T2 Biosystems Announces Sale of Four T2Dx Instruments to Existing European Distributor
T2 Biosystems (NASDAQ: TTOO) has announced the sale of four T2Dx® Instruments to its European distributor, marking significant commercial expansion in multiple EU countries. The sale includes a second instrument to a major reference hospital, a first-time installation in a new country, and two instruments to existing market countries.
The company's T2Resistance Panel, which runs on the FDA-cleared T2Dx® Instrument, can detect 13 antibiotic resistance genes directly from blood samples in 3-5 hours without waiting for blood culture. A recent prospective study published in March 2024 demonstrated the panel's high accuracy with 94.7% sensitivity and 97.4% specificity, rapid results delivery (4.4 vs 58.3 hours), and positive clinical interventions in 41% of study patients.
T2 Biosystems (NASDAQ: TTOO) ha annunciato la vendita di quattro strumenti T2Dx® al suo distributore europeo, segnando un'importante espansione commerciale in diversi paesi dell'UE. La vendita include un secondo strumento a un importante ospedale di riferimento, una prima installazione in un nuovo paese e due strumenti per paesi già presenti sul mercato.
Il T2Resistance Panel dell'azienda, che opera sull'FDA-cleared T2Dx® Instrument, può rilevare 13 geni di resistenza agli antibiotici direttamente da campioni di sangue in 3-5 ore, senza attendere la coltura del sangue. Uno studio prospettico recente pubblicato a marzo 2024 ha dimostrato l'alta accuratezza del pannello con una sensibilità del 94,7% e una specificità del 97,4%, consegna rapida dei risultati (4,4 contro 58,3 ore) e interventi clinici positivi nel 41% dei pazienti dello studio.
T2 Biosystems (NASDAQ: TTOO) ha anunciado la venta de cuatro instrumentos T2Dx® a su distribuidor europeo, lo que marca una importante expansión comercial en varios países de la UE. La venta incluye un segundo instrumento para un importante hospital de referencia, una primera instalación en un nuevo país y dos instrumentos para países ya existentes en el mercado.
El T2Resistance Panel de la empresa, que funciona en el instrumento T2Dx® aprobado por la FDA, puede detectar 13 genes de resistencia a los antibióticos directamente de muestras de sangre en 3-5 horas, sin esperar la cultura de sangre. Un estudio prospectivo reciente publicado en marzo de 2024 demostró la alta precisión del panel con una sensibilidad del 94,7% y una especificidad del 97,4%, entrega rápida de resultados (4,4 frente a 58,3 horas) e intervenciones clínicas positivas en el 41% de los pacientes del estudio.
T2 바이오시스템즈 (NASDAQ: TTOO)는 유럽 유통업체에 네 대의 T2Dx® 기기 판매를 발표하며 여러 EU 국가에서 상업적 확대를 의미합니다. 이번 판매에는 주요 참조 병원에 두 번째 기기, 새로운 국가에서의 첫 설치와 기존 시장 국가에 두 대의 기기가 포함됩니다.
회사의 T2Resistance Panel은 FDA 승인을 받은 T2Dx® 기기에서 작동하며, 혈액 샘플에서 3-5시간 내에 13개의 항생제 내성 유전자를 직접 탐지할 수 있으며, 혈액 배양을 기다릴 필요가 없습니다. 2024년 3월에 발표된 최근의 전향적 연구는 패널의 높은 정확성을 보여주었고, 94.7%의 민감도와 97.4%의 특이도를 기록했으며, 결과 전달 속도가 빠르고(4.4시간 대 58.3시간) 임상 개입이 연구 환자의 41%에서 긍정적이었다고 합니다.
T2 Biosystems (NASDAQ: TTOO) a annoncé la vente de quatre instruments T2Dx® à son distributeur européen, marquant une expansion commerciale significative dans plusieurs pays de l'UE. La vente comprend un deuxième instrument pour un grand hôpital de référence, une première installation dans un nouveau pays, et deux instruments pour des pays déjà présents sur le marché.
Le T2Resistance Panel de l'entreprise, qui fonctionne sur l'instrument T2Dx® approuvé par la FDA, peut détecter 13 gènes de résistance aux antibiotiques directement à partir d'échantillons de sang en 3-5 heures, sans attendre la culture sanguine. Une étude prospective récente publiée en mars 2024 a démontré la haute précision du panneau avec une sensibilité de 94,7 % et une spécificité de 97,4 %, une livraison rapide des résultats (4,4 contre 58,3 heures) et des interventions cliniques positives dans 41 % des patients de l'étude.
