The two could turn out to be potential growth companies for entirely different reasons. Imricor Medical Systems is actively expanding its reach by activating more existing sites, signing new ones, and launching pivotal clinical trials like VISABL-AFL and VISABL-VT. Among the growing companies to invest in, it is in robust momentum. The other one from ASX listed companies is Neurizon Therapeutics, which is making significant strides in developing treatments for ALS, with a strong global intellectual property position and several promising patents. They aim to capitalize on the more than 200,000 people living with ALS worldwide, where current treatment options are limited and costly and can become one of the high growth stocks
Imricor Medical Systems, Inc. (ASX: IMR)
Imricor Medical Systems recently provided a significant update on its NorthStar 3D mapping system, achieving a major milestone in collaboration with Philips. The NorthStar system successfully met all technical objectives of the SIGNET trial, demonstrating compatibility with Philips’ MRI platform during comprehensive testing at Amsterdam University Medical Centre on October 10th. This achievement enables Imricor and Philips to initiate commercialization efforts for NorthStar on the Philips platform. Additionally, Imricor anticipates launching NorthStar on Siemens’ MRI platform in 2025 and is actively advancing discussions with GE Healthcare for future compatibility. This progress places Imricor in a strong position to deliver on its MRI-guided electrophysiology vision across three leading MRI platforms, driving both one-time and recurring revenue streams.
Operationally, Imricor’s Q3 2024 report highlighted several strategic developments. In a landmark achievement, the first MRI-guided ablation on U.S. soil was successfully performed at Johns Hopkins University Hospital. The company also completed a two-tranche placement, raising $35 million to strengthen its balance sheet, ensuring ample resources to achieve its growth milestones. Although the commencement of the VISABL-VT trial has been shifted to Q4 due to regulatory considerations around MR-compatible defibrillator enhancements, the trial remains a priority as a pivotal step toward validating NorthStar’s effectiveness. Financially, Q3 revenue reached $270,000, a 13% decrease from Q2, impacted by delayed consumable orders with revenue shifted to Q4 per the company’s revenue recognition policy. Operating cash outflows were contained at $4 million, including annual D&O insurance premiums, which will not recur in subsequent quarters. Imricor’s cash balance stood at $19.6 million as of September 30.
Imricor’s unique MRI-guided technology comes at a time when demand for complex ablations, such as VT and Afib, continues to rise globally, challenging hospitals to optimize EP lab efficiency and success rates. MRI-guided ablations promise faster procedures, higher first-attempt success rates, and reduced procedural costs, making them highly attractive to physicians and administrators. As Imricor continues to execute on its commercialization strategy, the company is positioned to benefit from the growing market need, promising robust future revenue and shareholder value.
Neurizon Therapeutics Limited (ASX: NUZ)
On November 11, 2024, Neurizon Therapeutics Limited (ASX: NUZ) announced that it had received a positive opinion from the European Medicines Agency (EMA) for Orphan Medicinal Product Designation (OMPD) for its lead drug candidate, NUZ-001, aimed at treating Amyotrophic Lateral Sclerosis (ALS). This represents a landmark for Neurizon as it opens the door to several benefits, including 10 years of market exclusivity in the European Union upon approval, reduced regulatory fees, and free protocol assistance. This recognition positions Neurizon to advance NUZ-001 through its Phase 2/3 clinical trial, expected to begin enrolling patients in early 2025. The designation will also complement the US FDA's grant of Orphan Drug Designation to support further strengthening of Neurizon's global development strategy for NUZ-001.
Neurizon is advancing NUZ-001 as part of the prestigious HEALEY ALS Platform Trial, which will begin enrolling patients in the first half of 2025. The company’s approach is designed to facilitate early regulatory approval for NUZ-001, addressing the urgent need for effective treatments for ALS, a severe and progressive neurodegenerative disease. In addition to the positive opinion from the EMA, Neurizon has been actively engaging with regulators in both Europe and the United States to ensure a smooth clinical development process. The positive opinion from the EMA is particularly significant given the high prevalence of ALS in Europe, which is twice as common as in the United States.
Neurizon’s recent quarterly activities report highlighted several key achievements, including the acceptance of NUZ-001 into the HEALEY ALS Platform Trial, positive interim results from the OLE Study, and securing Small and Medium Enterprise (SME) status with the EMA. The company also successfully raised $7.8 million in a Share Purchase Plan, strengthening its cash position to $15 million. Moving forward, Neurizon will focus on finalizing the clinical trial protocol for the HEALEY ALS Platform Trial, opening an Investigational New Drug (IND) application with the US FDA, and receiving the official Orphan Designation from the European Commission in December 2024.
Source: Company’s Report
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