Novasight Hybrid™ System
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Conavi Medical Corp. Announces Closing of $12M Public Offering
Globenewswire· 2026-01-13 14:05
Core Viewpoint - Conavi Medical Corp. has successfully closed an equity offering, raising approximately $12 million to support the commercialization of its Novasight Hybrid system and other corporate purposes [1][2][4]. Group 1: Offering Details - The equity offering generated gross proceeds of approximately $12 million, with subscribers purchasing 26,666,670 common shares at a price of $0.45 per share [1][3]. - The proceeds will be utilized for obtaining US FDA 510(k) clearance for the Novasight Hybrid system and initiating a targeted market release in the United States, along with working capital and general corporate purposes [2][4]. Group 2: Company Background - Conavi Medical focuses on designing, manufacturing, and marketing imaging technologies for minimally invasive cardiovascular procedures, with its Novasight Hybrid system being the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) [7]. - The first-generation Novasight Hybrid system has already received 510(k) regulatory clearance in the U.S., Canada, China, and Japan [7]. Group 3: Agent and Compensation - Bloom Burton Securities Inc. acted as the sole agent for the offering, receiving a total cash commission of approximately $701,479.49 and 1,558,843 compensation options, each allowing the purchase of one common share at $0.45 until January 13, 2028 [3][6].
Conavi Medical Corp. Announces Filing of Amended & Restated Final Prospectus
Globenewswire· 2026-01-08 02:38
Core Viewpoint - Conavi Medical Corp. is conducting a public offering of common shares and pre-funded common share purchase warrants to raise between $12 million and $15 million for regulatory clearance and market release of its Novasight Hybrid system, along with working capital needs [2][3][6]. Group 1: Offering Details - The offering consists of a minimum of 26,666,667 and a maximum of 33,333,333 securities priced at $0.45 per common share or $0.44999 per pre-funded warrant [2]. - Each pre-funded warrant allows the holder to acquire one common share at an exercise price of $0.00001, with no expiration and can be exercised on a cashless basis [2]. - The offering may be completed in one or more tranches, with an expected initial closing date around January 13, 2026, subject to regulatory approvals [6]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to obtain US FDA 510(k) clearance for the Novasight Hybrid system and to facilitate a targeted market release in the United States [3]. - Additional proceeds will be allocated for working capital and general corporate purposes [3]. Group 3: Agent and Fees - The company will pay the agent, Bloom Burton Securities Inc., a cash fee of 6.5% of the gross proceeds and grant compensation options equal to 6.5% of the total number of securities issued [7]. - A reduced cash commission of 3.25% will apply for certain purchasers on a president's list, with no compensation options for those sales [7]. Group 4: Regulatory Filings - An amended and restated final short form prospectus was filed on January 7, 2026, with securities regulatory authorities in Alberta, British Columbia, and Ontario [5]. - The offering is subject to customary closing conditions, including necessary regulatory and stock exchange approvals [6]. Group 5: Company Overview - Conavi Medical focuses on designing, manufacturing, and marketing imaging technologies for minimally invasive cardiovascular procedures [12]. - The Novasight Hybrid system combines intravascular ultrasound and optical coherence tomography into a single device, enabling simultaneous imaging of coronary arteries [12].
Conavi Medical Corp. Announces Filing of Amended & Restated Final Prospectus
Globenewswire· 2026-01-08 02:38
Core Viewpoint - Conavi Medical Corp. is conducting a public offering of common shares and pre-funded common share purchase warrants to raise between $12 million and $15 million for regulatory clearance and market release of its Novasight Hybrid system, along with working capital needs [2][3]. Offering Details - The offering consists of a minimum of 26,666,667 and a maximum of 33,333,333 securities priced at $0.45 per common share or $0.44999 per pre-funded warrant [2]. - Each pre-funded warrant allows the holder to acquire one common share at an exercise price of $0.00001, with no expiration and can be exercised on a cashless basis [2]. Use of Proceeds - The net proceeds from the offering will be used to obtain US FDA 510(k) clearance for the Novasight Hybrid system and to support a targeted market release in the United States, as well as for working capital and general corporate purposes [3]. Regulatory and Closing Information - The offering is expected to close on or about January 13, 2026, subject to customary closing conditions and necessary regulatory approvals [6]. - An amended and restated final short form prospectus was filed on January 7, 2026, which must be approved before any sale of securities [5]. Agent Compensation - The company will pay the agent a cash fee of 6.5% of the gross proceeds and grant compensation options equal to 6.5% of the total number of securities issued [7]. - A reduced cash commission of 3.25% will apply for certain purchasers on a president's list, with no compensation options for those sales [7]. Company Overview - Conavi Medical focuses on designing, manufacturing, and marketing imaging technologies for minimally invasive cardiovascular procedures, with its Novasight Hybrid system being the first to combine intravascular ultrasound and optical coherence tomography [12].
