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Technology Name: Image-guided therapy with magnetic nanoparticles 

Company Background

Weinberg Medical Physics LLC, founded in 2008, is a privately-held company based in Bethesda, Maryland. WMP has special competence in medical imaging and image-guided therapy. Its mission is to introduce disruptive technologies that address compelling clinical indications. The company works closely with investigators at University of Maryland. Company currently has 8 employees and 4 university subcontracts.

Technology Overview

We have developed a new image-guided therapy system. The system has two properties that have never before been realized in therapeutics:

• It can deliver any drug to any location in the body non-invasively

• It can image any location in the body with cellular resolution (20 microns)

The system consists of two components: (1) an MRI-like set of electromagnetic (EM) coils and drivers that can steer magnetic particles and rapidly image tissues, and (2) proprietary magnetic particles that can carry any drug or molecule, and can ablate tissues through rotational motion. The proprietary EM drivers are enabled through novel and energy-efficient application of pulsed power technology, which has been shown to have less bio-effects than conventional methods.  The EM drivers alternately propel and image magnetizable particles as they are moved into and within solid organs (e.g., brain).

The company’s particles are built with proprietary scalable nano-engineering processes to have specific magnetic and drug-eluting properties. These particles can deliver concentrated boluses of drugs or gene products to specific locations and can rotate rapidly in order to disrupt bio- films or ablate solid tumors. The system does not require liquid helium, and thus can be used portably and in sites without extensive infrastructures. The size of the body part to be targeted impacts product cost, and so we have selected diseases of the head/brain as first targets.

Market Potential

The system will be comparable in function to advanced radiation therapy and minimally-invasive devices, but with the advantage of being able to deliver molecular therapy non-invasively. The image-guidance component of the systems will be priced in the million-dollar range, lower than devices (e.g., robotic surgery, proton therapy) with similar therapeutic missions. We have selected chronic refractory sinusitis as the first clinical indication for FDA pre-market approval, because of the high prevalence of the disease (10M patients in USA), lack of attractive surgical options, and likely device status of the application. Subsequent drug-device versions of the system will serve as minimally invasive alternatives to surgery for treatment of brain and head/neck tumors. Including renewable revenues from supplied unit-dose particle formulations, total revenues are expected to be several hundred million dollars per year within 5 years of FDA approval.

Competitive Advantages

Unlike prior systems for directing nanoparticles that could not concentrate assemblies of the particles at desired locations, our proprietary systems use pulsed fields to alternatively align, propel, and focus the particles. These fast and strong magnetic fields, which are interposed with imaging pulse sequences, have been proven to be well-tolerated by patients in clinical trials, and can realize spatial resolution at cellular levels. The particles used in the system have been shown to evade the blood-brain barrier by traveling in the interstitial spaces, and are made of biodegradable and biocompatible materials. Unlike other particle drug-delivery systems, the drugs in our system are not linked chemically to the particles, but are contained in an inner chamber that releases the drug to the body through an aperture. As a result, the elution time of drugs carried by the particles can be adjusted in the nano-manufacturing process, with is massively scalable. Additionally, there is no constraint to the type of drug, for example whether it is a biologic, chemical compound, siRNA molecule, or a viral vector.

Financial Overview

WMP has received more than $10 million in Federal and State funding to develop the strong magnetic drivers that are at the heart of the system, and is currently licensing some of its technology in fields unrelated to this application. Company is seeking additional $7 million from investors and/or foundations (to be partially matched by Federal funds) in order to build a human-head-sized prototype that could be used in clinical trials, establish particle safety, submit an IDE to the FDA, and conduct the clinical trial.

Intellectual Property

USA and foreign patents have been granted for the use of strong magnetic fields without bio-effects. As a result of this innovation, magnetic gradients can be used in vivo, that are orders of magnitude stronger and faster than in conventional MRI systems. Other foreign patents and patents of additional innovations are pending. Company has out-licensed the application of its high-field low bio-effect magnetic technology for dental diagnostic imaging, a field with no overlap to the proposed interventional application that is the basis of this presentation.

Commercialization Strategy

To date, WMP has taken a licensing approach in order to further develop its core technology. Those licenses relate to niche diagnostic applications of strong/fast MRI (e.g., dentistry). Our preference would be to work with selected investors and/or strategic partners in order to develop and validate the therapeutic system. To this end, we will work with selected luminary sites to validate the safety and efficacy of the magnetic delivery technology in a breakthrough clinical device indication with existing high reimbursements for competitive technologies (e.g., chronic sinusitis). Upon FDA premarket approval of this first indication, we will either sell the company to a major medical device company, license the particle technology to a drug company, or raise financing necessary for commercialization through an IPO.  Because of the large potential scope of the innovation, our preference would be to eventually go public.

Pipeline Products

The company has already demonstrated transport of drug-laden particles in rat brain, and will develop oncology and neurology products based on these particles. WMP’s proprietary particle designs could be adapted to deliver most drug and/or gene products. Considering that the current roles for gene and RNA therapy have historically been delivery-limited, we anticipate that the new interventional system could play a role in advancing applications of these products.

Management Team

·         President Irving Weinberg has been a serial medical device entrepreneur for 15 years. His designs that have helped over one million people with suspected or confirmed breast cancer, and have recently been acknowledged by manufacturers of medical imaging systems as addressing critical issues in the development of new high-field MRI systems. Dr. Weinberg is an experimental physicist and practicing radiologist who has worked at the Johns Hopkins Hospital, UCLA, and the National Institutes of Health. He has founded companies that have raised over $50 million, and initiated multi-center clinical trials. He will continue to lead the technical team, and assist in coordinating clinical trials.

·         Chief Physicist Pavel Stepanov MS has been responsible for instrumentation design and implementation for the 4 FDA-approved products introduced by Dr. Weinberg. He will supervise quality and design control for the project, and assist in preparation of the premarket approval application to the FDA.

·         Lead bioengineer Alek Nacev PhD has a doctorate in magnetic control, and has been key in demonstrating the capability to concentrate particles magnetically. He will manage the development of the coil, driver, and software.

·         Bioengineer Lamar Mair PhD has a doctorate and post-doctoral NIST work in nanoparticle fabrication, and is the designer of our nano-engineering processes. He will manage particle development and transfer of the technology to a GMP-qualified supplier.

·         Senior Biologist Mika Shimoji PhD has implemented preclinical studies of magnetic nanoparticles with GLP rigor. She will manage GLP-level animal studies.