Inspiremd Stock Price, News & Analysis

InspireMD (Nasdaq: NSPR) reported Q2 2025 financial results, marking a transformative period highlighted by the FDA approval and U.S. commercial launch of their CGuard Prime carotid stent system. The company secured $58 million in gross proceeds through equity private placement and warrant exercises.

Q2 2025 revenue increased 2.3% to $1.78 million, while operating expenses rose 55.2% to $13.33 million due to U.S. sales force expansion. The company reported a net loss of $13.15 million ($0.26 per share). Cash position stood at $19.37 million as of June 30, 2025. Additional milestones include CE Mark approval for CGuard Prime EPS and key leadership appointments.

InspireMD (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system, has appointed Raymond W. Cohen to its Board of Directors. Cohen brings over 40 years of medical technology leadership experience, most notably as CEO of Axonics, which he led to a $3.7 billion acquisition by Boston Scientific in 2024.

Cohen's appointment comes at a strategic time following the PMA approval of InspireMD's CGuard Prime carotid stent system. His extensive experience includes leading SoniVie Ltd. (acquired for $600 million), and serving as CEO of Vessix Vascular and Cardiac Science. The company aims to leverage Cohen's expertise in scaling commercial operations as it focuses on the U.S. market launch of its stroke prevention technology.

InspireMD (NASDAQ: NSPR) has secured combined financings of $58 million through a private placement (PIPE) and warrant exercises. The PIPE financing, led by OrbiMed and Marshall Wace, raised $40.1 million by issuing 16,556,184 shares at $2.42 per share. An additional $17.9 million was generated through warrant exercises triggered by FDA approval of the company's CGuard Prime carotid stent system.

The funding will support the U.S. commercial launch of CGuard Prime, which recently received FDA premarket application approval (PMA). The company benefits from a favorable reimbursement environment, including a national coverage decision for carotid stenting. BofA Securities served as the exclusive placement agent for the PIPE transaction, which is expected to close by August 1, 2025.

InspireMD (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system, will release its Q2 2025 financial results on Tuesday, August 5, 2025. The company will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss financial results and recent highlights.

Investors can access the earnings call by dialing 1-800-579-2543 (domestic) or 1-785-424-1789 (international). A webcast will be available on InspireMD's website, and a replay will be archived for later viewing.

InspireMD (Nasdaq: NSPR) has officially launched its CGuard Prime carotid stent system in the U.S. market following FDA PMA approval. The innovative device, designed for stroke prevention, features three key advantages: a dual layer design with the largest open-cell frame and smallest mesh pore size, a MicroNet™ bio-stable mesh made from 20 μm PET, and SmartFit™ technology for precise vessel wall apposition.

The company has already achieved double-digit market share across 30+ countries and has assembled an experienced commercial team for the U.S. launch. Dr. D. Chris Metzger, System Vascular Chief at OhioHealth, highlighted the system's enhanced embolic protection and deliverability, while Ballad Health's involvement demonstrates the technology's progression from clinical trials to commercial use.

InspireMD (NASDAQ: NSPR) has received FDA PMA approval for its CGuard Prime Carotid Stent System, designed for stroke prevention. The approval is supported by the C-GUARDIANS pivotal trial, which demonstrated exceptional safety metrics with the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates in any carotid intervention study.

The trial, involving 316 patients across 24 sites in the US and Europe, validates the effectiveness of the company's MicroNet™ mesh technology. With over 65,000 implants sold and studies in over 2,000 patients, CGuard Prime represents a significant advancement in carotid disease treatment.

The approval triggers a warrant tranche expected to generate $17.9M in gross proceeds if fully exercised, supporting the US commercial launch and further product development.

InspireMD (NSPR) has achieved CE Mark approval under European MDR for its CGuard Prime Embolic Prevention System, a carotid stent system designed to prevent strokes. The CGuard Prime, featuring proprietary MicroNet mesh technology, was developed based on user feedback to enhance deliverability and deployment. The system works by trapping debris against vessel walls and preventing plaque prolapse and embolization that can lead to strokes. CEO Marvin Slosman highlighted this approval as a significant milestone, enabling commercial launch across CE-marked markets. The company plans to launch the same platform in the United States later in 2025, pending FDA approval, which would allow for unified platform deployment across their markets.

InspireMD (NSPR) has appointed Michael Lawless as its new Chief Financial Officer, effective by June 30, 2025, succeeding Craig Shore who served in the role for nearly 15 years. Lawless brings extensive healthcare industry experience, having previously served as CFO of Lifeward and the Life Sciences unit of Brooks Automation. As part of his compensation package, Lawless will receive 465,000 shares of restricted stock and options to purchase 212,000 shares, vesting over three years. The appointment comes at a crucial time as InspireMD prepares for the U.S. market launch of its CGuard Prime carotid stent system, designed for treating carotid artery disease and preventing stroke.

InspireMD (NSPR) reported Q1 2025 financial results, showing a 1.2% revenue increase to $1.53 million from $1.51 million in Q1 2024. The company reported a net loss of $11.17 million ($0.22 per share), compared to $7.03 million ($0.21 per share) in Q1 2024. Operating expenses increased 52.5% to $11.75 million due to U.S. sales force expansion. Cash position stood at $26.09 million as of March 31, 2025. The company continues engagement with FDA for CGuard Prime carotid stent system approval, anticipated in Q3 2025, while advancing commercial infrastructure for U.S. launch. The CGUARDIANS II pivotal study for TCAR procedures continues enrollment.