Conavi Medical Reports Fiscal Q3 2025 Interim Results and Operational Highlights
Conavi Medical (OTCQB:CNVIF), a medical device company specializing in cardiovascular imaging technology, reported its fiscal Q3 2025 results and provided key operational updates. The company remains on track to submit its 510(k) application for the Novasight Hybrid™ system to the FDA in Q3 2025, targeting a commercial launch in H1 2026.
Financial highlights include a significant reduction in operating loss to $4.6M from $8.9M year-over-year, and improved cash position of $11.3M following a $20M equity offering completed in April. Revenue was $63,000, down from $401,000 in the prior year, reflecting the company's focus on next-generation product development.
Operational achievements include successful validation testing with leading cardiologists and a notable publication in JSCAI validating their hybrid IVUS/OCT imaging approach.
Conavi Medical (OTCQB:CNVIF), società di dispositivi medici specializzata in tecnologie di imaging cardiovascolare, ha annunciato i risultati del terzo trimestre fiscale 2025 e fornito aggiornamenti operativi chiave. L'azienda conferma l'intenzione di presentare la domanda 510(k) per il sistema Novasight Hybrid™ alla FDA nel terzo trimestre 2025, puntando a un lancio commerciale nella prima metà del 2026.
I principali dati finanziari mostrano una riduzione significativa della perdita operativa a $4,6M rispetto a $8,9M nell'anno precedente, e una posizione di cassa migliorata a $11,3M dopo un'offerta azionaria da $20M completata in aprile. I ricavi sono stati di $63.000, in calo rispetto a $401.000 dell'anno precedente, riflettendo la focalizzazione dell'azienda sullo sviluppo della prossima generazione di prodotti.
Tra i traguardi operativi, test di validazione completati con cardiologi di primo piano e una pubblicazione su JSCAI che conferma l'efficacia dell'approccio ibrido IVUS/OCT.
Conavi Medical (OTCQB:CNVIF), compañía de dispositivos médicos especializada en tecnología de imagen cardiovascular, informó sus resultados del tercer trimestre fiscal de 2025 y presentó actualizaciones operativas clave. La empresa mantiene su plan de presentar la solicitud 510(k) para el sistema Novasight Hybrid™ ante la FDA en el tercer trimestre de 2025, con la mira puesta en un lanzamiento comercial en la primera mitad de 2026.
Entre los aspectos financieros destaca la reducción significativa de la pérdida operativa a $4.6M desde $8.9M año contra año, y una mejor posición de efectivo de $11.3M tras una oferta de acciones por $20M completada en abril. Los ingresos fueron de $63,000, por debajo de $401,000 del año anterior, reflejando el enfoque de la compañía en el desarrollo de la próxima generación de productos.
Los logros operativos incluyen pruebas de validación exitosas con cardiólogos líderes y una publicación notable en JSCAI que avala su enfoque híbrido de imagen IVUS/OCT.
Conavi Medical (OTCQB:CNVIF), 심혈관 영상 기술을 전문으로 하는 의료기기 회사가 2025 회계연도 3분기 실적과 주요 운영 업데이트를 발표했습니다. 회사는 Novasight Hybrid™ 시스템에 대한 510(k) 신청서를 2025년 3분기에 FDA에 제출할 계획을 유지하며, 2026년 상반기 상용화를 목표로 하고 있습니다.
재무 하이라이트로는 영업손실이 전년 대비 $8.9M에서 $4.6M으로 크게 감소했고, 4월 완료된 $20M 주식 공모 이후 현금 잔액이 $11.3M으로 개선되었습니다. 매출은 $63,000로 전년의 $401,000 대비 감소했으며, 이는 차세대 제품 개발에 대한 회사의 집중을 반영합니다.
운영 성과로는 주요 심장 전문의들과의 검증 테스트 성공과 하이브리드 IVUS/OCT 영상 접근법을 입증한 JSCAI 학술지 게재가 포함됩니다.
Conavi Medical (OTCQB:CNVIF), entreprise de dispositifs médicaux spécialisée dans les technologies d'imagerie cardiovasculaire, a publié ses résultats du troisième trimestre fiscal 2025 et fourni des mises à jour opérationnelles clés. La société reste en voie de soumettre sa demande 510(k) pour le système Novasight Hybrid™ à la FDA au T3 2025, visant un lancement commercial au premier semestre 2026.
Parmi les points financiers, on note une réduction significative de la perte d'exploitation à $4,6M contre $8,9M d'une année sur l'autre, et une trésorerie améliorée de $11,3M après une offre d'actions de $20M finalisée en avril. Les revenus se sont élevés à $63 000, en baisse par rapport à $401 000 l'année précédente, reflétant l'orientation de la société vers le développement de la prochaine génération de produits.
Parmi les réalisations opérationnelles figurent des tests de validation réussis avec des cardiologues de premier plan et une publication notable dans JSCAI validant leur approche d'imagerie hybride IVUS/OCT.
Conavi Medical (OTCQB:CNVIF), ein Medizintechnikunternehmen spezialisiert auf kardiovaskuläre Bildgebung, hat seine Ergebnisse für das dritte Fiskalquartal 2025 veröffentlicht und wesentliche betriebliche Updates bekanntgegeben. Das Unternehmen bleibt auf Kurs, die 510(k)-Anmeldung für das Novasight Hybrid™-System im dritten Quartal 2025 bei der FDA einzureichen und peilt eine kommerzielle Markteinführung in der ersten Hälfte 2026 an.
