Archives for July 2007
HemCon Dental Dressing Receives CE Mark
HemCon Medical Technologies, of Portland, OR, has received clearance to sell its Dental Dressing in Europe, satisfying the international demand that’s been present since the product became available last year in the U.S. Armed with the CE Mark, the company will begin distributing dressings in the U.K., Germany and other EU countries.
The HemCon Dental Dressing is designed to be used by oral surgeons and dentists following tooth extractions and other oral procedures; it has also been used successfully to treat oral trauma. This dressing uses the same materials and technology as HemCon’s bandages, which are used by the military to control severe bleeding on the battlefield. Earlier this month, HemCon signed a deal with Cardinal Health to expand the use of its bandages into hospitals and surgery centers.
The Dental Dressing measures 10mm x 12mm and, when placed in an extraction socket, adheres
Chembio Teams Up with Pall Corporation
Chembio Diagnostics, of Medford, NY, has signed an R&D deal with Pall Corporation for use of Chembio’s new Dual Path Platform (DPP) immunoassay. The collaboration will involve a two-phase funded feasibility study to determine certain performance characteristics of DPP when used in conjunction with certain markers that are of interest to East Hills, NY-based Pall.
The companies did not specify the application for which Pall is conducting tests. But in the medical arena, Pall, a filtration and purification company, is involved in such things as cell separation technology, platelet-transfusion safety and developing influenza breathing filters, among others.
Chembio’s DPP is a lateral flow technology that employs separate membrane strips for sample migration and test reagents. The design allows for complete control and management of the sample flow, and as a result, the immunological reaction is much more efficient than conventional single path
New Cerebral-Aneurysm Device Cleared in Europe
ev3, a Plymouth, MN-based endovascular device firm, has received CE Mark approval for a new product that treats cerebral aneurysm. The Axium Detachable Coil System was approved for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Coiling procedures involve the delivery of platinum coils to the aneurysm via a small microcatheter. While still maintaining normal blood flow, the coils are threaded through the catheter into the aneurysm until the ballooned area is completely filled.
Using coiling to treat cerebral aneurysms is not new, but ev3, whose name stands for the three endovascular markets it occupies — peripheral vascular, cardiovascular and neurovascular — says its device was crafted with a neurosurgeon’s “wish list” in mind. The company says Axium boasts the following benefits:
–A high degree of coil conformability, which facilitates the physician’s goal of
Breast-Cancer Detection Firm Seeks Series C Funding
Infrared Sciences, a Stony Brook, NY-based company focused on early breast-cancer detection, is seeking $5 million in fourth-round financing, to further advance its Sentinel BreastScan technology.
Unlike mammography, ultrasound or MRI, which detect anatomical features such as a mass, the Sentinel BreastScan uses infrared technology to identify physiological features of the breast tissue — areas of blood perfusion and angiogenesis, when abnormal cells begin forming their own blood supply, as well as temperature signs — that are often present at the earliest stages of cancer. Studies have shown that angiogenesis can start 10-12 years before a cancerous lesion is large enough to be detected by conventional technologies.
A Sentinel BreastScan procedure takes about 10 minutes and does not involve any compression or touching of the breast. The patient sits in a chair disrobed from the waist up, with her arms on the
New England Aesthetic Startups Attract Venture Capital
A number of aesthetic startups from Boston and its surrounding areas may be hitting the scene at precisely the right time. That’s according to the latest edition of “Innovation Economy,” a new Boston Globe column about entrepreneurship, which says that financially able baby boomers and a lack of interest among large pharmaceutical and biotech companies are making the aesthetic market an opportune place to be — and venture capitalists are taking notice.
The paper reports that by 2010, the U.S. market for aesthetic devices and therapies will reach $4.2 billion, up from $2 billion in 2005.
“Millions of dollars in venture capital funding are flowing into the sector dubbed ‘aesthetic medicine,’” reports the Globe, “puffing up local startups like a shot of collagen injected into a pair of lips.”
Among the puffed up is Follica, a Boston-based company that’s researching how stem cells can be
BioForce Nanosciences Backed by NIH Grant
BioForce Nanosciences, a nanotech company based in Ames, IA, has received the second half of a $400,000 grant from the National Institutes of Health (NIH).
