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$TTOO CDC's Actions Aimed at Optimizing U.S. Hospitals
Sepsis Programs. TTOO: Right products at the Right Time.
https://research.tdameritrade.com/grid/public/research/stocks/news/article?dockey=100-240u4810-1
$TTOO …T2 Biosystems... …US/FDA… …US/HHS…
…September Sepsis Month… News coming any day.
https://www.highergov.com/contract/75A50119C00053/
Investors do your DD: https://www.t2biosystems.com/
$TTOO …T2 Biosystems... …US/FDA… …US/HHS…
…September Sepsis Month… News coming any day.
https://www.highergov.com/contract/75A50119C00053/
Investors do your DD: https://www.t2biosystems.com/
Kicking the DWAC’ked can down the road.
When does the SEC shut down this scam.
Just a money funnel for lawyers payment.
Everyone know the orange boss is broke.
$TTOO: “Market expected to reach estimated 10 Billion
[Dollars] by 2028 with a CAGE of 81 from 2023 to 2028“ https://www.globenewswire.com/news-release/2023/09/05/2737763/0/en/The-global-sepsis-diagnostic-market-is-expected-to-reach-an-estimated-1-0-billion-by-2028-with-a-CAGR-of-8-1-from-2023-to-2028.html
$TTOO: “Market expected to reach estimated 10 Billion
[Dollars] by 2028 with a CAGE of 81 from 2023 to 2028“ https://www.globenewswire.com/news-release/2023/09/05/2737763/0/en/The-global-sepsis-diagnostic-market-is-expected-to-reach-an-estimated-1-0-billion-by-2028-with-a-CAGR-of-8-1-from-2023-to-2028.html
Another DWAC’ked p&d fading again.
Congrats to those who sold it for coin.
The Grifted got mugged again.
Lawyers charging fees
for their efforts.
DWAC’ked
again.
$TTOO T2-Biosystems: Hot Stock with a Bright Future
Waiting for a new FDA update…and contracts following
https://www.livetradingnews.com/t2-biosystems-a-hot-stock-with-a-bright-future-221913.html
$TTOO T2-Biosystems: Hot Stock with a Bright Future
Waiting for a new FDA update…and contracts following
https://www.livetradingnews.com/t2-biosystems-a-hot-stock-with-a-bright-future-221913.html
“DWAC TruthSocial investors about to take a bath”. “Online personality Jeff Tiedrich also seemed to expect the downfall”.
https://www.msn.com/en-us/news/politics/dollar-store-reject-social-platform-trump-s-truth-social-ridiculed-amid-investor-crunch/ar-AA1g9OYp?ocid=winp2fptaskbarhover&cvid=8e8d7790c63342f1bc3736cfad8291e1&ei=40 DWAC’ked sliding downward since spring.
$TTOO “9/14/23 Current End Date 9/14/23 Potential End-Date” “Since initial award, the Potential End Date has been shortened from 08/29/24 to 09/14/23 and… the Potential Award value has increased up 12% from $68,952,025 to $77,030,934”. It is now September 2023. FDA news is pending.
https://www.highergov.com/contract/75A50119C00053/#overview
$TTOO “9/14/23 Current End Date 9/14/23 Potential End-Date” “Since initial award, the Potential End Date has been shortened from 08/29/24 to 09/14/23 and… the Potential Award value has increased up 12% from $68,952,025 to $77,030,934”. It is now September 2023. FDA news is pending.
https://www.highergov.com/contract/75A50119C00053/#overview
$TTOO T2 Biosystems Announces Preliminary
Q2 2023 Highlights and Financial Results
Published: Jul 12, 2023
LEXINGTON, Mass., July 12, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems Inc. (NASDAQ:TTOO), a leader in the rapid detection
of sepsis-causing pathogens and of antibiotic resistance genes,
today announced preliminary unaudited financial and operational results for the second quarter 2023.