Zu den finanziellen Eckdaten gehört eine bedeutende Reduzierung des Betriebsverlusts auf $4,6M gegenüber $8,9M im Vorjahreszeitraum sowie eine verbesserte Cash-Position von $11,3M nach einer im April abgeschlossenen Eigenkapitalplatzierung über $20M. Der Umsatz belief sich auf $63.000 und sank damit gegenüber $401.000 im Vorjahr, was die Fokussierung des Unternehmens auf die Entwicklung der nächsten Produktgeneration widerspiegelt.
Betriebliche Erfolge umfassen erfolgreiche Validierungstests mit führenden Kardiologen und eine bedeutende Publikation in JSCAI, die den hybriden IVUS/OCT-Bildgebungsansatz bestätigt.
- Successful completion of $20M equity financing strengthens balance sheet
- Operating loss reduced by 48% year-over-year to $4.6M
- R&D expenses decreased from $6.3M to $3.2M as product development nears completion
- Successful validation testing with key opinion leaders confirms market readiness
- Cash position improved to $11.3M from $0.4M in September 2024
- Revenue declined 84% year-over-year to $63,000
- Net loss of $3.6M despite reduced operating expenses
- Significant cash commission and compensation options issued for the equity offering
- US FDA 510(k) submission remains on track for calendar Q3 2025
- Successful validation testing of Novasight Hybrid™ system with key opinion leaders
- Recent academic publications underscore importance of intravascular imaging and potential of hybrid IVUS / OCT
$20 million financing completed in April strengthens balance sheet and supports anticipated U.S. launch
TORONTO, Aug. 29, 2025 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi Medical” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today announced its financial results for the fiscal quarter ended June 30, 2025.
“Fiscal Q3 was an important quarter as we completed validation testing with leading interventional cardiologists, giving us confidence that our next generation Novasight™ is designed to be a best-in-class product,” said Thomas Looby, CEO of Conavi Medical. “We remain on track to submit our 510(k) application to the U.S. FDA in calendar Q3 2025, a key milestone that positions us for an anticipated U.S. launch in the first half of calendar 2026. Importantly, the
A recent publication in the Journal of the American College of Cardiology (JACC) underscores the rising importance of intravascular imaging in the treatment of patients with complex coronary artery disease, a market that continues to grow as physicians increasingly rely on imaging to guide better outcomes. Combined with hands-on validation by experts using our system, these developments highlight the strong clinical and commercial momentum behind our hybrid IVUS / OCT technology and its potential to transform patient care.
Business Highlights:
Successful Validation Testing with Key Opinion Leaders: In July 2025, Conavi conducted two pre-clinical animal experiments with several leading interventional cardiologists, confirming that next generation Novasight meets key customer specifications for usability, imaging performance, and workflow integration. These studies validated market readiness and established that the system is competitive with best-in-class stand-alone IVUS and OCT solutions.
510(k) Regulatory Submission Remains on Track: The Company remains on track to submit its 510(k) application to the U.S. FDA in Q3 of calendar 2025, a critical milestone toward its planned U.S. launch in H1 calendar 2026.
Transfer to Production Underway: Conavi advanced preparations to transition next generation Novasight from development to manufacturing. Transfer to production is expected to be completed to coincide with the planned U.S. launch in H1 calendar 2026.
Peer-Reviewed JSCAI Publication: In July 2025, Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) published a case study with images from the first-generation Novasight system highlighting hybrid IVUS / OCT imaging as a breakthrough modality for guiding complex coronary interventions, further validating Conavi’s unique clinical approach.
Upcoming Targeted Milestones (calendar dates):
Q3 2025
- Planned submission of next generation Novasight U.S. FDA 510(k) application.
Q4 2025
- Publish additional whitepapers and case studies to drive awareness.
H1 2026
- Expected FDA clearance and U.S. commercial launch of next generation Novasight.
Fiscal Q3 2025 Financial Results
All amounts are in Canadian dollars unless specified otherwise:
As previously reported, in the two preceding fiscal years and in FY Q2 2025, the Company focused on development of the next-generation Novasight system and on incorporating clinical user feedback from its earlier Novasight system. This focus and shift in resources continued into FY Q3 2025. For the quarter ended June 30, 2025, the Company recorded revenue of
Operating expenses for the three months ended June 30, 2025, were
The Q3 FY 2025 net loss was
As of June 30, 2025, cash and cash equivalents were
For detailed financial results, please refer to Conavi Medical’s filings on SEDAR+ and the Company’s website www.conavi.com.
Additional Disclosure Regarding
Further to the Company’s press release dated April 23, 2025 regarding the closing of its public equity offering for aggregate gross proceeds of
About Conavi Medical
Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid™ System has regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit conavi.com.
Cautionary Statement Regarding Forward-Looking Information
This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s plans for the commercialization of its Novasight Hybrid™ System and expected FDA clearance and the commercial launch of next generation Novasight in the U.S.
These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements.
Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Contact:
Stefano Picone
Chief Financial Officer
(416) 483-0100
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