Archives for October 2007
MRI to Lead Growth in Medical-Imaging Market
The U.S. medical-imaging market — including ultrasound, magnetic resonance imaging (MRI), radiography and mammography, and computed tomography (CT) — will be worth an estimated $11.4 billion by 2012, according to a new report by BCC Research, Medical Imaging: Equipment and Related Products.
CT currently accounts for the largest share of the market — worth an estimated $2.3 billion in 2007 — and is predicted to top $3.2 billion by 2012.
But MRI scanners, now with the second-most market share, are the fastest-growing segment, with a projected CAGR of 9.8 percent. Currently valued at over $1.8 billion, the MRI scanner market is expected to exceed $2.8 billion in 2012.
The third-largest segment, ultrasound equipment, is currently valued at $1.6 billion and is expected to grow with a CAGR of 6.9 percent to $2.3 billion in 2012.
Radiography and mammography equipment also is expected to experience
Minneapolis Firm Raises $11.8M for Lymphedema System
Tactile Systems Technology, a Minneapolis, MN, company whose technology treats vascular disorders such as lymphedema, has raised $11.8 million. The financing, led by Galen Partners of Stamford, CT, will be used to increase sales of the company’s lead product, Flexitouch, within the lymphedema market, and to expand into the chronic-wound space.
The Flexitouch system consists of a programmable controller that attaches to segmented garments covering the limb, trunk and chest. Therapy is delivered through chambers in the garments that inflate and deflate sequentially, simulating manual lymphatic drainage. This at-home therapy usually follows manual lymphatic therapy provided by therapists in clinical settings. Tactile received FDA approval for Flexitouch for lymphatic drainage in 2002 and more recently for the treatment of wounds.
“This funding will enable us to accelerate our growth in the market and provide important therapy to the increasing number of patients
New Cervical-Cancer Test Cleared in Europe
Diamics, a Novato, CA, diagnostics company, has received CE Mark approval for a molecular-based cervical cancer-screening tool designed to improve the effectiveness of traditional testing methods.
The Pap-Map System — which uses Diamics’ FDA-approved CerCol Cervical Cancer Collection System, for collecting cellular and fractional histological material from the entire cervix with a single, soft-tipped device — provides a “map” of collected cervical material. The system helps guide physicians’ diagnoses and decisions about subsequent colposcopy and biopsy procedures.
Diamics says the system delivers more accurate, localized and definitive information than that provided by traditional screening methods. The company claims it reduces overall cervical cancer-screening and diagnostic costs as well.
Cancer of the cervix is the second most commonly diagnosed cancer in women worldwide. Approximately 500,000 new cases are diagnosed each year, 80 percent of which occur in developing countries. It is estimated that of
CNS Amends Trial for Treatment-Resistant Depression
CNS Response, a Costa Mesa, CA, company whose database-analysis technology helps guides psychiatrists toward appropriate treatments for mentally ill patients, is amending the design of its ongoing trial for treatment-resistant depression.
The changes — unblinding the treating physicians, using a new treatment algorithm as a comparative measure for CNS’s technology, and modifying the inclusion criteria of the trial subjects — follow a quality assurance analysis performed by CNS executives, the company’s scientific advisory board and its regional medical directors, specific trial site medical leadership, and the clinical study management team.
CNS’s system, known as rEEG (for referenced electroencephalogram) utilizes EEG in conjunction with a normative database and a clinical database to identify abnormal patient physiology. Appropriate medications are then statistically selected to normalize discovered abnormalities.
The current nationwide study was designed to examine the efficacy of rEEG-guided pharmacotherapy in comparison to generally accepted
Innovention Attracts $115K for Robotic Surgical Probe
Innovention Technologies, a Pittsburgh, PA, spin-out from Carnegie Mellon University, has received $115,000 to further development of a new robotic surgical probe designed to alleviate limitations of endoscopic devices currently on the market.
The money — from The Pittsburgh Life Sciences Greenhouse (PLSG), an organization founded in 2001 to grow southwestern Pennsylvania’s life sciences industry — comes as Innovention is preparing to enter human clinical trials for its first product.
HARP, which stands for highly-articulated robotic probe, is a teleoperatively maneuverable device. Once entered through a natural orifice or small incision, HARP steers around organs to reach anatomical targets not normally accessible by conventional endoscopic tools.
HARP’s mechanical features include its ability to alternate between being rigid and flexible, and “remember” its previous configurations. This allows the device to reach very small cavities within the body and remain in a desired shape and
VisEn Raises $7M for In Vivo Imaging Technology
VisEn Medical, a Woburn, MA, company using imaging technology to develop real-time molecular mapping of disease states, has raised $7 million in a Series B round.
