Archives for June 2007
Strong Showing of Healthcare Firms on FSB 100
Fortune Small Business is out with its annual FSB 100, a list of the most successful small public companies in the U.S. Almost a quarter of the list (21 companies) is made up of healthcare-related enterprises. Here’s a look at who made the cut and what makes them worthy:
Palomar Medical Technologies, ranked number 8, is a Burlington, MA-based firm that makes pulsed light and laser systems for aesthetic applications such as permanent hair reduction, leg veins, acne, pigmented lesion removal, wrinkle reduction, vascular treatments and tattoo removal.
Somanetics (13), of Troy, MI, makes the INVOS Cerebral Oximeter, a non-invasive patient monitoring system that continuously measures changes in blood oxygen levels in the brain.
United Therapeutics (22), based in Silver Spring, MD, makes drugs for cardiovascular, cancer and infectious diseases. It also works in telemedicine, through its Medicomp subsidiary. Its FDA-approved heart monitor, CardioPAL SAVI, is
Michigan Firms Band Together to Support Startups
Medical device manufacturers in western Michigan are coming together to support the region’s life sciences startups.
Seven local companies have created the West Michigan Medical Device Consortium, a membership organization designed to assist small firms with product innovation, business collaboration, marketing and lean manufacturing technologies. The effort is backed by the West Michigan Science & Technology Initiative (WMSTI), a four-year-old partnership that was formed to grow and diversify the community economy by supporting the commercialization of science and technology.
“The consortium has the capacity and capability to develop new products from a napkin sketch through to market launch,” said Linda Chamberlain, executive director of WMSTI, in a press release. “It can also provide direct outsourcing manufacturing opportunities for existing products.”
So far, the following west Michigan med tech firms have signed on as members: ATEK Medical, Autocam Medical, Emerald Medical Devices and Supplies,
Pervasis Technology More than a ‘Stentless Stent’
Pervasis Therapeutics, a Cambridge, MA, firm whose endothelial cell technology is shown to reverse vascular dysfunction and disruption, is working on a product that could serve as a viable alternative to controversial drug-eluting stents. But the company’s brass tells Technology Review this week that the product, Vascugel, shouldn’t be thought of as “just a ’stentless stent.’”
Vascugel, as the name suggests, is a gel, which gets wrapped around the artery at the site of angioplasty and then biodegrades after 30-60 days. The gel is made of endothelial cells, which are contained in the inner linings of blood vessels. When placed around the artery, the cells within the gel release biochemical factors that promote healing and prevent restenosis, a narrowing of the blood vessel — and the problem that drug-eluting stents were designed to address. Stent growth, though, has been stymied recently by studies
Against Odds, CryoCor Gets Advisory Panel Nod
Two days after CryoCor got word that FDA was not satisfied with safety and efficacy data for the company’s Cryoablation System, the agency’s advisory panel recommended the device for approval. FDA is not required to follow the advice of its advisors, but it typically does. A final decision by FDA is expected in August.
San Diego-based CryoCor is seeking an approval for atrial flutter, a condition where the upper chambers of the heart beat too fast. Unlike other devices on the market that use heat to treat atrial flutter, the Cryoablation System uses extreme cold to destroy damaged cardiac tissue.
This is CryoCor’s second go-around with trying to gain approval for the Cryoablation System. FDA rejected the company’s application last year, prompting CryoCor to amend and resubmit in November 2006.
North Carolina Firm Puts New Twist on Brachytherapy
CivaTech Oncology, a startup based in Research Triangle Park, NC, that’s developing a device for delivering more consistent radiation to prostate-cancer patients, has raised $800,000 in an oversubscribed private financing.
The funding demonstrates angel investors’ confidence in the firm’s technology, which puts a new twist on brachytherapy. Typically, brachytherapy, a type of radiation treatment for cancer that utilizes implanted radioactive sources to kill tumor cells, surgically implants “seeds.” CivaTech Oncology’s new device will replace these individual seeds with a “radioactive string,” which the company believes should provide more uniform and consistent radiation delivery.
