1 / 26

Medvantage International Inc.

Medvantage International Inc. Product Development Plan for the Vascular Coupling Device. Overview.

jasper-daniel
Download Presentation

Medvantage International Inc.

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Medvantage International Inc. Product Development Plan for the Vascular Coupling Device

  2. Overview Medvantage International Inc. has acquired the rights to engage in the final development phase and marketing of a new surgical device based on technology developed at the University of Utah Research Foundation that represents a practical alternative to existing manual suturing. Our coupler device is effective and user-friendly, with multiple procedure applications. The only competing device currently on the market is only partially effective and difficult and awkward to use for anastomosis. Medvantage will use its patent pending designs to fill the need in the market for an easier to use, more effective vascular coupling device.

  3. The Device Overview of the anastomosis process using Vascular Coupling Device (VCD): (A) Open status of the VCD. Four wings are attached to the base by plastic hinges and four stainless steel spikes can move back and forth (B) One end of the blood vessel is sent through the VCD and four spikes are pressed perpendicular through the vessel wall (C) Close status of the VCD. Four wings are rotated 90 degrees and the end of the blood vessel is stretched open. (D) Two blood vessels with VCDs are coupled with each other by inserting four spikes into the corresponding holes.

  4. USA and EU PATENTS Patent applications for the US and EU markets are submitted. The submission date was March 24, 2011 US- 2013/0204275 EU -11769684.9

  5. The Technology Traditional methods of using this type of surgical product call for arteries and veins to be sutured together using glue or staples. However, these techniques call for extreme caution when performing them in regards to microvascular surgery. The product that is currently being developed by the Company uses a clamping method that easily allows the surgeon to affix (through loopholes in the device) arteries or veins that can be attached to one another with a coupler. This system allows for less damage to the repaired tissue structures, enables the procedure to be completed in a fraction of the time and provides for a faster healing time for the patient. Additionally, the vascular coupling system and its couplers can be used in minimally invasive procedures.

  6. Expected Advantages • Versatile device that can be used for both arterial and venous repair or connection • Significantly reduces surgical time to complete the anastomosis • Minimizes human error and surgeon fatigue associated with manual suturing • Significantly reduces the amount of specialized training required to complete microvascular repair • Reduces the risk of thrombosis and thrombosis-related tissue or limb loss complications that are common with the hand-sewn technique

  7. The Market It is estimated that 340,000 microsurgery operations are performed in the US each year with a US market potential of $340M in 2011 Micro Vascular market was growing at 44% CAGR over 5 years . Medvantage is planning to capture 10% of this market in the first two years of operations.

  8. Continued DevelopmentFirst stage after acquiring the technology Medvantage International’s team will continue to perfect the design during the next few month, additional testing on animals and on cadavers is needed, additional prototype devices will be made, the prototype devices from a rapid prototype CNC company will be the testing models. The first stage of the acquisition is critical to the project, all of the final touches to the invention will be done during the period of 4-6 months. commence with component cost pricing, open a bid system for medical device manufacturers Within the period, pre FDA submittal preparation will be done. The estimated cost for the first stage is projected at $520,000

  9. FDA Process Introduction- classification of our product – Class II Pre submission review ………………………………………………………………………………………………………………………….$0.00 Biocompatibility testing………………………………………………………………………………………………………………..…$190,000 Preparation of a submittal package ……………………………………………………………………………………………….…$46,000 FDA consultant …………………………………………………………………………………………………………………………...$12,500 Log-in Procedures ……………………………………………………………………………………………………………………………..$4,400 Division Acceptance and Review – We identify predicate devices already cleared for sale in the US Reviewer Assignment FDA Requests for Additional Information Decision Letter Issued 510(k) Status Program The total process shall take 90-110 days with an associated cost of $ 253,000

  10. TIMELINE BELOW DEMONSTRATES OUR PROJECTIONS 510K Submission. ($2,750) Form #21CFR289. Determine what ISO standards and/or guidance documents apply. Predicate comparison study (Cannot be done with prototype). FDA has 90 days to approve or deny. January March April May June September FDA consultants prepare submission package. Within 30 days. ($12,500) Once approved, the manufacturing company registers device with FDA and pays about $2,000 per year. FDA responds within 30 days(usually less), and either okays device for submission or requests additional information. Manufacturing in place and unit is ready for sale, labeling done.