Recent Financial and Operational Highlights (unaudited)
Achieved second quarter total revenue of $2.0 million, comprised entirely of product revenue. Achieved sepsis test panel revenue of $1.3 million, representing an increase of 7% compared to the prior year period, despite ending the second quarter with a $0.4 million sepsis test backorder. Executed contracts for 11 T2Dx® Instruments during the second quarter, including 4 in U.S. and 7 internationally. Secured multi-year contract with a European distributor for 7 T2Dx Instruments and sepsis test panels for Poland – including T2Bacteria® Panel, T2Candida® Panel, and T2Resistance® Panel. Implemented a restructuring program in May 2023, including a workforce reduction of nearly 30%.
Strengthened balance sheet by converting $10.0 million, or approximately 20%, of term loan debt with CRG Servicing LLC (“CRG”) in exchange for 48,345,798 shares of T2 Biosystems common stock and Series B Convertible Preferred Stock convertible into 93,297,259 shares of common stock.
Completed Nasdaq listing compliance hearing and a response is expected within 30 days.
Cash and cash equivalents totaled $16.1 million as of June 30, 2023, including $18.5 million of net proceeds from the sale of shares through the ATM facility in the second quarter.
Recent Pipeline and Clinical Highlights
Completed patient enrollment in the U.S. clinical trial for the T2Resistance Panel. Filed FDA submission for T2Biothreat™ Panel, a direct-from-blood diagnostic test that runs on the FDA-cleared T2Dx Instrument and detects six biothreat pathogens identified as threats by CDC. Submitted for FDA Breakthrough Device Designation for a direct-from-blood diagnostic test to detect Candida auris, a multidrug-resistant fungal pathogen identified by CDC as an urgent threat. Established a clinical collaboration with Vanderbilt University Medical Center to implement the T2Bacteria Panel and assess its impact on antibiotic usage and clinical interventions.
“We achieved a number of significant milestones during the second quarter, including record demand for our sepsis test panels, the second largest sepsis-driven instrument order in company history, the FDA 510(k) submission for the T2Biothreat Panel, and the FDA Breakthrough Device Designation application for our Candida auris test,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “In addition, we recently strengthened our balance sheet through sales of common stock and the conversion of $10 million of debt to equity, extending our cash runway to pursue strategic initiatives.”
The Company’s second quarter 2023 financial results are preliminary and are subject to the completion of the audit of the Company’s second quarter 2023 financial statements. Complete second quarter 2023 financial results will be announced in August.
2023 Financial Outlook
The Company now expects full year 2023 total sepsis and related product revenue of $9.5 million to $10.5 million, representing growth of 13% to 25%, compared to $8.4 million in 2022.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the Company’s proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the Candida auris test, the T2Lyme™ Panel, the T2Biothreat™ Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our revenue results and cash balance, financial outlook, cost improvement measures, timing of completion of clinical trials, anticipated strategic priorities, status of product development pipeline, product demand, commitments or opportunities, and growth expectations or targets, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406
$TTOO T2 Biosystems Announces Preliminary
Q2 2023 Highlights and Financial Results
Published: Jul 12, 2023
LEXINGTON, Mass., July 12, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems Inc. (NASDAQ:TTOO), a leader in the rapid detection
of sepsis-causing pathogens and of antibiotic resistance genes,
today announced preliminary unaudited financial and operational results for the second quarter 2023.
Recent Financial and Operational Highlights (unaudited)
Achieved second quarter total revenue of $2.0 million, comprised entirely of product revenue. Achieved sepsis test panel revenue of $1.3 million, representing an increase of 7% compared to the prior year period, despite ending the second quarter with a $0.4 million sepsis test backorder. Executed contracts for 11 T2Dx® Instruments during the second quarter, including 4 in U.S. and 7 internationally. Secured multi-year contract with a European distributor for 7 T2Dx Instruments and sepsis test panels for Poland – including T2Bacteria® Panel, T2Candida® Panel, and T2Resistance® Panel. Implemented a restructuring program in May 2023, including a workforce reduction of nearly 30%.
Strengthened balance sheet by converting $10.0 million, or approximately 20%, of term loan debt with CRG Servicing LLC (“CRG”) in exchange for 48,345,798 shares of T2 Biosystems common stock and Series B Convertible Preferred Stock convertible into 93,297,259 shares of common stock.
Completed Nasdaq listing compliance hearing and a response is expected within 30 days.
