BIOFEST INVEST APPLICANT

Vivifi Medical Inc

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  • What is the problem that your company will solve?

    Vivifi Medical’s vision is to eliminate the need for prostatectomies and hysterectomies. Common leading causes include BPH, Prostate Cancer, uterine fibroids, and endometriosis. All of these conditions are fueled by sex hormones such as testosterone and estrogen.
    By redirecting this hormone-rich blood away from the prostate and uterus, these conditions can be reversed. This is best achieved by vascular re-plumbing in the pelvic floor. And our laparoscopic technology enables just that through a small incision.
    We are starting off with BPH as our beachhead indication, an obtainable market of $1.9B in the US alone.

  • What is your solution and how does it solve the problem?

    BPH can be reversed by minimizing prostate’s exposure to localized testosterone. This is best achieved by redirecting testosterone-rich blood away from the prostate, thereby normalizing systemic testosterone, through replumbing of pelvic vasculature via vascular anastomosis. Our first-of-its-kind device enables sutureless-anastomosis through a small incision.

  • Describe any proof of concept or testing you have completed so far.

    Demonstrated in an animal study – leakproof anastomosis over 3 months and achieved a 53% reduction in prostate volume in canines with spontaneous BPH

  • Describe your market opportunity, i.e., size, competition.

    12M active BPH patients, 500k surgeries annually, with our device priced at $2,500, opens into a $3B market.
    Competitors: Baxter, Medtronic, Synovis
    Buyers: Hospitals and surgical centers with urologists or PE/Physician (Urologists) owned facilities.
    Users: Urologists. More specifically, Endourologists and General urologists performing robotic & Laparoscopic simple prostatectomies.

  • Describe your sales strategy, including reimbursement plan, sales channel (distributors, direct), location.

    Our go-to-market strategy involves developing an internal sales force and engaging with established medical device distributors, forming strategic partnerships with large medical device companies to leverage preexisting, mature distribution channels with hospital GPOs (General Purchasing Organizations) and VACs (Value Add Committees).
    Vivifi team includes influential well known and recognized Key opinion leaders in the field of Urology, who will be the champions and advocates for the adoption of our technology in settings such as large medical institutions and private care facilities. Vivifi’s steering committee of Clinical advisors will push for adoption through AUA guidelines & coding committee, dissemination of clinical results through premier conferences, communicating with regional medical directors & CMS, and training other urologists on the technology.

  • What is your regulatory strategy?

    510(k) clearance for Vascular Anastomosis, followed by De Novo study to expand the indication of use to BPH.

  • Describe your management team.

    Tushar Sharma
    CEO/Founder
    PhD – University of Texas at Austin
    10+ years of experience across MedTech startups & large corporations.

    Nathan Starke
    CMO (Chief Medical Officer)
    MD – Baylor College of Medicine
    Urologist, Houston Methodist Hospital
    Co-Director, Methodist Men’s Health Center.

    Steven Nguyen
    Head, R&D
    20+ years of experience taking laparoscopic technologies from concept through product launch

    Natnael Abraha
    R&D Engineer
    Biomedical Engg (UTSA), experienced medical device engineer

  • How much funding have you received since your company was founded and what types (grants, investors, friends/family, etc.)?

    $1.3M in grants
    $900k in investor funding
    Over $100k in in-kind services

  • Do you currently have an open round of funding? If yes, how much is the round, how much have you raised so far, and when will the round close?

    Oversubscribed Pre-Seed round (initial target $500k)
    Raised to date: $850k
    Looking to close by March 2024

  • How many pitch competitions have you entered in the last 12 months, and how many have you won?

    Startup Prize (won)
    BioKansas Innovation (won)
    M2D2 (won – lightning round)
    Biofest 2023 – Did not win

  • Check the box(es) for your IP situation (licensed or company-owned)
    Provisional patent pending Non-provisional patent pending
  • If patent applications, please list foundational patent application numbers and application dates

    1. Pending US 17/842,511 – IR and laparoscopic means to connect two vessels together
    2. Pending US 63/409,115 – Laparoscopic devices to connect two vessels through a port
    3. PCT/US22/21363 – Advanced laparoscopic device to connect two vessels through a port.

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