Biotech focus

Pressure BioSciences Ramps Up Commercialization of Next-Generation Instrument with CE Marking

The life sciences industry has rapidly evolved over the past decade. For example, newly developed proteomic and genomic analysis techniques have helped researchers improve the detection, treatment, and prevention of cancers and other serious diseases. New programs, such as the Cancer Moonshot Initiative, are designed to invest in these new technologies to accelerate the research and development of new treatment options for patients, as well as new preventive strategies.

Pressure BioSciences, Inc.’s (OTCQB: PBIO) patented Pressure Cycling Technology (PCT) enables researchers to better understand the bio-molecular interactions that underpin these new techniques within the $6 billion life sciences industry.

Pressure Bio Launches Barocycler 2320EXT

Sample preparation is a complex, time-consuming, and error-prone process that is widely used in the life sciences industry. Traditional sample preparation involves breaking cells using mechanical means to extract lipids, proteins, nucleic acids, or other components, but the process can unfortunately end up modifying, damaging or destroying the biomolecules that scientists are trying to release from the cell for their investigational studies.

Pressure Bio’s Pressure Cycling Technology improves upon the sample preparation process by subjecting cells to alternating cycles of hydrostatic pressure between ambient and high/ultra levels. This enables researchers to quickly, safely, and reproducibly control the cell lysis (breakage) process by effectively squeezing out important cellular components with minimal or no damage whatsoever - like squeezing things out of a sponge.

Pressure Bio recently launched the Barocycler 2320EXTREME - the first major update of its flagship PCT-based sample preparation instrument in years. This release followed years of extensive user feedback. The compact, benchtop instrument offers many features and benefits not found in its predecessor, including data logging options, user-level security, computer-operated control with touch screen programming, and the ability to customize multiple pressure cycling parameters. These new features and benefits could greatly expand the universe of potential users worldwide.

These features have already positioned the new product as an instrument of choice for life science key opinion leaders around the world when preparing protein samples for analysis. For example, Professor Ruedi Aebersold, a world-renowned protein chemist and Director of the Institute of Molecular Systems Biology in Zurich, Switzerland, who has become a leading proponent of the PCT technology, has used it extensively in his own research and one was of the company’s first clients to switch to the new Barocycler 2320EXT.

CE Mark Opens Door to European Sales

Pressure Bio recently announced that it secured a CE Marking for the Barocycler 2320EXT - a key milestone that enables it to sell the device throughout the entire European Economic Area, which includes 31 countries. Since 1985, the CE Mark has been required for products in 24 different categories sold within the European Economic Area, with each product falling under various directives that determine specific requirements designed to meet safety, health, and/or environmental requirements.

“Achievement of CE Marking for the Barocycler 2320EXT is an important next step in our commercialization plans for this powerful and enabling sample preparation instrument, especially since CE Marking is required prior to selling the Barocycler 2320EXT to the large and potentially lucrative biopharmaceutical market in Europe,” said Dr. Nate Lawrence, VP of Marketing & Sales for Pressure Bio.

The company recently signed agreements with several distribution partners throughout Europe that could open the door to near-term revenue. In addition, the company is entering the second year of its co-marketing agreement with SCIEX - a global provider of lab instrumentation with a large presence in Europe. Many key opinion leaders, like Professor Ruedi Aebersold, have also purchased the product, which has demonstrated its usefulness in advanced research operations.

“We believe we are well prepared for our upcoming, planned launch of the CE Marked Barocycler 2320EXT in Europe,” added Dr. Lawrence. “These are very exciting times for PBI.”

Growing Revenue & Potential Growth

Pressure Bio recently reported third quarter revenue of $535,334, including record product and services revenue that surpassed the half-million dollar mark for the first time ever, at $500,949. Instrument sales also reached a record of $383,789, which is a positive sign given the recurring nature of the consumable test tubes that the instrument requires. While grant revenue fell to $34,386, the company expects this revenue to begin increasing in the fourth quarter and continue to rise into 2017.

In November, the company closed $610,000 in gross proceeds in a $2.5 million private placement with additional closes expected over the near-term. The company also announced that it closed on a $2 million line of credit with an accredited investor on favorable terms. These financings should help the company execute on its business plan and successfully enter the European market with its innovative product.

Finally, the company’s participation in the Cancer Moonshot Initiative through its collaboration with the Children’s Medical Research Institute should raise its visibility within the life sciences industry. CMRI already purchased the first three commercially available Barocycler 2320EXT instruments in June 2016. Management was also invited to present at the gala opening of the ProCan cancer center at CMRI near Sydney, Australia.

Looking Ahead

Pressure BioSciences Inc. (OTCQB: PBIO) is approaching a tipping point in its corporate history with the collaboration with SCIEX, its recent CE Mark, and its publicly stated plan to enhance and expand its current sales and marketing capabilities. With financing in place, the company is well prepared to execute on its growth plans and expand operations as it increases its visibility within the $6 billion life sciences industry. Investors may want to keep an eye on the stock given these developments and near-term catalysts.

For more information, visit the company’s website at www.pressurebiosciences.com.