Archives for November 2007
[Video] Interview with Tom Steinke, CEO and Founder of Minnow Medical
This interview with Tom Steinke of Minnow Medical was filmed back in September at AdvaMed 2007.
Minnow’s first product is designed to treat peripheral artery disease (PAD). It is estimated that 12 million Americans have PAD - a condition that results in limb loss for 150,000 Americans each year.
Through the use of a proprietary process called Guided Re-Shaping Technology, Minnow takes advantage of the differing electromagnetic properties of healthy and atherosclerotic tissue, and targets diseased tissue.
The novel design of the probe allows for pre-treatment diagnosis via a 360° scan of the arterial wall, immediately followed by molecular excitation of atherosclerotic tissue. Plaque shrinks instantly and the artery lumen is opened to increased blood flow. Further lumen opening is expected through the body’s natural recovery process. The procedure is completed within a matter of seconds. The catheter can then be repositioned to another
ATS 3f Enable Aortic Bioprosthesis Shows Early Promise
A total of 47 patients have now undergone aortic valve replacement with ATS Medical’s 3f Enable Aortic Bioprosthesis at seven investigative sites in Europe; eight patients have surpassed the two year implant duration.
In October 2006, ATS completed a $58 million purchase of 3F Therapeutics, a privately held developer of tissue heart valve products. This acquisition opened the door to the $600 million tissue valve market and brought less-invasive surgical technology to ATS – including the valve in question.
The ATS 3f Enable Aortic Bioprosthesis is designed to eliminate the traditional suturing needed to replace a diseased aortic heart valve. If suturing can be eliminated, surgeons can potentially reduce procedure time and offer less invasive treatment alternatives.
Friedrich Eckstein of the University Hospital of Bern stated, “Because we are able to eliminate the suturing and much of the time that normally accompanies aortic valve
[Video] Interview with Joseph Gulfo, President and CEO of Electro-Optical Sciences
We gathered this footage back in September at the Think Equity G5 Growth Conference. In this segment, Gulfo discusses MelaFind - a handheld device that capture images of suspicious pigmented skin lesions. The data is then analyzed against a database of melanomas and benign lesions. The “Lesion Classifier” recommends whether the lesion should be biopsied.
With assistance provided by MelaFind, physicians could diagnose more melanomas at the earliest curable stage, reducing both treatment costs and the number of unnecessary biopsies. Gulfo describes MelaFind as “better, cheaper medicine.”
Electro-Optical Sciences (EOS) initiated a clinical trial back in January and anticipates submitting the PMA to the FDA by the end of 2007; in October 2006, EOS received notification of an Expedited Review designation.
Skin cancer is the most common form of cancer in the U.S., with over one million cases diagnosed each year. It also is
Stock Offering Fuels Inverness’ Thirst for Acquisition
Buoyed by a recent stock offering, the Inverness Medical machine continues to gobble up companies as they consolidate the disease and health management service space.
The most recent acquisition of ParadigmHealth will cost the company $230 million in an all cash deal. Paradigm offers disease management services for the acutely ill, with a focus on newborns and cancer patients. The company, founded in 1991, reported $60 million in revenues over the past twelve months.
Inverness said it is buying the ParadigmHealth as part of an expansion into disease-management services from medical testing and diagnostics.
Inverness has been on a buying spree this past year, having acquired or made substantial investments in: Alere Medical, Biosite, Cholestech, Diamics, HemoSense and Quality Assured Services, Inc., among others.
We’ve followed a number of these deals in the past months including the fierce bidding war with Beckman Coulter that broke out over
Synergetics, Pointing to Pricing Pressure in the Neurosurgery Market, to Introduce New Generator
Synergetics USA has introduced a lower priced, electrosurgical generator with full feature cut and coagulation modes. The new unit is designed to fill the price gap created by its coagulation only unit, COAG, and the up-market Advantage, named DualWave.
The company’s decision was spurred by pricing pressure of competing manufacturers, who have flattened the formerly healthy margins of its premium product line. Synergetics reports that the new product should “dramatically improve sales profit margins”.
Like the DualWave bipolar generator, the new system (which will employ the Malis waveform) is capable of performing the two separate functions of cutting and coagulation. However, the system will not have the improved cutting ability of the DualWave system and will not accept hand-switched bipolar pencils.
“This unit will provide us with selling options, especially when confronted with the price compression that we’ve seen from competitors,” said Gregg D.