  11. Steps To FDA Approval

  12. Cuvaslar cost to FDA approval

  13. Marketing Plan Medvatage International will create effective market forces leading to cost savings that far exceed all other models. Healthcare Reform asks physicians and hospitals to align and develop innovative means to reduce cost while maintaining quality. Our goal at Medvantage is to be the leader in cost effectiveness in the vascular coupling category, passing our savings to Hospitals and Surgeons. Marketing Objectives

  14. Marketing Strategies

  15. Product Marketing • Management intends to develop an expansive sales and marketing literature package that will showcase the many benefits of using Medvantage’s Vascular Coupler Device. • Our device will be distributed through channels dominated by large distributors and strategic association with these players will be key to gaining acceptance in this market.  .

  16. Business and Consulting Team • Comprised of high level business executives. Additional executives will be added to the management team in the coming weeks. • FDA consultants with decades of experience to address and manage the regulatory path. • Medical consultants with extensive experience developing, manufacturing and commercializing medical technologies.

  17. Meet the Inventor Jay Agarwal, MD, is an assistant professor in the Department of Surgery, Division of Plastic Surgery, at the University of Utah School of Medicine and a Huntsman Cancer Institute investigator. His clinical interests include aesthetic plastic surgery, hand surgery, and reconstructive microsurgery with a focus on reconstruction of traumatic injuries and defects caused by cancer. He emphasizes using perforator flaps, a cutting-edge technique that uses the patient's own tissues to reconstruct the breast, head and neck, and extremities. Agarwal graduated from medical school at Case Western Reserve University in Cleveland, Ohio, and completed residency training in both general surgery and plastic surgery at the University of Chicago. After six years in Chicago, he went on to specialize in hand surgery and microvascular surgery at the Buncke Clinic in San Francisco.

  18. Tzvi Milshtein

  19. Chairman: Corey Park Mr. Park is a Certified Hedge Fund Professional (CHP), with additional (CHP) certifications at the highest level in Portfolio Analytics & Risk Management. He also attended the Notre Dame Mendoza College of Business (Leadership & Management) and has served in executive leadership positions for over 20 years. Mr. Park has closed several acquisitions and multimillion dollar lines of credit from hedge funds; as well as negotiated and / or closed many mergers, strategic partnerships, license agreements, CRADA’s and joint ventures. As a lifelong student of business strategy, he has read, studied and applied numerous books and countless articles relating to business strategy (According to the Wall Street Journal, the most sought after executive skill set is strategic thinking).

  20. EJ Smith of Smith & Associates, FDA ConsultantsSpecializing in Regulatory Affairs for FDA Compliance Since 1994, under the direction of E J Smith, President, Smith & Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, cosmetics, biologics and blood. We have recently added Drug Monograph consulting to our portfolio. Smith & Associates has extensive experience in all aspects of the regulatory processes of 510(k), 513(g), Pre-IDE, IDEs and PMA/BLA submissions. Our successes with 510(k)s, PMA, and IDEs, are summarized in our 510/IDE/PMA. Comprehensive list of projects and clients can be found at: FDACONSULTANTS.COM

  21. Dennis A. Repella, Ph.D. Dennis A. Repella, Ph.D. Smith & Associates November 2012 to Present: Smith & Associates, Crofton, Maryland, Associate for Technical Affairs. Responsibilities include coordination with clients and testing laboratories to perform specific tests in support of 510 (k), IDE, and PMA submissions to FDA. In concert with client requirements, review of Standard Operating Procedures, Chemical Testing Protocols, Process Validation Protocols, and Clinical Testing Protocols based on CLSI and ISO Standards for In Vitro Diagnostic device manufacturers. OTC Drug and Cosmetics label reviews. Perform QSR Audits and Gap Analysis. Represent clients at meetings with FDA staff. April 2007 to October 2012: Owner and President of Repella & Associates, Inc., a Nevada Corporation providing regulatory and technical consulting for the medical device industry. Coordination of testing and writing of reports, for 510 (k), IDE, and PMA submissions to FDA. Creation of Standard Operating Procedures, Chemical Testing Protocols, Process Validation Protocols, and Clinical Testing Protocols based on CLSI and ISO Standards for In Vitro Diagnostic device manufacturers. Perform QSR Audits and Gap Analysis. Represent clients at meetings with FDA staff. Preparation and submission of EPA pre-manufacturing notifications (PMN) and New Substance Notifications (NSN) for Health Canada.

