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Vivifi Medical

Company Contact:

Legal Entity Type: LLC

Company Type: Medical Device

Company Stage: Feasibility

No. of Employees: 3

Desired Financial Amount: $1.1 (Current Seed round)

Background

Company Background

Vivifi Medical was formed to develop and commercialize a comprehensive surgical solution for the treatment of varicoceles with superior outcomes and lower costs compared to existing methods of treatment. Company Origins | The concept for the proprietary product, Calexis-Lap System, came about through Vivifi’s investigation into the association between varicoceles and various male urological, androgenic, and reproductive disorders. Both co-founders, Dr. Sharma and Dr. Garbin, specialize in developing novel devices to address unmet clinical needs. Upon diving deeper into the science behind varicocele, it was apparent that there was a unique opportunity to help patients struggling with these disorders. Traction | Vivifi’s co-founders filed an initial provisional patent in 2019, followed by additional filings in 2020. Since then, Vivifi Medical has been rapidly moving the technology towards commercialization by: ● Designing proof-of-concept devices ● Refining and improving the deployment and stability of the prototype devices ● Adding to the Intellectual Property portfolio ● Recruiting strong panel of clinical and business advisors ● Validating the market and business model with physicians and other medtech entrepreneurs ● Establishing residency within Johnson & Johnson’s Center for Device Innovation

Management

Vivifi currently has three employees, and the company will bring on Matthew Kuhn (full-time) as the COO and Joanna Nathan (part-time) as an additional business advisor with the close of its Seed round ($1.1M). Our team includes experienced medtech executives in both startup and corporate settings as well as professional engineers with a wide range of experience from early-stage prototyping to large-scale manufacturing. Our team has been involved with the launch of several early-stage medical device companies, which have collectively raised over $100M in equity-based capital. Tushar Sharma, PhD | CEO: 10+ years of innovation and product development experience across academia, startups, and large corporations like J&J and Intel; PhD in Biomedical Engineering from University of Texas at Austin; Scientific Member of American Urology Association (AUA) Matthew Kuhn, MS | COO: 5+ years of medical device development, pre-clinical and clinical testing, and manufacturing and scaling experience at Ethicon and Siemens; 40+ US patents; Master’s in Bioengineering from Rice University Nicolo Garbin, PhD | CTO: 5+ years of medical device development and consulting, professional engineering, and manufacturing experience; PhD in Biomedical Engineering from Vanderbilt University Frida Montoya |R&D Engineer: Oversees the design and testing of prototypes and representative models; BS in Biomedical Engineering from the University of Texas at San Antonio Juan Pardo, PhD |Business & Tech Advisor: 5+ years of early stage medtech device development with Class II and III technologies; startup leadership experience; PhD in Biomedical Engineering from Washington University in St. Louis Joanna Nathan, MBA | Business Advisor: 10+ years of startup leadership and venture capital experience; Experience in medtech across product development, regulatory strategy, commercialization strategy and fundraising; MBA from Rice University

Board of directors

Vivifi does not have a formalized board of directors yet. However, the Advisory team is comprised of the following personnel: Dana Deardorff, PhD | J&J Impact Ventures; Managing Director, Johnson & Johnson CDI@TMC William E Cohn, MD | Cardiothoracic surgeon; Serial medtech entrepreneur with multiple acquisitions totaling >$1B Stan Rowe |Inventor of the TAVR (Trans aortic valve replacement) procedure and technology, with market cap of >$8B Clinical Advisors: Alex Pastuszak, MD, PhD | Assistant Professor, Urology, University of Utah; Chief Clinical Officer, Vault Health; Founder & CMO, Woven Health Nathan Starke, MD |(Chief Clinical Officer): Urologist & Andrologist, Methodist Urology Associates, Houston, TX; Co-Director, Men’s Health Center, Methodist Urology Associates; Assistant Professor, Houston Methodist Academic Institute; Assistant Professor, Weill-Cornell Medicine Steven Summers, MD | Assistant Professor, Urology, University of Utah; Urologist at Salt Lake City Veterans Administration Center; Leading clinician with highest number of laparoscopic and robotic treatments for large prostates

