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Simpson Interventions Receives FDA Breakthrough Device Designation for Acolyte™ Image Guided Crossing and Re-Entry Catheter System

Retrieved on:

Thursday, April 11, 2024

Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced that its groundbreaking Acolyte Image Guided Crossing and Re-Entry Catheter System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

Key Points:

Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced that its groundbreaking Acolyte Image Guided Crossing and Re-Entry Catheter System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
The Acolyte Image Guided Crossing and Re-Entry Catheter System aims to overcome these challenges by providing clinicians with this breakthrough device that has enhanced visualization and navigation capabilities, ultimately improving CTO crossing, procedural success rates, and patient outcomes.
"We are thrilled to receive FDA's Breakthrough Device Designation for our Acolyte Image Guided Crossing and Re-Entry Catheter System," said Dr. John B. Simpson, PhD, MD, Founder and CEO of Simpson Interventions.
Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System.

Breakthrough Study Reveals Somavedic Device's Potential Impact on Wet AMD Patients

Retrieved on:

Tuesday, April 23, 2024

AMD, Patient, CNV, Health, Angiography, Research, OCT, CRT, Quality of life, Sleep, SAN, Visual acuity

SAN FRANCISCO, April 23, 2024 /PRNewswire/ -- Somavedic, a trailblazer in sleep and digital pollution-neutralizing frequency therapy technology, in collaboration with researchers from the Eye Clinic of Jan Evangelista Purkyně University and Masaryk Hospital in Ústí nad Labem in the Czech Republic, have unveiled groundbreaking findings from a study showcasing the effectiveness of the Somavedic device in supporting individuals with wet age-related macular degeneration (wet AMD), a prevalent cause of severe vision impairment among older adults.

Key Points:

The study enrolled patients with newly diagnosed wet AMD and active choroidal neovascularization (CNV), where anti-VEGF therapy was indicated.
Patients received a functioning Somavedic device for home use, while the other group was administered a non-functional placebo device.
"We are immensely encouraged by the positive outcomes of this study, which underscore the potential of Somavedic to make a meaningful impact on the lives of individuals affected by wet age-related macular degeneration.
The positive outcomes of this study pave the way for larger-scale clinical trials to substantiate the efficacy of Somavedic in wet AMD management.

MediciNova Receives a Notice of Allowance for a New Patent Covering MN-166 (ibudilast) for the Treatment of Macular Injury in Japan

Retrieved on:

Tuesday, March 26, 2024

OCT, Optical coherence tomography, Patent, Multiple sclerosis, Capsule, Tablet, Code, MD, SPRINT, MPH, Tokyo Stock Exchange, Pharmaceutical industry

Once issued, this patent is expected to expire no earlier than October 2039.

Key Points:

Once issued, this patent is expected to expire no earlier than October 2039.
The allowed claims cover the use of MN-166 (ibudilast) for treating macular injury associated with progressive multiple sclerosis and for decreasing macular volume loss associated with progressive multiple sclerosis.
The allowed claims specifically cover both primary progressive multiple sclerosis and secondary progressive multiple sclerosis.
Previously, we reported positive Optical Coherence Tomography (OCT) results from the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis.

Titan Announces Merger Agreement with Conavi

Retrieved on:

Monday, March 18, 2024

TSX Venture Exchange, Agreement, Health Canada, IP, OCT, RAS, Chairperson, Toronto Stock Exchange, Consolidation, Combined, Reverse, Concurrency, Food, TMD, TSX, Transaction, IVUS, Security (finance)

TORONTO, Ontario, March 18, 2024 (GLOBE NEWSWIRE) -- Titan Medical Inc. (“Titan”) (TSX: TMD; OTC: TMDIF) is pleased to announce that it has entered into a definitive amalgamation agreement (the “Amalgamation Agreement”) dated March 17, 2024 with Conavi Medical Inc. (“Conavi”) to combine the companies in an all-stock transaction.

Key Points:

TORONTO, Ontario, March 18, 2024 (GLOBE NEWSWIRE) -- Titan Medical Inc. (“Titan”) (TSX: TMD; OTC: TMDIF) is pleased to announce that it has entered into a definitive amalgamation agreement (the “Amalgamation Agreement”) dated March 17, 2024 with Conavi Medical Inc. (“Conavi”) to combine the companies in an all-stock transaction.
Under the terms of the Agreement, Titan will acquire all of the issued and outstanding shares of Conavi (the “Conavi Shares”) and in exchange Conavi shareholders will be issued common shares of Titan (the “Combined Entity Shares”).
Throughout 2023, it was made clear to Titan that a merger with another RAS company was not a viable option and Titan broadened its search for a merger partner beyond RAS.
The Titan Board is unanimous in its decision to execute the Amalgamation Agreement and to recommend this Transaction to its shareholders (the “Titan Shareholders”).

Nicox Updates on Corporate, Pipeline and Financing Perspectives and Will Hold a Webcast on March 18, 2024

Retrieved on:

Wednesday, March 13, 2024

“Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.

Key Points:

“Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.
We are reducing costs, including the size of the organization, and are exploring advancing NCX 1728, through collaborations.
In January 2024, Nicox expanded the territory of the exclusive licensing agreement with Harrow, Inc., to include Canada.
The Company is financed to at least November 2024, based on focusing exclusively on the development of NCX 470.

Perimeter Medical Imaging AI Announces Participation at the Upcoming Annual Meeting of the American Society of Breast Surgeons (ASBrS) and Provides Corporate Updates

Retrieved on:

Thursday, April 4, 2024

OCT, TSX Venture Exchange, News, TSX, TMX, Perimeter, CIRO, Legislation, Security (finance)

On April 3, 2024, the Company approved the grant of 470,000 stock options to certain directors and company officers, and 863,177 options to employees as a key retention incentive tool.