CivaTech is starting with prostate cancer, but its goal is to expand into treating other types of cancer with this form of low-dose-rate brachytherapy. Armed with a U.S. patent for its technology, the company is keeping headcount low while it gathers data for FDA submission. It is turning to
Cytori Forgoes Drugs for Devices
Cytori Therapeutics may be on to something. The San Diego firm is using stem and regenerative cell therapies to develop products for treating cardiovascular disease and performing reconstructive surgery. But unlike so many stem cell companies that are looking to commercialize their technologies through drugs, Cytori is taking a quicker and less grueling route, by bringing its treatment to market in the form of a device, reports TheStreet.com.
The device, cleverly named Celution System, automates a process that releases stem and regenerative cells residing within adipose (fat) tissue. The adipose tissue is taken from 
the patient using a minor liposuction-like procedure, placed into the system and, with the touch of a button, the processing begins. About an hour later, following a tissue wash, cell separation and concentration — also performed by the device — a meaningful dose of stem and regenerative cells may
New Reports Predict Growth for Device Sector
BBC Research is out with a few reports that look at the medical device sector — and make hopeful predictions.
One, “The Global Market for Pain Management Drugs and Devices,” says devices account for only a small sliver of the pain-management pie — $1.87 billion in 2007, compared with $29 billion for pharmaceuticals. Devices, though, are expected to grow at a compound annual growth rate (CAGR) of 6.5% to reach $2.6 billion by 2012. That compares to a CAGR of 5.63% for the entire pain-management sector and 5.6% for pharmaceuticals that address pain. The driver? BBC Research says it’s devices’ lack of side effects and their success at treating pain that is not successfully being addressed by drugs.
A second report, “The Medical Equipment Market in China,” also predicts growth. China sold approximately $9.2 billion worth of medical equipment in 2006, an
CardioDynamics Streamlines ICG Business
CardioDynamics, a San Diego-based company that uses impedance cardiography (ICG) technology to monitor the heart’s ability to deliver blood to the body, has decided to sell its Vermed subsidiary for $8 million.
The move allows CardioDynamics to focus exclusively on its ICG business and BioZ product line. BioZ diagnostics, modules and monitors measure blood as it enters and leaves the heart, and look at changes in impedance to calculate 
hemodynamic parameters. It’s a non-invasive alternative to pulmonary artery catheterization, a costly and time-consuming procedure.
In a press release, CardioDynamics CEO Michael Perry said the cash infusion from selling Vermed will go toward “continued expansion of our sales and clinical application specialist team, further investment in clinical trial research, and investment in core technology improvement.” Long-term, the company is looking to establish its technology as a standard of care for cardiovascular disease. “Our
FDA Gives CryoCor the Cold Shoulder
San Diego-based CryoCor suffered a blow today, when it learned that FDA is yet again unhappy with the company’s pre-market approval application for its Cryoblation System, which uses extreme cold to treat cardiac arrhythmias. The news came two days before CryoCor was scheduled to present clinical data at an FDA advisory panel meeting.
CryoCor is seeking an approval for atrial flutter, a condition where the upper chambers of the heart beat too fast. Unlike other devices on the market that use heat to treat atrial flutter, the Cryoablation System uses extreme cold to destroy damaged cardiac tissue. Watch this video to see how it works. (And read here about another company that recently sunk money into cryoenergy devices.)
As of last week, system’s were a go, with CryoCor issuing a press release to remind investors that the PMA meeting was on track. But on Monday, FDA
Shelhigh Consent Agreement Stops Short of Recall
Shelhigh has agreed to stop distributing its implantable devices, roughly two months after FDA seized products made at the company’s Union, NJ, manufacturing facility. Under a court order signed last Friday, Shelhigh is required to hire independent consultants to inspect its facility and certify to FDA that everything is up to snuff. The order, though, stopped short of demanding a recall.
In April, FDA announced that it had uncovered “significant deficiencies” in Shelhigh’s manufacturing processes, expressing concern about the sterility of its devices, which include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts. The agency seized what it could find at the Union facility, and ordered physicians to consider using alternative devices and to monitor patients already implanted with Shelhigh products.
Two weeks after the seizure, FDA asked Shelhigh to voluntarily recall its devices, but the company did not