Cash and cash equivalents totaled $16.1 million as of June 30, 2023, including $18.5 million of net proceeds from the sale of shares through the ATM facility in the second quarter.
Recent Pipeline and Clinical Highlights
Completed patient enrollment in the U.S. clinical trial for the T2Resistance Panel. Filed FDA submission for T2Biothreat™ Panel, a direct-from-blood diagnostic test that runs on the FDA-cleared T2Dx Instrument and detects six biothreat pathogens identified as threats by CDC. Submitted for FDA Breakthrough Device Designation for a direct-from-blood diagnostic test to detect Candida auris, a multidrug-resistant fungal pathogen identified by CDC as an urgent threat. Established a clinical collaboration with Vanderbilt University Medical Center to implement the T2Bacteria Panel and assess its impact on antibiotic usage and clinical interventions.
“We achieved a number of significant milestones during the second quarter, including record demand for our sepsis test panels, the second largest sepsis-driven instrument order in company history, the FDA 510(k) submission for the T2Biothreat Panel, and the FDA Breakthrough Device Designation application for our Candida auris test,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “In addition, we recently strengthened our balance sheet through sales of common stock and the conversion of $10 million of debt to equity, extending our cash runway to pursue strategic initiatives.”
The Company’s second quarter 2023 financial results are preliminary and are subject to the completion of the audit of the Company’s second quarter 2023 financial statements. Complete second quarter 2023 financial results will be announced in August.
2023 Financial Outlook
The Company now expects full year 2023 total sepsis and related product revenue of $9.5 million to $10.5 million, representing growth of 13% to 25%, compared to $8.4 million in 2022.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the Company’s proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the Candida auris test, the T2Lyme™ Panel, the T2Biothreat™ Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our revenue results and cash balance, financial outlook, cost improvement measures, timing of completion of clinical trials, anticipated strategic priorities, status of product development pipeline, product demand, commitments or opportunities, and growth expectations or targets, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406
$TTOO T2Biosystems Regains Nasdaq’s Listed Securities Requirement Compliance
LEXINGTON, Mass., Aug. 09, 2023 (GLOBE NEWSWIRE) --
T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it received written notice from the NASDAQ Stock Market LLC (“NASDAQ”) on August 8, 2023 informing the Company that it has regained compliance with the market value of listed securities (“MVLS”) requirement, as set forth in Nasdaq Listing Rule 5550(b)(2) (the “Rule”) for continued listing on the NASDAQ Capital Market.
As previously reported, T2 Biosystems was notified by the NASDAQ on November 22, 2022 that it was not in compliance with the NASDAQ’s Capital Market requirement because it failed to maintain a MVLS of at least $35 million for a period of 30 consecutive business days. To regain compliance with the Rule, the Company was required to maintain a MVLS of at least $35 million for at least 10 consecutive trading days. This requirement was met on August 7, 2023, the tenth consecutive trading day when the MVLS was at least $35 million.
The Company must still demonstrate compliance with Listing Rule 5550(a)(2), the Bid Price Rule, by November 20, 2023.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the Candida auris test, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements about the Company’s ability to regain compliance with the listing requirements of the Nasdaq Capital Market, including its ability to effect a reverse share split, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
philip@gilmartinIR.com
415-937-5406
$TTOO T2Biosystems Regains Nasdaq’s Listed Securities Requirement Compliance
LEXINGTON, Mass., Aug. 09, 2023 (GLOBE NEWSWIRE) --
T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it received written notice from the NASDAQ Stock Market LLC (“NASDAQ”) on August 8, 2023 informing the Company that it has regained compliance with the market value of listed securities (“MVLS”) requirement, as set forth in Nasdaq Listing Rule 5550(b)(2) (the “Rule”) for continued listing on the NASDAQ Capital Market.
As previously reported, T2 Biosystems was notified by the NASDAQ on November 22, 2022 that it was not in compliance with the NASDAQ’s Capital Market requirement because it failed to maintain a MVLS of at least $35 million for a period of 30 consecutive business days. To regain compliance with the Rule, the Company was required to maintain a MVLS of at least $35 million for at least 10 consecutive trading days. This requirement was met on August 7, 2023, the tenth consecutive trading day when the MVLS was at least $35 million.
