation treatment in the past and experienced recurrent cancer. The HIFU procedure provides these patients with a treatment option when few others remain.
Ablatherm-HIFU is approved for use in Canada and throughout Europe, where it has more than eight years of patient follow-up data. In Europe, clinical experience now totals more than 7,000 treatments. The technology does not yet have FDA approval, but trials are expected to begin in the U.S. soon.
With success rates of up to 93% reported in European studies, EDAP said the procedure offers “a safe and effective alternative to more radical treatments such as surgery or radiation, currently the primary treatment methods.” In addition, it said Ablatherm-HIFU can be repeated and does not exclude patients from undergoing other treatment options if their cancer is found to be more aggressive or recurring.
Hugues de Bantel, CEO of EDAP, said, “Canada represents a significant and important opportunity to bring this treatment technology and its benefits to men suffering from prostate cancer in North America.”
The company also is developing the Ablatherm technology for the treatment of certain other types of tumors. EDAP also produces equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy.
Second CTLM system for Polish center
Imaging Diagnostic Systems (Fort Lauderdale, Florida) said it would fulfill a request by the Maria Sklodowska-Curie Memorial Institute in Poland to install a second CT Laser Mammography (CTLM) system for clinical research.
The initial system was installed in January and patient volumes at the institute have continued to increase, the company said.
The CTLM system uses laser technology and proprietary algorithms to create 3-D cross-sectional images of the breast.
Tyco appoints two for China
Tyco (Pembroke, Bermuda) has made two hires to represent it in China. Michael Byrnes was named vice president of public affairs and president of Tyco China, and Ross Ma was named director of communications for China.
Byrnes, who will be based in Beijing, will serve as Tyco’s liaison to national, provincial and municipal government officials, relating to trade, investment, regulatory affairs and U.S./China relations. He most recently served as chief representative and vice president of China operations for Rockwell International. Ma will be responsible for company communications, branding and employee communications activities in China. He has worked at various multi-national companies in China, including Boeing, Burson Marsteller and Edelman.
Tyco reports having nearly 28,000 employees, representing each of the company’s five businesses, including healthcare, electronics, fire and security, engineered products and services and plastics and adhesives.