Catheter Precision, Inc. Announces Publication of LockeT Data in the Journal of Cardiovascular Electrophysiology
Catheter Precision, Inc. (NYSE American:VTAK) has announced the publication of its first LockeT study in the Journal of Cardiovascular Electrophysiology. The study, involving 102 patients and 182 LockeT devices, demonstrates the effectiveness and safety of LockeT, a novel external compression vascular closure device. Key findings include:
- Immediate hemostasis achievement
- 98% hemostasis retention at 2 hours
- No major complications observed
- Majority of patients discharged same day
- Average time to ambulation under 4 hours
The study suggests LockeT offers benefits similar to manual compression without prolonged bed rest or monitoring, facilitating early mobilization and same-day discharge. Further studies are ongoing, with the next one expected to conclude this year.
Catheter Precision, Inc. (NYSE American: VTAK) ha annunciato la pubblicazione del suo primo studio LockeT nel Journal of Cardiovascular Electrophysiology. Lo studio, che coinvolge 102 pazienti e 182 dispositivi LockeT, dimostra l'efficacia e la sicurezza di LockeT, un innovativo dispositivo di chiusura vascolare a compressione esterna. I risultati principali includono:
- Raggiungimento immediato dell'emostasi
- 98% di mantenimento dell'emostasi a 2 ore
- Nessuna complicazione maggiore osservata
- Maggiore parte dei pazienti dimessa lo stesso giorno
- Tempo medio per l'ambulazione inferiore a 4 ore
Lo studio suggerisce che LockeT offre benefici simili alla compressione manuale senza la necessità di un prolungato riposo a letto o monitoraggio, facilitando la mobilizzazione precoce e la dimissione lo stesso giorno. Sono in corso ulteriori studi, con il prossimo che si prevede di concludere quest'anno.
Catheter Precision, Inc. (NYSE American: VTAK) ha anunciado la publicación de su primer estudio LockeT en el Journal of Cardiovascular Electrophysiology. El estudio, que involucró a 102 pacientes y 182 dispositivos LockeT, demuestra la efectividad y seguridad de LockeT, un novedoso dispositivo de cierre vascular por compresión externa. Los hallazgos clave incluyen:
- Logro inmediato de hemostasia
- 98% de retención de hemostasia a las 2 horas
- No se observaron complicaciones mayores
- La mayoría de los pacientes fueron dados de alta el mismo día
- Tiempo promedio para la deambulación inferior a 4 horas
El estudio sugiere que LockeT ofrece beneficios similares a la compresión manual sin la necesidad de reposo prolongado en cama o monitoreo, facilitando la movilización temprana y el alta el mismo día. Se están llevando a cabo más estudios, siendo el próximo esperado para concluir este año.
Catheter Precision, Inc. (NYSE American: VTAK)는 Journal of Cardiovascular Electrophysiology에 첫 번째 LockeT 연구 발표를 했습니다. 이 연구는 102명의 환자와 182개의 LockeT 장치를 포함하며, LockeT가 혁신적인 외부 압축 혈관 폐쇄 장치로서의 효과성과 안전성을 입증합니다. 주요 결과는 다음과 같습니다:
- 즉각적인 지혈 달성
- 2시간 후 98%의 지혈 유지
- 심각한 합병증 없음
- 대부분의 환자가 같은 날 퇴원
- 보행 시작까지 평균 4시간 미만
이 연구는 LockeT가 장시간 침대에 누워 있거나 모니터링할 필요 없이 수동 압축과 유사한 이점을 제공하여 조기 이동 그리고 같은 날 퇴원을 촉진한다고 제안합니다. 추가 연구가 진행 중이며, 다음 연구는 올해 종료될 예정입니다.
Catheter Precision, Inc. (NYSE American: VTAK) a annoncé la publication de sa première étude LockeT dans le Journal of Cardiovascular Electrophysiology. L'étude, impliquant 102 patients et 182 dispositifs LockeT, démontre l'efficacité et la sécurité de LockeT, un nouveau dispositif de fermeture vasculaire par compression externe. Les résultats clés incluent :
- Atteinte immédiate d'hémostase
- 98 % de maintien de l'hémostase à 2 heures
- Aucune complication majeure observée
- La majorité des patients sortis le même jour
- Temps moyen pour l'ambulatoire inférieur à 4 heures
L'étude suggère que LockeT offre des avantages similaires à la compression manuelle sans besoin d'un repos prolongé au lit ou de surveillance, facilitant la mobilisation précoce et la sortie le même jour. D'autres études sont en cours, la prochaine étant prévue pour se terminer cette année.