The Company must still demonstrate compliance with Listing Rule 5550(a)(2), the Bid Price Rule, by November 20, 2023.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the Candida auris test, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements about the Company’s ability to regain compliance with the listing requirements of the Nasdaq Capital Market, including its ability to effect a reverse share split, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
philip@gilmartinIR.com
415-937-5406
$TTOO Update on FDA clearance of T2Bio's BioThreatPanel is
expected at any day. Last month the DOD updated their posture:
2023 Biodefense Posture Review: Department of Defense 2023
https://www.defense.gov/News/News-Stories/Article/Article/3502656/pentagon-official-calls-for-total-force-focus-on-emerging-biothreats/
Links to the pdf file are included in this article:
https://sih-st-charts.stocktwits-cdn.com/production/original_543278163.jpg
$TTOO Update on FDA clearance of T2Bio's BioThreatPanel is
expected at any day. Last month the DOD updated their posture:
2023 Biodefense Posture Review: Department of Defense 2023
https://www.defense.gov/News/News-Stories/Article/Article/3502656/pentagon-official-calls-for-total-force-focus-on-emerging-biothreats/
Links to the pdf file are included in this article:
https://sih-st-charts.stocktwits-cdn.com/production/original_543278163.jpg
DWAC’ked like black mold and fungus spores.
Meanwhile its red slide since spring continues.
The mini-p&d’s since then are just distractions.
Spot-on. “In a world increasingly focused on sustainability, the shift towards nature-inspired solutions for h2s removal is inevitable. And leading this change is 21st Century Energy Solutions, Inc.” $PCTL
$TTOO News: “T2-Biosystems Receives FDA Breakthrough Device Designation for Candida Auris Diagnostic Test” Call…or email them
https://www.globenewswire.com/news-release/2023/07/20/2708188/32489/en/T2-Biosystems-Receives-FDA-Breakthrough-Device-Designation-for-Candida-Auris-Diagnostic-Test.html
LEXINGTON, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s Candida auris (C. auris) direct-from-blood molecular diagnostic test.
This marks the third T2 Biosystems’ product to receive FDA Breakthrough Device designation, as the Company was previously granted FDA Breakthrough Device designation for its T2Resistance® Panel and T2Lyme™ Panel. The Company plans to expand the test menu on its FDA-cleared T2Dx® Instrument by adding the C. auris diagnostic test that is designed to detect C. auris species directly from blood in just 3-5 hours, without the need to wait days for a positive blood culture.
"We are pleased with the FDA’s decision to grant Breakthrough Device designation for our Candida auris test, which provides greater and more frequent access to the FDA and may accelerate our path to FDA clearance,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We believe adding Candida auris to the test menu on our FDA-cleared T2Dx Instrument will provide clinicians with a valuable tool to rapidly detect a dangerous, multidrug-resistant fungal pathogen much faster than blood culture-based methods, strengthening our value proposition and increasing the attractiveness of our products to U.S. hospitals.”
Candida auris is a multidrug-resistant fungal pathogen recognized as a serious global health threat with a mortality rate of up to 60%, and is difficult to identify with standard laboratory methods, which can lead to inappropriate treatment. The CDC estimates the costs associated with U.S. fungal diseases, in general, are as high as $48 billion annually, and has called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the life-saving benefits of early detection and proper treatment.
The Company currently markets and sells the T2Candida® Panel, the only FDA-cleared diagnostic test able to detect sepsis-causing fungal pathogens directly from blood, without the need to wait days for a positive blood culture. The T2Candida Panel runs on the fully-automated T2Dx Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. Rapid detection of these pathogens, as well as Candida auris, is essential to getting infected patients on appropriate antifungal therapy and improving clinical outcomes.
