Program areas at AMF
Implantable myoelectric sensor ii (infinity) + ossurthe initial imes collaboration was re-vitalized to commence Research and development work on a second generation of imes, imes infinity, which will contain advanced features based on patient feedback received from The imes i clinical trial. These features are intended to improve medical outcomes at no additional cost to The patient or healthcare system. The technology has been licensed to ossur and is in design transfer.status: additional analysis and development work was done to predict feasibility of The use of The device on lower limbs; The product was transferred to a commercial partner (ossur) including documentation of all elements of The upper limb product; build of initial clinical imes infinity units was started at amf; an evaluation of potential approaches to regulatory approval within The us and in europe was conducted.
New project developmentthis program covers (a) The monitoring and evaluation of several early stage advanced Research and development efforts underway that are directed at developing advanced technologies, project ideas and concepts before they are elevated to The status of full-fledged development programs, and (b) ongoing efforts related to The advancement of commercial development and protection of intellectual property of these projects across The development lifecycle. The team comprises The full range of expertise available at amf, including senior executive management, Research scientists and engineers, legal and intellectual property experts, business strategists and analysts.expenses may include ongoing participation in The development effort including Research and development support, collaboration management, service in management or on The board of directors of spinout entities, patent prosecution and The prosecution of infringement actions to protect The value of The intellectual property we create. In addition to payroll expenses and direct expenses paid to outside vendors for goods and services related to projects, expenses in this program may include patent prosecution expenses and fees, legal fees (for internal and outside legal counsel) for expenses to create, preserve and protect intellectual property from infringement and remedy past infringement, and incentive and other compensation payments to employees and others related to these programs and actions. In some cases, certain of these expenditures might be incurred long after The projects have been launched into spinout companies or licensed to third parties.revenues associated with these projects (some of which may accrue long after The project and any related program have been out-licensed or launched into a spinout company) may include recoveries of judgments or settlements from patent infringement litigation, royalties on net sales of licensed products, milestone payments, ongoing contract r&d from partners, licensees and spinout companies, interest, and proceeds of liquidity events (e.g., initial public offerings, acquisitions) involving retained equity interests in projects that have been spun out into startup companies.status:a thorough assessment of 22 potential new indications for a novel amf neuromodulation system was completed, including The development of a scoring metric to help prioritize potential projects; a business case analysis was completed for The three indications that emerged as The leading candidates in order to further prioritize; an extensive review of The intellectual property landscape for these indications was completed; assessment of approximately ten early-stage companies was conducted to determine if there was a potential collaboration fit with amf; a potential joint venture was explored in some depth. While The joint venture did not materialize, there remains a possibility that amf will license technology/ip from The other party; incentive compensation payments were issued to participants in two long-term incentive plans related to a) axonics, and b) cochlear litigation award received in 2020, resulting from The resolution of The patent infringement litigation relating to cochlear implant intellectual property owned by amf. Legal expenses continue to be accrued through The wrap-up phase of this litigation.
Obstructive sleep apnea amf is investigating The need for newer methods to treat osa (obstructive sleep apnea). Osa is an under-diagnosed and under-treated medical condition that has been linked to several serious co-morbidities, including heart disease. Current treatment options are poorly tolerated and when adopted, have low compliance rates. The aim of The amf program is to develop a neurostimulation system that will improve medical outcomes at a lower cost than currently available treatment options, while addressing The patient compliance issue. Such a product system will consist of a fully implantable neural stimulator sensor, closed loop system with seamless operation requiring minimal interaction from a patient, with The goal of offering a higher level of patient satisfaction, adoption, and compliance.status:a new mechanical design was developed and built into demo units; prototype electronics circuity for demonstration purposes has been developed and built into form factor units; demonstration software was developed using a tablet computer; planning, design, and development of The firstin-human implant and externals have been initiated and are well under way; several non-significant risk clinical studies are underway or completed, including a study at ucla, one conducted by harvey mudd college, and an internal volunteer study.