Conavi Medical Reports Fiscal Year 2025 Results and Operational Highlights
Globenewswire· 2025-12-29 12:38
Core Insights - Conavi Medical Corp. experienced a transformational fiscal year 2025, achieving significant regulatory, clinical, financial, and operational milestones, including the submission of its next-generation Novasight Hybrid™ system to the FDA and strengthening its balance sheet through U.S. institutional investments [2][3][6]. Business and Operational Highlights - The company completed its U.S. FDA 510(k) submission for the Novasight Hybrid™ IVUS/OCT system in September 2025, following successful validation testing with interventional cardiologists [3]. - Multiple peer-reviewed publications during fiscal 2025 emphasized the importance of intravascular imaging in complex coronary interventions, supporting Conavi's dual-modality imaging approach [4]. - Conavi participated in key cardiovascular conferences, such as TCT 2025, to showcase its hybrid imaging technology and engage with interventional cardiologists ahead of its commercial launch [5]. Financial Highlights - For the fiscal year ended September 30, 2025, Conavi reported total revenue of CAD 9.1 million, a significant increase from CAD 2.2 million in the previous year, primarily driven by licensing and milestone revenue from a technology transfer agreement in China [11]. - Operating expenses decreased to CAD 22.5 million from CAD 26.3 million in the prior year, resulting in an operating loss of CAD 14.9 million, an improvement from CAD 26.2 million in fiscal 2024 [12]. - The net loss for fiscal 2025 was CAD 20.5 million, or CAD 0.36 per share, compared to a net loss of CAD 43.6 million, or CAD 7.08 per share, in the previous year, attributed to a gain from the change in fair value of the company's warrant liability and lower operating expenses [13]. Funding and Financial Position - In April 2025, Conavi completed a public equity financing, raising CAD 20 million, and secured eligibility for up to CAD 2.5 million in non-dilutive funding from the Province of Ontario to support commercialization activities [6][14]. - As of September 30, 2025, the company reported cash and cash equivalents of CAD 5.8 million, a significant increase from CAD 0.4 million as of September 30, 2024 [14]. Market Outlook - With U.S. and European clinical guidelines now recommending the use of IVUS or OCT for guiding PCI in complex coronary interventions, Conavi is positioned to capitalize on the growing demand for intravascular imaging following anticipated FDA clearance and U.S. commercial launch [8].
Conavi Medical Corp. Announces Pricing of Public Offering of Common Shares and/or Pre-Funded Warrants
Globenewswire· 2025-12-18 13:45
Core Viewpoint - Conavi Medical Corp. is conducting a public offering of common shares and pre-funded common share purchase warrants to raise between $15 million and $20 million for the development of its Novasight Hybrid system and general corporate purposes [2][3][4]. Offering Details - The offering consists of a minimum of 33,333,333 and a maximum of 44,444,444 securities priced at $0.45 per common share or $0.44999 per pre-funded warrant [3]. - Each pre-funded warrant allows the holder to acquire one common share at an exercise price of $0.00001, with no expiration and can be exercised on a cashless basis [3]. Use of Proceeds - The net proceeds will be used to obtain US FDA 510(k) clearance for the Novasight Hybrid system, complete a limited market release, and initiate a broader commercial launch in the U.S. [4]. Closing and Regulatory Compliance - The offering is expected to close on or about December 23, 2025, subject to customary closing conditions and regulatory approvals [6]. - A final short form prospectus will be filed with securities regulatory authorities in Alberta, British Columbia, and Ontario [5]. Agent and Fees - The company will pay the agent a cash fee of 6.5% of the gross proceeds and grant compensation options equal to 6.5% of the total number of securities issued [7]. - A reduced cash commission of 3.25% will apply to certain purchasers on a president's list [7]. Company Overview - Conavi Medical focuses on designing, manufacturing, and marketing imaging technologies for minimally invasive cardiovascular procedures, with its Novasight Hybrid system combining intravascular ultrasound and optical coherence tomography [12].
Conavi Medical Corp. Announces Proposed Public Offering of Common Shares and Pre-Funded Warrants
Globenewswire· 2025-11-21 21:30
Core Viewpoint - Conavi Medical Corp. has filed a preliminary short form prospectus for an offering of common shares and/or pre-funded common share purchase warrants to support the launch of its Novasight Hybrid system and for general corporate purposes [2][4]. Offering Details - The offering will be conducted on a commercially reasonable efforts agency basis through Bloom Burton Securities Inc. [3] - The final terms, including the number of securities and pricing, will be determined through negotiations between the company and the agent [3]. - The expected closing date for the offering is around December 12, 2025, subject to customary closing conditions and regulatory approvals [5]. Use of Proceeds - The net proceeds from the offering will be utilized to obtain US FDA 510(k) clearance for the Novasight Hybrid system, complete a limited market release, and initiate a broader commercial launch in the United States [4]. Company Overview - Conavi Medical focuses on designing, manufacturing, and marketing imaging technologies for minimally invasive cardiovascular procedures [9]. - The Novasight Hybrid™ System combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, allowing simultaneous imaging of coronary arteries [9][10].