The financing, co-led by new investor Merck Capital Ventures and Flagship Ventures, will be used to expand sales, marketing and customer support programs, and further advance development of the company’s fluorescent in vivo technology in clinical imaging and other applications.
“We look for companies with strong management and proven technology platforms,” said Per Lofberg, Merck Capital Ventures’ CEO, who was named to VisEn’s board in conjunction with the financing. “VisEn Medical exemplifies these qualities and has already established a clear leadership position in fluorescence in vivo imaging, a field of growing importance in the pharmaceutical and healthcare industries.”
VisEn’s FMT System and Optical Probe Portfolio harness fluorescent technology in vivo by providing quantifiable molecular reporting in a range of diseases
FDA Grants 501(k) Clearance to ‘Smart’ Oxygen Device
Inspired Technologies, a North Huntingdon, PA, company that makes respiratory devices, has received 510(k) clearance for its VIAspire Oxygen Portable product. The device, part of Inspired’s VIAspire Personal Oxygen System, provides a ready supply of liquid oxygen for patients requiring oxygen therapy, such as those with Chronic Obstructive Pulmonary Disease (COPD).
The VIAspire Oxygen Portable features Inspired’s SmartDose technology, a proprietary algorithm that responds to patient‘s breath rates. The technology delivers more oxygen when the patient needs it most, supporting optimal oxygen saturation levels and thus promoting activity.
Last month, another component of the VIAspire Personal Oxygen System, the VIAspire Liquefier, received FDA 510(k) clearance. The Liquefier creates liquid oxygen in the home from the patient’s oxygen concentrator. The Oxygen Portable docks to the Liquefier, allowing it to fill faster and last longer than transfilled gas portables on the market.
“Unlike other systems that focus on oxygen
Regulatory Milestones Inch Stent Stapler Closer to Launch
Lombard Medical Technologies, a London-based company that makes cardiovascular devices and polymer coatings, has received two regulatory approvals that move the 
company’s stent graft fixation product closer to launch.
The approvals — a CE Mark and conditional IDE — are for EndoRefix, a device that provides fixation of endovascular stent grafts that treat abdominal aortic aneurysms. In certain anatomies, stent grafts have a tendency to migrate, which can cause endoleaks. EndoRefix delivers percutaneously tiny fasteners (staples), which are pushed through both the walls of the stent graft and aorta to keep the graft in place.
The CE Mark is for the reconfiguration of EndoRefix, to incorporate a new coating to the clip cartridge catheter, which improves the controllability and performance.
The conditional IDE approval allows Lombard to begin patient treatment enrollment at investigational centers that have obtained their IRB approval of the protocol
HemCon Ranked on Deloitte 2007 Fast 500
HemCon Medical Technologies, a wound-care company from Portland, OR, was ranked number 42 on Deloitte’s 2007 Technology Fast 500 list. The announcement comes on the heels of HemCon’s rank as 219 on Inc. magazine’s 26th annual list of America’s 500 fastest-growing private companies. Now in its 13th year, the Deloitte program recognizes the fastest growing technology, media, telecommunications and life sciences companies in North America. Deloitte ranked companies based on fiscal year revenue growth from 2002–2006, a period when HemCon’s revenue increased by more than 4,000 percent.
Using Chitosan, an extract from shrimp shells, HemCon Bandages control moderate to severe external bleeding within minutes of being applied directly to moderate- or high-pressure, high-flow external bleeds. They aggressively adhere to the site on contact with blood or moisture. This adhesive-like action forms a strong, flexible barrier that seals and stabilizes the wound.
HemCon Bandages,
ReBuilder Invests Heavily in Customer Service
ReBuilder Medical Technologies, a Charles Town, WV, company that manufacturers a device for treating peripheral neuropathy, is making a big investment in customer service. The company is hiring licensed medical professionals to take calls from potential and existing customers.
“In our five years of marketing the ReBuilder System on the Internet and handling call-in inquiries, we found that when a person calls in and can speak one-on-one with a medical professional, the closing ratio increases significantly,” said ReBuilder CEO David Phillips, in a statement.
ReBuilder’s flagship product is the FDA-cleared ReBuilder System, for treating peripheral neuropathy. It’s a portable, battery- powered device that’s non-invasive, has no side effects, and can actually strengthen muscles while increasing blood flow.
Peripheral neuropathy is pain and numbness in the feet and hands that can lead to complete loss of mobility, gangrene, and eventual amputations. According to ReBuilder,
