Ra Medical registers for $87m IPO

Ra Medical yesterday registered for an initial public offering worth up to $86.5 million, according to a recently posted SEC filing. The Carlsbad, Calif.-based company said it plans to list on the New York Stock Exchange under the symbol “RMED,” according to the SEC posting. Piper Jaffray and Cantor Fitzgerald are acting as joint book runners for the offering, according to the filing. Ra Medical produces the Dabra atherectomy catheter laser designed to treat patients with peripheral artery disease. The system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, which the company touts as having significant advantages over traditional balloon angioplasty systems. Ra Medical won FDA 510(k) clearance for the system last May, and CE Mark approval in the European Union in 2016. The company has not yet released details on the IPO, but had initially planned to launch the offering in February this year. The post Ra Medical registers for $87m IPO appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Initial Public Offering (IPO) Ra Medical Source Type: news

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Authors: Giannopoulos S, Armstrong EJ Abstract Introduction: Femoropopliteal lesions account for a significant proportion of endovascular interventions for peripheral artery disease. In this manuscript we review the literature on the application of newly approved devices in the treatment of atherosclerotic lesions at this segment. Areas covered: New drug-coating technologies provide sustained drug-eluting over time and better scaffolds are more resistant to the increased biomechanical stress at the femoropopliteal segment. Thus, the newer drug-eluting stents (i.e.Eluvia®), nitinol interwoven stents (i.e.Supera&...
Source: Expert Review of Cardiovascular Therapy - Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research
FDA has granted a breakthrough device designation for Orchestra BioMed's Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease. The designation comes just a few months after the New Hope, PA-based announced its partnership with Terumo. The agreement included a $30 million up-front payment to Orchestra plus an equity commitment of $5 million. Virtue SEB is a novel, first-in-class drug/device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating. Breakthrough d...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
AbstractPurpose of reviewPaclitaxel-based endovascular devices have become the standard of care in symptomatic, medication-refractory peripheral artery disease (PAD) and in critical limb ischemia (CLI). This review examines the data on the efficacy and safety of these devices relative to standard balloon angioplasty (PTA) and bare metal stents (BMS).Recent findingsRandomized controlled trials (RCTs) have found that peripheral devices coated with paclitaxel result in superior patency rates and decreased target lesion revascularization (TLR) compared with non-drug-coated devices. Recently, a meta-analysis of randomized contr...
Source: Current Treatment Options in Cardiovascular Medicine - Category: Cardiology Source Type: research
This article describes less-invasive endovascular alternatives, such as atherectomy, drug-coated balloons and stenting, and their results. The popliteal artery is also difficult to treat in an endovascular manner due to biomechanical forces during bending and stretching of the knee or leg. Thus, we also describe currently available minimally invasive treatment options for the popliteal artery. PMID: 31476793 [PubMed - as supplied by publisher]
Source: Surgical Technology International - Category: Surgery Tags: Surg Technol Int Source Type: research
Concept Medical’s MagicTouch AVF might have the “magic touch” when it comes down to nabbing breakthrough device designations. The proposed indication for the latest breakthrough device designation is for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure. Concept Medical said its first pilot study to investigate the safety and efficacy of Magic Touch PTA Sirolimus balloon was started in Singapore in 2018. Led by Principal Investigator, Dr. Tan Chieh Suai, a multi-disciplinary team of doctors ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
Concept Medical just received a huge burst of speed in its quest to get its drug-coated balloon for the treatment of peripheral artery disease (PAD) commercially available in the U.S. The Tampa, FL-based company has received breakthrough device designation from FDA for the MagicTouch PTA, a Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). So far, Concept Medical said MagicTouch has been performing extremely well. In the XTOSI pilot study, the majority of patients enrolled had major comorbidities (diabetes and end-stage renal failure) and the indicat...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
A company backed by serial Tampa Bay entrepreneur Dr.  Kiran Patel has secured a key designation that will help advance a product from the medical device company. Concept Medical Inc. has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration for MagicTouch Percutaneous Transluminal Angioplasty, which is a Sirolimu s drug coated balloon catheter, for the treatment of peripheral artery disease. The device is for a disease that takes place below the knee, also…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - Category: Pharmaceuticals Authors: Source Type: news
We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons.MethodsThis is a retrospective cohort analysis utilizing Medicare data for 100% of fee-for-service beneficiaries from 2015–2016 who had a claim for femoropopliteal intervention. The use of drug-coated balloons was identified via specific transitional pass-through codes. All-cause mortality, all-cause hospitalization, repeat femoropopliteal intervention, and major lower extremity amputation at 1 year were the clinical outcomes...
Source: American Heart Journal - Category: Cardiology Source Type: research
Authors: Spiliopoulos S, Karamitros A, Reppas L, Brountzos E Abstract Introduction: Percutaneous transluminal angioplasty (PTA) currently remains the endovascular treatment of choice in a large percentage of patients suffering from peripheral artery disease (PAD). However, the mechanism of angioplasty itself can cause some extent of arterial dissection leading to early vessel restenosis/reocclusion. Current endovascular imaging studies have reported a higher rate of arterial dissection than previously reported in literature and advocated the correlation of dissection with poor patency. Thus, there is the need of de...
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017. The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputati...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Wall Street Beat Intact Vascular peripheral Source Type: news
More News: Angioplasty | Baloon Angioplasty | Peripheral Vascular Disease (PVD)