An example of the precision afforded by Misonix ultrasound cutting technologies: an eggshell is cut and the membrane is left intact. In an agreement finalized Tuesday, Aesculap announced it will distribute the FDA-cleared Misonix BoneScalpel, a new ultrasonic bone cutting device for use in orthopedic and neurological applications. The agreement (which sets minimum purchase requirements) gives Aesculap rights to the device in the U.S. and specifies royalty payment for the sale of disposables. Misonix is investigating other international distribution partners. Previously, Misonix had collaborated with Aesculap in the distribution of the company’s Sonastar Ultrasonic Aspirator for neurosurgery. Misonix believes Aesculap…
Author: Global Cancer Consortium
More partnering news, this time from CombiMatrix and Clarient, who will market and sell a genomics-based cancer test called HemeScan. HemeScan was developed by CombiMatrix; the test forecasts the probable outcome of chronic lymphocytic leukemia (CLL) and other cancers at the time of diagnosis. CombiMatrix believes HemeScan could have a “transformative impact” on the clinical stratification of CLL, enabling prognosis at diagnosis and patient-appropriate risk-adapted treatment. HemeScan assays all of the genomic loci for copy number aberrations and incorporates recently-identified genomic markers. The test has been validated by a number of high-profile academic centers. “The HemeScan test has proven to…
Aethlon Medical and Delcath Systems have agreed to jointly research and develop a new filtration cartridge for use in Delcath’s percutaneous hepatic perfusion (“PHP”) system. PHP is a technology designed to isolate and deliver high doses of anti-cancer agents to specific organs, while minimizing harmful drug exposure in the rest of the body. One of the central problems in using chemotherapy to treat cancer is its harmful effect on organ health. Lower dosages of the drug are often used to limit side effects, which may diminish the benefit of the therapy. Delcath has developed a drug delivery system that isolates…
Company eyes large opportunity in treating liver cancer Rockland, MA-based BioSphere Medical reported this week that the Medical Device Department of the People’s Republic of China approved BioSphere’s Embosphere Microspheres for clinical use in treating vascular embolizations, arteriovenous malformations, hypervascularized tumors, and symptomatic uterine fibroids. Approximately 200 million Chinese have health coverage, creating a market opportunity close to that found in the U.S. Notably, the opportunity for hepatocellular carcinoma (HCC or primary liver cancer) treatment represents roughly half of the total worldwide, with an annual incidence of approximately 350,000. The high occurrence of HCC in China is attributed to the…
A new study in The New England Journal of Medicine found that a modest insurance co-pay was enough to deter many older women from getting potentially life-saving mammograms. The study examined 366,475 women between the ages of 65 to 69 enrolled at 174 Medicare managed-care plans. Screening rates were 8.3% lower for women whose plans required a co-payment (versus women whose plans covered the entire cost). Co-pays averaged $20, but ranged from $12.50 to $35. During the four-year study, the number of plans requiring co-pays rose 10%, from three plans in 2001 to 21 in 2004. Mammography has been shown…
Irvington-NY based Electro-Optical Sciences (EOS), developer of The MelaFind System, a handheld imaging device that detects melanomas at an early stage, announced last week that its pivotal trial is over two-thirds complete. Six study sites are currently active, with an additional seventh and final site expected to come online in the coming weeks. MelaFind is a non-invasive, point-of-care instrument that emits various wavelengths of light up to 2.5mm deep into the skin in order to capture images of suspicious pigmented skin lesions. This data is then analyzed against a database of melanomas and benign lesions. As early-stage melanomas often appear…
In February 2003, the FDA’s General and Plastic Surgery Devices Advisory Committee met and discussed thermal ablation of lung tumors. Concerns were raised about the safety and adverse event reporting associated with Radio Frequency ablation (RFA) of lung tumors. Last week, the FDA released a Public Health Notification, specifically warning against lung tumor ablation using RFA. Pointing to several studies, the statement noted, “[The] FDA has received reports of patient deaths associated with lung tumor ablation using RF ablation devices…Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities.”…
High Intensity Focused Ultrasound (HIFU) is competitive with currently accepted non-surgical standards of care, such as radiotherapy, but results in milder side effects, reveals the first long-term study of HIFU for the treatment of localized prostate cancer. In an editorial accompanying the published article, Dr. Vincenzo Ficarra from the University of Padua, Italy said, “These oncologic results can be considered competitive with those reported after radical prostatectomy or external-beam radiation therapy. Beyond the oncologic outcomes, the article by Blana et al confirmed the very promising functional data of HIFU treatments in terms of urinary continence and recovery of erectile function.”…