About FDA Breakthrough Devices Program
The FDA Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request). This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health. For more information, please visit:
https://www.fda.gov/media/108135/download.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the Candida auris test, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the potential that the Breakthrough Device designation will accelerate the FDA clearance of the Candida auris test or the Company’s commercialization of the Candida auris test, the ability of the Candida auris test to successfully detect Candida auris, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406
$TTOO News: “T2-Biosystems Receives FDA Breakthrough Device Designation for Candida Auris Diagnostic Test” Call…or email them
https://www.globenewswire.com/news-release/2023/07/20/2708188/32489/en/T2-Biosystems-Receives-FDA-Breakthrough-Device-Designation-for-Candida-Auris-Diagnostic-Test.html
LEXINGTON, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s Candida auris (C. auris) direct-from-blood molecular diagnostic test.
This marks the third T2 Biosystems’ product to receive FDA Breakthrough Device designation, as the Company was previously granted FDA Breakthrough Device designation for its T2Resistance® Panel and T2Lyme™ Panel. The Company plans to expand the test menu on its FDA-cleared T2Dx® Instrument by adding the C. auris diagnostic test that is designed to detect C. auris species directly from blood in just 3-5 hours, without the need to wait days for a positive blood culture.
"We are pleased with the FDA’s decision to grant Breakthrough Device designation for our Candida auris test, which provides greater and more frequent access to the FDA and may accelerate our path to FDA clearance,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We believe adding Candida auris to the test menu on our FDA-cleared T2Dx Instrument will provide clinicians with a valuable tool to rapidly detect a dangerous, multidrug-resistant fungal pathogen much faster than blood culture-based methods, strengthening our value proposition and increasing the attractiveness of our products to U.S. hospitals.”
Candida auris is a multidrug-resistant fungal pathogen recognized as a serious global health threat with a mortality rate of up to 60%, and is difficult to identify with standard laboratory methods, which can lead to inappropriate treatment. The CDC estimates the costs associated with U.S. fungal diseases, in general, are as high as $48 billion annually, and has called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the life-saving benefits of early detection and proper treatment.
The Company currently markets and sells the T2Candida® Panel, the only FDA-cleared diagnostic test able to detect sepsis-causing fungal pathogens directly from blood, without the need to wait days for a positive blood culture. The T2Candida Panel runs on the fully-automated T2Dx Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. Rapid detection of these pathogens, as well as Candida auris, is essential to getting infected patients on appropriate antifungal therapy and improving clinical outcomes.
About FDA Breakthrough Devices Program
The FDA Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request). This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health. For more information, please visit:
https://www.fda.gov/media/108135/download.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the Candida auris test, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the potential that the Breakthrough Device designation will accelerate the FDA clearance of the Candida auris test or the Company’s commercialization of the Candida auris test, the ability of the Candida auris test to successfully detect Candida auris, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406
I’m having a hard time deciding if this stock is gonna go up. The comments are back and forth and do they have revenue? Dead?
$TTOO T2Biosystems is now awaiting more FDA goodness
and next sepsis conference. https://www.t2biosystems.com/
TTOO medical equipment and products fight against sepsis.
https://www.globenewswire.com/news-release/2023/05/30/2678417/32489/en/T2-Biosystems-Announces-Second-Largest-Sepsis-Driven-Instrument-Sale-in-Company-History.html
$TTOO T2Biosystems is now awaiting more FDA goodness
and next sepsis conference. https://www.t2biosystems.com/
TTOO medical equipment and products fight against sepsis.
https://www.globenewswire.com/news-release/2023/05/30/2678417/32489/en/T2-Biosystems-Announces-Second-Largest-Sepsis-Driven-Instrument-Sale-in-Company-History.html
$TTOO Actions Aimed at Optimizing Hospital Sepsis Programs:
The U.S. Centers for Disease Control and Prevention Releases 2023 Hospital Sepsis Program Core Elements
https://www.biospace.com/article/releases/t2-biosystems-praises-cdc-s-actions-aimed-at-optimizing-u-s-hospital-sepsis-programs-the-u-s-centers-for-disease-control-and-prevention-releases-2023-hospital-sepsis-program-core-elements/
$TTOO
$TTOO Actions Aimed at Optimizing Hospital Sepsis Programs:
The U.S. Centers for Disease Control and Prevention Releases 2023 Hospital Sepsis Program Core Elements
https://www.biospace.com/article/releases/t2-biosystems-praises-cdc-s-actions-aimed-at-optimizing-u-s-hospital-sepsis-programs-the-u-s-centers-for-disease-control-and-prevention-releases-2023-hospital-sepsis-program-core-elements/
$TTOO
DWAC’ked on the dump side of its pump
again? Friday dumpings and profit-taking.