The funding will be used to develop and test BioForce’s Chip-on-a-Tip technology, a nanobiosensor capable of detecting protein biomarkers from just a few cells. It’s designed to provide fast analysis of minute protein samples, such as those studied in forensics or biopsy microsamples. The longterm, healthcare goal is to use Chip-on-a-Tip for early detection of cancer and other diseases, with a significant reduction in patient discomfort.
“This concept creates a test so small that it can be brought directly to the sample origin, for example a cell, eliminating the difficulties associated with transporting extremely small quantities of sample extracts to a remote test site,” said BioForce CEO Eric Henderson, in a press release. “The technology has the
Plexus Biomedical Raises $2 Million
Plexus Biomedical, a small device company based in Oakland, TN, has raised $2 million from individual investors, according to an exclusive report by TechJournal South.
The company’s CEO, David Burton, was tight lipped about Plexus’ technology, but research by TechJournal on clinicaltrials.gov uncovered a study by Plexus Biomedical and the University of Tennessee Health Science Center of the HEM-AVERT Perianal Stablizer, a device designed to reduce the occurrence or severity of hemorrhoids during childbirth.
According to clinicaltrials.gov, the HEM-AVERT Perianal Stablizer “is both non-invasive and poses a non-significant risk. It is classified as a manual, general instrument with no specific indications, but has a general indication of stabilizing pressure.”
The study description says there is currently no preventative treatment for the 9-34% of vaginal births that cause hemorrhoids. TechJournal says the study has enrolled 300 patients and is scheduled to start this month.
VC Industry Takes Up Reimbursement with Congress
The National Venture Capital Association (NVCA) is meeting with Congress today to make recommendations for more transparent and expedited reimbursement policies for new medical technologies.
The association will be talking with Congress’ House Medical Technology Caucus, about how inefficient reimbursement processes plagued by administrative barriers create an environment in which investors tend to back products with minimal risk and more predictable regulatory pathways — and not necessarily the innovative technologies coming out of emerging companies.
NVCA’s presentation is focused mainly on new technologies that have no precedent for reimbursement. In the interest of streamlining the reimbursement process for the small companies developing these products, the association is calling for an expanded, ombudsman role for the Council on Technology and Innovation, better process descriptions, and more explicit time frames for decisions. NVCA is also recommending that devices cleared for expedited FDA review be
Medivance Hopes D Financing Leads to Profitability
Medivance, a Louisville, CO, company that makes temperature-management devices, has completed a $23 million Series D financing. The money will be used to expand the market for the private company’s Arctic Sun Temperature Management 
System. Increased sales of the product, said CEO Robert Kline in a statement, will provide Medivance with “the means to reach profitability.”
Arctic Sun — a water-based, non-invasive thermoregulatory device that monitors and automatically controls patient temperature within an acceptable range — is FDA 501(k) and CE Mark cleared, and is currently being used in ERs and ICUs worldwide. In November 2006, the product was selected for Frost & Sullivan’s Product Differentiation Innovation Award, and earlier that year, Arctic Sun was recognized as a breakthrough medical technology in The Wall Street Journal’s Technology Innovation Awards.
A growing body of clinical evidence suggests therapeutic cooling may improve patient outcomes
Trans1 Files for IPO
Trans1, a spinal-surgery device company based in Wilmington, NC, has filed to raise up to $80.5 million in an initial public offering of stock. The company, which hopes to be known as “TSON” on the Nasdaq exchange, did not reveal how many shares it would offer or how much it would charge.
Founded in 2000, Trans1 is a 60-person firm that makes surgical devices for treating degenerative disc disease affecting the lower lumbar region of the spine. The company’s AxiaLIF product is a percutaneous access and fusion system that enables lumbar fusion to be performed with complete preservation of the annulus and all paraspinal soft tissue structures. This video shows how it works.
TranS1 is also developing two mobility platforms: a disc replacement and prosthetic disc nucleus, both delivered through the same percutaneous, trans-sacral approach. According to The News & Observer, TranS1 plans to
