MASSDEVICE ON CALL — Topera Medical, a once-stealthy medical device start-up formerly based in San Diego, hired a former Boston Scientific Corp. (NYSE:BSX) vice president and moved clear across the country.
The firm, now based in Lexington, Mass., is looking to commercialize technology developed by Dr. Sanjiv Narayan at the University of California, San Diego. It hired former Boston Scientific VP Edward Kerslake to be its CEO in December 2010, according to Xconomy.
Kerslake told Xconomy’s Ryan McBride that the company raised a small, undisclosed amount of Series A financing recently, from a group of individuals including veteran medical technology executives. Additional tranches in the round could come later this year, according to McBride.
The Topera technology, although closely guarded until an unveiling in May at the annual Heart Rhythm Society meeting, is apparently designed to detect electrical signals in the heart via catheter, then use software to analyze the signals to create a 3D, electro-physiological "map" of the heart. The aim is to help diagnose and treat atrial fibrillation and atrial flutter, which cause abnormal electrical flows in the heart muscle.
As McBride notes, systems made by St. Jude Medical (NYSE:STJ) and Biosense Webster, a Johnson & Johnson (NYSE:JNJ) subsidiary, can already deliver 3D heart maps, and Burlington, Mass.-based Rhythmia Medical is working to improve the speed and resolution of such tools.
FDA recalls Gen-Probe strep, tuberculosis tests
The FDA issued a Class I recall for three tests made by Gen-Probe Inc. (NSDQ:GPRO) because the kits may contain partially empty or empty solution tubes.
“Possible false-negative results may occur. This may cause serious adverse consequences and/or death,” according to an FDA press release.
The recall affects Gen-Probe’s AccuProbe Group B streptococcus test (model 2820, lots 554077, 551345, 556007, 556185, 555368, 554864, 556421, 555167, 555096, 555166, 556184 and 554524), the AccuProbe mycobacterium avium complex test (model 2860, lots 554628, 555170 and 556204) and the AccuProbe mycobacterium tuberculosis test (model 2835, lot 555767).
Gen-Probe is recommending that customers discontinue using the affected kits.
"For customers who used these batches and obtained negative results, the firm recommends that the referring physician be notified about the possibility of a false negative result. Customers will receive a customer response rorm to complete," according to the FDA release. "The company requested customers to separate the affected kits from other kits in their inventory that were listed on the customer response form."
Separated kits are to be documented and destroyed by customers.
GE Healthcare plans to expand in India
General Electric Co.’s (NYSE:GE) GE Healthcare unit plans to literally redouble its research & development efforts in India, doubling the number of engineers there over the next two years.
CEO John Dineen said the company will add 1,000 engineers to its R&D facility in Bangalore. GE Healthcare plans to invest $50 million in its Indian operations over the next few years, introducing up to 10 new products a year.
Indian sales are expected to reach $400 million for GE Healthcare’s fiscal 2010, up from $300 million in 2009, with an average growth rate of 30 percent a year until 2015. Dineen said.
Sagentia, Photocure team up for drug/device combo
Photocure ASA, a Norwegian specialty pharmaceutical company, and research & development firm Sagentia are teaming up to create a drug/device combination to treat human papilloma virus.
The Cevira device "delivers a targeted light-activated treatment (also known as photodynamic therapy or PDT) intended to be used to destroy tissue infected by Human Papilloma Virus (HPV) and treat pre-cancerous lesions on the cervix, without damaging healthy tissue," according to a press release.
A Phase II clinical trial of the device is expected to start this spring. The companies call the technology "the first therapeutic treatment that uses advanced LED technology in a self-powered, disposable device which can be deployed inside a body cavity."
"The Cevira device contains a LED light source that in combination with a medicinal product initiates a photochemical reaction in exposed tissue," according to the release." The fully integrated, single-use device is easily administered by a trained gynecologist or colposcopist and is then left in place on the cervix up to 24 hours, during which time the patient is able to leave the hospital and continue with her daily activities, before removing and disposing of the device herself."
Are CT scans more dangerous that nuclear accidents?
Many common medical imaging tests deliver doses of radiation far greater than doses received by populations around nuclear plant accidents like Three Mile Island, Chernobyl and the ongoing crisis in Japan.
Here’s a chart from CurrentMedicine.TV comparing radiation levels from exposure to Chernobyl, TMI and World War II atomic bombs with CT scans and X-rays.
"In addition to the dangerous nature of many medical imaging studies, this category of medical cost has ballooned to become one of the biggest costs to the Medicare/Medicaid and private insurance payers,” according to the blog “MedPAC recently issued another report (PDF) on this problem. These often-unnecessary procedures not only hurt your DNA but also your IRA (and federal deficit).”
Retina Implant to launch U.S. trial for sub-retinal impact
Retina Implant AG plans to launch a trial of its sub-retinal implant for the treatment of retinitis pigmentosa with the Wills Eye Institute in Philadelphia.
The implant has been in clinical trials for more than six years in Germany. Retina Implant plans to expand a second human clinical trial into the U.K. this summer.
Results from the first trial were published in the Proceedings of the Royal Society B last November. The results showed that the implant helped blind people recognize foreign objects and read words.
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