Vital Images Expands Partnership with Toshiba Medical Systems
More partnering news, this time from Vital Images, who report they have expanded their partnering agreement with Toshiba Medical Systems to include Toshiba’s newly launched AquilionONE dynamic volume CT scanner.
Toshiba bills the FDA cleared system as the, “most advanced diagnostic imaging computed tomography equipment available”. AquilionONE, slated for a summer launch, will allow physicians to create not only a three-dimensional depiction of an organ, but also characterize that organ’s dynamic blood flow and function. AquilionONE can scan one organ in one rotation - eliminating the need to reconstruct slices from multiple points in time - reducing exam time and radiation exposure.
Vital Images will apply ViTAL - their visualization and analysis software - as part of the worldwide distribution and licensing agreement. The agreement includes, for the first time, penetration into the Japanese market.
Previously, through its partnership with Toshiba, Vital Images
Partnership with GE Healthcare Sends iCAD Shares Soaring
Last week GE Healthcare announced would it would be incorporating iCAD’s SecondLook technology into its line of Senographe Full-Field Digital mammography systems. iCAD shares opened 10% higher on the news; shares have continued to climb to a high of $2.39 today.
SecondLook is a computer aided detection (CAD) technology that helps distinguish cancers from other anomalies in the breast. SecondLook is able to detect up to 72% of actionable missed cancers an average of 15 months earlier. The software integrates seamlessly with DICOM systems - a standard adopted by most medical digital imaging device manufacturers. iCAD will develop a customized version of iCAD’s SecondLook for GE.
GE hopes the partnership will enhance the overall clinical performance of Senographe and Seno Advantage systems – by improving sensitivity to breast cancer imaging, enhancing usability and workflow and by providing diagnostic support tools to radiologists.
“In an effort
EndoBarrier: An Endoscopic Alternative to Gastric Bypass
With 3000 calories and 229 grams of fat in the average Thanksgiving Day meal (just the meal itself!) – the morbidly obese may soon be looking for options to assuage their post-holiday guilt – while bettering their chances of long term survival.
According to the American Society for Bariatric Surgery, doctors perform 140,000 gastric bypass surgeries in the United States each year. The most common types are Roux-en-Y gastric bypass and Laparoscopic Adjustable Gastric Banding.
About 1% of patients who are candidates for gastric bypass surgery actually have the procedure. Mortality risk is the major deterrent to broader use of the Roux-en-Y; although the estimated 1% rate is far lower than the perceived 10% mortality reported by patients and some physicians.
While all surgeries carry some risks, certain factors put patients in a high risk category for gastric bypass. According to a Duke University
More Good News from Aethlon, Hemopurifier Reverses Immune Suppression in Cancer Patients
Aethlon’s prospects seem to be growing brighter by the minute. Last week I reported that the company had initiated a research collaboration to study the in vitro effectiveness of clearing HIV from blood. This Monday, Aethlon announced that researchers have documented Hemopurifier’s ability to remove the immunosuppressive activity normally found in the fluid of cancer patients.
In studies led by Dr. Douglas Taylor at the University of Louisville, Hemopurifier captured tumor secreted exosomes that inhibit the immune system’s ability to combat cancer.
Exosomes are released by solid tumors, lymphomas, and leukemia. They induce T-cell apoptosis (programmed cell death), and block T-cell signaling, proliferation, and cytokine production. High concentrations of circulating exosomes correlate with reduced T-cell production and tumor progression in cancer patients. The ability to reduce the presence of circulating exosomes can reverse immune suppression and increase patient responsiveness to both immunotherapy and chemotherapy.
In the
Kensey Nash Delivers OsseoFit, Further Strengthening its Biomaterials Division
Kensey Nash announced the first commercial shipment of its OsseoFit Porous Tissue Matrix to Biomet Sports Medicine, the sports medicine subsidiary of Biomet Inc. The event triggers a milestone payment, which had been planned for the current quarter.
In January 2007, Kensey and Biomet signed an exclusive marketing and distribution agreement for OsseoFit. Under the agreement, Kensey will manufacture and Biomet will market and distribute the product.
OsseoFit Porous Tissue Matrix is an implant manufactured using Kensey’s proprietary Porous Tissue Matrix technology, which creates foamed scaffolds suited for tissue engineering applications. OsseoFit utilizes several resorbable biomaterials including a proprietary collagen formulation, synthetic polymers and ceramics.
“Meeting this milestone is an important accomplishment in achieving full commercialization of this novel product and technology, and we are pleased to have completed this as planned,” said Joseph W. Kaufmann, President and CEO of Kensey Nash. The product kit
