Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an
innovative life sciences technology company providing mission
critical automation solutions to facilitate the efficient
manufacturing and fast, safe release of healthcare products, today
announced that it expects the commercial launch of the Growth
Direct Rapid Sterility application by mid-year 2024.
Sterility testing is the final quality check for
microbial contamination before a pharmaceutical product is released
for commercial sale and is typically performed in a facility that
manufactures products such as biologics or sterile injectables. The
Company has developed a novel, proprietary Rapid Sterility
application for use with its Growth Direct system. This innovative
solution delivers time to organism detection (“TTD”) in as little
as 12 hours and final time-to-result (“TTR”) in as little as one to
three days. This capability represents a significant improvement
over widely used traditional test methods, which generally require
a 14-day endpoint incubation, and provides compelling
differentiation when compared to current rapid sterility
products.
“We are extremely excited about the data and the
results we have achieved with our new Growth Direct Rapid Sterility
application – this is truly a breakthrough technology,” said Robert
Spignesi, President and CEO of Rapid Micro Biosystems. “We expect
Rapid Sterility to provide customers with significant advantages
compared to both the traditional compendial method and other
current technologies and practices being used today. The technology
behind this new product aligns with our corporate mission of
helping enable pharmaceutical customers to safely manufacture
life-saving treatments for patients faster, and we are extremely
proud of this innovation.”
The Growth Direct Rapid Sterility application
leverages the Company’s platform technology, providing customers
with all the benefits they are accustomed to with the Growth Direct
system. These benefits include full automation, enhanced data
integrity, reduced human error and lower hands-on labor costs. In
addition, we expect that the Growth Direct Rapid Sterility
application will enable faster release of final pharmaceutical
product, allowing manufacturers to benefit from faster time to
market, less potential waste and reduced inventory and holding
costs.
The Growth Direct Rapid Sterility application
delivers TTD in as little as 12 hours and final TTR in as little as
one to three days across an expanded panel of stressed
microorganisms most commonly found in biomanufacturing
environments, inclusive of the U.S. Pharmacopeia (USP)<71>
microorganisms. The application has been designed to meet a limit
of detection of one colony forming unit (CFU) as directed by
USP<1223>.
Commercial launch of the Growth Direct Rapid
Sterility application is expected by mid-year 2024.
About Rapid Micro
Biosystems
Rapid Micro Biosystems is an innovative life
sciences technology company providing mission critical automation
solutions to facilitate the efficient manufacturing and fast, safe
release of healthcare products such as biologics, vaccines, cell
and gene therapies, and sterile injectables. The Company’s flagship
Growth Direct System automates and modernizes the antiquated,
manual microbial quality control (“MQC”) testing workflows used in
the largest and most complex pharmaceutical manufacturing
operations across the globe. The Growth Direct System brings the
quality control lab to the manufacturing floor, unlocking the power
of MQC automation to deliver the faster results, greater accuracy,
increased operational efficiency, better compliance with data
integrity regulations, and quicker decision making that customers
rely on to ensure safe and consistent supply of important
healthcare products. The Company is headquartered and has U.S.
manufacturing in Lowell, Massachusetts, with global locations in
Lexington, Massachusetts, Switzerland, Germany, and the
Netherlands. For more information, please
visit www.rapidmicrobio.com or follow the Company on X
(formerly known as Twitter) at @rapidmicrobio or
on LinkedIn.
Available Information
Rapid Micro Biosystems announces material
information to the public about the Company, its products and
services, and other matters through a variety of means, including
filings with the U.S. Securities and Exchange Commission (“SEC”),
press releases, public conference calls, webcasts, the investor
relations section of the Company website at
investors.rapidmicrobio.com, and the Company’s X (formerly known as
Twitter) account @rapidmicrobio in order to achieve broad,
non-exclusionary distribution of information to the public and for
complying with its disclosure obligations under Regulation FD.
Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. All statements contained in this press release
that do not relate to matters of historical fact should be
considered forward-looking statements, including, but not limited
to, statements regarding the expected commercial launch of the
Growth Direct Rapid Sterility application by mid-year 2024;
customer interest in and adoption of the Company's Growth Direct
Rapid Sterility application; and the anticipated benefits of Growth
Direct Rapid Sterility application for the Company’s customers.
In some cases, you can identify forward-looking
statements by terminology such as “outlook,” “aim,” “anticipate,”
“assume,” “believe,” “contemplate,” “continue,” “could,” “due,”
“estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,”
“predict,” “potential,” “positioned,” “seek,” “should,” “target,”
“will,” “would” and other similar expressions that are predictions
of or indicate future events and future trends, or the negative of
these terms or other comparable terminology, although not all
forward-looking statements contain these words. Forward-looking
statements involve known and unknown risks, uncertainties and
assumptions which may cause actual results to differ materially
from any results expressed or implied by any forward-looking
statement, including, but not limited to, the Company’s significant
losses since inception; the Company’s ability to meet its publicly
announced guidance and other expectations about its business and
operations; the Company’s limited experience in marketing and sales
and the effectiveness of its sales processes; the Company’s need to
develop new products and adapt to technological changes; the
Company’s ability to establish and maintain its position as a
leading provider of automated microbial quality control testing;
the Company’s ability to maintain its manufacturing facility; risks
related to third-parties; the Company’s ability to retain key
management and other employees; risks related to regulatory and
intellectual property matters; risks related to supply chain
disruptions and the impact of inflation; the impact of
macroeconomic volatility and public health crises on the Company’s
business and operations, including further delays in placements and
validation of new systems; and the other important factors outlined
under the caption “Risk Factors” in the Company’s Annual Report on
Form 10-K filed with the SEC on March 10, 2023, as such factors may
be updated from time to time in its other filings with the SEC,
which are available on the SEC's website at www.sec.gov and the
Investor Relations page of its website at
investors.rapidmicrobio.com. Although the Company believes that the
expectations reflected in its forward-looking statements are
reasonable, it cannot guarantee future results. The Company has no
obligation, and does not undertake any obligation, to update or
revise any forward-looking statement made in this press release to
reflect changes since the date of this press release, except as may
be required by law.
Investor Contact:
Michael Beaulieu, CFA
Vice President, Investor Relations and Corporate Communications
investors@rapidmicrobio.com
Media Contact:
media@rapidmicrobio.com
Rapid Micro Biosystems (NASDAQ:RPID)
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