The emergence and growth of the medical technology industry is one of the most creative and promising new markets worldwide, especially in the field of early screening and diagnostic tools. By making these tools available to doctors at the point-of-care when seeing patients, it could have a profound impact on public health and safety. Market and Markets projects that the global molecular diagnostics market will reach $10.12 billion by 2021, growing at a compound annual growth rate of 9.1% and new technology will be a key part of this surge. It is actually the rise of early-detection diagnostic devices that might have the biggest impact on saving lives in the future. With technology that is non-invasive and handheld, Breathtec Biomedical (BTH:CNX)(BTHCF) is a true innovator in this critical space.
Breathtec Joins Battle Against Zika
Breathtec recently announced a strategic partnership with ZeptoMetrix Corporation, an industry leader for Infectious Disease Diagnostic Development, to study identifiable biomarkers associated with the Zika virus. Breathtec CEO, Guy LaTorre, commented, “Over the past six months, we have been working diligently on our flagship handheld prototype to prepare for clinical trials later this year. This strategic relationship with ZMC will enable us to achieve two objectives: first, to add additional disease biomarkers so that our device sensitivity can be fine-tuned to further eliminate false-positives, and second, to address a serious threat to public health where there is no active vaccine or medication.”
“Our extensive experience and expertise in propagation and purification of infectious disease cultures will be a tremendous asset in this relationship,” explained Dr. Gregory R. Chiklis, President and CEO of ZeptoMetrix Corporation. “I am excited and pleased in what both ZeptoMetrix(TM) and Breathtec are committed to bringing to this alliance in order to help provide patients with proper results.”
Bringing the FAIMS Technology to Market
Breathtec’s flagship handheld device is a breath analyzer that uses High-Field Asymmetric Waveform Ion Mobility Spectrometry (FAIMS) to enhance diagnostic screening in the doctor’s office and at the Point of Care level. The device works by analyzing molecules in the patient’s breath that inhabit their respiratory tract, as well as molecules that have diffused out of the blood and into their breath. Unlike mass spectrometry and other molecular separations and filter devices, FAIMS is conducive for miniaturization and with development could function as a standalone portable screening device.
“During the design process, we learned a lot about addressing the types of challenges that are required to get a technique like FAIMS from the benchtop to a handheld device,” LaTorre told Equities. “That includes how we optimize the design and components to achieve that high degree of sensitivity and reproducibility required for clinical use. But we’ve also learned a lot about the miniaturization process and have been able to miniaturize the electronic components as well as the FAIMS cells that we use to allow for us to make a truly portable device. We have made some major advances in our new V2 prototype verses our earlier V1 prototype, including reducing its size by more than tenfold.”
Breathtec continues to make progress in its regulatory timeline and has provided important updates this year. At Pittcon, a leading laboratory science showcase, Breathtec’s Chief Technology Officer, Dr. Michael Costanzo, announced that the company’s initial area of study for the FAIMS device will concentrate on respiratory disease and infection. Prominent applications include viral vs. bacterial infection, hospital-borne infections, and communicable diseases.
“We are pleased with the progress our team has made over the past six months since our last public presentation on this work and are encouraged by the advancement of the design and the device’s capabilities,” said Dr. Costanzo. “The continued development and foreseeable clinical benefit of a portable screening device has garnered overwhelmingly positive feedback from our peers and practitioners in the health care community.”
Breathtec also announced an additional member to the management team. Alfred Wong will be joining as VP of Corporate Development and Communications. Mr. Wong has experience in building multiple start-ups to successful commercialization/exits across multiple industries.
Equities.com reached out to Mr. Wong for a comment:
“I am very excited to join the Breathtec team and to be working alongside Guy and Michael, who have extensive experience in the medical technology field. I hope that my experience in business development and mergers & acquisitions to generate greater shareholder value.
But my motive for joining Breathtec is a very personal one. My youngest son had a fever when he was only 10 days old. He was prescribed the whole spectrum of antibiotics at a high-dosage because the risk of waiting for test results before treating could be catastrophic. It was a heart-wrenching experience as a parent wondering what the future side-effects may be. Breathtec’s early-screening capability, could fundamentally change how doctors manage the treatments for their patients. With accurate information at the point-of-care, doctors can make a better assessment of the risks and benefits for each type of treatment.”
With a unique diagnostic analyzer that will soon be ready for clinical trials, Breathtec is positioning itself well in a medtech sector that is predicted to grow over the next five years. The company’s market is certainly full of upsides, but, most importantly, the technology itself could be essential to saving lives and sparking new possibilities in patient care and quality of life.