Key Points:

On April 3, 2024, the Company approved the grant of 470,000 stock options to certain directors and company officers, and 863,177 options to employees as a key retention incentive tool.
Velocity Trade is a member of the TMX, and of the Canadian Investment Regulatory Organization (CIRO).
The funding and securities required for these services undertaken will be provided by Velocity Trade.
Velocity Trade and Perimeter are not related parties and have no other agreements other than the market liquidity agreement which is the subject of this news release.

Perimeter Medical Imaging AI Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update

Retrieved on:

Thursday, March 28, 2024

OCT, Growth, International, International Financial Reporting Standards, Mayo Clinic, University, AI, Software, Clinical trial, OTC, S series, Breast cancer, IAS, PINK, Perimeter

TORONTO and DALLAS, March 28, 2024 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) ("Perimeter" or the "Company") – a commercial-stage medical technology company – today reported financial results for the quarter and year ended December 31, 2023 and provided a corporate update.

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TORONTO and DALLAS, March 28, 2024 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) ("Perimeter" or the "Company") – a commercial-stage medical technology company – today reported financial results for the quarter and year ended December 31, 2023 and provided a corporate update.
Mr. Mendes continued, "As we enter 2024, patient enrollment is outpacing our original projections for our pivotal clinical trial.
In addition, our pipeline of product innovations is growing, with several new product introductions and AI enhancements anticipated this year.
The Company will host a conference call and live audio webcast today at 4:30 pm Eastern Time to discuss its fourth quarter and year-end 2023 results and provide a corporate update.

Specsavers and Municipal Retirees Organization Ontario Partner to Make Eye Health More Affordable for over 36,000 Members

Retrieved on:

Tuesday, March 26, 2024

OMERS, Partnership, OCT, Optometry, Patient, Eye, 3D, Contact, Specsavers, Lens

TORONTO, March 26, 2024 /CNW/ - Specsavers, a leading eyecare and eyewear provider, has announced a partnership with the Municipal Retirees Organization Ontario (MROO), the largest organization supporting OMERS pensioners.

Key Points:

TORONTO, March 26, 2024 /CNW/ - Specsavers, a leading eyecare and eyewear provider, has announced a partnership with the Municipal Retirees Organization Ontario (MROO), the largest organization supporting OMERS pensioners.
Beginning today, MROO members can visit one of the over 50 Specsavers locations in Ontario to save when it comes to maintaining their eye health.
"We're delighted to partner with MROO and bring our passion for making quality eyecare and eyewear affordable and accessible to all their members," said Bill Moir, Managing Director of Specsavers Canada.
"The focus on eye health and great value makes Specsavers a perfect partner for MROO," said Keith Robicheau, President of MROO.

Perimeter Medical Imaging AI Provides Corporate Update on Grant Funding Opportunities and Announces Conference Call/Webcast to Discuss Fourth Quarter and Year-End 2023 Financial Results

Retrieved on:

Wednesday, March 20, 2024

OCT, PSI, Webcast, Society, Surgeon, Clinical trial, OTC, Surgical oncology, PINK, Perimeter, DARPA, Pharmaceutical industry

DALLAS and TORONTO, March 20, 2024 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) ("Perimeter" or the "Company") – a commercial-stage medical technology company – announced upcoming events and provided a corporate update on grant funding opportunities to support its next-generation AI technology development.

Key Points:

DALLAS and TORONTO, March 20, 2024 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) ("Perimeter" or the "Company") – a commercial-stage medical technology company – announced upcoming events and provided a corporate update on grant funding opportunities to support its next-generation AI technology development.
Although disappointing, it's important to note that these funds were proposed for future tissue type investigations and related product development.
We look forward to providing a more detailed corporate update when we announce our year-end 2023 results next week."
A telephonic playback of the conference call will be available for 14 days after the conference call by calling 1-844-512-2921 or 1-412-317-6671 and referencing conference ID 62216896.

NEC and Skyloom to Pioneer 100 Gbps Space Optical Communications, Transforming Global Internet Connectivity

Retrieved on:

Tuesday, March 19, 2024

Constellation, Radio, OCT, Communication, Entrepreneurship, Intelligence, Partnership, History, Artificial intelligence, NEC, Data-rate units, Orbit, Communications satellite

TOKYO and DENVER, March 19, 2024 /PRNewswire-PRWeb/ -- NEC Corporation (NEC; TSE: 6701) and Skyloom Global Corporation have joined forces to revolutionize space communications with the development of cutting-edge optical communication equipment for multi-orbit satellite networks. The collaboration aims to commercialize and make available on the open market one of the world's fastest space optical terminals, achieving remarkable high-speed inter-satellite communications of 100 Gbps and more, propelling the space industry into a new era of connectivity.

Key Points:

TOKYO and DENVER, March 19, 2024 /PRNewswire-PRWeb/ -- NEC Corporation (NEC; TSE: 6701) and Skyloom Global Corporation have joined forces to revolutionize space communications with the development of cutting-edge optical communication equipment for multi-orbit satellite networks.
"In partnership with NEC, we are committed to the joint development, testing, and manufacturing of the groundbreaking 100 Gbps WARP Optical Communications Terminal (OCT), slated for completion by the end of 2025.
In anticipation of this demand growth, NEC and Skyloom are at the forefront of developing technology to achieve optical communication speeds of 100 Gbps and higher.
"We expect that our collaboration with Skyloom on space optical communication will contribute to expanding space utilization in the era of networked satellite constellations."