MEMS Journal -- The Largest MEMS Publication in the World

Medical MEMS: SQZ Biotech raises $65 million to develop cell therapies

SQZ Biotechnologies (SQZ), a clinical stage cell therapy company developing innovative treatments for multiple therapeutic areas, announced this week the completion of a $65 million Series D preferred stock financing. The round was led by Temasek with participation from another new large, US-based fund as well as additional participation from existing investors, including GV, Illumina Ventures, Invus, JDRF T1D Fund, NanoDimension, and Polaris Partners. The company also announced the expansion of its cellular vaccine platform, currently in trial for oncology, into infectious diseases, and development of a point-of-care system to potentially generate patient product directly at treatment centers.

Sensera's MEMS devices mimic human organs through bioengineering

Sensera is adapting its MEMS technology for new applications in bioengineering. The company's MEMS technology is now being used at Harvard University for the creation of microfluidic devices which mimic the functions of living human organs, including the lung, intestine, kidney, skin, bone marrow and blood-brain barrier. "Sensera is a key partner providing critical microdevice component fabrication, which enables our growing applications in precision medicine and personalized health," said Dr. Richard Novak, Senior Staff Engineer at Harvard University's Wyss Institute for Biologically Inspired Engineering. "These microchips, called "organs-on-chips", offer a potential alternative to traditional animal testing. Each organ-on-chip comprises a polymeric membrane that contains hollow channels lined by living human cells."

Medical MEMS: Biolinq raises $10 million for painless blood glucose sensors

Biolinq announced this week the close of a $10 million Series A financing led by M Ventures, in collaboration with Hikma Ventures. Biolinq is a digital health company with a unique, wirelessly-enabled biosensor patch that is capable of continuously monitoring multiple biomarkers. Grey Sky Venture Partners, Three Leaf Ventures, LifeSci Venture Partners and a group of high-net-worth individuals specialized in the diabetes field are also contributing to the round. Biolinq's first commercial product, a unique minimally-invasive technology, will allow patients with diabetes to continuously monitor their blood glucose without the pain and hassle of traditional continuous glucose monitoring (CGM) systems.

Tronics opens MEMS production facility for healthcare applications

Tronics, a TDK Group company that designs and manufactures nano and microsystems, has announced the opening of a MEMS production facility located in Addison, Texas, near Dallas.  The fab expands Tronics' MEMS development and manufacturing capabilities in North America.  Tronics aims to utilize the full control of its manufacturing assets to provide custom MEMS services tailored for healthcare applications such as diagnostic chips, microfluidics, lab-on-chips, and also suitable for chemical sensors, infrared sensors, and optical grating devices needed in the industrial field.

Tronics rides the medical MEMS wave

According to our research, the MEMS market for medical applications is currently approximately $2.1 billion, and is projected to grow at double digit rates for the next decade.  Since MEMS based motion sensors for consumer applications are rapidly getting commoditized, medical MEMS may represent the most lucrative emerging opportunity for MEMS device designers and manufacturers.  Tronics, a MEMS foundry services provider, is already manufacturing MEMS devices for several key players in the medical industry.  The company says that it has made this market segment a priority and wants to grow its medical business to more than $20 million annually within three to five years.  We recently spoke with Herve Borrel, Tronics’ President of North America.

BioMEMS: navigating the medical device FDA approval process

by David DiPaola
Managing Director, DiPaola Consulting

With major advances in MEMS and nanotechnology and their proliferation into medicine, it is important to have a working knowledge of the critical steps in obtaining U.S. Food and Drug Administration (FDA) approval for commercialization.  An understanding of the core elements and expedited review opportunities for medical devices provides entrepreneurs a key advantage in decision making, development and commercialization for the shortest time to market.

Many MEMS products intended for use with humans are considered medical devices under the FDA approval process. This includes products for diagnostics, monitoring, surgical and therapeutic applications.  For a manufacturer to market or commercially distribute a medical device, it must first comply with the regulatory requirements of the FDA.  The critical steps of this process are outlined in the flow chart below.

ISSYS receives $1.5 million grant for the development of MEMS based pediatric cardiac implants

Integrated Sensing Systems, Inc. (ISSYS) and the University of Michigan announced that they have received a $1.5 million National Institute of Health (NIH) grant titled "Novel Micro-Implant To Measure Intracardiac Pressure In Congenital Heart Patients."  Dr. Martin Bocks, a pediatric cardiologist at the University of Michigan and the project's medical principal investigator, stated that "we are extremely excited to continue working with ISSYS to develop a wireless, implantable pressure sensor for our patients with complex forms of congenital heart disease. This pressure sensing implant has the potential to greatly improve the care we provide to our most complex patients and will provide us with unprecedented opportunities to learn more about their unique physiology."

MEMS and microelectrode technologies for hearing restoration

by John Williamson
Contributing Editor, MEMS Investor Journal

Two common types of hearing loss suffered by millions of people worldwide are sensorineural hearing loss and conductive hearing loss.  The former is caused primarily by damage to the cochlea, the snail-shell like structure of the inner ear containing hair cells, the movement of which is interpreted by the brain as sound.   On the other hand, conductive hearing loss relates to problems with conducting sound waves along the route between the outer ear to the middle ear, and may occur along with sensorineural hearing loss.  This article examines MEMS based approaches to improving the ability to hear.

Bio-Rad acquires QuantaLife's microfluidic technology for $162 million

Bio-Rad Laboratories, a manufacturer and distributor of life science research and clinical diagnostics products, announced this week that it has acquired QuantaLife, a microfluidic technology startup, for $162 million in cash plus potential future milestone payments.  QuantaLife raised $17.2 million in venture capital financing in December 2010.

PerkinElmer to acquire microfluidics company Caliper for $600 million

PerkinElmer, a global biomedical company, announced this week that it has signed a definitive agreement to acquire Caliper Life Sciences, a Hopkinton, Massachusetts-based firm that specializes in microfluidic technologies for life sciences research, diagnostics and environmental markets, for a total net purchase price of approximately $600 million in cash.  The total purchase price represents a premium of 42% for Caliper Life Sciences shareholders.  "The acquisition of Caliper Life Sciences brings innovative molecular imaging and detection technologies to our portfolio, complementing our world-leading offerings in life science, diagnostics, environmental and food markets," said PerkinElmer's CEO Robert F. Friel.