  22. Bruce Conway, Ph. D CPG Consulting 125 Devonshire Lane Madison, CT 06443 203-779-5577 215-534-1806 (c) bconwayLLL@yahoo.com bruce@conwaypharmagrp.com  Accomplished, team-oriented leader with 17 years of experience in multiple areas of biotechnology and pharmaceutical discovery/early development research Extensive experience providing leadership and vision for the identification, evaluation, selection and vetting of novel opportunities and technologies (targets, compounds, biomarkers, secondary indications, screening platforms) Served as the principal scientific liaison with academic investigators, faculty inventors, and technology transfer personnel to facilitate university-based partnerships aimed at achieving proof-of-concept for novel targets Demonstrated ability to build alliances and find synergies among all stakeholders to successfully advance programs towards critical milestones Experience working with KOLs to define relevant translational endpoints and roadblocks to success Ability to inform and educate key scientific leaders on drug discovery/early development processes Experience working with senior colleagues to build-out the core competencies (therapeutic areas, screening platforms, facilities) of both small and large organizations Direct management experience for all non-chemistry line functions including in vitro Biology, Pharmacology, and DMPK Recruited and trained teams of experienced biologists and pharmacologists to expand core competencies within the organization Responsible for resourcing departmental needs and budgetary decisions as well as goal setting and performance reviews Proven ability to foster a team-oriented approach to problem solving while maintaining aggressive timelines across multiple projects, therapeutic areas and target classes Experience in the preparation and delivery of business development and investor relations presentations to Senior Management and potential partners Proven capability to manage scientific collaborations and external research programs with selected CROs. Created and organized the Peer Assist Program at Johnson and Johnson to mentor junior professionals Exceptional interpersonal skills and strong presentation skills Assumed a leadership role to assure the highest scientific rigor within both large and mid-size organizations

  23. Brad Mieners, Ph.D. 25 years at AstraZeneca pharmaceuticals in drug discovery and am currently retired.  I have a PhD in biochemistry.  During my tenure at AstraZeneca I became expert at the uses of Microsoft Excel and Microsoft Word in a scientific environment. Created complex templates, using array formulas and VBA as needed, for data reduction, data visualization, and statistical analysis.  As an information specialist I wrote similar programs for use across the corporation.  Furthermore, I created and taught numerous classes on the use of Excel both in person and as webinars. My technical writing skills were honed through the creation of many reports to management and papers for submission to scientific journals.Responsibilities:Right functional requirements documents for R&D computer systemsEvaluate and recommend changes in existing systems used by scientistsOffer first-line support for scientists with computer-related problemsEvaluate and recommend software and hardware for scientific applicationsCreate and maintain Excel-based programs for data reduction, data visualization, and statistical analysis of scientific dataCreate and teach courses on the scientific uses of excel in person and as well as webinars.

  24. Medical Distributors • Intuitive surgical • Alliance surgical distributors • Millennium surgical corp. • Accrington surgical • Henry Schein International

  25. Medvantage Legal Team Lance Brunson Laura Anthony, Esq. Alex Brito P.A. Steven Glueck P.A. Christopher Langen P.A. Frugal patents - Patent consultant Bay Area IP group- Patent attorney’s

  26. Conclusion Medvantage International is committed to the final development phase, as well as securing FDA approval for Dr. Agarwal’s Vascular Coupler Device. And, in turn commercialize this new technology that we believe will have an immense impact on how effectively surgeons are able to perform microvascular surgery.

More Related