DWAC’kd again. Just like a drunk lawyer
stumbling since the spring. Falling again.
Former DWAC‘d board member on the airwaves soon.
>>> https://apple.news/AyYGTwV5_SLCvgoatzHyLpw
Meanwhile, current p&d will yield to the 2023 red slide.
Best sell & run, or take the tax loss at the end of 2023.
$TTOO T2 Biosystems Praises CDC’s Actions Aimed at Optimizing U.S. Hospital Sepsis Programs. In disclosure: TTOO has received clearances, has pending FDA for products. August 28 2023 8:30am
LEXINGTON, Mass., Aug. 28, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today praised actions taken by the U.S. Centers for Disease Control and Prevention (CDC) aimed at optimizing hospital sepsis programs in the United States.
https://www.streetinsider.com/dr/news.php?id=22094226
$TTOO T2 Biosystems Praises CDC’s Actions Aimed at Optimizing U.S. Hospital Sepsis Programs. In disclosure: TTOO has received clearances, has pending FDA for products. August 28 2023 8:30am
LEXINGTON, Mass., Aug. 28, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today praised actions taken by the U.S. Centers for Disease Control and Prevention (CDC) aimed at optimizing hospital sepsis programs in the United States.
https://www.streetinsider.com/dr/news.php?id=22094226
GM Grifted DWAC'd Fans, Another chance to contribute
to the big red slide since last Spring, with periodic p&d’s
since then. Just another one.......Repeat Repeat Repeat
$TTOO FDA clearance could hit any day followed
by contracts for purchase and use. Check ‘em out.
Go to https://www.t2biosystems.com/news/ or see
products: https://www.t2biosystems.com/about-t2/
$TTOO
$TTOO FDA clearance could hit any day followed
by contracts for purchase and use. Check ‘em out.
Go to https://www.t2biosystems.com/news/ or see
products: https://www.t2biosystems.com/about-t2/
$TTOO
TY. Best of luck. I review MBB alerts daily.
Lots of leads and info by many to consider.
$PCTL News: Permian Basin O&G/EOR Sales and Marketing
Staff for O&G Clients; Extensive O&G/Engineering Experience
Please welcome the newest addition to our staff: Reece Perkins, based in Midland, Texas. Reece will be handling Business Development - Sales and working with our current and prospective customers! Reece comes to us with extensive O&G and Engineering experience. Welcome!
— 21st Century-Energy (@21stEnergy) August 30, 2023
$PCTL News: Permian Basin O&G/EOR Sales and Marketing
Staff for O&G Clients; Extensive O&G/Engineering Experience
Please welcome the newest addition to our staff: Reece Perkins, based in Midland, Texas. Reece will be handling Business Development - Sales and working with our current and prospective customers! Reece comes to us with extensive O&G and Engineering experience. Welcome!
— 21st Century-Energy (@21stEnergy) August 30, 2023
$PCTL Reminder! 1pm EDT Cannabis Disease Solution Podcast
https://twitter.com/PCTL_/status/1696912197413113940?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1696912197413113940%7Ctwgr%5E2a7dfb8c3beebbd5826430a281ebbb8558b9aa45%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Finvestorshub.advfn.com%2Fboards%2Fread_msg.aspx%3Fmessage_id%3D172720488
$PCTL
$PCTL Reminder! 1pm EDT Cannabis Disease Solution Podcast
https://twitter.com/PCTL_/status/1696912197413113940?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1696912197413113940%7Ctwgr%5E2a7dfb8c3beebbd5826430a281ebbb8558b9aa45%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Finvestorshub.advfn.com%2Fboards%2Fread_msg.aspx%3Fmessage_id%3D172720488
$PCTL
$PCTL Update today 1pm: PCT’s Expansion into Cannabis Market
The firm will post its podcast on PCT’s solutions for plant diseases.
https://twitter.com/PCTL_/status/1696177837131153621?s=20
$PCTL