Catheter Precision, Inc. (NYSE American: VTAK) hat die Veröffentlichung seiner ersten LockeT-Studie im Journal of Cardiovascular Electrophysiology bekannt gegeben. Die Studie, an der 102 Patienten und 182 LockeT-Geräte beteiligt waren, zeigt die Wirksamkeit und Sicherheit von LockeT, einem neuartigen externen Kompressions-Gerät zur Gefäßverschluss. Die wichtigsten Ergebnisse umfassen:
- Sofortige Erreichung der Hämostase
- 98% Hämostaseerhalt nach 2 Stunden
- Keine schwerwiegenden Komplikationen beobachtet
- Die Mehrheit der Patienten wurde am selben Tag entlassen
- Durchschnittliche Zeit bis zur Mobilisation unter 4 Stunden
Die Studie legt nahe, dass LockeT ähnliche Vorteile wie die manuelle Kompression bietet, ohne dass ein längerer Bettruhe oder Monitoring erforderlich ist, was eine frühe Mobilisation und die Entlassung am selben Tag erleichtert. Weitere Studien sind im Gange, und die nächste wird voraussichtlich noch in diesem Jahr abgeschlossen.
- Successful clinical study of LockeT device published in a reputable journal
- Demonstrated effectiveness in achieving immediate hemostasis in 98% of patients
- No major complications observed in the study
- Facilitated same-day discharge for majority of patients
- Average time to ambulation under 4 hours, indicating quick recovery
- None.
Insights
The publication of LockeT data in a peer-reviewed journal is a significant milestone for Catheter Precision. This study provides crucial clinical evidence supporting the safety and efficacy of their vascular closure device. The results are promising, showing immediate hemostasis achievement and maintenance in
The key advantage of LockeT appears to be enabling early mobilization and same-day discharge, which could lead to improved patient outcomes and reduced healthcare costs. The average time to ambulation of under 4 hours is particularly noteworthy, as it could significantly enhance patient comfort and hospital efficiency.
However, investors should note that while these results are encouraging, further studies are needed to solidify LockeT's position in the market. The planned conclusion of an additional study this year will be important in providing more comprehensive data.
This publication positions Catheter Precision favorably in the competitive vascular closure device market. The positive clinical outcomes could translate into increased adoption by healthcare providers, potentially driving revenue growth. The device's ability to facilitate same-day discharge aligns with the healthcare industry's push towards cost-effective, outpatient procedures.
Investors should consider the market potential: with an aging population and increasing prevalence of cardiovascular procedures, demand for efficient vascular closure devices is likely to grow. However, it's important to monitor how LockeT compares to existing solutions in terms of cost-effectiveness and ease of use.
The company's commitment to ongoing studies indicates a strong R&D focus, which could lead to further product improvements and market expansion. This proactive approach to clinical validation could be a key differentiator in securing market share and potential partnerships with healthcare systems.
FORT MILL, SC / ACCESSWIRE / August 6, 2024 / Catheter Precision, Inc. (NYSE American:VTAK), a US based innovative medical device company, announced today the publication of its first LockeT study in the Journal of Cardiovascular Electrophysiology. The study titled, Feasibility, safety and efficacy of a novel external compression vascular closure device: The LockeT Study, was made available online on August 5, 2024.
The study demonstrates the first clinical use of LockeT in 102 patients utilizing 182 LockeT devices and suggests that LockeT is effective for hemostasis, and early ambulation can be achieved with no major complications. The use of LockeT appears to generate the same benefits as standard of care (manual compression) without needing prolonged bed rest or monitoring, facilitating early mobilization and same-day discharge. Highlights of the study include:
Hemostasis was immediately achieved
Hemostasis remained at 2 hours in
98% of patientsNo major complications were observed
The majority of patients were discharged same day
Average Time to ambulation was under 4 hours
Further studies with LockeT are underway and the next study is planned to be concluded this year with additional data.
