A Diagnostics & Imaging Week
InfraScan (Philadelphia), a device firm specializing in brain injury diagnostic products, reported receiving the CE mark for the Infrascanner handheld brain hematoma detector. The company said it plans to launch international sales this fall.
The Infrascanner is a small, completely portable device, which can detect the presence and location of a brain hematoma based on differential NIR light absorption of a hematoma and normal brain tissue.
InfraScan will present the results of a pivotal, 400-patient, multi-center study to the FDA later this year to support its 510(k) application and a subsequent U.S. launch of the device.
It said a pilot study with an earlier Infrascanner prototype involving more than 300 patients demonstrated high sensitivity for detecting bleeding in the brain and for rapidly detecting the onset of delayed hematomas.
"Receiving our CE mark represents significant progress toward InfraScan's strategic goal of providing our potentially life-saving technology to patients in some of the world's top established and emerging markets," said President/CEO Baruch Ben Dor, PhD.
He noted that the company had passed a British Standards Institute audit and received ISO 13485:2003 quality certification earlier this year. "This facilitated our obtaining the CE mark for the Infrascanner and allowed us to sign our first distributors in the UK, Spain, Israel, India and Africa," Dor said
Infrascan says the Infrascanner is "the first hand-held device of its kind designed to assist first responders and emergency room personnel in identifying life-threatening brain hematomas, allowing expedient assessment of patients and potentially facilitating crucial treatment."
It added, "Intracranial hematomas resulting from a traumatic brain injury are life-threatening and patient outcomes can improve significantly if treated within an hour after an injury – known as the golden hour.'"
The company noted that, "while most hospitals have a computer-aided tomography scanner, which is viewed as the state-of-the-art technology for diagnosing a brain hematoma, many facilities lack the neurosurgical capabilities to treat the condition."
It said the early identification of a brain hematoma "can play a significant role in facilitating transportation of critically injured patients to facilities, which can both verify Infrascanner's early diagnosis and offer surgical intervention."
An estimated 1.5 million individuals seek medical treatment for head trauma in the U.S. each year, and a total of 10 million individuals seek head trauma treatment annually worldwide, the company said.
In addition to the Infrascanner's first application for detecting brain hematomas, the company will pursue future applications for the product, including the monitoring of stroke victims using the same NIR technology.
InfraScan has received early-stage funding from the Office of Naval Research, BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, Ben Franklin Technology Partners of Southeastern Pennsylvania, and from the Philadelphia Industrial Development Corp.
Nanobiotix receives nanoparticles patent
Nanobiotix (Paris), an emerging nanomedicine company focused on cancer therapy, said the European Patent Office has issued patent No. 1744789 to the company, related to its "novel activable particles that can be used in the health sector."
The patent protects "composite particles that can generate free radicals or heat when excited by X-rays, and to the uses thereof in health, particularly human. The inventive particles comprise an inorganic-based, and optionally organic-based, nucleus and can be activated in vivo, in order to label or alter cells, tissues or organs. [The patent protection] also relates to methods for the production of said particles, and to pharmaceutical or diagnostic compositions containing same."
"We are ... pleased that our platform technology, nanoXray, is now patent-protected throughout the European Union. We are hopeful that we will soon receive similar patent protection in the U.S. as well," said Laurent Levy, president/CEO of Nanobiotix and co-president of the French Technology Platform on Nanomedicine.
He added, "NanoXray is designed to allow the precise destruction of cancer cells via the controlled application of an outside-the-body energy source – a standard X-ray. Of course, protecting this intellectual property is key to long-term commercial success."
"The nanoXray platform allows for the controlled generation of physical reactions in targeted cells when triggered by the application of an external energy source – a standard X-ray. This may have significant ramifications for cancer therapy in the not-too-distant future," added Paras Prasad, PhD, a global authority on nanotechnology who is a co-founder of Nanobiotix and executive director of the Institute for Lasers, Photonics and Biophotonics at State University of New York at Buffalo.
Nanobiotix is an emerging nanomedicine company combining dramatic advances in nanotechnology and molecular biology to develop nanoXray, a technology platform that is expected to be turned "on" and "off" outside the body to selectively treat a variety of cancers noninvasively.
The company said use of nanoXray is intended to resolve radiation therapy's biggest drawback: the destruction of healthy tissue and its subsequent deleterious side effects when a high dose of X-ray is necessary.
It said the core of a nanoXray nanoparticle is an inactive and inert substance – not a drug – that can be activated to locally (intratumor) increase the dose of X-ray, which is then expected to lead to higher efficiency.
After nanoXray nanoparticles accumulate in the target tissues, a standard X-ray is applied that is intended to generate a local therapeutic effect, designed to destroy only the targeted tumor cells.
Distribution accord for Pioneer Surgical
Pioneer Surgical Technology's (Marquette, Michigan) European subsidiary has reported a distribution agreement with Swedish Medical Imaging Devices (Swemacimaging; T by, Sweden).
Under terms of the agreement, Pioneer Surgical Technology (Driebergen, the Netherlands) will distribute Swemacimaging's Biplanar 500e, in Germany, the UK, Italy, Benelux, Switzerland, and Turkey. Formerly a division within the Saab-Scania group, Swemacimaging is now part of the Scanflex Healthcare Group, a developer of medical radiology products.
Pioneer described the Biplanar 500e as "the only mobile biplane digital fluoroscopy system."
"This implication of this partnership is very exciting," said Lex Giltaij, MD, VP Europe & business development. "We can now meet the growing need of our customers for biplanar imaging in the spinal and orthopedic market. The Biplanar 500e allows our customers to work faster, more accurate, safer, and with less radiation exposure."
Lars Johnson, chairman/CEO of Swemacimaging, said, "The Biplanar 500e meets today's highest clinical demands in the surgical environment, is easy to use, yet allows full access to the operating area, with total control at each step of the procedure." He added, "The cooperation with Pioneer Surgical will ... position our company's product in select markets, delivering a highly advanced solution for intra-operative bi-planar imaging."
The Biplanar 500e is a fully mobile system, which Pioneer said is "ideal for a variety of applications where positioning accuracy and ease of use is essential."
Swemacimaging has more than 30 years of experience within the X-ray/orthopedic field and is developing and marketing mobile X-ray TV-systems. The company originally was a division within the Saab-Scania group, and now is part of the Scanflex Healthcare Group, a leading company in the medical radiology field.
Pioneer Surgical Technology's European subsidiary was established in the Netherlands in August 2006 following the introduction of the NuBac disc arthroplasty system in Europe. Pioneer BV carries a full range of Pioneer's spine products and works with distributors in several countries in Europe, including Italy, the UK, Switzerland and the Benelux countries. Pioneer is establishing its own sales team in Germany.