Print
Email
Print Edition Stories
Stuart Garfield
Friday, March 13, 2009
Inside Medical Devices
Smaller medical device manufacturers find niche in add-ons
By Lucy Caldwell-Stair, Special to Mass High Tech
MHT's Galen Moore: Charities score with online fundraising
MHT managing editor Rodney Brown on NECN: 22 tech companies give back to community
Rodney Brown on NECN: Hacking into medical devices
Medical devices that are placed in the body may be wondrous inventions, but they can also trigger life-threatening infections. Adding urgency to the problem are new insurance reimbursement rules that penalize hospitals for preventable hospital-acquired infections.
Small medical device companies are responding to this potential market opportunity by using new types of antimicrobials for coatings, polymers and freestanding devices. These new materials repel the bacteria that are attracted to catheters, wounds and cardiac lines. They also eradicate dangerous or persistent infections in other parts of the body. It’s one example of how small companies in the medical device sector are carving out new markets by providing enhancements to offerings by the industry giants.
To build the new products, material scientists use silver ions or laser light to kill infection-causing bacteria. These devices do a better job of killing bacteria than antibiotic drugs because the bacteria don’t seem to know how to evolve resistance against them, according to experts.
The market is significant. A 2006 Frost and Sullivan study estimated the U.S. market for antimicrobial coatings for medical devices as well as for other sectors will be $558.7 million by 2012.
But with their hands full developing the devices in the first place, it’s no surprise that device companies turn to smaller players for product enhancement, said Jeffrey Trogolo, chief technology officer of Agion Technologies Inc., a 20-person, privately held company in Wakefield.
“Medical device companies go outside for biocompatible polymers, for drug eluding stents and for drugs themselves, while focusing on designing the devices themselves,” he said.
Agion has patented a silver-based antimicrobial polymer that is used in a number of medical devices. One of its first products is a catheter that has been on the market for five years. Its material is embedded with Agion’s zenolite carriers, which store silver ions and release them when the device is near moisture, an indicator that bacteria are nearby.
“Silver is all the same, but it’s the delivery that’s the challenge.” said Trogolo.
Agion has numerous partners — acentral venous catheters with Vygon Corp., spinal implants with Diffusion Technologies Inc., pain management catheters with Stryker Corp., and needleless connectors with Medegen Inc.
More products are planned for orthopedics, wound care, endoscopy and catheters. Each product requires a customized coating, and all products have an indwelling life span of seven to 30 days.
“We put material in at different loadings and grades to make the antimicrobial effect stronger or longer-lasting,” said Trogolo.
Another company developing anti microbials is AdvanSource Biomaterials Corp. in Wilmington.
Like Agion and other companies, the firm uses silver, but its process is unique, according to CEO Michael Adams, whose 18-person, public company reported sales of $2.5 million for nine months ending in December 2008.
“We process and produce an antimicrobial polymer very differently from anybody else,” he said in an investor update last month. “The result is a medical device that is completely anti microbial, in and out.”
Silver ions are trapped in a biodegradable glass that is incorporated in the manufacture of the polymer itself, said Andrew Reed, vice president of science and technology.
“Other folks who process antimicrobials do a blend or coating. What happens then is you have voids in the polymer which are not covered or a coating that may wear off,” Adams said.
Its long-lasting antimicrobial may be useful for implantable orthopedic materials and other permanent devices.
“The very uniform dispersion of silver leads to a prolonged life or use. We can go out months,” said Reed.
Nomir Technologies Inc. in Waltham has responded to hospital demand for treating pre-surgical patients who are Methicillin-resistant Staphylococcus aureus carriers with a photo-inactivation device designed to greatly reduce these common drug-resistant bacteria.
“We use photons to affect bacterial and fungal cells using two wavelengths of near-infrared light,” said CEO Richard Burtt.
Nomir has filed a series of patents on its photo-damaging systems and plans a portfolio of applications — root canals, diabetic foot ulcers, nasal bacteria. Its first produce will treat toenail fungus.
“The standup laser devices runs for six minutes and can treat four toes at a time,” said Burtt.
“We can harness this lethal power at energy fields low enough for safe human therapy,” he said. Bacteria and fungi can’t develop resistance to this damage, as they can with antibiotic drugs, he said.
To build a sales force, Nomir is planning a Series B round of venture capital in the second quarter of this year, and the company will file for U.S. Food and Drug Administration approval this spring, said Burtt.
Also in the pipeline is a device for diabetic foot ulcers that reduces, if not eradicates, the bioburden in the foot.
“We believe we can eliminate bacteria, reduce inflammation, stimulate granulation to help the body with the process of healing and avoid amputation.” Burtt said.
Lucy Caldwell-Stair is a freelance writer in Newton.
Comments
If you are commenting using a Facebook account, your profile information may be displayed with your comment depending on your privacy settings. By leaving the 'Post to Facebook' box selected, your comment will be published to your Facebook profile in addition to the space below.
RSS Feeds