Conavi Expands Leadership Team to Support Next Phase of U.S. Commercialization
Globenewswire· 2025-11-03 12:00
Core Insights - Conavi Medical has appointed Mark Quick as Chief Financial Officer to support its U.S. expansion and commercialization efforts for the Novasight Hybrid imaging system [1][3][5] - The company has submitted its next-generation Novasight Hybrid IVUS/OCT system to the FDA for 510(k) clearance, aiming for a successful launch in the U.S. market [2][5] - Stefano Picone transitions to a strategic role as Chief Strategy Officer, focusing on ensuring continuity during the company's growth phase [1][4][5] Leadership Changes - Mark Quick brings over 20 years of experience in medical technology and life sciences, having held senior financial roles in publicly traded companies [3][6] - Stefano Picone has played a crucial role in Conavi's previous growth phases and will now concentrate on strategic execution [4][5] Product Development - The Novasight Hybrid System is the first device to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT), allowing simultaneous imaging of coronary arteries [7] - The first-generation Novasight Hybrid System has already received regulatory clearance in multiple countries, including the U.S., Canada, China, and Japan [7] Market Strategy - The company is actively building the necessary infrastructure to support its U.S. launch, which is critical as the U.S. is the largest market for intravascular imaging [2][5] - Leadership changes are aligned with the company's strategy to enhance its presence in the capital markets and ensure successful commercialization [1][5]
Conavi Medical announces agreement with the Province of Ontario as part of the Life Sciences Scale-Up Fund
Globenewswire· 2025-10-29 11:00
Core Insights - Conavi Medical Corp. has entered into an agreement with the Province of Ontario under the Life Sciences Scale-Up Fund (LSSUF) to support the commercial launch of its next-generation Novasight Hybrid™ system [1][2][3] Group 1: Financial Support and Project Details - The LSSUF will provide Conavi with up to $2.5 million CAD, covering up to one-third of eligible project costs related to the Novasight Hybrid™ system [2] - The funding is contingent upon meeting certain requirements as part of the project [2] Group 2: Product and Technology - The Novasight Hybrid™ system integrates intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, offering comprehensive imaging of coronary arteries [3][4] - This dual-modality approach aims to enhance the precision of diagnosis and treatment for cardiovascular diseases [3] Group 3: Industry Context and Impact - Heart disease is a leading cause of death in Canada and globally, highlighting the importance of advancements in intravascular imaging technologies [3] - The partnership with the Province of Ontario is expected to reinforce the region's position as a leader in life sciences innovation [3]
Conavi Medical to Present at the Planet MicroCap Showcase: TORONTO in partnership with MicroCapClub on Wednesday, October 22, 2025
Globenewswire· 2025-10-16 11:00
Core Points - Conavi Medical Corp. is a commercial-stage medical device company focused on imaging technologies for minimally invasive cardiovascular procedures [1][3] - The company will present at the Planet MicroCap Showcase: TORONTO 2025 on October 22, 2025, at 9:30 AM EST [1][2] - Tom Looby, the CEO of Conavi Medical, will host the presentation and answer questions afterward [1] Company Overview - Conavi Medical specializes in designing, manufacturing, and marketing imaging technologies, particularly the Novasight Hybrid™ System [3] - The Novasight Hybrid™ System is the first device to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) for simultaneous imaging of coronary arteries [3] - The first-generation Novasight Hybrid™ System has received regulatory clearance in the U.S., Canada, China, and Japan [3] Event Details - The Planet MicroCap Showcase: TORONTO 2025 is organized in partnership with MicroCapClub [4] - Live presentations will be accessible via a webcast link provided for attendees [2][3] - Attendees can schedule 1x1 investor meetings with Conavi Medical during the conference [2]
Conavi Medical Reports Fiscal Q3 2025 Interim Results and Operational Highlights
Globenewswire· 2025-08-29 11:00
Core Insights - Conavi Medical Corp. reported its financial results for the fiscal quarter ended June 30, 2025, highlighting significant developments in its product pipeline and financial position [1][11]. Business Highlights - The company completed successful validation testing of its next-generation Novasight™ system with leading interventional cardiologists, confirming its competitiveness with existing IVUS and OCT solutions [2][3]. - A $20 million financing round completed in April 2025 strengthens the company's balance sheet, providing resources for regulatory submission and production transition [6][8]. Regulatory and Production Milestones - Conavi is on track to submit its 510(k) application to the U.S. FDA in Q3 2025, which is crucial for its planned U.S. launch in the first half of 2026 [4][10]. - The transition of the Novasight system from development to manufacturing is underway, expected to align with the U.S. launch timeline [4]. Financial Performance - For Q3 FY 2025, the company recorded revenue of CAD 63,000, a decrease from CAD 401,000 in the same period the previous year [11]. - Operating expenses were CAD 4.7 million, down from CAD 8.8 million year-over-year, leading to a reduced operating loss of CAD 4.6 million compared to CAD 8.9 million in Q3 FY 2024 [12]. - The net loss for Q3 FY 2025 was CAD 3.6 million, or CAD 0.05 per share, significantly improved from a net loss of CAD 13.0 million, or CAD 2.12 per share, in the prior year [13]. Market Context - A publication in the Journal of the American College of Cardiology emphasizes the growing importance of intravascular imaging in treating complex coronary artery disease, indicating a favorable market environment for Conavi's hybrid imaging technology [2][5].