Wavegate Corporation | January 14, 2022
Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a reasonable expectation that the device will provide improved effectiveness compared to the standard of care.
"We are pleased the FDA has granted Breakthrough Device designation for our novel StimuLux™ technology. This underscores the urgent need within our society for more effective treatments of chronic, debilitating pain. We are eager to closely collaborate with the FDA as Wavegate works toward advancing the state of the art."
Erich Wolf, MD, PhD, Chief Executive Officer
"This designation underscores the urgent need within our society for more effective treatments of chronic, debilitating pain."
StimuLux™ is a component of Wavegate Corporation's Ellipse neuromodulation platform which integrates multiple patented technologies which aim to systematically address unmet clinical needs within the neuromodulation industry.
About Wavegate Corporation
Wavegate Corporation is a privately-held start-up neuromodulation company focused on developing and commercializing a suite of technological innovations including: waveform-independent closed-loop adaptive stimulation, a stimulation paradigm for modulation of both ascending and descending spinal cord pain pathways, new implant geometry for reduced surface contact pressures, rapid lead anchoring, and others.
Crosscope Inc. | April 11, 2022
Crosscope Inc. teams up with Waleed Pharmacy & Stores LLC. The latter focuses on fetching healthcare, hospital, and pharmaceutical solutions to the Sultanate of Oman, whereas Crosscope provides AI-enabled digital pathology software.
Both have signed Memorandum of Understanding to facilitate a makeover in the Histopathology arena that uses Crosscope’s AI-enabled digital pathology platform. Moreover, both aim to bring pioneering technical solutions to Oman that allows commercial use that will reduce the country's cancer load, which is one of the chief health concern around the world.
Oman is facing severity in terms of Cancer spread, as per World Health Organization. Crosscope Dx comes with an integrated workflow that works on the platform of vendor-agnostic digital pathology, which comes with comprehensive solutions for digital pathology.
Moreover, Crosscope presents features such as advanced workflow, cohesive and easy to follow workflow solutions and open and scalable architecture designed for pathologists to decrease their workload, lessen the reversal time, guarantee quicker diagnosis, and a reduced outbreak of the disease in the region.
Because of this partnership, Waleed Pharmacy will be Crosscope's official representative in Oman. Both firms plan to provide cancer diagnosis service providers with state-of-the-art comprehensive Digital Pathology Platforms, AI, and ML capabilities. They'll also look into all available options for collaboration, collaborating and using each other's knowledge, network, and know-how to improve the region's cancer diagnostics environment.
"We are delighted to join forces with the Waleed Pharmacy group. Waleed Pharmacy's experienced team has a proven track record of delivering and deploying healthcare IT solutions in the Oman region and represents a perfect partner for Crosscope. By teaming up, we are confident that we have created the synergies to boost the development and commercialization of our digital pathology workflows,"
Dr. Jayendra Shinde, CEO of Crosscope
Crosscope may collaborate with the region's most respected key opinion leaders in prestigious hospitals, clinical institutions, diagnostic chains, R&D labs, research organizations, pharma companies, and other organizations in the related space where the company's products provide clinical value to users.
Harrow Health, Inc. | August 18, 2021
Harrow Health, Inc. an ophthalmic‑focused healthcare company, today announced that it has entered into an agreement with Wakamoto Pharmaceutical Co., Ltd. to acquire the U.S. and Canadian commercial rights for drug candidate MAQ-100, a preservative-free triamcinolone acetonide ophthalmic injection.
MAQ-100 is marketed and sold by Wakamoto in Japan as MaQaid®. Following Japan’s Ministry of Health Labor and Welfare (or MHLW) approval, MaQaid was launched in Japan in 2010, indicated as an intravitreal injection for visualization for vitrectomy. Since its initial MHLW approval, the indication for MaQaid was expanded to include (a) treatments for alleviation of diabetic macular edema, (b) macular edema associated with retinal vein occlusion (or RVO), and (c) non‑infectious uveitis. Harrow intends to leverage the clinical data used for Japanese market approval of MaQaid, initially to support a clinical program and U.S. market NDA submission of MAQ-100 for visualization during vitrectomy.
Mark L. Baum, CEO of Harrow Health, stated, “We are indeed honored to work with our new partners at Wakamoto to bring MAQ-100 to the U.S. and Canadian markets. This transaction is an excellent strategic fit with our recent commitment to expand our footprint to include retina‑focused surgeons and follows our recent announcement of the acquisition of AMP‑100, a patented, innovative ocular surface anesthetic drug candidate. Both transactions represent progress towards the execution of our strategic goal to grow Harrow through the addition of high-value products to our pharmaceutical portfolio. And both transactions allow us to leverage our wholly owned, efficient, scalable, and tech‑enabled ImprimisRx ophthalmic-focused platform to expand the portfolio of ophthalmic pharmaceutical products we provide to the thousands of prescribers we serve across the country.”
Norihisa Kojima, CEO for Wakamoto Pharmaceuticals, stated, “We are very glad to have an opportunity to collaborate with Harrow Health. We believe Harrow Health’s exclusive focus on ophthalmology and commitment to thousands of American ophthalmic surgeons, providing high‑quality and innovative medications, make Harrow an excellent selection for potential expansion to the U.S. and Canada markets.”
Under the terms of the agreement, Wakamoto will receive payments based on the achievement of commercial milestones and supply Harrow with MAQ-100. Harrow Health will have marketing rights for the U.S. and Canada, while Wakamoto Pharmaceuticals will retain MAQ-100 marketing rights in other countries.
B. Riley Securities acted as financial advisors to Harrow Health and MP Advisors acted as strategic advisors to Wakamoto on the transaction.
About Wakamoto Pharmaceutical Co., Ltd.
Wakamoto Pharmaceutical Co., Ltd. (Head office: Tokyo, CEO: Norihisa Kojima), a Japanese pharmaceutical company, started in 1929. Wakamoto Pharmaceuticals manufactures and sells various kinds of ethical drugs in ophthalmology, OTC products and food supplements.
About Harrow Health
Harrow Health, Inc. is an ophthalmic-focused healthcare company. The Company owns and operates ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical businesses, and Visionology, a direct-to-consumer eye care subsidiary focused on chronic eye disease. Harrow Health also holds non-controlling equity positions in Eton Pharmaceuticals, Surface Ophthalmics and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries, and owns royalty rights in four clinical-stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals. For more information about Harrow Health