Product / Service

disease area / application

Urology Space – targeting Benign Prostate Hyperplasia as the beach head indication

product / Service

There are over 12M actively managed BPH patients in the US alone. Majority of them are approved for surgery. However, only ~300k surgeries are performed each year. All the existing treatment options only provide temporary symptomatic relief at the cost of relief-duration, pain and sexual functionality. The gold standard is a ‘roto-rooter’ procedure (TURP) that shaves urethral and prostatic tissue away, is associated with significant pain involved and 6 months of average recovery time. A better solution that addresses the root cause could have a transformative impact and have an expanded patient population. Multiple clinical studies have shown the BPH is caused due to venous valve failure that redirects testosterone-rich blood towards the prostate, and that decompression of the venous system leads to complete and natural reversal of BPH. Vivifi’s Laparoscopic device enables a superior version of procedure that is clinically proven to naturally reverse BPH, while simultaneously boosting testosterone levels and restoring pre-existing sexual dysfunctions – totaling penetrable market potential of >$20B. Vivifi Medical is building the first device that would allow connecting two blood vessels through a trocar port (minimally invasive surgery). Presently, the only way to connect two small (<5mm diameter) blood vessels through a port is to suture them together using a surgical robot. Our technology allows a quick & easy mechanical stapling of two vessels together and can be performed using a laparoscopic tool, making the procedure faster and affordable. As the trend is moving towards robotic and MIS, Vivifi's technology would be pivotal in minimizing surgery time by eliminating suturing for coupling two blood vessels together. Additionally, for patients of BPH, Vivifi's technology would offer a paradigm changing treatment. The patients would never have to come back for retreatment.

technology / ip

Our technology offers several differentiated advantages over competitive products, representing a highly attractive therapeutic solution for stakeholders in the BPH treatment market. Presently, performing a vascular anastomosis is a highly challenging procedure that requires both extensive surgical training as well as expensive medical equipment. Due to the lack of dedicated medical devices available, physicians performing this procedure are limited to inadequate, poorly suited surgical tools and non-standardized surgical techniques, resulting in longer procedure times, high patient costs, and poor treatment outcomes. Our technology automates what is currently a manual process, allowing for quick, easy, and reliable anastomosis with our disposable, minimally-invasive medical device solution. Vivifi Medical has filed a PCT provisional application US Application # 62940595 titled “Treatment of Blood Vessel Related Conditions” covering different methods and embodiments (devices) to perform vascular anastomosis – filed in Nov 2020 and will convert in May 2022. Two additional provisional patent applications were filed in Mar and Jul 2021. As a result of completely organic growth, all the Intellectual property is filed and owned by Vivifi Medical. These patents cover different methods and devices to perform vascular anastomosis for treatment of varicocele and varicocele-associated disorders such as benign prostate hyperplasia, prostate cancer, infertility, low testosterone, and pelvic congestion. Vivifi Medical has been working with a highly talented team of IP attorneys at Cooley, LLP. The team includes Scott Talbot, JD, who has over 30 years of experience in medtech intellectual property. Lastly, Vivifi has conducted a preliminary initial IP landscape search, and has reason to believe that Vivifi has freedom to operate within the space.

distribution channels

Vivifi plans to employ a distribution model to sell our device directly to large hospital institutions, private urology clinics, and fertility clinics. Our go-to-market strategy involves developing an internal sales force and engaging with established medical device distributors, which may include 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). Through initial discussions with stakeholders at the Houston Methodist hospital GPO, the company has gained a better understanding of the purchasing decision matrix and has received support from physician early-adopters to create the demand that would drive admission of product through the new product integration process.

market size

Total Addressable Market (US) = $20B+ 8.5M patients currently treated for BPH x $2500 ASP Our target patient population is men under medical treatment (7M men) or discontinued medication due to side effects (1.5M men) for BPH. We are pursuing BPH as our beach-head market because of a clear path to market, attractive reimbursement codes, and ease of clinician adoption. Once we have demonstrated clinical efficacy for BPH, we will pursue expansion of our technology into several additional male urological, reproductive, and androgenic disorders such as varicocele, male infertility, and hypogonadism (testosterone deficiency); each of which represent market opportunities of $1B+.

