QuantalX (from website)
Revamp Medical, Inc., an Israeli medtech startup developing solutions for Heart Failure congestion management, closed a Series A preferred stock financing round to support clinical trials for its Doraya catheter for treating heart failure patients. At the same time, BioNanoSim (BNS), an Israeli-based nanotechnology drug discovery and development company, is set to merge with the Greek pharmaceutical company and established European manufacturer with expertise in Ophthalmics RAFARM. This while another Israeli medtech firm, QuantalX, the developer of Delphi-MD, a novel point-of-care neurodiagnostic device, received the FDA breakthrough designation medical device status for another clinical application, Normal Pressure Hydrocephalus (NPH).
The FDA recognized the innovative value of the device in diagnosing NPH patients and predicting the response to the recommended treatment for NPH, ventriculoperitoneal shunting (VPS) surgery.
QuantalX states the firm is dedicated to providing better patient care and reducing healthcare systems’ burden through early detection, differential diagnosis and treatment prediction of brain abnormalities by leveraging novel neurodiagnostic technology, the Delphi-MD device.
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The company explains NPH is a condition characterized by disturbed cerebrospinal fluid (CSF) dynamics, which manifests as a clinical triad of difficulty in walking and balancing, urinary disturbances, and cognitive decline. Although the prevalence of NPH is around 2% among people older than 65 years, it is estimated to be widely under-detected due to the invasive and inaccessible nature of the diagnostic procedure. NPH is a progressive neurodegenerative condition, and its symptoms are often confused with other types of dementia or movement disorders such as Alzheimer’s disease, vascular dementia, or Parkinson’s disease.
“This second breakthrough designation status granted to Delphi-MD, focusing on NPH detection and treatment prediction is a major achievement and yet another reinforcement of our vision, providing a reliable tool for improved brain diagnosis and optimal personalized patient care.” Said Dr. Iftach Dolev, CEO and Co-Founder of QuantalX.
Incorporated in 2016, Revamp Medical is a privately held medical technology company committed to developing solutions for acute Heart Failure congestion management. The Company has developed the Doraya catheter, a temporary venous catheter system designed to enable clinician control over renal afterload, central venous pressure, and venous return to address unmet needs in management of Acute Heart Failure.
The Doraya catheter is placed temporarily in the inferior vena cava just below the renal veins. Clinicians can manage venous system hemodynamics by using the Doraya which is intended to reduce renal afterload, central venous pressure, and venous return, which may enhance blood flow through the kidneys and improve diuresis.
“We are pleased to report that our recently published first-in-human results demonstrated safety and initial evidence of improved hemodynamics, diuresis, and congestion relief” said Yael Shohat, Revamp CEO.
And as for BioNanoSim (BNS), the company is led by Prof. Simon Benita who has decades of scientific expertise as well as proven commercial success in bringing nanoparticle-based products to market. BioNanoSim is backed by strong leadership, the collective know-how of a talented cross-functional team, and affiliation with the Hebrew University.
Over the past five years, BNS has developed the proprietary nano-technology platform (NTPO).
After merging with RAFARM, the new company will be called BNS Ophthalmics (BNSO). BNS will contribute its intellectual property and R&D expertise to BNSO while Rafarm will provide appropriate funding, together with infrastructure for development, commercial scale manufacturing, and distribution.
Professor Benita stated, “We are very pleased to partner with RAFARM and to leverage both organizations’ expertise and infrastructure for promoting improved therapeutic options in the ocular area. At BNS, we synthesize new chemical entities and develop innovative delivery approaches to address some of healthcare’s greatest challenges. BNSO will use our proprietary carrier technologies to improve the delivery, stability, and bioactivity of drugs in multiple ocular segments.”