About LockeT
Catheter Precision's LockeT is a suture retention device intended to assist in hemostasis after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA.
About Catheter Precision
Catheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.
Forward-Looking Statements
Statements in this press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to substantial risk and uncertainties. Forward-looking statements can be identified by words such as "believe," "anticipate," "may," "might," "can," "could," "continue," "depends," "expect," "expand," "forecast," "intend," "ongoing," "predict," "plan," "rely," "should," "will," "may," "seek," "would," "forward," or the negative and alternative word forms of these terms and other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, statements that LockeT appears to generate the same benefits as standard of care (manual compression) without needing prolonged bed rest or monitoring, facilitating early mobilization and same-day discharge, and that the next study is planned to be concluded this year with additional data. The Company's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks and changes in circumstances, including but not limited to the risk that Phases II and III LockeT studies will not achieve the outcomes that we expect; that members of the EP community and other doctors and hospitals will fail to recognize LockeT's value or for other reasons will prefer other methodologies and/or products, including the products of our current competitors as well as possible new and emerging competing products of which we are not yet aware; the risk that hospitals undergoing initial evaluations may not choose to continue using LockeT following such evaluation; risks that we will be unable to obtain the necessary financing to carry out our business goals, including to continue ongoing efforts to gather and publish clinical data and to build out LockeT as well as VIVO; risk that peer-reviewed journals or other journals may choose not to publish data submitted in connection with our products; risks that our business relationships with distribution partners and customers could be disrupted by armed conflicts and unrest in Israel and the Gaza strip and elsewhere, and/or changes in U.S. international relations and/or related geopolitical changes; and other, or disruptions to local and global economies; and the other risks and uncertainties attendant to our business included under the caption "Risk Factors" in the Company's Form 10-K and other SEC filings available at www.sec.gov. These additional risks and uncertainties include, but aren't limited to, risks that our cash needs will continue to exceed our liquidity, we will not be able to reach profitability unless we are able to achieve our product expansion and growth goals, our research and development and commercialization efforts may depend on entering into agreements with corporate collaborators, we have entered into joint marketing agreements with respect to our products, and may enter into additional joint marketing agreements, that will reduce our revenues from product sales, royalty agreements with respect to our LockeT device will reduce any future profits from this product, if we experience significant disruptions in our information technology systems, our business may be adversely affected, litigation and other legal proceedings may adversely affect our business, if we make acquisitions or divestitures, we could encounter difficulties that harm our business, failure to attract and retain sufficient qualified personnel could also impede our growth, failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock, we have determined that our internal controls and disclosure controls were not effective as of December 31, 2023 and March 31, 2024, and as a result, without effective remediation of the material weaknesses that we have identified, we may not be able to accurately report our financial results or prevent fraud, our revenues may depend on our customers' receipt of adequate reimbursement from private insurers and government sponsored healthcare programs, we may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do, our future operating results depend upon our ability to obtain components and finished product in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components or finished product, or we may be unable to manage these components or product procurement effectively or obtain these components or products on such terms, if hospitals, physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any, our medical device operations are subject to pervasive and continuing FDA regulatory requirements, our products may be subject to potential product liability risks as well as additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business, changes in trade policies among the U.S. and other countries, in particular the imposition of new or higher tariffs, could place pressure on our average selling prices as our customers seek to offset the impact of increased tariffs on their own products, increased tariffs or the imposition of other barriers to international trade could have a material adverse effect on our revenues and operating results. The risks and uncertainties described above may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty, or other pandemics, disruptions to our ability to conduct business overseas, including to our supply chain, from the Ukraine war, the Israeli-Hamas armed conflict and other ongoing hostilities and instabilities in the Middle East and elsewhere, and ongoing volatility in the stock markets and the U.S. economy in general. In addition, market conditions that are outside our control could significantly how our stock is viewed by potential investors.
CONTACTS:
At the Company
David Jenkins
973-691-2000
IR@catheterprecision.com
# # #
Contact Information
Missiaen Huck
COO
mhuck@catheterprecision.com
9736912000
SOURCE: Catheter Precision
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FAQ
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