competition

Direct: Baxter (acquirer of the Synovis GEM Coupler) Indirect: Surgical robotic companies (Intuitive Surgical, Medtronic, J&J). Other: All major players in urology could become eventual competitors (Boston Scientific, Olympus, Karl Storz, Braun, and Cook Medical) The Synovis GEM Coupler is Vivifi’s main direct competitor. The GEM coupler is a handheld device that allows for microsurgical anastomosis of blood vessels and is commonly used by plastic surgeons in breast reconstruction surgeries. Synovis was acquired by Baxter in 2011 for $325M. The GEM coupler was only designed for use in open surgical procedures and cannot be used in minimally invasive procedures, and is therefore poorly suited for use in the field of surgical urology. Urologists most commonly treat BPH via minimally invasive laparoscopic or robotic procedures and would be eager adopters of an anastomotic coupler capable of laparoscopic deployment – Vivifi directly addresses this unmet need with our technology. We’ve identified significant applicability of our technology to the field of surgical robotics. Patient and physician access to surgical robotic systems has rapidly grown in the past few years, representing one of the fastest growing sectors of the healthcare market. Urologists tend to be early adopters of new medical device innovations, with more than 84% of urology clinics in the U.S. performing laparoscopic or robotic procedures. Vivifi plans on capitalizing on the opportunity to expand into the surgical robotics market by developing a robotic end-effector compatible design of our technology for use in robotic vascular anastomosis procedures. Therefore, companies that market laparoscopic surgical tools and robotic surgical systems – such as Medtronic, Intuitive Surgical, and Johnson & Johnson – are Vivifi’s indirect competitors. These competitors have some presence in the field of minimally invasive microvascular anastomosis via their associated surgical device products; however, none offer a dedicated BPH treatment solution.

Financials

Desired financial amount

$1.1 (Current Seed round)

previous funding

$256,000 (NSF SBIR Award) + $18,000 (Founders, competitions)

current financials

$83,000 available cash, $8,000/mo burn rate ~ 10mos runway.

financial use

Funds from seed round will be used for the following main milestones: Prototype refinement | Add features to enhance device functionality. Test and refine design through benchtop testing. Preclinical studies | Demonstrate the efficacy of Vivifi’s procedure and technology in reversing BPH through animal studies Team Building | Bringing in the talent that will allow Vivifi to hit all the critical milestones in time The seed round will significantly de-risk the company’s technology, clinical procedure and position the company to fundraise Series A for FIH studies.

revenue

Our preliminary analysis of the reimbursement landscape suggests the potential for coverage of our technology under existing CPT codes for venous anastomosis (CPT code: 37160), reimbursing customers up to $10,520 per procedure leaving a significant profit margin for purchasers, generating additional revenue for healthcare providing institutions and increasing compensation for urologists and other physician end-users. We will recruit a CMS consultant in 2023 to validate our reimbursement pathway with the eventual goal of getting our own CPT codes through clinical studies.

exit strategy

Because we are developing a novel medical device platform technology with strong therapeutic value and significant impact potential in many different patient populations across a spectrum of clinical specialties (including urology, cardiology, reproductive health, andrology, and oncology), Vivifi represents a diversified portfolio of potential products offerings, the creation of new revenue streams, and broadly-applicable IP that can be sold independently to strategic acquirers and other large medical device companies. We anticipate initial indication of our technology for the treatment of BPH followed by expansion into several additional male urological, reproductive, and androgenic disorders such as varicocele, male infertility, and hypogonadism (testosterone deficiency). Potential acquirers include large medical device companies with strategic focus on urologic disorders and/or laparoscopic surgery – specifically, our technology is well-suited for integration into the product portfolios of Medtronic, Boston Scientific, and Johnson & Johnson. Acquisition by a major strategic could take place anytime from initial clinical studies through market launch. While strategic acquisition will be our primary exit strategy, we will continue to scale our business with venture financing to expand our core team with experienced talent as well as accelerate commercialization to grow Vivifi into a successful commercial entity. Due to our technology’s user-friendly ergonomic design, low-cost, and potential for superior patient outcomes, we anticipate an eventual leading position in the BPH treatment market. We will explore an Initial Public Offering (IPO) as an alternate long-term exit strategy. With a potential pipeline of multiple disruptive medical device product revenue streams across several multi-billion dollar markets, a $1B+ acquisition of Vivifi by one of the market’s leading medical device companies is a strong possibility. Anticipated acquisition – 2025 $500M – $1B

Pitch Video

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