A Medical Device Daily
Medifocus (Vancouver, British Columbia) said it has been granted Investigational Testing Authorization (ITA) from Health Canada's Medical Device Bureau to initiate a pivotal trial with the Microfocus APA 1000 Breast Thermotherapy System for the treatment of breast cancer.
The initial trial sites are Ville Marie Medical Center and St. Mary's Hospital in Montreal, with additional sites to be added, according to the company.
Medifocus owns a microwave-focusing technology platform, the Adaptive Phased Array (APA) technology, which can precisely target and control microwave energy to cause heating in cancerous tumors anywhere in the body reliably and repeatedly.
The company said the ability to target tumors with a controlled dose of heat "can be used to destroy tumors at higher temperatures, to treat tumors in combination with chemotherapy and/or radiation at moderate temperatures for increased effectiveness and reduced toxicity and to trigger the targeted release of therapeutic drugs and genes at tumor sites at lower temperatures."
The core technology was licensed from the Massachusetts Institute of Technology (Cambridge), but Medifocus has further refined the precision of the microwave focusing and control ability and developed a commercial system dedicated exclusively for the treatment of breast cancer.
The pivotal trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, using its focused microwave heat energy in combination with neo-adjuvant chemotherapy over chemotherapy alone on large breast cancer tumor.
Ville Marie is one of the most active comprehensive breast cancer centers in Quebec and St. Mary's Hospital is a teaching hospital of McGill University. Dr. Kyserlingk, the director of Ville Marie Medical Center, will be the principal investigator in Canada for the pivotal study. A total of 238 patients will be entered into the study.
The basis of this ITA-approved pivotal study was from the data analyzed from an FDA-approved Phase II multi-center, randomized study using the Microfocus APA 1000 Thermotherapy System on large breast tumors.
The data showed that the median tumor shrinkage in the thermo-chemo arm was 88.4% and for the chemotherapy-alone arm the median tumor shrinkage was only 58.8%. This increase in median tumor shrinkage was statistically significant. In addition, the data indicated that for the thermo-chemo treatment arm, almost 80% of all breast tumors treated had a tumor volume reduction of 80% or more compared to only 20% for the chemotherapy alone arm.
Dr. Augustine Cheung, chairman/CEO of Medifocus, said; "[This] approval initiates the final step towards the commercialization of the company's APA focused heat treatment system for breast cancer. We believe that the increased efficacy in the shrinkage of large breast tumors will facilitate increased breast conservation surgery which is desired by both the patients and the surgeons."
He added, "[We] look forward to completion of the pivotal trial and obtaining commercial approval in a timely manner so that we can enter the huge global marketplace for breast cancer treatment. According to the American and Canadian cancer societies, over 1.2 million new cases of breast cancer are diagnosed each year. More than 75% of these newly detected breast cancer patients will be scheduled for complete breast removal surgery unless the size of the tumor can be significantly reduced."
Cheung said the company's focused heat treatment "may be in a position to help these patients to improve their chance of breast conservation."
China okays NeuroLogica's CT scanner
NeuroLogica (Danvers, Massachusetts), a provider of portable imaging equipment in CT and SPECT, has expanded into the Chinese medical device market with the approval of the company's life CereTom portable CT Scanner by the Chinese State Food and Drug Administration.
The company also said it will establish a business liaison office in Beijing.
The CereTom is a portable, eight-slice CT scanner that can be used in the ICU, ER, OR, NICU, MICU, SICU, interventional suite, or any medical clinic. The unit is compact and lightweight; only 29 inches deep, 5 feet tall and 4 feet wide and weighs roughly 750 pounds.
"We are extremely pleased with the cooperative effort among various Chinese State agencies, and especially the FDA, in granting approval of our Portable CT scanner for the Chinese market," said President/CEO Dr. Eric Bailey. "We believe the performance and convenience of our portable CT scanner will make a positive contribution to the quality of healthcare throughout China."
Final approval of the CereTom Portable CT to the Chinese standard included several key components. The device was required to pass safety testing by an independent Chinese testing laboratory, including review of submitted safety data regarding the scanner's history of performance. In addition, NeuroLogica's design and manufacturing systems had to demonstrate compliance with the rigorous ISO 13485 international quality system requirements for medical devices and the FDA's Quality System Regulations.
NeuroLogica's products are CE-marked for distribution in Europe.
Canadian distributor for Havel's U/S needles
Havel's (Cincinnati), a distributor of needle devices, has partnered with Canadian Hospital Specialties (CHS), which will become the exclusive distributor of Havel's EchoStim and EchoBlock ultrasound needles throughout Canada.
CHS is a supplier of regional anesthesia products to healthcare facilities and clinics across Canada. Scott Lees, vice president, sales and marketing, said, "The EchoStim and EchoBlock needles provide best-in-class technology to our customers in the rapidly expanding ultrasound-guided regional anesthesia market. We are [pleased] to be the exclusive representative of these products in Canada."
The EchoStim and EchoBlock needles both feature corner cube reflectors, providing multiple angled surfaces near the tip for maximum reflection even at steep injection angles. The EchoStim needle can be used with or without ultrasound guidance. The EchoBlock needle has fixed injection tubing, and is used under ultrasound guidance by those no longer using nerve stimulators.