T2 Biosystems (NASDAQ: TTOO) hat den Verkauf von vier T2Dx®-Geräten an seinen europäischen Distributor bekannt gegeben, was eine erhebliche kommerzielle Expansion in mehreren EU-Ländern markiert. Der Verkauf umfasst ein zweites Gerät für ein großes Referenzkrankenhaus, eine erstmalige Installation in einem neuen Land und zwei Geräte für bereits vorhandene Märkte.
Das T2Resistance Panel des Unternehmens, das auf dem von der FDA zugelassenen T2Dx®-Gerät läuft, kann 13 Antibiotika-Resistenzgene direkt aus Blutproben in 3-5 Stunden erkennen, ohne auf eine Blutkultur warten zu müssen. Eine kürzlich im März 2024 veröffentlichte prospektive Studie zeigte die hohe Genauigkeit des Panels mit 94,7% Sensitivität und 97,4% Spezifität, eine schnelle Ergebnisübermittlung (4,4 gegenüber 58,3 Stunden) und positive klinische Interventionen bei 41% der Studienteilnehmer.
- Sale of four T2Dx Instruments demonstrates market expansion in Europe
- T2Resistance Panel showed 94.7% sensitivity and 97.4% specificity in recent study
- Clinical interventions achieved in 41% of study patients
- Significant time reduction in results delivery (4.4 vs 58.3 hours)
- FDA Breakthrough Device designation received for T2Resistance Panel
- None.
Insights
The sale of four T2Dx Instruments represents meaningful commercial expansion in Europe, particularly given TTOO's small market cap. The deal's structure is strategically sound, targeting both market penetration and same-store growth. The T2Resistance Panel's high accuracy (
For a micro-cap company with a market cap under
Multiple instrument sale demonstrates growing market penetration of T2 Biosystems’ sepsis tests
LEXINGTON, Mass., Dec. 18, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced the sale of four T2Dx® Instruments to its European (EU) distributor that represents multiple EU counties, demonstrating commercial expansion and increased international market penetration.
The multiple instrument sale demonstrates commercial expansion to enable increased utilization of the T2Bacteria® Panel, the T2Candida® Panel, and the T2Resistance® Panel. The target hospitals for the new instruments include:
- Selling a second T2Dx Instrument to a major reference hospital to expand “same store” sales;
- Selling the first T2Dx Instrument to a hospital in a country for initial market penetration; and
- Selling two T2Dx Instruments to hospitals in countries that already utilize T2 Biosystems’ products.
“Our international distributors continue to expand the global footprint of the T2Dx Instruments and make direct-from-blood diagnostic tests available to new sepsis patients,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “The availability of the T2Resistance Panel in international markets strengthens the value proposition of our T2Dx platform and we believe the clinical experience using direct-from-blood detection of antibiotic resistance genes in these markets is an important precursor to our U.S. launch of the T2Resistance Panel. We previously received Breakthrough Device designation from the FDA for the T2Resistance Panel and plan to submit a FDA 510(k) premarket notification next quarter.”
The T2Resistance Panel, which runs on the FDA-cleared T2Dx® Instrument, is a direct-from-blood test panel that detects 13 antibiotic resistance genes from both Gram-positive and Gram-negative bacterial pathogens (KPC, OXA-48, CTX-M-14/15, AmpC (CMY/DHA), NDM/IMP/VIM, mecA/C, vanA/B) in 3-5 hours, without the need to wait for a positive blood culture. The T2Resistance Panel is commercially available in Europe under a CE-mark and was granted “Breakthrough Device” designation from the FDA, which provides for a prioritized FDA review process. In March 2024, the Company announced the results of a new prospective study that was published in the Journal of Clinical Microbiology, highlighting the performance and clinical benefits of the T2Resistance Panel compared to blood culture and standard microbiology methods, including high accuracy (i.e.,
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 are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology and include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the T2Lyme™ Panel, and the expended T2Candida Panel to add the detection of Candida auris. 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 likelihood that the sale of additional instruments will result in increased sepsis test revenue and the customer adoption of the Company’s direct-from-whole-blood technology will continue to grow and the likelihood that the international clinical experience with direct-from-blood detection of antibiotic resistance genes will be an important precursor to the potential launch of the T2Resistance Test in the U.S. market; and all other 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, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, 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
FAQ
What is the significance of T2 Biosystems' (TTOO) recent sale of four T2Dx Instruments in Europe?
What are the performance metrics of TTOO's T2Resistance Panel according to the March 2024 study?
When will TTOO submit the FDA 510(k) premarket notification for the T2Resistance Panel?
How many antibiotic resistance genes can TTOO's T2Resistance Panel detect?
